Establishment name,FDA registration number,FEI number,Street,City,State,Postal code,Country,Owner or operator,Owner or operator number,Establishment types,Device types listed,Product codes,Device names,Device classes,Brand names,First device listed,510(k) clearances,Latest clearance,PMA approvals,Recall events,Class I recall events,Registered through,Source
Medtronic Engineering and Innovation Center (MEIC),3018094310,3018094310,"BSR Tech Park Survey No.135, 138, 141 & 142 Nanakramguda Main Road",Hyderabad Telangana,,500032,India,"Medtronic, Inc.",2112641,Complaint file establishment,383,BSJ; BSK; BSR; BSY; BTG; BTI; BTO; BTQ; BTR; BTS; BTT; BWA; BYD; BYE; BYG; BZA; BZO; BZQ; BZT; CAE; CAH; CAI; CBI; CBK; CCK; CCW; DPS; DPZ; DQA; DRS; DSA; DTB; DTE; DWH; DWJ; DXH; DXJ; DXT; DXY; DXZ; DZE; EFQ; EOB; EOQ; EOX; EPP; EPW; EQJ; ERL; ESZ; ETA; ETB; ETD; ETN; EZW; EZX; FAJ; FBQ; FCG; FDX; FEB; FER; FET; FFT; FFX; FHM; FHO; FLL; FMF; FMH; FMI; FOX; FPD; FRG; FRN; FRQ; FSM; FST; FSZ; FTL; FTM; FTY; FYD; FZO; FZP; FZS; FZT; FZX; FZY; GAA; GAB; GAD; GAG; GAH; GAL; GAM; GAP; GAQ; GAR; GAT; GAW; GBX; GCI; GCJ; GCT; GDF; GDG; GDH; GDI; GDJ; GDO; GDT; GDW; GEA; GEF; GEI; GET; GEX; GEY; GFF; GWE; GWF; GWG; GWJ; GWM; GWQ; GXD; GXI; GXN; GXR; GXY; GXZ; GYK; GZB; GZF; HAO; HAW; HBB; HBC; HBE; HBG; HBI; HBL; HBO; HBQ; HCA; HCF; HDA; HET; HIG; HIH; HMX; HNW; HOZ; HRR; HRS; HRX; HSZ; HTC; HTD; HTE; HTF; HTJ; HTO; HTQ; HTR; HTS; HTW; HTX; HTZ; HWA; HWB; HWC; HWE; HWI; HWJ; HWK; HWM; HWN; HWR; HWT; HWX; HXB; HXC; HXD; HXG; HXK; HXL; HXP; HXQ; HXR; HXT; HXW; HXX; HXZ; IKD; IKN; IKT; ISN; ITX; IYE; IYN; IZD; JAA; JAC; JAK; JDI; JDK; JDN; JDQ; JDR; JDZ; JEY; JOH; JOL; JOS; JOW; JXG; JYM; JZF; KAH; KAM; KAR; KCN; KCT; KDD; KDG; KDW; KFK; KGS; KGX; KGZ; KHJ; KIH; KKX; KMA; KNS; KNT; KNW; KOA; KOD; KRE; KRG; KTZ; KWF; KWI; KWP; KWQ; KZD; LBM; LBN; LDF; LDZ; LFB; LFL; LGW; LJS; LJT; LKG; LKK; LLZ; LNH; LRC; LRE; LRK; LRN; LRP; LTB; LWH; LWP; LWS; LXB; LXH; LYA; LYC; LYS; MAI; MAJ; MAX; MBI; MBP; MBX; MCA; MDM; MFR; MHY; MJG; MJO; MJY; MMP; MNH; MNI; MNL; MPN; MPW; MQP; MQV; MRU; MRW; MTJ; MUD; MWI; MXD; NAB; NAM; NBH; NDN; NEK; NEU; NEY; NEZ; NHL; NIK; NKB; NKC; NKE; NKG; NLF; NNO; NOK; NOU; NPM; NPZ; NQO; NQP; NQR; NQW; NSI; NUN; NVN; NVR; NVY; NVZ; NWW; NYV; OAG; OCL; OCT; OCW; ODP; OJX; OLM; OLO; ONO; OQU; ORQ; OSH; OSR; OUG; OUR; OVD; OVE; OVN; OWB; OWI; OWN; OXC; OXJ; OXK; OXO; PCB; PGD; PGM; PGW; PID; PIE; PJS; PLR; PML; PNZ; PUI; QDF; QEM; QGI; QIH; QON; QPB; QPT; QQC; QRB; QSW; SCV; SGS,"Mask, Gas, Anesthetic; Cuff, Tracheal Tube, Inflatable; Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Brush, Biopsy, Bronchoscope (Non-Rigid); Compressor, Air, Portable; Tube, Tracheostomy (W/Wo Connector); Airway, Nasopharyngeal; Tube, Tracheal (W/Wo Connector); Tube, Bronchial (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Unit, Electrosurgical And Coagulation, With Accessories; Condenser, Heat And Moisture (Artificial Nose); Attachment, Breathing, Positive End Expiratory Pressure; Mask, Oxygen; Connector, Airway (Extension); Set, Tubing And Support, Ventilator (W Harness); Monitor, Breathing Frequency; Stethoscope, Esophageal, With Electrical Conductors; Airway, Oropharyngeal, Anesthesiology; Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector); Ventilator, Continuous, Facility Use; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Laryngoscope, Rigid; Electrocardiograph; Oximeter, Ear; Oximeter; Transducer, Blood-Pressure, Extravascular; Cable, Transducer And Electrode, Patient, (Including Connector); Permanent Pacemaker Electrode; Pulse-Generator, Pacemaker, External; Blade, Saw, Surgical, Cardiovascular; System, Thermal Regulating; Transmitters And Receivers, Electrocardiograph, Telephone; Display, Cathode-Ray Tube, Medical; Injector And Syringe, Angiographic; Implantable Pacemaker Pulse-Generator; Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene; Implant, Endosseous, Root-Form; Gauze/Sponge, Internal; Nasopharyngoscope (Flexible Or Rigid); Bronchoscope (Flexible Or Rigid); Esophagoscope (Flexible Or Rigid); Splint, Nasal; Support, Head, Surgical, Ent; Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Tube, Shunt, Endolymphatic; Replacement, Ossicular Prosthesis, Total; Prosthesis, Partial Ossicular Replacement; Tube, Tympanostomy; Stimulator, Nerve; Stimulator, Electrical, Implantable, For Incontinence; Mesh, Surgical, Metal; Cystoscope And Accessories, Flexible/Rigid; Trocar, Gastro-Urology; Biopsy Needle; Endoscopic Cytology Brush; Accessories, Cleaning, For Endoscope; Anoscope And Accessories; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Electrode, Ph, Stomach; System, Gastrointestinal Motility (Electrical); Apparatus, Suturing, Stomach And Intestinal; Pneumoperitoneum Needle; Continuous Measurement Thermometer; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Stand, Infusion; Tube, Feeding; Wrap, Sterilization; Pump, Infusion; Tube, Levine; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Light, Surgical, Carrier; Mesh, Surgical, Polymeric; Mesh, Surgical; Tape, Measuring, Rulers And Calipers; Apparatus, Exhaust, Surgical; Chisel, Surgical, Manual; Clip, Implantable; Curette, Surgical, General Use; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Retractor; Stapler, Surgical; Stylet, Surgical, General & Plastic Surgery; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Catheter, Irrigation; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Light Source, Endoscope, Xenon Arc; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Removable (Skin); Staple, Implantable; Cannula, Surgical, General & Plastic Surgery; Applier, Staple, Surgical,; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Pneumatic Powered; Powered Laser Surgical Instrument; Motor, Surgical Instrument, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Stimulator, Photic, Evoked Response; Stimulator, Electrical, Evoked Response; Endoscope, Neurological; Stimulator, Auditory, Evoked Response; Device, Monitoring, Intracranial Pressure; Full-Montage Standard Electroencephalograph; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Plate, Cranioplasty, Preformed, Non-Alterable; Cover, Burr Hole; Electrode, Cutaneous; Electrode, Needle; Instrument, Shunt System Implantation; Stimulator, Spinal-Cord, Implanted (Pain Relief); Stimulator, Peripheral Nerve, Implanted (Pain Relief); Instrument, Surgical, Non-Powered; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Motor, Drill, Electric; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Manual); Illuminator, Fiberoptic, Surgical Field; Holder, Head, Neurosurgical (Skull Clamp); Clip, Scalp; Instrument, Clip Removal; Catheter, Ventricular; Instrument, Ligature Passing And Knot Tying; Forceps, Obstetrical; Laparoscope, Gynecologic (And Accessories); Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Cannula, Ophthalmic; Dilator, Lachrymal; Sponge, Ophthalmic; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Arthroscope; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Reamer; Broach; Rasp; Knife, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Corkscrew; Awl; Trephine; Osteotome; Instrument, Compression; Driver, Prosthesis; Template; Tap, Bone; Probe; Wrench; Clamp; Tamp; Holder, Needle; Orthopedic; Mallet; Instrument, Bending Or Contouring; Crimper, Pin; Spatula, Orthopedic; Tape, Orthopedic; Bender; Screwdriver; Cutter, Wire; Cable, Electrode; Electromyograph, Diagnostic; Electrode, Needle, Diagnostic Electromyograph; Cable; Transducer, Ultrasonic, Diagnostic; Accelerator, Linear, Medical; System, Imaging, Pulsed Doppler, Ultrasonic; Probe, Uptake, Nuclear; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Film Marking, Radiographic; System, X-Ray, Tomography, Computed; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Cement Restrictor; Implant, Fixation Device, Spinal; Cerclage, Fixation; Staple, Fixation, Bone; Mixer, Cement, For Clinical Use; Plate, Bone; Tube Tracheostomy And Tube Cuff; Catheter And Tip, Suction; Electrode, Electrosurgical; Sleeve, Limb, Compressible; Shunt, Central Nervous System And Components; Inserter, Myringotomy Tube; Tube, Ear Suction; Microrule, Ent; Cannula, Sinus; Irrigator, Sinus; Ear Wick; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Chisel (Osteotome); Container, Specimen Mailer And Storage, Temperature Controlled, Sterile; Saw, Pneumatically Powered; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material); Dispenser, Cement; Drape, Surgical, Antimicrobial; Irrigator, Powered Nasal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Surgical Instruments, G-U, Manual (And Accessories); Catheter, Urological; Analyzer, Pacemaker Generator Function, Indirect; Programmer, Pacemaker; Caliper; Prosthesis, Finger, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Infusor, Pressure, For I.V. Bags; Porous Polyethylene Ossicular Replacement; Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene; Electrode, Pacemaker, Temporary; Fixative, Alcohol Containing; Button, Nasal Septal; Instrument, Ultrasonic Surgical; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Port & Catheter, Implanted, Subcutaneous, Intraventricular; Pump, Infusion, Implanted, Programmable; System, Image Processing, Radiological; System, Nuclear Magnetic Resonance Imaging; Instrument, Ent Manual Surgical; Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile; Device, Anti-Snoring; Wire, Surgical; Tray, Surgical; Cyclosporine Radioimmunoassay; Counter, Sponge, Surgical; Implantable Pulse Generator, Pacemaker (Non-Crt); Implantable Cardioverter Defibrillator (Non-Crt); Hearing Aid, Bone Conduction; Orthopedic Manual Surgical Instrument; Splint, Intranasal Septal; Bone Grafting Material, Synthetic; Bone Mill; Fastener, Fixation, Biodegradable, Soft Tissue; Catheter, Percutaneous, Intraspinal, Short Term; Intervertebral Fusion Device With Bone Graft, Lumbar; Fastener, Fixation, Nondegradable, Soft Tissue; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Stimulator, Thalamic, Epilepsy, Implanted; Tape, Surgical, Internal; Instrument, Manual, Surgical, General Use; Stimulator, Brain, Implanted, For Behavior Modification; Stimulator, Electrical, Implanted, For Parkinsonian Tremor; Device, Percutaneous, Biopsy; Prosthesis, Intervertebral Disc; Kit, Serological, Negative Control; Cover, Barrier, Protective; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Accessories, Cleaning Brushes, For Endoscope; Tissue Adhesive For The Topical Approximation Of Skin; Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; Implanted Subcortical Electrical Stimulator (Motor Disorders); System, Facet Screw Spinal Device; Wax, Bone; Oximeter, Tissue Saturation; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection); Gauze / Sponge,Nonresorbable For External Use; Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction; Marker, Radiographic, Implantable; System, Ablation, Microwave And Accessories; System, Imaging, Gastrointestinal, Wireless, Capsule; Stimulator, Electrical, Implanted, For Parkinsonian Symptoms; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D); Thoracolumbosacral Pedicle Screw System; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P); Posterior Cervical Screw System; Oximeter, Reprocessed; Jig, Piston Cutting, Ent, Non-Sterile; Material, External Aesthetic Restoration, No Adhesive; Continuous, Ventilator, Home Use; Bone Grafting Material, Animal Source; Bone Grafting Material, Dental, With Biologic Component; Prosthesis, Spinous Process Spacer/Plate; Posterior Metal/Polymer Spinal System, Fusion; Sealant, Dural; Orthosis, Spine, Plate, Laminoplasty, Metal; System, Imaging, Esophageal, Wireless, Capsule; Bone Grafting Material, Human Source; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes; Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar; Permanent Defibrillator Electrodes; Pulse Generator, Permanent, Implantable; Hysteroscope Accessories; Gastrointestinal Motility System, Capsule; Garment, Storage, Peritoneal Dialysis Catheter; Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Tissue Approximation Device; Intervertebral Fusion Device With Bone Graft, Cervical; Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode; Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd); Orthopedic Stereotaxic Instrument; Neurosurgical Laser With Mr Thermography; Airway Monitoring System; Mesh, Surgical, Deployer; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Pacemaker/Icd/Crt Non-Implanted Components; Medical Device Data System; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Suture Kit; Interventional Fluoroscopic X-Ray System; Bone Fixation Cerclage, Sublaminar; Confocal Optical Imaging; Mesh, Surgical, Absorbable, Staple Line Reinforcement; Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects; Mesh, Surgical, Collagen, Large Abdominal Wall Defects; Image-Intensified Fluoroscopic X-Ray System, Mobile; External Cerebrospinal Fluid (Csf) Diversion; Colon Capsule Imaging System; Growing Rod System; Ear, Nose, And Throat Stereotaxic Instrument; Esophageal Dilator Balloon With Or Without Electrode Sensors; Esophageal Dilator With Balloon And Electrode Sensors; Stimulator, Electrical, Implanted, For Essential Tremor; Spinal Vertebral Body Replacement Device - Cervical; Bone Cement, Posterior Screw Augmentation; Eustachian Tube Balloon Dilation Device; Drape, Surgical, Exempt; Parathyroid Autofluorescence Detection Device; Cerebral Oximeter; Air-Handling Apparatus Accessory; Automated Radiological Image Processing Software; Implanted Electrical Device Intended For Treatment Of Fecal Incontinence; System, Suction, Lipoplasty For Removal; Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence; Brain Stimulation Programming Planning Software.; Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy; Endoscopic Traction Device; Modular Electromechanical Surgical System; Deep Brain Stimulation For The Treatment Of Dystonia",1; 2; 3; U; f,", MOTORS; 01-00XX Series, Drape; 1 X 8 Test Stimulation Lead; 3875 1 X 8 Subcompact Lead; 4070 Temp Monitor; 87410 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (10mm); 87430 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (3 mm ); 87435 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (3.5 mm); 87440 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (4 mm); 87445 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (4.5 mm); 87450 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (5 mm); 87455 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (5.5 mm); 87460 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (6 mm); 87465 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (6.5 mm); 87470 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (7 mm); 87475 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (7.5 mm); 87480 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (8 mm); 87485 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (8.5 mm); 87490 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (9 mm); 87495 Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP (9.5 mm); ACPii Atlantis Cervial Plate; ACUCLIP; AEX Generator Refurbished; AFFINITY; ALAR Nasal Valve Stent; ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT; ANTERIOR CERVICAL PLATE SYSTEM; ANTI-FOG; AQUAMANTYS SS4 BIPOLAR SEALER, MODEL 23-121-1; ARCHITEX; ARES Antibiotic Impregnated Catheters; ARTHROSCOPE; ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology; AS Meniscal; ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS"" Anterior Cervical Plate System; ATLANTIS- Anterior Cervical Plate System; ATLAS; AURORA EV-ICD™ MRI SURESCAN™ SW041; AUSTIN ENDOLYMPH DISPERSMENT SHUNT; AUTO SUTURE ENDO CATCH SPECIMAN BAG; AUTOSUTURE ENDOSCOPIC CLAMP; AXIS Fixation; AbsorbaTack; AbsorbaTack 30x; Absorbatack; Access Review Therapy Controller; Access Therapy Controller; Accessories; AccuGuide Injection Monitor; AccuMesh; AccuView pH & pH-Z software; Accurian™; Activa Dystonia Therapy; Activa PC Neurostimulator; Activa Parkinsons Control Therapy; Activa RC Neurostimulator; Activa SC Neurostimulator; Activa Tremor Control Therapy; Activation Fixture; Adapter Cable; Adapters; Adaptix™ Interbody System with Titan nanoLock™ Surface Technology; Adaptor Extender Kit; Adaptor Kit; Adhesive; Adhesive Discs; Adult/Neonatal Adhesive Sensor Wrap < 3 kg > 40 kg; Air-handling apparatus accessory; Airvance; Airway Connector with Flex Tube; Alinity i HAVAb IgG Controls (LN 08P2710); Altaviva™ Clinician Kit; Altaviva™ Clinician Programmer Kit; Altaviva™ Neurostimulator; Altaviva™ Patient Programmer Kit; Amplia MRI CRT-D SureScan; Amplia MRI Quad CRT-D SureScan; Analyzer Adapter; Analyzer Cable; Anatomic Peek; Anatomic Peek PTC Cervical Fusion System Cage; Anatomic Peek- Cervical Fusion System; Anesthesia Face Mask; Ankle Band; Anteralign Spinal System with Titan nanolOCk; Anteralign™ Spinal System with Titan NanoLOCK™ Surface Technology Navigated Instruments; Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology; Anti-snoring device; Appose Skin Staplers; Aquamantys 2.3 Bipolar Sealer (23-113-1);; Aquamantys Epidural Vein Sealer (23-121-1); Aquamantys Mini EVS 3.4 Epidural Vein Sealer (23-314-1); Aquamantys SBS 5 Sheathed Bipolar Sealer (23-312-1); Arcpoint; Argon 3"" Flexible Electrode, E3530-3; Argon 6"" Flexible Electrode, E3530-6; Argyle Connecting Tube; Argyle Coude Suction Catheter with Chimney Valve; Argyle Frazier Sugical Suction Instrument; Argyle Graduated Suction Catheter Kit with Chimney Valve; Argyle Graduated Suction Catheter Tray with Chimney Valve; Argyle Graduated Suction Catheter with Chimney Valve; Argyle Poole Surgical Suction Set with Tubing; Argyle Rigid Yankauer; Argyle Sigmoid Sugical Suction Instrument; Argyle Sigmoid Surgical Suction Set; Argyle Suction Catheter Kit with Chimney Valve; Argyle Suction Catheter Tray with Chimney Valve; Argyle Suction Catheter with Chimney Valve; Argyle Suction Catheter with Straight Connector; Argyle Suction Tubing; Argyle Surgical Aspirator Tip; Argyle Thoracic Catheter; Argyle Thoracic PVC Catheter; Argyle Yankauer; Argyle Yankauer Bulb; ArthroPort; Arthroscopic Electrodes; Ascenda Catheter; Aspen; Aspiration Needles; Atlantis Translational Plate; Atlantis Vision Anterior Cervical; Atlas Cable; Atlas Cable System Ti; Attain; Attain Ability Lead; Attain Ability MRI SureScan Lead; Attain Ability Plus Lead; Attain Ability Plus MRI SureScan Lead; Attain Ability Straight Lead; Attain Ability Straight MRI SureScan Lead; Attain Bipolar OTW Lead; Attain OTW; Attain Performa Lead; Attain Performa MRI SureScan Lead; Attain Performa S Lead; Attain Performa S MRI SureScan Lead; Attain Performa Straight Lead; Attain Performa Straight MRI SureScan Lead; Attain Stability Quad MRI SureScan Lead; Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator; Auto Suture; Autosonix; BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM; BECKER EXTERNAL DRAINAGE/MONITOR SYSTEM LUMBAR CATHETER; BIOFLEK; BIPOLAR PENCIL; BIT DRILLS; BLUNTGRIP - SURGIGRIP; BNX Fine Needle Aspiration System; BONE HOOK; BONE MILL; BONE SCREW RULER; BONE TAP; BRIDGEMASTER SPLINT; BRYAN Cervical Disc; Bard-Parker; Barrierbac; Barrierbac S; Barrx 360 Express RFA Balloon Catheter; Barrx 360 RFA Balloon Catheter and Barrx RFA Cleaning Cap; Barrx 360 Soft Sizing Balloon; Barrx 60 RFA Focal Catheter; Barrx 90 RFA Focal Catheter; Barrx Anorectal RFA Wand; Barrx Channel RFA Endoscopic Catheter; Barrx Flex RFA Energy Generator; Barrx RFA Endoscopic Guidewire; Barrx RFA Self-Sizing Balloon Catheter; Barrx SB RFA Endoscopic Catheter; Barrx Ultra Long RFA Focal Catheter; Basis Vetebral Body Spacers; Beacon EUS Access System; Beacon Fine Needle Aspiration System; Beacon Fine Needle Fiducial System; Becker External Drainage and Monitoring System; BiZact Tonsillectomy Device Advance Bipolar Tissue Sealer/Divider, BZ4212A; BiZact"" Tonsillectomy Device Advanced Bipolar Tissue Sealer Divider; BiZact™ Open Sealer/Divider; Biosyn; Bipolar Footswitch; Bipolar Forceps; Bipolar Forceps Cord; Bipolar forcep; Blade Electrodes; Blunt Tip Trocars; Bluntport; Bone Cement HV-R w/Mixer - US; Bone Graft Washer; Bone Mill; Bone Wax; Bralon & Surgidac; Brava; Brava Quadripolar CRT-D; Bravo System; Bravo™ CF reflux recorder; Bravo™ Reflux Capsule with Delivery Device; BronchoCath with CPAP; C-Curve; CAPSTONE CONTROL PTC Spinal System; CAPSTONE CONTROL Spinal System; CAPSTONE PTC SPINAL SYSTEM; CAPSTONE PTC™ SPINAL SYSTEM; CAPSTONE Spinal System; CAPSTONE-L SPINAL SYSTEM; CATHETER, IRRIGATION; CATHETERS; CCD Spine System; CD 4.5 Crosslink Plates; CD 5.5mm Set Screws; CD Anterior Spinal System; CD Cannulated Screw; CD Central Rod; CD Cobalt Chrome; CD Eclipse Screws; CD Engage Cap; CD Engage Components; CD Engage Plate; CD Engage Y Parts; CD HA Coated; CD HORIZON; CD HORIZON ESSENCE; CD HORIZON ESSENTIALS™ Spinal System; CD HORIZON Fenestrated Screw Set; CD HORIZON Growth Rod Conversion Set; CD HORIZON Longitude 2 Instruments and Rods; CD HORIZON Multiaxial screw; CD HORIZON SEXTANT II Spinal System; CD HORIZON SOLERA SPINAL SYSTEM; CD HORIZON SOLERA Spinal System; CD HORIZON SOLERA""; CD HORIZON SPINAL SYSTEM; CD HORIZON SPIRE(TM) Z Spinal System; CD HORIZON Solera 5.5/6; CD HORIZON Spinal System; CD HORIZON Spinal System SDS Pre-Bent Rods; CD HORIZON Spinal System SOLERA; CD HORIZON Spinal System, CD HORIZON ESSENTIALS"" Spinal System; CD HORIZON Threaded Rods; CD HORIZON VOYAGER Extended Tab Screws; CD HORIZON VOYAGER""; CD HORIZON(R) Spinal System; CD HORIZONSPINAL SYSTEM; CD HORIZONSpinal System; CD HORIZON™ Spinal System; CD HORIZON® Fenestrated Screw Set; CD HORIZON® SOLERA® Spinal System; CD HORIZON® Spinal System; CD Horizan Eclipse M8 Screws; CD Horizan M8 Screws; CD Horizan Spinal Ti Spinal System; CD Horizon 3.2/4.5 Connectors; CD Horizon 3.5 Rods; CD Horizon 4.5 Cannulated Screws; CD Horizon 6.35 Crosslink Plates; CD Horizon Advanta; CD Horizon Antares Spinal System; CD Horizon Ballast"" Spinal System; CD Horizon Eclipse; CD Horizon Eclipse Screws; CD Horizon Ilio Sacral; CD Horizon Legacy 4.5; CD Horizon Legacy 6.35 Ti; CD Horizon M8 M10 Reduction Hooks; CD Horizon MAS Design Enhancement; CD Horizon Minor Mod; CD Horizon ModuLeX Spinal System - Degen Scoli Phase 2; CD Horizon Reduction; CD Horizon SMA Staple; CD Horizon Set Screws; CD Horizon Solera 5.5/6 Sagittal Adjusting Screws; CD Horizon Solera HA Screws; CD Horizon Spinal System; CD Horizon Spinal System ; CD Horizon Mazor Modulex Spinal System; CD Horizon Spinal System MAS; CD Horizon Spinous Plate; CD Horizon TAH Pedicle Hooks; CD Horizon Ti; CD Horizon- Spinal System; CD Horizon-Spinal System/ CD Horizon SOLERA; CD HorizonSpinal System; CD Horizon™ Astute™ Spinal System; CD Horizon™ ModuLeX™ FNS Screw Set; CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ LigaMAS Head Assm; CD Horizon™ ModuLeX™ Spinal System; CD Horizon™ Modular 5.5/6mm Spinal System; CD Horizon™ Spinal System; CD Horizon™ Spinal System and PASS LP™ Spinal System; CD Horizon® Spinal System; CD Ilio Sacral Screws; CD Instrumentation; CD LIBERTY POSTERIOR SPINCAL SYSTEM; CD M8 RMAS; CD Modified Set Screws; CD Modified Sextant II Instruments; CD Perc Trauma; CD Roller Burnished/Shot Peened Rod; CD Sextant II Reduction; CD Sextant Instruments; CD Spinal System; CD Spinal System for DDD TI; CD Spine Implants for DTT #3; CD Spire Spikes; CD Staples and Screws; CDH Legacy 5.5; CDH Solera 4.75; CEMENT; CHEMOSITE TUNNELER; CLIP GUN WITH RANEY TYPE SCALP CLIP; CLIP IMPLANTABLE; CLYDESDALE Spinal System; COLORADO 2 Spinal Sys 6.35 Rods and; COLORADO 2 Spinal System; COLORADO II Spinal System SS; COLORADO II Spinal System Ti; CONTACT EMG Rotatable Endotracheal Tube; CORKSCREW; CORNERSTONE PSR Cervical Fusion System; CORNERSTONEPSR Spinal System; CPAP; CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM; CRESCENT Vertebral Body Spacer; CRESCENT™ SPINAL SYSTEM; CRESCENT™ SPINAL SYSTEM TITANIUM; CRESENT Ti Spinal System; CROSSLINK Axial & CROSSLINK Offset; CROSSLINK Plate Non Grooved; CSF CARDIAC PERITONEAL CATHETER; CSF-CARDIAC/PERITONEAL CATHETER; CSF-FLOW CONTROL VALVE; CSF-FLOW CONTROL VALVE, ULTRA SMALL; CSF-VENTRICULAR CATHETER, STANDARD; CSF-VENTRICULOSTOMY RESERVOIR; Cannula; Introducer tool; CapSure Lead; CapSure Sense; CapSure Sense MRI SureScan Leads; CapSure Unipolar Lead; CapSure VDD-2 Lead; CapSureFix Lead; CapSureFix MRI SureScan Lead; CapSureFix Novus Leads; CapSureFix Novus MRI SureScan Leads; Caprosyn; Capstone Control; Capstone Control™ Spinal System; Capstone Spinal System; Capsure SP Novus; CardioSight Reader; CareLink Encore Programmer; CareLink Encore Programmer RF Head; CareLink Express Mobile System - Android; CareLink Express Mobile System - iOS; CareLink Express Monitor; CareLink Mobile Application; CareLink Network Software; CareLink Programmer RF Head; CareLink SmartSync Base 24970A; CareLink SmartSync Common Application iOS; CareLink SmartSync Host Application; CareLink SmartSync PSA Application; CareLink SmartSync Patient Connector 24967; CareLink SmartSync Percepta, Solera, Serena Application; CareLink SmartSync Platform Android; CareLink SmartSync Platform iOS; CareLink SmartSync Power Cord 249705; CareLink SmartSync Power Supply 249701; CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025; CareLink Wireless Network Adapter Card; Catalyft PL Expandable Interbody System; Catalyft™ LS Expandable Interbody System; Catalyft™ PL Expandable Interbody System; Cement Restrictor; Cement Restrictor Material Peek; Centerpiece Plate Fixation System; Chemosite; Chisel, Surgical, Manual; Circuit, breathing (w connector, adaptor, y piece); Claria MRI CRT-D; Claria MRI Quad CRT-D; Clearify; Clearify Trocar Wipe; Clearview Surgical Dissecting Tools; Clip Applier; Clydesdale Spinal System; Clydesdale- Spinal System; Coated Electrodes; Coaxial; Cobalt DR MRI Surescan; Cobalt HF CRT-D MRI SureScan; Cobalt HF Quad CRT-D MRI SureScan; Cobalt VR MRI Surescan; Cobalt XT DR MRI Surescan; Cobalt XT HF CRT-D MRI SureScan; Cobalt XT HF Quad CRT-D MRI SureScan; Cobalt XT VR MRI Surescan; Communicator; Compia MRI CRT-D SureScan; Compia MRI Quad CRT-D SureScan; Compressor; Compressor, air, portable; Concerto ICD; Concerto II CRT-D; ConcordeMultifire Premium skin stapler; Consulta CRT-P; Consulta DF4 ICD; Consulta ICD; Container; Continuous, ventilator, home use; Cool Tip E-Series; Cool-Tip Generator; Cool-Tip RF System; Cool-Tip Switching Controller, CTSW; Cool-tip; Cool-tip RF Ablation System E Series; Cooling Tubing Sets; Cornerstone PSR; Cotrel-Dubousset Spinal System; Covidien; Covidien AccuVac smoke attachment extender; Covidien Nellcor™ Adult Respiratory Sensor; CovidienNellcor™ Respiration Rate Software, Version 1; Covidien™ Edge™ Footswitching Pencil Blade Electrode, Holster, E3250H; Covidien™ Edge™ Footswitching Pencil Blade Electrode, Holster, E3250HNSB; Covidien™ Valleylab™ Argon Handset, E3520H; Covidien™ Valleylab™ Footswitching Pencil Holster, E3504H; Covidien™ Valleylab™ Footswitching Pencil Holster, E3504NSB; Covidien™ Valleylab™ Footswitching Pencil, E3504; Covidien™ Valleylab™ Laparoscopic Smoke Evacuation System, Active, Passive, SEL7010; Covidien™ Valleylab™ Monopolar Cord, E10503; Cranial/Ortho/Neuro Elec Drill Sys; Crescent; Crescent Spinal System Interbody F; Crome DR MRI Surescan; Crome HF CRT-D MRI SureScan; Crome HF Quad CRT-D MRI SureScan; Crome VR MRI Surescan; Curette; Current Monitor E3350; Current Monitor E3351; CytoRich Red; Cytosponge; DBS Extension Kit; DBS Therapy for Dystonia; DBS Tunneling tool; DC compressor; DF-1 Port Pin Plug; DG Surgilene Suture; DIVERGENCE Anterior Cervical Fusion System; DIVERGENCE(TM) Anterior Cervical Fusion System; DIVERGENCE-L"" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM; DR3; DRILL BIT (ORTHOPEDIC MA; DRILL GUIDES; DRILLS; DUET; DUET EDMS; DUET External Drainage And Monitoring System; DUET with Tri-Staple; Danek Infant System; Danek Plate and Screw System; Danek Precision Rod Set; Danek Sacral Hook; Danek Unit Rod; DanekScope Micro-Endo Systems; Dermalon & Surgilon; Detection Consoles, 01-0030, 01-0034, 01-0043, 01-0027, and 01-0029; Detection Scanners, 01-0044, 01-0046, 01-0035, 01-0023, 01-0031, and 01-0049, 02-0029R; Dexon; Dextile™ Anatomical Mesh; Digitrapper pH Z; Discovery Link MDDS; DiscoveryLink MDDS; Disp. Dome; Disposable Balloons; Divider One-step Sealing, Nano-coated (LF1930T); Donaldson; Doubletime Trocar; Drill; Introducer Tool; Duatene™ Bilayer Mesh; Duet EDMS; Duet External Drainage and Monitoring System (EDMS); DuraSeal Spine; Duraseal; Dyan-Lok Anterior Posterior Plating; Dyna-Lok Classic; Dyna-Lok PLUS Spinal System; Dyna-Lok Plate and Screw; Dyna-Lok Rods Bolts Connectors; Dyna-Lok Ti Spinal System; Dyna-lok/Danek Plate Screw; Dynamic Compression Shape Memory; E3770-36, Valleylab™ Laparoscopic Straight Spatula Electrode, Solid, 36cm; E3770-36C, CleanCoat™ Laparoscopic Straight Spatula Electrode Coated, 36cm; E3771-36, Valleylab™ Laparoscopic Curved Spatula Electrode, Solid, 36cm; E3771-36C, CleanCoat™ Laparoscopic Curved Spatula Electrode, Coated, 36cm; E3771-45, Valleylab™ Laparoscopic Curved Spatula Electrode, Solid, 45cm; E3771-45C, CleanCoat™ Laparoscopic Curved Spatula Electrode, Coated, 45cm; E3772-36, Valleylab™ Laparoscopic Wire J-Hook Electrode, Solid, 36cm; E3772-36C, CleanCoat™ Laparoscopic Wire J-Hook Electrode, Coated, 36cm; E3773-36, Valleylab™ Laparoscopic Wire L-Hook Electrode, Solid, 36cm; E3773-36C, CleanCoat™ Laparoscopic Wire L-Hook Electrode Coated, 36cm; E3773-45, Valleylab™ Laparoscopic Wire L-Hook Electrode, Solid, 45cm; E3773-45C, CleanCoat™ Laparoscopic Wire L-Hook Electrode , Coated, 45cm; E3774-36, Valleylab™ Laparoscopic Flat L-Hook Electrode, Solid, 36cm; E3774-36C, CleanCoat™ Laparoscopic Flat L-Hook Electrode, Coated, 36cm; E3774-45, Valleylab™ Laparoscopic Flat L-Hook Electrode, Solid, 45cm; E3774-45C, CleanCoat™ Laparoscopic Flat L-Hook Electrode, Coated, 45cm; ECG Cable; ECG Output Adapter; ECG Port Plug; EEA Circular Stapler with Tri-Staple Technology; EEA DLU; EEA Hemorrhoid stapler and Accessor; EEA OrVil; EEA Stapler; EEA Surgical Stapler; EEA TAID; EEA'M Circular Stapler with Tri-Staple"" Technology; EEA™ Circular Stapler with Tri-Staple™ Technology; EGIA AVM; EGIA Radial Reload; EGIA Tristaple Reloads; EGIA Ultra Black; EGIA Ultra Stapler; ELEVATE"" Spinal System; ELEVATE™ SPINAL SYSTEM; ELEVATOR; EM ENT Navigated Suction; ENDO BAG; ENDO CATCH; ENDO CLOSE; ENDO GIA ROTICULATOR Staplers; ENDO LUNG; ENDO MINI-RETRACT; ENDO MINI-SHEARS; ENDO PADDLE RETRACT; ENDO PEANUT; ENDO SHEARS; ENDO SLIDE; ENDO STITCH; ENDO TA; ENDOSCOPE CONSOLE; ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD; ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT; ENDOSKELETON TC; ENDOSKELETON TO; ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD); ENDOSKELETON(R) TAS; ENDOSKELETON(R) TL INTERBODY FUSION DEVICE; ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL; ENDOSKELETON® TA nanoLOCK® Surface Technology; ENDOSKELETON® TL; ENDURAGen™ Collagen Implant; ENT Drill & Handpiece, elec & pneu; ENT); EPG Cover; ES-310; ES-320; ES-330; EZ Anchor; Edge Blade Electrode, (3” (, 7.62 cm), E1450G and E1450GNSB; Edge Blade Electrode, (4"", (10.16 cm), E1450-NSB; Edge Blade Electrode, (6.5"" (, 16.51 cm), E1450-6 and E1450-6NSB; Edge Coated Blade Extended Electrode, ( 4"" , (10.16 cm), E1450-4; Edge Hex-locking Blade Electrode, (2.5” (, 6.35 cm), E1450X and E1450XNSB; Edge Insulated Blade Electrode, (2.75"", (7 cm), E1455; Edge Insulated Blade Electrode, (4"", (10.16 cm), E1455-4 and E1455-4NSB; Edge Insulated Blade Electrode, (6.5"", (16.51 cm), E1455-6 and E1455-6NSB; Edge Insulated Blade Electrode, Safety Sleeve (2.75"", (7 cm), E1455NSB; Edge Insulated Blade Electrode, Safety Sleeve, (2.75"" (, 7 cm), E1455B; Edge Insulated Blade Electrode, Safety Sleeve, (2.75"", (7 cm), E1455BNSB; Edge Insulated Blade Electrode, Safety Sleeve, (4"" (, 10.16 cm), E1455B4; Edge Insulated Blade Electrode, Safety Sleeve, (4"", (10.16 cm), E1455B-4NSB; Edge Insulated Needle Electrode, (2.8"", (7.2 cm), E1465; Edge Insulated Needle Electrode, (2.8"", (7.2 cm), E1465NSB; Edge Insulated Needle Electrode, 6.5"" (16.51 cm), E1465-6; Edge Insulated Needle Electrode, Safety Sleeve, (2.8"", (7.2 cm), E1465B and E1465BNSB; Edge Insulated Needle Electrode, Safety Sleeve, (4"", (10.16 cm), E1465B-4; Edge Needle Electrode, (2.8"" (, 7.2 cm), E1452; Edge Needle Electrode, (2.8"", (7.2 cm), E1452NSB; Edge Needle Electrode, (6.5"" (, 16.51 cm), E1452-6; Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDBNSB; Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HGNSB; Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450H; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HDBNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HGNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2450HS; Edge™ Insulated Blade Electrode, E1455G; Edge™ Pencil Blade Electrode, Holster, E2250H; Edge™ Pencil Blade Electrode, Holster, E2250HNSB; Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350H; Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350HDB; Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HS; Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HSNSB; Electrode; Electrodes; Emprint Ablation System with Thermosphere Technology; Emprint Microwave Ablation System- CAMSYS; Emprint Procedure Planning Application CAMPA; Emprint Procedure Planning Application CAMPP; Emprint Procedure Planning Application CAMPV; Emprint SX Ablation Platform (CASYS100); Emprint SX Field Generator Spacers (Bed Pads) (CAFGSP1); Emprint SX Laparoscopic Ultrasound Tracking Sensor (CAAL9150L); Emprint SX Laparoscopic Ultrasound Tracking Sensor (CABK8666L); Emprint SX Long Navigation Antenna with Thermosphere Technology (CA30L3N); Emprint SX Open Ultrasound Tracking Sensor (CAAL9132); Emprint SX Open Ultrasound Tracking Sensor (CABK8816); Emprint SX Short Navigation Antenna with Thermosphere Technology (CA15L2N); Emprint SX Table Top Field Generator (CAFG1); Emprint SX Table Top Field Generator Cart (CAFGCART1); Emprint SX Ultrasound Surgical Navigation (software) Application (CAUS1SN); Emprint Standard Navigation Antenna with Thermosphere Technology (CA20L2N); Emprint"" Reinforced Long Percutaneous Antenna with Thermosphere"" Technology, CA30L2; Emprint"" Reinforced Short Percutaneous Antenna with Thermosphere"" Technology, CA15L2; Emprint"" Reinforced Standard Percutaneous Antenna with Thermosphere"" Technology, CA20L2; Emprint™ Ablation Visualization Application, CAVA; EnTrust ICD; Endo Clip III; Endo Clip MultApplier; Endo Clip lll; Endo GIA Extra Long Adapter; Endo GIA Pancreas Indication; Endo GIA Reinforced Reload Tristaple Technology; Endo GIA Reload; Endo Lube; Endo Universal 65; Endo-Scrub 2 Lens Cleaning System;Endo-Scrub 2 Lens Cleaning Sheaths; EndoFlip Catheter; EndoFlip System; EndoSaph Vein Harvest System; Endoscopic Devices; Endoscopy System; Endoscrub; Endosheath System; Endosheath system; Endoskeleton TAS Plate; Endoskeleton TCS Interbody Fusion Device; Endoskeleton TCS System; Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device; Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device; Endoskeleton(R) TCS System; Endoskeleton® TAS Hyperlordotic Interbody Fusion Device And Endoskeleton® TCS Interbody Fusion Device; Endoskeleton® TAS Interbody Fusion Device; Endoskeleton® TO; Epsila EV™ MRI SureScan™ extravascular lead; Epsila EV™ Sternal Tunneling Tool; Epsila EV™ Transverse Tunneling Tool; Equation Fixation System; EsoFLIP; EsoFlip Catheter; Esoph. Steth w/Temp Sens/Gastric Su; Evera; Evera MRI S DR SureScan; Evera MRI S VR; Evera MRI XT DR SureScan; Evera MRI XT VR SureScan; Evera S DR; Evera S VR; Evera XT DR; Evera XT VR; Exacta External Drainage and Monitoring System (EDMS); Expandable Cage; Extended Tip Applicator; External Pacemaker Pulse Generator; External Pulse Generator; Extra View Sterile Balloons; Ez-Tack; FLEXON TEMPORARY CARDIAC PACER LEAD; FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM; FORCEPS (MANUAL INSTRU; FRED; FUSION Compact Navigation System; Falcon; Feathertouch XPS; Feeding Tube; Fiberoptic; Filter, bacterial, breathing-circuit; Fisch; Fisch Modified Total; Fisch Spandrel II Total with Shoe; Fitting Software; Flexlife; Flip Topography Module; Foley-Temp; Foot Control; Footswitch- RFASW; & Remote Temperature Probe- RTP20; Footswitches; Force Argon II System; Force EZ; Force FX; Force FX™ Electrosurgical Generator 8C, Force FX-8C; Force FX™ Electrosurgical Generator 8CAS Autobipolar, Force FX-8CAS; Force FX™ Electrosurgical Generator 8CS, Force FX-8CS; Force GSU TM Handset; Force GSU TM System; Force TriVerse; Force TriVerse™ Electrosurgical Device Holster 10' (3 m), FT3000; Force TriVerse™ Electrosurgical Device Holster 15' (4.6 m), FT300DB; ForceTriad Bipolar Resection Activation Kit; ForceTriad Electrosurgical Generato; ForceTriad Electrosurgical Generator; ForceTriad Three pedal footswitch; ForceTriad™ Bipolar Resection Activation Kit, FTBRKIT; ForceTriad™ Bipolar Resection Cord Stroz™, Reusable, 15' (4.6m), FT0021S; ForceTriad™ Bipolar Resection Cord Wolf, Reusable, 15' (4.6m), FT0022W; ForceTriad™ Monopolar Cord 15' (4.6 m), FT0510; ForceTriad™ Remote Control Activation Kit, FTRCKIT; Fuse Spinal System; Fuse Spinal System/ PLIF Titanium Cage; GDLH Posterior Spinal System; GE ApexPro CH SpO2 - Nellcor Cable; GE ApexPro FH SpO2 - Nellcor Cable; GIA PREMIUM; GIATM Stapler with Tri-StapleTM Technology; GIA™ Auto Suture™ Stapler with DST Series™ Technology, GIA™ Auto Suture™; GIA™ Stapler with Tri-Staple™ Technology; GRIP CLIP - CLIP; GUIDE WIRES (PINS); Galaky Spinal system; Gas/Pres Monit ET Conn/Adop; GastriSail™ Gastric Positioning System; Gastrisail; GenCut Core Biopsy System; General Instrument; General Instruments; General Non-Sterile Surgical Inst; GoldenEye Micro-Magnetic Tracking; Goode T-Tube; Grafton DBM; Grafton II eDBM; Guedel Airway; Guide Pin; Introducer Tool; Gut; Gut Suture; Gynecology Instrument Tray; HALO360+ Ablation Catheter and HALO Cap; HALO360+ Sizing Balloon; HALO60 Ablation Catheter; HALO90 Ablation Catheter; HALO90 System; HALO90 ULTRA Ablation Catheter; HALOFLEX Energy Generator; HET Temperature Monitor, HET Bipolar Forceps, HET Reusable Cable; HET™ Bipolar System; HME for Tracheostomized Patients; HOLDER NEEDLE; HOLDER, NEEDLE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE); HV-R Bone Cement US; HYSTEREOSCOPY PUMP HM4; Handswitching electrode; Helix Drill; Hi-Lo Evac & Evac II ET Tubes; Hi-Lo Temp Esophageal Steth.; Hi-Lo Temp Gen. Purpose Temp Probe; Hi-Pro Programming Cable; High Frequency Electrosurgical Gene; High Pressure Flex ConnectingTubing; HourGlass Vertebral Body Spacer; Hugo™ Robotically Assisted Surgery (RAS) System; Hunsake Mon-jet Ventilation Tube; Hybrobac S; Hydrosorb CR; Hygrobaby; Hygrobac; Hygroboy; Hygrolife; Hygroster; IB3D™ PL Spinal System; ICAL INST); ILA GIA Staplers; ILA, EEA, LDS reusable staplers; ILAN; ILLUMISITE Bronchoscope Adapter Fujinon; ILLUMISITE Bronchoscope Adapter Olympus; ILLUMISITE Bronchoscope Adapter Olympus 190; ILLUMISITE Bronchoscope Adapter Pentax; ILLUMISITE Console; ILLUMISITE Endobronchial Procedure Kit 180 Catheter; ILLUMISITE Endobronchial Procedure Kit 45 Catheter; ILLUMISITE Endobronchial Procedure Kit 90 Catheter; ILLUMISITE Patient Sensor Patch; IMPIX 3D Print; IMPIX ALIF S/A; IMPIX MANTA CERVICAL INTERBODY DEVICE; INFINITY™ OCT System; INFUSE BONEGRAFT Tibial Fracture; INFUSE BONEGRAFT/ LT-CAGE Lumbar TF; INFUSE BONGRAFT for Oral Max; INNERVISION CATHETER; INSTRUMENT, PROSTHESIS; INTERFIX Device (TIBFD); INTRACRANIAL PRESSURING MONITORING SYSTEM; INVOS™ Cerebral/Somatic Oximeter Sys: 5100C; INVOS™ Infant Regional Saturation Sensor; INVOS™ PM7100 Patient Monitor; INVOS™ PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor; INVOS™ rSO2 Micro-module (PMC71VP-GE); IO+ Port; IPC - Integrated Power Console Drill System; IPI ALGO-LINE CATHETER; IRRIGATION SYSTEM; IS-1 Port Pin Plug Kit; Immerge Image Correlation V2; InReach System; Inceptiv™ Implantable Neurostimulator; Inceptiv™ LT Implantable Neurostimulator; Includes Generator- CAGEN1; Percutaneous Antenna- CA15L1, CA20L1, CA30L1; Pump- CAPUMP1; Reusable Cable- CA190RC1; Indermil; Indura 1P Catheter; Infinity™ OCT System And PASS OCT Spinal System; Inflate FX Fracture Management Inflatable Bone Tamp; InflateFX; Injex BiWing Anchor; Injex Bumpy Anchor; Inserter, Myringotomy Tube; Instrument Command Library (ICL)Device Command Library (DCL); Insync; Integrated Diagnostics Data Calculation Module Model 5242; Integrated Power Console; Intellis™ Pro Implantable Neurostimulator; Intellis™ with AdaptiveStim™ Implantable Neurostimulator; InterStim II Neurostimulator; InterStim II Sacral Nerve Stim; InterStim Micro™ Implantable Neurostimulator; InterStim Neurostimulator; InterStim Sacral Nerve Stimulation; InterStim Therapy System; InterStim iCon Patient Programmer; InterStim iCon Programmer; InterStim™ SureScan™ MRI leads; InterStim™ X Implantable Neurostimulator; Intercept™; Intrinsic ICD; Irrigation Tubing Sets; Irrigator, Sinus; IsoMed Infusion Pump Refill; Itrel 4 Neurostimulation System; Itrel 4 Neurostimulator; Itrel EZ Programmer; Juhn Tym-Tap Middle Ear Fluid Aspirator/Collector; KYPHON Cement Delivery System; KYPHON ELEMENT"" Inflatable Bone Tamp; Kendall DL 11 Pin Adapter; Kendall DL 12 Pin Adapter; Kendall DL 17 Pin Adapter; Kendall DL 6 Pin Adapter; Kendall DL 8 Pin Adapter; Kendall DL Adapter; Kendall DL Disposable Cable; Kendall DL Disposable Cable and Lead System; Kendall DL Disposable Cable and Lead Wire System; Kendall DL Disposable Chest Lead Set; Kendall DL Disposable Chest Leads; Kendall DL Disposable Direct Connect; Kendall DL Disposable Lead; Kendall DL Disposable Lead System; Kendall SCD Controller Tubing Assembly; Kendall SCD Controller Tubing Extension Assembly; Kendall SCD Express Foot Cuff; Kendall SCD Express Sequential Compression System; KyphX 11 Gauge Bone Access Needle; KyphX Bone Biopsy Device; KyphX Bone Filler Device; KyphX Handle; Introducer; KyphX Latitude Curette; KyphX Osteointroducer; Kyphon; Kyphon Anchor Facet Screw System; Kyphon Exact Inflatable Bone Tamp; Kyphon Express Inflatable Bone Tamp; Kyphon HV-R Fenestrated Screw Cement; Kyphon Inflation Syringe; Kyphon Mixer; Kyphon VuE Bone Cement and Kyphon Mixer Pack; Kyphon Xpander II Inflatable Bone Tamp; Kyphon Xpede Bone Cement; LAA Selection Guide; LAMINOPLASTY; LAMP-C; LASER-FLEX™ TRACHEAL TUBE (CUFFED); LEGEND Power Adapter; LIGAPASS; LIGASURE MARYLAND; LT CAGE PEEK; LXMJ23L - LigaSure™ XP Maryland Jaw Sealer/Divider, Open, Latching Handle, Nano-Coated, 5 mm - 23 cm; LXMJ23S - LigaSure™ XP Maryland Jaw Sealer/Divider, Open, One-Step Sealing, Nano-Coated, 5 mm - 23 cm; LXMJ37L - LigaSure™ XP Maryland Jaw Sealer/Divider, Laparoscopic, Latching Handle, Nano-Coated, 5 mm - 37 cm; LXMJ37S - LigaSure™ XP Maryland Jaw Sealer/Divider, Laparoscopic, One-Step Sealing, Nano-Coated, 5 mm - 37 cm; LXMJ44L - LigaSure™ XP Maryland Jaw Sealer/Divider, Laparoscopic, Latching Handle, Nano-Coated, 5 mm - 44 cm; LXMJ44S - LigaSure™ XP Maryland Jaw Sealer/Divider, Laparoscopic, One-Step Sealing, Nano-Coated, 5 mm - 44 cm; Laparascopic Electrodes w/Retractab; Laparoscope; Laparoscopic Cord; Laparoscopic Handswitch/Electrodes; Lapro-Clip; Laproclip; Laproclip remover; LaserFlex; Lead Analyzer; Lead Introducer; Lead anchoring Sleeve; Lectrobrasive(R) E2401",1978-02-15,1316,2026-04-21,30,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223018094310%22&limit=1
Exel Inc. Dba DHL Supply Chain (usa),3008868758,3008868758,9440 South State Road 39 Suite 200,Mooresville,IN,46158,United States,Exel Inc. dba DHL Supply Chain (USA),10026656,Repackager or relabeler,131,DZI; DZJ; DZL; EOB; ERL; ETN; EZX; FCW; FMF; FQP; FSQ; FTM; FXP; FYE; GAM; GAQ; GAS; GAT; GCJ; GEI; GFA; GFF; GWO; GXN; GXP; GXR; GZT; HAW; HBB; HBE; HBG; HBW; HRS; HRX; HRY; HSB; HSD; HSN; HSX; HSZ; HTN; HTO; HTR; HTY; HWC; HWE; HXY; JDB; JDI; JDJ; JDK; JDN; JDO; JDP; JDQ; JDR; JDS; JDW; JDX; JEC; JEY; JWH; KCT; KGS; KRO; KRR; KTT; KTW; KWA; KWI; KWL; KWP; KWQ; KWS; KWT; KWY; KWZ; KYJ; KYK; LOD; LPH; LWJ; LXC; LXT; LYU; LZN; LZO; LZY; MAI; MAX; MBF; MBH; MBI; MDI; MEH; MNH; MNI; MQN; MQP; MQV; MRW; NBH; NDN; NEI; NEW; NJL; NKB; NKG; NOV; NPJ; NQW; ODP; OIS; OIY; OLO; OOG; OSH; OSN; OUR; OVD; OVE; OWY; OXB; OXE; OXH; PAJ; PBJ; PDQ; PGM; PHX; PML,"Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Screw, Fixation, Intraosseous; Nasopharyngoscope (Flexible Or Rigid); Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Stimulator, Nerve; Mesh, Surgical, Metal; Light Source, Fiberoptic, Routine; Syringe, Piston; Lamp, Operating-Room; Light, Surgical, Instrument; Mesh, Surgical; Cover, Shoe, Operating-Room; Dress, Surgical; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Plate, Cranioplasty, Preformed, Alterable; Plate, Cranioplasty, Preformed, Non-Alterable; Methyl Methacrylate For Cranioplasty; Cover, Burr Hole; Retractor, Self-Retaining, For Neurosurgery; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Manual); Fastener, Plate, Cranioplasty; Plate, Fixation, Bone; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Washer, Bolt Nut; Reamer; Rasp; Pin, Fixation, Smooth; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Brace, Drill; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Prosthesis, Hip, Cement Restrictor; Implant, Fixation Device, Spinal; Device, Fixation, Proximal Femoral, Implant; Condylar Plate Fixation Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Instrument, Surgical, Sonic And Accessory/Attachment; Component, Traction, Invasive; Plate, Bone; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Retention Device, Suture; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Finger, Constrained, Polymer; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Monitor, Pressure, Intracompartmental; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Accessory, Surgical Apparel; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Rib Replacement; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; External Mandibular Fixator And/Or Distractor; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Prosthesis, Condyle, Mandibular, Temporary; Suture, Surgical, Absorbable, Polydioxanone; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Anchor, Suture, Bone Fixation, Metallic; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Cervical; Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Stereotaxic Instrument; Knee Arthroplasty Implantation System; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Software For Diagnosis/Treatment; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction; Mesh, Surgical, Collagen, Staple Line Reinforcement; Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery; Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed; Cranial Distraction System; Neurosurgical Nerve Locator; Growing Rod System; Shoulder Prosthesis, Reverse Configuration; Bone Cement, Posterior Screw Augmentation",1; 2; 3; U,"(TRANSFERRED) STEAM STERILIZATION UPDATE (REMOVED MR COMPATIBILITY] FOR MULTIPLE TRAUMA INTERNAL FIXATION SYSTEMS (BUNDL; 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES; 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM; 2.4MM CORTEX SCREW, SELF-TAPPING; 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES; 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM; 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM; 2.7MM LCP ULNA OSTEOTOMY SYSTEM; 3.5 MM LCP DISTAL HUMERUS SYSTEM; 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM; 4/2.5 MM SELF-DRILLING SCHANZ SCREW; 510(k) clearance; ADJUSTABLE LARGE FIXATOR SYSTEM; AMK 3 PEG PATELLA; AMK FEMORAL, TIBIAL TRAYS, INSERTS, PIN AND CLIP, PATELLA; AML HIP - RAW MATERIAL CHANGE FROM CAST TO FORGED (FROM ORIG. K012364); AML HIP PROSTHESIS; AML II (AML+) TITANIUM ACETABULAR CUP (ACS); ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT; ANGLED BLADE PLATE; ANTEGRA-T; K081568; APEX HOLE ELIMINATOR PS; ARIZONA CONDYLAR TIBIAL PLATEAU; ARTICUL/EZE FEMORAL HEADS; ATTUNE (TM) KNEE SYSTEM - CRUCIATE RETAINING AOX POLY FIXED BEARING (FORMERLY PROJECT BLUE BOOK PBB)) -TRADITIONAL; ATTUNE (TM) MEDIALIZED DOME &* MEDIALIZED ANATOMIC PATELLAE {TRADITIONAL} AOX; ATTUNE All Polyethylene Tibia; ATTUNE CEMENTED TIBIAL BASE, FIXED BEARING; ATTUNE KNEE SYSTEM - CEMENTLESS CR & PS FEMORAL COMPONENTS; ATTUNE PS [POSTERIOR STABILIZED] KNEE SYSTEM W/ AOX INSERTS (TRADITIONAL); ATTUNE REVISION KNEE SYSTEM; ATTUNE Revision LPS Insert; Additional VIPER PRIME screws with fenestrations; Arthroscopic clearance; Attune Shelf Life Extension 5 - 8 years; BENGAL STACKABLE CAGE SYSTEM; BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL; BIO-INTRAFIX TIBIAL SCREW AND SHEATH; BIOCRYL RAPIDE INTERFERENCE SCREW; BIOKNOTLESS AND LUPINE PLUS ANCHORS; BLUE ORTHOCORD SUTURE; BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM; C-STEM AMT (SPECIAL) (AMT= ARTICUL/EZE MINI TAPER); C-STEM SYSTEM; CANNULATED FEMORAL NAIL; CAS HIP INSTRUMENTATION; CAS KNEE INSTRUMENTATION (TRADITIONAL); CEMENT EXTRACTOR DRILL; CEMENT RESTRICTORS; CERAMIC FEMORAL HEAD (DELTA) SPECIAL 510(K); CERAMIC FEMORAL HEAD (SPECIAL - DESIGN MODIFICATION TO K031803); CHANGE IN PACKAGING OF UHMWPE COMPONENTS; CI HIP INSTRUMENTS (SPECIAL); CLAMPFIX; K090605; CLICK'X MONOAXIAL SCREWS AND HOOKS; K031175; CLICK'X; K992739; CONCORDE BULLET SPINAL SYSTEM; CONCORDE Bullet Lumbar Interbody System; CONCORDE Bullet Spinal System; CONFIDENCE HIGH VISCOSITY BONE CEMENT; CONFIDENCE High Viscosity Spinal Cement, VIPER and EXPEDIUM Fenestrated Screw Systems; CONTROL CABLE SYSTEM; COUGAR LS 15 LATERAL CAGE SYSTEM; COUGAR LS LATERAL CAGE SYSTEM; Clearance Letter K201321; Clearance Letter Special 510(k) K203414; Corail AMT Hip Prosthesis - Line Extension 2; Corail Line Extension; Corail Stem Cork HA Special 510k; Craniomaxillofacial Distraction System (CMFD); DARWIN KNEE SYSTEM (PFC SIGMA) (CRUCIATE RETAINING) POROUS COATED AND NON-POROUS COATED (ALSO KNOWN AS PFC II KNEE SYSTE; DARWIN KNEE SYSTEM (PFC SIGMA) (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED; DARWIN KNEE SYSTEM (TC3=TOTAL CONDYLAR 3) (PFC SIGMA); DELTA CERAMIC FEMORAL HEAD (SPECIAL); DELTA TS (TAPERED SLEEVE) CERAMIC FEMORAL HEADS (TRADITIONAL); DEPUY ACROMED VBR SYSTEM; DEPUY ACTIS DUOFIX HIP PROSTHESIS; DEPUY ADVANTAGE FIXATION SCREW SYSTEM; DEPUY C-STEM AMT (SPECIAL) (AMT= ARTICUL/EZE MINI TAPER); DEPUY C-STEM SYSTEM; DEPUY ECLIPSE HIP PROSTHESIS (ACTIS); DEPUY FEMORAL HEADS (S-ROM ZIRCONIA / ZIRCONIA ARTICULEZE); DEPUY MITEK MILAGRO INTERENCE SCREWS; DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM; DEPUY PULSE LUMBAR CAGE SYSTEM; DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS; DEPUY SPINE LATERAL CAGE SYSTEM; DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS); DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM; DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM; DEPUY/DUPONT REPEL GLOVES (SZ LARGE/MEDIUM); DURALOC ACETABULAR CUP LINERS (CROSS-LINKED POLYETHYLENE)(MARATHON); DURALOC ACETABULAR CUP SYSTEM 36MM MARATHON +4 POLYETHYLENE LINERS; DURALOC CEMENTLESS ACETABULAR CUP SYSTEM; DYNACORD Suture; DYNAMIC HIP SCREW; DYNATAPE Suture; DePuy Spine_K090230; DePuy Spine_K122861 XTOOL; DePuy Spine_K171439; DePuy Spine_K173095; DePuy Spine_K173526; DePuy Spine_K173787; DePuy Spine_K181949; DePuy Spine_K190895; DePuy Spine_K192014; DePuy Spine_K200245; DePuy Synthes 2 mm Quick Insertion Screws; DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long; DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile; DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm); DePuy Synthes Cortex, Cannulated, and Compression Screws K161616; DePuy Synthes Femoral Neck System; DePuy Synthes Hammertoe Continuous Compression Implant; DePuy Synthes MAXFRAME Multi-Axial Correction System; DePuy Synthes Sterilization Container System; DePuy Synthes T-PAL Spacer System; K181231; DePuy Synthes T-PAL Ti Spacer; K151276; DePuy Synthes TFNA Augmentation System; DePuy Synthes Variable Angle Locking Patella Plating System; Delta Xtend Alternate Angle 510(k); Delta Xtend Reverse Shoulder Lateralized Glenosphere; Dental Bone Cutting Instruments; Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2 mm Plates and Screws); ELITE MODULAR HIP SYSTEM (THACKRAY) -{ALSO SEE LIST OF PNS IN K940743-RANDA); ENDURANCE ALL POLY CEMENTED CUP; ENDURANCE CALCAR HIP PROSTHESIS; ESL MARATHON +4 POLYETHYLENE LINERS FOR PINNACLE ACETABULAR CUP SYSTEM (TRADITIONAL); EXPEDIUM 4.5MM SPINE SYSTEM; EXPEDIUM ANTERIOR SPINE SYSTEM; EXPEDIUM MIS SPINE SYSTEM; EXPEDIUM SPINE SYSTEM; EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS; EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM; EXPEDIUM SYSTEM, VIPER SYSTEM; EXPEDIUM Spine System/Synapse System; K142460; EXPEDIUM VERSE SPINE SYSTEM; EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM; Elite Nitinol Fixation System; Expedium Spine System, VIPER and VIPER 2 Systems; FASTIN RC ANCHOR; FEMORAL AND TIBIAL AUGMENT BLOCKS (FOR USE WITH S-ROM NOILES MODUALR ROTATING HINGED KNEE); FEMORAL INTRAFIX SCREW AND SHEATH; FMS DUO SYSTEM; FMS INTERMEDIARY TUBING AND STERILE ZONE KIT; FMS SHAVER BLADES AND BURRS; FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE; FOCUS TOTAL HIP SYSTEM AND FEMORAL HEADS; GRIPTION TF 5.5MM STERILE LOCKING SCREWS; GRYPHON Anchors with DYNACORD Suture; GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY; GRYPHON BR ANCHORS WITH PERMACORD; GRYPHON BR AND HEALIX BR ANCHORS; GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814; GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD; GRYPHON T AND P BR ANCHORS; Global Unite Platform Shoulder System Short Stem; HAND REAMERS; HEALIX ADVANCE Anchor with DYNACORD Suture; HEALIX ADVANCE BR ANCHOR; HEALIX ADVANCE BR ANCHORS, HEALIX ADVANCE PEEK ANCHORS; HEALIX ADVANCE KNOTLESS BR ANCHOR; HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM); HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM); HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM); HEALIX ADVANCE PEEK ANCHOR; HEALIX ADVANCE SP BIOCOMPOSITE Anchors; HEALIX ADVANCE SP PEEK Anchor; HEALIX ANCHOR; HEALIX TI ANCHOR; HEALIX TI ANCHORS; HEALIX Ti ANCHOR with DYNACORD; HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture; HEX BUTTON; HPS II SMOOTH STEM; Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T And P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor,; INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER; INTRAFIX PEEK TAPERED SCREW; INTRAFIX(TM) Advance Tibial Fastener System; ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS; ISOLA SPINAL SYSTEM; ISOLA TANDEM CONNECTOR; JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS - PFC MODULAR KNEE SYSTEM (NOT SIGMA); K091499; K102298; K123359 Purevue Camera Control System; K133520; K151004; K151154; K152539; K160856; K170306; K171284; K172157; K183506/ Healix Advance Anchor with Dynacord Suture; K191943 SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set (UNAS); K200791 Navigation Enabled Instruments (NavLock); K201145; K201336; K201346; K201661 SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set; K202472 - ACTIS Hip Prosthesis - Special 510(k); K941541 HSW Owned Laparoscope 510k; LATARJET CORTICAL SCREW SET; LCP RADIAL HEAD PLATING SYSTEM; LCS FEMORAL HIP PROSTHESIS; LIFELINER SURGICAL GLOVE LINER; LPS - MATERIAL CHANGETO K003182 (TRADITIONAL); LPS DIAPHYSEAL & METAPHYSEAL SLEEVES; LPS DISTAL FEMORAL COMPONENT (TRADITIONAL); LPS METAPHYSEAL SLEEVE (TRADITIONAL); LPS PROXIMAL TIBIAL COMPONENT (SPECIAL); LPS UNIVERSAL HINGE INSERT ASSEMBLY {ASSEMBLY = *HINGE POST & *POLY BEARING} (TRADITIONAL); M-SPEC 36MM FEMORAL HEADS (TRADITIONAL) {EXTENSION TO K980513 & K003523}; MARATHON CROSS-LINKED POLY ACET. CUP LINERS (FORMERLY CALLED DURALOC); MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM); MATRIXRIB FIXATION SYSTEM; MATRIXWAVE MMF SYSTEM; MAXILLARY DISTRACTOR; MEDIVISION ARTHROSCOPE; MERLIN SPINE SYSTEM; MICRO QA+ ANCHOR WITH #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE; MICROFIX QUICKANCHOR PLUS; MILAGRO ADVANCE INTERFERENCE SCREW; MILAGRO ADVANCE PEEK Interference Screw; MILAGRO INTERFERENCE SCREW; MILAGRO INTERFERENCE SCREWS; MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD; MINILOK QUICKANCHOR PLUS; MITEK ANCHOR II; MITEK BONE ANCHOR, MODIFICATION; MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER; MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE; MITEK FASTIN RC ANCHOR; MITEK MICRO QUICKANCHOR; MITEK MINI ANCHOR, MODIFICATION; MITEK MINI QUICKANCHOR PLUS; MITEK ROTATOR CUFF QUICKANCHOR PLUS; MITEK SUPER QUICKANCHOR, MODIFICATION; MITEK THRADED ANCHOR (MTA); MODFICATION TO: EXPEDIUM SPINE SYSTEM; MODIFICATION TO EXPEDIUM SPINE SYSTEM; MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS; MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LARGE 40/44 I.D. ESC LINERS (SPECIAL) [ULTAMET XL - FOR USE W/M SPEC HEA; MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM; MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM; MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM; MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION); MODIFICATION TO SYNTHES CERVIFIX SYSTEM; K030377; MODIFICATION TO SYNTHES MATRIX SYSTEM; MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM; K990745; MODIFICATION TO SYNTHES USS; K000450; MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK ROD AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE;; MODIFICATION TO VBR SPINAL SYSTEM; MODIFICATION TO VIPER SPINE SYSTEM; MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR; MODIFICATION TO: EXPEDIUM SPINE SYSTEM; MODIFICATION TO: VIPER SPINE SYSTEM; MODIFICATION TO:EXPEDIUM SPINE SYSTEM; MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM); MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE; MODIFICATIONS TO EXPEDIUM SPINE SYSTEM; MODIFIED PROFILE FEMORAL HIP (CEMENTRALIZER); MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU; MODULAR CATHCART FRACTURE SYSTEM; MODULAR FOOT SYSTEM - 2.7 MM MODULE; MODULAR M HEADS MODIFICATION TO THE ARTICUL/EZE FEM HEADS(SPECIAL) [ULTAMET XL]; MONARCH SPINE SYSTEM; MONARCH SPINE SYSTEM DePuy Spine_K010576; MOUNTAINEER OCT SPINAL SYSTEM; MatrixRIB Fixation System; Milagro / Milagro Advance Interference Screw; Mitek VAPR System; NEW JERSEY MODULAR FEMORAL HIP; NOILES CRUCIATE RETAINING KNEE (S-ROM); NOILES ROTATING HINGE KNEE; NOILES TOTAL KNEE PROSTHESIS; NORIAN DRILLABLE; NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY; NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY; NORIAN SRS BONE VOID FILLER; Nails MR Conditional; Not Specified; OMNICUT RESECTION BLADE; OMNISPAN MENISCAL REPAIR SYSTEM; ORACLE SPACER OPAL SPACER; K072791; ORTHOCORD #2-0 SUTURE WITH OR WITHOUT NEEDLES; ORTHOCORD SUTURE; ORTHOGENESIS LPS; ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT SYSTEM; ORTHOMESH; ORTRON 90 HIP PROSTHESIS; OSSE-LIGN; PANALOK LOOP ANCHOR; PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR; PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732; PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM; PFC CERAMIC HIP HEAD; PFC MODULAR KNEE SYSTEM; PFC MODULAR PLUS OFFSET TIBIAL TRAY; PFC MODULAR TOTAL KNEE SYSTEM, MODUALR ""PLUS"" TIBIAL TRAY AND WEDGES; PFC SIGMA CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) [PRIOR NAME DARWIN]; PFC SIGMA INSET PATELLA; PFC SIGMA KNEE SYSTEM (SIZE 1.5); PFC SIGMA KNEE SYSTEM STABILIZED PLUS; PFC TOTAL HIP SYSTEM - POROUS COATED LONG STEM; PFC TOTAL KNEE SYSTEM OVAL PATELLA; PINNACLE 100 W/GRIPTION ACETABULAR CUP (SPECIAL); PINNACLE ACETAB SYS. -MINOR TOLERANCE ADJUSTMNTS TO METAL SHELL & LINER PKG INSERT REVIS.; PINNACLE ACETABULAR ALTRX CUP LINERS (TRADITIONAL) [NON METAL ON METAL BEARING ALTERNATIVE] (ALTRALINK TM PROCESS); PINNACLE ACETABULAR REVISION SYS. MODIFICATION -ADD'L LG SZ'S, ADDING STANDARD PROFILE & DPX REVISION SHELLS, ADDING LIP; PINNACLE ACETABULAR SYS. (PREVIOUSLY SUMMIT); PINNACLE ALTRX ACETABULAR CUP LINERS - [USE W/ CERAMIC HEADS] (TRADITIONAL); PINNACLE ALTRX ACETABULAR LINERS - TRADITIONAL; PINNACLE ALTRX ACETABULAR LINERS -ADD'L SIZES (SPECIAL -EXTENSION TO K072963); PINNACLE CONSTRAINED ACETABULAR LINER - LARGER SIZES; PINNACLE CONSTRAINED ACETABULAR LINERS (TRADITIONAL); PINNACLE DUOFIX HA ACETABULAR CUPS (SPECIAL 510(K) DEVICE MODIFICATION OF PINNACLE ACETABULAR CUPS); PINNACLE Dual Mobility; PINNACLE W/ GRIPTION ACETABULAR CUPS (SPECIAL); PINNACLE W/ GRIPTION ACETABULAR CUPS (SPECIAL) -ADDING DEVICE CODES KWA, JDI, LZO; PIPELINE II ACCESS SYSTEM; PM Change - Pinnacle HA - DePuy Ireland; PROTRUSIO CAGES; PROXIMAL FEMORAL NAIL (PFN) SYSTEM; QUICKANCHOR, MODIFICATION; RASPS FOR SCRAPING BONE; RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE; RECLAIM REVISION HIP SYSTEM (TRADITIONAL) FOR METAL ON METAL, METAL ON POLY, AND CERAMIC ON POLY ARTICULATION; REPEL LITE CUT RESISTENT GLOVE LINERS; REPEL SURGICAL GLOVE LINERS; RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS; RIGIDFIX BIOCRYL CROSS PIN KITS; RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM; RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM; RIGIDLOOP ADJUSTABLE CORTICAL FIXATION SYSTEM; RIGIDLOOP CORTICAL FIXATION SYSTEM; RIGIDLOOP Cortical Fixation System XL Implant; Revolution Radial Head; S-ROM 135 FEMORAL STEM & COLLAR (PART OF THE S-ROM TOTAL HIP SYSTEM); S-ROM FEMORAL HIP STEM; S-ROM FEMORAL HIP STEM (SIZES 12 X 06 X 155 & 12 X 07 X 115); S-ROM HIP SYSTEM -LOCKING PLUG (PIN); S-ROM LF FEMORAL HEAD; S-ROM NOILES MARK 3 KNEE; S-ROM STD STEM (SPECIAL); S-ROM TOTAL HIP SYSTEM WITH CERAMIC HEAD; S-ROM TROCHANTER SCREW AND WASHER AND CALCAR REPLACEMENT FEMORAL STEM; S-ROM ZTT SLEEVES; SDB CERCLAGE SYSTEM; SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN); SFX SNAP-FIT CROSS CONNECTOR; SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND; SIGMA CO-CR TIBIAL TRAYS (SPECIAL 510(K))-----TIBIAL INSERTS WERE ALSO SUBMITTED BUT FDA SPLIT THEM INTO A SEPARATE 510(; SIGMA CR-F FEMORAL COMPONENT (TRADITIONAL) (CR150... NAME MAY CHANGE AGAIN); SIGMA CRUCIATE RETAINING PORO FEM COMP (TRADITIONAL); SIGMA HIGH PERFORMANCE PARTIAL KNEE SYSTEM (PREVIOUSLY CALLED: UNITY KNEE RESURFACING SYS. & PRIOR TO THAT CALLED GCK) [; SIGMA HIGH PERFORMANCE PARTIAL KNEE SYSTEM [PREVIOUSLY CALLED & CLEARED UNDER - GCK (GRADUATED COMPARTMENTAL KNEE)]; SIGMA HIGH PERFORMANCE PARTIAL KNEE SYSTEM [PREVIOUSLY CALLED - GCK FEMORAL AND TIBIAL COMPONENTS] (TRADITIONAL); SIGMA KNEE PROSTHESIS FEMORAL ADAPTER (MODIFICATION TO K950010) [SPECIAL]; SIGMA PS (POSTERIOR-STABILIZED, CRUCIATE SUBSTITUTING) FEMORAL COMPONENTS -DEVICE MODIFICATION (SPECIAL); SIGMA TIBIAL INSERTS [BANNISTER - GVF] (SPECIAL OFF DARWIN K943462)082627; SIGMA XLK TIBIAL INSERTS [BANNISTER] (TRADITIONAL); SINUSCOPE AND ACCESSORIES; SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST; SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM; SMALL STATURE USS; K994121; SMALL TITANIUM WRIST FUSION PLATE; SMF STAINLESS STEEL BONE SCREWS; SMF TITANIUM (TI) ALLOY BONE SCREWS; SOLUTION SYSTEM HIP PROSTHESIS (DESIGN CHANGES TO VISION K953703 & AML K012364) SPECIAL 510(K); SOLUTION SYSTEM HIP PROSTHESIS (SPECIAL-MATERIAL CHANGE); SONGER CABLE SYSTEM; SPA POROUS COATED PROXIMAL SLEEVES (TRADITIONAL); SPEEDTRAP Graft Preparation System; SPIKED WASHER; SPL CRIMP SYSTEM; K002110; SPOTLIGHT ACCESS SYSTEM; STERILE VIEW KNEE-HIGH BOOTS AND DEPUY SHOE BOOTS; SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM; SUMMIT ACETABULAR SYSTEM (SHELLS, LINERS, SCREWS AND APICAL PLUG); SUMMIT BASIC PRESS-FIT HIP STEMS (SPECIAL 510(K)); SUMMIT CEMENTED HIP PROSTHESIS; SUMMIT DUOFIX HIP PROSTHESIS; SUMMIT FX CEMENTED HIP STEMS; SUMMIT OCT SPINAL SYSTEM; SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System; SYNAPSE SYSTEM 4MM, OC FUSION SYSTEM 4MM; SYNAPSE SYSTEM SYNTHES OC FUSION SYSTEM; K141897; SYNAPSE SYSTEM; K070573; SYNAPSE SYSTEM; K133698; SYNATOMIC VARIABLE FIT TIBIAL PLATEAU; SYNFIX Evolution Secured Spacer System; K150673; SYNFIX-LR SPACER; K072253; SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE; SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM; K963045; SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR; K962608; SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM; K964416; SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS; SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM; SYNTHES (USA) 1/1.22 MM CRANIOFACIAL SCREWS; SYNTHES (USA) 2.4 MM LCP WRIST PLATE; SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES; SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE; SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES; SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS; SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES; SYNTHES (USA) 2MM TITANIUM T-PLATE; SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP; SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES; SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS; SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES; SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES; SYNTHES (USA) 3.5MM LCP HOOK PLATE; SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES; SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES; SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES; SYNTHES (USA) 5MM/7.3MM CRIMP POSITIONING PINS; SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS; SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM; SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM; SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM; SYNTHES (USA) CHRONOS; SYNTHES (USA) CHRONOS; K043045; SYNTHES (USA) CLAVICLE HOOK PLATES; SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM; SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM; SYNTHES (USA) CRANIOFACIAL PLATES; SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM; SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM; SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION; SYNTHES (USA) DHS HELIX SYSTEM; SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM; SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS); SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP; SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION; SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION); SYNTHES (USA) ELBOW HINGE FIXATOR; SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM; SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE; SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR; SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS; SYNTHES (USA) IMF SCREWS; SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE; SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE; SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM; SYNTHES (USA) LCP CURVED PLATES; SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM; SYNTHES (USA) LCP MODULAR FOOT PLATES; SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES; SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS; SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG; SYNTHES (USA) LCP WRIST FUSION PLATES; SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM; SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES; SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM; SYNTHES (USA) MIDFACE DISTRACTOR; SYNTHES (USA) MIDFACIAL SYSTEM; SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM; SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM; SYNTHES (USA) NEW/STERIAL ORBITAL PLATES; SYNTHES (USA) ORIBITAL MESH PLATES; SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS; SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM; SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS; SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP; SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RATCHETING DISTRACTOR; SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM; SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS; SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM; SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM; SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION; SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE; SYNTHES (USA) TIBIAL NAIL SYSTEM EX; SYNTHES (USA) TITANIUM WIRE; SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES; SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS; SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW; SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM; SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST; K930891; SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM); K951794; SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM; SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR; SYNTHES (USA) [SYNTHES] MMFS - 2 MM SAGITTAL SPLIT PLATES; SYNTHES (USA) [SYNTHES] SELF-DRILLING SCHANZ SCREW; SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS; SYNTHES 1.3 MM SELF-DRILLING SCREW; SYNTHES 1.5MM TI BROW LIFT SCREW; SYNTHES 1.5MM/2MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS; SYNTHES 1/1.2 MM PLUSDRIVE SCREWS; SYNTHES 2 MM LOCKING PLATE SYSTEM (2 LPS); SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW; SYNTHES 2.4 MM CANNULATED SCREW; SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS; SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM; SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM; SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER; SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES; SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE; SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM; SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP); SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES; SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE; SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM; SYNTHES 3.5MM CORTEX SCREWS; SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM; SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW; SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES; SYNTHES 3.5MM SPRING PLATE; SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES; SYNTHES 3.9 MM PELVIC SCREWS; SYNTHES 4 AND 5 MM LOCKING SCREWS; SYNTHES 4 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE; SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS; SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM; SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM; SYNTHES 4MM TITANIUM (TI.) LOCKING SCREWS; SYNTHES 5/7.3 MM CANNULATED LOCKING SCREWS; SYNTHES 6 COCR AND CPT TI-3 RODS; K103287; SYNTHES 6.5 MM CANNULATED SCREW; SYNTHES 6.5MM MIDFOOT FUSION BOLT; SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE); SYNTHES 7/7.3 MM CANNULATED SCREWS; SYNTHES 90 DEGREE SCREWDRIVER; SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR; SYNTHES ACIS/VERTEBRAL SPACER CR; K120275; SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM; SYNTHES AFS; K032534; SYNTHES AIR PEN DRIVE (APD) SYSTEM; SYNTHES ANATOMICAL LOCKING PLATE SYSTEM; SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS); SYNTHES ANTEGRA SYSTEM; K063158; SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM; K031276; SYNTHES ANTERIOR CSLP SYSTEM; SYNTHES ANTERIOR CSLP SYSTEM; K000742; SYNTHES ANTERIOR CSLP SYSTEM; K030866; SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM; K022791; SYNTHES ANTEROLATERAL CALCANEAL PLATE; SYNTHES BUTTON PLATE; SYNTHES CALCANEAL PLATE; SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM; SYNTHES CERCLAGE POSITIONING PIN; SYNTHES CERVIFIX SYSTEM; K001864; SYNTHES CERVIFIX SYSTEM; K011969; SYNTHES CERVIFIX SYSTEM; K990965; SYNTHES CERVIFIX SYSTEM; K991089; SYNTHES CERVIFIX SYSTEM; K994187; SYNTHES CERVIFIX/ AXON; K023675; SYNTHES CHRONOS COMPOSITE; K071046; SYNTHES CONTOURED SYNMESH SPACER; K041389; SYNTHES CORTICAL SCREWS; SYNTHES CRANIAL FLAP TUBE CLAMP; SYNTHES CRANIAL PLATES; SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM; SYNTHES CRANIOFACIAL PLATES; SYNTHES CURVED RECONSTRUCTION PLATE; SYNTHES CURVILINEAR DISTRACTION SYSTEM; SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM; SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS; SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM; SYNTHES DUAL-OPENING USS; K020517; SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM; SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL; SYNTHES EXTERNAL MIDFACE DISTRACTOR; SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM; SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE; SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL; SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM; SYNTHES LCP ANKLE ARTHRODESIS PLATES; SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES; SYNTHES LCP DISTAL FEMUR PLATES; SYNTHES LCP DISTAL TIBIA PLATES; SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES; SYNTHES LCP PEDIATRIC PLATE SYSTEMS; SYNTHES LCP PROXIMAL HUMERUS PLATES; SYNTHES LCP PROXIMAL TIBIA PLATE; SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION; SYNTHES LIGHT GUIDE; K993314; SYNTHES LOCKING CALCANEAL PLATES; SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM; SYNTHES LOCKING HAND PLATES; SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD; SYNTHES LOW PROFILE NEURO SYSTEM; SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS; SYNTHES LOW PROFILE RECONSTRUCTION PLATES; SYNTHES MANDIBLE EXTERNAL FIXATOR; SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM; SYNTHES MATRIX MIS RODS; K093668; SYNTHES MATRIX SYSTEM; K092929; SYNTHES MATRIX SYSTEM; K100634; SYNTHES MATRIX SYSTEM; K120838; SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM; SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES; SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM; SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES; SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES; SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM; SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM; SYNTHES MAXILLOFACIAL TITANIUM MICRO SET; SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE; SYNTHES MIDFACE DISTRACTOR; SYNTHES MINI EXTERNAL FIXATOR; SYNTHES MINI LENGTHENING APPARATUS; SYNTHES MODULAR FOOT SYSTEM; SYNTHES MULTILOC HUMERAL NAILING SYSTEM; SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM; SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS; SYNTHES OC FUSION SYSTEM; K053418; SYNTHES ORACLE SPACER; K062933; SYNTHES PANGEA MONOAXIAL SYSTEM; K052151; SYNTHES PANGEA SYSTEM; K052123; SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT; SYNTHES PATIENT SPECIFIC PLATE; SYNTHES PEDIATRIC ROD SYSTEM; K991552; SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM; SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM; SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM; K983530; SYNTHES PROXIMAL TIBIA PLATING SYSTEM; SYNTHES RADIAL HEAD PROSTHESIS SYSTEM; SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES; SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES; SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM; SYNTHES RIA SYSTEM (EXPANDED INDICATIONS); SYNTHES RIB FIXATION SYSTEM; SYNTHES SACRAL BAR SYSTEM; K001720; SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF); SYNTHES SMALL COBINATION CLAMP-MR SAFE; SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM; SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM; K974525; SYNTHES SPINE CERVIFIX SYSTEM; SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM; SYNTHES SPINE PEDIATRIC ROD SYSTEM; K980761; SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM; K980358; SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM; K984612; SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM; SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM; SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN); SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM; SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES; SYNTHES STERILE 3 MM CANNULATED SCREW AND THREADED WASHER; SYNTHES STERILE 3.5 MM AND 4 MM CANNULATED SCREWS; SYNTHES STERILE 4.5 MM CANNULATED SCREWS; SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES; SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT; SYNTHES STERNAL FIXATION SYSTEM; SYNTHES STERNAL ZIPFIX SYSTEM; SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM; SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS; SYNTHES SYNAPSE TRANSCONNECTOR; K090549; SYNTHES SYNCAGE EVOLUTION SPACER; K122639; SYNTHES SYNEX SPACER SYSTEM; K003836; SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM; K130146; SYNTHES SYNMESH SPACER SYSTEM; K003275; SYNTHES SYNMESH; K983766; SYNTHES T-PAL SPACER; K100089; SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP); K020244; SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM; SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL; SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM; SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM",2021-11-15,823,2021-04-08,1,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008868758%22&limit=1
"Zimmer Biomet Taiwan Co., Ltd.",3011683674,3011683674,"7F., No. 35, Ln. 11, Guangfu N. Rd.,Songshan Dist.",Taipei,,105410,Taiwan,Zimmer Biomet APAC DFE,10056128,Exporter to the US,108,EFQ; FLE; FMF; FQH; FTY; FZP; FZW; GAM; GAS; GAT; GCJ; GDG; GDH; GEI; HAW; HRS; HRX; HRY; HSB; HSD; HSO; HSX; HSZ; HTC; HTD; HTF; HTJ; HTN; HTP; HTX; HTY; HWA; HWC; HWM; HWO; HXK; HXN; HXW; HYA; JCX; JDB; JDC; JDG; JDI; JDL; JDO; JDQ; JDR; JDS; JDW; JDX; JDZ; JEC; JWH; JWJ; KCY; KGS; KMC; KRO; KRR; KTT; KTW; KTZ; KWA; KWB; KWH; KWI; KWL; KWS; KWT; KWY; KWZ; KXA; LOD; LPH; LWJ; LXT; LZN; LZO; LZY; MAI; MAY; MBB; MBF; MBH; MBI; MBL; MBV; MEH; MJT; MLR; MQP; MQV; NDF; NDH; NEU; NJD; NJL; NQP; ODP; OIY; OLO; OQG; OQH; OQI; PAO; PBI; PHX,"Gauze/Sponge, Internal; Sterilizer, Steam; Syringe, Piston; Lavage, Jet; Tape, Measuring, Rulers And Calipers; Clip, Implantable; Expander, Surgical, Skin Graft; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Saw; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Curette; Gauge, Depth; Washer, Bolt Nut; File; Rongeur; Pin, Fixation, Smooth; Impactor; Screw, Fixation, Bone; Osteotome; Skid, Bone; Holder, Needle; Orthopedic; Applier, Cerclage; Bender; Forceps, Wire Holding; Apparatus, Suction, Ward Use, Portable, Ac-Powered; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Instrument, Surgical, Sonic And Accessory/Attachment; Mixer, Cement, For Clinical Use; Component, Traction, Invasive; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained; Tourniquet, Pneumatic; Retention Device, Suture; Prosthesis, Hip, Semi-Constrained,  Composite/Metal; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal; Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Femoral, Resurfacing; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented; Sterilizer, Chemical; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; Plate, Fixation, Bone, Non-Spinal, Metallic; Nail, Fixation, Bone, Metallic; Marker, Radiographic, Implantable; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing; Posterior Metal/Polymer Spinal System, Fusion; Intervertebral Fusion Device With Bone Graft, Cervical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Stereotaxic Instrument; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive; Shoulder Prosthesis, Reverse Configuration",1; 2; 3; U,"A. L. P. S. Clavicle Plating System; AFX® Femoral Implant with Inserter; ALLthread™ Titanium Suture Anchor; ANA0TOMICAL SHOULDER TM COMBINED SYSTEM; BENDER; BIOMET CEMENT; MIXER; BIOMET DEPTH; GAUGE; Gauge Biomet Depth; BIOMET FILE; BIOMET IMPACTOR; BIOMET OSTEOTOME; BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS; Bi-Metric CoCr Head/Neck Replacement Hip Stems; Biolox® delta Option Ceramic Heads; Biomet Knee Joint Replacement Prostheses; Biomet Modular Femoral Revision System; Biomet Variable Pitch Compression Screw System; CALIPER; Cable-Ready Cable Grip System; Cable-Ready Bone Plate System; Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables; Cannulated Screw System by Pionee; Comprehensive Humeral Fracture; Comprehensive Shoulder System; Comprehensive® Primary Shoulder Stems; Comprehensive® Reverse Shoulder; CuffLinkTm Suture Anchor; Curette; Dual Port/Single Bladder Disposable Cuff; EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE; FORCEPS; G7 Acetabular System; HOOK, SURGICAL, GENERAL & PLASTIC SURGERY; INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM; LORENZ PECTUS SUPPORT BAR STABILIZER; Lateralized Taperloc® Microplasty™ Femoral Components; MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL; Mallory/Head Calcar Replacement with Interlocking Slots Bi-Metric Porous Collared Stem with Interlocking Slots; MeshGraft II; NON-STERILE ZIMMER PLATES AND SCREWS SYSTEM; Orthopedic Salvage System - OSS; PLIERS, SURGICAL; Persona Partial Knee System; Persona Revision Knee System; Pioneer ZCS; Prolong Highly Crosslinked Poly Cru; Pulsavac Plus; QuattroTm Link Knotless Anchor; RONGUER; STRAIGHT; ROSA® Knee System; RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM; TAPE, MEASURING, RULERS AND CALIPERS; THE NATURAL-KNEE REVISION; Taper 2™ Porous Femoral Stem; TaperLoc Complete; Taperloc Complete Hip Stems; Taperloc Complete Microplasty System; Taperloc Complete Size 4mm and XR 123; Taperloc Complete, Sizes 5mm and 6mm; Titanium Interference Screws; ToggleLocTM System; VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT; VANGUARD SSK 360 REVISION KNEE SYSTEM; Vanguard 360 Revision Knee System; Vanguard XP Knee System; X-SERIES BI-METRIC HIP FEMORAL COMPONENTS; XR-Series Bi-Metric® Femoral Components; Zimmer; Zimmer NexGen Tibial and Femoral Augments; Zimmer Periarticular Locking Plate System",2018-04-05,634,2022-10-04,2,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011683674%22&limit=1
"Zimmer (Shanghai) Medical International Trading Co., Ltd.",3015207155,3015207155,Ground Floor 129 North Fu Te Road Pilot Free Trade Zone Pudong District,Shanghai,,200131,China,Zimmer Biomet APAC DFE,10056128,Exporter to the US,106,EFQ; FLE; FMF; FTY; FZP; GAM; GAS; GAT; GCJ; GDG; GDH; GEI; HAW; HRS; HRX; HRY; HSB; HSD; HSO; HSX; HSZ; HTC; HTD; HTF; HTJ; HTN; HTP; HTX; HTY; HWA; HWC; HWM; HWO; HXK; HXN; HXW; HYA; JCX; JDB; JDC; JDG; JDI; JDL; JDO; JDQ; JDR; JDS; JDW; JDX; JDZ; JEC; JWH; JWJ; KCY; KGS; KMC; KRO; KRR; KTT; KTW; KTZ; KWA; KWB; KWH; KWI; KWL; KWS; KWT; KWY; KWZ; KXA; LOD; LPH; LWJ; LXT; LZN; LZO; LZY; MAI; MAY; MBB; MBF; MBH; MBI; MBL; MBV; MEH; MJT; MLR; MQP; MQV; NDF; NDH; NEU; NJD; NJL; NQP; ODP; OIY; OLO; OQG; OQH; OQI; PAO; PBI; PHX,"Gauze/Sponge, Internal; Sterilizer, Steam; Syringe, Piston; Tape, Measuring, Rulers And Calipers; Clip, Implantable; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Saw; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Curette; Gauge, Depth; Washer, Bolt Nut; File; Rongeur; Pin, Fixation, Smooth; Impactor; Screw, Fixation, Bone; Osteotome; Skid, Bone; Holder, Needle; Orthopedic; Applier, Cerclage; Bender; Forceps, Wire Holding; Apparatus, Suction, Ward Use, Portable, Ac-Powered; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Instrument, Surgical, Sonic And Accessory/Attachment; Mixer, Cement, For Clinical Use; Component, Traction, Invasive; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained; Tourniquet, Pneumatic; Retention Device, Suture; Prosthesis, Hip, Semi-Constrained,  Composite/Metal; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal; Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Femoral, Resurfacing; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented; Sterilizer, Chemical; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; Plate, Fixation, Bone, Non-Spinal, Metallic; Nail, Fixation, Bone, Metallic; Marker, Radiographic, Implantable; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing; Posterior Metal/Polymer Spinal System, Fusion; Intervertebral Fusion Device With Bone Graft, Cervical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Stereotaxic Instrument; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive; Shoulder Prosthesis, Reverse Configuration",1; 2; 3; U,"A. L. P. S. Clavicle Plating System; AFX® Femoral Implant with Inserter; ALLthread™ Titanium Suture Anchor; ANA0TOMICAL SHOULDER TM COMBINED SYSTEM; BENDER; BIOMET CEMENT; MIXER; BIOMET DEPTH; GAUGE; Gauge Biomet Depth; BIOMET FILE; BIOMET IMPACTOR; BIOMET OSTEOTOME; BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS; Bi-Metric CoCr Head/Neck Replacement Hip Stems; Biolox® delta Option Ceramic Heads; Biomet Knee Joint Replacement Prostheses; Biomet Modular Femoral Revision System; Biomet Variable Pitch Compression Screw System; CALIPER; Cable-Ready Cable Grip System; Cable-Ready Bone Plate System; Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables; Cannulated Screw System by Pionee; Comprehensive Humeral Fracture; Comprehensive Shoulder System; Comprehensive® Primary Shoulder Stems; Comprehensive® Reverse Shoulder; CuffLinkTm Suture Anchor; Curette; Dual Port/Single Bladder Disposable Cuff; EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE; FORCEPS; G7 Acetabular System; HOOK, SURGICAL, GENERAL & PLASTIC SURGERY; INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM; LORENZ PECTUS SUPPORT BAR STABILIZER; Lateralized Taperloc® Microplasty™ Femoral Components; MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL; Mallory/Head Calcar Replacement with Interlocking Slots Bi-Metric Porous Collared Stem with Interlocking Slots; Orthopedic Salvage System - OSS; PLIERS, SURGICAL; Persona Partial Knee System; Persona Revision Knee System; Pioneer ZCS; Prolong Highly Crosslinked Poly Cru; QuattroTm Link Knotless Anchor; RONGUER; STRAIGHT; ROSA® Knee System; RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM; TAPE, MEASURING, RULERS AND CALIPERS; THE NATURAL-KNEE REVISION; Taper 2™ Porous Femoral Stem; TaperLoc Complete; Taperloc Complete Microplasty System; Taperloc Complete Size 4mm and XR 123; Taperloc Complete, Sizes 5mm and 6mm; Titanium Interference Screws; ToggleLocTM System; VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT; VANGUARD SSK 360 REVISION KNEE SYSTEM; Vanguard 360 Revision Knee System; Vanguard XP Knee System; X-SERIES BI-METRIC HIP FEMORAL COMPONENTS; XR-Series Bi-Metric® Femoral Components; Zimmer; Zimmer NexGen Tibial and Femoral Augments; Zimmer Periarticular Locking Plate System",2018-04-05,632,2022-10-04,2,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015207155%22&limit=1
Zimmer Biomet Korea Ltd.,3015542154,3015542154,"5F, Ilshin Building, 98 Hannamdae-ro, Yongsan-gu",Seoul,,04418,South Korea,Zimmer Biomet APAC DFE,10056128,Exporter to the US,108,EFQ; FLE; FMF; FQH; FTY; FZP; FZW; GAM; GAS; GAT; GCJ; GDG; GDH; GEI; HAW; HRS; HRX; HRY; HSB; HSD; HSO; HSX; HSZ; HTC; HTD; HTF; HTJ; HTN; HTP; HTX; HTY; HWA; HWC; HWM; HWO; HXK; HXN; HXW; HYA; JCX; JDB; JDC; JDG; JDI; JDL; JDO; JDQ; JDR; JDS; JDW; JDX; JDZ; JEC; JWH; JWJ; KCY; KGS; KMC; KRO; KRR; KTT; KTW; KTZ; KWA; KWB; KWH; KWI; KWL; KWS; KWT; KWY; KWZ; KXA; LOD; LPH; LWJ; LXT; LZN; LZO; LZY; MAI; MAY; MBB; MBF; MBH; MBI; MBL; MBV; MEH; MJT; MLR; MQP; MQV; NDF; NDH; NEU; NJD; NJL; NQP; ODP; OIY; OLO; OQG; OQH; OQI; PAO; PBI; PHX,"Gauze/Sponge, Internal; Sterilizer, Steam; Syringe, Piston; Lavage, Jet; Tape, Measuring, Rulers And Calipers; Clip, Implantable; Expander, Surgical, Skin Graft; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Saw; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Curette; Gauge, Depth; Washer, Bolt Nut; File; Rongeur; Pin, Fixation, Smooth; Impactor; Screw, Fixation, Bone; Osteotome; Skid, Bone; Holder, Needle; Orthopedic; Applier, Cerclage; Bender; Forceps, Wire Holding; Apparatus, Suction, Ward Use, Portable, Ac-Powered; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Instrument, Surgical, Sonic And Accessory/Attachment; Mixer, Cement, For Clinical Use; Component, Traction, Invasive; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained; Tourniquet, Pneumatic; Retention Device, Suture; Prosthesis, Hip, Semi-Constrained,  Composite/Metal; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal; Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Femoral, Resurfacing; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented; Sterilizer, Chemical; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; Plate, Fixation, Bone, Non-Spinal, Metallic; Nail, Fixation, Bone, Metallic; Marker, Radiographic, Implantable; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing; Posterior Metal/Polymer Spinal System, Fusion; Intervertebral Fusion Device With Bone Graft, Cervical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Stereotaxic Instrument; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive; Shoulder Prosthesis, Reverse Configuration",1; 2; 3; U,"A. L. P. S. Clavicle Plating System; AFX® Femoral Implant with Inserter; ALLthread™ Titanium Suture Anchor; ANA0TOMICAL SHOULDER TM COMBINED SYSTEM; BENDER; BIOMET CEMENT; MIXER; BIOMET DEPTH; GAUGE; Gauge Biomet Depth; BIOMET FILE; BIOMET IMPACTOR; BIOMET OSTEOTOME; BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS; Bi-Metric CoCr Head/Neck Replacement Hip Stems; Biolox® delta Option Ceramic Heads; Biomet Knee Joint Replacement Prostheses; Biomet Modular Femoral Revision System; Biomet Variable Pitch Compression Screw System; CALIPER; Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables; Cannulated Screw System by Pionee; Comprehensive Humeral Fracture; Comprehensive Shoulder System; Comprehensive® Primary Shoulder Stems; Comprehensive® Reverse Shoulder; CuffLinkTm Suture Anchor; Curette; Dual Port/Single Bladder Disposable Cuff; EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE; FORCEPS; G7 Acetabular System; HOOK, SURGICAL, GENERAL & PLASTIC SURGERY; INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM; LORENZ PECTUS SUPPORT BAR STABILIZER; Lateralized Taperloc® Microplasty™ Femoral Components; MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL; Mallory/Head Calcar Replacement with Interlocking Slots Bi-Metric Porous Collared Stem with Interlocking Slots; MeshGraft II; NON-STERILE ZIMMER PLATES AND SCREWS SYSTEM; Orthopedic Salvage System - OSS; PLIERS, SURGICAL; Persona Partial Knee System; Pioneer ZCS; Prolong Highly Crosslinked Poly Cru; Pulsavac Plus; QuattroTm Link Knotless Anchor; RONGUER; STRAIGHT; ROSA® Knee System; RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM; TAPE, MEASURING, RULERS AND CALIPERS; THE NATURAL-KNEE REVISION; Taper 2™ Porous Femoral Stem; TaperLoc Complete; Taperloc Complete Hip Stems; Taperloc Complete Microplasty System; Taperloc Complete Size 4mm and XR 123; Taperloc Complete, Sizes 5mm and 6mm; Titanium Interference Screws; ToggleLocTM System; VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT; Vanguard 360 Revision Knee System; Vanguard XP Knee System; X-SERIES BI-METRIC HIP FEMORAL COMPONENTS; XR-Series Bi-Metric® Femoral Components; Zimmer; Zimmer NexGen Tibial and Femoral Augments",2018-04-05,629,2022-10-04,2,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015542154%22&limit=1
"Biomet, Inc.",1825034,1825034,56 E Bell Dr Po Box 587,Warsaw,IN,46581,United States,Zimmer Inc,1825034,Contract manufacturer; Manufacturer; Manufacturer for export; Remanufacturer; Repackager or relabeler; Specification developer,204,BWN; CCX; DZE; DZL; FMF; FRL; FSM; FTY; FZO; FZP; FZS; FZT; FZX; FZY; GAB; GAD; GAM; GAS; GAT; GAZ; GCJ; GCY; GDG; GDH; GDJ; GDR; GEA; GEI; GEN; GES; GEY; GFA; GFC; GFI; GFJ; GWO; GXN; GXP; GXR; HAW; HBE; HBW; HRR; HRS; HRT; HRX; HRY; HSB; HSD; HSH; HSN; HST; HSX; HSZ; HTC; HTD; HTF; HTJ; HTN; HTO; HTP; HTQ; HTR; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWD; HWE; HWI; HWJ; HWK; HWM; HWN; HWP; HWQ; HWR; HWT; HWW; HWX; HXB; HXC; HXD; HXG; HXI; HXK; HXL; HXN; HXO; HXP; HXQ; HXW; HXX; HXZ; HYA; IMD; INP; JDB; JDC; JDG; JDI; JDL; JDO; JDQ; JDR; JDS; JDT; JDW; JDX; JDY; JDZ; JEB; JEC; JEY; JQC; JWH; JWJ; KDD; KGS; KIH; KIL; KMC; KQW; KQZ; KRO; KRR; KSS; KTT; KTW; KTZ; KWA; KWB; KWH; KWI; KWL; KWN; KWO; KWP; KWQ; KWR; KWS; KWT; KWY; KWZ; KXD; KYZ; LLZ; LOD; LPH; LRP; LRW; LWE; LWJ; LXH; LXI; LXT; LYS; LZO; LZY; MAI; MAY; MBB; MBF; MBH; MBI; MBL; MBP; MBV; MDM; MEH; MJT; MNH; MNI; MQN; MQV; MRA; NBH; NDF; NDH; NEI; NEU; NHB; NRA; NTG; NXT; OIY; OJH; OOG; OQG; OQH; OQI; OVZ; PAO; PBI; PHX; PIX; PJY; PKC; PZT; PZU; PZV,"Table And Attachments, Operating-Room; Support, Patient Position; Implant, Endosseous, Root-Form; Screw, Fixation, Intraosseous; Syringe, Piston; Fiber, Medical, Absorbent; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Clip, Implantable; Curette, Surgical, General Use; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Suturing, Disposable; Retractor; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Tubing, Noninvasive; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Saw, Manual And Accessories; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Blade, Scalpel; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Driver, Surgical, Pin; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Plate, Cranioplasty, Preformed, Alterable; Plate, Cranioplasty, Preformed, Non-Alterable; Methyl Methacrylate For Cranioplasty; Cover, Burr Hole; Neurological Stereotaxic Instrument; Drills, Burrs, Trephines & Accessories (Simple, Powered); Fastener, Plate, Cranioplasty; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Stripper, Surgical; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented); Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; File; Broach; Rasp; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Corkscrew; Awl; Trephine; Osteotome; Instrument, Compression; Punch, Femoral Neck; Passer; Driver, Prosthesis; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Tamp; Passer, Wire, Orthopedic; Holder, Needle; Orthopedic; Mallet; Applier, Cerclage; Pusher, Socket; Instrument, Bending Or Contouring; Crimper, Pin; Bender; Screwdriver; Cutter, Wire; Forceps, Wire Holding; Pack, Hot Or Cold, Disposable; Tips And Pads, Cane, Crutch And Walker; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Cap, Bone; Pin, Fixation, Threaded; Instrument, Surgical, Sonic And Accessory/Attachment; Evacuator, Vapor, Cement Monomer; Mixer, Cement, For Clinical Use; Table, Surgical With Orthopedic Accessories, Manual; Component, Traction, Invasive; Plate, Bone; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained; Kit, Surgical Instrument, Disposable; Retention Device, Suture; Dispenser, Cement; Positioner, Socket; Prosthesis, Hip, Semi-Constrained,  Composite/Metal; Goniometer, Nonpowered; Component, Traction, Non-Invasive; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Supplies, Blood-Bank; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal; Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Wrist, Carpal Lunate; Prosthesis, Wrist, Carpal Scaphoid; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Constrained, Metal; Syringe, Irrigating (Non Dental); System, Image Processing, Radiological; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Tray, Surgical; Scissors, General, Surgical; Bone Marrow Collection/Transfusion Kit; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Guide, Drill, Ligament; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Bone Mill; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Instrument, Manual, Surgical, General Use; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; External Mandibular Fixator And/Or Distractor; Filler, Bone Void, Calcium Compound; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented; Accessories, Arthroscopic; Plate, Fixation, Bone, Non-Spinal, Metallic; Nail, Fixation, Bone, Metallic; Prosthesis, Condyle, Mandibular, Temporary; Marker, Radiographic, Implantable; Polymer, Ear, Nose And Throat, Synthetic, Absorbable; Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing; Prosthesis, Ankle, Uncemented, Non-Constrained; Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Tray; Knee Arthroplasty Implantation System; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Pin, Fixation, Resorbable, Hard Tissue; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive; Shoulder Prosthesis, Reverse Configuration; Elbow Joint Metal/Polymer, Constrained, Porous Coated, Uncemented Prosthesis; Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Peripheral Blood Processing Device For Osteoarthritis; Bone Marrow Processing Device For Clinical Use; Peripheral Blood Processing Device For Clinical Use",1; 2; 3; N,"& BONE SCREWS; (BEARINGS / TRAYS); '- GLENOID GUIDE SYSTEM; /LORENZ 2 FT PLATES; 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS; 1.5MM, 2MM SYSTEM; 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3; 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES; 100KGY E-POLY MAXROM ACETABULAR LINERS; 130 MODIFIED INTEGRAL FEMORAL COMPONENT; 131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424; 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S; 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH; 2.5 MM LACTOSORB SCREWS; 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-; 2.5MM INLINE FUSION PLATE; 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS; 20-HOLE ADAPTATION PLATE; 23 MM SINGLE-PEG PATELLA COMPONENT; 2MM PEDIATRIC FLEX NAIL; 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM; 3.5MM INLINE FUSION PLATE; 3.5MM MTP PLATE (LEFT AND RIGHT); 36MM BIOLOX DELTA CERAMIC HEADS; 3MM BIOMET CANNULATED SCREW SYSTEM; 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5; 44MM E1 ACETABULAR; 4MM M A MAGNUM; 6.5MM SOLID CANCELLOUS BONE SCREW; 824677021, 22, 824071001, 824071101, 824671001, 82467; A-B ACETABULAR COMPONENT; A. L. P. S. Clavicle Plating System; A.L.P.S. CALCANEAL PLATING SYSTEM; A.L.P.S. Clavicle Plating System; A.L.P.S. Proximal Humerus Plating System; A.L.P.S. Small Fragment Plating System; ABSORBANT; AC-POWERED MOTOR; ACCESSORIES; ACCESSORIES AND ATTACHMENTS; ACE 100 DEGREES TUBULAR PLATE; ACE 3.5MM CORTICAL BONE SCREW; ACE 8MM CANNULATED CANCELLOUS BONE SCREW; ACE AIM TTC FUSION NAIL; ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM; ACE BEADED K-WIRES ACE OLIVE WIRES; ACE BIO WIN TIBIAL NAILING SYSTEM; ACE BROOKER BONE PLATING SYSTEM; ACE CANCELLOUS BONE SCREW; ACE CANNULATED CORTICAL BONE SCREW; ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW; ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW; ACE CORTICAL BONE SCREW; ACE CORTICAL LAG SCREW; ACE EXTERNAL BONE CLAMP PART #S11; ACE FISCHER EXTERNAL FIXATION SYSTEM; ACE HUMERAL NAIL; ACE HUMERUS & RADIUS PLATES; ACE MULTIPLE PIN PLATE; ACE NANCY NAIL; ACE OPEN-BACK HALO RING; ACE ORTHOPAEDIC WASHERS; ACE ORTHOPEDIC MANUFACTURING CO.; ACE PELVIC STABILIZER; ACE PROXIMAL HUMERAL NAIL SYSTEM; ACE RECONSTRUCTIVE PLATE; ACE SUPRACONDYLAR PLATE; ACE UNILATERAL FIXATOR II; ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL; ACE UNIVERSAL RECONSTRUCTION PLATE; ACE VERSANAIL; ACE WIRE TENSION CLAMP; ACE-DUPONT COMPOSITE RINGS; ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL; ACE/FISCHER PERCUTANEOUS HALF PINS; ACE/FISHER EXTERNAL FIXATOR; ACE/FISHER PERCUTANEOUS TRANSFIXING PINS; ACE/KYLE CAPTURED HIP SCREW; ACID ETCHED LAG SCREWS; ADAPTER; ADD-ON CONDYLE; ADDITIONAL COMPONENTS; AGC REVISION KNEE PROTHESIS; AGC TOTAL KNEE PROSTHESIS; AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM; AGC V2 REVISION KNEE SYSTEM; AIM TIBIAL NAIL; ALLTHREAD LACTOSORB SUTURE ANCHOR; ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER; ALLthread PEEK Suture Anchor; ALLthread™ Titanium Suture Anchor; ALTRA FX HIP SYSTEM; ALTRA PRESS-FIT HIP SYSTEM; ANATOMIC LOCKING PLATING SYSTEM; ANCHOR; ANCHOR PUSH SCREW; AND ANKLE ARTHRODESIS NAIL; AND PADS, CANE,; AND PREBENT; ANTERIOR STABILIZED TIBIAL BEARINGS; ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM; APPARATUS; APS Kit; ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS; ARCOMXL POLYETHYLENE LINERS; ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS; ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS; ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS; ARCOS FEMORAL; ARCOS INTERLOCKING DISTAL STEMS; ARCPM 1050 RESIN-HIPS; ARTHRORIVET; ARTHROSCOPIC; ARTHROTEK INTERFERENCE SCREW; ARTHROTEK LACTONAIL; ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE; ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW; ARTHROTEK SET SCREW; ARTHTOTEK PRECISION HAND INSTRUMENTATION; ASCENT KNEE REVISION FEMORAL STEM; ASCENT KNEE SYSTEM; ASCENT SYSTEM; ASCENT XXL OPEN BOX FEMORAL COMPONENT; AUGMENTS; AUSTIN-MOORE MODULAR HIP PROSTHESIS; AVL HINGE KNEE SYSTEM; AccuFill Bone Substitute Material, AccuFill PreFill; Affixus Tibial Nailing System; BACKED ACETABULAR CUP; BALANCE HIP SYSTEM; BEARING PARTIAL KNEE REPLACEMENT; BENDING AND; BI-ANGULAR SHOULDER SYSTEM; BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM; BIMETRIC TOTAL HIP SYSTEM; BIO-MODULAR REVERSE SHOLDER; BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS; BIO-MODULAR SHOULDER SYSTEM; BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA); BIODRIVE CANNULATED SCREW SYSTEM; BIODRIVE MICRO SCREW SYSTEM; BIOLOX DELTA CERAMIC HEADS; BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR; BIOLOX DELTA OPTION CERAMIC HEADS; BIOMET; BIOMET APPARATUS,; BIOMET AWL; BIOMET BENDER; BIOMET BI-POLAR SHOULDER SYSTEM; BIOMET BIAXIAL TOTAL ELBOW; BIOMET BIPOLAR PROSTHESIS; BIOMET BLADE/; BIOMET BONE; BIOMET BONE SCREW; BIOMET BONE SCREW STARTER; BIOMET BROACH; BIOMET CALCANEAL PLATE; BIOMET CANNULATED; BIOMET CEMENT; BIOMET CEMENT DISPENSER; BIOMET CLAMP; BIOMET COBALT-CHROME FEMORAL COMPONENTS; BIOMET CONCENTRIC HEX SCREW; BIOMET CURETTE; BIOMET CURETTE, SURGICAL; BIOMET DEPTH; BIOMET DRILL BIT; BIOMET FEMORAL; BIOMET FEMORAL LOCKING NAIL SYSTEM; BIOMET FILE; BIOMET FORCEPS; BIOMET FORERUNNER LOCKING PLATE SYSTEM; BIOMET GENERAL; BIOMET HEADLESS COMPRESSION AND TWIST OFF SCREWS; BIOMET IMPACTOR; BIOMET INSTRUMENT; BIOMET LATERAL TROCH PLATE; BIOMET MALLET; BIOMET MANUAL; BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED; BIOMET MICROFIXATION; BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER; BIOMET MODULAR FEMORAL REVISION SYSTEM; BIOMET MODULAR SHOULDER PROSTHESIS; BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKIN; BIOMET ORTHOPAEDIC; BIOMET OSTEOTOME; BIOMET PASSER; BIOMET PATIENT; BIOMET PHOENIX ANKLE NAIL; BIOMET PHOENIX ANKLE NAIL SYSTEM; BIOMET POSITIONER; BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION; BIOMET PROBE; BIOMET PROSTHESIS; BIOMET RASP; BIOMET REAMER; BIOMET RONGEUR; BIOMET SAW; BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE; BIOMET SINGLE; BIOMET SPORTS MEDICINE; BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP; BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT; BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR; BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM; BIOMET SURGICAL; BIOMET SURGICAL CUTTER; BIOMET SURGICAL,; BIOMET SURGICIAL; BIOMET TAMP; BIOMET TAPE; BIOMET TEMPLATE; BIOMET TIBIAL LOCKING NAIL SYSTEM; BIOMET TIPS; BIOMET TRAY,; BIOMET TREPHINE; BIOMET VAPOR; BIOMET VISION FOOTRING SYSTEM; BIOMET WIRE; BIOMET WRENCH; BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR; BLADE; BMP CABLE SYSTEM; BODIES WITH A COMPRESS FEMALE TAPER; BONE CLAMP, ACE EXTERNAL; BONE MILL; BONE MULCH SCREW; BONE MULCH SCREW SYSTEM; BOS Bone Marrow Aspirate Kit; BioCUE Concentration System; BioCUE Concentration System with ACD-A; BioCUE Platelet Concentration Kit; Biomet Headless Compression and Twist-Off Screws; Biomet Kirschner Wires (K-Wires); Biomet Knee Joint Replacement Prostheses; Biomet Microfixation OmniMax MMF System; Biomet Microfixation RibFix Blu Thoracic Fixation System; Biomet Microfixation SternaLock 360 Sternal Closure System; Biomet Microfixation Sternal Closure System; Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial; Biomet Proximal Humerus Plating System; Biomet Variable Pitch Compression Screw System; CALCIGEN-S BONE VOID FILER; CALIPERS; CANNULA; CANNULATED ARTHRORIVET AND CANNULATED RC; CEMENT; CEMENT MONOMER; CEMENT SPACER MOLDS; CEMENTED/UNCEMENTED; CENTRIFUGES; CFE TOTAL HIP FEMORAL COMPONENT; CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021; CLOSURE SYSTEM; CM-6 TOTAL HIP SYSTEM; CO-CR ANSWER FEMORAL COMPONENT; COATED GLENOID COMPONENTS; COATING; COBALT BONE CEMENT; COBALT G HV BONE CEMENT; COBALT MV BONE CEMENT; COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE; COCR BI-ANGULAR HUMERAL COMPONENT; COCR REPICCI II UNICONDYLAR KNEE; COLLARED PROXIMAL POROUS FEMORAL STEMS; COLLES C SERIES FRAME STERILE PACK; COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN; COMPONENT; COMPONENT(GEN II)/VANGUARD; COMPONENTS/MODULAR HEADS/CENTRALIZERS; COMPREHENSIVE; COMPREHENSIVE CONVERTIBLE GLENOID; COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE; COMPREHENSIVE HUMERAL FRACTURE SYSTEM; COMPREHENSIVE PRIMARY SHOULDER STEMS; COMPREHENSIVE REVERSE; COMPREHENSIVE REVERSE SHOULDER; COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSHPERE; COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE; COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS); COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS); COMPRESS ANTI-ROTATION SPINDLES; COMPRESS DISTAL FEMORAL REPLACEMENT; COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM; COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM; COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT; COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM; COMPRESSION; CONSTRUCTS; CONSTRUX EXTERNAL FIXATION DEVICE; CONTOURING; CONTRAINDICATIONS; COPELAND EAS HUMERAL RESURFACING HEADS; COPELAND MB RESURFACING HUMERAL HEADS; COPELAND MB/HA RESURFACING HUMERAL HEADS; CORKSCREW; CORRECTION SYSTEM; CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY; CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE; COUNTERSINK; CRANIOFACIAL ANCHORS; CRIMPER PIN; CRUCIATE LIGAMENT BUTTON; CRUTCH AND; CURVTEK TSR SYSTEM; CUSTOM FLANGED ACETABULAR COMPONENT; CUTTER; CoAxial Applicator System; Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate; Comprehensive Humeral Fracture Positioning Sleeves; Comprehensive Nano Stemless Shoulder; Comprehensive Reverse Shoulder - HA Glenosphere Baseplates; Comprehensive SRS/Nexel Elbow; Comprehensive Segmental Revision System (SRS); Comprehensive Segmental Revision System(SRS); Comprehensive Shoulder System; Comprehensive Vault Reconstruction System; Comprehensive® Convertible Glenoid - Vivacit-E Liner; Comprehensive® Reverse Shoulder; Compress Humeral; Compress and Mini Compress Anti-Rotation Spindles; DECOMPRESSION SYSTEM; DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL; DEPUY ACE AIM TITANIUM TIBIAL NAIL; DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL; DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE; DEPUY ACE COMPOSITE LOCKING NUT; DEPUY ACE SPIDER PLATE; DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE; DEPUY ACE TIMAX META PLATE; DEPUY ACE TROCHANTERIC SIDE PLATE; DEPUY ACE VERSANAIL TIBIAL NAIL; DEPUY AE TK2 HIP SCREW SYSTEM; DEPUY FRACTURE AND FUSION PLATING SYSTEM; DEPUY PEAK FX HIP PLATE; DEPUY ROCKWOOD CLAVICLE PIN; DIAPHYSEAL PLATE; DIMENSION-HA HIP PROSTHESIS; DISCOVERY ELBOW; DISCOVERY ELBOW - X-SMALL; DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT; DISPOSABLE; DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE; DISTAL RADIUS VOLAR RIM PLATE STANDARD AND NARROW; DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM; DISTAL VOLAR RADIUS PLATING SYSTEMS; DISTRACTOR SYSTEM; DORSAL NAIL PLATE, ANATOMICAL; DRILLING SCREWS; DVR DORSAL PLATE; DVR LATERAL PLATE; DVR ULNA PLATE; Discovery Elbow, HA Coated; Distal Centralizers; E-POLY TIBIAL BEARINGS; E1 ANTIOXIDANT INFUSED TECHNOLOGY; E1 AVANTAGE HEAD; E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG; EBI DFS JOINT FIXATOR, MODEL 02800; EBI DFS OPTIROM ELBOW FIXATOR; EBI DISTAL RADIUS PLATING SYSTEM; EBI DYNAFIX COMPRESSION BONE SCREW; EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM; EBI DYNAFIX VISION FOOTPLATE SYSTEM; EBI DYNAFIX VS OSTEOTOMY SYSTEM; EBI OPTILOCK PERIARTICULAR PLATING SYSTEM; EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM; EBI P148 SPINAL FIXATION SYSTEM; EBI PERIARTICULAR PLATING SYSTEM; EBI TROCHANTERIC NAIL SYSTEM; EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM; EBI X FIX DYNAFIX SYSTEM (DFS); EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS; EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM; EBI XFIX DFS OPTIROM ELBOW FIXATOR; EBI XFIX DFS RAIL SYSTEM; EBI XFIX DFS SYSTEM; EBI XFIX DFS WRISTFIX SYSTEM; EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS; EBI XFIX OPTIROM KNEE FIXATOR; EBI XFIX RAIL SYSTEM; EBI XFIX VISION FIXATION SYSTEM; ECHO BI-METRIC MICROPLASTY; ECHO BI-METRIC MICROPLASTY HIP SYSTEM; ECHO BI-METRIC PRESS-FIT STEMS; EVACUATOR; EXPANDABLE KNEE; EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE; EXPLORER RADIAL HEAD PLATING SYSTEM; EXTENSION; EXTERNAL ARTICULATION; EXTRACTORS; EZLOC FEMORAL FIXATION DEVICE; ExpressBraid Graft Manipulation; FACIAL PLATING SYSTEM; FEMORAL CEMENT RESTRICTOR; FEMORAL HOOK; FENNING FEMORAL COMPONENT; FILTER SYSTEM, ALTNER DISPOSABLE; FINE GRAIN CAST COBALT CHROMIUM HIP STEMS; FINN KNEE PROSTHESIS; FINN KNEE SYSTEM; FISCHER WIRE/PIN CLAMP; FIXATORS; FIXED BEARING UNI COMPONENT; FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE; FRACTURE/RECONSTRUCTION; FRAGMENT PLATE SYSTEM; FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES; FREEDOM CONSTRAINED LINERS; FREEMAN/SAMUELSON; FRS SCREW; FULL HEMISPHERE RING-LOC LINER; G7 ACETABULAR SYSTEM; G7 Acetabular System; G7 Dual Mobility System; G7 Dual Mobility System, Active Articulation System; G7 FINNED ACETABULAR SHELL; G7 FREEDOM AND OFFSET LINERS, FREEDOM HEAD, SIZE 32; G7 OSSEOTI ACETABULAR SHELLS; GAUGE; GENERAL USE; GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS; GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH; GONIOMETER; GPS III Mini Platelet Concentrate Separation Kit with ACD-A; GPS III Platelet Concentrate Separation Kit with ACD-A; GPS III Platelet Concentrate Separation Kit with ACD-A Double Kit; GPS PLATELET SEPARATION KI; GROWTH CONTROL PLATING SYSTEM; GUIDE; Gauge  Biomet Depth; HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD; HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH; HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLAR; HAMMER; HAMMERLOC TM TIBIAL FIXATION DEVICE; HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES); HARPOON SUTURE ANCHORS; HEADS; HEALEY REVISION COMPONENT SYSTEM; HFN 125 DEG 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM,; HFN RH 125 DEGREE 9-13MM; HIGH TEMPERATURE CAUTERY; HIP SEMI-CONSTRAINED; HITCH LACTOSORB SUTURE ANCHOR; HOLDING FORCEPS; HUMERAL HEAD; IM TOTAL FEMUR; IMF SCREW; INDEX ACETABULAT COMPONENT; INNERVUE DIAGNOSTIC SCOPE SYSTEM; INSTRUMENT; INSTRUMENTS FOR HIP APPLICATIONS; INTEGRAL CO-CR FEMORAL COMPONENT; INTEGRAL TOTAL HIP SYSTEM; INTEGRATED ENDOSCOPY SYSTEM 1000; INTERGRO DBM; INTERLOK / HA COPELAND RESURFACING HEADS; INTERLOK BIO-MODULAR HUMERAL STEMS; IRRIGATING; JUGGERKNOT; JUGGERKNOT BONE TO BONE IMPLANTS/BONE INSTRUMENTS/BONE IMPLANT AND INSTRUMENT KITS; JUGGERKNOT MINI SOFT ANCHOR; JUGGERKNOTLESS M SOFT ANCHORS; JUGGERKNOTLESS SOF; JUGGERKNOTLESS SOFT ANCHORS; JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES; JuggerKnot Soft Anchors; JuggerStitch Meniscal Repair Device; KIRSCHNER MODULAR HIP SYSTEM; KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS; KIRSCHNER NEER-III PROXIMAL HUMERUS; KIRSCHNER PROXIMAL FEMUR; KIRSCHNER SHOLDERS; KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM; KM-4(TM) METAL-BACKED ACETABULAR CUP; KM-5 METAL; KNEE SYSTEM; KONSTRUCT PATELLAR COMPONENT; LACTOSCREW SCREW ANCHOR; LACTOSORB 5 MM WASHER; LACTOSORB BONE PIN; LACTOSORB CRANIOFACIAL; LACTOSORB HAND SYSTEM; LACTOSORB MENISCAL REPAIR DEVICE; LACTOSORB MENISCAL SCREW; LACTOSORB MINI INTERFERENCE SCREW; LACTOSORB PANEL; LACTOSORB PANELS AND FASTENERS; LACTOSORB PLATES, MESHES, AND PANELS/SHEETS; LACTOSORB POP RIVET; LACTOSORB PUSH SCREW; LACTOSORB RAPIDFLAP; LACTOSORB SUTURE ANCHOR; LACTOSORB TIBIAL L-15 SCREW AND WASHER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY; LAPIDUS PLATE,; LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSIO; LATERALIZED FEMORAL STEM; LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL; LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS; LINERS; LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM; LONG TROCHANTERIC NAIL SYSTEM; LORENZ; LORENZ 1.5 MM; LORENZ 1MM,; LORENZ BLUE DEVICE; LORENZ DISTRACTION; LORENZ IMF SCREW; LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS; LORENZ LACTOSORB PANELS AND FASTENERS; LORENZ PECTUS; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM; LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ RECONSTRUCTION; LORENZ RESORBABLE; LORENZ RESORBABLE DISTRACTION; LORENZ SELF DRILLING SCREWS; LORENZ STERNAL; LORENZ STERNAL CLOSURE SYSTEM; LORENZ TITANIUM FRACTURE; LOWER EXTREMITY EXTERNAL FIXATION; LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS; LactoSorb Heat Pen; M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST); M2A 32MM TAPER SYSTEM; M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR; MAC MALE ADAPTER; MAESTRO CARPAL HEMIARTHROPLASTY; MAESTRO TOTAL WRIST; MAESTRO WRIST FRACTURE IMPLANT; MAK OSS FEMORAL KNEE COMPONENTS; MAK OSS KNEE FEMORAL COMPONENTS; MALLET, SURGICAL, GENERAL AND PLASTIC SURGERY; MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS; MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS; MALLORY-HEAD TOTAL HIP SYSTEM; MALLORY/HEAD - PF ACETABULAR COMPONENT; MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS; MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL; MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA; MALLORY/HEAD TOTAL HIP SYSTEM; MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP; MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL; MANDIBULAR FRACTURE; MANUAL ACCESSORIES; MANUAL CHISEL; MANUAL INSTRUMENT; MAXFIRE MARXMEN MENISCAL; MAXIM ACCEL (VANGUARD) PS+ BEARINGS; MAXIM ACCEL KNEE SYSTEM; MAXIM KNEE SYSTEM; MAXIM RPG PS FEMORAL COMPONENT; MAXROM AND +3 HI-WALL; MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM; MEASURING,; MEDICAL FIBER; MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES,; MEDIVISION ARTHROSCOP; MEMBRANE TACK; MEMORY STAPLE; MEMORY STAPLE (20 SIZES AVAILABLE); METAL SCREW ANCHOR; METAL/CERAMIC; METALLIC TOATAL HIP SYSTEM; MICROMAX SUTURE ANCHOR; MICROPLASTY TIBIAL TRAYS; MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR; MINI BONE PLATES; MIXER; MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE; MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM; MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM; MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR; MODIFICATION TO EBI XFIX DFS SYSTEM; MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL; MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM; MODIFICATION TO SHOULDER FIXATION SYSTEM; MODIFICATION TO SMALL BONE FIXATION SYSTEM; MODIFICATION TO: BIOMET HUMERAL CABLE PLATES; MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR; MODIFIED BMP TROCHANTERIC PLATES; MODIFIED DISTAL RADIUS; MODULAR ARTHRODESIS NAIL; MODULAR FEMORAL HEAD WITH OFFSET TRUNION; MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-; MODULAR HYBRID GLENOID; MODULAR PROTUSIO CUP; MODULAR RADIAL HEAD REPLACEMENT DEVICE; MODULAR REACH HIP; MOLDED POLY TIBIA; MOLDS FOR TEMPORARY HIP; MULTIDIRECTIONAL THREADED PEG; MULTIPLICITY OF PRODUCTS; Manual Surgical Instrument for General Use; NANCY NAIL; NECK PUNCH; NEEDLE; NEURO PACK; NEURO PLATING; NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER; NON-POWERED; OFFSET TIBIAL TRAY; OLECRANON PLATES MODEL 131218704-708; 851318704-708, 1312182; ONCOLOGY SALVAGE SYSTEM; OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING; OPTION CERAMIC HEAD OR; ORTHOPEDIC; ORTHOPEDIC CUTTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME; ORTHOPEDIC SALVAGE SYSTEM - OSS; ORTHOSORB LS; OSS DIAPHYSEAL SEGMENTS; OSS MODULAR STEMS; OSS-BODIES PROXIMAL TIBIAL SLEEVE; OSS/Arcos IM Total Femur Rod; OSSTM Orthopedic Salvage System; OSTEO-CABLE SLEEVE; OSTEOTOMY; OXFORD FIXED LATERAL; OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD; OXFORD MENISCAL UNICOM; OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT; Orthosize; Osteo Tutor; PAR 5 ACETABULAR COMPONENT; PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE; PATIENT CARE SYSTEM; PATIENT USE; PATIENT-SPECIFIC; PATRIOT PROTRUSIO CAGE; PE.R.I. II KNEE FRACTURE SYSTEM; PEANUT GROWTH CONTROL PLATING SYSTEM; PEDIATRIC FIXATION RODS; PEEK KNOTLESS ANCHORS; PEGGED ACETABULAR COMPONENT; PERFUSE PERCUTANEOUS; PIN, DRIVER; PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,; PLATES SYSTEMS; PLATING SYSTEM; PLR SPLINED REVISION STEM; PMI® Custom Device; POLY-MEDICS HEAT PACK; POLYAX LOCKED PLATING SYSTEM; POROUS COATED ACETABULAR COMPONENTS; POROUS COATED COMPREHENSIVE FRACTURE STEMS; POROUS COATED DISCOVERY ELBOW; POROUS LATERALIZED FEMORAL STEM; POROUS METAL; POROUS TITANIUM ACETABULAR AUGMENTS; POROUS TITANIUM ACETABULAR SHELLS; POSITION; POSTERIOR LATERAL PLATES; POWER TEK II; PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO),; PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO),; PRELUDE PF PATELLA COMPONENTS,; PRELUDE PF PATELLAE; PROFILE AND MULTIDIRECTIONAL SCREWS; PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM; PROSTHESES; PROSTHESIS; PROSTHESIS DRIVER; PROSTHESIS WITH REINFORCEMENT STEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER; PROSTHESIS, KNEE, TOTAL; PROSTHESIS,HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED; PROXIMAL CEMENT SPACER; PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW; PUSHER, SOCKET; Patient Specific Planning Solution™ Bone Models; Persona Partial Knee; Persona Partial Knee System; Precision Cannula; RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP; RANAWAT/BURSTEIN TOTAL HIP SYSTEM; RAPIDFIRE SELF; REACH FEMORAL COMPONENT; REACH FEMORAL HIP COMPONENT; REACH HIP COMPONENT; RECONSTRUCTION DEVICES; RECONSTRUCTION PLATING SYSTEM; RECOVERY PROTRUSIO CAGE; REDUCED SIZE ONCOLOGY SALVAGE SYSTEM; REGENEREX POROUS TITANIUM SLEEVE AUGMENTS; REGENEREX TIBIAL COMPONENTS; REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE; REGENERX RINGLOC + MODULAR ACETABULAR SHELLS; REPAIR DEVICE; REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING; REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT; REPICCI II UNICONDYLAR KNEE; REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS; RESORBABLE BONE PINS; RESORBABLE HAMMERTOE PIN; RESORBABLE INTERFERENCE SCREW; RESORBABLE LACTOSORB-L ACL CROSSPIN; RESORBABLE NO PROFILE; RESORBABLE SCREW ANCHOR; RETRACTOR; REUNITE FUSION SCREW; REUNITE SCREWS; REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW; REVERSE SHOULDER; REVISION SYSTEM; RINGLOC + HYBRID ACETABULAR SYSTEM; RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS; RINGLOC BI-POLAR ACETABULAR COMPONENT; RINGLOC CONSTRAINED LINERS; RINGLOC CONSTRAINED LINERS II; ROCKWOOD CLAVICLE PINS; RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM); RULERS AND; RX 90 ACETABULAR COMPONENT SYSTEM; RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM; RX90 FEMORAL COMPONENT; RX90 LOW PROFILE ACETABULAR SYSTEM; Recover G; Recover GP; Recover P; SALVAGE SYSTEM (OSS); SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM; SAW AND; SCALPEL; SCARF THREAD-HEAD SCREW; SCISSORS; SCISSORS, GENERAL SURGICAL; SCP Convenience Kits; SCREW AND WASHER; SCREW SYSTEM; SCREWDRIVER; SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL; SELF-DRILLING; SHOULDER FIXATION SYSTEM; SHOULDER HUMERAL TRAY; SHOULDER NAIL PLATE; SHOULDER SCREWS; SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR; SIGNATURE PERSONALIZED; SIGNATURE PLANNER / SIGNATURE GUIDES; SIGNATURE PLANNER,SIGNATURE GUIDES; SIGNATURE PLANNER; SIGNATURE GUIDES; SIRIUS FEMORAL STEM; SIZE 4MM & XR 123; SLEEVE AND BUTTON SOFT TISSUE DEVICES; SMALL BONE LOCKING PLATING SYSTEM; SMALL EXTERNAL FIXATOR (S/E/F/); SMALL FRAGMENT LOCKING PLATING SYSTEM; SMALL HAMMER TOE PIN; SMPLE PLATE AND SCREWS; SOCKET; SPIN DOWN RAPIDFLAP; SPINDLE AND ANCHOR PLUG); STABILIZER; STAGEONE DISPOSABLE; STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP; STAGEONE SELECT CEMENT SPACER; STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED; STAPLE FIXATION, BONE; SCREW FIXATION BONE; STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S; STERNAL CLOSURE; STERNALOCK SYSTEM; STRIPPER; SUCTION; SUPPORT; SUPPORT BAR; SURGICAL; SURGICAL CLAMP; SURGICAL GOUGE; SURGICAL HOOK; SURGICAL INSTRUMENT; SURGICAL PLIERS; SURGICAL SUTURE; SURGICAL TRAY; SURGICAL, ORTHOPEDIC,; SUTURING; SYRINGE; SYSTEM; SYSTEM (TRAUMAONE); SYSTEM OR EXPANDER; SYSTEM TEN MODEL 100 SURGICAL SYSTEM; SYSTEM WITH MODULAR SCREW; SYSTEM; BI-METRIC FEMORAL COMPONENTS; Sirius Femoral; SnapShot Fixation System; StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis; StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis; StageOne Knee Cement Spacer Molds; StageOne Select Cement Spacer Molds for Temporary Hip Replacement; StageOne Select Hip Cement Spacer Molds; StageOne Shoulder Cement Spacer Molds; Stem, Size 30A; SternaLock® 360 Sternal Closure System; TABLE; TAP; TAPER 2 POROUS FEMORAL STEM; TAPERLOC 12/14 TAPER FEMORAL COMPONENTS; TAPERLOC COMPLETE; TAPERLOC COMPLETE MICROPLASTY STEM; TAPERLOC COMPLETE, SIZE 5 AND 6; TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM; TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS; TEMP F; TEMPFIX EXTERNAL FIXATION SYSTEM; TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE; TEXAS T - PLATE; THACKRAY TITANIUM MINI-PLATING SYSTEM; THE NEW BIO-MOORE ENDO HEADS; THP Hip Fracture Plating System; THREADED PIN, SELF DRILLING; TI - SCREW ANCHOR SP; TI-MAX PROTRUSIO CAGE; TIBIAL BODIES; TIBIAL SLEEVE AUGMENT; TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM; TITANIUM; TITANIUM ANKLE ARTHRODESIS NAIL; TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES; TITANIUM LOW PROFILE SCREWS; TITANIUM PEDIATRIC FEMORAL NAIL; TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS; TITANIUM TOGGLE BUTTON(S); TITANIUM VERSA-DIAL; TOGGLELOC AND JUGGERLOC   Single/multiple component metallic bone fixation appliances  and accessories; TOGGLELOC SYSTEM; TOGGLOC WITH ZIPLOOP INLINE; TOTAL HIP SYSTEM; TOTAL KNEE SYSTEM; TRACTION,; TRAUMA INTERNAL FIXATION SYSTEMS; TRAUMAONE SYSTEM; TRI-POLAR SYSTEM; TROCHANTERIC NAIL; TROCHANTERIC NAIL SYSTEM; TSP HIP FRACTURE; TWIST DRILL; TWIST-OFF (TM) SCREW; TWIST-OFF SCREW; Table and Attachments, Operating-Room; Taperloc Complete Hip Stem; Taperloc® Complete Hip Stems; TiTHON Staple with OsseoTi Technology; Titanium Interference Screws; ToggleLoc System; TunneLoc Tibial Fixation Device; ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT; ULTRA-DRIVE 3; UNIVERSAL ACETABULAR; UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE; VANGUARD 360 OSSEOTI; VANGUARD 360 REVISION KNEE SYSTEM; VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS; VANGUARD ASYMMETRICAL PATELLAR COMPONENT; VANGUARD COMPLETE KNEE SYSTEM; VANGUARD FEMORAL COMPONETS; VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS; VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS; VANGUARD PATELLA COMPONENTS; VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS; VANGUARD REMOVABLE; VANGUARD REMOVABLE MOLDED POLY TIBIA; VANGUARD SSK KNEE SYSTEM; VANGUARD XP; VANGUARD XP FEMORAL; VANGUARD XP KNEE SYSTEM; VARI-ANGLE HIP SCREW (VHS) SYSTEM; VERSA-DIAL HUMERAL HEAD; VERSA-DIAL HUMERAL HEAD PROSTHESIS; VHS PEDIATRIC HIP SCREW SYSTEM; VHS SUPRACONDYLAR PLATE SYSTEM; Vanguard 360 Revision Knee System; Vanguard Knee System; Vanguard XP Knee System; WALKER; WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI; WATSON-FARRAR TOTAL HIP REPLACEMENT; WEDGES; WIN Flexible Nail System; WIRE & STEINMAN PINS; WIRE, ORTHOPEDIC; WITH 44MM BIOLOX DELTA; WITH ORTHOPEDIC; WITH TITANIUM PLASMA SPRAY; WUERZBURG; WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS; WasherLoc™ and No-Profile Screw and Washer Systems; X-SERIES BI-METRIC HIP FEMORAL COMPONENTS; X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS; X-SERIES INTEGRAL RPP FEMORAL COMPONENTS; XFIX DFS RAIL SYSTEM; XFIX DFS SYSTEM; XFIX VISION FIXATION SYSTEM; XP FEMORAL TRIAL; XR-SERIES BI-METRIC FEMORAL COMPONENTS; ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM); ZINDRICK IM ROD; ZINDRICK IM ROD INSTRUMENTS; ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER; ZIRCONIA CERAMIC MODULAR HEADS; Zimmer; Zimmer Biomet; Zimmer Biomet OSS Orthopedic Salvage System OsseoTi Sleeves and Augments; Zimmer Biomet X Series; Zimmer Plates and Screws (ZPS), Forte Screws; Zimmer Plates and Screws (ZPS)-Non-Sterile Plate Line Extension, Sterile/Non-Sterile ZPS, Screws and Washers; Zimmer Plates and Screws (ZPS)-Non-Sterile Plates; Zimmer Plates and Screws System (ZPS)-Non-Sterile Plates and Screws; Zimmer Plates and Screws System-Non Sterile ZPS; component, traction, non-invasive; guide, drill, ligament; nSTRIDE APS Kit; pin, fixation, smooth",1977-12-28,613,2026-09-23,1,254,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221825034%22&limit=1
Synthes (USA) Products LLC,3008812560,3008812560,1301 Goshen Pkwy,West Chester,PA,19380,United States,SYNTHES (USA) Products LLC,2520274,Complaint file establishment; Manufacturer; Specification developer,173,BXB; CAN; DYX; DZI; DZJ; DZK; DZL; EML; ERL; EZX; FDG; FMF; FQP; FSM; FTL; FTM; FTY; FZO; FZT; FZX; FZY; GAA; GAD; GAH; GAQ; GAS; GBX; GDG; GDH; GDI; GDJ; GDX; GDZ; GEA; GEN; GEY; GFA; GFC; GFF; GFG; GFI; GWO; GXL; GXN; GXP; GXQ; GXR; HAW; HBB; HBE; HBG; HBW; HBX; HCF; HRS; HRX; HSB; HSD; HST; HSZ; HTC; HTD; HTE; HTF; HTJ; HTN; HTO; HTQ; HTR; HTT; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWD; HWE; HWJ; HWK; HWM; HWN; HWQ; HWR; HWT; HWW; HWX; HXB; HXC; HXD; HXG; HXI; HXK; HXL; HXO; HXP; HXQ; HXR; HXS; HXW; HXX; HXZ; HYA; IKD; IPM; JDN; JDO; JDP; JDQ; JDR; JDS; JDW; JDZ; JEC; JEY; JTQ; KCT; KDD; KGS; KIH; KIK; KKY; KQW; KTT; KTW; KTZ; KWI; KWP; KWQ; KWT; LOD; LRP; LRW; LRY; LXC; LXH; LXT; LYC; MAI; MAX; MBF; MBI; MDI; MJG; MJO; MNH; MNI; MOQ; MQN; MQP; MQV; MTJ; NBH; NDG; NDN; NEI; NKB; NKG; NQW; OAR; OAT; OCJ; ODP; OIS; OJV; OLO; OMR; OSN; OUR; OVD; OVE; PBJ,"Exerciser, Powered; Regulator, Pressure, Gas Cylinder; Lock, Wire, And Ligature, Intraoral; Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Wire, Fixation, Intraosseous; Screw, Fixation, Intraosseous; Chisel, Bone, Surgical; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Mesh, Surgical, Metal; Retractor, Fiberoptic; Syringe, Piston; Lamp, Operating-Room; Tray, Surgical, Instrument; Mesh, Surgical, Polymeric; Mesh, Surgical; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Aspiration And Injection, Disposable; Retractor; Stylet, Surgical, General & Plastic Surgery; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyester; Catheter, Irrigation; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Scalpel, One-Piece; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Forceps, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Driver, Surgical, Pin; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Osteotome, Manual; Plate, Cranioplasty, Preformed, Alterable; Screwdriver, Skullplate; Plate, Cranioplasty, Preformed, Non-Alterable; Methyl Methacrylate For Cranioplasty; Dura Substitute; Cover, Burr Hole; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Manual); Fastener, Plate, Cranioplasty; Instrument, Cranioplasty Material Forming; Instrument, Ligature Passing And Knot Tying; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Instrument, Compression; Passer; Driver, Prosthesis; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Tamp; Passer, Wire, Orthopedic; Holder, Needle; Orthopedic; Mallet; Pusher, Socket; Instrument, Bending Or Contouring; Crimper, Pin; Spatula, Orthopedic; Twister, Wire; Bender; Screwdriver; Cutter, Wire; Forceps, Wire Holding; Cable, Electrode; Cover, Limb; Implant, Fixation Device, Spinal; Device, Fixation, Proximal Femoral, Implant; Condylar Plate Fixation Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Mixer, Cement, For Clinical Use; Component, Traction, Invasive; Plate, Bone; Bath, Incubators/Water, All; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Retention Device, Suture; Dispenser, Cement; Hook, Bone; Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction; Goniometer, Nonpowered; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Prosthesis, Elbow, Hemi-, Radial, Polymer; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Bone Cement; Tray, Surgical; Scissors, General, Surgical; Punch, Surgical; Monitor, Pressure, Intracompartmental; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Bone Grafting Material, Synthetic; Fastener, Fixation, Biodegradable, Soft Tissue; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Rib Replacement; Device, Percutaneous, Biopsy; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Battery, Replacement, Rechargeable; External Mandibular Fixator And/Or Distractor; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; Wax, Bone; Accessories, Arthroscopic; Washer, Bolt, Nut, Non-Spinal, Metallic; Cement, Bone, Vertebroplasty; Prosthesis, Condyle, Mandibular, Temporary; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Orthosis, Spine, Plate, Laminoplasty, Metal; Injector, Vertebroplasty (Does Not Contain Cement); Implant, Endosseous, Orthodontic; Spinal Channeling Instrument, Vertebroplasty; Intervertebral Fusion Device With Bone Graft, Cervical; Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation; Single Use Instrument Tray; Orthopedic Stereotaxic Instrument; Vessel Guard Or Cover; Software For Diagnosis/Treatment; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Cranial Distraction System",1; 2; 3; U,"1.3 & 1.5MM CONTOURABLE TITANIUM (T; 1.5mm Headless Comp. Screws; 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM; 2.4/2.7mm VA-LCP Forefoot/Midfoot; 2.4MM CORTEX SCREW, SELF-TAPPING; 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES; 2.4mm VA LCP Volar DR Plates; 2.4mm VA-LCP Intercarpal Fusion System; 2.7/3.5 LCP Ant. Lat. Dist. Tibia P; 2.7/3.5 LCP Distal Fibula Plates; 2.7/3.5 VA-LCP Anterior Clavicle Plate Sytem; 2.7MM LCP ULNA OSTEOTOMY SYSTEM; 2.7mm VA LCP Clavicle Plate System; 3.5 MM 90 CANNULATED LIMITED CONTAC; 3.5 MM LCP DISTAL HUMERUS SYSTEM; 3.5/4.5 LCP w/ Expanded Indications; 3.5mm Distal Tibia T Plates; 3.5mm LCP Hook Plate; 3.5mm Locking Attachment Plates; 3.7MM/5MM DYNAMIC LOCKING SCREW; 4.5 VA-LCP Curved Condylar System; 4.5mm/6.5mm Headless Comp. Screws; 4/2.5 MM SELF-DRILLING SCHANZ SCREW; 5/7.3 Crimp Positioning Pins; 6.5mm Midfoot Fusion Bolt; 80:20 Resorbable Polypin; ACIS/Vertebral Spacer CR; ADJUSTABLE LARGE FIXATOR SYSTEM; AND LIGATURE; ANGLED BLADE PLATE; ANTEGRA-T; AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT; ARICULATED TENSION DEVICE SYNTHES TEN; AWL; Akros Fibulink Syndesmosis Repair Kit; Akros Fibulink™ Syndesmosis Repair Kit; Akros Suture Anchor Lisfranc Repair Kit; Ankle Trauma; Aspiration; BONE FORCEPS STANDARD SET; BONE STAPLE(S); BROACH; Bone Marrow Aspiration (BMA) Syringe; Burr, Orthopedic; CANNULATED FEMORAL NAIL; CEMENT MIXING BOWL; CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY; CLAMPFIX; CLICK'X MONOAXIAL SCREWS AND HOOKS; CMFD Mandible; CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD; COUNTERSINK; COUNTERSINK (MULTIPLE BRANDS); CURETTE; Caliper; Cerclage, fixation; ChronOS - GXP; ChronOS BMA; Craniomaxillofacial Distraction System (CMFD); CrossCLIP Implant System; CrossRoads Bone Screw; CrossRoads Screw; CrossRoads Screw System; CrossTIE; CrossTIE Instraosseous Fixation System; DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS); DEPUY SYNTHES MAXFRAME AUTOSTRUT System; DEPUY SYNTHES SPINE DENS ACCESS SYSTEM; DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM; DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY; DYNAMIC CONDYLAR SCREW OR D.C.S.; DYNAMIC HIP SCREW; DePuy Synthes (USA) 5mm / 7.3mm Crimp Positioning Pins – MR Conditional; DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile; DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System); DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System; DePuy Synthes 2mm Quick Insertion Screws; DePuy Synthes 3.5 mm Intrapelvic Acetabular System; DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System; DePuy Synthes 4 Mm And 4.5 Mm Cortex Screws, DePuy Synthes 2.4 Mm Cannulated Screws, DePuy Synthes 3.5 Mm And 4 Mm C; DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional; DePuy Synthes Femoral Neck System; DePuy Synthes Femoral Recon Nail System; DePuy Synthes MatrixNEURO Reconstruction Mesh; DePuy Synthes MatrixSTERNUM Fixation System; DePuy Synthes Maxillofacial Portfolio - MR Conditional; DePuy Synthes Plates And Screws Portfolio; DePuy Synthes Porous Polyethylene Implants And Titanium Wires Portfolio – MR Conditional; DePuy Synthes Static Staples; DePuy Synthes Sterilization Container System; DePuy Synthes T-PAL Ti Spacer; DePuy Synthes TFNA Augmentation System; DePuy Synthes Tibial Nail Advanced; DePuy Synthes Trauma Orthopedic Nail Implants; DePuy Synthes Trauma Orthopedic Plates And Screws; DePuy Synthes Trauma Screws; DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) System; DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System; DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System; DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System; DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2 mm Plates  and Screws); DePuy Synthes Variable Angle Locking Patella Plating System; Dental Bone Cutting Instruments; Depuy Synthes Femoral Neck System; Depuy Synthes Maxillofacial Portfolio - MR Conditional; Depuy Synthes Retrograde Femoral Nail Advanced System; Depuy Synthes Retrograde Femoral Nail Advanced System and DePuy Synthes Locking Screws for Medullary Nails, 5 mm; Device, Percutaneous, Biopsy; Drill Bits & Taps; DynaFORCE; DynaFORCE HiMAX; DynaFORCE MotoBAND Max; DynaFORCE MotoCLIP MAX; DynaFORCE VERO; EXPEDIUM Spine System/Synapse System; Elevator; Epoca Shoulder Prosthesis, HA Stems; GONIOMETER; GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY; Guide, Surgical, Instrument; HAMMERLOCK 2; HEX BUTTON; HOHMANN RETRACTOR; Hammerlock; Hammertoe Continuous Compression Implant; HiMAX; HiMAX Plus; Hook; IMPACTOR; INSTRUMENT SET FOR ANGLED BLADE; INSTRUMENT SET FOR RE; INTRAORAL; Injector, Vertebroplasty (Does Not Contain Cement); Instrument, surgical, orthopedic, pneumatic powered & accessory/attachment; Introduction/drainage catheter and accessories; Keel Lock; LCP RADIAL HEAD PLATING SYSTEM; LOCK; LOCKING CONDYLAR PLATE (LCP) SYSTEM; MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM); MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM; MATRIXRIB FIXATION SYSTEM; MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System; MAXFRAME Autostrut; MAXFRAME Multi-Axial Correction System (Aka MAXFRAME); MAXILLARY DISTRACTOR; MEDULLARY INSTRUMENT SET; MIS Bunion Plating System; MOBILIMB-CPM UPPER/LOWER LIMB DEVICE; MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM; MODIFICATION TO SYNTHES MATRIX SYSTEM; MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD; MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES; MODULAR FOOT SYSTEM - 2.7 MM; MR Conditional; Mandible External Fixator - MR Conditional; Manual surgical instrument; Matrix CoCr Locking Cap; Matrix Sagittal screws; MatrixMANDIBLE Fine Pitch Screws; MatrixMANDIBLE Reconstruction Plates; MatrixMandible Self-Drilling Screws; MatrixORTHOGNATHIC Plating System; MatrixRIB Fixation System; MatrixWAVE MMF System; Maxframe; MiniBUNION Plating System; MotoBAND; MotoBAND CP; MotoBAND CP DynaForce; MotoBAND Max; MotoCLIP; MotoCLIP Superelastic Fusion System; MotoCLIP/HiMAX Step Staple Implant System; NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY; NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY; Norian CRS; Norian Drillable; OPAL Spacer; ORTHODONTIC BONE ANCHOR SYSTEM; OSSE-LIGN; OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS; Oracle spacer, opal spacer; Orthomesh; Orthopedic manual surgical instrument; PELVIC C-CLAMP; PLASTIC SPATULA; POSITIONING PLATE; PRODISC; PRODISC-C TOTAL DISC REPLACEMENT; PROXIMAL FEMORAL NAIL (PFN) SYSTEM; Passer; Periarticular Prox Humerus Plates; Plate; Porous Polyethylene Implants; Posteromedial Proximal Tibia Plate; Punch, Surgical; RAM; RAPIDSORB PLUS SCREW SYSTEM; RASP; REAMER; REGULATORS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES; RONGEUR; Radial Head; Radial Head Prosthesis; Rapid Resorb. Cranial Clamp; Rapid Resorbable Tack System; Resorbable Cranial Clamp; Retention Device, Suture; SCHUHLI IMPLANT SYSTEM; SCREWDRIVER; SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM; SMALL FRAGMENT DYNAMIC COMPRESSION; SMALL STATURE USS; SMALL TITANIUM WRIST FUSION PLATE; SMF Resorbable Mesh and Sheets; SMF STAINLESS STEEL BONE SCREWS; SMF TITANIUM (TI) ALLOY BONE SCREWS; SPEEDBUTTON ANCHOR SYSTEM; SPIKED WASHER; SPL CRIMP SYSTEM; STERILE BUTTON PLATE; STROPP; STRoPP; SUSA Resorbable Mesh and Sheets; SUTURE GRASPER; SUTURE PASSER; SYN VA LCP ELBOW SYS MEDIAL & POSTERLAT DISTAL HUMERUS PLT; SYNAPSE SYSTEM; SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM; SYNEX II; SYNFIX Evolution Secured Spacer System; SYNFIX-LR; SYNFIX-LR SPACER; SYNFRAME; SYNMESH System; SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY; SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE; SYNTHES (U.S.A.) POLYPIN; SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM; SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACR; SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIV; SYNTHES (USA) (SYNTHES) LOW PROFI; SYNTHES (USA) (SYNTHES) SINGLE VECT; SYNTHES (USA) 1.3 MM CRANIOFACIAL S; SYNTHES (USA) 1/1.22 MM CRANIOFAC; SYNTHES (USA) 2.4 MM LCP WRIST PLAT; SYNTHES (USA) 2.4/2.7 MM LOCKING FO; SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP; SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES; SYNTHES (USA) 3.5 MM BROAD LCP & 4.; SYNTHES (USA) 3.5/4.5MM LCP MEDIAL; SYNTHES (USA) 3.5MM CONICAL SCREWS; SYNTHES (USA) 6.5 MM CANCELLOUS SCR; SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM; SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM; SYNTHES (USA) CALVICLE HOOK PLATE; SYNTHES (USA) CANNULATED TITANIUM H; SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM; SYNTHES (USA) CLAVICLE HOOK PLATES; SYNTHES (USA) COMPARTMENTAL PRESSUR; SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM; SYNTHES (USA) CRANIOFACIAL PLATES; SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM; SYNTHES (USA) DDHS/DCS SYSTEM MODIF; SYNTHES (USA) DHS HELIX SYSTEM; SYNTHES (USA) DISTAL FEMUR PLATE (D; SYNTHES (USA) DISTAL RADIUS PLATE S; SYNTHES (USA) ELASTIC INTRAMEDULLAR; SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION; SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE; SYNTHES (USA) ELBOW HINGE FIXATOR; SYNTHES (USA) ELECTRIC PEN DRIVE SY; SYNTHES (USA) EPOCA SHOULDER PROSTH; SYNTHES (USA) EXTERNAL FIXATION COM; SYNTHES (USA) EXTERNAL MULTI VECTOR; SYNTHES (USA) FLEXIBLE HUMERAL NAIL; SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS; SYNTHES (USA) HYDROXYAPATITE (HA) C; SYNTHES (USA) IMF SCREWS; SYNTHES (USA) LARGE EXTERNAL FIXATI; SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP); SYNTHES (USA) LATERAL ENTRY FEMORAL; SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM; SYNTHES (USA) LCP CURVED PLATES; SYNTHES (USA) LCP DYNAMIC HELICAL H; SYNTHES (USA) LCP MODULAR FOOT PLAT; SYNTHES (USA) LCP PROXIMAL FEMUR HO; SYNTHES (USA) LCP PROXIMAL FEMUR PL; SYNTHES (USA) LCP PROXIMAL HUMERUS; SYNTHES (USA) LCP WRIST FUSION PLAT; SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM; SYNTHES (USA) LOW-PROFILE WRIST FIX; SYNTHES (USA) MEDIAL DISTAL TIBIA P; SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM; SYNTHES (USA) MIDFACE DISTRACTOR; SYNTHES (USA) MIDFACIAL SYSTEM; SYNTHES (USA) MODIFICATION TO STERN; SYNTHES (USA) MODULAR MINI FRAGMENT; SYNTHES (USA) NEURO PLATE AND SCREW; SYNTHES (USA) NEW/STERIAL ORBITAL P; SYNTHES (USA) ORIBITAL MESH PLATES; SYNTHES (USA) PATIENT SPECIFIC CRAN; SYNTHES (USA) PEDIATRIC LCP HIP PLA; SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RATCHETING DISTRACTOR; SYNTHES (USA) REAMER IRRIGATOR AS; SYNTHES (USA) RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RESORBABLE TACK SYSTEM; SYNTHES (USA) RETROGRADE/ANTEGRADE; SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM; SYNTHES (USA) RIA SYSTEM; SYNTHES (USA) SMALL ADJUSTABLE CLAM; SYNTHES (USA) SPHERICAL WASHERS; SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM; SYNTHES (USA) STERILE ADJUSTABLE DI; SYNTHES (USA) STERILE STERNAL FIXAT; SYNTHES (USA) STERNAL FIXATION SYST; SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION; SYNTHES (USA) STERNAL RECONSTRUCTIO; SYNTHES (USA) SYNTHES MMFS-ADJUSTAB; SYNTHES (USA) TIBIAL NAIL SYSTEM EX; SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER; SYNTHES (USA) TITANIUM WIRE; SYNTHES (USA) TROCHANTER STABILIZ; SYNTHES (USA) TROCHANTER STABILIZAT; SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM; SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST; SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM); SYNTHES (USA) VARIABLE ANGLE-LOCKIN; SYNTHES (USA) WRIST FUSION PLATES (; SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS); SYNTHES (USA) [SYNTHES] MINI EXTERN; SYNTHES (USA) [SYNTHES] MMFS - 2; SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]; SYNTHES (USA) [SYNTHES} PERI-PROSTH; SYNTHES 1.3 MM SELF-DRILLING SCREW; SYNTHES 1.5MM TI BROW LIFT SCREW; SYNTHES 1.5MM/2MM ORTHOGNATHIC MA; SYNTHES 1/1.2 MM PLUSDRIVE SCREWS; SYNTHES 1MM TI. CORTEX, SELF-DRIL; SYNTHES 1MM TI. CORTEX, SELF-DRILLING SCREWS; SYNTHES 2 MM CRANIOFACIAL LOCKING PLATES; SYNTHES 2 MM LOCKING PLATE SYSTEM; SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW; SYNTHES 2.4 MM CANNULATED SCREW; SYNTHES 2.4 MM TITANIUM (TI.) LOCKI; SYNTHES 2.4 MM UNIVERSAL LOCKING PL; SYNTHES 2.7 MM CANNULATED SCREW AND; SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE; SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES; SYNTHES 3 MM PC-FIX SYSTEM; SYNTHES 3.5 MM BROAD LC-DCP PLATES; SYNTHES 3.5 MM LOW PROFILE PELVIC R; SYNTHES 3.5MM CORTEX SCREWS; SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM; SYNTHES 3.5MM SPRING PLATE; SYNTHES 3.5MM TITANIUM LCP PROXIMAL; SYNTHES 3.9 MM PELVIC SCREWS; SYNTHES 3MM HEADLESS COMPRESSION; SYNTHES 4 AND 5 MM LOCKING SCRE; SYNTHES 4 MM ADJUSTABLE CLAMP FOR; SYNTHES 4.5 MM LCP POSTEROLATERAL P; SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES; SYNTHES 4.5 MM TITANIUM LCP PROXIMA; SYNTHES 4MM TITANIUM (TI.) LOCKIN; SYNTHES 5/7.3 MM CANNULATED LOCKI; SYNTHES 6.5 MM CANNULATED SCREW; SYNTHES 7/7.3 MM CANNULATED SCREW; SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR; SYNTHES ADOLESCENT LATERAL ENTRY FE; SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM; SYNTHES AFS; SYNTHES AIR PEN DRIVE (APD) SYSTEM; SYNTHES ANATOMICAL LOCKING PLATE SYSTEM; SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS); SYNTHES ANKLE ARTHRODESIS PLATE; SYNTHES ANTEGRA SYSTEM; SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM; SYNTHES ANTERIOR CERVICAL LOCKING P; SYNTHES ANTERIOR CSLP SYSTEM; SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM; SYNTHES ANTEROLATERAL CALCANEAL PLA; SYNTHES BIORESORBABLE SUTURE ANCHOR; SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS; SYNTHES BUTTON PLATE; SYNTHES CALCANEAL PLATE; SYNTHES CANNULATED ANGLE BLADE PLAT; SYNTHES CERVICAL VERTABRAE PLATES; SYNTHES CERVIFIX SYSTEM; SYNTHES CERVIFIX/ AXON; SYNTHES CHRONOS COMPOSITE; SYNTHES COMBINATION CLAMP AND DYNAM; SYNTHES CONTOURED SYNMESH SPACER; SYNTHES CRANIAL FLAP TUBE CLAMP; SYNTHES CRANIAL PLATES; SYNTHES CRANIAL SPRING CLIP (CSC); SYNTHES CRANIOFACIAL PLATES; SYNTHES CURVED RECONSTRUCTION PLATE; SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM; SYNTHES DISTRACTION OSTEOGENESIS SY; SYNTHES DORSAL DISTAL RADIUS PLATE; SYNTHES ELASTIC INTRAMEDULLARY NAIL; SYNTHES EXTERNAL FIXATION DEVICES,; SYNTHES EXTERNAL MIDFACE DISTRACTOR; SYNTHES FLEXNAIL; SYNTHES HAMSTRING LOOP; SYNTHES HEMOSTATIC BONE PUTTY; SYNTHES HEMOSTATIC BONE PUTTY (HBP); SYNTHES HIGH TIBIAL OSTEOTOMY (HTO); SYNTHES HIGH TIBIAL OSTEOTOMY PLATE; SYNTHES HINDFOOT ARTHRODESIS NAIL S; SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM; SYNTHES LARGE COMBINATION CLAMP AND; SYNTHES LARGE FRAGMENT DYNAMIC COMP; SYNTHES LCP ANKLE ARTHRODESIS PLATE; SYNTHES LCP DIAPHYSEAL-METAPHYSEAL; SYNTHES LCP DISTAL FEMUR PLATES; SYNTHES LCP DISTAL TIBIA PLATES; SYNTHES LCP DYNAMIC HELICAL HIP SYS; SYNTHES LCP PEDIATRIC PLATE SYSTEMS; SYNTHES LCP PROXIMAL HUMERUS PLATES; SYNTHES LCP PROXIMAL TIBIA PLATE; SYNTHES LCP PROXIMAL TIBIA PLATES L; SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT; SYNTHES LOCKING CALCANEAL PLATES; SYNTHES LOCKING DISTAL RADIUS PLATI; SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEA; SYNTHES LOW PROFILE NEURO SYSTEM; SYNTHES LOW PROFILE NEURO SYSTEM -; SYNTHES LOW PROFILE RECONSTRUCTION; SYNTHES MANDIBLE DISTRACTOR; SYNTHES MANDIBLE EXTERNAL FIXATOR; SYNTHES MANDIBULAR MODULAR FIXATION; SYNTHES MATRIX MIS RODS; SYNTHES MATRIXMANDIBLE PLATE AND SC; SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES; SYNTHES MAXILLOFACIAL TITANIUM MICR; SYNTHES MEDIUM EXTERNAL FIXATION SY; SYNTHES METALLIC SPIKED WASHERS; SYNTHES MIDFACE DISTRACTOR; SYNTHES MINI EXTERNAL FIXATOR; SYNTHES MINI LENGTHENING APPARATUS; SYNTHES MIRS; SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM; SYNTHES MODULAR FOOT SYSTEM; SYNTHES MULTILOC HUMERAL NAILING SYSTEM; SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM; SYNTHES OC FUSION AND SYNAPSE SYSTEMS; SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM; SYNTHES ORACLE SPACER; SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM; SYNTHES PANGEA MONOAXIAL SYSTEM; SYNTHES PANGEA SYSTEM; SYNTHES PATIENT SPECIFIC CRANIAL/CR; SYNTHES PEDIATRIC ROD SYSTEM; SYNTHES PILON PLATE; SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY; SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM; SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION; SYNTHES PROXIMAL HUMERAL NAIL; SYNTHES PROXIMAL TIBIA PLATING SYST; SYNTHES QUICK LOCK IMF SYSTEM; SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM; SYNTHES RECONSTRUCTIVE PLATES `Y` P; SYNTHES RESORBABLE CONTOURABLE MESH; SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED); SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM; SYNTHES RIB FIXATION SYSTEM; SYNTHES SACRAL BAR SYSTEM; SYNTHES SCALLOPED DISTAL TIBIA PLAT; SYNTHES SCHUHLI IMPLANT SYSTEM; SYNTHES SCOUT VESSEL GUARD; SYNTHES SIMPLE SMALL EXTERNAL FIXAT; SYNTHES SMALL COBINATION CLAMP-MR SAFE; SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM; SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM; SYNTHES SPINE PEDIATRIC ROD SYSTEM; SYNTHES SPINE POSTERIOR CERVICAL/TH; SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM; SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLAT; SYNTHES SPIRAL BLADE FOR HUMERAL NA; SYNTHES STAINLESS STEEL MODULAR HAN; SYNTHES STERILE 2.7 MM RECONSTRUCTI; SYNTHES STERILE 3 MM CANNULATED S; SYNTHES STERILE 3.5 MM AND 4 MM C; SYNTHES STERILE DRILL BITS; SYNTHES STERILE LOW PROFILE NEURO C; SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT; SYNTHES STERILE PINLESS EXTERNAL FIXATOR; SYNTHES STERNAL FIXATION SYSTEM; SYNTHES STERNAL ZIPFIX SYSTEM; SYNTHES STRAIGHT WRIST FUSION PLATE; SYNTHES SYNCAGE EVOLUTION SPACER; SYNTHES SYNEX SPACER SYSTEM; SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM; SYNTHES SYNMESH; SYNTHES SYNMESH SPACER SYSTEM; SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPL; SYNTHES T-PAL SPACER; SYNTHES TI-15 MO LOCKING DISTAL RAD; SYNTHES TI-6AI-7NB UNREAMED FEMORAL; SYNTHES TITANIUM (TI) ALLOY HIGH TI; SYNTHES TITANIUM ALLOY VOLAR DISTAL; SYNTHES TITANIUM DIASTAL FEMORAL NA; SYNTHES TITANIUM EXTERNAL FIXATOR C; SYNTHES TITANIUM MULTI-VECTOR DISTR; SYNTHES TITANIUM UNREAMED FEMORAL NAIL; SYNTHES TOMOFIX OSTEOTOMY SYSTEM; SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL; SYNTHES TRANSLATING MAXILLARY DISTR; SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES; SYNTHES UNIVERSAL LOCKING TROCHANTE; SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION; SYNTHES UNREAMED HUMERAL NAIL (URHN; SYNTHES USS (10MM SIDE OPENING SCREWS; SYNTHES USS CONNECTOR; SYNTHES USS CONNECTORS; SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM; SYNTHES VECTRA SYSTEM; SYNTHES VECTRA-ONE SYSTEM; SYNTHES VECTRA-T SYSTEM; SYNTHES VERTEBRAL SPACER TI; SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW); SYNTHES WIRE MOUNT; SYNTHES ZERO-P; SYNTHES ZERO-P VARIABLE ANGLE (VA); SYNTHES(U.S.A.) ANTERIOR SPINAL PLA; SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS); SYNTHS ONE-THIRD TUBULAR DCL PLATE; SYnthes XRL; Screw Selection Probe; Spinal Channeling Instrument, Vertebroplasty; Staple; Suprapatellar; Surgical Scissors; Synapse Occipital-Cervical-Thoracic (OCT) System; SyntheCel; Synthes (USA) 2.4 VA-LCP 2-Col Narr; Synthes 1.5mm Mini Fragment LCP Sys; Synthes 2.4 LCP Vol. Col. Distal Ra; Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System; Synthes 3.5 Quadrilateral Surface P; Synthes 3.5/4.5 Curved Narrow/Broad; Synthes 3.5mm LCP Clavicle Plate Sy; Synthes 3.5mm VA-LCP Proximal Tibia Plate; Synthes 4.5mm VA-LCP Curved Condylar Plate System; Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins; Synthes 6 CoCr and CP Ti - 3 Rods; Synthes 7.3mm Cann. SCFE Screws; Synthes 90 Degree Screwdriver; Synthes Cervifix System; Synthes Clampfix System; Synthes Cortex Screws; Synthes Craniofacial Plate & Screw; Synthes Curvilinear Distraction System; Synthes Distraction Osteogenesis Sy; Synthes Falcon Spacers; Synthes Hybrid External Fixator; Synthes In-Situ Bender/Cutter; Synthes Large Ex Fix MR Conditional; Synthes Light Guide; Synthes Locking Hand Plates; Synthes MATRIXMANDIBLE SUBCONDYLAR; Synthes Matrix System; Synthes MatrixMANDIBLE Preformed Reconstruction Plates; Synthes Navigable Pedicle Preparation Instruments; Synthes Oracle Plate; Synthes Patient Specific Implants; Synthes Patient Specific Plates; Synthes Reprocessed External Fixati; Synthes Self-Drilling Schanz Screw; Synthes Set Screw for Ti Trochanteric Fixation Nail (TFN); Synthes Sternal Fixation System; Synthes Synapse 4 System; Synthes Synapse Transconnector; Synthes Synsonic Ulna Nail System; Synthes SyntheCel Dura Replacement Devices; Synthes TFN Screw; Synthes Thoracolumbar Spine Locking; Synthes USA RIA System; Synthes Universal Spinal System; Synthes Zero-P; Synthes graphic case & tray system; Synthes(USA) 3.5mm Low Profile Cortical Screw; TENSION DEVICE; TI-6AL-7NB URTN; TI. ALLOY 2 MM CORTEX SCREW; TITANIUM CANNULATED TIBIAL NAIL (TI; TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS); TITANIUM TUBE TO TUBE CLAMP; TITANIUM UNIVERSAL CLAMP; TORQUE LIMITING ATTACHMENT; TRAUMACEM™ V+ Injectable Bone Cement; TRAUMAFIX (TM) EXTERNAL FIXATOR; TRAYS AND RACKS.; TRILEAP Plating System; TRS C-BVF; Tamp; Titanium Small Recon Plates; Titanium T-Plate; Titanium TomoFix Medial High Tibia Plate Anatomical; TomoFix Medial Distal Femur Plates; Tomofix; Trauma Screw; Tray, Surgical; TriLEAP Plating System; TriMAX Implant System; Trochanteric Reattachment Device; TruMatch Graft Cage - Long Bone; UNIVERSAL FEMORAL NAIL; UNIVERSAL TIBIAL NAIL AND UNREAMED; USS Iliosacral and Polyaxial System; USS-LINE EXTENSION; VA LCP Two-Column Volar Distal Radius Plate 2.4/2.7 mm, Extra-Long; VARIOUS TYPES AND; VARIOUS TYPES OF CASES; VARIOUS TYPES OF GUIDES; VARIOUS TYPES OF HAMMERS; VARIOUS TYPES OF IMPACTORS; VARIOUS TYPES OF MANUAL; VARIOUS TYPES OF SPI; VBB SYSTEM; VERO; VERTEBRAL SPACER; VOLAR DISTAL RADIUS PLATE; VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System; VOLT™ Proximal Humerus 3.5 Plating System; Vertecem; Vertecem II; Vertical Expandable Prosthetic Titanium Rib; WAGNER RESURFACE INSTRUMENT SET; WATER BATH TRAY; WIRE INSTRUMENT SET; WIRE PASSER; WRENCH; ZERO-P NATURAL PLATE; Zero-P VA; appliance; arthoscopic accessories; battery; bender; bit; blade; bone filler; bone grafting material; bone screw; bur; cable; cannula; chisel; chronOS - ß-TCP - LPK; clamp; cover, limb; cutter, surgical; cutter, wire; dispenser; dissector, surgical, general & plastic surgery; drill kit; driver; ePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm); forceps; gauge; general, plastic surgery; hook; instrument; instrument, surgical, orthopedic, ac-powered motor and accessory/attachment; mandibular fiaxtion; measuring; osteotome; osteotome, manual; plate; pliers; power; probe; pusher, socket; retractor; scalpel; screw; screwdriver, skullplate; spine fixation; spine instrument; tap; traction; trephine",1978-03-16,597,2026-06-11,2,74,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008812560%22&limit=1
Sanicure BV,3012494290,3012494290,Evert van de Beekstraat 104,SCHIPHOL Noord-Holland,,11118 CN,Netherlands,Sanicure BV,10052769,Exporter to the US,414,BSF; BSJ; BSP; BSR; BSS; BSY; BTG; BTK; BTO; BTR; BTT; BWC; BWF; BYD; BYE; BYG; BYP; BYY; BZA; BZG; BZH; BZO; CAE; CAH; CAI; CAZ; CCK; CCQ; CCW; CCX; CDM; CEN; DOF; DQA; DQD; DQO; DQY; DRG; DRT; DRX; DSF; DWD; DWH; DWI; DWJ; DWL; DXN; DXO; DXQ; DYH; DZA; DZN; DZP; EAT; EAX; EBC; EBF; EBG; EBI; EBL; EBZ; ECB; ECS; EFA; EFB; EFN; EFS; EFX; EGD; EGS; EGZ; EHK; EHL; EHM; EHY; EHZ; EIA; EID; EIE; EIG; EIH; EIL; EJG; EJI; EJJ; EJK; EJL; EJQ; EKD; EKL; EKM; EKR; EKS; ELC; ELR; ELW; ELZ; EMA; EMD; EMF; EMG; EMJ; EMN; EMS; EOQ; EPN; EPP; EQJ; ERA; ERL; ESD; ETD; EWO; EXB; EXH; EYK; EYQ; EZQ; FAM; FBQ; FCG; FCL; FCM; FCY; FDI; FDS; FER; FFL; FFO; FHK; FHN; FHO; FHQ; FKX; FLL; FMF; FMH; FMI; FMK; FMP; FMR; FOZ; FPA; FPB; FPD; FQH; FQL; FQM; FQP; FRC; FRG; FRN; FRO; FRZ; FSH; FSM; FWW; FXX; FXY; FYA; FYD; FYF; FZP; FZS; FZX; GAA; GAD; GAL; GAM; GAP; GAQ; GAR; GAT; GAW; GAZ; GBS; GBW; GBX; GCA; GCD; GCJ; GCX; GCY; GDM; GDO; GDT; GDX; GEA; GEG; GEI; GEN; GES; GFA; GFB; GFF; GGK; GIO; GKR; GNX; GQG; GTZ; GWQ; GXB; GXY; GXZ; GYB; HAB; HAM; HAW; HBA; HBE; HBF; HBO; HBT; HET; HFF; HFG; HFW; HGE; HHI; HHK; HIB; HIF; HIH; HJN; HLI; HLJ; HLS; HMR; HMX; HNN; HNY; HOY; HOZ; HRX; HTC; HTD; HTR; HTW; HTY; HWE; IKT; ILH; ILI; IOY; IPT; IQE; IQI; IQK; IQZ; ITG; ITW; ITX; IYO; JAY; JCX; JDZ; JEP; JFA; JHI; JIL; JIN; JIO; JIR; JJB; JJH; JJX; JJY; JKA; JMA; JMT; JOH; JOJ; JOS; JOW; JQC; JRC; JRE; JSM; JTW; JXW; JYR; KBE; KBN; KCL; KCT; KCY; KDC; KDI; KDQ; KDT; KEO; KES; KGC; KGN; KGO; KGX; KGZ; KHA; KHR; KIF; KIZ; KKX; KLE; KME; KMF; KMK; KMW; KNP; KNQ; KNS; KNT; KNW; KOC; KOX; KQO; KQT; KTI; KTN; KXG; KXR; KYG; KYW; KYX; KYZ; LBH; LDE; LFL; LGH; LGX; LGZ; LHI; LJC; LJE; LJH; LJT; LJX; LKF; LQY; LRC; LRW; LRY; LSL; LWH; LWK; LXH; LYR; LYU; LYY; LZA; LZC; MBI; MDM; MEG; MGP; MHW; MJM; MKJ; MLA; MLN; MLR; MMK; MMP; MND; MNK; MNL; MPN; MQB; MQM; MSH; MUH; MVL; MWI; MZO; MZR; NAB; NAC; NAD; NAE; NBH; NBY; NDP; NEC; NEW; NFB; NGT; NKC; NNI; NOC; NRD; NRU; NYL; NZP; OAS; OCC; OCT; ODG; OEA; ONB; OOI; OPJ; OZE; OZN; PGX; PIO; PKL; PPM; PSZ; PTM; PUI; QBP; QDO; QJC; QSU,"Absorber, Carbon-Dioxide; Mask, Gas, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Tube, Nasogastric; Catheters, Suction, Tracheobronchial; Brush, Biopsy, Bronchoscope (Non-Rigid); Strap, Head, Gas Mask; Tube, Tracheostomy (W/Wo Connector); Tube, Tracheal (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Needle, Emergency Airway; Spirometer, Therapeutic (Incentive); Condenser, Heat And Moisture (Artificial Nose); Attachment, Breathing, Positive End Expiratory Pressure; Mask, Oxygen; Mouthpiece, Breathing; Tube, Aspirating, Flexible, Connecting; Connector, Airway (Extension); Spirometer, Diagnostic; Meter, Peak Flow, Spirometry; Set, Tubing And Support, Ventilator (W Harness); Airway, Oropharyngeal, Anesthesiology; Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Anesthesia Conduction Kit; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Laryngoscope, Rigid; Support, Patient Position; Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.); Dye-Indicator, Ph (Urinary, Non-Quantitative); Lead, Atomic Absorption; Oximeter; Stethoscope, Electronic; Catheter, Intravascular, Diagnostic; Catheter, Percutaneous; Transmitters And Receivers, Physiological Signal, Radiofrequency; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Electrode, Electrocardiograph; Recorder, Paper Chart; Suction Control, Intracardiac, Cardiopulmonary Bypass; Blade, Saw, Surgical, Cardiovascular; Saw, Electrically Powered; System, Thermal Regulating; Stocking, Medical Support (To Prevent Pooling Of Blood In Legs); System, Measurement, Blood-Pressure, Non-Invasive; Transducer, Pressure, Catheter Tip; Blood Pressure Cuff; Adhesive, Bracket And Tooth Conditioner, Resin; Drill, Dental, Intraoral; Instruments, Dental Hand; Instrument, Diamond, Dental; Tester, Pulp; Mirror, Mouth; Sealant, Pit And Fissure, And Conditioner; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Resin, Denture, Relining, Repairing, Rebasing; Pin, Retentive And Splinting, And Accessory Instruments; Activator, Ultraviolet, For Polymerization; Unit, Syringe, Air And/Or Water; Pusher, Band, Orthodontic; Handpiece, Belt And/Or Gear Driven, Dental; Handpiece, Air-Powered, Dental; Cotton, Roll; Unit, Oral Irrigation; Protector, Silicate; Wax, Dental, Intraoral; Handpiece, Contra- And Right-Angle Attachment, Dental; Holder, Film, X-Ray; Cup, Prophylaxis; Point, Abrasive; Strip, Polishing Agent; Tray, Impression, Preformed; Evacuator, Oral Cavity; Unit, Operative Dental; Syringe, Restorative And Impression Material; Dam, Rubber; Retractor, All Types; Powder, Porcelain; Gauge, Depth, Instrument, Dental; Forceps, Rubber Dam Clamp; Syringe, Cartridge; Alloy, Amalgam; Liner, Cavity, Calcium Hydroxide; Bur, Dental; Wheel, Polishing Agent; Instrument, Cutting, Operative; Point, Silver, Endodontic; Gutta-Percha; Plugger, Root Canal, Endodontic; File, Pulp Canal, Endodontic; Scaler, Ultrasonic; Post, Root Canal; Material, Impression; Crown, Preformed; Cement, Dental; Hemostat, Surgical; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Elevator, Surgical, Dental; Scaler, Periodontic; Curette, Periodontic; Bronchoscope (Flexible Or Rigid); Pump, Nebulizer, Manual; Splint, Nasal; Bur, Ear, Nose And Throat; Otoscope; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Hearing Aid, Air-Conduction, Prescription; Tube, Tympanostomy; Audiometer; Collector, Ostomy; Bag, Urinary, Ileostomy; Connector, Ureteral Catheter; Garment, Protective, For Incontinence; Pouch, Colostomy; Sigmoidoscope And Accessories, Flexible/Rigid; Trocar, Gastro-Urology; Biopsy Needle; Forceps, Biopsy, Non-Electric; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Bulb, Inflation, For Endoscope; Snare, Flexible; Gastroscope And Accessories, Flexible/Rigid; Anoscope And Accessories; Dislodger, Stone, Basket, Ureteral, Metal; Retractor, Self-Retaining; Spreader, Bladder Neck; Ligator, Hemorrhoidal; Pneumoperitoneum Needle; Holder, Needle, Gastroenterologic; System, Peritoneal, Automatic Delivery; Continuous Measurement Thermometer; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Protector, Skin Pressure; Device, Transfer, Patient, Manual; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Filter, Infusion Line; Tube, Feeding; Lavage, Jet; Stocking, Medical Support (For General Medical Purposes); Bandage, Elastic; Lamp, Operating-Room; Indicator, Biological Sterilization Process; Wrap, Sterilization; Pump, Infusion; Dressing, Wound, Drug; Device, Patient Transfer, Powered; Tray, Surgical, Needle; Tray, Surgical, Instrument; Table, Operating-Room, Pneumatic; Mask, Surgical; Hood, Surgical; Gown, Surgical; Apparatus, Exhaust, Surgical; Cap, Surgical; Clip, Implantable; Curette, Surgical, General Use; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Retractor; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tubing, Noninvasive; Catheter, Ventricular, General & Plastic Surgery; Catheter, Peritoneal; Catheter, Irrigation; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Connector, Catheter; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Needle, Aspiration And Injection, Reusable; Applier, Surgical, Clip; Staple, Removable (Skin); Scalpel, One-Piece; Cannula, Surgical, General & Plastic Surgery; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Blade, Scalpel; Blade, Saw, General & Plastic Surgery, Surgical; Head, Surgical, Hammer; Bur, Surgical, General & Plastic Surgery; Products, Red-Cell Lysing Products; Tube, Collection, Capillary Blood; System, Hemoglobin, Automated; Antigens, Cf (Including Cf Control), Influenza Virus A, B, C; Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus; Antisera, All Groups, Streptococcus Spp.; Full-Montage Standard Electroencephalograph; Esthesiometer; Electrode, Cutaneous; Electrode, Needle; Media, Electroconductive; Saw, Powered, And Accessories; Apparatus, Electrosurgical; Neurological Stereotaxic Instrument; Neurosurgical Paddie; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Compound, Powered); Clip, Scalp; Applier, Hemostatic Clip; Laparoscope, Gynecologic (And Accessories); Aspirator, Endometrial; Coagulator, Laparoscopic, Unipolar (And Accessories); Clamp, Umbilical; Amniotome; System, Abortion, Vacuum; Curette, Suction, Endometrial (And Accessories); Speculum, Vaginal, Nonmetal; Insufflator, Laparoscopic; Hysteroscope (And Accessories); Transilluminator, Battery-Powered; Ophthalmoscope, Ac-Powered; Ophthalmoscope, Battery-Powered; Exophthalmometer; Marker, Ocular; Cannula, Ophthalmic; Knife, Ophthalmic; Cystotome; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Sponge, Ophthalmic; Arthroscope; Pliers, Surgical; Forceps; Rasp; Bit, Drill; Pin, Fixation, Smooth; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Electrode, Needle, Diagnostic Electromyograph; Splint, Hand, And Components; Sling, Arm; Support, Arm; Orthosis, Thoracic; Orthosis, Lumbar; Orthosis, Limb Brace; Orthosis, Cervical; Hand, External Limb Component, Powered; Bandage, Cast; Joint, Ankle, External Brace; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; Support, Breathing Tube; Apparatus, Suction, Ward Use, Portable, Ac-Powered; Mixer, Cement, For Clinical Use; Retainer, Matrix; Exerciser, Finger, Powered; Visual, Pregnancy Hcg, Prescription Use; Method, Enzymatic, Glucose (Urinary, Non-Quantitative); Nitroprusside, Ketones (Urinary, Non-Quant.); Blood, Occult, Colorimetric, In Urine; Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.); Clinical Sample Concentrator; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Tubes, Vials, Systems, Serum Separators, Blood Collection; Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric); Diazo (Colorimetric), Nitrite (Urinary, Non-Quant); Tube Tracheostomy And Tube Cuff; Indicator, Physical/Chemical Sterilization Process; Electrode, Electrosurgical; Sleeve, Limb, Compressible; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Micro Pipette; Refractometer For Clinical Use; Culture Media, Non-Propagating Transport; System, Transport, Aerobic; Die, Wire Bending, Ent, Sterile; Nipper, Malleus; Snare, Nasal; Gag, Mouth; Blower, Powder, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Bottle, Collection, Vacuum; Container, Specimen Mailer And Storage, Sterile; Formulations, Paraffin, All; Coverslips, Microscope Slide; Tube, Gastro-Enterostomy; Wound Dressing With Animal-Derived Material(S); Surgeon'S Gloves; Tape And Bandage, Adhesive; Accessories, Catheter; Mask, Scavenging; Absorber, Saliva, Paper; Resin, Root Canal Filling; Dish, Tissue Culture; Drape, Surgical, Antimicrobial; Agent, Tooth Bonding, Resin; Bedding, Disposable, Medical; Bandage, Liquid; Device, Intravascular Catheter Securement; Handpiece, Rotary Bone Cutting; Orthosis, Corrective Shoe; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Accessories, Blood Circuit, Hemodialysis; Solvent, Adhesive Tape; Automated Urinalysis System; Evacuator, Gastro-Urology; Bronchoscope Accessory; System, Test, Infectious Mononucleosis; Applicator, Absorbent Tipped, Sterile; Applicator, Resin; Device, Irrigation, Ocular Surgery; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Varnish, Cavity; Stethoscope, Manual; Instrument, Ultrasonic Surgical; Instrument, Cast Removal, Ac-Powered; Table, Examination, Medical, Powered; Warmer, Thermal, Infusion Fluid; Set, I.V. Fluid Transfer; Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group); Catheter, Nephrostomy; System, Irrigation, Urological; Port & Catheter, Implanted, Subcutaneous, Intravascular; Test, Urine Leukocyte; Cannula, Manipulator/Injector, Uterine; Locator, Root Apex; Instrument, Ent Manual Surgical; Scissors, General, Surgical; Punch, Surgical; Dna-Reagents, Neisseria; Counter, Sponge, Surgical; Razor, Surgical; Orthopedic Manual Surgical Instrument; Helicobacter Pylori; Accessory, Surgical Apparel; Latex Patient Examination Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Syringe, Antistick; Dressing, Wound And Burn, Occlusive; Dressing, Compression; Dna Probe, Gardnerella Vaginalis; Automated External Defibrillators (Non-Wearable); Dna Probe, Yeast; Electrode, Electrocardiograph, Multi-Function; Sterilizer, Chemical; Container, Sharps; Cover, Barrier, Protective; Ligator, Esophageal; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Tissue Adhesive For The Topical Approximation Of Skin; Solid State X-Ray Imager (Flat Panel/Digital Imager); Bilirubin (Total And Unbound) In The Neonate Test System; Respirator, Surgical; System, X-Ray, Extraoral Source, Digital; Cord, Retraction; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Topical Approximation System; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Accessories, Arthroscopic; Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene; Accessories, Implant, Dental, Endosseous; Bandage, Liquid, Skin Protectant; Suture, Surgical, Absorbable, Polydioxanone; Conserver, Oxygen; Saline, Vascular Access Flush; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Container, Specimen, Non-Sterile; Splint, Extremity, Non-Inflatable, External, Non-Sterile; Unit, Operative Dental, Accessories; Chair, Dental, Without Operative Unit; Handpiece, Air-Powered, Root Canal Irrigation; Sealant, Microbial; X-Ray, Tomography, Computed, Dental; Respiratory Virus Panel Nucleic Acid Assay System; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Ultrasound System, Gastroenterology-Urology; Non-Surgical Gown; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Real Time Nucleic Acid Amplification System; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Influenza A And Influenza B Multiplex Nucleic Acid Assay; C. Difficile Toxin Gene Amplification Assay; Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System; Enteral Specific Transition Connectors; Hemostatic Metal Clip For The Gi Tract; General Purpose Reagent; Devices Detecting Influenza A, B, And C Virus Antigens; Syringe, Balloon Inflation, Exempt; Drape, Surgical, Exempt; Cap, Device Disinfectant; Fentanyl And Other Opioid  Protection Glove; Plaque Disclosing Agent; Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test",1; 2; 3; U,"ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION; AGENT, TOOTH BONDING, RESIN; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE; Attest Indicator; CEMENT, DENTAL; CLAVE Vial Access Spike; Container, sharps; EBG - CROWN AND BRIDGE, TEMPORARY, RESIN EBF - Material, tooth shade, resin; Electrode, electrocardiograph, multi-function; Electrosurgical; HANDPIECE, ROTARY BONE CUTTING; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE); Handpiece, air-powered, dental; Handpiece, contra- and right-angle attachment, dental; MATERIAL, IMPRESSION; Material, tooth shade, resin; Mepilex Border Lite; Polymer patient examination glove; RESIN, DENTURE, RELINING, REPAIRING, REBASING; Single use only blood lancet with an integral sharps injury prevention feature; Suture, absorbable, synthetic, polyglycolic acid; Suture, surgical, absorbable, polydioxanone; Suture, surgical, nonabsorbable, expanded, polytetraflouroethylene; Tray, catheterization, sterile urethral, with or without catheter (kit); Tubes, gastrointestinal (and accessories); Unit, operative dental; Vacuette Blood Collection Set 23 Gauge 3/4 Inch Needle",2017-01-03,590,2026-03-11,2,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012494290%22&limit=1
Zimmer Biomet Pty Ltd,3035366890,3035366890,"Level 4, 12 Narabang Way, Belrose, NSW",Sydney New South Wales,,2085,Australia,Zimmer Biomet APAC DFE,10056128,Exporter to the US,102,EFQ; FLE; FMF; FQH; FTY; FZP; FZW; GAM; GAS; GAT; GCJ; GDG; GDH; GEI; HAW; HRS; HRX; HRY; HSB; HSD; HSO; HSX; HSZ; HTC; HTD; HTF; HTJ; HTN; HTP; HTX; HTY; HWA; HWC; HWM; HWO; HXK; HXN; HXW; HYA; JDB; JDC; JDG; JDI; JDL; JDO; JDQ; JDR; JDS; JDW; JDX; JDZ; JEC; JWH; JWJ; KGS; KMC; KRO; KRR; KTT; KTW; KTZ; KWA; KWB; KWH; KWI; KWL; KWS; KWT; KWY; KWZ; KXA; LOD; LPH; LWJ; LXT; LZN; LZO; LZY; MAI; MAY; MBB; MBF; MBH; MBI; MBL; MBV; MEH; MJT; MLR; MQV; NDF; NDH; NEU; NJD; NQP; OIY; OQG; OQH; OQI; PAO; PBI; PHX,"Gauze/Sponge, Internal; Sterilizer, Steam; Syringe, Piston; Lavage, Jet; Tape, Measuring, Rulers And Calipers; Clip, Implantable; Expander, Surgical, Skin Graft; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Saw; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Curette; Gauge, Depth; Washer, Bolt Nut; File; Rongeur; Pin, Fixation, Smooth; Impactor; Screw, Fixation, Bone; Osteotome; Skid, Bone; Holder, Needle; Orthopedic; Applier, Cerclage; Bender; Forceps, Wire Holding; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Instrument, Surgical, Sonic And Accessory/Attachment; Mixer, Cement, For Clinical Use; Component, Traction, Invasive; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained; Retention Device, Suture; Prosthesis, Hip, Semi-Constrained,  Composite/Metal; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal; Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Femoral, Resurfacing; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented; Sterilizer, Chemical; Filler, Bone Void, Calcium Compound; Plate, Fixation, Bone, Non-Spinal, Metallic; Nail, Fixation, Bone, Metallic; Marker, Radiographic, Implantable; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Posterior Metal/Polymer Spinal System, Fusion; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive; Shoulder Prosthesis, Reverse Configuration",1; 2; 3; U,"ANA0TOMICAL SHOULDER TM COMBINED SYSTEM; BENDER; BIOMET CEMENT; MIXER; BIOMET DEPTH; GAUGE; Gauge Biomet Depth; BIOMET FILE; BIOMET IMPACTOR; BIOMET OSTEOTOME; Bi-Metric CoCr Head/Neck Replacement Hip Stems; Biolox® delta Option Ceramic Heads; Biomet Knee Joint Replacement Prostheses; Biomet Modular Femoral Revision System; CALIPER; Cannulated Screw System by Pionee; Comprehensive® Primary Shoulder Stems; Curette; FORCEPS; G7 Acetabular System; HOOK, SURGICAL, GENERAL & PLASTIC SURGERY; INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM; Lateralized Taperloc® Microplasty™ Femoral Components; MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL; MeshGraft II; NON-STERILE ZIMMER PLATES AND SCREWS SYSTEM; Orthopedic Salvage System - OSS; PLIERS, SURGICAL; Pioneer ZCS; Pulsavac Plus; RONGUER; STRAIGHT; RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM; TAPE, MEASURING, RULERS AND CALIPERS; THE NATURAL-KNEE REVISION; Taper 2™ Porous Femoral Stem; TaperLoc Complete; Taperloc Complete Microplasty System; Taperloc Complete Size 4mm and XR 123; Taperloc Complete, Sizes 5mm and 6mm; Vanguard XP Knee System; X-SERIES BI-METRIC HIP FEMORAL COMPONENTS; XR-Series Bi-Metric® Femoral Components; Zimmer",2018-04-05,560,2017-07-28,1,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223035366890%22&limit=1
CBR Enterprise Limited,3013557562,3013557562,"300 Des Voeux Road Central Suite A, 9/F., Wah Kit Commercial Centre",Hong Kong,,Hong Kong,Hong Kong,CBR Enterprise Limited,10054430,Exporter to the US,367,BRZ; BSB; BSF; BSJ; BSP; BSR; BSY; BTL; BTM; BTO; BTR; BTT; BWC; BWF; BYD; BYE; BYG; BYH; BYP; BYX; BYY; BZA; BZD; BZE; BZG; BZH; BZK; BZL; BZO; BZQ; CAE; CAF; CAH; CAI; CAP; CAT; CAZ; CBC; CBK; CBL; CBQ; CBR; CBS; CCK; CCL; CCQ; CCW; DPS; DPZ; DQA; DQD; DQK; DQO; DQX; DQY; DRC; DRX; DSF; DTL; DWH; DWJ; DXN; DXO; DXQ; DYB; DYN; DZA; DZN; EFH; EFW; EIC; EJJ; ELR; EMJ; EOB; EOQ; EQJ; ERA; ERL; ETD; EWO; EXB; EXD; EXE; EXF; EXG; EXH; EYY; EZC; EZL; EZN; EZR; FAJ; FAM; FAQ; FBQ; FCG; FCL; FED; FER; FFF; FFL; FFY; FGE; FHX; FJK; FLG; FLL; FMA; FMF; FMG; FMH; FMI; FMK; FMP; FMR; FNY; FOC; FOK; FOZ; FPA; FPB; FQH; FQM; FRC; FRG; FRL; FRN; FRO; FSA; FSH; FSM; FTA; FXP; FXX; FXY; FYA; FYD; FZP; FZS; FZZ; GAA; GAM; GAR; GAW; GAX; GAZ; GBM; GBO; GBW; GBX; GCA; GCD; GCI; GCJ; GCX; GCY; GDG; GDM; GDO; GDT; GDX; GDY; GDZ; GEA; GEC; GEI; GES; GEX; GFA; GFD; GFF; GIM; GQG; GWM; GWQ; GWX; GXY; GXZ; HAM; HAW; HBA; HBE; HBF; HBG; HBL; HBO; HCY; HDF; HDX; HEB; HFG; HFW; HGE; HGI; HHI; HHK; HHW; HIB; HIF; HIG; HIH; HIO; HLI; HLJ; HLS; HMF; HMX; HNF; HNN; HNY; HOY; HRX; HWE; IKD; IKT; IKX; ILH; IMD; IME; IPG; IPW; IQE; ITG; ITM; ITW; ITX; IWZ; JDZ; JEQ; JES; JKA; JKS; JOH; JOJ; JOL; JOS; JOW; JRL; JSM; JTW; JXG; JYG; JYQ; KAE; KCN; KCP; KCT; KDC; KDD; KDI; KDQ; KDT; KDW; KEW; KGE; KGO; KGX; KIA; KKX; KME; KMF; KMJ; KMK; KNQ; KNS; KNT; KNW; KNX; KOB; KOC; KOD; KOE; KPD; KPE; KRA; KSZ; KTI; KXF; KXG; KYR; KYW; KYX; KYZ; KZD; LDD; LDE; LFL; LGZ; LHI; LIO; LJE; LJH; LJS; LJT; LKF; LQR; LRC; LRD; LRW; LRY; LWK; LXH; LXZ; LYG; LYU; LYY; LYZ; LZA; LZC; MDB; MEG; MGP; MGQ; MHW; MHX; MKJ; MLR; MMK; MMX; MND; MNL; MON; MQM; MSD; MSH; MUD; MWI; MZO; NAB; NAC; NAD; NAE; NEC; NEP; NEU; NEW; NFB; NHO; NHP; NHQ; NNI; NNK; NNW; NOI; NRU; NTW; NWB; NZU; OCT; OCY; OEA; OHY; OMP; ONB; OPJ; PIF; PJE; PKL; PNG; PNR; PSZ; PTI; PUI; QAU; QDO; QPC,"Set, Blood Transfusion; Warmer, Blood, Non-Electromagnetic Radiation; Absorber, Carbon-Dioxide; Mask, Gas, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Ventilator, Emergency, Powered (Resuscitator); Ventilator, Emergency, Manual (Resuscitator); Tube, Tracheostomy (W/Wo Connector); Tube, Tracheal (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Needle, Emergency Airway; Spirometer, Therapeutic (Incentive); Condenser, Heat And Moisture (Artificial Nose); Attachment, Breathing, Positive End Expiratory Pressure; Mask, Oxygen; Drain, Tee (Water Trap); Mouthpiece, Breathing; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Connector, Airway (Extension); Ventilator, Non-Continuous (Respirator); Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer; Spirometer, Diagnostic; Meter, Peak Flow, Spirometry; Spirometer, Monitoring (W/Wo Alarm); Computer, Oxygen-Uptake; Set, Tubing And Support, Ventilator (W Harness); Monitor, Breathing Frequency; Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Monitor, Airway Pressure (Includes Gauge And/Or Alarm); Cannula, Nasal, Oxygen; Anesthesia Conduction Kit; Bottle, Collection And Trap, Breathing System (Uncalibrated); Ventilator, Continuous, Facility Use; Absorbent, Carbon-Dioxide; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Laryngoscope, Rigid; Electrocardiograph; Oximeter, Ear; Oximeter; Stethoscope, Electronic; Computer, Diagnostic, Programmable; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Trocar; Electrode, Electrocardiograph; Recorder, Paper Chart; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Blade, Saw, Surgical, Cardiovascular; System, Thermal Regulating; System, Measurement, Blood-Pressure, Non-Invasive; Transducer, Pressure, Catheter Tip; Blood Pressure Cuff; Introducer, Catheter; Mouthpiece, Saliva Ejector; Drill, Dental, Intraoral; Instruments, Dental Hand; Paper, Articulation; Toothbrush, Manual; Syringe, Periodontic, Endodontic, Irrigating; Alloy, Amalgam; Post, Root Canal; Elevator, Surgical, Dental; Nasopharyngoscope (Flexible Or Rigid); Bronchoscope (Flexible Or Rigid); Bur, Ear, Nose And Throat; Otoscope; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Tube, Tympanostomy; Audiometer; Collector, Ostomy; Irrigator, Ostomy; Protector, Ostomy; Bag, Bile Collecting; Bag, Urine Collecting, Ureterostomy; Bag, Urinary, Ileostomy; Drape, Urological, Disposable; Catheter, Coude; Catheter, Retention Type, Balloon; Dilator, Catheter, Ureteral; Cement, Stomal Appliance, Ostomy; Cystoscope And Accessories, Flexible/Rigid; Sigmoidoscope And Accessories, Flexible/Rigid; Bag, Urine Collection, Leg, For External Use, Sterile; Trocar, Gastro-Urology; Biopsy Needle; Forceps, Biopsy, Non-Electric; Endoscopic Access Overtube, Gastroenterology-Urology; Anoscope And Accessories; Cover, Biopsy Forceps; Dislodger, Stone, Basket, Ureteral, Metal; Adaptor, Bulbs, Miscellaneous, For Endoscope; Stents, Drains And Dilators For The Biliary Ducts; Jelly, Lubricating, For Transurethral Surgical Instrument; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve; Cleaner, Ultrasonic, Medical Instrument; Continuous Measurement Thermometer; Depressor, Tongue, Non-Surgical; Syringe, Piston; Stopcock, I.V. Set; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Protector, Skin Pressure; Device, Transfer, Patient, Manual; Basin, Emesis; Bag, Urine Collection, Newborn; Pad, Neonatal Eye; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Filter, Infusion Line; Lavage, Jet; Bandage, Elastic; Indicator, Biological Sterilization Process; Wrap, Sterilization; Fiber, Medical, Absorbent; Pump, Infusion; Dressing, Wound, Drug; Lift, Patient, Non-Ac-Powered; Tray, Surgical, Needle; Tray, Surgical, Instrument; Light, Surgical, Accessories; Cover, Shoe, Operating-Room; Mask, Surgical; Hood, Surgical; Gown, Surgical; Apparatus, Exhaust, Surgical; Clip, Implantable; Curette, Surgical, General Use; Marker, Skin; Needle, Aspiration And Injection, Disposable; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polypropylene; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Urethral; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Peritoneal; Catheter, Irrigation; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Connector, Catheter; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Hook, Surgical, General & Plastic Surgery; Needle, Aspiration And Injection, Reusable; Applier, Surgical, Clip; Staple, Removable (Skin); Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Brush, Scrub, Operating-Room; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Scalpel; Powered Laser Surgical Instrument; Blade, Saw, General & Plastic Surgery, Surgical; Dermatome; Bur, Surgical, General & Plastic Surgery; Tubes, Vacuum Sample, With Anticoagulant; Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus; Device, Monitoring, Intracranial Pressure; Full-Montage Standard Electroencephalograph; Fork, Tuning; Electrode, Cutaneous; Electrode, Needle; Apparatus, Electrosurgical; Neurological Stereotaxic Instrument; Neurosurgical Paddie; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Compound, Powered); Drills, Burrs, Trephines & Accessories (Manual); Holder, Head, Neurosurgical (Skull Clamp); Clip, Scalp; Curette, Uterine; Speculum, Vaginal, Metal; Dilator, Vaginal; Tampon, Menstrual, Unscented; Coagulator, Laparoscopic, Unipolar (And Accessories); Clamp, Umbilical; Amniotome; Electrocautery, Gynecologic (And Accessories); System, Abortion, Vacuum; Curette, Suction, Endometrial (And Accessories); Pessary, Vaginal; Speculum, Vaginal, Nonmetal; Insufflator, Laparoscopic; Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Sampler, Amniotic Fluid (Amniocentesis Tray); Ophthalmoscope, Ac-Powered; Ophthalmoscope, Battery-Powered; Exophthalmometer; Stand, Instrument, Ac-Powered, Ophthalmic; Cannula, Ophthalmic; Scissors, Ophthalmic; Knife, Ophthalmic; Cystotome; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Arthroscope; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Cable, Electrode; Electrode, Needle, Diagnostic Electromyograph; Aid, Transfer; Splint, Hand, And Components; Pack, Hot Or Cold, Disposable; Pack, Hot Or Cold, Reusable; Shoe, Cast; Orthosis, Sacroiliac, Soft; Orthosis, Lumbar; Bandage, Cast; Cage, Knee; Joint, Ankle, External Brace; Transducer, Ultrasonic, Diagnostic; Film, Radiographic; Mixer, Cement, For Clinical Use; Toothbrush, Powered; Floss, Dental; Tubes, Vials, Systems, Serum Separators, Blood Collection; Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide; Tube Tracheostomy And Tube Cuff; Indicator, Physical/Chemical Sterilization Process; Catheter And Tip, Suction; Electrode, Electrosurgical; Sleeve, Limb, Compressible; Unit, Filter, Membrane; Culture Media, Non-Propagating Transport; System, Transport, Aerobic; Shunt, Central Nervous System And Components; Curette, Ear; Loop, Wire; Forceps, Ent; Ear Wick; Syringe, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Bottle, Collection, Vacuum; Container, Specimen Mailer And Storage, Sterile; Container, Specimen Mailer And Storage, Temperature Controlled, Sterile; Slides, Microscope; Forceps, Biopsy, Electric; Surgeon'S Gloves; Tape And Bandage, Adhesive; Cover, Cast; Drape, Surgical, Antimicrobial; Bedding, Disposable, Medical; Bandage, Liquid; Lubricant, Patient; Device, Intravascular Catheter Securement; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Collector, Urine, (And Accessories) For Indwelling Catheter; Catheter, Suprapubic (And Accessories); Accessories, Blood Circuit, Hemodialysis; Catheter, Urological; Dilator, Urethral; Strip, Temperature, Forehead, Liquid Crystal; Container, I.V.; Catheter, Continuous Flush; System, Test, Automated Blood Grouping And Antibody; Bronchoscope Accessory; Applicator, Absorbent Tipped, Non-Sterile; Applicator, Absorbent Tipped, Sterile; Bag, Ice; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Dc-Defibrillator, Low-Energy, (Including Paddles); Stethoscope, Manual; Instrument, Ultrasonic Surgical; Warmer, Thermal, Infusion Fluid; Set, I.V. Fluid Transfer; Device, Specimen Collection; Catheter, Nephrostomy; System, Irrigation, Urological; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Cannula, Manipulator/Injector, Uterine; Dislodger, Stone, Biliary; Instrument, Ent Manual Surgical; Applicator, Ent Drug; Scissors, General, Surgical; Punch, Surgical; Razor, Surgical; Orthopedic Manual Surgical Instrument; Guard, Instrument; Massager, Therapeutic, Manual; Accessory, Surgical Apparel; Latex Patient Examination Glove; Vinyl Patient Examination Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; System, Blood Culturing; Syringe, Antistick; Dressing, Wound And Burn, Occlusive; Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic; Dressing, Compression; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Automated External Defibrillators (Non-Wearable); Sterilizer, Chemical; Container, Sharps; Device, Percutaneous Retrieval; Ligator, Esophageal; Accessories, Cleaning Brushes, For Endoscope; System, Hemodialysis, Remote Accessories; Bilirubin (Total And Unbound) In The Neonate Test System; Catheter, Hemodialysis, Implanted; Respirator, Surgical; Oximeter, Tissue Saturation; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Bandage, Liquid, Skin Protectant; System/Device, Pharmacy Compounding; Marker, Radiographic, Implantable; Suture, Surgical, Absorbable, Polydioxanone; Conserver, Oxygen; Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration); Container, Specimen, Non-Sterile; Container, Specimen Mailer And Storage, Non-Sterile; Bag, Urine Collection, Leg, For External Use, Non-Sterile; Stand, Instrument, Ophthalmic, Battery Powered; Chair, Dental, Without Operative Unit; System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test; Endoscope, Accessories, Narrow Band Spectrum; Collector, Urine, Powered, Non Indwelling Catheter; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Guidewire, Gastroenterology-Urology; Non-Surgical Gown; Pill Crusher/Cutter; Negative Pressure Wound Therapy Powered Suction Pump; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Gastrointestinal Tubes With Enteral Specific Connectors; Blood/Plasma Collection Device For Dna Testing; Hemostatic Metal Clip For The Gi Tract; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Enteral Syringes With Enteral Specific Connectors; Devices Detecting Influenza A, B, And C Virus Antigens; Non-Coring (Huber) Needle; Drape, Surgical, Exempt; Hemostatic Device For Endoscopic Gastrointestinal Use; Fentanyl And Other Opioid  Protection Glove; Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection",1; 2; 3; U,"3ml Syringe W/Dtchbl Needle 21G x 1 1/2""; APPLICATOR; BAG, URINE COLLECTING; BAG, URINE COLLECTION, LEG,; BLOOD TRANSFER AND LUER LOCK ACCES; Bandage, liquid, skin protectant; CLEANING BRUSHES, FOR ENDOSCOPE; COLLECTOR, OSTOMY; CONNECTOR; CONNECTOR, AIRWAY; CONTAINER, LIQUID MEDICATION, GRADUATED; CONTAINER, SPECIMEN, STERILE; COVER, CAST; COVER,PROBE,CLEAN,TROPHON; CURETTE, EAR; CURETTE, SUCTION, ENDOMETRIAL; Catheter; Cleaner, ultrasonic, medical instrument; Collector, urine; DRESSING, WOUND 4""X5"" MEPILEX TRANSFER AG (5/BX; DRILL, DENTAL, INTRAORAL; Device, monitoring, intracranial pressure; Device, specimen collection; Drape; ENDOSCOPE; Electrode, needle; Electrosurgical; Electrosurgical, cutting & coagulation & accessories; Exophthalmometer; FORCEPS, BIOPSY, ELECTRIC; FORCEPS, BIOPSY, NON-ELECTRIC; FUSION OMNI-TOME; HOOK, SURGICAL, GENERAL & PLASTIC SURGERY; HUMIDIFIER, RESPIRATORY GAS; HYSTEROSCOPE; HYSTEROSCOPE (; INSTRUMENT, ENT MANUAL SURGICAL; INSTRUMENTS, DENTAL HAND; Indicator, physical/chemical sterilization process; Instrument, ultrasonic surgical; Insufflator, hysteroscopic; Irrigator, ostomy; MBO-INDICATOR,CHEMICAL,TROPHON; Mask, surgical; NEEDLE BC 21X1.25 ECL; Needle; Oximeter; Oximeter, ear; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR; POST, ROOT CANAL; PROTECTOR, OSTOMY; Polymer patient examination glove; SET, TUBING AND SUPPORT, VENTILATOR; SHOE, CAST; SLEEVE, LIMB, COMPRESSIBLE; SOLUTION SET, CLEARLINK BURETROL; SPECULUM; SPIROMETER, MONITORING; STOPCOCK MANIFOLD 3 GANG LARGE BORE; Set, administration, intravascular; Shunt, central nervous system and components; Stethoscope; Syringe; Syringe, piston; Tampon, menstrual, unscented; Thermometer, electronic, clinical; Tube tracheostomy and tube cuff; Tubes; Tubes, Blood Collection; Tubes, gastrointestinal; Tubes, vials, systems, serum separators, blood collection; VENTILATOR; dc-defibrillator,; intravascular; negative pressure wound therapy Powered suction pump",2017-03-22,548,2026-04-10,4,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013557562%22&limit=1
Mainline Medical Dental Supply,3012421607,3012421607,Rossdean Dr,North York Ontario,,M9L 2S1,Canada,Mainline Medical Dental Supply,10052656,Exporter to the US,302,BSB; BSP; BTT; BYX; BZG; CAE; CCK; CCQ; CDM; CEN; DPS; DQD; DRX; DWJ; DXN; DXQ; DYH; DYJ; DYN; DYW; DZA; DZB; DZC; DZD; DZM; DZN; DZP; DZS; EAT; EAX; EBC; EBD; EBF; EBG; EBH; EBI; EBL; EBZ; ECB; ECI; ECO; ECR; EEF; EEG; EFB; EFH; EFL; EFN; EFS; EFT; EFW; EGD; EGN; EGS; EGZ; EHA; EHJ; EHL; EHM; EHY; EHZ; EIA; EIC; EID; EIE; EIF; EIG; EIH; EIL; EIR; EIS; EIX; EIY; EJB; EJE; EJF; EJI; EJJ; EJK; EJL; EJR; EJW; EJY; EJZ; EKB; EKC; EKG; EKH; EKI; EKJ; EKK; EKM; EKN; EKP; EKQ; EKR; EKS; EKT; EKX; ELC; ELR; ELW; ELY; ELZ; EMA; EMB; EMD; EMG; EMH; EMJ; EMN; EMR; EMS; ERA; EXB; EXE; EXG; EXI; EXX; EYJ; EYQ; EZL; EZP; EZQ; FAM; FCY; FER; FHQ; FLE; FLG; FLL; FMF; FMH; FMI; FNY; FOZ; FPA; FQM; FQZ; FRC; FRG; FRL; FRO; FSM; FXG; FXP; FXX; FYA; FYE; FZZ; GAA; GAG; GAL; GAM; GAN; GAP; GAQ; GAR; GAT; GAW; GAX; GAZ; GBJ; GBX; GCW; GDT; GEA; GEI; GES; GIM; GXQ; HBA; HBF; HBT; HHD; HIB; HLI; HLJ; HLS; HNC; HOY; HRQ; IMD; IME; IPR; IPW; IQI; ITG; IWZ; JAC; JEP; JEQ; JER; JES; JEX; JFY; JIL; JIN; JIO; JIR; JJB; JKA; JMT; JOH; JOJ; JOL; JRE; JXG; KCO; KCQ; KCT; KCY; KGO; KGX; KGZ; KHR; KIA; KIF; KJJ; KKX; KLE; KMF; KMJ; KMK; KNM; KNP; KNT; KOD; KOJ; KOX; KOZ; KQM; KST; KXF; KXR; KYS; KYT; KYW; KYZ; KZF; LBH; LDE; LDS; LFC; LFR; LJX; LMF; LMG; LRJ; LRP; LYU; LYY; LYZ; LZA; LZC; LZG; LZH; MDA; MDB; MDM; MEG; MGO; MGP; MHW; MHX; MMK; MOQ; MPO; MSH; MUH; MVL; MWI; MZW; NAB; NAC; NAD; NAE; NBW; NBY; NDC; NDP; NEW; NGT; NHA; NJM; NKC; NNI; NOA; NRD; NRH; NTN; NZU; NZW; OEA; OIZ; OXZ; PME; PNP; PNR; PPM; PZY; QDO,"Warmer, Blood, Non-Electromagnetic Radiation; Needle, Conduction, Anesthetic (W/Wo Introducer); Humidifier, Respiratory Gas, (Direct Patient Interface); Tubing, Pressure And Accessories; Spirometer, Diagnostic; Airway, Oropharyngeal, Anesthesiology; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.); Dye-Indicator, Ph (Urinary, Non-Quantitative); Electrocardiograph; Stethoscope, Electronic; Electrode, Electrocardiograph; System, Thermal Regulating; System, Measurement, Blood-Pressure, Non-Invasive; Blood Pressure Cuff; Adhesive, Bracket And Tooth Conditioner, Resin; Retainer, Screw Expansion, Orthodontic; Mouthpiece, Saliva Ejector; Bracket, Plastic, Orthodontic; Drill, Dental, Intraoral; Headgear, Extraoral, Orthodontic; Wire, Orthodontic; Tube, Orthodontic; Needle, Dental; Instruments, Dental Hand; Instrument, Diamond, Dental; Capsule, Dental, Amalgam; Tester, Pulp; Mirror, Mouth; Sealant, Pit And Fissure, And Conditioner; Coating, Filling Material, Resin; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Material, Impression Tray, Resin; Resin, Denture, Relining, Repairing, Rebasing; Pin, Retentive And Splinting, And Accessory Instruments; Activator, Ultraviolet, For Polymerization; Unit, Syringe, Air And/Or Water; Band, Elastic, Orthodontic; Spring, Orthodontic; Setter, Band, Orthodontic; Clamp, Rubber Dam; Heat Source For Bleaching Teeth; Handpiece, Air-Powered, Dental; Paper, Articulation; Forceps, Dressing, Dental; Cotton, Roll; Unit, Oral Irrigation; Cleanser, Denture, Over The Counter; Toothbrush, Manual; Wax, Dental, Intraoral; Scissors, Surgical Tissue, Dental; Handpiece, Contra- And Right-Angle Attachment, Dental; Holder, Film, X-Ray; Aligner, Beam, X-Ray; Disk, Abrasive; Point, Abrasive; Strip, Polishing Agent; Tray, Impression, Preformed; Evacuator, Oral Cavity; Unit, Operative Dental; Syringe, Periodontic, Endodontic, Irrigating; Syringe, Restorative And Impression Material; Dam, Rubber; Accessories, Retractor, Dental; Retractor, All Types; Powder, Porcelain; Gauge, Depth, Instrument, Dental; Scissors, Collar And Crown; Remover, Crown; Probe, Periodontic; Instrument, Filling, Plastic, Dental; Handle, Instrument, Dental; Frame, Rubber Dam; Bracket, Metal, Orthodontic; Syringe, Cartridge; Alloy, Amalgam; Liner, Cavity, Calcium Hydroxide; Bur, Dental; Agent, Polishing, Abrasive, Oral Cavity; Clasp, Wire; Pliers, Operative; Knife, Margin Finishing, Operative; Explorer, Operative; Excavator, Dental, Operative; Condenser, Amalgam And Foil, Operative; Carver, Dental Amalgam, Operative; Carrier, Amalgam, Operative; Burnisher, Operative; Spreader, Pulp Canal Filling Material, Endodontic; Gutta-Percha; Point, Paper, Endodontic; Reamer, Pulp Canal, Endodontic; Preparer, Root Canal Endodontic; Plugger, Root Canal, Endodontic; File, Pulp Canal, Endodontic; Curette, Endodontic; Handpiece, Direct Drive, Ac-Powered; Scaler, Ultrasonic; Post, Root Canal; Material, Impression; Mercury; Crown, Preformed; Cement, Dental; Zinc Oxide Eugenol; Hemostat, Surgical; Forceps, Tooth Extractor, Surgical; Forceps, Rongeur, Surgical; Elevator, Surgical, Dental; Scaler, Periodontic; File, Periodontic; Curette, Periodontic; Otoscope; Collector, Ostomy; Protector, Ostomy; Bag, Urine Collecting, Ureterostomy; Device, Paste-On For Incontinence, Sterile; Probe, Rectal, Non-Powered; Holder, Ureteral Catheter; Garment, Protective, For Incontinence; Catheter, Retention Type, Balloon; Rod, Colostomy; Pouch, Colostomy; Sigmoidoscope And Accessories, Flexible/Rigid; Bulb, Inflation, For Endoscope; Anoscope And Accessories; Holder, Needle, Gastroenterologic; Sterilizer, Steam; Cleaner, Ultrasonic, Medical Instrument; Continuous Measurement Thermometer; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Basin, Emesis; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Bandage, Elastic; Thermometer, Clinical Color Change; Indicator, Biological Sterilization Process; Wrap, Sterilization; Fiber, Medical, Absorbent; Dressing, Wound, Drug; Tray, Surgical, Instrument; Specula Accessories; Cover, Shoe, Operating-Room; Mask, Surgical; Gown, Surgical; Dress, Surgical; Marker, Skin; Needle, Aspiration And Injection, Disposable; Stapler, Surgical; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Absorbable, Synthetic; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Prosthesis, Adhesive, External; Catheter, Irrigation; Transformer, Endoscope; Staple, Removable (Skin); Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Scalpel; Tubes, Vacuum Sample, With Anticoagulant; Dura Substitute; Neurosurgical Paddie; Drills, Burrs, Trephines & Accessories (Compound, Powered); Applier, Hemostatic Clip; Pad, Menstrual, Unscented; Speculum, Vaginal, Nonmetal; Ophthalmoscope, Ac-Powered; Ophthalmoscope, Battery-Powered; Exophthalmometer; Specula, Ophthalmic; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Hemostat; Pack, Hot Or Cold, Disposable; Pack, Hot Or Cold, Reusable; Crutch; Orthosis, Sacroiliac, Soft; Orthosis, Limb Brace; Bandage, Cast; Film, Radiographic; System, X-Ray, Film Marking, Radiographic; Retainer, Matrix; Toothbrush, Powered; Cleaner, Denture, Mechanical; Floss, Dental; Plier, Orthodontic; Enzymatic Method, Creatinine; Method, Enzymatic, Glucose (Urinary, Non-Quantitative); Nitroprusside, Ketones (Urinary, Non-Quant.); Blood, Occult, Colorimetric, In Urine; Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.); Tubes, Vials, Systems, Serum Separators, Blood Collection; Diazo (Colorimetric), Nitrite (Urinary, Non-Quant); Tube Tracheostomy And Tube Cuff; Indicator, Physical/Chemical Sterilization Process; Catheter And Tip, Suction; Refractometer For Clinical Use; Shunt, Central Nervous System And Components; Nasal Spray, Ent Delivery; Tube Impression And Matrix; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Tourniquet, Pneumatic; Surgeon'S Gloves; Tape And Bandage, Adhesive; Accessories, Catheter; Absorber, Saliva, Paper; Cover, Cast; Resin, Root Canal Filling; Cleanser, Root Canal; Drape, Surgical, Antimicrobial; Agent, Tooth Bonding, Resin; Bandage, Liquid; Lubricant, Patient; Device, Intravascular Catheter Securement; Device, Pressure Applying; Orthosis, Corrective Shoe; Tubes, Gastrointestinal (And Accessories); Catheter, Urological; Airbrush; Solvent, Adhesive Tape; Beads, Hydrophilic, For Wound Exudate Absorption; Camera, Surgical And Accessories; System, Blood Collection, Vacuum-Assisted, Manual; Applicator, Absorbent Tipped, Non-Sterile; Applicator, Resin; Insoles, Medical; Light, Examination, Medical, Battery Powered; Container, Liquid Medication, Graduated; Syringe, Irrigating (Non Dental); Device, Medical Examination, Ac Powered; Varnish, Cavity; Stethoscope, Manual; Device, Pasteurization, Hot Water; Device, Caries Detection; Glucose Dehydrogenase, Glucose; Test, Urine Leukocyte; Agent, Absorbable Hemostatic, Collagen Based; Agent, Absorbable Hemostatic, Non-Collagen Based; Disinfectant, Medical Devices; Tray, Surgical; Accessory, Surgical Apparel; Latex Patient Examination Glove; Vinyl Patient Examination Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; Pump, Infusion, Insulin; Pump, Infusion, Enteral; Elastomer, Silicone, For Scar Management; System, Blood Culturing; Instrument, Manual, Surgical, General Use; Syringe, Antistick; Closure, Wound, Adhesive; Dressing, Wound And Burn, Occlusive; Dressing, Compression; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Container, Sharps; Battery, Replacement, Rechargeable; Infant Heel Warmer (Chemical Heat Pack); Respirator, Surgical; System, X-Ray, Extraoral Source, Digital; Cord, Retraction; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; System, Test, Blood Glucose, Over The Counter; Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene; Calculator, Drug Dose; Accessories, Implant, Dental, Endosseous; Suture, Surgical, Absorbable, Polydioxanone; Saline, Vascular Access Flush; Abutment, Implant, Dental, Endosseous; Bracket, Ceramic, Orthodontic; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Container, Specimen, Non-Sterile; Device, Paste-On For Incontinence, Non-Sterile; Unit, Operative Dental, Accessories; System, Breath Measurement; Led Light Source; Collector, Urine, Powered, Non Indwelling Catheter; Heparin, Vascular Access Flush; Non-Surgical Gown; Foot Examination Tool For Inflammatory Changes; Pediatric/Child Facemask; External Cleaning Solution; Dental Abutment Design Software For Dental Laboratory; Enteral Syringes With Enteral Specific Connectors; General Purpose Reagent; Additively Manufactured, Preformed, Resin Denture Tooth; Fentanyl And Other Opioid  Protection Glove",1; 2; 3; U,,2016-09-02,546,2026-04-10,2,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012421607%22&limit=1
Synthes GMBH,3009417901,3009417901,Luzernstrasse 21,Zuchwil Solothurn,,CH-4528,Switzerland,SYNTHES GMBH / Synthes Produktions GmbH,9071542,Specification developer,166,DZI; DZJ; DZL; EML; EQJ; ERL; ETN; EZX; FDG; FMF; FQP; FSM; FTL; FTM; FTY; FZO; FZT; FZX; FZY; GAA; GAD; GAH; GAQ; GBX; GDG; GDH; GDI; GDJ; GDZ; GEA; GEN; GEY; GFA; GFC; GFF; GFG; GFI; GWO; GXL; GXN; GXP; GXQ; GXR; GXZ; HAW; HBB; HBC; HBE; HBF; HBG; HBW; HRS; HRX; HSB; HSD; HSO; HST; HSZ; HTC; HTD; HTE; HTF; HTJ; HTN; HTO; HTQ; HTR; HTT; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWD; HWE; HWJ; HWK; HWM; HWN; HWR; HWT; HWW; HWX; HXB; HXC; HXD; HXG; HXI; HXJ; HXL; HXO; HXP; HXQ; HXS; HXW; HXX; HXZ; HYA; IPM; JAQ; JDN; JDO; JDP; JDQ; JDR; JDS; JDW; JEC; JEY; JTQ; KCT; KDC; KGS; KIH; KIK; KQW; KTE; KTT; KTW; KTZ; KWI; KWP; KWQ; KWT; LOD; LRP; LRY; LXC; LXH; LXT; LYC; MAX; MBF; MBI; MDI; MJG; MJO; MNH; MNI; MON; MOQ; MQN; MQP; MQV; NBH; NDG; NDN; NEI; NKB; NKG; NQW; OAR; OCJ; ODP; OIS; OJV; OLO; OSH; OSN; OUR; OVD; OVE; PBJ; PGM,"Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Screw, Fixation, Intraosseous; Chisel, Bone, Surgical; Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Stimulator, Nerve; Mesh, Surgical, Metal; Retractor, Fiberoptic; Syringe, Piston; Lamp, Operating-Room; Tray, Surgical, Instrument; Mesh, Surgical, Polymeric; Mesh, Surgical; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Aspiration And Injection, Disposable; Retractor; Stylet, Surgical, General & Plastic Surgery; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Catheter, Irrigation; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Forceps, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Driver, Surgical, Pin; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Osteotome, Manual; Plate, Cranioplasty, Preformed, Alterable; Screwdriver, Skullplate; Plate, Cranioplasty, Preformed, Non-Alterable; Methyl Methacrylate For Cranioplasty; Dura Substitute; Cover, Burr Hole; Electrode, Needle; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Motor, Drill, Electric; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Compound, Powered); Drills, Burrs, Trephines & Accessories (Manual); Fastener, Plate, Cranioplasty; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Saw; Apparatus, Traction, Non-Powered; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Instrument, Compression; Driver, Prosthesis; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Tamp; Passer, Wire, Orthopedic; Staple Driver; Mallet; Pusher, Socket; Instrument, Bending Or Contouring; Crimper, Pin; Twister, Wire; Bender; Screwdriver; Cutter, Wire; Forceps, Wire Holding; Cover, Limb; System, Applicator, Radionuclide, Remote-Controlled; Implant, Fixation Device, Spinal; Device, Fixation, Proximal Femoral, Implant; Condylar Plate Fixation Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Component, Traction, Invasive; Plate, Bone; Bath, Incubators/Water, All; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Instrument, Surgical, Disposable; Retention Device, Suture; Dispenser, Cement; Hook, Bone; Goniometer, Nonpowered; Trocar, Ent; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Prosthesis, Elbow, Hemi-, Radial, Polymer; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Bone Cement; Tray, Surgical; Punch, Surgical; Monitor, Pressure, Intracompartmental; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Bone Grafting Material, Synthetic; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Rib Replacement; Device, Percutaneous, Biopsy; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; System, Hemodialysis, Remote Accessories; Battery, Replacement, Rechargeable; External Mandibular Fixator And/Or Distractor; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; Accessories, Arthroscopic; Washer, Bolt, Nut, Non-Spinal, Metallic; Cement, Bone, Vertebroplasty; Prosthesis, Condyle, Mandibular, Temporary; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Orthosis, Spine, Plate, Laminoplasty, Metal; Injector, Vertebroplasty (Does Not Contain Cement); Spinal Channeling Instrument, Vertebroplasty; Intervertebral Fusion Device With Bone Graft, Cervical; Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation; Single Use Instrument Tray; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Software For Diagnosis/Treatment; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Cranial Distraction System; Growing Rod System",1; 2; 3; U,"2.4/2.7mm VA-LCP Forefoot/Midfoot; 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES; 2.4mm Cannulated Compression Screw; 2.4mm Cannulated Screw; 2.4mm VA LCP Two Column Volar DR; 2.4mm Variable Angle LCP Volar Rim Distal Radius System; 2.7mm VA LCP Clavicle Plate System; 3.5 / 4.5 MM LCP METAPHYSEAL PLATES; 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP); 3.5 MM LCP DISTAL HUMERUS SYSTEM; 3.5/4.5 LCP w/ Expanded Indications; 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System; 3.5mm LCP Hook Plates; 3.5mm Locking Attachment Plates; 3.5mm VA LCP Proximal TIbia Plate System; 3.7mm/ 5mm Dynamic Locking Screws; 3MM HEADLESS COMPRESSION SCREWS; 4.5 MM AND 6.5 MM HEADLESS COMPRESS; 4.5 MM LCP STRAIGHT RECONSTRUCTION; 6.5mm Midfoot Fusion Bolt; ANGLED BLADE PLATE; ANTERIOR CSLP SYSTEM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT; APPLIANCE, FIXATION, SPINAL INTERLAMINAL; AWL; Accessories, arthroscopic; Akros Fibulink Syndesmosis Repair Kit; Akros Fibulink"" Syndesmosis Repair Kit; Akros Scruture Anchor Lisfranc Repair Kit; Ankle Trauma System; Anspach Attachments; Anspach AutoLube; Anspach BlackMax Pneumatic Drill System; Anspach Bone Collector; Anspach Compact SpeedReducer; Anspach Dissection Tools; Anspach Helix Dissection Tools; Anspach Irrigation System; Anspach Lubricating System II; Anspach MRI Safe Surgical Drill System; Anspach MicroMax System; Anspach Pneumatic Instrument System Accessories; Anspach Shielded Attachments; Anspach Speed Reducer; Anspach XMax Pneumatic Drill System; Anspach eMax 2 Electric Drill System; Anspach eMax Electric Drill System; Appliance Fix, Nail Blade Plate Com; Appliance, fixation, spinal intervertebral body; Arthroscope; BATH, INCUBATORS/WATER, ALL; BENDER; BIT, DRILL; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL; BURR, ORTHOPEDIC; CANNULATED FEMORAL NAIL; CATHETER, IRRIGATION; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY; CLICK`X; COVER, BURR HOLE; COVER, LIMB; CURETTE; Calcium salt bone void filler, drillable, non-screw augmentation; Cerclage, fixation; Condylar Head Add-on-System; Cranial Distraction System; DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS); DEPUY SYNTHES MAXFRAME AUTOSTRUT System; DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT; DHS-Troch Stabilizaiton Plate; DRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL); DYNAMIC HIP SCREW; DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long; DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System); DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System; DePuy Synthes 2.7mm VA LCP Clavicle Plate System; DePuy Synthes Cortex and Cannulated Screws; DePuy Synthes Femoral Neck System; DePuy Synthes Femoral Recon Nail System; DePuy Synthes MAXFRAME Multi-Axial Correction System; DePuy Synthes MatrixSTERNUM Fixation System; DePuy Synthes TFNA Augmentation System; DePuy Synthes Tibial Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 4 and 5 mm; DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) System; DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System; DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System; DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System; DePuy Synthes Variable Angle Locking Patella Plating System; DePuySynthes Next Generation Hand System; Dental Bone Cutting Instruments; Depuy Synthes Retrograde Femoral Nail Advanced System; Depuy Synthes Retrograde Femoral Nail Advanced System and DePuy Synthes Locking Screws for Medullary Nails, 5 mm; Depuy Synthes Variable Angle Locking Hand System - 1.3 mm and 2 mm Plates and Screws; Dispenser, Cement; Drills, Burrs, Trephines & Powered; EG1™; EIN End Cap; ELASTIC INTRAMEDULLARY NAIL (EIN) E; ELBOW HINGE FIXATOR; ELECTRODE, NEEDLE; EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR; EXTRACTOR; Expedium Anterior Spine System; Expedium SFX Cross Connector System; Expedium Spine System; FILLER, BONE VOID, CALCIUM COMPOUND; Filter; G1 High Speed Electric System; GONIOMETER; GOUGES; HA COATED SCHANZ SCREWS; HANDLE, SCALPEL; HINDFOOT ARTHRODESIS NAIL; Hook; INSTRUMENT, CUTTING, ORTHOPEDIC; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Intervertebral fusion device with bone graft, cervical; Intervertebral fusion device with bone graft, lumbar; Irrigation clips; KAM SuperSucker; KINCISE; LCP; LCP CURVED PLATES; LOCKING CONDYLAR PLATE (LCP) SYSTEM; LOCKING RECONSTRUCTION; MANDIBLE EXTERNAL FIXATOR; MATRIXRIB FIXATION SYSTEM; MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System; MAXFRAME Autostrut; METHYL METHACRYLATE FOR CRANIOPLASTY; MINI LENGTHENING APPARATUS; MIRS; MODIFICATION TO SYNTHES CERVIFIX SYSTEM; MODIFICATION TO SYNTHES MATRIX SYSTEM; MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK; MODULAR FOOT SYSTEM - 2.7 MM MODULE; MONITOR, PRESSURE, INTRACOMPARTMENTAL; MOUNTAINEER Laminoplasty System; Matrix RIB Fixation System; Matrix Sagittal Screws; MatrixORTHOGNATHIC Plating System; Mesh, surgical; Mesh, surgical, metal; Mesh, surgical, polymeric; Moss Miami Spine System; Mountaineer OCT Spinal System; NAIL, FIXATION, BONE; Needle; OCM-G1; OSTEOTOME; OSTEOTOME, MANUAL; Orthomesh; Orthopedic Wire Passer; Orthosis, spinal pedicle fixation; Orthosis, spondylolisthesis spinal fixation; Otologic Attachment and Curved Burrs; PIN, FIXATION, SMOOTH; PIN, FIXATION, THREADED; PLATE, BONE; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER; Pelvic C-Clamp; Plate fixation, bone; Plate, cranioplasty, preformed, alterable; Plate, fixation, bone; Posteromedial Proximal Tibia Plate; Prosthesis, intervertebral disc; Prosthesis, rib replacement; REAMER; RETRACTOR, FIBEROPTIC; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES; Rasp; SAW; SCREW, FIXATION, INTRAOSSEOUS; SCREWDRIVER, SKULLPLATE; SMALL FRAGMENT DYNAMIC COMPRESSION; SMALL STATURE USS; SOCKET PUSHER; SPIKED WASHER; SS Elastic IM Nail; STAPLE INSERTER; STIMULATOR, NERVE; SYMPHONT OCT System; SYNAPSE SYSTEM; SYNFIX Evolution; SYNFIX Lateral; SYNFIX-LR; SYNFIX-LR SPACER; SYNTHECEL DURA REPLACEMENT DEVICES; SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE; SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM; SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACR; SYNTHES (U.S.A.) UNIVERSAL SPINAL P; SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIV; SYNTHES (USA) 2.4 MM LCP WRIST PLATE; SYNTHES (USA) 2.4/2.7 MM LOCKING FO; SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES; SYNTHES (USA) 3.5MM CONICAL SCREWS; SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS; SYNTHES (USA) ALVEOLAR RIDGE DISTRA; SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM; SYNTHES (USA) CALVICLE HOOK PLATE; SYNTHES (USA) CLAVICLE HOOK PLATES; SYNTHES (USA) CONDYLAR HEAD ADD-ON; SYNTHES (USA) ELECTRIC PEN DRIVE SY; SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM; SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR; SYNTHES (USA) LARGE FRAGMENT LOCKIN; SYNTHES (USA) LATERAL ENTRY FEMORAL; SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM; SYNTHES (USA) LCP MODULAR FOOT PLATES; SYNTHES (USA) LCP PROXIMAL HUMERUS; SYNTHES (USA) LCP WRIST FUSION PLATES; SYNTHES (USA) LOW-PROFILE WRIST FIXATOR; SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES; SYNTHES (USA) MODULAR MINI FRAGMENT; SYNTHES (USA) RAPID RESORBABLE CRAN; SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM; SYNTHES (USA) TIBIAL NAIL SYSTEM EX; SYNTHES (USA) UNIV SPINE ROD/SACRAL; SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM; SYNTHES (USA) [SYNTHES] MINI EXTERN; SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS; SYNTHES 1.5MM/2MM ORTHOGNATHIC MA; SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM; SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM; SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM; SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM; SYNTHES 5/7.3 MM CANNULATED LOCKING SCREWS; SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM; SYNTHES AFS; SYNTHES ANTERIOR CERVICAL LOCKING P; SYNTHES ANTERIOR CSLP SYSTEM; SYNTHES ANTERIOR TENSION BAND (ATB); SYNTHES BUTTON PLATE; SYNTHES CALCANEAL PLATE; SYNTHES CANNULATED ANGLE BLADE PLATE; SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM; SYNTHES CERVIFIX/ AXON; SYNTHES CRANIAL FLAP TUBE CLAMP; SYNTHES CURVED RECONSTRUCTION PLATE; SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM; SYNTHES DUAL-OPENING USS; SYNTHES EXTERNAL FIXATION DEVICES,; SYNTHES HIGH TIBIAL OSTEOTOMY (HTO); SYNTHES LARGE FRAGMENT DYNAMIC COMP; SYNTHES LCP DISTAL TIBIA PLATES; SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES; SYNTHES LCP PROXIMAL HUMERUS PLATES; SYNTHES LCP PROXIMAL TIBIA PLATES L; SYNTHES LOCKING CALCANEAL PLATES; SYNTHES LOCKING DISTAL RADIUS PLATI; SYNTHES LOW PROFILE RECONSTRUCTION PLATES; SYNTHES MANDIBLE DISTRACTOR; SYNTHES MINI EXTERNAL FIXATOR; SYNTHES MODULAR FOOT SYSTEM; SYNTHES OC FUSION AND SYNAPSE SYSTEMS; SYNTHES OC FUSION SYSTEM; SYNTHES PANGEA MONOAXIAL SYSTEM; SYNTHES PANGEA SYSTEM; SYNTHES PILON PLATE; SYNTHES POLY (L-LACTIDE-CO-GLYCOLID; SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM; SYNTHES RECONSTRUCTIVE PLATES `Y` P; SYNTHES REPROCESSED EXTERNAL FIXATI; SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF); SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM; SYNTHES SPINE PEDIATRIC ROD SYSTEM; SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM; SYNTHES SPINE UNIVERSAL SPINAL HOOK; SYNTHES STAINLESS STEEL MODULAR HAN; SYNTHES STERILE 3 MM CANNULATED SCREW AND THREADED WASHER; SYNTHES STERILE 4.5 MM CANNULATED SCREWS; SYNTHES STERNAL FIXATION SYSTEM; SYNTHES SYNAPSE TRANSCONNECTOR; SYNTHES SYNEX SPACER SYSTEM; SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM; SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR; SYNTHES UNIVERSAL SPINAL SYSTEM; SYNTHES USS; SYNTHES USS (10MM SIDE OPENING SCREWS; SYNTHES USS CONNECTORS; SYNTHES USS, CLICK`X, USS VAS, DUAL; SYNTHES VA LCP ANKLE TRAUMA SYSTEM; SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM; SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES); SYNTHES VECTRA SYSTEM; SYNTHES VECTRA-ONE SYSTEM; SYNTHES VECTRA-T SYSTEM; SYNTHES XRL; SYNTHES(USA) SYNTHES HYBRID EXTERNA; SYNTHS ONE-THIRD TUBULAR DCL PLATE; SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES; Sacroiliac joint fixation; Screw, fixation, bone; Set Screw for Ti Trochanteric Fixation Nail (TFN); Single use instrument tray; Small Stature Ant. Cerv. Vertebral; Smooth threaded metallic bone fix; Spinal vertebral body replacement device; Staple, fixation, bone; Sterile 2.7mm recon Plates; Sterilization wrap containers, trays, cassettes & other accessories; Sternal Fixation System; Stimulator, Nerve; Stylet, Surgical, General & Plastic Surgery; Summit SI OCT Spinal Fixation System; Suprapatellar Insertion Instruments; Surgical Bit; Surgical Punch; Surgical Titanium Mesh; Suture, nonabsorbable, steel, monofilament and multifilament, sterile; SynCage Evolution Spacer; Synapse Occipital-Cervical-Thoracic (OCT) System; Synapse System, Synthes OC Fusion System; Synthecel Dura Repair, Synthecel Dura Onlay; Synthes (USA) 2.4mm Cortex Screw; Synthes (USA) VA-LCP 2-Col Narrow; Synthes 1.5mm Headless Comp. Screws; Synthes 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM; Synthes 2.7mm LCP Ulna Osteotomy Plate System; Synthes 3.5/4.5 Curved Narrow/Broad; Synthes 4.5mm VA-LCP Curved Condylar Plate System; Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins; Synthes 6 CoCr and CP Ti-3 Rods; Synthes 90 Degree Screwdriver; Synthes ASLS System; Synthes Air Pen Drive System; Synthes Angular Stable Locking Syst; Synthes Angular Stable Locking System; Synthes Cervifix System; Synthes ClampFix System; Synthes Cortical Screws; Synthes Curvilinear Distraction System; Synthes Graphic Case & Tray System; Synthes LCP Pediatric Plate System; Synthes Large Ex Fix, MR Cond.; Synthes Light Guide; Synthes Locking Hand Plates; Synthes Matrix MIS Rods; Synthes Matrix System; Synthes MatrixMANDIBLE Preformed Re; Synthes MatrixMANDIBLE Preformed Reconstruction Plates; Synthes MultiLoc Humeral Nailing System; Synthes Multiloc Proximal Humeral Nailing System; Synthes Navigable Pedicle Preparation Instruments; Synthes Neuro Plate and Screw System; Synthes Oracle Plate; Synthes Patient Specific Implants; Synthes Self Drilling Schanz Screws; Synthes Self-Drilling Schanz Screws; Synthes Sternal ZipFix System; Synthes Synapse 4 System; Synthes T-PAL Spacer; Synthes TFN Screw; Synthes Unreamed Humeral Nail; Synthes Zero-P; Synthes2.4 LCP Vol. Col. Dist. Radi; SynthesCel; Syringe, piston; T-PAL; T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System; T-PAL Ti Spacer; TAMP; TAN Unreamed Femoral Nail; TAP; TEMPLATE; TITANIUM (TI) ALLOY HIGH TIBIAL OST; TITANIUM CANNULATED TIBIAL NAIL (TI; TITANIUM LOCKING PLATE SYSTEM; TOMOFIX OSTEOTOMY SYSTEM; TORQUE LIMITING ATTACHMENT; TRAUMACEM"" V+ Injectable Bone Cement; TREPHINE; TROCHANTERIC FIXATION NAIL (TFN); Thoracolumbosacral pedicle screw system; Titanium Distal Femoral Nail; Titanium TomoFix Medial High Tibia Plate Anatomical; TomoFix Medial Distal Femur Plates; TomoFix Medial High Tibia Pl. Small; Trochanter Stabilization Plate DHS; UNIVERSAL FEMORAL NAIL; UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM; USS; USS Iliosacral and Polyaxial System; USS System; USS VAS; USS-LINE EXTENSION; VARIOUS BATTERY POWE; VARIOUS RECHARGEABLE BATTERIES; VBB System; VERTECEM II CEMENT KIT; VOLAR DISTAL RADIUS PLATE; VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System; VOLT™ Proximal Humerus 3.5 Plating System; Vertebroplasty Needle Kit; Vienna System; Viper 2 System; Viper System; WASHER, BOLT NUT; WASHER, BOLT, NUT, NON-SPINAL, METALLIC; WRENCH; ZERO-P NATURAL Plate; Zero-P VA; bender; blade; bone grafting material; broach; burr; caliper; cannula; chisel; countersink; crimper; cutter; device; dissector; driver; e12 Electric Instrument System; eMax 2 Plus System; elevator; filler; forceps; gauge; guide; hammer; impactor; injector; instrument; mallet; nail, fixation, bone; plate; plate, fixation, bone; pliers; probe; reamer; retention device; retractor; rongeur; screw; screwdriver; spinal channeling instrument, vertebroplasty; starter; surgical instrument; syringe; tape; traction; tray; tray, surgical; trocar",1981-02-24,538,2026-06-11,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009417901%22&limit=1
Zimmer Pte. Ltd.,3013176080,3013176080,401 Commonwealth Drive #06-03 How Par Techno Centre,Singapore South East,,149598,Singapore,Zimmer Biomet APAC DFE,10056128,Exporter to the US,82,EFQ; FLE; FMF; FZP; GAM; GAS; GAT; GCJ; GEI; HAW; HRS; HRX; HRY; HSB; HSD; HSX; HSZ; HTN; HTY; HWC; HXK; HXN; JDB; JDC; JDG; JDI; JDL; JDO; JDQ; JDR; JDS; JDW; JDX; JEC; JWH; JWJ; KGS; KMC; KRO; KRR; KTT; KTW; KWA; KWH; KWI; KWL; KWS; KWT; KWY; KWZ; KXA; LOD; LPH; LWJ; LXT; LZN; LZO; LZY; MAI; MAY; MBB; MBF; MBH; MBI; MBL; MBV; MEH; MJT; MLR; MQV; NDF; NDH; NEU; NJD; NQP; OIY; OQG; OQH; OQI; PAO; PBI; PHX,"Gauze/Sponge, Internal; Sterilizer, Steam; Syringe, Piston; Clip, Implantable; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Washer, Bolt Nut; Pin, Fixation, Smooth; Screw, Fixation, Bone; Holder, Needle; Orthopedic; Applier, Cerclage; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Instrument, Surgical, Sonic And Accessory/Attachment; Component, Traction, Invasive; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained; Retention Device, Suture; Prosthesis, Hip, Semi-Constrained,  Composite/Metal; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Femoral, Resurfacing; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented; Sterilizer, Chemical; Filler, Bone Void, Calcium Compound; Plate, Fixation, Bone, Non-Spinal, Metallic; Nail, Fixation, Bone, Metallic; Marker, Radiographic, Implantable; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Posterior Metal/Polymer Spinal System, Fusion; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive; Shoulder Prosthesis, Reverse Configuration",1; 2; 3; U,Biomet Knee Joint Replacement Prostheses; THE NATURAL-KNEE REVISION,2018-08-14,538,2017-07-28,1,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013176080%22&limit=1
Philips Electronics Ltd,3000126629,3000126629,"1875 Buckhorn Gate, 5th Floor",Mississauga Ontario,,L4W 5P1,Canada,Philips Medical Systems International BV,1217116,Exporter to the US,195,BSY; BSZ; BTI; BTK; BTT; BWF; BXK; BXP; BYE; BYG; BYH; BYI; BYP; BYT; BZA; BZC; BZD; BZE; BZG; BZH; BZK; BZO; BZQ; BZR; BZS; CAE; CAF; CAI; CAP; CAT; CAW; CBK; CBQ; CBR; CBS; CCK; CCL; CEM; CGZ; DPS; DPZ; DQA; DQK; DQX; DQY; DRB; DRE; DRG; DRJ; DRO; DRQ; DRS; DRT; DRW; DRX; DRY; DSA; DSB; DSF; DSH; DSI; DSJ; DSK; DSP; DXG; DXH; DXJ; DXN; DXO; DXQ; EFS; ERL; EXS; FCG; FLL; FRW; GDF; GWQ; GWR; GWS; HCC; HFM; HFN; HFS; HGL; HGM; HGP; HGX; HGY; HOY; IKD; IKK; ILQ; IMD; ISD; ITX; ITY; IWE; IXA; IXJ; IXL; IXQ; IXR; IXY; IYB; IYN; IYO; IZI; IZL; IZO; IZW; IZZ; JAA; JAK; JEQ; JFL; JFP; JGS; JKS; JOM; JOP; JQP; KGB; KGX; KLK; KNW; KOI; KPD; KPR; KPS; KPW; KRA; KRB; KRC; KXJ; KZF; LDD; LDE; LHO; LIX; LKD; LLZ; LNH; LNI; LPP; LRK; MCW; MFA; MHX; MIG; MJN; MKJ; MLC; MLD; MLO; MNK; MNR; MNS; MNT; MOS; MPO; MQB; MQM; MSX; MUE; MUJ; MWI; MYB; NEU; NHJ; NHO; NHP; NHQ; NOB; NOU; NSA; NVP; NWX; NXQ; OBJ; OED; OLT; OLV; OLW; OLZ; OMC; ORT; OUG; OWB; OXO; PDU; PNO; PSY; QIH; SDT,"Catheters, Suction, Tracheobronchial; Gas-Machine, Anesthesia; Compressor, Air, Portable; Strap, Head, Gas Mask; Humidifier, Respiratory Gas, (Direct Patient Interface); Spirometer, Therapeutic (Incentive); Gas, Calibration (Specified Concentration); Transducer, Gas Flow; Attachment, Breathing, Positive End Expiratory Pressure; Mask, Oxygen; Drain, Tee (Water Trap); Percussor, Powered-Electric; Mouthpiece, Breathing; Ventilator, External Body, Negative Pressure, Adult (Cuirass); Connector, Airway (Extension); Calculator, Pulmonary Function Data; Ventilator, Non-Continuous (Respirator); Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer; Spirometer, Diagnostic; Meter, Peak Flow, Spirometry; Spirometer, Monitoring (W/Wo Alarm); Set, Tubing And Support, Ventilator (W Harness); Monitor, Breathing Frequency; Mixer, Breathing Gases, Anesthesia Inhalation; Stethoscope Head; Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Circuit, Breathing (W Connector, Adaptor, Y Piece); Monitor, Airway Pressure (Includes Gauge And/Or Alarm); Cannula, Nasal, Oxygen; Generator, Oxygen, Portable; Ventilator, Continuous, Facility Use; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Electrode, Ion Specific, Potassium; Electrode, Ion-Specific, Chloride; Electrocardiograph; Oximeter, Ear; Oximeter; Computer, Diagnostic, Programmable; Wire, Guide, Catheter; Catheter, Percutaneous; Stylet, Catheter; Dilator, Vessel, For Percutaneous Catheterization; Transmitters And Receivers, Physiological Signal, Radiofrequency; System, Signal Isolation; Pacemaker, Cardiac, External Transcutaneous (Non-Invasive); Amplifier And Signal Conditioner, Transducer Signal; Transducer, Blood-Pressure, Extravascular; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Adaptor, Lead Switching, Electrocardiograph; Electrode, Electrocardiograph; Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass; Cable, Transducer And Electrode, Patient, (Including Connector); Plethysmograph, Impedance; Recorder, Paper Chart; Recorder, Magnetic Tape, Medical; Detector And Alarm, Arrhythmia; Alarm, Blood-Pressure; Computer, Blood-Pressure; System, Balloon, Intra-Aortic And Control; Computer, Diagnostic, Pre-Programmed, Single-Function; Transmitters And Receivers, Electrocardiograph, Telephone; Display, Cathode-Ray Tube, Medical; System, Measurement, Blood-Pressure, Non-Invasive; Transducer, Pressure, Catheter Tip; Blood Pressure Cuff; Unit, Oral Irrigation; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Urinometer, Electrical; Biopsy Needle; Continuous Measurement Thermometer; Scale, Patient; Guide, Needle, Surgical; Full-Montage Standard Electroencephalograph; Generator, Electroencephalograph Test Signal; Analyzer, Spectrum, Electroencephalogram Signal; Device, Biofeedback; Monitor, Uterine Contraction, External (For Use In Clinic); Transducer, Pressure, Intrauterine; Shield, Nipple; Transducer, Ultrasonic, Obstetric; System, Monitoring, Perinatal; Electrode, Circular (Spiral), Scalp And Applicator; Pump, Breast, Powered; Pump, Breast, Non-Powered; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Cable, Electrode; System, Isokinetic Testing And Evaluation; System, Communication, Powered; Pack, Hot Or Cold, Disposable; Exerciser, Measuring; Transducer, Ultrasonic, Diagnostic; Assembly, Tube Housing, X-Ray, Diagnostic; Monitor, Patient Position, Light-Beam; Cassette, Radiographic Film; Grid, Radiographic; Device, Spot-Film; Table, Radiographic, Stationary Top; Table, Radiographic, Tilting; Holder, Radiographic Cassette, Wall-Mounted; Tube Mount, X-Ray, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; System, X-Ray, Mobile; Generator, High-Voltage, X-Ray, Diagnostic; Collimator, Automatic, Radiographic; Table, Radiographic, Non-Tilting, Powered; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Tomography, Computed; Toothbrush, Powered; Ph Rate Measurement, Carbon-Dioxide; Electrode, Ion Specific, Calcium; Electrode, Ion Specific, Sodium; Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide; Plethysmograph, Photoelectric, Pneumatic Or Hydraulic; Transducer, Ultrasonic; Calculator/Data Processing Module, For Clinical Use; Mask, Oxygen, Non-Rebreathing; Tape And Bandage, Adhesive; Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia; Instrument, Biopsy; Stimulator, Nerve, Peripheral, Electric; Strip, Temperature, Forehead, Liquid Crystal; System, X-Ray, Stationary; System, Tomography, Computed, Emission; Device, Beam Limiting, X-Ray, Diagnostic; Catheter, Continuous Flush; Probe, Thermodilution; Tester, Electrode, Surface, Electrocardiographic; Table, Radiologic; Device, Medical Examination, Ac Powered; Dc-Defibrillator, Low-Energy, (Including Paddles); Stethoscope, Manual; Instrument, Quality-Assurance, Radiologic; Aid, Cardiopulmonary Resuscitation; Monitor, Carbon-Dioxide, Cutaneous; System, Image Processing, Radiological; System, Nuclear Magnetic Resonance Imaging; System, Nuclear Magnetic Resonance Spectroscopic; Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia; Device, Anti-Snoring; Catheter, Peripheral, Atherectomy; Device, Removal, Pacemaker Electrode, Percutaneous; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Strip, Test Isoniazid; Catheter, Intravascular Occluding, Temporary; Automated External Defibrillators (Non-Wearable); Monitor, St Segment; Monitor, St Segment With Alarm; Electrocardiograph, Ambulatory, With Analysis Algorithm; Endoscopic Bite Block; Ventilatory Effort Recorder; Ventilator, Continuous, Non-Life-Supporting; Continuous, Minimal Ventilatory Support, Facility Use Ventilator; Coil, Magnetic Resonance, Specialty; Infant Heel Warmer (Chemical Heat Pack); Solid State X-Ray Imager (Flat Panel/Digital Imager); Bilirubin (Total And Unbound) In The Neonate Test System; System, Network And Communication, Physiological Monitors; Full Field Digital, System, X-Ray, Mammographic; System, Planning, Radiation Therapy Treatment; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Pillow, Cervical (For Mild Sleep Apnea); Marker, Radiographic, Implantable; Device, Positive Pressure Breathing, Intermittent; Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration); Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile; Continuous, Ventilator, Home Use; Over-The-Counter Automated External Defibrillator; Holding Chambers, Direct Patient Interface; Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring; Reminder, Medication; Catheter, Ultrasound, Intravascular; Antimicrobial Blood Pressure Cuff; Non-Normalizing Quantitative Electroencephalograph Software; Standard Polysomnograph With Electroencephalograph; Index-Generating Electroencephalograph Software; Automatic Event Detection Software For Polysomnograph With Electroencephalograph; Reduced- Montage Standard Electroencephalograph; Burst Suppression Detection Software For Electroencephalograph; Medical Device Data System; Interventional Fluoroscopic X-Ray System; Image-Intensified Fluoroscopic X-Ray System, Mobile; Catheter For Crossing Total Occlusions; Catheter, Percutaneous, Cutting/Scoring; Whole Slide Imaging System; Automated Radiological Image Processing Software; Intra-Pulmonary Percussive Vibration (Ipv) Devices",1; 2; 3; U,"0.6T Marconi Wrist and Hand Array; 0.6T Panorama 4Ch Breast Array; 0.9 OTW TURBO ELITE; 05-10000 - Heartstream Pads to QUIK-COMBO Adapter [FR2]; 05-10100 - Heartstream Pads to Zoll Adapter; 1.5T 16CH Cardiac Coil- Anterior; 1.5T 16CH Cardiac Coil- Posterior; 1.5T 16Ch GE Shoulder Coil; 1.5T 32CH Cardiac Coil- Anterior; 1.5T 32Ch Cardiac Coil- Anterior; 1.5T 8CH Obelix digital shoulder coil; 1.5T AND 3T GENERAL PURPOSE FLEX COILS; 1.5T Array Upper Extremity (MSK Coil); 1.5T Breast Coil Assembly; 1.5T Breast Speeder 8ch; 1.5T GE COMPATIBLE HNC COIL SYS; 1.5T HD 8HR Brain Array for HDe (Receive Only); 1.5T HD T/R KNEE ARRAY; 1.5T HD T/R Knee Coil (flat base); 1.5T HD T/R QUAD EXTREMITY COIL (flat base); 1.5T Musculoskeletal Array; 1.5T Precision Shoulder Array; 1.5T QUAD EXTREMITY COIL T/R; 1.5T SENSE GP Flex 8; 1.5T/3T 8 ch medium general purpose Flex Coil; 1037632 Bilichek (Advanced); 12-Lead Patient Cables: 989803184921, 989803184931, 989803184941, 989803184951; 12/24V Battery Cable w/terminals or adapter; 12L5A Linear Array Transduce; 12L5A Linear Array Transducer; 13943B Solid Gel Tab Electrode, Resting ECG; 13951C Neonatal/Pediatric Solid Gel Electrode; 13952A Preattached Leadwire Electrode medium; 13952B Preattached Leadwire electrode medium; 13952D Metallic Preattached Leadwire Electrode, Medium; 13953A Preattached Leadwire electrode square; 13953B Preattached leadwire electrode square; 13953D Metallic Preattached Leadwire Electrode, Square; 13953E Radiolucent Preattached Leadwire Electrode, Square; 13955C Neonatal/Pediatric Snap Electrode, Square; 15mm Male/Female Adapter; 15mm Male/Female Adapter Low Deadspace; 16 Ch Body Array Anterior 1.5T; 16 Ch Body Array Anterior 3T; 16Ch Shoulder Coil; 21075A Esophageal/Rectal 12 Fr Temperature Probe; 21076A Esophageal/Rectal 10 Fr Temperature Probe; 21078A Skin Surface Temperature Probe; 21221B (C1914C); 21223B (D5014V); 21228B (D1914V); 21321A (C3540); 21330A (S4); 21350A (S8); 21359A (L7535); 21360A (L5035); 21369A (Omni II); 21373B (C5040); 21380A (S12); 21390A (15-61); 21422A; 21475A; 3Ch Left Coil Element Sen 1.5T; 3Ch Left Coil Element Sen 3T; 3Ch Right Coil Element Sen 1.5T; 3Ch Right Coil Element Sen 3T; 3D Auto LAA; 3D6-2; 3D8-4; 3D9-3v; 3T 16Ch GE Shoulder Coil; 3T 32Ch CardiaC Coil- Anterior; 3T 32Ch Cardiac Coil - Anterior; 3T 32Ch Cardiac Coil- Posterior; 3T HD T/R KNEE ARRAY; 3T HD T/R Knee Coil (flat base); 3T HD T/R Quad Extremity Coil (flat base); 3T Precision Shoulder Array; 3T QUAD EXTREMITY COIL T/R; 3T SENSE MEDIUM GP FLEX 8; 4 CH Shoulder Large - 4 CH Shoulder Small; 4-ch SENSE Breast Coil 3T; 4-ch SENSE Shoulder Coil 3T; 4-ch SENSE Wrist Coil 1.5T; 40420A HI-Tack Foam Wet Gel ECG Electrode; 40493D Foam Wet Gel ECG Electrode; 40493E Foam Wet Gel ECG Electrode; 453564588501, Transpac IV Dual IBP Cable; 459801507722 Biospy Grid, Sterilized; 459801508642 Breast Grid (User-Sterilized); 4V2A Sector Transducer; 4ch SENSE Shoulder Coil 1.5T; 4ch SENSE Shoulder Coil 3T; 5000 Compact Series Ultrasound Systems; 528GE Series; 5C2A Curved Linear Array Transducer; 68-PCHAT, Fast Respond Kit; 7 CHANNEL BREAST COIL 3T; 7 Channel Breast MR Coil Kit 3T, GE Exite HDx 3T 7CH BBC, Philips 7ch SENSE Breast Coil 3T; 784027, DynaCAD; 8 CH HR Brain Array 3 T; 8 CHANNEL FOOT ANKLE COIL 1.5T; 8 CHANNEL KNEE COIL; 8 CHANNEL WRIST COIL 1.5T; 8 CHANNEL WRIST COIL 3T; 8 Ch High Resolution Knee Array; 8 Channel Foot Ankle MR Coil Kit 1.5T; 8 Channel Foot Ankle MR Coil Kit 3T; 8 Channel Head Array; 8 Channel High Resolution Brain Coil; 8 Channel Knee Array MR Coil Kit Avanto, Siemens HRK, AVANTO 1.5T 8CH PA; 8 Channel Wrist Coil; 8 Channel Wrist MR Coil Kit 1.5T; 8 Channel Wrist MR Coil Kit 3T; 861304 HeartStart FRx Defibrillator; 863286, SureSigns VS4 Government Bundle; 866009, Philips IntelliVue GuardianSoftware, SW Rev. C; 866060 IntelliVue Patient Monitor MX400; 866062 IntelliVue Patient Monitor MX450; 867030, IntelliVue Multi-Measurement Module X3; 867033, IntelliVue Patient Monitor MX100; 867036, IntelliVue Multi-Measurement Module MMX; 867039, IntelliVue Hemodynamic Extension; 867040 - IntelliVue Capnography Extension; 867041 - IntelliVue Microstream Extension; 867043, IntelliVue Dock; 867061 Philips IntelliSpace Perinatal Rev. K0 Large Architecture; 867062 Philips IntelliSpace Perinatal Rev. K0 Small Architecture; 8CH FOOT ANKLE MR COIL 3T; 8CH HIGH RESOLUTION KNEE ARRAY; 8Ch High Resolution Brain Array; 8Ch High Resolution Brain Array (Receive Only); 8Ch Neuro Vasculat Array (Receive Only); 8EC4A Curved Array Transducer; 8V3A Sector Transducer; 8ch Wrist Array; 920 & 920M Handheld Pulse Oximeter; 920M Plus Pulse Oximeter; 989603203464 MRI Needle Block 12G; 989603203474MRI Needle Block 14G; 989603203484 MRI Needle Block 18G; 989603203524 Grid Immobilization Plate; 989603203574 Pillar Immobilization Plate OBC; 989603203584 Mammotome Immobilization Plate; 989603203594 OBC Grid Immobilization Plate; 989603204304 MRI Needle Block 16G; 989603209064 Grid Immobilization Plate LBS; 989603209104 Pillar Immobilization Plate; 989603209144 Lateral Grid dS Breast 16CH I/T; 989603214204 Biospy Grid, Sterilized; 989803101301 HI-Tack Foam Wet Gel ECG Electrode; 989803129231, Alligator Clips, AMMI; 989803137631 Fetal Spiral Electrode; 989803137651-DECG Reusable Leg plate Adapter Cable; 989803139261 SMART Pads II; 989803139301 Aviation FRx Battery; 989803139311 Infant/Child Key; 989803149981 and 989803149991 SMART Pads III; 989803150031 Pediatric Key; 989803150111, Fast Response Kit, FR3; 989803150161 Primary Battery; 989803151631, 12-Lead Complete Lead Set (AAMI), Standard Length; 989803151641, 12-Lead Complete Lead Set (IEC), Standard Length; 989803151651, 12-Lead Complete Lead Set (AAMI), Long; 989803151661, 12-Lead Complete Lead Set (IEC), Long; 989803151671, 12-Lead Chest Lead Set (AAMI/IEC), Standard Length; 989803151691, 12-Lead Chest Lead Set (AAMI/IEC), Long; 989803151711, 12-Lead Limb Lead Set (AAMI/IEC), Standard Length; 989803151731, 12-Lead Limb Lead Set (AAMI/IEC), Long; 989803151751, 15/16/18-Lead Upgrade Kit (AAMI), Standard Length; 989803151761, 15/16/18-Lead Upgrade Kit (IEC), Standard Length; 989803151771, 15/16/18-Lead Upgrade Kit (AAMI), Long; 989803151781, 15/16/18-Lead Upgrade Kit (IEC), Long; 989803156201 Adult Disposable Metallic 3 Leadwire Electrode Set, AAMI; 989803156221 Adult Disposable Radiolucent 3 Leadwire Electrode Set, AAMI; 989803156231 Adult Disposable Radiolucent 3 Leadwire Electrode Set, IEC; 989803156241 Adult Disposable Metallic 5 Leadwire Electrode Set, AAMI; 989803156261 Adult Disposable Radiolucent 5 Leadwire Electrode Set, AAMI; 989803156271 Adult Disp Radiolucent 5 Leadwire Electrode Set, IEC; 989803157481, DigiTrak XT Patient Cable, short; 989803157491, DigiTrak XT Patient Cable, Medium; 989803157501, DigiTrak XT Patient Cable, Long; 989803158211 and 989803158221 DP Pads; 989803159581 Microstream® EtCO2 VitaLine H Set; 989803160241 Microstream® EtCO2 Consumables Filterline Set Long; 989803160261 Microstream® EtCO2 VitaLine H Set Long; 989803160271 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long; 989803160301 Microstream® EtCO2 Consumables Smart CapnoLine Plus Long; 989803163181 Mobile CL Disposable Small Adult Cuff; 989803163191 Mobile CL Reusable Adult Cuff; 989803163201 Mobile CL Disposable Adult Cuff; 989803163211 Mobile CL Reusable Large Adult Cuff; 989803163221 Mobile CL Disposable Large Adult Cuff; 989803163251 Mobile CL NBP Cradle Kit; 989803164281, USB Patient Data Cable, Class B; 989803166021 - HeartStart Adult/Child Preconnect Pads; 989803166031, Clear Tab/Snap Adapter; 989803167541 Neonatal Single-Patient NIBP Cuffs; 989803167551 Neonatal Soft Single-Patient NIBP Cuffs; 989803168881 Mobile CL Transmitter Cradles; 989803171811 ECG 3 lead Grabber, AAMI + SpO2, Tele; 989803171821 ECG 5 lead Snaps, AAMI, Tele; 989803171831 ECG 5 lead Grabber, AAMI, Tele; 989803171841 ECG 5 lead Snaps, AAMI + SpO2, Tele; 989803171851 ECG 5 lead Grabber, AAMI + SpO2, Tele; 989803171861 ECG 6 lead Grabber, AAMI, Tele; 989803171871 CBL ECG 6lead Grabber, AAMI + SpO2, Tele; 989803171911 ECG 3 lead Grabber, IEC + SpO2, Tele; 989803171931 ECG 5 lead Grabber, IEC, Tele; 989803171951 ECG 5 lead Grabber, IEC + SpO2, Tele; 989803171961 ECG 6 lead Grabber, IEC, Tele; 989803171971 CBL ECG 6 Lead Grabber, IEC+SpO2, Tele; 989803172031 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172051 ECG 5 lead Graber, AAMI + SpO2, SPU, Tele; 989803172131 SPU ECG Lead Set, 5 Lead, AAMI, Grabber; 989803172151 ECG 5 lead Grabber, IEC + SpO2,SPU,Tele; 989803172221 ECG 5L Grabber, AAMI, SpO2, Tele; 989803173121 3-Lead Set, Single Patient Use Disposable, Bedside, AAMI; 989803173131 5-Lead Set, Single Patient Use Disposable, Bedside, AAMI; 989803173151 5-Lead Set, Single Patient Use Disposable,Telemetry, AAMI; 989803174201 3-Lead Set, Single Patient Use Disposable, Bedside, IEC; 989803174211 5-Lead Set, Single Patient Use Disposable,Bedside, IEC; 989803175891, 12-Lead Patient Cable (IEC), Standard Length; 989803175901, 12-Lead Patient Cable (AAMI), Standard Length; 989803175911, 12-Lead Patient Cable (IEC), Long; 989803175921, 12-Lead Patient Cable (AAMI), Long; 989803177951 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult; 989803177961 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Adult Long; 989803177971 Microstream® EtCO2 Consumables Smart CapnoLine® H 02 Pediatric; 989803177981 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Pediatric Long; 989803178001 Microstream® EtCO2 Consumables CapnoLine® H O2 Infant/ Neonatal; 989803178021 Microstream® EtCO2 Consumables Nasal FilterLine Infant/Neonatal; 989803179101 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult; 989803179111 Microstream® EtCO2 Consumables Nasal Filterline O2 Adult; 989803179121 Microstream® EtCO2 Consumables Filterline O2 Pediatric; 989803179381 Genius 2 Probe Covers; 989803179541 Mobile CL Respiration Pod Attachment; 989803180121, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Grabber; 989803180131, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Grabber; 989803180141, ST80i 12-Lead Complete Lead Set (AAMI), Standard Length, Snaps; 989803180151, ST80i 12-Lead Complete Lead Set (IEC), Standard Length, Snaps; 989803180831 Tethered Genius 2 Tympanic Thermometer; 989803180831, Genius 2 tympanic temperature probe; 989803182281 Single Care Cuff, Pediatric; 989803182291 Single Care Cuff, Small Adult; 989803182301 Single Care Cuff, Adult; 989803182311 Single Care Cuff, Adult XL; 989803182321 Single Care Cuff, Large Adult; 989803182911Microstream® EtCO2 Consumables Filterline Set; 989803182921 Microstream® EtCO2 FilterLine H Set; 989803182931 Microstream® EtCO2 FilterLine H Set; 989803182941 Microstream® EtCO2 VitaLine H Set; 989803182951 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Pediatric; 989803182961 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Adult; 989803182971 Microstream® EtCO2 Consumables Smart CapnoLine® H O2 Adult; 989803182981 Microstream® EtCO2 Consumables Smart CapnoLine® O2 Long,Adult; 989803183071 Microstream® EtCO2 Consumables CapnoLine® H O2; 989803183081 Mini NeoLead, AAMI metal lead; 989803183101 989803183101; 989803183121 NeoLead, AAMI radio lead; 989803183141 Micro NeoLead, AAMI radio lead; 989803183311 Multi Care Cuff, Infant; 989803183321 Multi Care Cuff, Pediatric; 989803183331 Multi Care Cuff, Small Adult; 989803183341 Multi Care Cuff, Adult; 989803183351 Multi Care Cuff, Adult XL; 989803183361Multi Care Cuff, Large Adult; 989803183371 Multi Care Cuff, Thigh; 989803184851- Avalon Belt Clip; 989803192141 5-Lead Set, Single Patient Use Disposable, Chest, AAMI; 989803192151 5-Lead Set, Single Patient Use Disposable, Chest, IEC; 989803192551 Clear Tape Wet Gel ECG Electrode; 989803192931, SureSigns VS Temporal Temperature HH; 989803194631, Expression MR IBP DPT Kit, A/P, Box 20; 989803194641, Expression MR IBP DPT Kit, I/N, Box 20; 989803197511 6-Lead Set, Patient Use Disposable, Bedside, AAMI; 989803197521 6-Lead Set, Single Patient Use Disposable, Bedside, IEC; 989803199071 ECG 6 lead Grabber, IEC + SpO2, Tele; 989803199081 MX40 Adapter SpO2-only; 989803199091 MX40 Adapter 5L+SpO2; 989803199101 MX40 Adapter 3L+SpO2; 989803199741, Dual IBP Adapter; 989803202381 MX40 Adapter 5-Lead + Masimo SpO2; 989803202391 MX40 Adapter Masimo SpO2-only; 989803202411 ECG 5L Grabber, AAMI, Masimo SpO2 , Tele; 989803202421 ECG 5L Grabber, IEC, Masimo SpO2 , Tele; 989803203561 Esophageal/Rectal Temperature Probe 12 Fr, Reusable, Autoclavable; 989803203571 Esophageal/Rectal Temperature Probe 10 Fr, Reusable, Autoclavable; 989803203581 Skin Temperature Probe, Reusable, Autoclavable; 989803204291 MX40 Adapter 6-Lead + Masimo SpO2; 989803205381 Philips Nasal Alar SpO2 Sensor; 989803205391 Philips Nasal Alar SpO2 Sensor; 989803205401 Philips Nasal Alar SpO2 Sensor; 989803205871 SPO2 Reus Ped-Adult Glove Sensor M1192A; 989803205881 SPO2 Reus Neo Hnd-Ft Wrap Sensor M1193A; 9MC3 Curved Array Transducer; A30 Heated Humidifier; A40 Heated Humidifier; AA &TRAY ASSY, ADU, ZOLL MED 8000-0262; AAA Model; ADULT AIRWAY ADAPTER, QTY 1, MAQUET; ADVANCED FILTER ECG CABLE - 989803170121; AF421 FFM; AF421 SE Full Face Mask; AF531 FFM; AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask; AF541 EE Leak 1 Full Face Mask; AF541 EE Leak 2 Full Face Mask; AF541 FFM; AF541 SE Full Face Mask; AF811 FFM; AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10; ALLURA XPER FD BIPLANE SERIES; ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x; AP111 EE/SE Nasal Mask; AP111 Nasal Mask; AVANTO BIOPSY BREAST ARRAY; Accessories, SENSE Head Coil, 6Ch 3T; Achieva; Achieva 1.5T family; Achieva 1.5T, 3T, and Intera 1.5T; Achieva Family; Achieva R4 1.5T (Ingenia); Achieva R4 3T (ingenia); Achieva TX Interventional Coil 3T; Actiware; Actiwatch Score; Actiwatch Spectrum Pro/Plus; Actiwatch Spectrum Pro/Plus + Dock; Adam Shell Thermocouple Assembly; Adapter ADU Reuse Capnostat 704-0002-00; Adaptive Needle Tracker; Adult Nasal/Oral CO2 Cannula Capnoflex; Advanced Apps ECG Cable - 989803176381; Affiniti 30 Circular Edition Ultrasound System; Affiniti 30 Diagnostic Ultrasound System; Affiniti 30 Diamond Select Ultrasound System; Affiniti 30 Ultrasound System; Affiniti 50 Circular Edition Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 50 Diamond Select Ultrasound System; Affiniti 50 Ultrasound System; Affiniti 50C Diagnostic Ultrasound System; Affiniti 50G Diagnostic Ultrasound System; Affiniti 50W Diagnostic Ultrasound System; Affiniti 70 Circular Edition Ultrasound System; Affiniti 70 Diagnostic Ultrasound System; Affiniti 70 Diamond Select Ultrasound System; Affiniti 70 Ultrasound System; Affiniti 70C Diagnostic Ultrasound System; Affiniti 70G Diagnostic Ultrasound System; Affiniti 70W Diagnostic Ultrasound System; Affiniti CVx Ultrasound System; Affiniti Circular Edition Diagnostic Ultrasound System; Affiniti Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound System; AirFloss; AirFloss Fill and Charge Station; AirFloss Pro; AirFloss Ultra; Airis Elite Rapid Extremity Coil; Airis Elite Rapid Head Coil; Airway Adapter - Single Patient Use - Adult/Pediatric; Airway Adapter - Single Patient Use - Neonatal; Airway Adapter Adult/Pediatric Capnoflex; Airway Adapter Adult/Pediatric Nafion Capnoflex; Airway Adapter Kit PED/INF 704-0024-00; Airway Adapter Pediatric/Infant Nafion Capnoflex; Airway, ADU-PED, SLM LoFlo, 10; Airway, Adult Pediatric, Zoll LoFlo, 10; Airway, DEHUM TBG, ADU PED Zoll LoFlo 10; Airway, DEHUM TBG, PED INF Zoll LoFlo10; Airway, Pediatric Infant, Zoll LoFlo, 10; AirwayAdapter PED/INF Nafion 704-0026-00; Alice 6 Headbox LDE; Alice 6 PSG Base Station LDE; Alice NightOne; Alice PDX; Alice PSG or components; Allura Xper FD10; Altaire Rapid Head Coil; Amara FFM - RIMR, RIMP; Amara View FFM - RIMR, RIMP; Amara View SE FFM; Anesthesia Gas Monitor; Anesthetic Oxygen (O2) Sensor - 989803162051; Angiosculpt PTA scoring balloon; Angiosculpt PTCA scoring balloon; Arrhythmia Detector and Alarm; Aspiration Biopsy Needle; Assess Low Range Peak Flow Meter; Asthma Check; Asthma Mentor; Automated External Defib; Avalon Basestation (866074); Avalon CL Fetal & Maternal Pod (866488); Avalon Fetal & Maternal Patch; Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A); Avalon Patient Module (M2738A); Avanto/Espree 1.5T 8Ch High Resolution Knee Array; B800-11 BilEclipse, 50 Pack; B800-500 BiliCal; 50 Pack; BIS Module; BP10-5ec; BREAST ARRAY COIL (Receive Only); BREAST ARRAY COIL, Philips 4-ch SENSE Breast Coil 3T; BREAST SPEEDER; BTP-1000A-Hybrid Patch; BTP-1000L-2-Lead Wire Adapter; BiPAP A30 Ventilatory Support System; BiPAP A40 Ventilatory Support System; BiPAP AVAPS (NGBL); BiPAP AVAPS or S/T C-Series; BiPAP AVAPS ventilatory support system; BiPAP AVAPS/BiPAP S/T; BiPAP Harmony 2 & S/T; BiPAP Plus M & Heated Humidifier; BiPAP Pro 2 & Heated Humidifier; BiPAP Q-Series; BiPAP Q-Series w/HT; BiPAP S/T ventilatory support system; BiPAP Synchrony (NGBL); BiPAP Synchrony 2 (NGBL); BiPAP V30 Auto; BiPAP Vision; BiPAP autoSV (NGBL); BiPAP autoSV ADV w/Hum 30cm (RIST); BiPAP autoSV Advanced; BiPAP autoSV advanced smartcard; Biopsy Breast Coil; Biopsy Grid; Biopsy Gun; Biopsy Needle; Bite Guard, Adult; Blood pressure monitor; Body Position Sensor; Brain Array 3T den; Breast Array Coil; Breast Grid (User-Sterilized); Breast MRI 8ch Table for GE 1.5T; Breast MRI 8ch Tabletop for Siemens 1.5T; Bridge Occlusion Balloon; BrightView XCT SPECT/CT Imaging System; Brilliance 16; Brilliance 16 Power CT Systems; Brilliance 6; Brilliance 64; Brilliance CT Big Bore; Bronchoscopy Elbow; Bronchoscopy Elbow, Click Style; Bronchoscopy elbow; Bucky Diagnost Family; BuckyDiagnost; BuckyDiagnost: TH2, THS; C10-3v; C10-4ec; C10-4ec; D2cwc; C5 LoFlo Sidestream Module; C5-1; C5-1; C6-2; C8-5; C9-2; C10-3v; C5-2; C5-2 (21426A); C6-2; C6-3; C8-4 (21437A); C8-4v; C8-5; C9-2; C9-3io; C9-3v; C9-4; C9-4ec; C9-4ec Transducer; C9-4v; C9-5ec; CAB,4 LD,CV MRI ECG - 9223; CAB,4 LD,MRI ECG - 9224; CAB,4 LD,NEO.MRI ECG - 9222; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE; CANNULA,DISP,INFANT (4200F); CAPNOSTAT 5 Mainstream CO2 sensor; CAPNOSTAT 5 Mainstream Sensor, Maquet; CATHETER, CONTINUOUS FLUSH; CBL 5 Lead, Snap, Shld, AAMI, Chest, Rgd - 989803176171; CBL 5 Lead, Snap, Shld, AAMI, Limb, Rgd - 989803176161; CBL 5 Lead, Snap, Shld, IEC, Limb, Rgd - 989803176181; CBL OR 3-Lead ECG Trunk Cable, AAMI/IEC - 989803170171; CBL OR 5-Lead ECG Trunk Cable, AAMI/IEC - 989803170181; CENTERING LIGHT (OR LASER); CIRC.COIL C1 1.5T 4598-000-5184x; CIRC.COIL C3 1.5T 4598-000-5196x; CL NBP Pod SW Rev. B2; CO2 Nasal Cannula - Infant; CO2 Nasal Cannula - Pediatric; CO2/Flow Sensor Adult; CO2/Flow Sensor Neonatal; CO2/Flow Sensor Pediatric; CS770 IntelliSpace Critical Care and Anesthesia H; CT 5300; CT XS Generator; CT XS Tube; CTR17xx Series; CTR21xx Series; CTR22xx Series; CTxxxx Series; CUFFF,CHILD,MRI,COLDER CONN - 989803169441; CX30 Diagnostic Ultrasound System; CX50 Circular Edition Diagnostic Ultrasound System; CX50 Diagnostic Ultrasound System; CX50 Diamond Select Diagnostic Ultrasound System; Cable Tray HYP VG ST; Cable Tray HYP VG STR; Cable Tray VG GE450; Cannula Nasal CO2 Adult 7040010-00; Cannula Nasal CO2 Adult Capnoflex; Cannula Nasal CO2 Only Pediatric Capnoflex; Cannula Nasal CO2 PED 704-0012-00; Cannula Nasal CO2/O2 ADU 704-0014-00; Cannula Nasal CO2/O2 Adult Capnoflex; Cannula Nasal CO2/O2 INF 704-0015-00; Cannula Nasal CO2/O2 PED 704-0016-00; Cannula Nasal/Oral CO2 ADU 704-0017-00; Cannula Oral/Nasal CO2/O2 Adult Capnoflex D; Cannula Style Thermocouples; Cannula, 02 CO2 Oral, ADU, Zoll LoFlo 10; Cannula, CO2 ORAL, ADU, Zoll LoFlo, 10; Cannula, CO2 Oral, PED, Zoll LoFlo, 10; Cannula, CO2, ADU, Zoll LoFlo, 10; Cannula, CO2, INF, Zoll LoFlo, 10; Cannula, CO2, PED, Zoll LoFlo, 10; Cannula, O2 CO2 ORAL, PED, Zoll LoFlo 10; Cannula, O2 CO2, ADU, Zoll LoFlo, 10; Cannula, O2 CO2, INF, 10, Zoll LoFlo; Cannula, O2 CO2, PED, Zoll LoFlo, 10; CannulaNasal/Oral CO2/O2 ADU 704-0020-00; CannulaNasal/Oral CO2/O2 PED 704-0022-00; CapnoTrak Airway Adapter Set; CapnoTrak CO2 Nasal Cannula; CapnoTrak CO2 Oral Nasal Cannula; CapnoTrak CO2 Sampling Extension Line; CapnoTrak CO2/O2 Nasal Cannula; CapnoTrak CO2/O2 Oral Nasal Cannula; CapnoTrak Dehumidification Tubing; CapnoTrak O2 Delivery Extension Line; CapnoTrak Water Filter Assembly; Capnography Sensor, Reusable; Capnostat 5 Mainstream CO2 Sensor; Capnostat 5 Mainstream CO2 Sensor for Goldway Medical; Capnostat 5 Mainstream CO2 Sensor for Mindray Medical; Care Orchestrator; CareEvent; Carescape CO2 - LoFlo; Certeray; Chest Shell and components; Chin Strap; ClearVue 350 Diagnostic Ultrasound System; ClearVue 550 Diagnostic Ultrasound System; ClearVue 580 Diagnostic Ultrasound System; ClearVue 650 Diagnostic Ultrasound System; ClearVue 850 Diagnostic Ultrasound System; ClipLoc Soft Tissue Marker; Cliploc Localization Needle, 3T ClipLoc Set; Coated Cuff; Coax Needle; Cobranded LoFlo CO2 Sampling Cannula; Cobranded LoFlo Sampling Line Kit; Cobranded LoFlo Sampling Line Kit w/Dehumidification Tubing; Coil Lateral 8CH Array Left VT 3T; Coil Medial Array VT 3T; Coil/ASM/Breast Coil for Echelon; Collaboration Live; Collimator BV300; Collimator IITV; Collimator P225 ACS Rev 1.1; CombiDiagnost R90; Comfort Gel Blue Nasal Mask; ComfortFull FFM - RSZ; ComfortGel Blue FFM; ComfortGel Blue SE FFM; CompuRecord System; Contour Deluxe/Comfort/Ptrak Nasal Mask; Cough Assist T70; CoughAssist; Crystal Trace Piezo Sensor; Cx50 Diagnostic Ultrasound System; D2 CW; D2 TC; D2cwc; D2tcd; D2tcd; D5cwc; D5cwc; DAUM-LECTRIC MRI Drilling Machine; DAxxx Series; DRxxx Series; DU, DR; DUxxx Series; DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE); Dehumidification Tubing - 1 ft.; Deluxe Compact Cart; Digital Manometer; DigitalDiagnost; DigitalDiagnost C90; DigitalDiagnost, BuckyVision, Bucky Diagnost TH, Bucky Diagnost CS2/CS4; DirectView Data Management System; Disposable 15 mm non-heated passive and heated active circuits; Disposable 15mm MPV circuit; Disposable 22mm non-heated passive and heated active circuits; Disposable Adult / Pediatric SpO2 Sensor (M1131A); Disposable Adult/Ped Heated Active Circuit; Disposable Adult/Ped Heated Passive Circuit; Disposable Swivel Passive Exhalation Port; Disposable/FEP/Invasive Circuits; Diverse Specialized Accessories and IntelliVue CL 865220 charging station; Dorma CPAP; DoseAware; DoseAware R2; Drain, Tee (water trap); DreamStation BiPAP AVAPS w/ & w/o Humidifier; DreamStation BiPAP Auto w/ & w/o Humidifier; DreamStation BiPAP Pro w/ & w/o Humidifier; DreamStation BiPAP S/T w/ & w/o Humidifier; DreamStation BiPAP autoSV w/ & w/o Humidifier; DreamStation CPAP Assist; DreamStation CPAP w/ & w/o Humidifier; DreamStation Go Auto CPAP; DreamStation Go CPAP; DreamWear Full Mask (RIMR/RISZ/Volcano); DreamWear Gel Pillows Mask (RIMR/RISZ); DreamWear Nasal Mask (RIMR/RISZ/Volcano); DreamWisp Nasal Mask (RIMR/RISZ/RIMP); Dreamstation 2 Advanced System; Dreamstation 2 System; Dreamstation CPAP Auto w/ & w/o Humidifier; Dreamstation CPAP Pro w/ & w/o Humidifier; Dreamstation GO w/ & w/o Humidifier; Dreamwear Silicone Pillows Mask (RIMR/RISZ); Dual Energy Option for Brilliance iCT Ctsystem; DuoDiagnost; DynaCAD; ECG electrode; ECG wireset; EEG Leadset - 989803180521; EEG Leadset - 989803180531; EEG Leadset - 989803180541; EEG Leadset - 989803180561; EPIQ 5 Circular Edition Ultrasound System; EPIQ 5 Diagnostic Ultrasound System; EPIQ 5 Diamond Select Ultrasound System; EPIQ 5 Ultrasound System; EPIQ 5C Diagnostic Ultrasound System; EPIQ 5G Diagnostic Ultrasound System; EPIQ 5W Diagnostic Ultrasound System; EPIQ 5W Ultrasound System; EPIQ 7 Circular Edition Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; EPIQ 7 Diamond Select Ultrasound System; EPIQ 7 Ultrasound System; EPIQ 7C Diagnostic Ultrasound System; EPIQ 7G Diagnostic Ultrasound System; EPIQ 7W Diagnostic Ultrasound System; EPIQ 7W Ultrasound System; EPIQ CVx Circular Edition Ultrasound System; EPIQ CVx Diagnostic Ultrasound System; EPIQ CVx Ultrasound System; EPIQ CVxi Diagnostic Ultrasound System; EPIQ CVxi Ultrasound System; EPIQ Circular Edition Diagnostic Ultrasound System; EPIQ Diagnostic Ultrasound System; EPIQ Diagnostic Ultrasound Systems; EPIQ Elite Circular Edition Ultrasound System; EPIQ Elite Diagnostic Ultrasound System; EPIQ Elite W Diagnostic Ultrasound System; EPIQ Series Diagnostic Ultrasound System; EPIQ Series Diagnostic Ultrasound Systems; ESys FMRI UPGRADE, ESys PATIENT ENTERTAINMENT SYSTEM; ESys fMRI; EZ-1 System Resp Sensor/ZRIP; Eagle Eye Platinum; Eagle Eye Platinum Catheter; Eagle Eye Platinum Short Tip Catheter; EarlyVue VS30 (863380); EarlyVue VS30 Vital Signs Monitor; EasyDiagnost; EasyDiagnost Eleva; Electrode; EnVisor Diagnostic Ultrasound System; Encore Anywhere; Encore Pro 2 Data Management System; Encore/Encore Pro Data Management System; EncoreAnywhere; Essenta DR; Essential MRI Patient Monitor (Model 865353); Essential Wireless Display, ROHS – 453564198611; EverFlo; EverFlo Quiet; Everflo Ultrafill; Everflo/Everflo Q/L4; Examination Light; Expert Shoulder Array Baseplate; Expression IP5 Information Portal; Expression IP5 Software Upgrade - 989803197491; Expression Informal Portal; Expression Information Portal; Expression MR Cuff,  Disp, NEO, MRI, Size #5 - 989803170421; Expression MR Cuff, Disp, NEO, MRI Size #3 - 989803170401; Expression MR ECG Leads, AAMI - 989803193721; Expression MR ECG Leads, AAMI, Neonatal - 989803193741; Expression MR ECG Leads, AAMI, Standard - 989803193731; Expression MR ECG Leads, IEC, CV - 989803193751; Expression MR ECG Leads, IEC, Neonatal - 989803193771; Expression MR ECG Leads, IEC, Standard - 989803193761; Expression MR FlexTEMP II Sensor - 989803194511; Expression MR FlexTEMP System, Jacket - 989803178181; Expression MR IBP Transducer Cable, 5ft - 989803194601; Expression MR Universal Gating Interface - 989803195521; Expression MR Wireless ECG Patient Module (Gen 3) 1-5 - 989803192761; Expression MR Wireless ECG Patient Module (Gen 3) 6-10 - 989803194341; Expression MR Wireless ECG Patient Module - 989803183661; Expression MR Wireless SPO2 Patient module (Gen 3) 1-5 - 989803192771; Expression MR Wireless SpO2 Patient Module (Gen 3)6-10 - 989803194331; Expression MR200 MRI Patient Monitoring System; Expression MR200 New MRI Monitor Accessories - 866177; Expression MR400 MRI Patient Monitoring System (Model MR400); Expression MR400 New MRI Monitor Accessories - 866428; Extended Compact Cart; External Flow Sensor Assembly Adult/Pediatric OR Pediatric/Infant; Extremity Coil 3T; FFM; FRU, COIL ASSY, PHC 1.5T 16CH; Fetal Imaging System; Fiducial Holder; Fiducial Holder, Needle Hub Assembly,; Fiducial Marker Grid Block Assembly; Fiducial Marker Sleeve Assembly; Film and Accessories; Flex Adapter; Flex Trach Adaptor 15 cm, 22M/15F-15F; Flex Trach Adaptor 15 cm, 22M/15F-22F; FlexTEMP System, Sensor - 989803178171; FloTrak CO2 Sensor; FloTrak Elite Module wI Capnostat 5 C02 Sensor; Flow Sensor; Fuji Ultima EC-MA Cassettes: CC, LC, PC, C-H, D-M, D-S; G7m Module; GAS Cal 1 cylinders for TCPC02, 6/bx; GAS, CALIBRATION (SPECIFIED CONCENTRATION; GE 0.35T MFO 4C PA OBC; GE 0.35T MFO PA WRIST; GE 0.5T SP Tx/Rx INTERVENTIONAL SPINE ARRAY; GE 0.7T LARGE OPENSPEED GENERAL PURPOSE COIL,; GE 0.7T MEDIUM OPENSPEED GENERAL PURPOSE COIL,; GE 0.7T OPENSPEED (HFO) WRIST; GE 0.7T OPENSPEED HFO 3C WRIST; GE 0.7T SMALL OPENSPEED GENERAL PURPOSE COIL,; GE 1.5T 32 Channel Cardiac Coil; GE 1.5T 32 Channel Cardiac Coil (Anterior); GE 1.5T 32 Channel Cardiac Coil (Posterior); GE 1.5T 32 Channel Cardiac Coil- Anterior Only; GE 1.5T 4C PA WRIST (OEM); GE 1.5T 4Ch Shoulder Coil; GE 1.5T 8C HEAD / BRAIN COIL VALUE; GE 1.5T 8CH WRIST COIL; GE 1.5T Excite HDx 1.5T KFC DS (Quadrature Lower Extremity Coil); GE 1.5T HDMR2-VALUE 4C NVA COIL VALUE; GE 1.5T HDMR2-VALUE 4C WRIST COIL; GE 1.5T HDMR2-VALUE 8C HEAD / BRAIN, MA Head Coil, GE 1.5T LXI 8C HEAD (OEM); GE 1.5T HDMR2-VALUE 8C NVA, MA Neurovascular Coil,; GE 1.5T HDMR2-VALUE 8C WRIST; GE 1.5T HNC - OPENVIEW; GE 1.5T Quadrature Lower Extremity Coil (KFC DS); GE 1.5T SIGNA 4C PA OBC; GE 1.5T SIGNA 4C PA SHOULDER; GE 1.5T SIGNA EXCITE 8C NVA COIL (OEM), GE Excite HD 1.5T 8-CHANNEL NVA COIL; GE 1.5T Signa Excite 8CH Shoulder; GE 16 Ch Knee Coil 1.5T; GE 16 Ch Knee Coil 3T; GE 16-CH 1.5T Hand/Wrist Coil; GE 1T HNC - OPENVIEW; GE 1T SIGNA 4C PA WRIST (OEM); GE 1T Signa 4CH OBC; GE 3T 32 Channel Cardiac Coil; GE 3T 32 Channel Cardiac Coil (Anterior Only); GE 3T 32 Channel Cardiac Coil (Anterior); GE 3T 32 Channel Cardiac Coil (Posterior); GE 3T 32 Channel Cardiac Coil- Anterior Only; GE 3T 32 Channel Cardiac Coil- Anterior and Posterior; GE 3T HD Tx/Rx 8C KNEE; GE 3T HDMR2-VALUE 8C HEAD / BRAIN; GE 3T SIGNA EXCITE 8C WRIST; GE 3T Signa Excite 8CH Shoulder; GE 3T VHI 8C HEAD / BRAIN (OEM); GE Cardiac Coil, 1.5T, 16ch; GE EXCITE 1.5T 8 CHANNEL T/R , High Res Knee Array Coil (HRK); GE EXCITE 1.5T SIGNA HD 8C Tx/Rx KNEE (OEM); GE Excite 1.5T 7CH BBC; GE Excite 1.5T 7Ch Biopsy Breast Array; GE Excite 1.5T 8Ch Foot and Ankle Coil (FAC); GE Excite 3T HDx 8Ch FAC; GE Excite 3T HDx Tx Rx KNEE COIL; GE Excite HD 1.5T 4 Channel Breast Coil; GE Excite HD 1.5T 4 Channel Musculoskeletal Array; GE Excite HD 1.5T 4 Channel Shoulder Coil; GE Excite HD 1.5T 4 Channel Wrist Coil (HRW-GE SIGNA); GE Excite HD 1.5T 8 Channel Wrist (PRECISION EIGHT WRIST ARRAY); GE Excite HDe 1.5T 4CH (HDMR2-VALUE 4C OBC); GE Excite HDx 1.5T 3Ch PHASED ARRAY UPPER EXTREMI; GE Excite HDx 1.5T 7ch BBC; GE Excite HDx 1.5T 8 Channel Neurovascular Array; GE Excite HDx 1.5T HDx 7CH BBC; GE Excite HDx 1.5T HDx 8Ch 1.5T FAC; GE Excite HDx 3T Hi Res Wrist Array Coil; GE Excite HDx 8 Channel High Res Head Array (1.5T)",1992-11-19,522,2025-05-15,5,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223000126629%22&limit=1
Oketz Logistics LLC,3038718579,3038718579,50 Minorca Ave,Coral Gables,FL,33134,United States,Oketz Logistics LLC,10093578,Repackager or relabeler,202,BRW; BTC; BWP; DYH; DYN; DZA; DZC; DZE; DZI; DZM; DZN; DZP; DZS; EAT; EAX; EBC; EBD; EBF; EBG; EBH; EBI; EBL; EBW; EBZ; ECB; ECM; ECQ; EEF; EEG; EFB; EFH; EFL; EFN; EFT; EFW; EGD; EGN; EGS; EGZ; EHJ; EHK; EHL; EHM; EHY; EHZ; EIA; EIB; EIC; EID; EIE; EIF; EIG; EIH; EIL; EIX; EIY; EJB; EJE; EJG; EJH; EJI; EJJ; EJK; EJL; EJQ; EJR; EKB; EKC; EKF; EKG; EKH; EKI; EKJ; EKK; EKL; EKM; EKN; EKP; EKQ; EKR; EKS; EKT; EKW; EKX; EKZ; ELA; ELC; ELL; ELR; ELW; ELY; ELZ; EMA; EMB; EMD; EMF; EMG; EMJ; EMK; EMN; EMR; EMS; EXB; EZR; FFR; FHQ; FLE; FLG; FMF; FMI; FMW; FQM; FRC; FRG; FRK; FSM; FXP; FXX; FYA; FYF; GAL; GAM; GAP; GAQ; GAR; GAT; GAW; GCZ; GDY; GDZ; GEC; GES; HBA; HDF; HOY; HRR; HTC; HTD; HTF; IMD; ITG; IWZ; JDZ; JEP; JES; JET; JEX; JOJ; JOL; KCP; KCQ; KCT; KHA; KHR; KIF; KJJ; KLE; KME; KMT; KMY; KOJ; KQM; KTZ; KXF; KXG; KXR; KYW; KYX; LBH; LDS; LFC; LFD; LGF; LQY; LRJ; LRW; LYC; LYU; LYY; LZA; LZC; MAU; MDM; MED; MSH; MUH; MVL; MZW; NAB; NAC; NHA; NRD; NRU; NTK; ODA; OEA; OPJ; PEM; PME; PUI; QDO; QSY,"Protector, Dental; Bag, Reservoir; Shoe And Shoe Cover, Conductive; Adhesive, Bracket And Tooth Conditioner, Resin; Mouthpiece, Saliva Ejector; Drill, Dental, Intraoral; Wire, Orthodontic; Implant, Endosseous, Root-Form; Drill, Bone, Powered; Needle, Dental; Instruments, Dental Hand; Instrument, Diamond, Dental; Capsule, Dental, Amalgam; Tester, Pulp; Mirror, Mouth; Sealant, Pit And Fissure, And Conditioner; Coating, Filling Material, Resin; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Material, Impression Tray, Resin; Resin, Denture, Relining, Repairing, Rebasing; Pin, Retentive And Splinting, And Accessory Instruments; Controller, Foot, Handpiece And Cord; Activator, Ultraviolet, For Polymerization; Unit, Syringe, Air And/Or Water; Band, Preformed, Orthodontic; Aligner, Bracket, Orthodontic; Clamp, Rubber Dam; Heat Source For Bleaching Teeth; Handpiece, Air-Powered, Dental; Paper, Articulation; Forceps, Dressing, Dental; Cotton, Roll; Cleanser, Denture, Over The Counter; Toothbrush, Manual; Wax, Dental, Intraoral; Scissors, Surgical Tissue, Dental; Handpiece, Contra- And Right-Angle Attachment, Dental; Holder, Film, X-Ray; Disk, Abrasive; Cup, Prophylaxis; Point, Abrasive; Strip, Polishing Agent; Tray, Impression, Preformed; Evacuator, Oral Cavity; Unit, Operative Dental; Syringe, Irrigating (Dental); Syringe, Periodontic, Endodontic, Irrigating; Syringe, Restorative And Impression Material; Dam, Rubber; Accessories, Retractor, Dental; Retractor, All Types; Powder, Porcelain; Gauge, Depth, Instrument, Dental; Probe, Periodontic; Instrument, Filling, Plastic, Dental; Handle, Instrument, Dental; Frame, Rubber Dam; Forceps, Rubber Dam Clamp; Alloy, Metal, Base; Syringe, Cartridge; Alloy, Amalgam; Liner, Cavity, Calcium Hydroxide; Bur, Dental; Wheel, Polishing Agent; Agent, Polishing, Abrasive, Oral Cavity; Explorer, Operative; Excavator, Dental, Operative; Instrument, Contouring, Matrix, Operative; Condenser, Amalgam And Foil, Operative; Carver, Dental Amalgam, Operative; Carrier, Amalgam, Operative; Burnisher, Operative; Spreader, Pulp Canal Filling Material, Endodontic; Point, Silver, Endodontic; Gutta-Percha; Point, Paper, Endodontic; Reamer, Pulp Canal, Endodontic; Preparer, Root Canal Endodontic; Plugger, Root Canal, Endodontic; File, Pulp Canal, Endodontic; Curette, Endodontic; Broach, Endodontic; Handpiece, Direct Drive, Ac-Powered; Unit, Electrosurgical, And Accessories, Dental; Instrument, Hand, Calculus Removal; Scaler, Ultrasonic; Teeth, Porcelain; Post, Root Canal; Material, Impression; Mercury; Crown, Preformed; Cement, Dental; Zinc Oxide Eugenol; Hemostat, Surgical; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Elevator, Surgical, Dental; Curette, Surgical, Dental; Scaler, Periodontic; File, Periodontic; Curette, Periodontic; Collector, Ostomy; Cement, Stomal Appliance, Ostomy; Device, Locking, For Intestinal Clamp; Holder, Needle, Gastroenterologic; Sterilizer, Steam; Cleaner, Ultrasonic, Medical Instrument; Syringe, Piston; Needle, Hypodermic, Single Lumen; Cover, Mattress (Medical Purposes); Bandage, Elastic; Indicator, Biological Sterilization Process; Wrap, Sterilization; Chair, Examination And Treatment; Tray, Surgical, Instrument; Cover, Shoe, Operating-Room; Mask, Surgical; Gown, Surgical; Cap, Surgical; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Retainer, Surgical; Gauze/Sponge, Internal, X-Ray Detectable; Handle, Scalpel; Brush, Scrub, Operating-Room; Blade, Scalpel; Neurosurgical Paddie; Speculum, Vaginal, Metal; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Scissors, Orthopedic, Surgical; Pliers, Surgical; Forceps; Curette; Pack, Hot Or Cold, Disposable; Bandage, Cast; Film, Radiographic; Mixer, Cement, For Clinical Use; Retainer, Matrix; Floss, Dental; Pick, Massaging; Plier, Orthodontic; Indicator, Physical/Chemical Sterilization Process; Catheter And Tip, Suction; Syringe, Ent; Tube Impression And Matrix; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Mask, Scavenging; Absorber, Saliva, Paper; Resin, Root Canal Filling; Cleanser, Root Canal; Agent, Tooth Bonding, Resin; Bedding, Disposable, Medical; Tray, Fluoride, Disposable; Positioner, Tooth, Preformed; Airbrush; Camera, Surgical And Accessories; Caliper; Applicator, Absorbent Tipped, Non-Sterile; Applicator, Absorbent Tipped, Sterile; Applicator, Resin; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Varnish, Cavity; Device, Pasteurization, Hot Water; Device, Caries Detection; Saliva, Artificial; Component, Cast; Locator, Root Apex; Disinfectant, Medical Devices; Scissors, General, Surgical; Bone Grafting Material, Synthetic; Accessory, Surgical Apparel; Latex Patient Examination Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; Eraser, Dental Stain; Instrument, Manual, Surgical, General Use; Sterilant, Medical Devices; Respirator, Surgical; System, X-Ray, Extraoral Source, Digital; Cord, Retraction; Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Abutment, Implant, Dental, Endosseous; Unit, Operative Dental, Accessories; Chair, Dental, Without Operative Unit; Light Transmission Caries Detector; Endoscopic Central Control Unit; Non-Surgical Gown; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Dental Barriers And Sleeves; External Cleaning Solution; Drape, Surgical, Exempt; Fentanyl And Other Opioid  Protection Glove; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; U,,2008-06-17,486,2025-01-31,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223038718579%22&limit=1
"Karl Storz Endoscopy-America, Inc.",3010202439,3007475226,2151 E. Grand Avenue,El Segundo,CA,90245,United States,KARL STORZ SE & CO KG,8010119,Complaint file establishment; Specification developer,220,BSJ; BSR; BSY; BTA; BTR; BWB; BYX; BYY; CAI; CAL; CAM; CBC; CCQ; CCW; DQI; DWS; DXC; DZN; EBA; EIA; EMF; ENZ; EOB; EOQ; EOX; EPP; EPT; EPY; EQH; EQJ; EQL; EQN; ERA; ERL; ETA; ETB; EWQ; EWY; EZN; EZO; FAH; FAJ; FAM; FAS; FAX; FBK; FBM; FBN; FBO; FBQ; FCL; FCR; FCS; FCW; FCX; FCY; FCZ; FDC; FDF; FDI; FDS; FDT; FDZ; FEA; FEC; FEI; FEM; FEO; FEQ; FET; FFD; FFK; FFL; FFS; FGA; FGB; FGC; FGO; FHQ; FJL; FKK; FSM; FSO; FSR; FSZ; FTA; FTS; FWC; FWF; FWZ; FXF; FXM; GAD; GAH; GAZ; GBA; GBX; GCC; GCF; GCI; GCJ; GCM; GCT; GCX; GCY; GDC; GDI; GDM; GDX; GEA; GED; GEI; GEN; GEX; GEY; GFF; GFJ; GWG; GWX; GZT; GZX; HAO; HAW; HCY; HDG; HDX; HET; HEW; HFA; HFB; HGI; HGK; HIF; HIG; HIH; HIN; HJO; HKI; HMW; HNI; HPP; HRX; HSZ; HTE; HTF; HWC; HWE; JAA; JOL; JOS; JYK; JYL; KAD; KAE; KAI; KAK; KAL; KAS; KAY; KBN; KCD; KCL; KCT; KDQ; KGE; KMA; KMN; KNF; KNS; KNY; KOA; KOC; KOE; KOH; KQT; KTG; KXF; KYT; KYW; KYZ; LJH; LLZ; LMD; LNS; LQC; LQR; LRC; LXH; LYK; LYU; MBI; MDM; MMP; MNK; MNL; MOK; MQV; MQW; NBH; NKC; NNQ; NTN; NVT; NWW; OAJ; OAY; OCV; OCW; OCX; OCY; OCZ; ODA; ODB; OFO; OSV; OWN; PGW; PHT; PUI; PYO,"Mask, Gas, Anesthetic; Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Pump, Portable, Aspiration (Manual Or Powered); Tube, Tracheal (W/Wo Connector); Forceps, Tube Introduction; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Circuit, Breathing (W Connector, Adaptor, Y Piece); Laryngoscope, Non-Rigid; Yoke Assembly, Medical Gas; Bottle, Collection And Trap, Breathing System (Uncalibrated); Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Laryngoscope, Rigid; Withdrawal/Infusion Pump; Instruments, Surgical, Cardiovascular; Clamp, Vascular; Instruments, Dental Hand; Light, Surgical Headlight; Unit, Operative Dental; Knife, Surgical; Telescope, Laryngeal-Bronchial; Nasopharyngoscope (Flexible Or Rigid); Bronchoscope (Flexible Or Rigid); Esophagoscope (Flexible Or Rigid); Splint, Nasal; Microscope, Surgical; Speculum, Ent; Source, Carrier, Fiberoptic Light; Bur, Ear, Nose And Throat; Laryngostroboscope; Laryngoscope, Nasopharyngoscope; Otoscope; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Replacement, Ossicular Prosthesis, Total; Prosthesis, Partial Ossicular Replacement; Saw, Surgical, Ent (Electric Or Pneumatic); Mediastinoscope, Surgical; Dilator, Catheter, Ureteral; Urethrotome; Dilator, Urethral, Mechanical; Cystoscope And Accessories, Flexible/Rigid; Sigmoidoscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Bougie, Urological; Endoscopic Injection Needle, Gastroenterology-Urology; Cannula And Trocar, Suprapubic, Non-Disposable; Choledochoscope And Accessories, Flexible/Rigid; Cystourethroscope; Trocar, Gastro-Urology; Forceps, Biopsy, Non-Electric; Light Source, Photographic, Fiberoptic; Light, Catheter, Fiberoptic, Glass, Ureteral; Light Source, Fiberoptic, Routine; Insufflator, Automatic Carbon-Dioxide For Endoscope; Bulb, Inflation, For Endoscope; Tube, Smoke Removal, Endoscopic; Resectoscope, Working Element; Colonoscope And Accessories, Flexible/Rigid; Snare, Flexible; Gastroscope And Accessories, Flexible/Rigid; Duodenoscope And Accessories, Flexible/Rigid; Attachment, Eyepiece, For Insertion Of Prescription Lens; Attachment, Teaching, For Endoscope; Obturator, For Endoscope; Instrument, Special Lens, For Endoscope; Accessories, Photographic, For Endoscope (Exclude Light Sources); Lithotriptor, Ultrasonic; Pump, Air, Non-Manual, For Endoscope; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Evacuator, Bladder, Manually Operated; Lithotriptor, Electro-Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Image, Illumination, Fiberoptic, For Endoscope ; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Urethroscope; Dislodger, Stone, Flexible; Holder, Needle, Gastroenterologic; Resectoscope; Clamp, Line; Tray, Surgical, Instrument; Microscope, Surgical, General & Plastic Surgery; Light, Headband, Surgical; Light, Surgical, Carrier; Light, Surgical, Accessories; Camera, Cine, Endoscopic, With Audio; Camera, Television, Surgical, With Audio; Camera, Television, Endoscopic, Without Audio; Operating Room Accessories Table Tray; Speculum, Illuminated; Camera, Still, Endoscopic; Retractor; Stylet, Surgical, General & Plastic Surgery; Tubing, Noninvasive; Catheter, Balloon Type; Catheter, Irrigation; Dilator, Catheter; Proctoscope; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Endoscope, Rigid; Light Source, Endoscope, Xenon Arc; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Table, Operating-Room, Electrical; Dissector, Surgical, General & Plastic Surgery; Needle, Aspiration And Injection, Reusable; Scalpel, One-Piece; Cannula, Surgical, General & Plastic Surgery; Brush, Dermabrasion, Manual; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Powered Laser Surgical Instrument; Motor, Surgical Instrument, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Mallet, Surgical, General & Plastic Surgery; Endoscope, Neurological; Fork, Tuning; Retractor, Self-Retaining, For Neurosurgery; Instrument, Microsurgical; Instrument, Surgical, Non-Powered; Neurological Stereotaxic Instrument; Curette, Uterine; Speculum, Vaginal, Metal, Fiberoptic; Dilator, Vaginal; Laparoscope, Gynecologic (And Accessories); Culdoscope (And Accessories); Amnioscope, Transabdominal (Fetoscope) (And Accessories); Forceps, Biopsy, Gynecological; Electrocautery, Gynecologic (And Accessories); Endoscope, Fetal Blood Sampling (And Accessories); Insufflator, Laparoscopic; Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Coagulator-Cutter, Endoscopic, Bipolar (And Accessories); Biomicroscope, Slit-Lamp, Ac-Powered; Camera, Ophthalmic, Ac-Powered; Drape, Microscope, Ophthalmic; Retractor, Ophthalmic; Headlamp, Operating, Battery-Operated; Arthroscope; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Elevator; Curette; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; System, X-Ray, Fluoroscopic, Image-Intensified; Catheter And Tip, Suction; Electrode, Electrosurgical; Holder, Ear Speculum; Hook, Microsurgical Ear; Elevator, Ent; Forceps, Ent; Mirror, Ent; Probe, Ent; Retractor, Ent; Knife, Nasal; Punch, Nasal; Gag, Mouth; Bougie, Esophageal, Ent; Blower, Powder, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Bottle, Collection, Vacuum; Forceps, Biopsy, Electric; Irrigator, Powered Nasal; Chair And Table, Medical; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Accessories, Catheter, G-U; Surgical Instruments, G-U, Manual (And Accessories); Accessories, Blood Circuit, Hemodialysis; Dilator, Urethral; Instrument, Manual, General Obstetric-Gynecologic; Evacuator, Gastro-Urology; Knife, Ent; Applicator, Absorbent Tipped, Non-Sterile; Light, Examination, Medical, Battery Powered; Container, Liquid Medication, Graduated; Syringe, Irrigating (Non Dental); System, Irrigation, Urological; System, Image Processing, Radiological; System, Digital Image Communications, Radiological; Lithotriptor, Extracorporeal Shock-Wave, Urological; Lithotriptor, Biliary Mechanical; Dislodger, Stone, Biliary; Instrument, Ent Manual Surgical; Orthopedic Manual Surgical Instrument; Angioscope; Accessory, Surgical Apparel; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Cover, Barrier, Protective; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Vaginoscope And Accessories; Filler, Bone Void, Calcium Compound; Transilluminator, Fiber Optic; Accessories, Arthroscopic; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Forceps, Wire Closure, Ent, Non-Sterile; Led Light Source; Tubing And Tubing/Filter Fits; Hysteroscope Accessories; Catheter, Drainage, Intraoral/Extraoral; Light Source System, Diagnostic Endoscopic; Endoscope Holder; Endoscopic Tissue Approximation Device; Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Grasping/Cutting Instrument, Non-Powered; Endoscopic Central Control Unit; Endoscopic Contamination Prevention Sheath; Airway Suction Kit; Insufflator, Endoscopic Vessel Harvesting; Confocal Optical Imaging; Ear, Nose, And Throat Stereotaxic Instrument; Basin For Endoscope Reprocessing; Drape, Surgical, Exempt; Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use",1; 2; 3; f,"11274AB Flex Pediatric BRONCHOSCOPE; 11274AC Flex. CHOLEDOCHOSCOPE; 12G-SDI CABLE,; 26025UC HAMOU Elctrnc HYSTEROFLATOR; 2800C Shouldr/Ankle/Elbw/Hip/TMJ/SM; 300W Light Source, Non-flash; 3D Endoscope; 3D Video System; 495N Series Fibr Optic Light Cables; 7.5 Fr. Flexible CHOLEDOSCHOSCOPE; ADVANCED IMAGE AND DATA; AIDA Compact II System; AIDA w/ DICOM and HL7 Interface; ANGIOMAT, Model 383320 20; ARTHRO PUMP; ARTHROPUMP DISP, Tubing Set; ARTHROPUMP Disposable Tubing Set; ARTHROPUMP Plus; ARTHROSCOPE; AUTOCON II 200 Electrosurg Generat; AUTOCON II 400 Electrosurgical Gen.; AUTOCON III 400; Ablation Electrodes; Adaptors for Documentation; Adult/Pede VISCOUS Fluid Inject.Set; Arthroforce; Arthroscopic Telescopes; Autocon II 400 Electrosurgical Gen; BETTOHI SNARE; BITE PROTECTORS; BOUGIES and Dilators; Balloon Catheter; Balloon Cathether; Basin for endoscope reprocessing; Battry Powered Light Source; Bipolar Coagulating Forceps; Bipolar Coagulation Electrodes; Bipolar Electrodes; Bipolar Electrotome; Blepharoplasty Set; Bridges, Adaptors; Bronchoscope; Bronchoscopes; C-Cam; C-MOUNT ARTHROSCOPE; CALCULASE HOLMIUM LASE; CALCULASE HOLMIUM LASER; CALCULASE Holmium Laser & Acc.; CALCUSON; CALCUSPLIT; CALCUTRIPT Elctrohydraulc LITHR SYS; CANNULA, OBTURATOR, VERESS NEEDLE; CCL Vaginal Extractor and Acc's; CHARDONNES Morcellation Knife; CLEARVISION Lens Irrigation System; CLICKLINE Scissors Inserts for single use; CMOS Endoscopes SSU; CMOS Video Rhino Laryngoscope; CMOS Video-Rhino-Laryngoscope System; CO2 ARTHROFLATOR; CO2 Endoflator; CO2 HYDROMAT Pump for Irrigation; CO2mbi LED SCB; CURETTE; Calculase II; Camera; Camera, ophthalmic, ac-powered; Cannula and Trocar; Carcinoma Gauges; Catheters; Catheters, MANDRIN, Plugs, Connect; Chair and Table, Medical; Cholangiography Set; Clamp; Cleaning Brushes and kits; Cold Knife; Cold Knife Blades; Contact Microlaryngoscope; Contact Nasal Micro-Endoscope; Continuous Flow Cystoscope; Continuous Flow RESECTOSCOPES; Cotton Applicator; Cover; Culdocentesis Set; Cutting Loop Elctrodes Modification; Cystoscope 78FAJ, Fiberoptic 78GDB; DCI Endoscope; DCI Telescope; DCI VIDEO LARYNGOSCOPE; DIGI-VIDEO; DION-GRACIA Set; Dental Endoscopes; Dental Hand Instruments; Deployable Cardiovascular Clamp; Device Imaging Storage; Dilators, Reducers, Sleeves; Disposable Equipment Covers; Dissector; Distending DIVERTICULOSCOPE; Drape; Drapery; Drill; ELEVATOR; ENDO-MAGNIFIER; ENDOFLATOR +; ENDOFLATOR 40&50; ENDOMAT DISP, Tubing Sets; ENDOMAT LC PUMP; ENDOMAT SELECT; ENDOPYELOTOMY Set; ENDOSCOPE ACCESSORIES; ENDOSPINE Oper Tube & Telesc Bridge; ENDOTIP System; ENT Elevators; ENT Forceps, Scissors, and Punches; ENT Rigid Telescopes; ENT Stent Applicator Forceps; ENT Surgical Instrument; ENT/NEURO/OMF System and Accessory; EPIDUROSCOPE; EQUIMAT Model 203020 20; EQUIMAT, Model 203020 20; ERCP CATHETER; EYEPIECE ATTACHMENT FOR INS; Elec Endoflator, Model 264305 20; Electronic LAPAROFLATOR; Electronic LAPAROFLATOR (10 LPM); Electronic LAPAROFLATOR (20 LPM); Endoflator LC; Endomat Select; Endomat Select (Model Number: UP210); Endoscope; Endoscope Accessories; Endoscope Accessory; Endoscope Holder; Endoscopic Assisted Intubation Set; Endoscopic guidewire, gastroenterology-urology; Endoscopy Instrument; Endoscopy Powder Blower; Endotack; Esophagoscope; Esophagoscope and Accessories; Extraction Bag; FELDMAN Mini-saw; FISCH TITANIUM MID; FISCH Titanium Mid Ear Prostheses; FLEX-X2; FORCEPS, EAR; FRIMBERGER Varioguide; Fascia Closer Device; Fetoscopy Set; Fiber Optic Light Cables; Fiber and Sheath; Fiberscope; Flex-XC; Flex. HYSTEROSCOPE; Flexible CHOLEDOCHOSCOPE; Flexible CMOS Video-Cysto Urethroscope; Flexible Choledochoscope; Flexible HD Cysto-Urethroscope System; Flexible HD Video Rhino-Laryngoscope System; Flexible Hysteroscope, 10.5 Fr; Flexible Intubation Video Endoscope – Sterile (FIVE-S); Flexible Trocar Sleeves; Flexible Video Cysto-Urethroscope; Flexible Video-Uretero-Choledochoscope-System; Flexible Video-Uretero-Renoscope; Flexible Video-urethro-cystoscope; Fluid Light Cables; Forceps; Forceps, ENDO/LAP; GAAB Rigid NEUROENDOSCOPES; GELET Uretero-Renoscope; GI CCU; Gas Mask; General/Plastic Surgery Instruments; Grasping, Biopsy, and Spoon Forceps; H1 Camera Head; HAMOU ENDOMAT; HAMOU ENDOMAT Disposable Tubing Set; HARTMANN Ear Speculum; HD Mediastinoscope; HD View; HD-View; HEMPFLING Dilation Set; HOPKINS I/II Autoclavable Telescope; HOPKINS Telescopes; HOPKINS Telescopes for Arthroscopy; HUZLY High Freq Cutting Loops; HYDROMAT Trumpet Valve & Tubing Set; HYDROMAT, Model 263110 20; HYSTEROSCOPIC INSU; Hand Extractor HECTOR; Headband; Headlight; Hysteromat II; Hysteroscope; Hysteroscope and accessories; IMAGE1; Image 1 SPIES; Image Processing System; Image1 S CCU, Image1 S 4U camera head; Infant Balloon VAGINOSCOPES; Instr Set Percut Discect/Nucleotomy; Instr, TX of Carpal Tunnel Syndrome; Instrument Tray; Instruments, Bipolar Coagulation; Insufflation Bulb; Insulated  Scissors & Rectal Snares; Insulated Biopsy Forceps; Insulated Biopsy Forceps, Grasping; Insulated Cannulae & Suction Tubes; Insulated Dissecting Cannulae; Insulated ELECTROSUGRICAL Instrum.; Insulated Scissors; Intra-Handpieces & Accessories; Intubation Fiberscope; Irrigation/Suction Sys/Handpiece; KARL STORZ BIOPSY FORCEPS; KARL STORZ BLADDER EVACUATOR; KARL STORZ BOUGIE; KARL STORZ BOUGIES; KARL STORZ Bipolar Resectoscopes with HF Cable; KARL STORZ CURETTES; KARL STORZ Cholangiography Set; KARL STORZ Cysto-Urethro-Fiberscope; KARL STORZ DE LA PLA; KARL STORZ ENDOSCOPE; KARL STORZ ENDOSCOPE LENS; KARL STORZ ENDOSCOPIC STILL CAMERA; KARL STORZ ENDOVISION HYSTEROCAM; KARL STORZ ENDOVISION UROCAM; KARL STORZ Endoscopic Accessories for Urology; KARL STORZ Endoscopic ICG Imaging System; KARL STORZ FELDMAN MIN; KARL STORZ FIBEROPTIC; KARL STORZ FLEXIBLE ASPIRATING TUBE; KARL STORZ FLEXIBLE VIDEO-; KARL STORZ FORCEPS; KARL STORZ Fiber Telescopes for Urology; KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S; KARL STORZ Flexible Video Neuro-Endoscope; KARL STORZ Flexible Video-Neuro-Endoscope System; KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC); KARL STORZ HOPKINS Telescopes; KARL STORZ HOPKINS Telescopes for Urology; KARL STORZ HYSTEROCAM; KARL STORZ ICG Imaging System; KARL STORZ ICG Imaging System with RUBINA Lens System; KARL STORZ ICG System; KARL STORZ Image1 S Camera Control Unit; KARL STORZ LARYNGOSCOPE; KARL STORZ LEG HOLDER; KARL STORZ Laryngoscopes and Accessories; KARL STORZ MEDICAL; KARL STORZ MODEL 28200C; KARL STORZ Mediastinoscopes and Instruments; KARL STORZ NAV1 Electromagnetic Navigation System; KARL STORZ NEEDLE HOLDERS; KARL STORZ OTOSCOPE; KARL STORZ PRESSURE T; KARL STORZ PULSAR II; KARL STORZ Ped. Cysto-Urethro-Fiberscope; KARL STORZ Pediatric Cysto-Urethro-Fiberscope; KARL STORZ REUSABLE ASPIR; KARL STORZ SHOULDER ARTHROSCOPY POS; KARL STORZ STONE DISLODGER; KARL STORZ SURGICAL CANNULA; KARL STORZ SURGICAL KNIFE; KARL STORZ SURGICAL STYLET; KARL STORZ Shuntscope; KARL STORZ Trocars with Valve Seals; KARL STORZ UDEL Sterilization Trays; KARL STORZ Urological Laser Accessories; KARL STORZ VAGINAL SPECULUM; KARL STORZ VIDEO GASTROSCOPES; KARL STORZ VIDEO LOWER; KARL STORZ suction and irrigation system; KNIFE, CURVED; KNIFE, ENT; KOH Micro-Suturing Instruments; KOH Needle Holders, Suture Forceps; KOH Needle Holders, Suturing Forcep; KS Lock; KSEA CLEARVISION II, MODEL 40334120; KSEA CLEARVISION LE; KSEA Monopolar Resectoscopes; KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE; Karl Storz Arthropump Power Irrigation/Suction Pump, Tubing; Karl Storz MegaFix-C Composite; Karl Storz Scalp Dura Retractor; Knives, Curettes; Knives,Curettes,Hooks,Needles; Knives,Curettes,Hooks,Probes; LAPAROCAM; LAPAROMAT Laparoscopic Suction; LED Headlight KS70; LED NOVA 100 Cold Light Fountain; LED light source; LEG HOLDER; Laparoscope; Laproscope; Laproscopy; Laproscopy Insstruments; Large Joint Arthroscopy Set; Laryngoscope Accessories; Laser Accessories; Light Cable; Light Fountain 50 Watts; Light source system, diagnostic endoscopic; Lithotripter; MAHNES Take-Apart Bipol Coag Forcep; MANHES Pneumotrocar; MIrror; MONOPOLAR VAPORIZATION Electrodes; MOUTH GAG; MTP ARTHROUMP TUBING SET; MTP CLEARVISION Disp Tubing Set; MTP Disposable Trocar Valves; MTP Disposable Trocars; MTP Extraction Bags; MTP LAPAROMAT Disposable Tubing Set; MTP Suction canisters/tubing; MULTIDRIVE II Mini Shaver; MVM 3.3 MM MICROENDOSCOPE; MVM 3.3 MM Micro-Endoscope; MVM 7.5 French Flex. HYSTEROSCOPE; MVM 7.5 French Flex. URETEROSCOPE; Magnifying Telescopes; Mallet; Medi Pack; Medicine Cups; MegaFix Bioabsorbable Screw; MegaFix Perforated Bioabsorbable; MegaFix-T Titanium Screw; Micro Surgical Instruments; Micro-ARTHROPLASTY System; Micro-ARTHROPLSTY Sys. Disp. Blade; Micro-Instrum. for Cochlear Implant; Microcast 4K Pro; Microcast HD Pro; Microsurgical Ear; Miniature Endoscope; Miniature Neuro Endoscope; Miniature Telescope and Accessories; Miniature Telescope for Urology; Model 26021C Bipolar COAGULATOR; Model 27080 LITHOTRIPTOR System; Model 27086C Ultrasonic LITHOTRITE; Model 27224P Continuous Flow Pump; Model 28805 ARTHRO Pump; Model28184 Pneumatic Shuttle Shaver; Modification to ENDOTIP System; Modified Veress Needle & Cannula; Mono Ball/Needle/Loop Electrodes; Mono Coag Ball Electrodes; Mono Coag Needle Electrode; Mono Coag Needle, Loop Electrodes; Mono High Freq Cords; Mono Vaporization Electrodes; Monopolar Coagulating Electrodes; Monopolr Cord, Endoscpc Hi-Frequncy; N20 ENDOFLATOR; NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER); NEO; NEO IP; Nasal Irrigator; Nasal Probe; Nasal Splint; Nasopharyngo/Broncho/Tracheoscopes; Nasopharyngoscope; Navigation Panel Unit; Needles; NeoVagina Surgery Set & Accessories; Nephroscope, Adult & Pediatric; Neuro FIBERSCOPE; Neuro-Fiberscope; Neuroscope and Accessories; New Generation Trocars; Non-Insulated Scissors; Nonpowered neurosurgical instrument; OP Server Lap; OR1 IP Camera; OR1 SCB CONTROL; OTOSCOPE; Obstetrical and Gynecological Surgical Devices; Obturators, Cannula Sheaths; Operating LARYNGOSCOPES & Accs; Optical Mediastinoscope; Optical Video Tongue Depressor; Ortho Manual Surgical Instruments; PT Coagulator, SEMM Crocodile Force; PUNCH, NASAL; Ped VANCAILLIE MANHES Take Apart; Ped VANCAILLIE Take Apart Bip Instr; Pede PYLORIC Spreader, PYLOROTOME; Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories; Percutaneous Foraminoscopy Set; Percutaneous Nephroscope System; Pivot Arm PAPARASCOPE Sleeve; Plastic Surgery Accessories; Plastic Trocars; Powder Blower and Accessories; Power LED 175; Power LED 175 Light Fountain; Powered Laser Surgical Instrument; Powershaver System S2; Pressure Cuff; Prism ELECTROSCOPE; Protoscopes, Sigmoidoscopes, Acc.; Puncture Cannula; Puncture, Injction, ENDOSCPIC VERES; QUADROSWITCH; REMORGIDA Forceps; RETRACTOR; RHINO-PHARYNGO-LARYNGO FIBERSCOPE; Reinsertion Forceps; Resectoscopes; Retractors,Probes,Dissectors,Hooks; Reverse Video; Rhino-Laryngo-Bronco Fiberscope; Rigid Culdoscope and Accessories; Rigid Telescopes; Rotocut G1 Morcellator, Electromech; S-Pilot; SACHSE DRILL; SAUER Endscpc Guide & Intbation Aid; SAWAHLE Electromech. Morcellator; SCB ACC CONTROL (AND OTHERS); SCB Interface Control #20090120; SCB Media Control; SCB-RUI (Realistic User Interface); SCB-RUI SCO; SCB/CONMED ESU INTERFACE MODULE; SCB/Covidien Force Triad Interface Module; SCB/STERIS OR-Light Interface Box; SCB/VALLEY LAB Force FX Interface; SCBCOM; SEMM Tissue Punch; SINGLE-USE TISSUE TRAP FILTER W/ADAPTER; SPIES 3D System; SSU Flexible Video-Uretero-Renoscope; STAMMBERGER SACSHE Drill; STEINER ELECTROMECHANIC MORCELLATOR; STEINER Electromechanic Morcellator; SUBGLOTTISCOPE, Infant & Neonate; SUPRALOOP; SYRINGE, IRRIGATING (NON DENTAL); Saphenous Vein Harvesting Set; Scalp Blood Collection Set; Scissors, ENDO/LAP; Semi-Rigid Micro-Endoscpes & Acc.; Semi-Rigid Micro-Endoscpes & Acces.; Semi-Rigid Microendoscope & Acc.; Semi-rigid Hysteroscope; Series 11274 Flex. URETEROSCOPE; Series 11274 Flexible Fiberscope; Shoulder Pro; Sialoendoscopes and Accessories; SilCut; SilGrasp; Slim Nasopharyngolaryngoscope; Smart Smoke Evacuation; Smoke Removal Tube; Snares; Speculum; Speculum, ENT; Spinoscope; Sterilization Tray; Sterilization Trays; Stone Basket; Storz SLX-F2 Storm Touch; Suction Catheter; Suction Catheters; Suction Tube; Suction/Drainage Tubes, Cannulae; Suction/Irrigation Tubes; Sunction Tube; Surgeon Connect; Surgical Instruments; Surgical Light Carrier; Surgical Microscope; Synthacer; Syntricer; TAMBERGER-SACHASE INTRANASAL DRILL; TEACHING ATTACHMENT; TELESCRUB; THERMOFLATOR, Model 26 4320 20; TIPCAM; TIPCAM 1S 3D System; TIPCAM1 Rubina Video Endoscope System; TRACHEAL RESECTOSCOPE; TUBING; TUBING SET FOR LAPAROSCOPIC INSUFFL; Take Apart Rotating Grasping Forcep; Take Apart Suture Forceps; Take-Apart Bipolar Forceps; Take-Apart Forceps; Take-Apart Scissors; Tape and bandage, adhesive, adjustable closing mechanism, OTC use; Targeting Unit; Telepack +; Telepack X LED; Telescope Bridges & Adaptors; Telescope Bridges/Inserts/Adaptors; Telescopes Holders; Telescopes, Rigid, HOPKINS I; Telescopes, Rigid/Magnifying; Telescpes, Rigid/Mgnifying/KS VARIA; Thermocoagulator, Model 26510020; Thoracic Surgery Instruments; Tissue Retractor; Trachea Tubes; Tracheal tube; Trans-Nasal Esophagoscopes; Transvaginal Endoscopy Set; Trocars, Cannulae and Sheaths; Tubing with Connector; Tuning Fork; Twin Transilluminator; Twin-Video; UNIDRIVE II Plus Disposable Tubing; UNIDRIVE II/II Plus & ENT Accessori; UNIDRIVE S III ENT; UNIDRIVE SIII System; UNIDRIVE Select System; UNIMAT 12; UNIMAT 45; UNIMAT Plus; UNIMAT Plus, Model 203210 01; UNIMAT Suction Pump; UNIMAT, Model 203200 20; URETERO-RENOSCOPES/URETEROSCOPE; UROMAT; UROMAT Disposable Tubing Set; UROMAT E.A.S.I; UROMAT for Urological Irrigation; UROPUMP; UROPUMP Disposable Tubing Set; Unidrive SIII ENT; Unidrive Shaver ARTHROSCOPY Blades; Ureter Resectoscope; Ureteroscope and accessories, flexible/rigid; Uterine Manipulator; VACUSAFE TUBING SETS; VISCOUS Fluid Injection Set; VITOM; VOICE1 SCB R-UI Speech Control App; Vacusafe Vacuum Cannister and Bottles; Vaporization Electrodes; Vascular Fiberscopes; Vein Discission; Video Flexible ENT Endoscope System; Video Gastroscopes; Video Lower G.I. Endoscope System; Whisker Arthroscopic Blade; Wiltek Grasping Forceps; Wire Crimper; Wound Closure Instruments; XENON NOPPVA; XR-MX X-Ray System; Xenon 100; Xenon Light Source (175W) 201320-20; Xenon Light Source/Flash; Xenon Nova Light Source; Zero Wire; manual surgical instrument ENT",1978-06-20,465,2026-10-14,1,27,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010202439%22&limit=1
"Medtronic Sofamor Danek Usa, Inc.",1030489,1000477302,1800 Pyramid Place,Memphis,TN,38132,United States,"Medtronic, Inc.",2112641,Repackager or relabeler; Specification developer,118,DZE; EQJ; ETN; EZX; FMH; FSM; FSZ; FTY; FZO; FZS; FZT; FZX; FZY; GAD; GDF; GDG; GDI; GEA; GEI; GET; GEY; GWF; GXD; GXI; GXZ; HBB; HBE; HNW; HRR; HRS; HRX; HTC; HTD; HTE; HTF; HTJ; HTO; HTQ; HTR; HTS; HTW; HTX; HTZ; HWA; HWB; HWE; HWI; HWJ; HWK; HWM; HWN; HWR; HWT; HWX; HXB; HXC; HXD; HXG; HXK; HXL; HXP; HXQ; HXT; HXW; HXX; HXZ; ISN; JDI; JDK; JDN; JDQ; JDR; JDZ; JEY; KCT; KDG; KIH; KTZ; KWF; KWI; KWP; KWQ; LRN; LRP; LXH; LYC; MAX; MBP; MJG; MJO; MNH; MNI; MPW; MQP; MQV; MRW; NBH; NDN; NEK; NKB; NKG; NPM; NPZ; NQO; NQP; NQW; NUN; NVR; ODP; OLO; OSH; OUR; OVD; OVE; OWI; PGM; PLR; PML,"Implant, Endosseous, Root-Form; Bur, Ear, Nose And Throat; Stimulator, Nerve; Mesh, Surgical, Metal; Container, Specimen, Sterile; Tray, Surgical, Instrument; Light, Surgical, Carrier; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Curette, Surgical, General Use; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Pneumatic Powered; Motor, Surgical Instrument, Ac-Powered; Stimulator, Electrical, Evoked Response; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Electrode, Needle; Motor, Drill, Pneumatic; Drills, Burrs, Trephines & Accessories (Simple, Powered); Dilator, Lachrymal; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Arthroscope; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Reamer; Broach; Rasp; Knife, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Corkscrew; Awl; Trephine; Osteotome; Instrument, Compression; Driver, Prosthesis; Template; Tap, Bone; Probe; Wrench; Clamp; Tamp; Holder, Needle; Orthopedic; Mallet; Instrument, Bending Or Contouring; Crimper, Pin; Tape, Orthopedic; Bender; Screwdriver; Cutter, Wire; Cable; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Cement Restrictor; Implant, Fixation Device, Spinal; Cerclage, Fixation; Staple, Fixation, Bone; Mixer, Cement, For Clinical Use; Plate, Bone; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Chisel (Osteotome); Dispenser, Cement; Caliper; Prosthesis, Finger, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Wire, Surgical; Tray, Surgical; Orthopedic Manual Surgical Instrument; Bone Grafting Material, Synthetic; Intervertebral Fusion Device With Bone Graft, Lumbar; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Device, Percutaneous, Biopsy; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Bone Grafting Material, Animal Source; Bone Grafting Material, Dental, With Biologic Component; Prosthesis, Spinous Process Spacer/Plate; Posterior Metal/Polymer Spinal System, Fusion; Orthosis, Spine, Plate, Laminoplasty, Metal; Bone Grafting Material, Human Source; Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Bone Fixation Cerclage, Sublaminar; Growing Rod System; Spinal Vertebral Body Replacement Device - Cervical; Bone Cement, Posterior Screw Augmentation",1; 2; 3; U,", MOTORS; ACPii Atlantis Cervial Plate; AFFINITY; ANTERIOR CERVICAL PLATE SYSTEM; ARCHITEX; ARTHROSCOPE; ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology; ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS"" Anterior Cervical Plate System; ATLANTIS- Anterior Cervical Plate System; AXIS Fixation; Accurian™; Adaptix™ Interbody System with Titan nanoLock™ Surface Technology; Anatomic Peek; Anatomic Peek PTC Cervical Fusion System Cage; Anatomic Peek- Cervical Fusion System; Anteralign Spinal System with Titan nanolOCk; Anteralign™ Spinal System with Titan NanoLOCK™ Surface Technology Navigated Instruments; Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology; Aspen; Atlantis Translational Plate; Atlantis Vision Anterior Cervical; Atlas Cable; Atlas Cable System Ti; BIT DRILLS; BONE HOOK; BONE MILL; BONE SCREW RULER; BONE TAP; BRYAN Cervical Disc; Bard-Parker; Basis Vetebral Body Spacers; Bipolar forcep; Bone Cement HV-R w/Mixer - US; Bone Graft Washer; CAPSTONE CONTROL PTC Spinal System; CAPSTONE CONTROL Spinal System; CAPSTONE PTC SPINAL SYSTEM; CAPSTONE PTC™ SPINAL SYSTEM; CAPSTONE Spinal System; CAPSTONE-L SPINAL SYSTEM; CCD Spine System; CD 4.5 Crosslink Plates; CD 5.5mm Set Screws; CD Anterior Spinal System; CD Cannulated Screw; CD Central Rod; CD Cobalt Chrome; CD Eclipse Screws; CD Engage Cap; CD Engage Components; CD Engage Plate; CD Engage Y Parts; CD HA Coated; CD HORIZON; CD HORIZON ESSENCE; CD HORIZON ESSENTIALS™ Spinal System; CD HORIZON Fenestrated Screw Set; CD HORIZON Growth Rod Conversion Set; CD HORIZON Longitude 2 Instruments and Rods; CD HORIZON Multiaxial screw; CD HORIZON SEXTANT II Spinal System; CD HORIZON SOLERA SPINAL SYSTEM; CD HORIZON SOLERA Spinal System; CD HORIZON SOLERA""; CD HORIZON SPINAL SYSTEM; CD HORIZON SPIRE(TM) Z Spinal System; CD HORIZON Solera 5.5/6; CD HORIZON Spinal System; CD HORIZON Spinal System SDS Pre-Bent Rods; CD HORIZON Spinal System SOLERA; CD HORIZON Spinal System, CD HORIZON ESSENTIALS"" Spinal System; CD HORIZON Threaded Rods; CD HORIZON VOYAGER Extended Tab Screws; CD HORIZON VOYAGER""; CD HORIZON(R) Spinal System; CD HORIZONSPINAL SYSTEM; CD HORIZONSpinal System; CD HORIZON™ Spinal System; CD HORIZON® Fenestrated Screw Set; CD HORIZON® SOLERA® Spinal System; CD HORIZON® Spinal System; CD Horizan Eclipse M8 Screws; CD Horizan M8 Screws; CD Horizan Spinal Ti Spinal System; CD Horizon 3.2/4.5 Connectors; CD Horizon 3.5 Rods; CD Horizon 4.5 Cannulated Screws; CD Horizon 6.35 Crosslink Plates; CD Horizon Advanta; CD Horizon Antares Spinal System; CD Horizon Ballast"" Spinal System; CD Horizon Eclipse; CD Horizon Eclipse Screws; CD Horizon Ilio Sacral; CD Horizon Legacy 4.5; CD Horizon Legacy 6.35 Ti; CD Horizon M8 M10 Reduction Hooks; CD Horizon MAS Design Enhancement; CD Horizon Minor Mod; CD Horizon ModuLeX Spinal System - Degen Scoli Phase 2; CD Horizon Reduction; CD Horizon SMA Staple; CD Horizon Set Screws; CD Horizon Solera 5.5/6 Sagittal Adjusting Screws; CD Horizon Solera HA Screws; CD Horizon Spinal System; CD Horizon Spinal System ; CD Horizon Mazor Modulex Spinal System; CD Horizon Spinal System MAS; CD Horizon Spinous Plate; CD Horizon TAH Pedicle Hooks; CD Horizon Ti; CD Horizon- Spinal System; CD Horizon-Spinal System/ CD Horizon SOLERA; CD HorizonSpinal System; CD Horizon™ Astute™ Spinal System; CD Horizon™ ModuLeX™ FNS Screw Set; CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ LigaMAS Head Assm; CD Horizon™ ModuLeX™ Spinal System; CD Horizon™ Modular 5.5/6mm Spinal System; CD Horizon™ Spinal System; CD Horizon® Spinal System; CD Ilio Sacral Screws; CD Instrumentation; CD LIBERTY POSTERIOR SPINCAL SYSTEM; CD M8 RMAS; CD Modified Set Screws; CD Modified Sextant II Instruments; CD Perc Trauma; CD Roller Burnished/Shot Peened Rod; CD Sextant II Reduction; CD Sextant Instruments; CD Spinal System; CD Spinal System for DDD TI; CD Spine Implants for DTT #3; CD Spire Spikes; CD Staples and Screws; CDH Legacy 5.5; CDH Solera 4.75; CEMENT; CLYDESDALE Spinal System; COLORADO 2 Spinal Sys 6.35 Rods and; COLORADO 2 Spinal System; COLORADO II Spinal System SS; COLORADO II Spinal System Ti; CORKSCREW; CORNERSTONE PSR Cervical Fusion System; CORNERSTONEPSR Spinal System; CRESCENT Vertebral Body Spacer; CRESCENT™ SPINAL SYSTEM; CRESCENT™ SPINAL SYSTEM TITANIUM; CRESENT Ti Spinal System; CROSSLINK Axial & CROSSLINK Offset; CROSSLINK Plate Non Grooved; Cannula; Introducer tool; Capstone Control; Capstone Control™ Spinal System; Capstone Spinal System; Catalyft PL Expandable Interbody System; Catalyft™ LS Expandable Interbody System; Catalyft™ PL Expandable Interbody System; Cement Restrictor; Cement Restrictor Material Peek; Centerpiece Plate Fixation System; Chisel, Surgical, Manual; Clydesdale Spinal System; Clydesdale- Spinal System; Container; Cornerstone PSR; Cotrel-Dubousset Spinal System; Crescent; Crescent Spinal System Interbody F; Curette; DIVERGENCE Anterior Cervical Fusion System; DIVERGENCE(TM) Anterior Cervical Fusion System; DIVERGENCE-L"" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM; DRILL BIT (ORTHOPEDIC MA; DRILL GUIDES; DRILLS; Danek Infant System; Danek Plate and Screw System; Danek Precision Rod Set; Danek Sacral Hook; Danek Unit Rod; DanekScope Micro-Endo Systems; Drill; Introducer Tool; Dyan-Lok Anterior Posterior Plating; Dyna-Lok Classic; Dyna-Lok PLUS Spinal System; Dyna-Lok Plate and Screw; Dyna-Lok Rods Bolts Connectors; Dyna-Lok Ti Spinal System; Dyna-lok/Danek Plate Screw; Dynamic Compression Shape Memory; EEA TAID; ELEVATE"" Spinal System; ELEVATE™ SPINAL SYSTEM; ELEVATOR; ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD; ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT; ENDOSKELETON TC; ENDOSKELETON TO; ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD); ENDOSKELETON(R) TAS; ENDOSKELETON(R) TL INTERBODY FUSION DEVICE; ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL; ENDOSKELETON® TA nanoLOCK® Surface Technology; ENDOSKELETON® TL; ENT); Endoskeleton TAS Plate; Endoskeleton TCS Interbody Fusion Device; Endoskeleton TCS System; Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device; Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device; Endoskeleton(R) TCS System; Endoskeleton® TAS Hyperlordotic Interbody Fusion Device And Endoskeleton® TCS Interbody Fusion Device; Endoskeleton® TAS Interbody Fusion Device; Endoskeleton® TO; Equation Fixation System; Expandable Cage; FORCEPS (MANUAL INSTRU; Fuse Spinal System; Fuse Spinal System/ PLIF Titanium Cage; GDLH Posterior Spinal System; GRIP CLIP - CLIP; GUIDE WIRES (PINS); Galaky Spinal system; General Instrument; General Instruments; Grafton DBM; Grafton DBM Paste; Grafton DBM Plus; Grafton II eDBM; Guide Pin; Introducer Tool; HOLDER NEEDLE; HOLDER, NEEDLE; HV-R Bone Cement US; HourGlass Vertebral Body Spacer; Hydrosorb CR; IB3D™ PL Spinal System; ICAL INST); INFINITY™ OCT System; INFINITY™ Occipitocervical Upper Thoracic System; INFUSE BONEGRAFT Tibial Fracture; INFUSE BONEGRAFT/ LT-CAGE Lumbar TF; INFUSE BONGRAFT for Oral Max; INTERFIX Device (TIBFD); Inflate FX Fracture Management Inflatable Bone Tamp; InflateFX; KYPHON Cement Delivery System; KYPHON ELEMENT"" Inflatable Bone Tamp; KyphX Bone Biopsy Device; KyphX Bone Filler Device; KyphX Latitude Curette; KyphX Osteointroducer; Kyphon; Kyphon Anchor Facet Screw System; Kyphon Exact Inflatable Bone Tamp; Kyphon Express II Inflatable Bone Tamp; Kyphon Express Inflatable Bone Tamp; Kyphon HV-R Fenestrated Screw Cement; Kyphon Inflation Syringe; Kyphon Mixer; Kyphon VuE Bone Cement and Kyphon Mixer Pack; Kyphon Xpander II Inflatable Bone Tamp; Kyphon Xpede Bone Cement; Kyphopak First Fracture Tray; LAA Selection Guide; LAMINOPLASTY; LEGEND Power Adapter; LT CAGE PEEK; Legacy 6.35 SS; Lever Screwdriver; Liberty Anterior System; Liberty Spinal System; Loop Spinal System/ TLIF- Cage; MAST QUADRANT™ Retractor System; MASTERGRAFT PUTTY; MASTERGRAFT Putty; MASTERGRAFT Strip; MASTERGRAFT(TM) BONE VOID FILLER; MEDTRONIC REUSABLE INSTRUMENTS FOR USE WITH THE IPC POWEREASE"" SYSTEM; MEROCEL SPONGE; METRx Endoscope; METRx Microscope; MICRO-FRANCE; MODIFICATION TO TENOR SPINAL SYSTEM-PLATES; MSB PYRAMESH® Implant System; MSB-Perimeter System; MSD Silo Spinal System; MULTIPLE (CHISELS; MULTIPLE (DEPTH GAUGES); MULTIPLE (DRIVER-EXTRACTORS); MULTIPLE (ORTHOPEDIC CLAMPS); MULTIPLE (ORTHOPEDIC OSTEOTOMES); MULTIPLE (ORTHOPEDIC REAMERS); MULTIPLE (SCISSORS); MULTIPLE (SURGICAL MALLETS); MULTIPLE FORCEPS; MULTIPLE TWIST; MUTIPLE TYPES OF BURS; MagniFuse; MagniFuse Bone Graft; Magnifuse II Bone Graft; Manual surgical instrument for general use; MasterGraft Matrix; MasterGraft Putty; Mastergraft ( UltraMatrix, Matrix EXT); Mastergraft Contain; Mastergraft Mini Granules; Medtronic Dissector Tool; Medtronic General Instrument; Medtronic Reusable Instrument; Medtronic Reusable Instruments; Medtronic Transportation/Sterilization Cassettes; Medtronic Transportation_Sterilization Cassettes; Multi Axial Screw System; Multiple High Speed systems; NAVIGATED INFINITY™ Instruments; NETTERVILLE LARYNGOLOPLASTIC STAGE; NIM; NIM SPINE SYSTEM; NO 8 HEXALOBE STRAIGHT DRIVER; Navigated Anterolateral Disc Prep Insturments; Navigated CD HORIZON SOLERA Screwdrivers and Taps; Navigated Disc Prep Instruments; Navigated Elevate Spinal System; Navigated Vertex Select Drill Bit; Navigated Vertex Select Tap; Navigated Vertex Select Threaded Driver; ORION Anterior Cervical; ORTHOPEDIC (ORTHOPEDIC MANUAL SURG; ORTHOPEDIC MANUAL SURGICAL INSTRUM; OSTEOTOMES); Orfil Spine Fixation system; Orion Anterior Cervical Plate; OsteoCool"" Cart Stand; OsteoCool"" Desk Stand; OsteoCool"" Independent Thermocouple; OsteoCool"" Pump and Pump Cable; OsteoCool"" RF Ablation Probe Kit; OsteoCool"" RF Ablation System Generator; OsteoCool™ 2 RF Ablation System; Osteocool"" Connector Hub; PASS LP Spinal System; PEEK Prevail Cervical Interbody Dev; PEEK Previal Cervical Interbody Dev; PERIMETER C SPINAL SYSTEM; PERIMETER INSERTER; PERIMETER INTERBODY FUSION DEVICE; PERIMETER Interbody Fusion Device; PERIMETER® C; PIVOX"" Oblique Lateral Spinal System; PLATE; POWEREASE; POWEREASE System; POWEREASE System Working Ends; PRESTIGE Cervical Disc; PRESTIGE LP Cervical Disc System; PROBE (ORTHOPEDIC MANU; PYRAMID +4 Anterior Lumbar Plate S; Peek Prevail; Peek Rod; Perimeter Interbody Fusion Device; Perimeter TI; Perimiter C; Plexur P; Premier Anterior Cervical Plate; Pyramesh C; Pyramesh Implant System; Pyramid +4 Anterior Lumbar Plate; Pyramid Non-constrained Cover Plate; Pyramid Tapered Shank Bone Screw; RETRACTOR; RIALTO™ SI Fusion System; ROD BENDER; RONGEUR; RadiaLux™; Radio-Opaque Scale; Rasp; Robotic Graft Delivery Instruments; SCREWDRIVER; SHILLA(TM) Growth Guidance System; SHILLA™ Growth Guidance System; SOLID SPHERE; SONGER; SONGER CABLE SYSTEM; SOVEREIGN Spinal System; SOVEREIGN™ SPINAL SYSTEM; SPINAL INTERVERTEBRAL FUSION; SPINE; SURGICAL DRIVE SYSTEM; Sextant Percutaneous; Slap Hammer; Sovereign; Sovereign Spinal System; Soveriegn Spinal System; Spacekeeper; Spinal System; Straight Tip Radiance Illumination System; Symmetrix™ L Spinal System; T2 Altitude 1.5 Spinal System; T2 STRATOSPHERE™ Expandable Corpectomy System; T2 STRATSOPHERE™ Expandable Corpectomy System; T2 Sceptor Universal Endcleats; T2 Sinal System; T2 TXVBR; T2 XVBR; TACOMA Sacral Fixation System; TEMPLATE; TENOR SPINAL SYSDYNA-LOK PLUS Plate; TENOR Spinal System; TOWEL; TRANSLACE™ Spinal Tethering System; TRAY, SURGICAL; TSRH; TSRH 3D Connectors; TSRH 3Dx 90 Degree Offset Connector; TSRH CROSSLINK Axial and Offset Pl; TSRH Central Post Hooks; TSRH Chromaloy Plus Precut Contoured Rods; TSRH Cobalt Chrome Rods; TSRH Crosslink System; TSRH Expanded Pedicle Screw; TSRH Hook Holder; TSRH L Rod Connector; TSRH Lateral Offset Plate; TSRH Offset and Slide Loading Hooks; TSRH Open Head Bone Screw; TSRH Osteogrip; TSRH SENTRY Posterior Spinal System; TSRH SENTRY VA Screws; TSRH Sacral Screw Central Post; TSRH Sentry Anterior/Posterior Spin; TSRH Silo; TSRH Spinal System; TSRH Spinal System 3D Connectors an; TSRH Spinal System 4.5 Screws; TSRH Spinal System Anterior L Plate; TSRH Spinal System MPA Screws; TSRH Spinal System Prebent/precut r; TSRH Spinal System RP; TSRH Spinal System S Rods and Unit Rods; TSRH Spinal system Crosslink Plates; TSRH TC 3D MPA Screw; TSRH TC Splined Connectors & Screws; TSRH TC Threaded Screws; TSRH Top Tightening T-Bolt; Telamon; Tenor Spinal System; Thoracolumbosacral pedicle screw system; Threaded Cement Restrictor Ti; Ti Cement Restrictor; Tissue Approximating Forceps; Titanium GDLH Posterior Spinal Syst; Titanium TSRH SpinalSystem; Townley Pedicle Screw; Townley Transfacetpedicular Screw; Transverse Oct Spinal Fixation; Transverse Spinal Fixation; Tray, Surgical, Instrument; UCSS Non-Cannulated; VENTURE™ Anterior Cervical Plate System; VERTE-STACK Spinal System; VERTE-STACK(TM)SPINAL SYSTEM; VERTEBROPLASTY; VERTEX; VERTEX CROSSLINKS Reconstruction System; VERTEX Reconstruction System; VERTEX SELECT Reconstruction System; VERTEX® Reconstruction System; Vantage Bolts; Vantage Plates; Variable Angle Screw; Venture Cervical Plate; Verte-Span Components; Verte-Span Lift VB; Verte-Stack Capstone L; Verte-Stack Capstone Peek; Verte-Stack Clydesdale; Verte-Stack Cornerstone Sm End Caps; Verte-Stack Crescent; Verte-Stack Modified Center Piece; Verte-Stack Modified Cornerstone; Verte-Stack Perimeter Peek; Verte-Stack Perimeter XS; Verte-Stack T-Peek; Verte-Stack Telamon Ti; Verte-Stack XS; Vertex Adjustable Plate; Vertex Cannulated Screw; Vertex Crosslinks; Vertex Keel Plate; Vertex Lateral Connectors; Vertex Max; Vertex OC MAS, Rods, Hooks; Vertex Occipital Components; Vertex Reconstruction Occipital; Vertex Reconstruction System; Vete-Stack Modified; WRENCH; Wave D- Spinal System; Wave O Spinal System; Wire Caddy; Wire Nest; X-STOP® Interspinous Spacer Titanium; XANTUS Anterior Lateral; Xantus; ZEVO Anterior Cervical Plate System; ZPlate II; Zephir Anterior Cervical Plate; Zephir Anterior Cervical Plate System; Zplate Anterior Fixation System; dilator, lachrymal; instrument tray; mastergraft; spinal system; surgical instrument",1978-02-15,455,2026-07-17,9,43,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221030489%22&limit=1
"Karl Storz Endoscopy-America, Inc.",2020550,2020550,28 Millbury Street,Auburn,MA,01501,United States,KARL STORZ SE & CO KG,8010119,Contract manufacturer; Repackager or relabeler,207,BSJ; BSR; BSY; BTA; BTR; BWB; BYX; BYY; CAI; CAL; CAM; CBC; CCQ; CCW; DQI; DWS; DXC; DZN; EBA; EIA; EMF; ENZ; EOB; EOQ; EOX; EPP; EPT; EPY; EQH; EQJ; EQL; ERA; ERL; ETA; ETB; EWQ; EWY; EZN; EZO; FAH; FAJ; FAM; FAS; FAX; FBK; FBM; FBN; FBO; FBQ; FCL; FCR; FCW; FCX; FCY; FCZ; FDC; FDF; FDI; FDS; FDT; FDZ; FEA; FEC; FEI; FEO; FEQ; FET; FFD; FFK; FFL; FFS; FGA; FGB; FGC; FGO; FHQ; FJL; FKK; FSM; FSO; FSR; FSZ; FTA; FTS; FWC; FWF; FWZ; FXF; FXM; GAD; GAH; GAZ; GBX; GCC; GCF; GCI; GCJ; GCM; GCT; GCX; GCY; GDC; GDI; GDM; GDX; GEA; GED; GEI; GEN; GEX; GEY; GFF; GWG; GWX; GZT; GZX; HAO; HCY; HDG; HDX; HET; HEW; HFA; HFB; HGI; HGK; HIF; HIG; HIH; HIN; HJO; HKI; HMW; HNI; HPP; HRX; HSZ; HTE; HTF; HWC; HWE; JAA; JOL; JOS; JYK; JYL; KAD; KAE; KAI; KAL; KAS; KAY; KBN; KCD; KCL; KCT; KDQ; KGE; KMA; KMN; KNF; KNS; KNY; KOA; KOC; KOE; KOH; KQT; KTG; KXF; KYT; KYW; KYZ; LJH; LLZ; LNS; LQC; LQR; LRC; LXH; LYK; LYU; MBI; MDM; MNK; MNL; MOK; MQW; NBH; NKC; NTN; NVT; NWW; OAY; OCV; OCW; OCX; OCY; OCZ; ODA; ODB; OSV; OWN; PGW; PHT; PUI; PYO,"Mask, Gas, Anesthetic; Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Pump, Portable, Aspiration (Manual Or Powered); Tube, Tracheal (W/Wo Connector); Forceps, Tube Introduction; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Circuit, Breathing (W Connector, Adaptor, Y Piece); Laryngoscope, Non-Rigid; Yoke Assembly, Medical Gas; Bottle, Collection And Trap, Breathing System (Uncalibrated); Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Laryngoscope, Rigid; Withdrawal/Infusion Pump; Instruments, Surgical, Cardiovascular; Clamp, Vascular; Instruments, Dental Hand; Light, Surgical Headlight; Unit, Operative Dental; Knife, Surgical; Telescope, Laryngeal-Bronchial; Nasopharyngoscope (Flexible Or Rigid); Bronchoscope (Flexible Or Rigid); Esophagoscope (Flexible Or Rigid); Splint, Nasal; Microscope, Surgical; Speculum, Ent; Source, Carrier, Fiberoptic Light; Bur, Ear, Nose And Throat; Laryngostroboscope; Otoscope; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Replacement, Ossicular Prosthesis, Total; Prosthesis, Partial Ossicular Replacement; Saw, Surgical, Ent (Electric Or Pneumatic); Mediastinoscope, Surgical; Dilator, Catheter, Ureteral; Urethrotome; Dilator, Urethral, Mechanical; Cystoscope And Accessories, Flexible/Rigid; Sigmoidoscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Bougie, Urological; Endoscopic Injection Needle, Gastroenterology-Urology; Cannula And Trocar, Suprapubic, Non-Disposable; Choledochoscope And Accessories, Flexible/Rigid; Cystourethroscope; Trocar, Gastro-Urology; Forceps, Biopsy, Non-Electric; Light Source, Photographic, Fiberoptic; Light Source, Fiberoptic, Routine; Insufflator, Automatic Carbon-Dioxide For Endoscope; Bulb, Inflation, For Endoscope; Tube, Smoke Removal, Endoscopic; Resectoscope, Working Element; Colonoscope And Accessories, Flexible/Rigid; Snare, Flexible; Gastroscope And Accessories, Flexible/Rigid; Duodenoscope And Accessories, Flexible/Rigid; Attachment, Eyepiece, For Insertion Of Prescription Lens; Attachment, Teaching, For Endoscope; Obturator, For Endoscope; Instrument, Special Lens, For Endoscope; Lithotriptor, Ultrasonic; Pump, Air, Non-Manual, For Endoscope; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Evacuator, Bladder, Manually Operated; Lithotriptor, Electro-Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Image, Illumination, Fiberoptic, For Endoscope ; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Urethroscope; Dislodger, Stone, Flexible; Holder, Needle, Gastroenterologic; Resectoscope; Clamp, Line; Tray, Surgical, Instrument; Microscope, Surgical, General & Plastic Surgery; Light, Headband, Surgical; Light, Surgical, Carrier; Light, Surgical, Accessories; Camera, Cine, Endoscopic, With Audio; Camera, Television, Surgical, With Audio; Camera, Television, Endoscopic, Without Audio; Operating Room Accessories Table Tray; Speculum, Illuminated; Camera, Still, Endoscopic; Retractor; Stylet, Surgical, General & Plastic Surgery; Tubing, Noninvasive; Catheter, Irrigation; Dilator, Catheter; Proctoscope; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Endoscope, Rigid; Light Source, Endoscope, Xenon Arc; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Table, Operating-Room, Electrical; Dissector, Surgical, General & Plastic Surgery; Needle, Aspiration And Injection, Reusable; Scalpel, One-Piece; Cannula, Surgical, General & Plastic Surgery; Brush, Dermabrasion, Manual; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Powered Laser Surgical Instrument; Motor, Surgical Instrument, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Endoscope, Neurological; Fork, Tuning; Retractor, Self-Retaining, For Neurosurgery; Instrument, Microsurgical; Instrument, Surgical, Non-Powered; Curette, Uterine; Speculum, Vaginal, Metal, Fiberoptic; Dilator, Vaginal; Laparoscope, Gynecologic (And Accessories); Culdoscope (And Accessories); Amnioscope, Transabdominal (Fetoscope) (And Accessories); Forceps, Biopsy, Gynecological; Electrocautery, Gynecologic (And Accessories); Endoscope, Fetal Blood Sampling (And Accessories); Insufflator, Laparoscopic; Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Coagulator-Cutter, Endoscopic, Bipolar (And Accessories); Biomicroscope, Slit-Lamp, Ac-Powered; Camera, Ophthalmic, Ac-Powered; Drape, Microscope, Ophthalmic; Retractor, Ophthalmic; Headlamp, Operating, Battery-Operated; Arthroscope; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Elevator; Curette; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; System, X-Ray, Fluoroscopic, Image-Intensified; Catheter And Tip, Suction; Electrode, Electrosurgical; Holder, Ear Speculum; Hook, Microsurgical Ear; Elevator, Ent; Forceps, Ent; Mirror, Ent; Retractor, Ent; Knife, Nasal; Punch, Nasal; Gag, Mouth; Bougie, Esophageal, Ent; Blower, Powder, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Bottle, Collection, Vacuum; Forceps, Biopsy, Electric; Irrigator, Powered Nasal; Chair And Table, Medical; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Accessories, Catheter, G-U; Surgical Instruments, G-U, Manual (And Accessories); Accessories, Blood Circuit, Hemodialysis; Dilator, Urethral; Instrument, Manual, General Obstetric-Gynecologic; Evacuator, Gastro-Urology; Knife, Ent; Applicator, Absorbent Tipped, Non-Sterile; Light, Examination, Medical, Battery Powered; Container, Liquid Medication, Graduated; Syringe, Irrigating (Non Dental); System, Irrigation, Urological; System, Image Processing, Radiological; Lithotriptor, Extracorporeal Shock-Wave, Urological; Lithotriptor, Biliary Mechanical; Dislodger, Stone, Biliary; Instrument, Ent Manual Surgical; Orthopedic Manual Surgical Instrument; Angioscope; Accessory, Surgical Apparel; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Vaginoscope And Accessories; Transilluminator, Fiber Optic; Accessories, Arthroscopic; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Led Light Source; Tubing And Tubing/Filter Fits; Hysteroscope Accessories; Light Source System, Diagnostic Endoscopic; Endoscope Holder; Endoscopic Tissue Approximation Device; Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Grasping/Cutting Instrument, Non-Powered; Endoscopic Central Control Unit; Endoscopic Contamination Prevention Sheath; Insufflator, Endoscopic Vessel Harvesting; Confocal Optical Imaging; Ear, Nose, And Throat Stereotaxic Instrument; Basin For Endoscope Reprocessing; Drape, Surgical, Exempt; Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use",1; 2; 3; f,"11274AB Flex Pediatric BRONCHOSCOPE; 11274AC Flex. CHOLEDOCHOSCOPE; 26025UC HAMOU Elctrnc HYSTEROFLATOR; 2800C Shouldr/Ankle/Elbw/Hip/TMJ/SM; 300W Light Source, Non-flash; 3D Endoscope; 3D Video System; 495N Series Fibr Optic Light Cables; 7.5 Fr. Flexible CHOLEDOSCHOSCOPE; ADVANCED IMAGE AND DATA; AIDA Compact II System; AIDA w/ DICOM and HL7 Interface; ANGIOMAT, Model 383320 20; ARTHRO PUMP; ARTHROPUMP DISP, Tubing Set; ARTHROPUMP Disposable Tubing Set; ARTHROPUMP Plus; ARTHROSCOPE; AUTOCON II 200 Electrosurg Generat; AUTOCON II 400 Electrosurgical Gen.; AUTOCON III 400; Ablation Electrodes; Adaptors for Documentation; Adult/Pede VISCOUS Fluid Inject.Set; Arthroforce; Arthroscopic Telescopes; Autocon II 400 Electrosurgical Gen; BETTOHI SNARE; BITE PROTECTORS; BOUGIES and Dilators; Balloon Catheter; Basin for endoscope reprocessing; Battry Powered Light Source; Bipolar Coagulating Forceps; Bipolar Coagulation Electrodes; Bipolar Electrodes; Bipolar Electrotome; Blepharoplasty Set; Bridges, Adaptors; Bronchoscope; Bronchoscopes; C-MOUNT ARTHROSCOPE; CALCULASE HOLMIUM LASE; CALCULASE HOLMIUM LASER; CALCULASE Holmium Laser & Acc.; CALCUSON; CALCUSPLIT; CALCUTRIPT Elctrohydraulc LITHR SYS; CANNULA, OBTURATOR, VERESS NEEDLE; CCL Vaginal Extractor and Acc's; CHARDONNES Morcellation Knife; CLEARVISION Lens Irrigation System; CMOS Endoscopes SSU; CMOS Video Rhino Laryngoscope; CMOS Video-Rhino-Laryngoscope System; CO2 ARTHROFLATOR; CO2 Endoflator; CO2 HYDROMAT Pump for Irrigation; CO2mbi LED SCB; CURETTE; Calculase II; Camera; Camera, ophthalmic, ac-powered; Cannula and Trocar; Carcinoma Gauges; Catheters; Catheters, MANDRIN, Plugs, Connect; Chair and Table, Medical; Cholangiography Set; Clamp; Cleaning Brushes and kits; Cold Knife; Cold Knife Blades; Contact Microlaryngoscope; Contact Nasal Micro-Endoscope; Continuous Flow Cystoscope; Continuous Flow RESECTOSCOPES; Cotton Applicator; Cover; Culdocentesis Set; Cutting Loop Elctrodes Modification; Cystoscope 78FAJ, Fiberoptic 78GDB; DCI Endoscope; DCI Telescope; DCI VIDEO LARYNGOSCOPE; DIGI-VIDEO; DION-GRACIA Set; Dental Endoscopes; Dental Hand Instruments; Deployable Cardiovascular Clamp; Device Imaging Storage; Dilators, Reducers, Sleeves; Dissector; Distending DIVERTICULOSCOPE; Drape; Drapery; Drill; ELEVATOR; ENDO-MAGNIFIER; ENDOFLATOR +; ENDOFLATOR 40&50; ENDOMAT DISP, Tubing Sets; ENDOMAT LC PUMP; ENDOMAT SELECT; ENDOPYELOTOMY Set; ENDOSCOPE ACCESSORIES; ENDOSPINE Oper Tube & Telesc Bridge; ENDOTIP System; ENT Elevators; ENT Forceps, Scissors, and Punches; ENT Rigid Telescopes; ENT Stent Applicator Forceps; ENT Surgical Instrument; ENT/NEURO/OMF System and Accessory; EPIDUROSCOPE; EQUIMAT Model 203020 20; EQUIMAT, Model 203020 20; ERCP CATHETER; EYEPIECE ATTACHMENT FOR INS; Elec Endoflator, Model 264305 20; Electronic LAPAROFLATOR; Electronic LAPAROFLATOR (10 LPM); Electronic LAPAROFLATOR (20 LPM); Endomat Select; Endomat Select (Model Number: UP210); Endoscope; Endoscope Accessories; Endoscope Accessory; Endoscope Holder; Endoscopic Assisted Intubation Set; Endoscopic guidewire, gastroenterology-urology; Endoscopy Instrument; Endoscopy Powder Blower; Endotack; Esophagoscope; Esophagoscope and Accessories; Extraction Bag; FELDMAN Mini-saw; FISCH TITANIUM MID; FISCH Titanium Mid Ear Prostheses; FLEX-X2; FORCEPS, EAR; FRIMBERGER Varioguide; Fascia Closer Device; Fetoscopy Set; Fiber Optic Light Cables; Fiberscope; Flex-XC; Flex. HYSTEROSCOPE; Flexible CHOLEDOCHOSCOPE; Flexible CMOS Video-Cysto Urethroscope; Flexible Choledochoscope; Flexible HD Cysto-Urethroscope System; Flexible HD Video Rhino-Laryngoscope System; Flexible Hysteroscope, 10.5 Fr; Flexible Intubation Video Endoscope – Sterile (FIVE-S); Flexible Trocar Sleeves; Flexible Video Cysto-Urethroscope; Flexible Video-Uretero-Choledochoscope-System; Flexible Video-Uretero-Renoscope; Flexible Video-urethro-cystoscope; Fluid Light Cables; Forceps; Forceps, ENDO/LAP; GAAB Rigid NEUROENDOSCOPES; GELET Uretero-Renoscope; Gas Mask; General/Plastic Surgery Instruments; Grasping, Biopsy, and Spoon Forceps; H1 Camera Head; HAMOU ENDOMAT; HAMOU ENDOMAT Disposable Tubing Set; HARTMANN Ear Speculum; HD View; HD-View; HEMPFLING Dilation Set; HOPKINS I/II Autoclavable Telescope; HOPKINS Telescopes; HOPKINS Telescopes for Arthroscopy; HUZLY High Freq Cutting Loops; HYDROMAT Trumpet Valve & Tubing Set; HYDROMAT, Model 263110 20; HYSTEROSCOPIC INSU; Hand Extractor HECTOR; Headband; Headlight; Hysteromat II; Hysteroscope; Hysteroscope and accessories; IMAGE1; Image 1 SPIES; Image Processing System; Image1 S CCU, Image1 S 4U camera head; Infant Balloon VAGINOSCOPES; Instr Set Percut Discect/Nucleotomy; Instr, TX of Carpal Tunnel Syndrome; Instrument Tray; Instruments, Bipolar Coagulation; Insufflation Bulb; Insulated  Scissors & Rectal Snares; Insulated Biopsy Forceps; Insulated Biopsy Forceps, Grasping; Insulated Cannulae & Suction Tubes; Insulated Dissecting Cannulae; Insulated ELECTROSUGRICAL Instrum.; Insulated Scissors; Intra-Handpieces & Accessories; Intubation Fiberscope; Irrigation/Suction Sys/Handpiece; KARL STORZ BIOPSY FORCEPS; KARL STORZ BLADDER EVACUATOR; KARL STORZ BOUGIE; KARL STORZ BOUGIES; KARL STORZ Bipolar Resectoscopes with HF Cable; KARL STORZ CURETTES; KARL STORZ Cholangiography Set; KARL STORZ Cysto-Urethro-Fiberscope; KARL STORZ DE LA PLA; KARL STORZ ENDOSCOPE; KARL STORZ ENDOSCOPE LENS; KARL STORZ ENDOSCOPIC STILL CAMERA; KARL STORZ ENDOVISION HYSTEROCAM; KARL STORZ ENDOVISION UROCAM; KARL STORZ Endoscopic Accessories for Urology; KARL STORZ Endoscopic ICG Imaging System; KARL STORZ FELDMAN MIN; KARL STORZ FIBEROPTIC; KARL STORZ FLEXIBLE ASPIRATING TUBE; KARL STORZ FLEXIBLE VIDEO-; KARL STORZ FORCEPS; KARL STORZ Fiber Telescopes for Urology; KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S; KARL STORZ Flexible Video-Neuro-Endoscope System; KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC); KARL STORZ HOPKINS Telescopes; KARL STORZ HOPKINS Telescopes for Urology; KARL STORZ HYSTEROCAM; KARL STORZ ICG Imaging System; KARL STORZ ICG Imaging System with RUBINA Lens System; KARL STORZ ICG System; KARL STORZ Image1 S Camera Control Unit; KARL STORZ LARYNGOSCOPE; KARL STORZ LEG HOLDER; KARL STORZ MEDICAL; KARL STORZ MODEL 28200C; KARL STORZ Mediastinoscopes and Instruments; KARL STORZ NAV1 Electromagnetic Navigation System; KARL STORZ NEEDLE HOLDERS; KARL STORZ OTOSCOPE; KARL STORZ PRESSURE T; KARL STORZ PULSAR II; KARL STORZ Ped. Cysto-Urethro-Fiberscope; KARL STORZ Pediatric Cysto-Urethro-Fiberscope; KARL STORZ REUSABLE ASPIR; KARL STORZ SHOULDER ARTHROSCOPY POS; KARL STORZ STONE DISLODGER; KARL STORZ SURGICAL CANNULA; KARL STORZ SURGICAL KNIFE; KARL STORZ SURGICAL STYLET; KARL STORZ Shuntscope; KARL STORZ Trocars with Valve Seals; KARL STORZ UDEL Sterilization Trays; KARL STORZ Urological Laser Accessories; KARL STORZ VAGINAL SPECULUM; KARL STORZ VIDEO GASTROSCOPES; KARL STORZ VIDEO LOWER; KARL STORZ suction and irrigation system; KNIFE, CURVED; KNIFE, ENT; KOH Micro-Suturing Instruments; KOH Needle Holders, Suture Forceps; KOH Needle Holders, Suturing Forcep; KS Lock; KSEA CLEARVISION II, MODEL 40334120; KSEA CLEARVISION LE; KSEA Monopolar Resectoscopes; KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE; Karl Storz Arthropump Power Irrigation/Suction Pump, Tubing; Karl Storz MegaFix-C Composite; Karl Storz Scalp Dura Retractor; Knives, Curettes; Knives,Curettes,Hooks,Needles; Knives,Curettes,Hooks,Probes; LAPAROCAM; LAPAROMAT Laparoscopic Suction; LED Headlight KS70; LED NOVA 100 Cold Light Fountain; LED light source; LEG HOLDER; Laparoscope; Laproscope; Laproscopy; Laproscopy Insstruments; Large Joint Arthroscopy Set; Laryngoscope Accessories; Laser Accessories; Light Fountain 50 Watts; Light source system, diagnostic endoscopic; Lithotripter; MAHNES Take-Apart Bipol Coag Forcep; MANHES Pneumotrocar; MIrror; MONOPOLAR VAPORIZATION Electrodes; MOUTH GAG; MTP ARTHROUMP TUBING SET; MTP CLEARVISION Disp Tubing Set; MTP Disposable Trocar Valves; MTP Disposable Trocars; MTP Extraction Bags; MTP LAPAROMAT Disposable Tubing Set; MTP Suction canisters/tubing; MULTIDRIVE II Mini Shaver; MVM 3.3 MM MICROENDOSCOPE; MVM 3.3 MM Micro-Endoscope; MVM 7.5 French Flex. HYSTEROSCOPE; MVM 7.5 French Flex. URETEROSCOPE; Magnifying Telescopes; Medi Pack; Medicine Cups; MegaFix Bioabsorbable Screw; MegaFix Perforated Bioabsorbable; MegaFix-T Titanium Screw; Micro Surgical Instruments; Micro-ARTHROPLASTY System; Micro-ARTHROPLSTY Sys. Disp. Blade; Micro-Instrum. for Cochlear Implant; Microcast 4K Pro; Microcast HD Pro; Microsurgical Ear; Miniature Endoscope; Miniature Neuro Endoscope; Miniature Telescope and Accessories; Miniature Telescope for Urology; Model 26021C Bipolar COAGULATOR; Model 27080 LITHOTRIPTOR System; Model 27086C Ultrasonic LITHOTRITE; Model 27224P Continuous Flow Pump; Model 28805 ARTHRO Pump; Model28184 Pneumatic Shuttle Shaver; Modification to ENDOTIP System; Modified Veress Needle & Cannula; Mono Ball/Needle/Loop Electrodes; Mono Coag Ball Electrodes; Mono Coag Needle Electrode; Mono Coag Needle, Loop Electrodes; Mono High Freq Cords; Mono Vaporization Electrodes; Monopolar Coagulating Electrodes; Monopolr Cord, Endoscpc Hi-Frequncy; N20 ENDOFLATOR; NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER); Nasal Irrigator; Nasal Splint; Nasopharyngo/Broncho/Tracheoscopes; Nasopharyngoscope; Needles; NeoVagina Surgery Set & Accessories; Nephroscope, Adult & Pediatric; Neuro FIBERSCOPE; Neuro-Fiberscope; Neuroscope and Accessories; New Generation Trocars; Non-Insulated Scissors; Nonpowered neurosurgical instrument; OP Server Lap; OR1 IP Camera; OR1 SCB CONTROL; OTOSCOPE; Obstetrical and Gynecological Surgical Devices; Obturators, Cannula Sheaths; Operating LARYNGOSCOPES & Accs; Optical Mediastinoscope; Optical Video Tongue Depressor; Ortho Manual Surgical Instruments; PT Coagulator, SEMM Crocodile Force; PUNCH, NASAL; Ped VANCAILLIE MANHES Take Apart; Ped VANCAILLIE Take Apart Bip Instr; Pede PYLORIC Spreader, PYLOROTOME; Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories; Percutaneous Foraminoscopy Set; Percutaneous Nephroscope System; Pivot Arm PAPARASCOPE Sleeve; Plastic Surgery Accessories; Plastic Trocars; Powder Blower and Accessories; Power LED 175; Power LED 175 Light Fountain; Powered Laser Surgical Instrument; Powershaver System S2; Pressure Cuff; Prism ELECTROSCOPE; Protoscopes, Sigmoidoscopes, Acc.; Puncture Cannula; Puncture, Injction, ENDOSCPIC VERES; QUADROSWITCH; REMORGIDA Forceps; RETRACTOR; RHINO-PHARYNGO-LARYNGO FIBERSCOPE; Reinsertion Forceps; Resectoscopes; Retractors,Probes,Dissectors,Hooks; Reverse Video; Rhino-Laryngo-Bronco Fiberscope; Rigid Culdoscope and Accessories; Rigid Telescopes; Rotocut G1 Morcellator, Electromech; S-Pilot; SACHSE DRILL; SAUER Endscpc Guide & Intbation Aid; SAWAHLE Electromech. Morcellator; SCB ACC CONTROL (AND OTHERS); SCB Interface Control #20090120; SCB Media Control; SCB-RUI (Realistic User Interface); SCB-RUI SCO; SCB/CONMED ESU INTERFACE MODULE; SCB/STERIS OR-Light Interface Box; SCB/VALLEY LAB Force FX Interface; SCBCOM; SEMM Tissue Punch; SINGLE-USE TISSUE TRAP FILTER W/ADAPTER; SSU Flexible Video-Uretero-Renoscope; STAMMBERGER SACSHE Drill; STEINER ELECTROMECHANIC MORCELLATOR; STEINER Electromechanic Morcellator; SUBGLOTTISCOPE, Infant & Neonate; SUPRALOOP; SYRINGE, IRRIGATING (NON DENTAL); Saphenous Vein Harvesting Set; Scalp Blood Collection Set; Scissors, ENDO/LAP; Semi-Rigid Micro-Endoscpes & Acc.; Semi-Rigid Micro-Endoscpes & Acces.; Semi-Rigid Microendoscope & Acc.; Semi-rigid Hysteroscope; Series 11274 Flex. URETEROSCOPE; Series 11274 Flexible Fiberscope; Shoulder Pro; Sialoendoscopes and Accessories; SilCut; SilGrasp; Slim Nasopharyngolaryngoscope; Smart Smoke Evacuation; Smoke Removal Tube; Snares; Speculum; Speculum, ENT; Spinoscope; Sterilization Tray; Sterilization Trays; Stone Basket; Storz SLX-F2 Storm Touch; Suction Catheter; Suction Catheters; Suction/Drainage Tubes, Cannulae; Suction/Irrigation Tubes; Sunction Tube; Surgeon Connect; Surgical Instruments; Surgical Light Carrier; Surgical Microscope; TAMBERGER-SACHASE INTRANASAL DRILL; TEACHING ATTACHMENT; TELESCRUB; THERMOFLATOR, Model 26 4320 20; TIPCAM; TIPCAM 1S 3D System; TIPCAM1 Rubina Video Endoscope System; TRACHEAL RESECTOSCOPE; TUBING; TUBING SET FOR LAPAROSCOPIC INSUFFL; Take Apart Rotating Grasping Forcep; Take Apart Suture Forceps; Take-Apart Bipolar Forceps; Take-Apart Forceps; Take-Apart Scissors; Tape and bandage, adhesive, adjustable closing mechanism, OTC use; Targeting Unit; Telepack +; Telepack X LED; Telescope Bridges & Adaptors; Telescope Bridges/Inserts/Adaptors; Telescopes Holders; Telescopes, Rigid, HOPKINS I; Telescopes, Rigid/Magnifying; Telescpes, Rigid/Mgnifying/KS VARIA; Thermocoagulator, Model 26510020; Thoracic Surgery Instruments; Tissue Retractor; Trachea Tubes; Tracheal tube; Trans-Nasal Esophagoscopes; Transvaginal Endoscopy Set; Trocars, Cannulae and Sheaths; Tubing with Connector; Tuning Fork; Twin Transilluminator; Twin-Video; UNIDRIVE II Plus Disposable Tubing; UNIDRIVE II/II Plus & ENT Accessori; UNIDRIVE S III ENT; UNIDRIVE SIII System; UNIDRIVE Select System; UNIMAT 12; UNIMAT 45; UNIMAT Plus; UNIMAT Plus, Model 203210 01; UNIMAT Suction Pump; UNIMAT, Model 203200 20; URETERO-RENOSCOPES/URETEROSCOPE; UROMAT; UROMAT Disposable Tubing Set; UROMAT E.A.S.I; UROMAT for Urological Irrigation; UROPUMP; Unidrive SIII ENT; Unidrive Shaver ARTHROSCOPY Blades; Ureter Resectoscope; Ureteroscope and accessories, flexible/rigid; Uterine Manipulator; VACUSAFE TUBING SETS; VISCOUS Fluid Injection Set; VITOM; Vacusafe Vacuum Cannister and Bottles; Vaporization Electrodes; Vascular Fiberscopes; Vein Discission; Video Flexible ENT Endoscope System; Video Gastroscopes; Video Lower G.I. Endoscope System; Whisker Arthroscopic Blade; Wiltek Grasping Forceps; Wire Tray; Wound Closure Instruments; XENON NOPPVA; XR-MX X-Ray System; Xenon 100; Xenon Light Source (175W) 201320-20; Xenon Light Source/Flash; Xenon Nova Light Source; Zero Wire; manual surgical instrument ENT",1978-06-20,437,2026-09-25,1,7,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222020550%22&limit=1
Teleflex Medical LLC,3011137372,3005747797,3015 Carrington Mill Blvd,Morrisville,NC,27560,United States,Teleflex,9062981,Complaint file establishment; Manufacturer; Specification developer,547,BRW; BSJ; BSK; BSO; BSP; BSR; BTC; BTK; BTM; BTO; BTQ; BTR; BTS; BTT; BWB; BWF; BYD; BYE; BYL; BYP; BYW; BYX; BYY; BZA; BZE; BZO; BZW; CAC; CAE; CAH; CAI; CAL; CAP; CAT; CAZ; CBG; CBH; CBI; CBN; CBO; CBP; CCK; CCL; CCQ; CCT; CCW; CCX; DQO; DQT; DQX; DQY; DRB; DRC; DSS; DTI; DTL; DWO; DWP; DWQ; DWS; DWX; DXC; DXE; DXT; DXZ; DYB; EAX; EBA; EFQ; EHJ; EIB; EIG; ELA; EMD; EME; EMF; EMG; EMH; EMI; EMK; EML; EMM; EMX; EOQ; EOX; EPE; EPY; EQH; EQN; ERA; ETK; EWY; EXX; EYK; EYR; EZB; EZC; EZL; EZM; FAP; FAQ; FAT; FAX; FBM; FBP; FBW; FBX; FCF; FCG; FCL; FCM; FCO; FCT; FCY; FCZ; FDE; FDG; FDZ; FEA; FEI; FEN; FFL; FFN; FFO; FFP; FFQ; FFR; FFY; FGE; FGM; FGN; FGO; FGS; FGY; FHA; FHH; FHI; FHL; FHN; FHQ; FKC; FLK; FLL; FMF; FMH; FMI; FMK; FMP; FNS; FNY; FOA; FOB; FOD; FOZ; FPA; FPD; FPF; FQH; FQK; FQM; FQP; FSM; FSR; FSW; FSX; FSY; FTA; FTD; FTX; FTY; FTZ; FWZ; FXE; FXF; FXM; FZO; FZP; FZQ; FZR; FZS; FZT; FZW; FZX; FZY; GAA; GAC; GAD; GAF; GAH; GAI; GAL; GAM; GAN; GAO; GAP; GAQ; GAR; GAS; GAT; GAW; GAX; GAZ; GBA; GBM; GBO; GBP; GBS; GBW; GBX; GBZ; GCA; GCB; GCC; GCD; GCE; GCJ; GCT; GCX; GCY; GDF; GDG; GDH; GDI; GDJ; GDM; GDN; GDO; GDR; GDT; GDW; GDX; GDY; GDZ; GEA; GEC; GEG; GEI; GEJ; GEN; GEO; GES; GEX; GFA; GFB; GFI; GFJ; GWX; GWY; GXZ; GZT; GZX; HAE; HAM; HAO; HBG; HBI; HBO; HBQ; HBR; HBT; HCF; HCH; HCY; HCZ; HDA; HDC; HDE; HDF; HDG; HDH; HDJ; HDK; HDL; HDQ; HDX; HER; HFB; HFW; HFX; HGC; HGI; HHF; HHK; HHM; HIF; HJB; HKF; HLF; HLN; HMQ; HMR; HMX; HNA; HNC; HND; HNE; HNF; HNG; HNH; HNI; HNJ; HNK; HNL; HNN; HNP; HNQ; HNR; HNW; HNX; HNY; HNZ; HOB; HOC; HOD; HOE; HOF; HOY; HOZ; HPQ; HRH; HRP; HRQ; HRR; HRS; HRT; HSO; HST; HTC; HTD; HTF; HTJ; HTP; HTR; HTS; HTT; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWI; HWJ; HWK; HWM; HWQ; HWW; HWX; HXB; HXC; HXD; HXE; HXG; HXI; HXK; HXL; HXP; HXQ; HXS; HXW; HXX; HXY; HXZ; IPY; IQI; ITX; IYN; IYO; JAY; JDW; JEK; JOH; JOK; JOL; JXL; JXS; JXT; JXX; JYA; JYC; JYD; JYE; JYG; JYH; JYJ; JYK; JYL; JYM; JYO; JYP; JYQ; JYR; JYT; JYY; JYZ; JZA; JZB; JZD; JZE; JZF; JZY; KAC; KAD; KAE; KAG; KAI; KAJ; KAK; KAL; KAM; KAN; KAO; KAP; KAQ; KAR; KAS; KAT; KAW; KAX; KAY; KAZ; KBA; KBB; KBC; KBD; KBE; KBH; KBJ; KBK; KBL; KBM; KBN; KBQ; KBS; KBT; KBZ; KCA; KCB; KCC; KCD; KCE; KCF; KCG; KCH; KCI; KCJ; KCP; KCT; KDC; KDD; KDG; KDQ; KGS; KGX; KGZ; KIC; KIK; KKX; KMK; KNA; KNQ; KNT; KNW; KNX; KOA; KOB; KOD; KOH; KPY; KRA; KRD; KTE; KTF; KTG; KTR; KYZ; LDE; LDF; LFJ; LGG; LJS; LKF; LLO; LMF; LNM; LOX; LQR; LRC; LRL; LRP; LRW; LRY; LXG; LXH; LZB; MAB; MAV; MCW; MDM; MDZ; MEB; MGB; MGP; MGZ; MHW; MIJ; MMX; MNK; MNL; MOQ; MPB; MSD; MTJ; MWS; MXY; MZY; NAB; NEW; NNY; NWT; NWV; OAR; OBJ; OCW; OES; OFA; OFC; OFK; OFR; OGG; OGR; OVB; OVN; OXC; PAD; PEW; POD; POZ; PPO; PYC; PYH; QEW; QEZ; QQS; QSX; QSY,"Protector, Dental; Mask, Gas, Anesthetic; Cuff, Tracheal Tube, Inflatable; Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Bag, Reservoir; Strap, Head, Gas Mask; Ventilator, Emergency, Manual (Resuscitator); Tube, Tracheostomy (W/Wo Connector); Airway, Nasopharyngeal; Tube, Tracheal (W/Wo Connector); Tube, Bronchial (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Forceps, Tube Introduction; Spirometer, Therapeutic (Incentive); Condenser, Heat And Moisture (Artificial Nose); Attachment, Breathing, Positive End Expiratory Pressure; Tent, Oxygen; Mouthpiece, Breathing; Device, Rebreathing; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Connector, Airway (Extension); Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer; Set, Tubing And Support, Ventilator (W Harness); Stethoscope, Esophageal; Apparatus, Autotransfusion; Airway, Oropharyngeal, Anesthesiology; Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Laryngoscope, Non-Rigid; Monitor, Airway Pressure (Includes Gauge And/Or Alarm); Cannula, Nasal, Oxygen; Anesthesia Conduction Kit; Spreader, Cuff; Device, Fixation, Tracheal Tube; Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector); Apparatus, Gas-Scavenging; Attachment, Intermittent Mandatory Ventilation (Imv); Valve, Non-Rebreathing; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Applicator (Laryngo-Tracheal), Topical Anesthesia; Laryngoscope, Rigid; Support, Patient Position; Catheter, Intravascular, Diagnostic; Occluder, Catheter Tip; Wire, Guide, Catheter; Catheter, Percutaneous; Stylet, Catheter; Trocar; Clip, Vascular; Sizer, Heart-Valve, Prosthesis; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Needle, Biopsy, Cardiovascular; Dilator, Vessel, Surgical; Stripper, Vein, External; Instruments, Surgical, Cardiovascular; Stripper, Artery, Intraluminal; Clamp, Vascular; Catheter, Embolectomy; Injector And Syringe, Angiographic; Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene; Introducer, Catheter; Mirror, Mouth; Light, Surgical Headlight; Gauze/Sponge, Internal; Disk, Abrasive; Syringe, Irrigating (Dental); Retractor, All Types; Instrument, Hand, Calculus Removal; Hemostat, Surgical; Punch, Biopsy, Surgical; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Forceps, Rongeur, Surgical; File, Bone, Surgical; Curette, Surgical, Dental; Chisel, Bone, Surgical; Chisel, Osteotome, Surgical; Balloon, Epistaxis; Bronchoscope (Flexible Or Rigid); Esophagoscope (Flexible Or Rigid); Brush, Cleaning, Tracheal Tube; Speculum, Ent; Source, Carrier, Fiberoptic Light; Laryngoscope, Nasopharyngoscope; Otoscope; Tube, Toynbee Diagnostic; Mediastinoscope, Surgical; Probe, Rectal, Non-Powered; Connector, Ureteral Catheter; Tourniquet, Gastro-Urology; Stylet For Catheter, Gastro-Urology; Catheter, Coude; Catheter, Retention Type, Balloon; Dilator, Esophageal (Metal Olive) Gastro-Urology; Cystometric Gas (Carbon-Dioxide) On Hydraulic Device; Bag, Urine Collection, Leg, For External Use, Sterile; Bougie, Esophageal, And Gastrointestinal, Gastro-Urology; Bougie, Urological; Cannula And Trocar, Suprapubic, Non-Disposable; Telescope, Rigid, Endoscopic; Filiform And Filiform Follower; Sound, Urethral, Metal Or Plastic; Instrument, Biopsy, Mechanical, Gastrointestinal; Biopsy Needle; Forceps, Biopsy, Non-Electric; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Box, Battery, Rechargeable; Headlight, Fiberoptic Focusing; Bulb, Inflation, For Endoscope; Tube, Smoke Removal, Endoscopic; Laparoscopy Kit; Retractor, Fiberoptic; Attachment, Eyepiece, For Insertion Of Prescription Lens; Attachment, Teaching, For Endoscope; Instrument, Special Lens, For Endoscope; Device, Cystometric, Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Clamp, Non-Electrical; Retractor, Self-Retaining; Dilator, Rectal; Speculum, Rectal; Device, Locking, For Intestinal Clamp; Adaptor, Bulbs, Miscellaneous, For Endoscope; Stents, Drains And Dilators For The Biliary Ducts; Probe And Director, Gastro-Urology; Retractor, Non-Self-Retaining; Dislodger, Stone, Flexible; Carrier, Sponge, Endoscopic; Cannula, Injection; Clamp, Penile; Crusher, Spur, Colostomy; Ring, Laparotomy; Scoop; Ligator, Hemorrhoidal; Holder, Needle, Gastroenterologic; Clamp, Cannula; Thermometer, Clinical Mercury; Continuous Measurement Thermometer; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Protector, Skin Pressure; Ring Cutter; Basin, Emesis; Board, Cardiopulmonary; Bedpan; Device, Occlusion, Umbilical; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Tube, Feeding; Bottle, Hot/Cold Water; Lavage, Jet; Binder, Perineal; Bandage, Elastic; Lamp, Operating-Room; Tray, Surgical, Instrument; Light, Headband, Surgical; Light, Surgical, Endoscopic; Light, Surgical, Connector; Light, Surgical, Ceiling Mounted; Light, Surgical, Accessories; Lamp, Surgical; Mirror, General & Plastic Surgery; Tape, Measuring, Rulers And Calipers; Locator, Magnetic; Operating Room Accessories Table Tray; Speculum, Non-Illuminated; Speculum, Illuminated; Camera, Still, Endoscopic; Chisel, Surgical, Manual; Clip, Implantable; Clip, Removable (Skin); Contractor, Surgical; Curette, Surgical, General Use; Cutter, Surgical; Expander, Surgical, Skin Graft; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Aspiration And Injection, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Spatula, Surgical, General & Plastic Surgery; Stylet, Surgical, General & Plastic Surgery; Stripper, Vein, Reusable; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Absorbable, Synthetic; Suture, Nonabsorbable; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Balloon Type; Catheter, Urethral; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Multiple Lumen; Catheter, Ventricular, General & Plastic Surgery; Catheter, Peritoneal; Catheter, Irrigation; Catheter, Cholangiography; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Needle, Catheter; Dilator, Catheter; Connector, Catheter; Adaptor, Catheter; Laparoscope, General & Plastic Surgery; Light Source, Endoscope, Xenon Arc; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Needle, Aspiration And Injection, Reusable; Knife, Amputation; Applier, Surgical, Clip; Saw, Manual And Accessories; Staple, Removable (Skin); Staple, Implantable; Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Brush, Scrub, Operating-Room; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Forceps, General & Plastic Surgery; File, Surgical, General & Plastic Surgery; Blade, Scalpel; Powered Laser Surgical Instrument; Blade, Saw, General & Plastic Surgery, Surgical; Head, Surgical, Hammer; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Fork, Tuning; Pinwheel; Electrode, Needle; Retractor, Self-Retaining, For Neurosurgery; Instrument, Microsurgical; Rongeur, Manual; Apparatus, Electrosurgical; Instrument, Surgical, Non-Powered; Drills, Burrs, Trephines & Accessories (Manual); Illuminator, Fiberoptic, Surgical Field; Clip, Scalp; Instrument, Clip Removal; Rack, Clip; Applier, Hemostatic Clip; Instrument, Ligature Passing And Knot Tying; Clip, Aneurysm; Curette, Uterine; Forceps, Surgical, Gynecological; Forceps, Obstetrical; Tenaculum, Uterine; Hook, Fibroid, Gynecological; Speculum, Vaginal, Metal; Speculum, Vaginal, Metal, Fiberoptic; Needle, Cerclage, Gynecological; Scissors, Umbilical; Scissors, Episiotomy; Retractor, Vaginal; Dilator, Cervical, Fixed Size; Dilator, Vaginal; Pelvimeter, External; Forceps, Biopsy, Gynecological; Clamp, Umbilical; Clamp, Circumcision; Clamp, Uterine; Electrocautery, Gynecologic (And Accessories); Remover, Intrauterine Device, Contraceptive, Hook-Type; Curette, Suction, Endometrial (And Accessories); Sound, Uterine; Insufflator, Laparoscopic; Instrument, Measuring, Corneal Radius; Mirror, Headband, Ophthalmic; Device, Measuring, Lens Radius, Ophthalmic; Gauge, Lens, Ophthalmic; Marker, Sclera; Marker, Ocular; Cannula, Ophthalmic; Spud, Ophthalmic; Specula, Ophthalmic; Spatula, Ophthalmic; Snare, Enucleating; Scissors, Ophthalmic; Rongeur, Lachrymal Sac; Ring, Ophthalmic (Flieringa); Retractor, Ophthalmic; Punch, Corneo-Scleral; Probe, Trabeculotomy; Probe, Lachrymal; Knife, Ophthalmic; Introducer, Sphere; Hook, Ophthalmic; Forceps, Ophthalmic; Dilator, Lachrymal; Depressor, Orbital; Cystotome; Curette, Ophthalmic; Clamp, Muscle, Ophthalmic; Clip, Iris Retractor; Clamp, Eyelid, Ophthalmic; Caliper, Ophthalmic; Burr, Corneal, Manual; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Sponge, Ophthalmic; Headlamp, Operating, Ac-Powered; Trephine, Manual, Ophthalmic; Pen, Marking, Surgical; Hemostat; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Stripper, Surgical; Saw; Apparatus, Traction, Non-Powered; Pliers, Surgical; Forceps; Curette; Gauge, Depth; File; Rasp; Knife, Orthopedic; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Corkscrew; Awl; Trephine; Osteotome; Passer; Countersink; Tap, Bone; Probe; Wrench; Clamp; Fork; Tamp; Passer, Wire, Orthopedic; Holder, Needle; Orthopedic; Mallet; Instrument, Bending Or Contouring; Crimper, Pin; Twister, Wire; Bender; Screwdriver; Brace, Drill; Cutter, Wire; Orthosis, Lumbo-Sacral; Orthosis, Limb Brace; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Support, Breathing Tube; Pin, Fixation, Threaded; Forceps, Biopsy, Bronchoscope (Rigid); Tube Tracheostomy And Tube Cuff; Scissors, Medical, Disposable; Catheter And Tip, Suction; Block, Bite; Block, Cutting, Ent, Sterile; Crimper, Wire, Ent, Sterile; Forceps, Wire Closure, Ent, Sterile; Scissors, Wire Cutting, Ent, Sterile; Cannula, Ear; Chisel, Mastoid; Chisel, Middle-Ear; Curette, Ear; Excavator, Ear; Gauge, Measuring; Holder, Ear Speculum; Hook, Microsurgical Ear; Inserter, Myringotomy Tube; Knife, Ear; Knife, Myringotomy; Loop, Wire; Nipper, Malleus; Pick, Microsurgical Ear; Rasp, Ear; Rod, Measuring Ear; Rongeur, Mastoid; Scissors, Ear; Snare, Ear; Spoon, Ear; Tube, Ear Suction; Knife, Laryngeal; Tube, Laryngectomy; Elevator, Ent; Forceps, Ent; Holder, Speculum, Ent; Mirror, Ent; Mobilizer, Ent; Probe, Ent; Retractor, Ent; Cannula, Sinus; Chisel, Nasal; Curette, Ethmoid; Curette, Nasal; Gouge, Nasal, Ent; Irrigator, Sinus; Knife, Nasal; Perforator, Antrum; Punch, Antrum; Punch, Ethmoid; Punch, Nasal; Rasp, Frontal-Sinus; Rasp, Nasal; Rongeur, Nasal; Saw, Nasal; Scissors, Nasal; Snare, Nasal; Adenotome; Curette, Adenoid; Curette, Salpingeal; Depressor, Metal Tongue, Surgical; Dissector, Tonsil; Gag, Mouth; Knife, Tonsil; Punch, Adenoid; Punch, Tonsil; Snare, Tonsil; Tonsillectome; Tube, Tonsil Suction; Bistoury, Tracheal; Bougie, Esophageal, Ent; Cannulae, Bronchial; Dilator, Esophageal, Ent; Dilator, Tracheal; Hook, Tracheal; Trocar, Tracheal; Applicator, Ent; Syringe, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Chisel (Osteotome); Bottle, Collection, Vacuum; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Cushion, Flotation; Hook, Bone; Drape, Surgical, Antimicrobial; Device, Intravascular Catheter Securement; Instrument, Manual, Specialized Obstetric-Gynecologic; Dilator, Esophageal; Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Collector, Urine, (And Accessories) For Indwelling Catheter; Surgical Instruments, G-U, Manual (And Accessories); Catheter, Suprapubic (And Accessories); Catheter, Urological; Instrument, Manual, General Obstetric-Gynecologic; Shield, Protective, Personnel; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Trocar, Ent; Punch, Ent; Knife, Ent; Tube, Aspirating, Bronchoscope, Rigid; Syringe, Irrigating (Non Dental); Stethoscope, Manual; Electrode, Pacemaker, Temporary; Catheter, Subclavian; Instrument, Cast Application/Removal, Manual; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Cannula, Manipulator/Injector, Uterine; Laser, Neodymium:Yag, Pulmonary Surgery; Agent, Absorbable Hemostatic, Collagen Based; Agent, Bulking, Injectable For Gastro-Urology Use; Catheters, Transluminal Coronary Angioplasty, Percutaneous; Dislodger, Stone, Biliary; Instrument, Ent Manual Surgical; Cushion, Hemorrhoid; Tray, Surgical; Scissors, General, Surgical; Punch, Surgical; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Orthopedic Manual Surgical Instrument; Finger Cot; Marker, Cardiopulmonary Bypass (Vein Marker); Syringe, Balloon Inflation; Catheter, Peripheral, Atherectomy; Instrument, Manual, Surgical, General Use; Cleaners, Medical Devices; Pump, Infusion, Elastomeric; Device, Hemostasis, Vascular; Dressing, Wound And Burn, Occlusive; Valvulotome; Dressing, Compression; Needle, Tumor Localization; Device, Percutaneous Retrieval; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Battery, Replacement, Rechargeable; Catheter, Hemodialysis, Non-Implanted; Catheter, Hemodialysis, Implanted; Wax, Bone; Stabilizer, Heart; Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal; Graft, Vascular, Stainless Steel Tunneler; Gauze / Sponge,Nonresorbable For External Use; Suture, Surgical, Absorbable, Polydioxanone; Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile; Endoscopic Cholangiogram Kit; Laparoscopic Accessories, Gynecologic; Injector, Vertebroplasty (Does Not Contain Cement); Catheter, Ultrasound, Intravascular; Endoscopic Tissue Approximation Device; Cardiac Catheterization Kit; Cardiovascular Surgical Instruments Tray; Catheter Introducer Kit; Percutaneous Atrial Catheter Kit; Tracheobronchial Suction Catheter Kit; Humidifier Nebulizer Kit; Ear, Nose, And Throat Surgical Tray; Hydrogel Spacer; Suture Kit; Mesh, Surgical, Absorbable, Staple Line Reinforcement; Chest Drainage Kit; Implantable Transprostatic Tissue Retractor System; Temporary, Internal Use Hemostatic; Biopsy Needle Kit; Multi-Lumen Hemodialysis Catheterization Kit; Paracentesis Tray; Surgical Retractor Kit; Peripheral Mechanical Thrombectomy With Aspiration; Aspiration Thrombectomy Catheter; Stapler, Skin; Hemostatic Wound Dressing With Thrombin Or Other Biologics; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; 3; U,"(K792088); , GEN; 0.2 Micron Filter; 0.2 Micron Flat Epidural Filter; 12 Fr Heparin Two-Lumen Hemodialysis Catheterization Kit/Set; 12 Fr. Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter; 14 Fr Two-Lumen Hemodialysis Catheterization Kit/Set; ACULUX-PILLING; ADAPT LAPAROSCOPIC; ADAPT UNIVERSAL LAPAROSCOPIC PORT,; ADENOID; ADENOTOME; AGT PVC Preform Nasal trachea tube uncuff w/ mur eye; AGT PVC Preform Oral trachea tube cuffed w/mur eye; ANTRUM; AORTIC OCCLUDER; APH IOOP; APPARATUS; ARROW Radial Artery Catheterization Set with Integral Needle Protection; ARROW® FlexBlock Continuous Peripheral Nerve Block Kits; ASPIRATING; ATOMIZER; ATOMIZERS; AVA NEB NEBULIZER; Abdominal Paracentesis Kit; Accumed Wrist Splint. Model Numbers 3565-Accumed PWPS and 3560-Accumed II, Flat; Adult ConchaSmart Breathing Circuits; Adult ConchaSmart Circuit/Column Kit; Adult ISO-GARD Breathing Circuits; Adult ISO-GARD Circuit/Column Kit; Airway Lifesaver Kit; Anesthesia Circuit; Anesthesia Face mask with / without hook ring, black; Anesthesia Face mask, pediatric; Antecubital Central Venous Catheterization Kit with Heparin-Coated Catheter; Aquapak; Aquapak Humidifier Reservoir with Adaptor; Aquapak Nebulizer Reservoir with Adaptor; Aquapak Prefilled Humidifier; Aquatherm; Arrow; Arrow Access Tray; Arrow Central Venous Catheterization Kit; Arrow Continuous Nerve Block Needle; Arrow Continuous Peripheral Nerve Block Kit; Arrow EZ-IO Intraosseous Vascular Access System; Arrow Echogenic Introducer Needle; Arrow Epidural Anesthesia Kit; Arrow Epidural Needle; Arrow FlexBlock Continuous Periphearl Nerve Block Kits; Arrow Jugular Puncture Kit; Arrow Large Bore Multi-lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter; Arrow MAC(TM) Two-Lumen Central Venous Access Kit; Arrow MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Non-Absorbable Silk Suture; Arrow OnControl Bone Lesion Biopsy System (Model No. 9401-OnControl Power Driver); Arrow OnControl Bone Marrow Biopsy System (Model Number 9401-OnControl Power Driver); Arrow PICC; Arrow Peripherally Inserted Central Catheter; Arrow Pressure Injectable Central Venous Catheterization Kit; Arrow Pressure Injectable PICC; Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Radial Artery; Arrow Select Kits; Arrow SharpsAwayII¿ Locking Disposal Cup; Arrow Single Shot Epidural Anesthesia Kit; Arrow StimuCath® Continuous Nerve Block Set; Arrow StimuQuik Echo Insulated Peripheral Nerve Block Needle; Arrow StimuQuik Insulated Peripheral Nerve Block Needle; Arrow StimuQuik® Echo Insulated Peripheral Nerve Block Needle; Arrow Stimulator Adapter Cable; Arrow Surgical Drape; Arrow Thoracentesis Kit; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis Set; Arrow UltraQuik Tuohy Ultrasound Peripheral Nerve Block Needle; Arrow UltraQuik Ultrasound Peripheral Nerve Block Needle; Arrow VPS G4 System; Arrow-Clark™ VectorFlow™ Antegrade Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Replacement Hub Set; Arrow-Johans¿ ECG Adapter for Right Atrial Electrocardiography; Arrow-Tretola Over-The-Wire PTD; Arrow-Tretola PTD; Arrow™ Large Volume Paracentesis Kit; Arrow™ OnControl™ Powered Bone Access System; Arrow™Temporary Pacing Catheters and Kits; Arrow® 0.2 Micron Flat Epidural Filter; Arrow® 10 mL Luer-Slip Loss of Resistance Syringe; Arrow® 5 mL Luer-Lock Loss of Resistance Syringe; Arrow® 5 mL Luer-Slip Loss of Resistance Syringe; Arrow® Emergency Infusion Device - EID¿; Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter; Arrow® Epidural Needle; Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath; Arrow® Sheath Adapter with Cath-Gard® Catheter Contamination Shield; Arrow® SnapLock™ Catheter/Syringe Adapter; Arrow® StimuQuik® Insulated Peripheral Nerve Block Needle; Arrow® Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set; Autofuser; BALLOON TYPE; BALLPEN SPINAL NEEDLE W/WO INTRODUC; BATTERY; BED PAN RUBBER ROUND; BETHEA SHEET HOLDER; BIPOLAR CORDS; BISTOURY; BITE BLOCK; BITEGARD ORAL PHARYNGEAL BITE BLOCK; BONDEK; BONDEK SYNTHETIC ABSO; BONE FIXATION PLATE; BOUGIE; BOX; BREATHING TUBE; BULBS; Bacterial/Viral Filter; Bandit guidewire. Modell numbers:7444 Bandit Guidewire 200cm5Pk and 7445 Bandit Guidewire 300cm5PK; Barrigel Injectable Gel; Barron, Tucker, McGivney; Beere Evolution; BightForceTM; Bite Gard; Bite-Gard Oral Bite Block; Bladder Catheter Tiemann; Bondek; Bondek Plus; CALCULUS REMOVAL; CANNULA; CANNULA EAR; CARDIOPULMONARY BYPASS; CARRIER LAHEY; CATHETER SPIGOTS; CENTIMETER SUBTRACTION; CERCLAGE; CHAMBER IRRIGATORS; CHISEL OSTEDTOME; CLAMP; CLEANING; CLIP; COLD WATER BOTTLES; COLOSTOMY; CONMED; CONNECTING; CONNECTOR; CONTRACTOR; CORNEAL RADIUS; CORR-A-TUBE; COTTONY II, Silky II, Polydek,; CPRAM Respiratory Assist Device; CRUSHER; CUFF; CUFF SPREADER; CUNNINGHAM PENILE CLAMP; CURETTE; Cannon Hemodialysis Catheter; Cannon II Plus; Cannon II Plus Replacement Hub Set; Cannon II Plus; Edge; Canyons Wound Irrigation System; Cath-Guide Guedel Airway; Catheter Hemodialysis; Catheter Mount; Catheter, Continuous Flush; Chocolate XD PTCA Balloon Catheter; Cleaning Brush; Clip Appliers.; Comfort Flo Humidification System; ConchaSmart Column; ConchaTherm Brackets; ConchaTherm III+; ConchaTherm IV; ConchaTherm IV+; ConchaTherm LHF; Condom Catheter; Convatec GentleCath; Corr A Flex; Corr A Tube; Cottony; Cottony II, Silky II Polydek; Cuff Pilot; D-Stat 2 Dry topical hemostat; D-Stat Clamp topical hemostat accessory; D-Stat Dry Clear topical hemostat; D-Stat Dry topical hemostat; D-Stat Flowable; D-Stat Flowable Hemostat; D-Stat Rad-Band topical hemostat; D-Stat Radial Topical Hemostat; DA VINCI; DEKNATEL; DEPTH; DIATEK CANNON-CATHETER; DIFFERENTIAL VENT. TUBES; Deflux Injectable Gel; Deklene; Deklene Maxx; Deknatel; Deknatel Thoracic; Deknatel Trocar; Deknatel®, Deklene®, Deklene® Maxx™, Capio; Deknatel®, Tevdek®, Capio, LSI, Niceloop, Polydek®, NextStich®, silky, Cottony; Devilbiss Oxygen Supply Tubing Connector; Devilbiss STAR LUMEN Tubing; Dilator, Vessel, Surgical; DispoGrip; DispoLED; Disposable Aortic Punch; Dolphin; Dual Channel Airway; E SUTURES; ECTIVE EYEWEAR AND POST-MYDRIATIC; EFx; ENDO5; ENT MANUAL SURGICAL; EPIDURAL TUOHY; ERU Catheter PVC Tiemann Pattern; ESOPHAGEAL; ETHMOID; EVACUPAK; EXTRACTOR; EZ-BLOCKER; EZ-IO; EZ-Stabilizer; Edgar Tube; Edge; Embolectomy Catheter; Encapsulon Epidural Catheter; End Tidal CO2 Tube; Endotest Cuff Pressure Gauge; Endotest Replacement Tube; Endotracheal MAD, MADett; Enfuse, Entube, various; EquipLED; EquipLite; Esmarch Bandage; Esophageal Intubation Detector, EID; Esophageal Stethoscope; Evolution Broken Screw Remover; Expro Elite Snare; External Catheter; External Fixation Devices; FACE; FACE TENT; FAST1; FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device; FASTTactical Sternal Intraosseous; FIBEROPTIC; FILIFORMS; FILTER, BACTERIAL, BREATHING-CIRCUIT; FLEXIBLE; FOLLOWERS; FOR ENDOSCOPE; FORCEPS; FRONTAL-SINUS; Facemask Silicone; Female catheter; Fiber Optic Laryngoscope Blades and Handles; FlexTip Plus Epidural Catheter; FlexTip Plus Epidural Catheterization Kit; Flocath and Easycath Intermittent Catheter; Force Fiber; Force Fiber Fusion; Force Fiber® Suture; GASTRO-UROLOGY; GAUZE/SPONGE, INTERNAL; GEN/PLASTIC SURGERY; GENERAL AND PLASTIC SURGERY; GENERAL OBSTETRIC-GENECOLOGIC; GENERAL OBSTETRIC-GYNECOLOGIC; GENERAL OBSTETRIC-GYNECOLOGIC MANU; GERY; GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG; GRAFT RING; GUARDIAN II HEMOSTASIS VALVE; GUARDIAN II NC HEMOSTASIS VALVE; Gas Sampling Lines; Gel-Bead embolization spheres; Gel-Block 10X embolization pledgets; Gel-Flow NT; Gibeck Humid-Flo and Passive Kits; Gibeck RCI Disposable PEEP Valve; Gibeck RCI SOFTFLEX; Gibeck RCI Softech Bi-Flo Cannula; Glider PTCA Balloon Catheter; GrebSet micro-introducer kit; GreenLED; GreenSpec; GuideLiner Coast Catheter M5270 GuideLiner Coast,M5271 GuideLiner Coast, M5272 GuideLiner Coast,M5273 GuideLiner Coast; Guideliner V3 Catheter; HEADBAND; HEAT AND MOISTURE; HEEL RING CUSHION; HEM O LOCK LIGATION CLIPS; HEMOCLIP; HEMOCLIP AUTOMATIC CLIPS MEDIUM; HEMOCLIP Ligating Clip Med/Lrg; HEMOLOCK; HEMOLOK; HEMOLOK Ligating Clips & Cartridges; HEMOLOK SMX Ligating Clip Polymer; HEMOSTAT; HOLDER ULM PATTERN; HOLDER, NEEDLE; HOLDERS; HORIZON; HOT WATER BOTTLE; HUDSON BURR BITS; HUDSON RCI LIFESAVER DISPOSABLE MANUAL RESUSCITATOR; HUMID-FLO; HUMID-VENT FILTER COMPACT; HUMID-VENT FILTER SMALL; HUMID-VENT HEAT AND MO; Hem-O-Clip Plus, Hem-O-Lok,; Hem-o-lok; Hem-o-lok Plus; Hem-o-lok PurplePlus; Hemoclip; Hemoclip Plus; Hemolok; Horizon; Horizon Ligating Clips, Titanium; Horizon, Hem-O-Clip Traditional,; Hudson Adult Rebreathing Circle Systems; Hudson Anesthesia Breathing Bags; Hudson Anesthesia Circuit; Hudson Anesthesia Circuit Accessories; Hudson Anesthesia Circuit Assessories; Hudson Bite-Guard; Hudson CPRAM Anesthesia Circuits; Hudson Disposable Adult Rebreathing Circle Systems; Hudson Head Harness; Hudson Isolation Valve; Hudson Mask Harness; Hudson Neoprene Pecan Breathing Bag; Hudson Non-Rebreathing Single Limb Systems; Hudson Pediatric Rebreathing Circle Systems; Hudson Pressure Tubing; Hudson RCI; Hudson RCI Adaptors and Connectors; Hudson RCI Aerosol Connector; Hudson RCI Aerosol T-Connector; Hudson RCI Circuit / Column Kits; Hudson RCI ConchaSmart Circuit; Hudson RCI Connector; Hudson RCI Conventional Breathing Circuit with Filter; Hudson RCI Conventional Breathing Circuit with Nebulizer; Hudson RCI Conventional Breathing Circuits; Hudson RCI Disposable PEEP Valve; Hudson RCI Flow Meter Adaptor; Hudson RCI IMV System; Hudson RCI Main Line Filter Kit; Hudson RCI Mouthpiece; Hudson RCI Neptune Heated Humidifier; Hudson RCI Oxygen Supply Tubing; Hudson RCI Oxygen Supply Tubing Connector; Hudson RCI Pressure Lines; Hudson RCI Pressure Monitoring Lines; Hudson RCI STAR LUMEN Tubing; Hudson RCI Sensor Tee; Hudson RCI Softech Bi-Flo Cannula; Hudson RCI Temperature Indicator; Hudson RCI Test Lung; Hudson RCI Tubing; Hudson Sampling Lines and Filters; Hudson Sampling lines and Filters; Hudsonas sampling lines and filters; Hudson®; Humid Vent HEPA; Humid-Vent Filter; Humidifier Filter, various; IMPACTOR; INC'D POST MYDRIATIC EYEWEAR; INFLATION CUSHION; INSTR RACKS AND HOLDERS; INSTRUMENT RACKS AND HOLDERS; INTRADUCER; INTRAVASCULAR CATHETER SECUREMENT; INTRODUCER; INTRODUCER NEEDLE; INTRODUCERS; INTRODUCTION DRAINAGE CATHETER; IRIS RETRACTOR; IRRIGATING; ISO GARD Breathing Circuit Kit; ISO-ARD HEPA FILTER-HME W/PORT; ISO-GARD Drain Circuit Technology; ISO-GARD HEPA FILTER-HME; ISO-Gard Mask; Infant Feeding Tube; Inflatable Nasal Tube, Masing pattern; Intermittent Urethral Catheter; Introducer Catheter; Iso-Gard Filter Angled/Iso-Gard Filter Straight; JINOTTI DUAL PURPOSE CATHETER; Jehle Catheters; KMEDIC; LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS; LAPAROTOMY; LARYNGEAL; LARYNGECTOMY; LASER RESISTANT TRACH TUBE; LASTIC SURGERY; LEBSCHE STERNUM KNIFE; LENS RADIUS; LIGATURE CARRIER; LIGHT; LMA Classic; LMA Classic Excel; LMA Cuff-Deflator; LMA EID; LMA Fastrach; LMA Fastrach (SU); LMA Fastrach ETT; LMA Fastrach ETT SU; LMA Fastrach Stabiliser Rod; LMA Flexible; LMA Flexible (S); LMA Flexible (S) Cuff Pilot; LMA Flexible (SU); LMA Flexible PreCurved; LMA Flexible PreCurved Cuff Pilot; LMA Flexible SU; LMA Gastro Cuff Pilot; LMA NovaPlus; LMA ProSeal; LMA ProSeal Cuff Deflator; LMA ProSeal Introducer; LMA Protector; LMA Protector Cuff Pilot; LMA Supreme; LMA Supreme Plus Pack; LMA Unique; LMA Unique (S); LMA Unique (S) Cuff Pilot; LMA Unique (Silicone Cuff); LMA Unique (Silicone Cuff) Cuff Pilot; LMA Unique Evo; LMA Unique Evo Cuff Pilot; LMA Unique PreCurved; LMA Unique PreCurved Cuff Pilot; LOCKING PLATES; Langston dual lumen catheter; Laparoscope, general & plastic surgery; Lifesaver Isolation Kits; Ligation Clips; Liver Biopsy Kit; Low Compliance Concha Column; MAD Nasal; MAD Nasal Mist; MADgic; MADgic Airway; MAGIL FORCEPS; MAGNET HOLLINGER; MALONEY AND HURST; MALONEY AND HURST BOUGIE; MANTA Depth Locator; MANTA Vascular Closure Device; MANUAL CAST REMOVAL INSTRUMENTS; MATCombat; MATResponder; MATResponder Elite; MEASURING TAPES; METAL OR PLASTIC; METAL OR PLASTIC URETHRALS; MICRO BULLDOG; MICROSURGICAL EAR; MINI-SAHARA; MINITAPE; MISCELLANEOUS; MOISTURE ARTIFICIAL NOSE CONDENSER; MONODEK; MULTIIPLE; MULTIPLE A-C POWERED; MULTIPLE ADENOID CURETTES; MULTIPLE ADENOID PUNCHES; MULTIPLE ADENOTOME; MULTIPLE AIRWAY PRESSURE MONIT; MULTIPLE AMPUTATION KNIFES; MULTIPLE AMPUTATION KNIVES; MULTIPLE ANEURYSM CLIPS; MULTIPLE ANTRUM PERFORATORS; MULTIPLE ANTRUM PUNCHES; MULTIPLE ATOMIZER AND TIP ENT; MULTIPLE ATOMIZERS; MULTIPLE BALLOON TYPE CATHETERS; MULTIPLE BED PANS; MULTIPLE BITE BLOCKS; MULTIPLE BONE FILES; MULTIPLE BONE HOOKS; MULTIPLE BONE TAPS; MULTIPLE BREATHING CIR; MULTIPLE BREATHING TUBE SUPPORTS; MULTIPLE BRONCHIAL CANNULAES; MULTIPLE CALCULUS REM; MULTIPLE CANNULA CLAMPS; MULTIPLE CARDIOVASC; MULTIPLE CATHETER ACCESSORIES; MULTIPLE CATHETER ADAPTORS; MULTIPLE CATHETER CONNECTORS; MULTIPLE CATHETER TI; MULTIPLE CEILING MOUNTED; MULTIPLE CLINICAL; MULTIPLE COLLECTIONS SYSTEMS; MULTIPLE COLOSTOMY SPUR CRUSHERS; MULTIPLE CONNECTOR SURGICAL LIGHTS; MULTIPLE CORNEAL RADIU; MULTIPLE CORONARY; MULTIPLE COUNTERSINKS; MULTIPLE CURETTES; MULTIPLE CUSHION FLOATIONS; MULTIPLE CYSTOMETRIC GAS (CARB; MULTIPLE DENTAL PROTECTORS; MULTIPLE DEPTH GAUGES; MULTIPLE DISPOSABL; MULTIPLE DISPOSABLE SURGICAL INSTRU; MULTIPLE DRILL BITS; MULTIPLE DRILL BRACES; MULTIPLE EMESIS BASINS; MULTIPLE ENDOSCOPI; MULTIPLE ENDOSCOPIC SPONGE CARRIERS; MULTIPLE ENDOSCOPIC STILL CAMERAS; MULTIPLE ENDOSCOPIC SURGICAL LIGHTS; MULTIPLE ENT APPLICATORS; MULTIPLE ENT ESOPHAGEAL BOUGIES; MULTIPLE ENT ESOPHAGEAL DILATORS; MULTIPLE ENT FORCEPS; MULTIPLE ENT MANUAL; MULTIPLE ENT MIRRORS; MULTIPLE ENT NASAL GOUGES; MULTIPLE ENT PROBES; MULTIPLE ENT RETRACTORS; MULTIPLE ENT SPECULUM HOLDERS; MULTIPLE ENT SPECULUMS; MULTIPLE EPISIOTOMY SCISSORS; MULTIPLE ESOPHAGEAL (METAL O; MULTIPLE ETHMOID CURETTES; MULTIPLE ETHMOID PUNCHES; MULTIPLE EXTERNAL PELVIMETER; MULTIPLE EXTERNAL VEIN STRIPPERS; MULTIPLE EYEPIECE ATTACHMENT FO; MULTIPLE FIBEROPTIC; MULTIPLE FIBEROPTIC RETRACTOR; MULTIPLE FILIFORM AN; MULTIPLE FLEXIBLE AN; MULTIPLE FLEXIBLE CONNE; MULTIPLE FLEXIBLE STONE DISLODGER; MULTIPLE FORCEPS; MULTIPLE FRONTAL SINUS RASPS; MULTIPLE GASEOUS-PHAS; MULTIPLE GASTRO-UROLOG; MULTIPLE GASTRO-UROLOGY ESOPHAG; MULTIPLE GASTRO-UROLOGY TOURNIQUETS; MULTIPLE GEN. PURPOSE LAB EQ; MULTIPLE GENERAL; MULTIPLE GENERAL AND PLAST; MULTIPLE GENERAL US; MULTIPLE GENERAL USE SUR; MULTIPLE GYNECOLOG; MULTIPLE GYNECOLOGI; MULTIPLE HEAT; MULTIPLE HEMORRHOIDAL LIGATOR; MULTIPLE ILLUMINATED SPECULUM; MULTIPLE INFLATION; MULTIPLE INTERMITANT MANDATORY; MULTIPLE INTERNAL GAUZE-SPONGES; MULTIPLE INTRALUMIN; MULTIPLE INTRAVASCULAR CA; MULTIPLE IRIS RETRACTOR CLIPS; MULTIPLE IRRIGATING; MULTIPLE IRRIGATING DENTAL SYRINGES; MULTIPLE LACHRYMAL DILATORS; MULTIPLE LACHRYMAL PROBES; MULTIPLE LACHRYMAL SAC RONGEUR; MULTIPLE LAPAROTOMY RINGS; MULTIPLE LARYNGEAL KNIFES; MULTIPLE LARYNGECTOMY TUBES; MULTIPLE LIGATURE; MULTIPLE LIGATURE PASSING; MULTIPLE LOCKING DEVICE; MULTIPLE LUMEN CATHETHERS; MULTIPLE MAGNETIC LOCATORS; MULTIPLE MANUAL CAST APPLICATION-RE; MULTIPLE MANUAL CORNEAL BURRS; MULTIPLE MANUAL INSTRUMENTS; MULTIPLE MANUAL SURGICAL CHISELS; MULTIPLE METAL FIBERO; MULTIPLE METAL OR PL; MULTIPLE METAL URETERAL; MULTIPLE MISCELLANEOUS AD; MULTIPLE MOUTH MIRRORS; MULTIPLE NASAL CHISELS; MULTIPLE NASAL CURETTES; MULTIPLE NASAL KNIFES; MULTIPLE NASAL PUNCHES; MULTIPLE NASAL RASPS; MULTIPLE NASAL RONGEUR; MULTIPLE NASAL SAWS; MULTIPLE NASAL SCISSORS; MULTIPLE NASAL SNARES; MULTIPLE NASOPHARYNGOS; MULTIPLE NEEDLE HOLDERS; MULTIPLE NEPHROSTOMY CATHETER; MULTIPLE NON-DISPOSABLE SUP; MULTIPLE NON-ILLUMINATED SPECULUM; MULTIPLE NON-POWERED RECTAL PROBES; MULTIPLE NON-SELF-R; MULTIPLE NONINVASIVE TUBINGS; MULTIPLE OBSTETRIC-GYNECOLOGIC; MULTIPLE OCCLUSIVE WO; MULTIPLE OPERATING; MULTIPLE OPERATING ROOM ACCESSORIES; MULTIPLE OPHTHALMI; MULTIPLE OPHTHALMIC CALIPERS; MULTIPLE OPHTHALMIC CANNULAS; MULTIPLE OPHTHALMIC CURETTES; MULTIPLE OPHTHALMIC EYE SHIELDS; MULTIPLE OPHTHALMIC EYELID CLAMPS; MULTIPLE OPHTHALMIC FORCEPS; MULTIPLE OPHTHALMIC HOOKS; MULTIPLE OPHTHALMIC KNIFES; MULTIPLE OPHTHALMIC LENS; MULTIPLE OPHTHALMIC LENS GAUGES; MULTIPLE OPHTHALMIC MUSCLE CLAMPS; MULTIPLE OPHTHALMIC RETRACTORS; MULTIPLE OPHTHALMIC SPATULAS; MULTIPLE OPHTHALMIC SPECULAS; MULTIPLE OPHTHALMIC SPONGES; MULTIPLE OPHTHALMIC SPUDS; MULTIPLE ORTHOPEDI; MULTIPLE ORTHOPEDIC; MULTIPLE ORTHOPEDIC BONE TAPS; MULTIPLE ORTHOPEDIC COUNTERSINKS; MULTIPLE ORTHOPEDIC DRILL BRACES; MULTIPLE ORTHOPEDIC KNIFES; MULTIPLE ORTHOPEDIC NEEDLE HOLDERS; MULTIPLE ORTHOPEDIC PASSERS; MULTIPLE ORTHOPEDIC TAMPS; MULTIPLE OSTEOTOME CHISELS; MULTIPLE OTOSCOPES; MULTIPLE OXYGEN TENTS; MULTIPLE PASSERS; MULTIPLE PERITONEAL CATHETERS; MULTIPLE PERSONNEL PROTECTIVE SHIEL; MULTIPLE POLYAMIDE SYNTH; MULTIPLE POSITIVE END EXPIRATOR; MULTIPLE PUNCHES; MULTIPLE RASPS; MULTIPLE RECHARGEABLE BATTERY BOXES; MULTIPLE RECTAL DILATOR; MULTIPLE RETRACTORS; MULTIPLE REUSABLE ASPIRAT; MULTIPLE REUSABLE VEIN STRIPPERS; MULTIPLE RIGID BRONCH; MULTIPLE RIGID BRONCHO; MULTIPLE RING CUTTERS; MULTIPLE RONGEURS; MULTIPLE RULERS AND CALIPERS; MULTIPLE SALPINGEAL CURETTE; MULTIPLE SAWS; MULTIPLE SCELERA MARKERS; MULTIPLE SCISSORS; MULTIPLE SCOOPS; MULTIPLE SELF RETAINING R; MULTIPLE SKIN PRESSURE PROTECTORS; MULTIPLE SMOKE REMO; MULTIPLE SPECIAL LENS IN; MULTIPLE STAINLESS STEE; MULTIPLE STAINLESS STEEL; MULTIPLE STERILE ABSORABLE SUTURES; MULTIPLE STERILE URETHRAL CATHET; MULTIPLE STERILE WIR; MULTIPLE STERILE WIRE; MULTIPLE SUCTION APPARATUS; MULTIPLE SUCTION CATHETERS AND TIPS; MULTIPLE SUPRAPUBIC CA; MULTIPLE SURGICAL BIOPSY PUNCHES; MULTIPLE SURGICAL BONE CHISELS; MULTIPLE SURGICAL CONTRACTORS; MULTIPLE SURGICAL CUTTERS; MULTIPLE SURGICAL FIELD; MULTIPLE SURGICAL GOUGE; MULTIPLE SURGICAL HEADBAND LIGHTS; MULTIPLE SURGICAL HEADLIGHT LIGHTS; MULTIPLE SURGICAL HEMOSTATS; MULTIPLE SURGICAL INSTRUMENT GUIDES; MULTIPLE SURGICAL INSTRUMENT TRAYS; MULTIPLE SURGICAL KNIFES; MULTIPLE SURGICAL LAMPS; MULTIPLE SURGICAL LIGHT ACCESSORIES; MULTIPLE SURGICAL MARKING PENS; MULTIPLE SURGICAL ME; MULTIPLE SURGICAL NEEDLE GUIDES; MULTIPLE SURGICAL PLIERS; MULTIPLE SURGICAL PUNCHES; MULTIPLE SURGICAL RONGEUR FORCEPS; MULTIPLE SURGICAL STRIPPERS; MULTIPLE SURGICAL TRAYS; MULTIPLE SURGICAL VESSEL DILATORS; MULTIPLE SUTURE RETENTION DEVICES; MULTIPLE TAMPS; MULTIPLE TEACHING ATTACHMENT FOR EN; MULTIPLE TEMPORARY; MULTIPLE TONSIL DISSECTORS; MULTIPLE TONSIL KNIFES; MULTIPLE TONSIL PUNCHES; MULTIPLE TONSIL SNARES; MULTIPLE TONSILLECTOMES; MULTIPLE TOYNBEE DIAGNOSTIC TUBES; MULTIPLE TRACHEAL BISTOURY; MULTIPLE TRACHEAL DILATORS; MULTIPLE TRACHEAL HOOKS; MULTIPLE TRACHEAL T; MULTIPLE TRACHEAL TROCAR; MULTIPLE TRACHEAL-BRONCHIAL; MULTIPLE TRACHEOSTOMY TUBES W; MULTIPLE TYPES OF SURGICAL PLIERS; MULTIPLE UMBILICAL; MULTIPLE UMBILICAL SCISSORS; MULTIPLE URETERAL CATHETERS; MULTIPLE URETHRAL CATHETERS; MULTIPLE UROLOGICAL BOUGIES; MULTIPLE VACUUM COLLECTION BOTTLES; MULTIPLE VAGINAL RETRACTORS; MULTIPLE VASCULAR CLAMPS; MULTIPLE VASCULAR CLIPS; MULTIPLE VEIN MARKERS; MULTIPLE WRENCHES; MULTIPLE, AUTOTRANSFUISON BAG; MULTIPLE, AUTOTRANSFUSION BAG; MULTIPLES; MYOWIRE-ATEMPORARY CARDIAC PACING W; Marked Spring-Wire Guide with Arrow Advancer; Martins Bandage; McKenzie V Clips; Micro Elite Snare; Microlaryngeal tube; Mindray Adaptor Patient Airway; MiniLap; Minnie Support Catheter; Monodek; Mouth Gag; Mucosal Atomization Device (MAD); Multiple Rebreathing Bags; Multiple Tracheal Tubes W/O Connect; Multiple Trephines; Multiple Ventilator T; Multiple oxygen analyzer/monitors; NEXTSTITCH; NO SCALPEL VASECTOMY INSTRUMENTS; NON-SELF-RETAINING; NON-VENTILATORY NEBULIZER; NON=VENTILATORY MEDICINAL NEBULIZE; NONP; NONPOWERED; Nasopharyngeal tube rubber, Wendl pattern; Needle, Conduction, ,Anesthetic; Nelaton catheter rubber, cylindrical / Robinson pattern / whistle tip / coaxial / Tiemann pattern; Nelaton-Robinson catheter, Tiemann pattern; Nelaton-Robinson catheter, cylindrical; NeoTract UroLift System (UL400); NextStep Antegrade; NextStep Retrograde; NextStep Retrograde (femoral lengths); NextStep Retrograde Replacement Hub Set; Nonabsorb Polypropylene Synthetic; Novaplus Addipak Unit Dose Vial; Novaplus Oxygen Supply Tubing; Novaplus Oxygen Supply Tubing Connector; OBSERVER SCOPE; OPCAB; OPCAB 3 IN 1 CLEARSITE; OPCAB IRRIGATION SYSTEM; OPEDIC; OPHTHALMIC (FLIERINGA); OPHTHALMIC (INCLUDING SUNLAMP PROT; OPTHAMEND; ORTHODEK; ORTHOP.; OTOSCOPE; Oberto Mouth prop; OnControl; OnControl Bone Access System; Oral/Nasal Safety Clear Trache tube cuffed, magill/murphy; Oropharyngeal Guedel Tube Black; OrthoTape; Ovassapian Airway; Oxygen Supply Tubing; Oxygen Therapy Start-Up Kit; PERFORATOR; PERINEAL DRAPE; PERITONEAL CATHETER; PERITONEAL#GENERAL AND PLASTIC SUR; PICK; PILING; PILLING; PILLING MICRO ANASTOMOSIS; PILLING WECK M-20 DISPOSABLE AUTOMA; PINEHOLE; PLASTIC SURGERY MIRRORS; PLASTIC SURGERY SURGICAL CLAMPS; PLASTIC SURGERY SURGICAL DISSECTOR; PLASTIC SURGERY SURGICAL HOOKS; PLASTIC SURGERY SURGICAL RASPS; PLASTIC SURGERY SURGICAL SPATULAS; PLASTIC SURGERY SURGICAL STYLETS; PLEUR EVAC A6000 ADULT/PED CHEST DRAINAGE; PLEUR EVAC CHEST DRAINAGE SYSTEM; PLEUR-EVAC; PLEUR-EVAC CHEST DRAINAGE SYSTEM; PLEUR-EVAC(R) A-8000--ADULT/PEDIATR; PLEUR-EVAC(R) A-8020--INFANT CHEST; PLUER-EVAC; PNEUMONECTOMY; POLYETHYLENE SYNTHETIC NONABSORBABL; POLYPROP, POLYETHYLE NYLON AND SILK; POLYPROPYLENE SYNTHETIC NONABSORBAB; POLYSORB SYNTHETIC ABSORBABLE SUTUR; PORGES DORMIA; PORTABLE; PROBE; PROBE AND DIRECTOR; Pediatric Reinforced Tracheal(or Endotracheal) tube, uncuff; Percutaneous Cavity DRAI; Percutaneous Cavity Drainage Catheterization Set/Kit; Percutaneous Sheath Introducers; Percuvance; Percuvance Percutaneous Surgical System; Percuvance(TM) Percutaneous Surgical System; Phokus Nonwoven Bandage; PiggyBack Wire Converter; Pilling; Pilling Esophageal Bougies; Pilling Lazer Bronchoscopes; Pleur-evac; Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System; Pneumothorax Set; Polydek; Polyglycolytic Acid Absorbable Sutr; Pronto 35; Pronto LP Extraction Catheter. Model number 5010 - PRONTO LP 6F; Pronto V4; PurplePlus; QUAPAK; QuickClot Control+ Hemostatic Device; QuickClot EMS; QuikClot Bleeding Control Dressing; QuikClot Combat Gauze, QuikClot Combat Gauze TraumaPad; QuikClot Control+; QuikClot Hemostatic Dressings, QuikClot 2x2, QuikClot 4x4, QuikClot TraumaPad, QuikClot Z-Fold, QuikClot Roll; QuikClot Interventional; QuikClot Radial; R SCOPE; R350 guidewire Model Number: 7390 R350 V2 Guidewire, 5pk; RADIOLOGY; RASP; REBREATHING; RECHARGEABLE; RECTAL SPECULUMS; RETRACTOR; REUSABLE BAG MANUAL; RF Ablation Procedure Pack and Micro-HV Introducer Kit; RING; RONGEUR; RS; RUBBER LATEX AND PVC TUBING; RULE; RUSCH AGT PVC PREFORM NASAL; RUSCH BRILLANT SILICONE FOLEY; RUSCH Bronchus Blocker; RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS; RUSCH Double lumen Bronchial tube, Carlens; RUSCH Double lumen Bronchial tube, White; RUSCH MANUAL RESUSCITATOR; RUSCH Miller-Abbott tube; Raider guidewire Model Numbers: 7448 Raider Guidewire, 200cm and 7449 Raider Guidewire, 300cm; Raney Scalp Clips; Ringer Perfusion Balloon Catheter; RuSCH SILICONE FOLEY CATHETER; Rusch Adult Anesthesia circuit; Rusch Adult Rebreathing Circle Systems; Rusch Anesthesia Breathing Bags; Rusch Anesthesia Circuit; Rusch Anesthesia Circuit Accessories; Rusch Anesthesia Circuit Tubing; Rusch Asherman Chest Seal; Rusch Belly Bag; Rusch Breathing Bag; Rusch CPRAM Anesthesia Circuits; Rusch Cantor Tube; Rusch Clear Comfort; Rusch Connector End Cap Female; Rusch Connector Logan Bow; Rusch Connector Oxygenator; Rusch Connector Trach Tee Fitting; Rusch Connector with Barbed Elbow; Rusch Corrugated Tubing; Rusch Disposable Adult Rebreathing Circle Systems; Rusch EPDM FLEX CONNECTOR; Rusch Easytube; Rusch Endobronchial Tubes; Rusch Endotracheal Tube Holder; Rusch Endotracheal Tube Stylet; Rusch Esmark Bandage; Rusch Face Mask Plug; Rusch Filiform-Spiral Tip; Rusch Filiform-Straight Tip; Rusch FloCath Quick; Rusch FloCath Quick 18 Fr. Coude Hydrophilic Intermittent Catheter; Rusch FloCath Quick kit, Female; Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter; Rusch Foley Catheter Plug; Rusch Follower-Bougie; Rusch Follower-Catheter; Rusch GreenLite; Rusch Greenspec Laryngoscope Handle; Rusch Head Harness; Rusch Intermittent Insertion Kit; Rusch Latex Gold Foley Catheter; Rusch Lite Laryngoscope Kit; Rusch MMG Closed System Intermittent Catheter; Rusch MMG H2O; Rusch MRI; Rusch Male Exeternal Catheter; Rusch Non-Rebreathing Single Limb Systems; Rusch PEEP Valve; Rusch Pecan Breathing Bag; Rusch Pediatric Rebreathing Circle Systems; Rusch Pocket Pac; Rusch Polaris; Rusch Pressure Tubing; Rusch RCI; Rusch RCI Conventional Breathing Circuits; Rusch Rectal Tube rubber, Nordmann patter, cylindrical; Rusch Sampling Lines, Rusch Anesthesia Circuit Accessories; Rusch Silicone Coated Foley, and pediatric; Rusch Simplastic Catheter; Rusch Simplastic Foley Catheters; Rusch Standard FloCath; Rusch Sure Seal; Rusch Ureteral Catheter-Blassucci Spiral; Rusch Ureteral Catheter-Braasch Bulb; Rusch Ureteral Catheter-Cone Tip; Rusch Ureteral Catheter-Olive Tip; Rusch Ureteral Catheter-Round Tip; Rusch Ureteral Catheter-Whistle Tip; Rusch Xmas Tree Adaptor; Rusch all purpose Robinson / Nelation; Rusch all purpose red rubber; Rusch drain bag extension tube; Rusch sampling lines and filters; RuschFlex, armoured Tracheal tube; RuschFlex, armoured tracheal tube, cuffed; Rush Pressure Tubing; Rush Tuohy Needle; S-FIBRE; SALPINGEAL; SAPH IOOP; SAPH LIFE; SAPHLOOP; SAW; SCOOP; SELF-RETAINING AND ACCESSORIES; SHER-I-BRONCH ACCESSORY PACK; SHER-I-BRONCH ENDOBRONCHIAL TUBE; SHERIDAN; SHERIDAN EZ-ENDO Endotracheal Tube; SHERIDAN LITA Cuffed Endotracheal Tube; SHERIDAN PED-SOFT UNCUFFED Endotracheal Tubes; SHERIDAN PREFORMED Endotracheal Tube; SHERIDAN STAT-MED Cuffed Endotracheal Tube; SHERIDAN T.T.X. Exchanger; SIMS Anesthesia Breathing Circuit; SINGLE PATIENT USE; SINUS IRRIGATOR; SL INSTRUMENTS; SPECIAL LENS; SPREADER; SPROTTE NEEDLE; SPUR; STRIPPER; STYLET; SUCTION TUBE CATHETE; SUPERCROSS; SURG-I-BAND; SURGICAL HAMMER; SURGICAL HEADLIGHT; SURGICAL HOOK FOR ENT; SURGICAL STRIPPERS; Safety Clear Plus Cuffed w/ Murphy eye; Safety Clear Uncuffed w/ Magill tip; Safety Clear uncuffed w/ Magill Tip; Safety Clear uncuffed w/ Murphy eye; Sher-I-Bronch Endobronchial Tube; Sher-I-Swiv Double Swivel Connector; Sher-I-Swiv/FO Double Swivel Connector; Sheridan Close Fitting Endotracheal Tube; Sheridan Flex-C-Pap; Sheridan HVT Endotracheal Tube; Sheridan LTS Endotracheal Tube; Sheridan Lar-A-Ject Reinforced Laryngectomy Tube; Sheridan Naz-al Endotracheal Tube; Sheridan Sher-I-Slip Intubating Stylet; Sheridan Soft-Tip Intubating Stylet; Sheridan Spiral-Flex Reinforced Endotracheal Tube; Sheridan Uncuffed Endotracheal Tube; Shucman 2; Silkobag Rebreathing Bag; Simplastic Councill Tip Catheter; SmartNeedle vascular access system; Smooth Flo Corr A Tube II; SnapLight; SnapLock™ Clamp Fastener; Soft Foam Mouth Cushions; Softech Plus ETCO2 Cannula; Solesta Injectable Gel; Spectre guidewire Model Numbers: 7386 Spectre Guidewire, 200cm and 7387 Spectre Guidewire, 300cm; SpyGlass Discover Imager II IOC Catheter; Stainless Steel, Multifiloment,; Standard Connector; Standard Laryngoscope Blades and Handles; Standard Precision Bougie Device; Standard Staple-Line Reinforcement; Standard Tapered Bougie, 38 Fr (STB38); Standard Trocar; Stapler, Skin; Stripper, Artery, Intraluminal; Suction Tube; Suction catheter with saline; Super Arrow Flex (SAF) PSIs; Super Arrow-Flex® Percutaneous Sheath Introducer Set; SuperCross FT (Model numbers:5340 SuperCross 014FT, 130cm and 5341 SuperCross 014 FT, 150cm); Suture; Sympro Elite Snare; TAUT; TAUT BALLOON CATHETER; TAUT INSUFFLATION NEEDLE; TFX Introducer Needle; TIP ENT; TONSILLECTOME; TOUPHY NEEDLE; TOYNBEE DIAGNOSTIC; TPODC; TPODCombat; TPODR; TPODResponder; TRACHEAL TUBE; TREPHINE; TROCAR; Taut; Teleflex; Teleflex ISIS HVT; Tevdek; Tevdek II; Thermistor Probe; Thrombi-Gel; Thrombi-Pad; ThrombiDisc topical hemostat, D-Stat Dry Silver Clear topical hemostat, Thrombix Silver topical hemostat, D-Stat Dry Silver topical hemostat; Thrombix topical hemostat; Titan SGS; Titan SGS Tapler with Titan SGS Standard Staple-Line Reinforcement; Trach collar; Tracheal Tube; Tracheal tube soft rubber; TracheoFix-Set; Tracheoflex set short with / without Cuff; Tracheoflex set short with / without Cuff and Phonation; Tracheostomy Tube; Transseptal Super ArrowFlex PSI; TrapLiner catheter. Model Numbers: 5566-TrapLiner catheter 6F, 5567-TrapLiner catheter 7F, 5568-TrapLiner catheter 8F; Triflo; TruLED; TruLite Secure; Tube, Tracheostomy (W/Wo Connector); Tube, tracheostomy (w/wo connector); Turnpike Catheter (135 cm),Turnpike Catheter (!50 cm),Turnpike Spiral Catheter (135 cm),Turnpike Spiral Catheter (150cm); Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3, Trapliner cath; Twin-Pass Dual Access Catheter; Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; ULTRABRAID; URETERAL CATHETER; URETHRAL; UroLift 2 ATC Advanced Tissue Control System, UL2 ATC",1985-04-29,421,2026-07-09,5,135,14,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011137372%22&limit=1
"Arthrex, Inc.",1220246,1220246,1370 Creekside Blvd,Naples,FL,34108,United States,"ARTHREX, INC.",1220287,Manufacturer; Specification developer,121,BWN; BZN; CCX; DXJ; EMH; EQH; FEI; FEM; FLE; FMF; FMP; FRG; FRO; FSM; FST; FTL; FWB; FWZ; FXR; FZW; GAB; GAP; GAS; GAT; GAZ; GBX; GCJ; GDZ; GEI; GEN; GES; GFA; GFF; HAB; HIF; HNW; HRS; HRX; HSB; HSD; HST; HSX; HTC; HTD; HTJ; HTN; HTO; HTW; HTY; HTZ; HWC; HWE; HWQ; HWR; HWT; HXB; HXC; HXD; HXJ; HXL; HXS; HXW; IQG; IZI; JDI; JDQ; JDR; JDW; JEC; JQC; JQO; JWH; JYQ; KGS; KIK; KNW; KQM; KQX; KQZ; KRR; KTT; KTW; KWD; KWI; KWS; KWY; LLZ; LMD; LRY; LXH; LXI; LZB; MAI; MBF; MBH; MBI; MBP; MDM; MHW; MNU; MQV; MRW; NAC; NAE; NBH; NDK; OIY; ORG; OSN; OSV; OUG; OWN; OWX; OWY; PHX; PKC; PLF; PUI; QHE; QHQ; QPB,"Table And Attachments, Operating-Room; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Support, Patient Position; Display, Cathode-Ray Tube, Medical; Forceps, Rongeur, Surgical; Source, Carrier, Fiberoptic Light; Instrument, Special Lens, For Endoscope; Accessories, Photographic, For Endoscope (Exclude Light Sources); Sterilizer, Steam; Syringe, Piston; Protector, Skin Pressure; Wrap, Sterilization; Dressing, Wound, Drug; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Mesh, Surgical, Polymeric; Camera, Television, Surgical, Without Audio; Operating Room Accessories Table Tray; Holder, Camera, Surgical; Expander, Surgical, Skin Graft; Needle, Suturing, Disposable; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Tubing, Noninvasive; Catheter, Irrigation; Laparoscope, General & Plastic Surgery; Handle, Scalpel; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Blade, Scalpel; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Saw, Powered, And Accessories; Insufflator, Laparoscopic; Dilator, Lachrymal; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Pliers, Surgical; Forceps; Gauge, Depth; Washer, Bolt Nut; Reamer; Bit, Drill; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Passer; Driver, Prosthesis; Template; Probe; Wrench; Clamp; Staple Driver; Mallet; Twister, Wire; Bender; Adaptor, Holder, Syringe; System, X-Ray, Angiographic; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Cerclage, Fixation; Staple, Fixation, Bone; Pin, Fixation, Threaded; Component, Traction, Invasive; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Balance, Analytical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Loop, Wire; Retention Device, Suture; Hook, Bone; Instrument, Biopsy; Camera, Surgical And Accessories; Goniometer, Ac-Powered; Component, Traction, Non-Invasive; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; System, Image Processing, Radiological; System, Digital Image Communications, Radiological; Punch, Surgical; Orthopedic Manual Surgical Instrument; Guide, Drill, Ligament; Finger Cot; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Instrument, Manual, Surgical, General Use; Dressing, Compression; Staple, Absorbable; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Dressing, Wound, Hydrophilic; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Accessories, Arthroscopic; System, External Fixator (With Metallic Invasive Components); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Platelet And Plasma Separator For Bone Graft Handling; Software For Diagnosis/Treatment; Insufflator, Endoscopic Vessel Harvesting; Medical Device Data System; Confocal Optical Imaging; Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon; Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Bone Wedge; Drape, Surgical, Exempt; Shoulder Arthroplasty Implantation System; Total Shoulder Arthroplasty System; System, Suction, Lipoplasty For Removal",1; 2; U,"40 L HIGH FLOW INSUFFLATOR F108; ACCIN Bipolar Head System; ACCIN Patellofemoral System; ACCIN Total Knee System; ACCIN Uni-Knee System; ACL TightRope; ACL TightRope Double Bundle; AESCULAP STERILCONTAINER SYSTEM; ANATOEMIC PROSTHESIS; AOS HUMERAL NAI; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT; ARTHREX ANATOEMIC P; ARTHROERESIS IMPLANT; ARTHROSCOPY LEG HOLDER; ARTHROSCOPY PUMP; Accessories for the SixFix® Hexapod Fixator; Accessories, Photographic, For Endoscope (Exclude Light Sources); Adaptor, Holder, Syringe; Apparatus, Traction, Non-Powered; Arrowhead Mini-Rail Fixator; Arthrex Ankle Fusion Plating System; Arthrex BioComposite SutureTak; Arthrex BioSuture; Arthrex Biocomposite Transfix; Arthrex Compression Plates; Arthrex Distal Extremity Plate System; Arthrex FiberTak Suture Anchors; Arthrex Fracture Plates; Arthrex Fracture Plates and Screws; Arthrex Fracture System; Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi; Arthrex Graft-Anchor; Arthrex Knotless SutureTak Anchor; Arthrex Low Profile Screws; Arthrex MicroSuture Anchors; Arthrex Mini TightRopes; Arthrex Minimally Invasive Ankle Fusion Plate; Arthrex PCL TightRope; Arthrex Plates, Screws, and Staples; Arthrex PushLock; Arthrex PushLock Tenodesis Anchor; Arthrex Pushlock; Arthrex RetroFusion Screw  Smooth or Threaded Metallic Bone Fixation Fastener; Arthrex Small External Fixation System; Arthrex Suture; Arthrex SwiveLock Anchors; Arthrex Tibial  GraftBolt; Arthrex Tibial GraftBolt; Arthrex Univers Apex; Arthrex Univers CA Heads; Arthrex Univers II Glenoid Components; Arthrex Univers II Shoulder Prosthesis; Arthrex iBalance BiCompartmental Arthroplasty System; Arthrex iBalance Patella Implant, Dome; Arthrex iBalance TKA System; Arthroscope; Arthroscope  Sheath; Arthroscopes; BENDER; BI-CORTICAL BIO-POST AND WASHER; BIO-ABSORBABLE CORKSCREW; BIO-BUTTON; BIO-COMPRESSION SCREW; BIO-CORKSCREW FT; BIO-FASTAK SUTURE ANCHOR; BIO-PIN; BIO-POST AND WASHER; BIOCOMPOSITE; BIOCOMPOSITE INTERFERENCE SCREW; BIOCOMPOSITE SUTURE ANCHORS; Balance, Analytical; Bio-Composite SutureTak; Biosync; Biosync Bone wedge; CHONDRAL DART; COBE Angel Whole Blood Separation System; COMPRESSION STAPLE; CONTAINER SYSTEM; CONTINUOUS WAVE III; CORKSCREW ANCHORS; Camera Heads; Camera, Television, Surgical, Without Audio; Catheter, Irrigation; Clamp; Component, Traction, Non-Invasive; DISCOSCOPES, CERVICAL ENDOSCOPES; DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER; DOLPHIX EXTERNAL FIXATION SYSTEM; DOUBLE SYRINGE (ACP) SYSTEM; Drape, Surgical, Exempt; Dressing, Compression; Driver, Prosthesis; Dual Wave Pump; EXTERNAL FIXATION CLAMP 5 MM PIN X9.5MM ROD MODEL 1151-100 EXTERNAL FIXATON CLAMP 9.5MM ROD; EXTERNAL FIXATOR ST.A R 90 F4; EXTERNAL FIXATOR SYSTEM; Elastic bandage; Energel Wound Hydrogel; FASTAK SUTURE ANCHOR; FIBERTAPE; FIBERWIRE BUTTON REPAIR KIT; FINGERSHIELD; Fastener, Fixation, nondegradable, soft tissue; FiberTak DR; FiberTape; FiberWire; Fiberstick; Forceps, General & Plastic Surgery; Forceps, Rongeur, Surgical; Fracture Plates & Screws; General Hospital and Personal Use Miscellaneous Devices; Graft Delivery Device with Integrated Stylet; HATRIC; HUMERAL FRACTURE PLATE; Holder, Camera, Surgical; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT; INTERFERENCE SCREW; INTERFERENCE SCREWS; Instrument, Special Lens, For Endoscope; Instrument, manual, surgical, general use; Insufflator 50L FM134; JumpStart Antimicrobial Wound Dressing; PowerHeal Antibacterial Wound Dressing; Procellera Antimicrobial Wound Dressing; JumpStart Pin Site Dressing Kit; JumpStart Antibacterial Wound Dressing; JumpStart FlexEFit Wound Dressing; Jumpstart Antimicrobial Wound Dressing; Procellera Helix Wound Dressing; Knee Joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; LATERAL SUPERIOR CLAVICLE PLATE LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE LEFT AND RIGHT; ANTERIOR CLAVICLE PLA; LOW PROFILE PLATE AND SCREW SYSTEM; Laproscopes; Loop, wire; MENISCAL CINCH; MENISCAL DART, DARTSTICK,; MINI BIO-ANCHOR; MINI TIGHTROPE; Mallet; Manual surgical instrument for general use.; Metallic Bone Fixation; Mini TightRope CMC; Nonabsorbable poly(ethylene terephthalate) Surgical Suture; OPES ELECTRODES AND ACCESSORIES; ORTHOPEDIC MANUAL INSTRUMENTS; OSTEOTOMY PLATE; OSTEOTOMY SYSTEM; Orthopedic Template; Orthopedic manual surgical instrument, Passer; PARS Needle; PROCELLERA; PROSTOP PLUS; PROWICK; PUSHLOCK; Pin, Fixation, Smooth; Pliers, Surgical; PowerHeal Antibacterial Wound Dressing; PowerHeal® Antibacterial Wound Dressing; PowerHeal® Energel; Procellera Composite Antibacterial Wound Dressing; Procellera FlexEFit Antibacterial Wound Dressing; Protector, Skin Pressure; RETROBUTTON; RF device, blade, hook; SHAVER BLADES; SHAVER SYSTEM; SHORT LATERAL SUPERIOR CLAVICLE PLATE LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT; SHOULDER HOLDER; SUPPORT, PATIENT POSITION; SUTTER ELECTROSURGICAL CABLES; Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis; Shoulder joint metal/ polymer semi-constrained cemented prosthesis; Single/multiple component metallic bone fixation appliances and accessories; SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS); Source, Carrier, Fiberoptic Light; Stimublast; Suction Lipoplasty Accessories; Sutter CURIS RF Generator; Syringe, piston; System, Digital Image Communications, Radiological; TAK FAMILY; TENODESIS FAMILY; TRIM-IT FAMILY; TWISTER, WIRE; Table Attachments, Operating-Room; Thrombinator System for use with the Arthrex Angel Concentrated Platelet Rich Plasma (PRP)System; UNIVERS FRACTURE; UNIVERS II; UNIVERS SHOULDER; Univers II; Univers Revers Shoulder Prosthesis System; VARIOUS BURS; VARIOUS IMPLANTS; VARIOUS INSTRUMENTS; Viscogel/Viscospray; WASHER; Weight, 2.5 lb (1.1kg); Wrench; cart, emergency, cardiopulmonary; display, cathode-ray tube, medical; drill bit; elevator, surgical, general & plastic surgery; fixation pin; fixation plate; handle, scalpel; hook, bone; iBalance; knee joint patellofemorotibial polymer/metal/polymer semi-constrained; orthopedic manual instrument; saw blade; single/ multiple component metallic bone fixation appliances and accessories; smooth or threaded metallic bone fixation fastener",1994-01-27,380,2026-10-29,0,18,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221220246%22&limit=1
Siemens Healthcare Diagnostics Inc.,2432235,2432235,511 Benedict Ave,Tarrytown,NY,10591,United States,SIEMENS HEALTHCARE DIAGNOSTICS INC.,9096044,Complaint file establishment; Repackager or relabeler; Specification developer,247,BXK; CAN; CDD; CDM; CDP; CDQ; CDT; CDX; CDZ; CEC; CEK; CEM; CEN; CEO; CEP; CEW; CFJ; CFL; CFN; CFO; CFP; CFR; CFT; CGA; CGI; CGJ; CGN; CGS; CGX; CGZ; CHH; CHI; CHL; CHP; CIC; CIG; CIT; CIX; CIZ; CJK; CJO; CJW; CJY; CKA; CKB; CKG; CZW; DAD; DBF; DBI; DCF; DCK; DCN; DDR; DDZ; DEM; DFC; DGC; DHA; DHB; DHR; DHX; DIC; DIF; DIH; DIO; DIP; DIS; DJG; DJR; DKB; DKJ; DKZ; DLJ; DLZ; DML; FMH; GFS; GGK; GGP; GGT; GIF; GIO; GIR; GJS; GKF; GKL; GKP; GKR; GKZ; GLK; GTQ; GWG; HYF; IAF; IEO; JCB; JCN; JFH; JFJ; JFM; JFP; JFT; JFY; JGJ; JGS; JGY; JHI; JHN; JHR; JHS; JHX; JIF; JIL; JIN; JIO; JIP; JIR; JIS; JIT; JIX; JIY; JJB; JJC; JJE; JJF; JJS; JJW; JJX; JJY; JKC; JKD; JKR; JLB; JLS; JLW; JMG; JMO; JMT; JNL; JNM; JPA; JPK; JPZ; JQA; JQB; JQP; JRE; JRI; JXM; JXN; JZG; JZJ; JZO; JZW; KEW; KHM; KHP; KHQ; KHS; KLB; KLI; KLR; KLS; KLT; KNK; KPA; KQO; KRX; KRY; KRZ; KSA; KSX; KXT; LAN; LAR; LAS; LBS; LCD; LCM; LCP; LCR; LDJ; LDO; LDP; LDZ; LED; LEG; LEH; LFM; LFX; LFZ; LGC; LGD; LGR; LGS; LIG; LIP; LJX; LKL; LKP; LKQ; LOJ; LOK; LOL; LOM; LOQ; LPS; LTJ; LTK; LYR; MKW; MLM; MMI; MOI; MQM; MRG; MRR; MSJ; MSW; MTF; MTG; MXJ; MYF; MZF; MZO; NAF; NBC; NCW; NDW; NDY; NGA; NHX; NIG; NNI; NQD; OVK; PDJ; PMT; PPM; PQO; QCH; QFO; QKP; QLC; QQB; SEI,"Gas, Calibration (Specified Concentration); Regulator, Pressure, Gas Cylinder; Radioassay, Vitamin B12; Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.); Radioimmunoassay, Total Triiodothyronine; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Total Thyroxine; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Dye-Indicator, Ph (Urinary, Non-Quantitative); Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Radioimmunoassay, Human Growth Hormone; Method, Nephelometric, Immunoglobulins (G, A, M); Titrimetric, Magnesium; Radioimmunoassay, Immunoreactive Insulin; Hexokinase, Glucose; Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Estriol; Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph; Radioimmunoassay, Estradiol; Cresolphthalein Complexone, Calcium; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Bromcresol Green Dye-Binding, Albumin; Radioimmunoassay, Androstenedione; Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes; Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes; Bromcresol Purple Dye-Binding, Albumin; Azo Dye, Calcium; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Acid Phosphatase, Naphthyl Phosphate; Radioimmunoassay, Acth; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; System, Test, C-Reactive Protein; Myoglobin, Antigen, Antiserum, Control; Albumin, Fitc, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; Ige, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Radioallergosorbent (Rast) Immunological; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Nad-Nadh, Specific Reagent For Alcohol Enzyme Method; Container, Specimen, Sterile; Standards And Controls, Hemoglobin, Normal And Abnormal; Products, Red-Cell Lysing Products; Test, Qualitative And Quantitative Factor Deficiency; Assay, Erythropoietin; Diluent, Blood Cell; Tube, Collection, Capillary Blood; Reagent, Russel Viper Venom; Test, Time, Prothrombin; Instrument, Hematocrit, Automated; Counter, Cell, Automated (Particle Counter); Instrument, Coagulation, Automated; System, Hemoglobin, Automated; Counter, Differential Cell; Control, Hematocrit; Antistreptolysin - Titer/Streptolysin O Reagent; Endoscope, Neurological; Giemsa Stain; Wright'S Stain; Processor, Tissue, Automated; Detergent; Control, Cell Counter, Normal And Abnormal; Acid Phosphatase (Prostatic), Tartrate Inhibited; Catalytic Methods, Amylase; Enzymatic Method, Bilirubin; Electrode, Ion Specific, Calcium; Fluorometric, Cortisol; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Electrode, Ion Specific, Sodium; Colorimetric Method, Triglycerides; Visual, Pregnancy Hcg, Prescription Use; Turbidimetric Method, Lipoproteins; Radioimmunoassay, Immunoglobulins (D, E); Differential Rate Kinetic Method, Cpk Or Isoenzymes; Fluorometric Method, Cpk Or Isoenzymes; Enzymatic Method, Ammonia; Method, Enzymatic, Glucose (Urinary, Non-Quantitative); Nitroprusside, Ketones (Urinary, Non-Quant.); Blood, Occult, Colorimetric, In Urine; Blood, Occult, Enzymatic Method, In Urine; Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.); Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Analyzer, Chemistry, Micro, For Clinical Use; Controls For Blood-Gases, (Assayed And Unassayed); Urinalysis Controls (Assayed And Unassayed); Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate); Radioimmunoassay, C-Peptides Of Proinsulin; Radioimmunoassay, Calcitonin; Atp And Creatine Kinase (Enzymatic), Creatine; Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Radioimmunoassay (Two-Site Solid Phase), Ferritin; Ferrozine (Colorimetric) Iron Binding Capacity; Diazo (Colorimetric), Nitrite (Urinary, Non-Quant); Immunochemical, Thyroglobulin Autoantibody; Immunochemical, Transferrin; System, Multipurpose For In Vitro Coagulation Studies; Mixture, Hematology Quality Control; Colorimetric Method, Gamma-Glutamyl Transpeptidase; Electrophoretic, Gamma-Glutamyl Transpeptidase Isoenzymes; Kinetic Method, Gamma-Glutamyl Transpeptidase; Calculator/Data Processing Module, For Clinical Use; Refractometer For Clinical Use; Cuvette, Thermostated; Enzyme Immunoassay, Benzodiazepine; Enzyme Immunoassay, Propoxyphene; System, Test, Beta-2-Microglobulin Immunological; Prealbumin, Antigen, Antiserum, Control; System, Test, Thyroid Autoantibody; Nephelometer; Slides, Microscope; Nephelometric, Amylase; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzymatic, Carbon-Dioxide; Radioimmunoassay, Tobramycin; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Enzyme Immunoassay, Lidocaine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Slide Stainer, Automated; Automated Urinalysis System; Calibrator For Cell Indices; Calibrator For Platelet Counting; Calibrator For Hemoglobin And Hematocrit Measurement; Calibrator For Red-Cell And White-Cell Counting; Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use; Enzyme Immunoassay, Digoxin; Enzyme Immunoassay, N-Acetylprocainamide; Enzyme Immunoassay, Procainamide; Drug Specific Control Materials; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Assay, Glycosylated Hemoglobin; Fluorescent Immunoassay, Tobramycin; Enzyme Immunoassay, Cannabinoids; Enzymatic Radiochemical Assay, Tobramycin; Colorimetry, Acetaminophen; Fixative, Alcohol Containing; Stains, Chemical Solution; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Immunoassay, Digitoxin; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus; Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total); Fluorescence Polarization Immunoassay, Theophylline; Radioassay, Intrinsic Factor Blocking Antibody; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Test, Urine Leukocyte; Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control; Anti-Sm Antibody, Antigen And Control; Antibody Igm,If, Cytomegalovirus Virus; Kit, Test,Alpha-Fetoprotein For Testicular Cancer; Kit, Test, Alpha-Fetoprotein For Neural Tube Defects; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Device, General Purpose, Hematology; Urinary Homocystine (Nonquantitative) Test System; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Helicobacter Pylori; Cyclosporine; Enzyme Immunoassay, Tracrolimus; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; Bilirubin (Total And Unbound) In The Neonate Test System; System, Test, Vitamin D; System, Test, Low Density, Lipoprotein; Apolipoproteins; System, Test, Thyroglobulin; Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Antigen(Complexed),Prostate Specific,(Cpsa); Test, Natriuretic Peptide; System, Test, Her-2/Neu, Monitoring; Assay, Porphyrin, Spectrophotometry, Lithium; Test, Cystatin C; Test, Follicle Stimulating Hormone (Fsh), Over The Counter; Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp); System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Container, Specimen, Non-Sterile; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Cytokeratin Fragments 21-1 Eia Kit; Hemoglobin A1c Test System; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; General Purpose Reagent; Anti-Müllerian Hormone Test System; Assayed Quality Control Material For Clinical Microbiology Assays; Zika Virus Serological Reagents; Coronavirus Antigen Detection Test System.; Interleukin 6; Prognostic Test For Assessment Of Liver Related Disease Progression; Qualitative And Quantitative Hepatitis B Virus Antibody Assays",1; 2; 3; N; U,"248 BG System; 3gAllergy Specific Allergens: Basil (F269), Cacao (F93),; 560 Hematology System; 600 Series Blood Gas; ACTH Control Module (ACT QC); ADIVA CENTAUR CP ANALYZER; ADVIA; ADVIA 120; ADVIA 120/2120; ADVIA 1200 Chemistry System; ADVIA 1650 CHOLESTEROL TEST SYSTEM; ADVIA 1650 CREATINE KINASE ASSAY; ADVIA 1650 GAMMA GLUTAMYL T; ADVIA 1650 HDL CHOLESTEROL ASSAY; ADVIA 1650 TRIGLYCERIDE TEST SYSTEM; ADVIA 1800 Chemistry System; ADVIA 2120; ADVIA 2120 and ADVIA 2120i Aspiration pathway Wash Kit; ADVIA 2120 and ADVIA 2120i Perox Flow cell wash kit; ADVIA 2120 and ADVIA 2120i RBC Flow Cell Wash Kit; ADVIA 2120 and ADVIA 2120i Vent Line Wash Kit; ADVIA 2400 Chemistry System; ADVIA 360 / 560 Calibrator; ADVIA 360 Cleaner; ADVIA 360 Control Set (L-N-H); ADVIA 360 Lyse 3P Diff; ADVIA 360, 560 Hypoclean; ADVIA 360/560 Dil; ADVIA 360/560 Hematology System; ADVIA 360/560 Hypoclean; ADVIA 560 5P Diff; ADVIA 560 Autoloader with AL; ADVIA 560 Control Set (L-N-H); ADVIA 560 Lyse; ADVIA 60; ADVIA Autoslide; ADVIA Autoslide Module; ADVIA Autoslide Slide Maker Stainer; ADVIA Autoslide System; ADVIA CENTAUR TOXOPLASM; ADVIA CHEMISTRY MICROALBUMIN (uALB_2); ADVIA Centaur; ADVIA Centaur AFP; ADVIA Centaur AMH Master Curve Material (AMH MCM); ADVIA Centaur AMH Quality Control (AMH QC); ADVIA Centaur Acid and Base Reagents; ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12); ADVIA Centaur Active-B12 Master Curve Material (AB12 MCM); ADVIA Centaur Active-B12 Quality Control (AB12 QC); ADVIA Centaur Alpha Fetoprotein Master Curve Material (AFP MCM); ADVIA Centaur Androstenedione (ANDRO) Master Curve Material (ANDRO MCM); ADVIA Centaur Anti-HBe2 Quality Control (aHBe2 QC); ADVIA Centaur Anti-Hbe2 (aHBe2); ADVIA Centaur Anti-Hepatitis B core Total (HBcT); ADVIA Centaur Anti-Hepatitis B core Total Quality Control (HBcT QC) Kit; ADVIA Centaur Anti-Hepatitis B surface Antigen 2 (aHBs2); ADVIA Centaur Anti-Hepatitis B surface Antigen 2 Master Curve Material Set (aHBs2 MCM); ADVIA Centaur Anti-Hepatitis B surface Antigen 2 Quality Control KIT (aHBs2 QC); ADVIA Centaur Anti-Mullerian Hormone (AMH); ADVIA Centaur Anti-Thyroglobulin (aTG); ADVIA Centaur Anti-Thyroglobulin II (aTgII); ADVIA Centaur Anti-Thyroid Peroxidase (aTPO); ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII); ADVIA Centaur B-type Natriuretic Peptide (BNP); ADVIA Centaur BNP 1,2,3 Quality Control (BNP QC); ADVIA Centaur BNP Calibrator (BNP CAL); ADVIA Centaur BNP Master Curve Material (BNP MCM); ADVIA Centaur BR Assay (BR); ADVIA Centaur BR Master Curve Material (BR MCM); ADVIA Centaur C-peptide (CpS); ADVIA Centaur C-peptide Master Curve Material (CpS MCM); ADVIA Centaur CA 125II (CA 125II); ADVIA Centaur CA 125II Calibrator (CA 125II CAL); ADVIA Centaur CA 125II Master Curve Material (CA 125II MCM); ADVIA Centaur CA 15-3 (CA15-3); ADVIA Centaur CA 15-3 Calibrator (CA 15-3 CAL); ADVIA Centaur CA 15-3 III; ADVIA Centaur CA 19-9 (CA 19-9); ADVIA Centaur CA 19-9 Diluent (CA 19-9 DIL); ADVIA Centaur CA 19-9 Master Curve Material (CA 19-9 MCM); ADVIA Centaur CEA Master Curve Material (CEA MCM); ADVIA Centaur CMV IgG (CMV IgG) Quality Control; ADVIA Centaur CMV IgG (CMV IgG) assay; ADVIA Centaur CMV IgM (CMV IgM); ADVIA Centaur CMV IgM Quality Control (CMV IgM QC); ADVIA Centaur CP Analyzer; ADVIA Centaur Calcitonin (CALCT) assay; ADVIA Centaur Calcitonin MCM (CALCT MCM); ADVIA Centaur Calibrator 1 (Cal 1); ADVIA Centaur Calibrator 80; ADVIA Centaur Calibrator C (Cal C); ADVIA Centaur Calibrator D; ADVIA Centaur Calibrator E (CAL E); ADVIA Centaur Calibrator G (CAL G); ADVIA Centaur Calibrator O (Cal O); ADVIA Centaur Calibrator U (Cal U); ADVIA Centaur Calibrator Y (CAL Y); ADVIA Centaur Carcinoembryonic Antigen (CEA); ADVIA Centaur Carcinoembryonic Diluent (CEA DIL); ADVIA Centaur Complexed Prostate-Specific Antigen Master Curve Material (cPSA MCM); ADVIA Centaur Complexed Prostate-specific Antigen (cPSA); ADVIA Centaur Complexed Prostate-specific Antigen Pretreatment Reagent (cPSA Pre); ADVIA Centaur Complexed Prostate-specific Antigen Quality Control (cPSA QC); ADVIA Centaur Cortisol (Cor); ADVIA Centaur Cortisol Master Curve Material (Cor MCM); ADVIA Centaur Cortisol Urine Reconstitution Buffer (COR Recon Buf); ADVIA Centaur Creatine Kinase MB (CKMB); ADVIA Centaur Creatine Kinase MB Calibrator (CKMB CAL); ADVIA Centaur Creatine Kinase MB Diluent (CKMB Dil); ADVIA Centaur Creatine Kinase MB Master Curve Material (CKMB MCM); ADVIA Centaur Cyclosporine Master Curve Material (CsA MCM); ADVIA Centaur DDT/Releasing Agent; ADVIA Centaur DHEA-SO4 (DHEAS); ADVIA Centaur DHEA-SO4 Master Curve Material (DHEAS MCM); ADVIA Centaur Digoxin (DIG); ADVIA Centaur EPO MCM (EPO MCM); ADVIA Centaur EPO QC (EPO QC); ADVIA Centaur Enhanced Estradiol (eE2); ADVIA Centaur Enhanced Estradiol Diluent (eE2 Dil); ADVIA Centaur Enhanced Estradiol Master Curve Material (eE2 MCM); ADVIA Centaur Enhanced Liver Fibrosis (ELF); ADVIA Centaur Enhanced Liver Fibrosis Master Curve Material (ELF MCM); ADVIA Centaur Enhanced Liver Fibrosis Quality Control (ELF QC); ADVIA Centaur Erythropoietin (EPO) Assay; ADVIA Centaur Ferritin Master Curve Material (FER MCM); ADVIA Centaur Folate (FOL); ADVIA Centaur Folate Diluent; ADVIA Centaur Folate Master Curve Material (FOL MCM); ADVIA Centaur Follicle Stimulating Hormone (FSH); ADVIA Centaur Follicle Stimulating Hormone Master Curve Material (FSH MCM); ADVIA Centaur Free Thyroxine (FT4); ADVIA Centaur Free Triiodothyronine (FT3); ADVIA Centaur Free Triiodothyronine Master Curve Material (FT3 MCM); ADVIA Centaur HCV; ADVIA Centaur HER-2/neu (H2n); ADVIA Centaur HER-2/neu 1,2 Quality Control Material (H2n QC); ADVIA Centaur HER-2/neu Calibrator (H2n Cal); ADVIA Centaur HER-2/neu Master Curve Material (H2n MCM); ADVIA Centaur HIV Ag/Ab Combo (CHIV); ADVIA Centaur HIV Ag/Ab Combo Quality Control Kit (CHIV QC); ADVIA Centaur Hepatitis A IgM (aHAVM); ADVIA Centaur Hepatitis A IgM Quality Control (aHAVM QC); ADVIA Centaur Hepatitis A Total (HAVT); ADVIA Centaur Hepatitis A Total Quality Control (HAVT QC); ADVIA Centaur Hepatitis B Core Antigen (aHBcM); ADVIA Centaur Hepatitis B Surface Antigen II (HBsII); ADVIA Centaur Hepatitis B e Antigen (HBeAg); ADVIA Centaur Hepatitis B e Antigen Quality Control (HBeAg QC); ADVIA Centaur Hepatitis B surface Antigen Confirmatory (HBsAg Conf); ADVIA Centaur Hepatitis B surface Antigen II (HBsAgII); ADVIA Centaur Hepatitis B surface Antigen Quality Control (HBs QC); ADVIA Centaur Hepatitis Core Antigen Quality Control (aHBcM QC); ADVIA Centaur Herpes-1 IgG (HSV1); ADVIA Centaur Herpes-2 IgG (HSV2); ADVIA Centaur Herpes-2 IgG Quality Control (HSV2 QC); ADVIA Centaur High-Sensitivity Troponin I (TNIH); ADVIA Centaur Homocysteine (HCY); ADVIA Centaur Homocysteine Calibrator (HCY CAL); ADVIA Centaur Homocysteine Diluent (HCY DIL); ADVIA Centaur Homocysteine Master Curve Material (HCY MCM); ADVIA Centaur IL6 Assay (IL6); ADVIA Centaur IL6 Quality Control Material (IL6 QC); ADVIA Centaur IgE Diluent (IgE Dil); ADVIA Centaur IgE Master Curve Material (IgE MCM); ADVIA Centaur Insulin Assay (IRI); ADVIA Centaur Insulin Diluent (IRI Dil); ADVIA Centaur Insulin Master Curve Material (IRI MCM); ADVIA Centaur Intact PTH IPTH); ADVIA Centaur Intact PTH Master Curve Material (iPTH MCM); ADVIA Centaur Intact Parathyroid Hormone (PTH); ADVIA Centaur Intact Parathyroid Hormone (PTH) Master Curve; ADVIA Centaur Intact Parathyroid Hormone (PTH) Quality Control; ADVIA Centaur Intact Parathyroid Hormone (iPTH); ADVIA Centaur Luteinizing Hormone (LH); ADVIA Centaur Luteinizing Hormone Master Curve Material (LH MCM); ADVIA Centaur Multi-Diluent 1 (M-Dil 1); ADVIA Centaur Multi-Diluent 10 (M-Dil 10); ADVIA Centaur Multi-Diluent 11 (M-Dil 11); ADVIA Centaur Multi-Diluent 15; ADVIA Centaur Multi-Diluent 2 (M-Dil 2); ADVIA Centaur Multi-Diluent 3 (M-Dil 3); ADVIA Centaur Myoglobin (MYO); ADVIA Centaur Myoglobin Master Curve Material (MYO MCM); ADVIA Centaur NT proBNPII (PBNPII); ADVIA Centaur PBNPII Master Curve Material (PBNPII MCM); ADVIA Centaur Pretreatment Reagent (BR PRE); ADVIA Centaur Progesterone (PRGE); ADVIA Centaur Progesterone Master Curve Material (PRGE MCM); ADVIA Centaur Prolactin (PRL); ADVIA Centaur Prolactin Master Curve Material (PRL MCM); ADVIA Centaur Prostate-Specific Antigen Master Curve Material (PSA MCM); ADVIA Centaur Prostate-specific Antigen (PSA); ADVIA Centaur Sample Cups; ADVIA Centaur Sample Tips; ADVIA Centaur Sex Hormone Binding Globulin (SHBG); ADVIA Centaur Sex Hormone Binding Globulin 2 Master Curve Material MCM (SHBG2); ADVIA Centaur Sex Hormone Binding Globulin Calibrator (SHBG CAL); ADVIA Centaur Systems Cuvette; ADVIA Centaur TSH3-UL MCM; ADVIA Centaur TSH3-Ultra (TSH3ULII); ADVIA Centaur TSH3-Ultra II (TSH3ULII); ADVIA Centaur TSH3-Ultra II Master Curve Material (TSH3ULII); ADVIA Centaur Testosterone II Master Curve Material (TSTII MCM); ADVIA Centaur ThCG; ADVIA Centaur ThCG Diluent; ADVIA Centaur Thyroid Stimulating Hormone 3-Ultra (TSH3-UL); ADVIA Centaur Total Triiodothyronine (T3); ADVIA Centaur Total Triiodothyronine Diluent (T3 DIL); ADVIA Centaur Total Triiodothyronine Master Curve Material (T3 MCM); ADVIA Centaur Tumor Marker Quality Control (TMQC); ADVIA Centaur Vitamin B12 (VB12); ADVIA Centaur Vitamin B12 DTT/Releasing Agent (VB12 DTT/REL); ADVIA Centaur Vitamin B12 Diluent (VB12 DIL); ADVIA Centaur Vitamin B12 Master Curve Material (VB12 MCM); ADVIA Centaur Vitamin D Total (VitD); ADVIA Centaur Vitamin D Total Diluent (VitD DIL); ADVIA Centaur Vitamin D Total Diluent Quality Control (VitD QC); ADVIA Centaur Vitamin D Total Master Curve Material (VitD MCM); ADVIA Centaur XP Analyzer; ADVIA Centaur XPT Cytokeratin Fragment 21-1 (CYFRA); ADVIA Centaur XPT Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL); ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM); ADVIA Centaur XPT System; ADVIA Centaur Zika Ab; ADVIA Centaur Zika Ab Controls; ADVIA Centaur Zika IgM; ADVIA Centaur Zika IgM Controls; ADVIA Centaur aCCP Control (aCCP QC); ADVIA Centaur aCCP MCM (aCCP MCM); ADVIA Centaur aTG Diluent (aTG Dil); ADVIA Centaur aTG Quality Control (aTG QC); ADVIA Centaur aTPO Diluent (aTPO Dil); ADVIA Centaur aTPO MCM (aTPO MCM); ADVIA Centaur aTPO QC (aTPO QC); ADVIA Centaur aTPOII Diluent (aTPOII DIL); ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM); ADVIA Centaur aTPOII Quality Control (aTPOII QC); ADVIA Centaur aTgII Master Curve Material (aTgII MCM); ADVIA Centaur aTgII Quality Control (aTgII QC); ADVIA Centaur anti-CCP IgG (aCCP); ADVIA Centaur® Testosterone II (TSTII); ADVIA Chemistry; ADVIA Chemistry A1c_E Pretreatment Buffer Kit; ADVIA Chemistry A1c_E Reagent (2x150 Kit); ADVIA Chemistry A1c_E Reagent (4x300 Kit); ADVIA Chemistry ALB; ADVIA Chemistry ALB_c; ADVIA Chemistry ALP_2 Calibrator; ADVIA Chemistry AMY; ADVIA Chemistry AST; ADVIA Chemistry AST_c; ADVIA Chemistry Albumin BCP (ALBP); ADVIA Chemistry Albumin BCP CAL (ALBP CAL); ADVIA Chemistry Apolipoprotein A-1/B Calibrator (APO A1 B Cal); ADVIA Chemistry CA; ADVIA Chemistry CA_c; ADVIA Chemistry CHE; ADVIA Chemistry CREA; ADVIA Chemistry CRE_2c; ADVIA Chemistry Calcium_2 Reagents (CA_2); ADVIA Chemistry Creatine Kinase (CK_L) Assay; ADVIA Chemistry Cystatin C_2 Assay (CYSC_2); ADVIA Chemistry Cystatin C_2 Calibrator; ADVIA Chemistry D-HDL Reagent; ADVIA Chemistry DBIL_2; ADVIA Chemistry DLDL; ADVIA Chemistry Electrode - Chloride; ADVIA Chemistry Electrode - Potassium; ADVIA Chemistry Electrode - Reference; ADVIA Chemistry Electrode - Sodium; ADVIA Chemistry Enzymatic Creatinine_3 (ECre3); ADVIA Chemistry Enzymatic Hemoglobin A1c Calibrator (A1c_E CAL); ADVIA Chemistry Enzyme 1 Calibrator (ENZ 1 CAL); ADVIA Chemistry Enzyme 2 Calibrator (ENZ 2 CAL); ADVIA Chemistry Enzyme 3 Calibrator (ENZ 3 CAL); ADVIA Chemistry HAPT; ADVIA Chemistry HDL/LDL Cholesterol Calibrator; ADVIA Chemistry HbA1c Denaturant Reagent (HbA1c Denat); ADVIA Chemistry IP; ADVIA Chemistry IP_c; ADVIA Chemistry IRON_2; ADVIA Chemistry ISE Serum Standard Set; ADVIA Chemistry ISE Urine Standard Set; ADVIA Chemistry LAC; ADVIA Chemistry LDLP; ADVIA Chemistry LDPL; ADVIA Chemistry Lipase; ADVIA Chemistry Lithium_2 (LITH_2); ADVIA Chemistry MG; ADVIA Chemistry MG_c; ADVIA Chemistry P5P; ADVIA Chemistry PAmy; ADVIA Chemistry Pyridoxal-5'-Phosphate Liquid (P5P_L) Reagent; ADVIA Chemistry Reagent Probe Wash 1 (PW1); ADVIA Chemistry Salicylate (SAL); ADVIA Chemistry Special Chemistry Calibrator (SPCL CHEM); ADVIA Chemistry TBIL_2; ADVIA Chemistry TP; ADVIA Chemistry TP_c; ADVIA Chemistry TRIG_2; ADVIA Chemistry TRIG_c; ADVIA Chemistry Total Bilirubin_2 (TBIL_2); ADVIA Chemistry ToxAmmonia Calibrator; ADVIA Chemistry UA; ADVIA Chemistry UA_c; ADVIA Chemistry UN; ADVIA Chemistry UN_c; ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL); ADVIA Chemistry Wedge; ADVIA Chemistry XPT; ADVIA Chemistry wrCRP Reagents; ADVIA Hematology; ADVIA Hematology 2120i RoHS/REACH instruments; ADVIA® Chemistry Toxicology Calibrators; ADVIA® Chemistry Toxicology Controls; AUTOTECHNICON ULTRA; AZO Test Strips; Acetest Reagent Tablets; Advia Centaur with StreamLAB; Albustix; Analyzer, ADVIA Centaur Classic; Anti-thyroglobulin antibody; Atellica CH 930 Analyzer; Atellica CH 930 Analyzer (Fully Refurbished); Atellica CH ?2-Microglobulin (B2M); Atellica CH ?2-Microglobulin Calibrator (B2M CAL); Atellica CH A-LYTE IMT Cleaner; Atellica CH A-LYTE Integrated Multisensor (IMT Na K CI); Atellica CH A1c_3 Calibrator (A1c_3 CAL); Atellica CH A1c_EZ PRE; Atellica CH Acetaminophen (Acet); Atellica CH Acetaminophen (AcetC); Atellica CH Acetaminophen 2 (ACTM); Atellica CH Acetaminophen 2 (ACTMC); Atellica CH Alanine Aminotransferase (ALT); Atellica CH Alanine Aminotransferase P5P (ALTPLc); Atellica CH Albumin (Alb); Atellica CH Albumin BCP (AlbP); Atellica CH Albumin BCP Calibrator (AlbP CAL); Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c); Atellica CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL); Atellica CH Alpha-1-Antitrypsin 2 (AAT2); Atellica CH Alpha-1-acid Glycoprotein (AAG); Atellica CH Ammonia (Amm); Atellica CH Amphetamines (Amp); Atellica CH Amphetamines (AmpC); Atellica CH Amylase_2 (AMY_2); Atellica CH Anti-Streptolysin-O_2 (ASO_2); Atellica CH Anti-Streptolysin-O_3 (ASO_3); Atellica CH Apolipoprotein A-1 & B Calibrator (APO A1 & B CAL); Atellica CH Apolipoprotein A-1 (APO A1); Atellica CH Apolipoprotein B (APO B); Atellica CH Aspartate Aminotransferase (AST); Atellica CH Aspartate Aminotransferase P5P (ASTPLc); Atellica CH Barbiturates (BrbC); Atellica CH Benzodiazepines (Bnz); Atellica CH Benzodiazepines (BnzC); Atellica CH Bilirubin Calibrator (BILI CAL); Atellica CH Brb; Atellica CH C-Reactive Protein_2 (CRP_2); Atellica CH C-Reactive Protein_2 Calibrators (CRP_2 CAL); Atellica CH CHEM III Calibrator (CHEM III CAL); Atellica CH CO2 Calibrator/Diluent (CO2 CAL); Atellica CH Calcium (Ca); Atellica CH Cannabinoids THC (Thc); Atellica CH Cannabinoids THC (ThcC); Atellica CH Carbamazepine (Carb); Atellica CH Carbon Dioxide, Concentrated (CO2_c); Atellica CH Check Reagent (CHK); Atellica CH Chemistry Calibrator (CHEM CAL); Atellica CH Cholesterol_2 (Chol_2); Atellica CH Cholinesterase_2 (CHE_2); Atellica CH Cleaner; Atellica CH Cocaine Metabolite (Coc); Atellica CH Cocaine Metabolite (CocC); Atellica CH Complement C3 (C3); Atellica CH Complement C4 (C4); Atellica CH Conditioner; Atellica CH Creatine Kinase (CK_L); Atellica CH Creatinine_2 (Crea_2); Atellica CH Creatinine_3 (Crea3); Atellica CH Cystatin C Calibrators (CysC CAL); Atellica CH Cystatin C_2 Assay (CYSC_2); Atellica CH DRUG CAL (DRUG CAL); Atellica CH DRUG CAL II; Atellica CH Diazo Direct Bilirubin (D_DBil); Atellica CH Diazo Total Bilirubin (D_TBil); Atellica CH Digoxin (Dgn); Atellica CH Diluent; Atellica CH Dilution Cuvette Segment; Atellica CH Direct Bilirubin 2 (DBil_2); Atellica CH EMPTY; Atellica CH EMPTY1; Atellica CH EMPTY2; Atellica CH ENZ 1 Calibrator (ENZ 1 CAL); Atellica CH ENZ 2 Calibrator (ENZ 2 CAL); Atellica CH ETOH; Atellica CH Ecstasy (Xtc); Atellica CH Ecstasy (XtcC); Atellica CH Enzymatic Creatinine_2 (ECre_2); Atellica CH Enzymatic Creatinine_3 (ECre3); Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Atellica CH Enzymatic Hemoglobin A1c_E Calibrator (A1c_E CAL); Atellica CH Ethyl Alcohol (EtohC); Atellica CH Fructosamine (Fruc); Atellica CH Fructosamine Calibrator; Atellica CH Gamma-Glutamyl Transferase (GGT); Atellica CH Gamma-Glutamyl Transferase_2 (GGT_2); Atellica CH Gentamicin (Gent); Atellica CH Glucose Hexokinase_3 (GluH_3); Atellica CH Glucose Oxidase (GluO); Atellica CH HA1c_E High Volume Bottles (5); Atellica CH HA1c_E High Volume Conversion Kit; Atellica CH HA1c_E High Volume Labels (50); Atellica CH HDL Cholesterol (HDLC); Atellica CH HDLC Calibrator (HDLC CAL); Atellica CH Haptoglobin_2 (Hapt_2); Atellica CH High Sensitivity C-Reactive Protein (hsCRP); Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2); Atellica CH High Sensitivity C-Reactive Protein Calibrator (hsCRP CAL); Atellica CH IMT Diluent (IMT Diluent); Atellica CH IMT Dilution Check (IMT Dilution Check); Atellica CH IMT Standard A (IMT Standard A); Atellica CH IMT Standard B + Salt Bridge (IMT Standard B + Salt Bridge); Atellica CH Immunoglobulin A_2 (IgA_2); Atellica CH Immunoglobulin G_2 (IgG_2); Atellica CH Immunoglobulin M_2 (IgM_2); Atellica CH Inorganic Phosphorus (IP); Atellica CH Iron3 (Iron_3); Atellica CH Iron_2 (Iron_2); Atellica CH LDL Cholesterol (LDLC); Atellica CH LDL Cholesterol Calibrator (LDLC CAL); Atellica CH LIDO Assay; Atellica CH Lac_3; Atellica CH Lactate Dehydrogenase L-P (LDLP); Atellica CH Lamp Coolant (LC); Atellica CH Lid Keying Feature; Atellica CH Lipoprotein(a) (Lp(a)); Atellica CH Lipoprotein(a) Calibrator (Lp(a) CAL); Atellica CH Liquid Specific Protein Calibrators (LSP CAL); Atellica CH Lithium_2 (LITH_2); Atellica CH Magnesium (Mg); Atellica CH Methadone (Mdn); Atellica CH Methadone (MdnC); Atellica CH Microalbumin_2 (?ALB_2); Atellica CH Microalbumin_2 Calibrator (?ALB_2 CAL); Atellica CH Opiates (Op); Atellica CH Opiates (OpC); Atellica CH Oxycodone (OXYC); Atellica CH Oxycodone Assay; Atellica CH Phencyclidine (Pcp) Assay; Atellica CH Phencyclidine (PcpC); Atellica CH Phenobarbital (Phnb); Atellica CH Phenytoin (Phny); Atellica CH Prealbumin (PALB); Atellica CH Prealbumin (PreAlb); Atellica CH Procainamide (PROC); Atellica CH Propoxyphene (Ppx); Atellica CH Protein 1 Calibrator (PROT1 CAL); Atellica CH Protein 2 Calibrator (PROT2 CAL); Atellica CH Reaction Cuvette Segment; Atellica CH Reagent Probe Cleaner 1 (RPC1); Atellica CH Reagent Probe Cleaner 2 (RPC2); Atellica CH Reagent Probe Cleaner 4 (RPC4); Atellica CH Revised C-Reactive Protein Assay (RCRP); Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL); Atellica CH Rheumatoid Factor (RF); Atellica CH Salicylate (Sal); Atellica CH Salicylate (SalC); Atellica CH Special Chem CAL (SPCL CHEM CAL); Atellica CH TDM Calibrators (TDM CAL); Atellica CH Tacrolimus; Atellica CH Theophylline (Theo); Atellica CH Tobramycin (Tob); Atellica CH Total Bilirubin_2 (TBIL_2); Atellica CH Total Bilirubin_2 (TBil_2); Atellica CH Total Iron Binding Capacity (TIBC); Atellica CH Total Protein_2 (TP_2); Atellica CH Toxicology Calibrator (TOX CAL); Atellica CH Transferrin (Trf); Atellica CH Triglyceride_2 (Trig_2); Atellica CH Triglycerides_2 (TRIG_2); Atellica CH Urea Nitrogen (UN_c); Atellica CH Uric Acid (UA); Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Atellica CH Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL); Atellica CH Urine Albumin (UAlb); Atellica CH Urine Albumin Calibrator (UAlb CAL); Atellica CH Valproic Acid (VPA); Atellica CH Vancomycin (Vanc); Atellica CH Vancomycin (Vanc) Assay; Atellica CH Wash; Atellica CH Water Bath Additive (WBA); Atellica CI Analyzer; (Model 1900); Atellica CI Dilution Cuvette Segments; Atellica CI Reaction Cuvette Segments; Atellica Data Manager (ADM); Atellica Direct Connect for CI; Atellica Direct Load; Atellica HEMA 580 Analyzer; Atellica HEMA Baso (HEMA Baso); Atellica HEMA Calibrator; Atellica HEMA Cleaner (HEMA Cleaner); Atellica HEMA Control (H); Atellica HEMA Control (L); Atellica HEMA Control (N); Atellica HEMA Control BF (H); Atellica HEMA Control BF (N); Atellica HEMA Decon (HEMA Decon); Atellica HEMA Diff (HEMA Diff); Atellica HEMA Diluent (HEMA Diluent); Atellica HEMA HGB (HEMA HGB); Atellica HEMA RET/PLTO (HEMA RET/PLTO); Atellica HEMA Retic Control (H); Atellica HEMA Retic Control (L); Atellica HEMA Retic Control (N); Atellica HEMA Slidemaker Stainer (SMS); Atellica HEMA Slidemaker Stainer Modified Wright Buffer; Atellica HEMA Slidemaker Stainer Modified Wright Stain; Atellica HEMA Slidemaker Stainer Wright-Giemsa Buffer; Atellica HEMA Slidemaker Stainer Wright-Giemsa Stain; Atellica IM; Atellica IM 1300 Analyzer; Atellica IM 1300 Analyzer (Fully Refurbished); Atellica IM 1600 Analyzer; Atellica IM 1600 Analyzer (Fully Refurbished); Atellica IM AMH Master Curve Material (AMH MCM); Atellica IM AMH Quality Control (AMH QC); Atellica IM Acid; Atellica IM Acid/Base; Atellica IM Active-B12 (Holotranscobalamin) (AB12); Atellica IM Active-B12 Master Curve Material (AB12 MCM); Atellica IM Active-B12 QC (AB12 QC); Atellica IM Alpha Fetoprotein (AFP); Atellica IM Alpha Fetoprotein Master Curve Material SET (AFP MCM); Atellica IM Ancillary Seal Kit; Atellica IM Androstenedione MCM (ANDRO MCM); Atellica IM Anti-CCP IgG Master Curve Material (aCCP MCM); Atellica IM Anti-CCP IgG Quality Control (aCCP QC); Atellica IM Anti-HBe2 (aHBe2); Atellica IM Anti-HBe2 Quality Control (aHBe2 QC); Atellica IM Anti-Hepatitis B core Total (HBcT); Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC) Kit; Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2); Atellica IM Anti-Hepatitis B surface Antigen 2 Master Curve Material Set (aHBs2 MCM); Atellica IM Anti-Hepatitis B surface Antigen 2 Quality Control (aHBs2 QC); Atellica IM Anti-Mullerian Hormone (AMH); Atellica IM Anti-Thyroglobulin (aTG); Atellica IM Anti-Thyroglobulin II (aTgII); Atellica IM Anti-Thyroglobulin Master Curve Material Set (aTG MCM); Atellica IM Anti-Thyroid Peroxidase (aTPO); Atellica IM Anti-Thyroid Peroxidase II (aTPOII); Atellica IM B-Type Natriuretic Peptide Quality Control (BNP QC); Atellica IM B-type Natriuretic Peptide (BNP); Atellica IM B-type Natriuretic Peptide Master Curve Material (BNP MCM); Atellica IM B.R.A.H.M.S PCT MCM (PCT MCM); Atellica IM B.R.A.H.M.S PCT QC (PCT QC); Atellica IM BNP Calibrator (BNP CAL); Atellica IM BR 27.29 (BR); Atellica IM BR 27.29 Calibrator (BR CAL); Atellica IM BR 27.29 Master Curve Material Set (BR MCM); Atellica IM BR 27.29 Pretreatment Reagent (BR PRE); Atellica IM BRAHMS Procalcitonin (PCT); Atellica IM Base; Atellica IM C-peptide (CpS); Atellica IM C-peptide Master Curve Material (CpS MCM); Atellica IM CA 125II (CA 125II); Atellica IM CA 125II Calibrator (CA 125II CAL); Atellica IM CA 125II Master Curve Material (CA 125II MCM); Atellica IM CA 15-3 (CA15-3); Atellica IM CA 15-3 Calibrator (CA15-3 CAL); Atellica IM CA 15-3 Master Curve Material Set (CA 15-3 MCM); Atellica IM CA 19-9 (CA 19-9); Atellica IM CA 19-9 Diluent (CA 19-9 DIL); Atellica IM CA 19-9 II (CA 19-9 II); Atellica IM CA 19-9 II Master Curve Material (CA 19-9 II MCM); Atellica IM CA 19-9 Master Curve Material (CA 19-9 MCM); Atellica IM CAL Q; Atellica IM CMV IgG (CMV IgG) assay; Atellica IM CMV IgG QC; Atellica IM CMV IgM (CMV IgM); Atellica IM CMV IgM Quality Control (CMV IgM QC); Atellica IM Calcitonin (CALCT) assay; Atellica IM Calcitonin MCM (CALCT MCM); Atellica IM Calibrator 1 (Cal 1); Atellica IM Calibrator 30 (CAL 30); Atellica IM Calibrator 80 (CAL 80); Atellica IM Calibrator C (Cal C); Atellica IM Calibrator E (CAL E); Atellica IM Calibrator O (Cal O); Atellica IM Calibrator U (Cal U); Atellica IM Calibrator Y (CAL Y); Atellica IM Carcinoembryonic Antigen (CEA); Atellica IM Carcinoembryonic Antigen Master Curve Material Set (CEA MCM); Atellica IM Carcinoembryonic Diluent (CEA DIL); Atellica IM Cleaner; Atellica IM Complexed Prostate-specific Antigen (cPSA); Atellica IM Complexed Prostate-specific Antigen Pretreatment Reagent (cPSA Pre); Atellica IM Complexed Prostate-specific Antigen Quality Control (cPSA QC); Atellica IM Cortisol (Cor); Atellica IM Cortisol Urine Reconstitution Buffer (COR Recon Buf); Atellica IM Creatine Kinase MB (CKMB); Atellica IM Creatine Kinase MB Calibrator (CKMB CAL); Atellica IM Creatine Kinase MB Diluent (CKMB Dil); Atellica IM Creatine Kinase MB Master Curve Material (CKMB MCM); Atellica IM Cyclosporine Master Curve Material (CsA MCM); Atellica IM Cytokeratin Fragment 21-1 (CYFRA); Atellica IM Cytokeratin Fragment 21-1 Calibrator (CYFRA CAL); Atellica IM Cytokeratin Fragment 21-1 MCM (CYFRA MCM); Atellica IM DHEA-SO4 (DHEAS); Atellica IM DHEA-SO4 Master Curve Material (DHEAS MCM); Atellica IM DHEAS2 Master Curve Material (DHEAS2 MCM); Atellica IM Digoxin (DIG); Atellica IM Digoxin Master Curve Material (Dig MCM); Atellica IM EPO Controls (EPO QC); Atellica IM EPO MCM (EPO MCM); Atellica IM Enhanced Estradiol (eE2); Atellica IM Enhanced Estradiol Diluent (eE2 DIL); Atellica IM Enhanced Estradiol Master Curve Material (eE2 MCM); Atellica IM Enhanced Liver Fibrosis (ELF); Atellica IM Enhanced Liver Fibrosis Master Curve Material (ELF MCM); Atellica IM Enhanced Liver Fibrosis Quality Control (ELF QC); Atellica IM Erythropoietin (EPO) Assay; Atellica IM Ferritin Assay; Atellica IM Ferritin Master Curve Material (FER MCM); Atellica IM Folate Assay (FOL); Atellica IM Folate DTT/Releasing Agent (Fol DTT/REL); Atellica IM Folate Diluent (FOL DIL); Atellica IM Folate RBC (Fol RBC); Atellica IM Follicle Stimulating Hormone (FSH); Atellica IM Follicle Stimulating Hormone Master Curve Material (FSH MCM); Atellica IM Free Thyroxine (FT4); Atellica IM Free Thyroxine Master Curve Material (FT4 MCM); Atellica IM Free Triiodothyronine (FT3); Atellica IM HER-2/neu (H2n); Atellica IM HER-2/neu 1,2 Quality Control Material (H2n QC); Atellica IM HER-2/neu Calibrator (H2n Cal); Atellica IM HIV Ag/Ab Combo (CHIV); Atellica IM HIV Ag/Ab Combo Quality Control Kit (CHIV QC); Atellica IM Hepatitis A IgM (aHAVM); Atellica IM Hepatitis A IgM Quality Control (aHAVM QC); Atellica IM Hepatitis A Total (HAVT); Atellica IM Hepatitis A Total Quality Control (HAVT QC); Atellica IM Hepatitis B Core Antigen (aHBcM); Atellica IM Hepatitis B Surface Antigen II (HBsII); Atellica IM Hepatitis B e Antigen (HBeAg); Atellica IM Hepatitis B e Antigen Quality Control (HBeAg QC); Atellica IM Hepatitis B surface Antigen II (HBsAgII); Atellica IM Hepatitis B surface Antigen II Confirmatory (HBsII Conf); Atellica IM Hepatitis B surface Antigen II Quality Control (HBsII QC); Atellica IM Hepatitis Core Antigen Quality Control (aHBcM QC); Atellica IM Herpes-1 IgG (HSV1); Atellica IM Herpes-2 IgG (HSV2); Atellica IM High Sensitivity Troponin I Master Curve Material (TnIH MCM); Atellica IM High-Sensitivity Troponin I (TnIH); Atellica IM Homocysteine (HCY); Atellica IM Homocysteine Calibrator (HCY CAL); Atellica IM Homocysteine Diluent (HCY DIL); Atellica IM IL6 Assay (IL6); Atellica IM IL6 Quality Control Material (IL6 QC); Atellica IM Insulin Assay (IRI); Atellica IM Insulin Calibrator (IRI Cal); Atellica IM Insulin Diluent (IRI Dil); Atellica IM Insulin Master Curve Material (IRI MCM); Atellica IM Intact Parathyroid Hormone (PTH); Atellica IM Intact Parathyroid Hormone Master Curve Material (PTH MCM); Atellica IM Intact Parathyroid Hormone Quality Control (PTH QC); Atellica IM Luteinizing Hormone (LH); Atellica IM Luteinizing Hormone Master Curve Material (LH MCM); Atellica IM Multi-Diluent 1 (M-Dil 1); Atellica IM Multi-Diluent 10 (M-Dil 10); Atellica IM Multi-Diluent 11 (M-Dil 11); Atellica IM Multi-Diluent 12 (M-Dil 12); Atellica IM Multi-Diluent 13 (M-Dil 13); Atellica IM Multi-Diluent 15 (M-Dil 15); Atellica IM Multi-Diluent 2 (M-Dil 2); Atellica IM Multi-Diluent 3 (M-Dil 3); Atellica IM Myoglobin (MYO); Atellica IM NT proBNPII (PBNPII); Atellica IM PBNPII Master Curve Material (PBNPII MCM); Atellica IM PSA MCM (PSA MCM); Atellica IM Probe Wash 3 (PW3); Atellica IM Progesterone (PRGE); Atellica IM Progesterone Master Curve Material (PRGE MCM); Atellica IM Prolactin (PRL); Atellica IM Prolactin Master Curve Material (PRL MCM); Atellica IM Prostate-specific Antigen (PSA); Atellica IM Rubella IgG (Rub G); Atellica IM Rubella IgG Quality Control (Rub G QC); Atellica IM Rubella IgM (Rub M); Atellica IM Rubella IgM Quality Control (Rub M QC); Atellica IM Sample Inactivation Media; Atellica IM Sex Hormone Binding Globulin (SHBG); Atellica IM Sex Hormone Binding Globulin Calibrator (SHBG CAL); Atellica IM Sex Hormone Binding Globulin Master Curve Material (SHBG MCM); Atellica IM T3/T4/VB12 Ancillary Reagent; Atellica IM TSH3-Ultra (TSH3ULII); Atellica IM Testosterone II (TSTII); Atellica IM Testosterone II Master Curve Material (TSTII MCM); Atellica IM Tg Master Curve Material (Tg MCM); Atellica IM Thyroglobulin (Tg); Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL); Atellica IM Total IgE (tIgE); Atellica IM Total IgE Diluent (tIgE DIL); Atellica IM Total Triiodothyronine (T3); Atellica IM Total Triiodothyronine Diluent (T3 DIL); Atellica IM Total Triiodothyronine Master Curve Material (T3 MCM); Atellica IM Total hCG (ThCG); Atellica IM Total hCG Diluent (ThCG Dil); Atellica IM Toxoplasma IgG (Toxo G); Atellica IM Toxoplasma IgG Quality Control (Toxo G QC); Atellica IM Toxoplasma IgM (Toxo M); Atellica IM Toxoplasma IgM Quality Control (Toxo M QC); Atellica IM Tumor Marker Quality Control (TMQC); Atellica IM Vitamin B12 (VB12); Atellica IM Vitamin B12 DTT/Releasing Agent (VB12 DTT/REL); Atellica IM Vitamin B12 Diluent (VB12 DIL); Atellica IM Vitamin D Total (VitD); Atellica IM Vitamin D Total Master Curve Material (VitD MCM)",1977-12-20,354,2026-08-10,17,129,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222432235%22&limit=1
Boston Scientific Corporation,2124215,2124215,4100 Hamline Ave N,Saint Paul,MN,55112,United States,Boston Scientific Corporation,9912058,Complaint file establishment; Manufacturer; Manufacturer for export; Specification developer,167,DQK; DQO; DQX; DQY; DRA; DRB; DRE; DRF; DRG; DRQ; DRX; DSA; DSK; DTB; DTC; DTD; DTL; DXF; DXK; DXO; DXY; DYB; EYB; EYK; EZB; EZN; EZW; EZY; FAD; FAE; FAJ; FCG; FCL; FED; FEM; FFA; FFD; FFK; FFL; FFY; FGA; FGB; FGE; FGO; FHQ; FHW; FOX; FTL; FTM; GAT; GBM; GBO; GBW; GBX; GCB; GCC; GCE; GCJ; GEH; GEI; GEX; GXD; GXI; GZB; HCG; HIG; IKD; ITX; IWJ; IWP; IYO; JCT; JCW; KDQ; KGZ; KNQ; KNS; KOA; KOD; KOE; KOH; KPY; KQT; KRA; KRD; KRG; LGW; LIT; LJE; LKK; LLZ; LNM; LOX; LPB; LWP; LWS; LZC; MAF; MAV; MCW; MCX; MHW; MHY; MIR; MJN; MTD; MXD; NAJ; NAW; NFA; NGV; NHL; NIK; NIM; NIN; NIO; NIP; NIQ; NIU; NJE; NKE; NOY; NTE; NVN; NVY; NVZ; NWX; OAD; OAE; OBJ; OCL; OCX; ODC; OEZ; OFK; OHD; OJX; ONU; OOB; OSR; OTM; OTN; OTO; OUG; OVB; OXH; PAH; PIJ; PJS; PNO; PPN; PTI; PTL; PTM; PUM; PWI; PWJ; QAN; QEW; QEY; QEZ; QGA; QGD; QKJ; QON; QRB; QZI,"Computer, Diagnostic, Programmable; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Stylet, Catheter; Dilator, Vessel, For Percutaneous Catheterization; Catheter, Electrode Recording, Or Probe, Electrode Recording; Transmitters And Receivers, Physiological Signal, Radiofrequency; Amplifier And Signal Conditioner, Transducer Signal; Electrode, Electrocardiograph; Cable, Transducer And Electrode, Patient, (Including Connector); Computer, Blood-Pressure; Permanent Pacemaker Electrode; Analyzer, Pacemaker Generator Function; Pacemaker Lead Adaptor; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Catheter, Septostomy; Echocardiograph; Transducer, Pressure, Catheter Tip; Implantable Pacemaker Pulse-Generator; Introducer, Catheter; Catheter, Ureteral, Gastro-Urology; Connector, Ureteral Catheter; Stylet For Catheter, Gastro-Urology; Dilator, Catheter, Ureteral; Stimulator, Electrical, Implantable, For Incontinence; Device, Incontinence, Mechanical/Hydraulic; Stent, Ureteral; Prosthesis, Penile; Cystoscope And Accessories, Flexible/Rigid; Biopsy Needle; Forceps, Biopsy, Non-Electric; Endoscopic Access Overtube, Gastroenterology-Urology; Accessories, Photographic, For Endoscope (Exclude Light Sources); Tube, Drainage, Suprapubic; Evacuator, Bladder, Manually Operated; Lithotriptor, Electro-Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Adaptor, Bulbs, Miscellaneous, For Endoscope; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Stents, Drains And Dilators For The Biliary Ducts; Dislodger, Stone, Flexible; Holder, Needle, Gastroenterologic; Device, Impotence, Mechanical/Hydraulic; Stand, Infusion; Mesh, Surgical, Polymeric; Mesh, Surgical; Suture, Nonabsorbable, Synthetic, Polyethylene; Catheter, Urethral; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Peritoneal; Catheter, Irrigation; Needle, Catheter; Dilator, Catheter; Adaptor, Catheter; Laparoscope, General & Plastic Surgery; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Stimulator, Spinal-Cord, Implanted (Pain Relief); Device, Neurovascular Embolization; Insufflator, Hysteroscopic; Cable, Electrode; Transducer, Ultrasonic, Diagnostic; System, Applicator, Radionuclide, Manual; Radiographic Protective Glove; System, Imaging, Pulsed Echo, Ultrasonic; Prosthesis, Tracheal, Expandable; Prosthesis, Penis, Inflatable; Bottle, Collection, Vacuum; Accessories, Catheter; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Surgical Instruments, G-U, Manual (And Accessories); Catheter, Urological; Dilator, Urethral; Instrument, Manual, General Obstetric-Gynecologic; Shield, Protective, Personnel; Evacuator, Gastro-Urology; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Programmer, Pacemaker; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Catheter, Angioplasty, Peripheral, Transluminal; Catheter, Nephrostomy; Pump, Infusion, Implanted, Programmable; System, Image Processing, Radiological; Agent, Bulking, Injectable For Gastro-Urology Use; Catheters, Transluminal Coronary Angioplasty, Percutaneous; Cardiac Ablation Percutaneous Catheter; Implantable Pulse Generator, Pacemaker (Non-Crt); Implantable Cardioverter Defibrillator (Non-Crt); Medical Glove, Specialty; Stent, Coronary; Syringe, Balloon Inflation; Catheter, Peripheral, Atherectomy; Catheter, Coronary, Atherectomy; Dressing, Compression; Stimulator, Electrical, Implanted, For Parkinsonian Tremor; Shunt, Portosystemic, Endoprosthesis; Catheter, Intravascular Occluding, Temporary; Catheter, Intracardiac Mapping, High-Density Array; Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection); Agents, Embolic, For Treatment Of Uterine Fibroids; Microspheres Radionuclide; Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection; System, Appendage Closure, Left Atrial; Stimulator, Electrical, Implanted, For Parkinsonian Symptoms; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D); Stent, Carotid; Stent, Renal; Stent, Iliac; Stent, Superficial Femoral Artery; Coronary Drug-Eluting Stent; Stent, Superficial Femoral Artery, Drug-Eluting; Intracranial Neurovascular Stent; Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P); Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia; Temporary Carotid Catheter For Embolic Capture; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes; Permanent Defibrillator Electrodes; Pulse Generator, Permanent, Implantable; Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation; Catheter, Ultrasound, Intravascular; Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue; Endoscopic Irrigation/Suction System; Endoscope Channel Accessory; Cardiovascular Procedure Kit; Percutaneous Atrial Catheter Kit; Gynecological Laparoscopic Kit; Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode; Drug-Eluting Peripheral Transluminal Angioplasty Catheter; Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter; Pacemaker/Icd/Crt Non-Implanted Components; Mesh, Surgical, For Stress Urinary Incontinence, Male; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator; Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed; Medical Device Data System; Hydrogel Spacer; Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling; Collagen Surgical Mesh Containing Drugs; Stimulator, Electrical, Implanted, For Essential Tremor; Catheter, Percutaneous, Cutting/Scoring; Percutaneous Catheter, Ultrasound; Non-Coring (Huber) Needle; Wire, Guide, Catheter, Exempt; Syringe, Balloon Inflation, Exempt; Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures; Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse; Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence; Stent, Iliac Vein; Peripheral Mechanical Thrombectomy With Aspiration; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter; Penile Implant Surgical Accessories; Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories; Stent, Central Venous; Implanted Electrical Device Intended For Treatment Of Fecal Incontinence; Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",1; 2; 3; U; f,"2x8 Contact Lead Extension Kit; 8 Contact Extension Kit; AC Power Cord; AC/DC Power Supply; ACCOLADE; ACCOLADE MRI; ACUITY STEERABLE; ACUITY Spiral; ACUITY X4 Flushing Tool/Wire Guide; ACUITY X4 Spiral; ACUITY X4 Straight; ADVANTIO; AGENT Paclitaxel-Coated Balloon Catheter; ALTRUA 2; ALTRUA 20; ALTRUA 40; ALTRUA 60; AMS 700 with Inhibizone; AMS 700 without Inhibizone; AMS 800 with Inhibizone; AMS 800 without Inhibizone; AUTOGEN CRT-D; AUTOGEN EL; AUTOGEN X4 CRT-D; Accessory kit For use with the Model 3120 Programmer Recorder Monitor PRM; Adhesive Kit; Ambicor; Anchor Sleeve; AngioJet Spiroflex Thrombecotmy Set; AngioJet Spiroflex VG Thrombectomy Set; AngioJet Ultra 5000A Console; Antenna; Apex PTCA Dilatation Catheter; Apex Push PTCA Dilatation Catheter; Artisan MRI Surgical Lead Kit; Artisan Surgical Lead Kit; AutoElite Thrombectomy System Console; Avista MRI Lead Kit; Axonics; Axonics Affirm Trial Stimulator; Axonics Rechargeable Sacral Neuromodulation System; Axonics SNM System; Axonics SNM Therapy; Axonics Sacral Neuromodulation System; Axonics Sacral Neuromodulation Therapy; Axonics System; Axonics Therapy; Axonics Therapy for Bowel Control; Axonics Therapy for Urinary Control; Axonics r-SNM System; BATTERY; Base Station; Bi Directional Torque Wrench; Bionic Navigator 24 Installer; Bionic Navigator 3D 4 Installer; Bionic Navigator 3D 4.1 Installer; Bionic Navigator 3D Installer; Bionic Navigator Installer; Blazer II HTD Temperature Ablation Catheter; Blazer II Temperature Ablation Catheter; Blazer II XP Temperature Ablation Catheter; Blazer Open-Irrigated Ablation Catheter; Blazer Prime HTD Temperature Ablation Catheter; Blazer Prime XP Temperature Ablation Catheter; Blazer Solid-Tip Ablation Cather Cable, Sterile Cable; Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable; Bulkamid Urethral Bulking System; CONTAK CD Software Application; CONTAK CD2 Software Application; CONTAK RENEWAL AVT Software; CONTAK RENEWAL Software Application; CONTAK RENEWAL TR Software Application; Cable IntellaTip MiFi OI to Maestro 4000; Cable IntellaTip MiFi XP Sterile Cable; Cable, IntellaNav Ablation Catheter; Cable, IntellaTip MiFi OI; Cable, Maestro 4000; Cable, USB Serial; Carotid WALLSTENT Monorail Endoprosthesis; Charger; Charger Belt; Charger Belt Extension; Charger Belt Loops Replacement; Charger Belt and accessories; Charger Spacer; Click Anchor; Clik Anchor Hex Wrench; Clik X Anchor; Clik X MRI Anchor; Clinician Programmer; Colpassist Vaginal Positioning Device; Connecting Tube; Connector Drainage Bag Connector; Connector Tools; Connector Ureteral Catheter Connector; CoverEdge 32 Surgical Lead Kit; CoverEdge MRI 4x8 Surgical Lead Kit; CoverEdge X 32 Surgical Lead Kit; CoverEdge X MRI 4x8 Surgical Lead Kit; D4 Splitter Kit; DF-1/3.2-mm Lead Port; DYNAGEN CRT-D; DYNAGEN EL; DYNAGEN MINI; DYNAGEN X4 CRT-D; EASYTRAK 2; EASYTRAK 2 IS-1; EASYTRAK 3; EASYTRAK 3 IS-1; ELUVIA Drug-Eluting Vascular Stent System; EMBLEM MRI S-ICD Subcutaneous Implantable Cardioverter Defibrillator; EMBLEM S-ICD Electrode; EMBLEM S-ICD Electrode Delivery System; EMBLEM S-ICD Electrode Insertion System; EMBLEM S-ICD Programmer; EMBLEM S-ICD Pulse Generator; EMBLEM S-ICD Subcutaneous Electrode; EMBLEM S-ICD Subcutaneous Implantable Cardioverter Defibrillator; EMBLEM S-ICD System Patient Screen Tool; ENDOTAK RELIANCE; ENDOTAK RELIANCE G; ENDOTAK RELIANCE S; ENDOTAK RELIANCE SG; ENERGEN; ENERGEN CRT-D; ENROUTE Transcarotid Stent System; ESSENTIO; ESSENTIO MRI; ETS battery; Electrophysiology Cable Non-Sterile Cable; Electrophysiology Cable Sterile Cable; Enhanced Steering Kit with Stylet Cap; Entrada Needle; Entrada Spare Sheath; Epic Vascular Self-Expanding Stent System; Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter; Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit; Express LD Iliac/Biliary Stent System; Express SD Renal/Biliary Premounted Stent System; Extension Kit; FARAPOINT Pulsed Field Ablation Catheter; FARASTAR AAMI Recoding System Module ECG Output Module; FARASTAR AAMI Recording System Module ECG Trunk Cable; FARASTAR AAMI Snap Cable R/L; FARASTAR AAMI Snap Cable V Set; FARASTAR Cable Set; FARASTAR Catheter Connection Cable; FARASTAR EGM Cable; FARASTAR EGM to EP Recording System Cable (FARAPOINT); FARASTAR Gen 2 Catheter Connection Cable; FARASTAR IEC Recording System Module ECG Output Module; FARASTAR IEC Recording System Module ECG Trunk Cable; FARASTAR IEC Snap Cable C Set; FARASTAR IEC Snap Cable R/L; FARASTAR Inter-Connection Box; FARASTAR Mapping System Module; FARASTAR Mapping System Module ABL Output to Signal Station ABL Input Cable FARASTAR to OPAL HDx; FARASTAR Mapping System Module Auxiliary Cable; FARASTAR Mapping System Module BNC-Phono Cable; FARASTAR Mapping System Module Back Patch Cable; FARASTAR Mapping System Module Back Patch Cable Male; FARASTAR Pulsed Field Ablation Generator; FARASTAR Recording System Module; FARASTAR Recording System Module Catheter Pin Cable; FARASTAR Recording System Module ECG Output to Signal Station ECG Input Cable FARASTAR to OPAL HDx; FARASTAR Recording System Module EGM Input Module; FARASTAR Recording System Module EGM Output to Singal Station EGM Input Cable FARASTAR to OPAL HDx; FARASTAR Stimulation Module Cable; FARASTAR Stimulation Module Female Cable; FARASTAR Stimulation Module Male Cable; FARASTAR Stimulation Module Y-Cable Long; FARASTAR Stimulation Module Y-Cable Short; FARAWAVE Nav Pulsed Field Ablation Catheter; FARAWAVE Pulsed Field Ablation Catheter; FINELINE II EZ Sterox; FINELINE II Sterox; FLEXTEND; FORMIO; FORMIO MRI; Fixation Tool; Flexima Nephrostomy Catheter System; Flexima Nephrostomy Catheter System Kit; Flexima Nephrostomy Catheter System Kit with Dissolving Tip; Flexima Nephrostomy Catheter System with Dissolving Tip; Flextome Cutting Balloon Microsurgical Dilatation Device; Foramen Finder; Freelink Remote Control; Freelink Remote Control Kit; INCEPTA; INCEPTA CRT-D; INGENIO; INGENIO MRI; INGEVITY MRI; INOGEN CRT-D; INOGEN EL; INOGEN MINI; INOGEN X4 CRT-D; INTELLAGEN Catheter Adapter Cable 0.3 Meter; INTELLAGEN ECG Connection Cable 3 Meter; INTELLAGEN Foot Pedal; INTELLAGEN Foot Pedal Extension Cable 7 Meter; INTELLAGEN Grounding Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 1 Meter; INTELLAGEN Irrigation Pump Connection Cable 10 Meter; INTELLAGEN Irrigation Pump Connection Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 5 Meter; INTELLAGEN Irrigation Pump Kit; INTELLAGEN RF Generator Kit; INTELLAGEN Remote Control Connection Cable 10 Meter; INTELLAGEN Remote Control Connection Cable 15 Meter; INTELLAGEN Remote Control Connection Cable 25 Meter; INTELLAGEN Remote Control Connection Cable 30 Meter; INTELLAGEN Remote Control Kit; INTELLAGEN Serial Communication Cable 15 Meter; INTELLAGEN Serial Communication Cable 3 Meter; INTELLAGEN Serial Communication Cable 5 Meter; INTELLAGEN Tubing Set; INTUA; INVIVE; IR Interface; IR Interface Holder; Infinion CX Lead Kit; Infinion Lead Kit; Infinion Pro Lead Kit; Innova Vascular Self-Expanding Stent System; Insertion Needle; Installer for BN3.1; IntellaNav MiFi Open-Irrigated Ablation Catheter; IntellaNav MiFi XP Temperature Ablation Catheter; IntellaNav Open-Irrigated Ablation Catheter; IntellaNav ST Ablation Catheter; IntellaNav StablePoint Ablation Catheter; IntellaNav StablePoint Catheter Cable; IntellaNav XP Temperature Ablation Catheter; IntellaTip MiFi Filter Module RF Frequency Filter; IntellaTip MiFi Open-Irrigated Ablation Catheter; IntellaTip MiFi Reference Cable Non-Sterile Electrophysiology Cable; IntellaTip MiFi XP Temperature Ablation Catheter; Intera 3000 Hepatic Artery Infusion Pump; Intera 3000 Hepatic Artery Infusion Pump Tapered Silicone Rubber Catheter (Radiopaque) with Connector; Introducer; J Shaped Lead Stylet; JINRO Pigtail Nephrostomy Catheter; JINRO Pigtail Nephrostomy Catheter Kit; JINRO Pigtail Nephrostomy Catheter Placement Kit; Keyboard; LATITUDE Clarity; LATITUDE Communicator; LATITUDE Communicator Inductive; LATITUDE Communicator Power Supply; LATITUDE Communicator RF; LATITUDE Communicator with Wand; LATITUDE Consult Communicator; LATITUDE Consult Power Supply; LATITUDE Consult System; LATITUDE Consult System Software; LATITUDE G2 Communicator; LATITUDE NXT; LATITUDE NXT Server Software; LATITUDE Patient Management System; LATITUDE Power Supply; LATITUDE Programming System; LATITUDE Server Software; LATITUDE WAVE Communicator; LUX-Dx; Lead Adapter; Lead Cap; Lead Cap Kit; Lead Extension Kit, 16 Contact; Lead Kit; Lead Pulling Tip; Lead Repair Kit; Lead Stabilizer Kit; Lead Stylet; Lead Stylets; Lead Tunneler Kit; Linear; Linear 3-4 Lead Kit; Linear 3-6 Lead Kit; Linear Lead Kit; Linear ST Lead Kit; Log Data Card for the Model 3200 EMBLEM S-ICD Programmer; MOMENTUM CRT-D; MOMENTUM EL ICD; MOMENTUM X4 CRT-D; Maestro 4000 Controller, RF Cardiac Ablation Controller; Maestro 4000 Pod, 100W, RF Cardiac Ablation Pod, 100W; Maestro 4000 RF Cardiac Ablation Controller; Maestro 4000 RF Cardiac Ablation Pod 100; Maestro 4000 Remote Control; Maestro Foot Switch; Maestro Remote Control Cable; Magnet; Malecot Nephrostomy Catheter Set; Medical Adhesive; MetriQ Foot Switch; MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set; MetriQ Pump Irrigation Pump; Mineral Oil; Model 1550 AICD Software Module; Model 6942 Bidirectional Torque Wrench; Multiple Application Utility (MAU); NaviGuide Percutaneous Access Needle; Non-Sterile Cable; Non-Sterile Cable (Controller to Pump or Remote Control); O.R. Cable and Extension; OPAL HDx Connection Box - MAESTRO; OPAL HDx Connection Box - MAESTRO STABLEPOINT; OPAL HDx Connection Box INTELLAGEN; OPAL HDx Connection Box INTELLAGEN STABLEPOINT; OR Cable 2x8, 61cm and Extension; PERCIVA HF ICD; PERCIVA ICD; POLARx Cryoablation Balloon Catheter; POLARx FIT Cryoablation Balloon Catheter; PROPONENT; PROPONENT MRI; PUNCTUA; PUNCTUA CRT-D; Paddle Blank for CoverEdge 32 Surgical Lead; Paddle Blank for CoverEdge X 32 Surgical Lead; Pairing Magnet; Patient Travel Case; Patient Trial Kit; Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip; Percuflex Locking Loop Nephrostomy Catheter; Percuflex Locking Loop Nephrostomy Catheter with Fader Tip; Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit; Percutaneous Access Needle; Percutaneous Access Needle with Echogenic Tip; Percutaneous Access Set; Power Adapter; Power Cord; Power Supply for S-ICD Programmer Tool; Power Supply for Tablet Computer; Power Unlimited, Power Adapter; Precision; Precision AC/DC Power Supply; Precision Adhesive Kit; Precision Base Station; Precision Battery AAA 1.5 Alkaline; Precision Cable, USB-Serial; Precision Charger; Precision Charging Belt; Precision Charging System Kit; Precision Clinician Programmer; Precision Connector; Precision Epimed Needle; Precision External Trial Stimulator; Precision Hex Wrench; Precision Holster; Precision IPG Port Plug; Precision IR Interface; Precision IRDA Dongle Holder; Precision Implantable Pulse Generator Kit; Precision Implantable Pulse Generator and Charging Kit; Precision Lead Blank; Precision Lithium Manganese Dioxide Battery 6 Volts; Precision M8 Adapter; Precision Montage Implantable Pulse Generator Kit; Precision Montage MRI Implantable Pulse Generator Kit; Precision Montage MRI Implantable Pulse Generator and Charging Kit; Precision Novi Implantable Pulse Generator Kit; Precision OMG Connector-A; Precision OMG Connector-M; Precision PC SC-7150; Precision Passing Elevator; Precision Patient Controller; Precision Patient Programmer Kit; Precision Patient Trial Belt; Precision Patient Trial Kit; Precision Power Supply & Adapter For Charger; Precision Primary Lithium Battery AA Type STD; Precision Remote Control; Precision Remote Control Case; Precision S8 Adapter; Precision Spectra  IPG Port Plug; Precision Spectra External Trial Stimulator; Precision Spectra IPG Port Plug; Precision Spectra Implantable Pulse Generator Kit; Precision Spectra Implantable Pulse Generator and Charging Kit; Precision Spectra OMG Adapter; Precision Spectra Patient Trial Belt; Precision Spectra Patient Trial Kit; Precision Spectra Remote Control; Precision Spectra Remote Control Kit; Precision Suture Sleeve; Precision Tablet PC Pen; Programming Wand; Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System; Push Button OR Cable; REBEL Platinum Chromium Coronary Stent System; RELIANCE 4-FRONT Defibrillation Lead; RESONATE CRT-D; RESONATE EL ICD; RESONATE HF CRT-D; RESONATE HF ICD; RESONATE X4 CRT-D; RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint; ROTAPRO Advancer Burr Advancing Device; ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; ROTAPRO Rotational Atherectomy System Console Kit; ROTAWIRE Drive and wireClip Torquer Extra Support; ROTAWIRE Drive and wireClip Torquer Floppy; Ranger Paclitaxel-Coated PTA Balloon Catheter; Re-entry Malecot Nephrostomy Catheter Set; Remote Control Case; Remote Control Holster; Remote Control Silicone Case; Rhythmia HDx Ablation Connection Box; Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN; Rhythmia HDx Ablation Connection Box - for INTELLAGEN; Rhythmia HDx Ablation Connection Box Maestro; Rhythmia Mapping System IntellaNav CB - Maestro; RotaLink Advancer Catheter Advancing Device; RotaLink Burr Exchangeable Burr Catheter; RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; RotaWire and wireClip Torquer Extra Support; RotaWire and wireClip Torquer Floppy; Rotablator Dynaglide Foot Pedal; Rotablator Rotational Atherectomy System Console Kit; Rotaglide Lubricant; SCS Implantable Materials Kit; SMARTFREEZE Catheter Extension Cable; SMARTFREEZE Cryo-Cable; SMARTFREEZE Cryo-Console; SMARTFREEZE Cryo-Console Foot Switch; SMARTFREEZE Diaphragm Movement Sensor; SMARTFREEZE Inter-Connection Box; SMARTFREEZE Remote Control; SP3 Platform Update Installer; SQ-RX Pulse Generator; STERILZABLE TELEMETRY WAND; SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System; Screw Cap Wrench; Software Disk for the VENTAK MINI Pulse Generators; Software Disk for the VENTAK PRx II / III Pulse Generators; Software Disk for the VENTAK PRx Pulse Generators; Spectra External Trial Stimulator; Spectra Implantable Pulse Generator Kit; Spectra Implantable Pulse Generator and Charging Kit; Spectra WaveWriter External Trial Stimulator; Spectra WaveWriter Implantable Pulse Generator; Spectra WaveWriter Implantable Pulse Generator and Charging Kit; Splitter Kit; Stone Cone Nitinol Urological Retrieval Coil; Straight Lead Stylet; Stylet; Stylet Kit with Stylet Cap; SureTek Burr Hole Cover Kit; Suture Sleeve; Suture Sleeve Accessory; Suture Sleeves; TLA Introducer Needle and Sheath Set; Tablet Pen; Telemetry Wand; TheraSphereY-90 Glass Microspheres; Tunneling Tool; USB Cable; USB Power Supply Remote Control (U.S.); USB Splitter; Ureteral Stent Positioners; Urovac Bladder Evacuator; VALITUDE; VALITUDE X4; VENOUS WALLSTENT Self-Expanding Stent; VIGILIANT CRT-D; VIGILIANT EL ICD; VIGILIANT X4 CRT-D; VISIONIST; VISIONIST X4; VITALIO; VITALIO MRI; VTC Nephrostomy Catheters System; VTC Nephrostomy Catheters System Kit; Vein Pick; Vercise Cartesia Directional Lead Kit; Vercise Cartesia HX Directional Lead Kit; Vercise Cartesia X Directional Lead Kit; Vercise Charger; Vercise Charger Collar; Vercise Charger Collar Accessories; Vercise Charging System; Vercise Charging System with Belt; Vercise DBS Controller; Vercise DBS Controller Clinician Kit; Vercise DBS Controller Patient Kit; Vercise DBS Directional Lead Kit; Vercise DBS External Trial Stimulator 2; Vercise DBS Remote Control 3; Vercise DBS Remote Control 3 Kit; Vercise DBS Remote Control 4 and Kit; Vercise ETS; Vercise ETS 3; Vercise ETS Adapter; Vercise External Trial Stimulator; Vercise Genus Implantable Pulse Generator Kits; Vercise Gevia Implantable Pulse Generator Kit; Vercise Implantable Pulse Generator Kit; Vercise M8 Adapter; Vercise Neural Navigator 2.1 Installer; Vercise Neural Navigator 3.1 Installer; Vercise Neural Navigator 4 Installer; Vercise Neural Navigator 5; Vercise PC Implantable Pulse Generator Kit; Vercise Physician's Spare Kit; Vercise Physician's Spare Kit, 16 Contact Lead; Vercise Remote Control; Vercise Remote Control Kit; Vercise S8 Adapter; W4 Splitter Kit; WALLSTENT Endoprosthesis Self-Expanding Stent; WALLSTENT RP Endoprosthesis Self-Expanding Stent; WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; Wand for SICD Programmer 3200; WaveWriter Alpha 16 IPG Kit; WaveWriter Alpha 16 IPG and Charging Kit; WaveWriter Alpha ETS; WaveWriter Alpha ETS Trial Belt; WaveWriter Alpha IPG Kit; WaveWriter Alpha IPG and Charging Kit; WaveWriter Alpha Patient Trial Kit; WaveWriter Alpha Prime 16 IPG Kit; WaveWriter Alpha Prime IPG Kit; Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device; Wrench Kit; ZOOM LATITUDE Programmer/Recorder/Monitor; ZOOM Wireless Transmitter; myLUX; mySCS GO Therapy Controller App; mySCS GO Therapy Controller App Patient Literature Kit; mySCS GO Therapy Controller Clinician Kit; mySCS GO Therapy Controller Patient Kit; wireClip Torquer",1983-09-09,318,2026-09-11,47,86,9,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222124215%22&limit=1
"Smith & Nephew, Inc.",1020279,1020279,1450 Brooks RD.,Memphis,TN,38116,United States,"Smith & Nephew, Inc.",1020279,Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,138,FNS; FQH; FSM; FTY; FZO; FZP; FZX; FZY; GAD; GDG; GEA; GEY; GFA; GFG; HAB; HAW; HRS; HRY; HSB; HSD; HSN; HST; HSX; HTC; HTD; HTE; HTF; HTJ; HTN; HTO; HTQ; HTR; HTT; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWD; HWE; HWJ; HWK; HWM; HWQ; HWR; HWT; HWW; HWX; HXB; HXC; HXD; HXG; HXI; HXJ; HXL; HXO; HXP; HXR; HXS; HXW; HXX; HXZ; HYA; IPR; IXG; JDB; JDG; JDI; JDJ; JDO; JDQ; JDR; JDS; JDW; JDY; JDZ; JOL; JWH; JWJ; KAZ; KGS; KIH; KIK; KIL; KQW; KRO; KRQ; KRR; KTT; KTZ; KWD; KWH; KWI; KWL; KWN; KWS; KWT; KWY; KWZ; KXE; KYI; KYJ; LPH; LRY; LWJ; LXH; LXT; LYS; LYU; LZJ; LZN; LZO; LZY; MBH; MBJ; MBL; MBV; MEH; MJW; NAB; NBH; NDG; NEG; NEU; NJD; NPJ; OIY; OJH; OLO; OMX; OOG; OQG; OSN; PBF; PHX; PKC,"Ring Cutter; Lavage, Jet; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Clip, Implantable; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Hook, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Bit, Surgical; Saw, Powered, And Accessories; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Passer; Driver, Prosthesis; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Tamp; Passer, Wire, Orthopedic; Staple Driver; Mallet; Pusher, Socket; Instrument, Bending Or Contouring; Spatula, Orthopedic; Twister, Wire; Bender; Screwdriver; Cutter, Wire; Forceps, Wire Holding; Crutch; Phantom, Anthropomorphic, Radiographic; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Evacuator, Vapor, Cement Monomer; Mixer, Cement, For Clinical Use; Catheter And Tip, Suction; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained; Rasp, Frontal-Sinus; Retention Device, Suture; Dispenser, Cement; Hook, Bone; Positioner, Socket; Goniometer, Nonpowered; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Wrist, Carpal Lunate; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Wrist, Hemi-, Ulnar; Prosthesis, Wrist, Carpal Trapezium; Prosthesis, Finger, Constrained, Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Punch, Surgical; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Bone Mill; Accessory, Surgical Apparel; Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Biodegradable, Hard Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Subtalar, Plug, Polymer; Gauze / Sponge,Nonresorbable For External Use; Accessories, Arthroscopic; Washer, Bolt, Nut, Non-Spinal, Metallic; Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis; Marker, Radiographic, Implantable; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Tray; Orthopedic Stereotaxic Instrument; High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis; Knee Arthroplasty Implantation System; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Software For Diagnosis/Treatment; Orthopaedic Surgical Planning And Instrument Guides; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained",1; 2; 3; U; f,"1.2 RAP-PAC A LATEX FREE; 1.2 RAP-PAC A, 72202796; 1.2 RAP-PAC B LATEX FREE; 1.2 RAP-PAC B, 72202797; 1.2 RAP-PAC C; 1.5 MM TENDON DRILL PIN; 1.5mm Guidewire, 12"", 72202189; 1.6MM DRILL & GUIDE DYNOMITE 2; 1.8MM DRILL & GUIDE SPYROMITE/MINI 2; 10 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10.5 MM CANNULATED DRILL; 10.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 10.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10MM DILATOR; 11 MM GRAFT SIZING TUBE; 11 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11.5 MM CANNULATED DRILL; 11.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 11.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11MM DILATOR; 12 MM GRAFT SIZING TUBE; 12 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 12.5 MM CANNULATED DRILL; 12.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 12MM DILATOR; 13 MM GRAFT SIZING TUBE; 13 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 13.5 MM CANNULATED DRILL; 14 MM GRAFT SIZING TUBE; 15 DEGREE CLOSED CURETTE 3 MM; 15 DEGREE OPEN CURETTE 2.5 MM; 15 DEGREE OPEN CURETTE 4 MM; 15 DEGREE OSTEOTOME 3MM; 2 MM FULL RADIUS MINI BLADES, POWER/EP-1, BLUE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2-5 MM OFFSET GUIDE; 2.4 MM FLEXIBLE PASSING PINS, STERILE 5 PER PACKAGE; 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE; 2.4MM PASSING PIN WITH CALIBRATION MARKS; 2.6 MM TWIST DRILL BIT FOR 2.3 ANCHOR; 2.6MM DRILL & GUIDE RAPTORMITE 3; 2.7 MM CHISEL GUARD; 2.7 MM DILATOR; 2.7 MM X 15 INCH 38 CM DRILL-TIP PASSING PIN, NON-STERILE 6 PER PACKAGE; 2.9 MM ABRADER MINI BURRS, POWER/EP-1, ORANGE, PACKAGED 6 PER BOX, STERILE; 2.9 MM BARREL ABRADER MINI BURRS, POWER/EP-1, PURPLE, PACKAGED 6 PER BOX, STERILE; 2.9 MM CUTTER MINI BLADES, POWER/EP-1, BEIGE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2.9 MM FULL RADIUS MINI BLADES RED, POWER/EP-1, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 20 DEGREE OSTEOTOME 4MM; 3.2MM DRILL & GUIDE RAPTORMITE 3.7; 3.5 MM ABRADER MINI BURRS, POWER/EP-1, AQUA, PACKAGED 6 PER BOX, STERILE; 3.5 MM CUTTER STRAIGHT BLADE; 3.5 MM DILATOR; 3.5 MM FULL RADIUS BLADE; 3.5 MM FULL RADIUS CURVED, CONCAVE, 8 CM MINI BLADES, POWER/EP-1, PLUM, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM HEX DRIVER, 2 MM CANNULATION; 3.5 MM INCISOR PLUS, 8 CM MINI BLADES, POWER/EP-1, SAGE GREEN, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM INCISOR STRAIGHT BLADE; 3.5 MM RAZORCUT STRAIGHT BLADE; 3.5 MM RAZORCUT, 8 CM MINI BLADES, POWER/EP-1, PUMPKIN/ORANGE, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 mm Bonecutter Platinum Blade; 3.5MM INCISOR PLUS PLAT BLD; 3.5MM SPADE TIP DRILL FOR USE WITH 4.5 MM ANCHOR HOLE PREPARATION DEVICE FOR HARD BONE; 3.5MM SYNOVATOR PLAT BLD; 30 DEGREE OPEN CURETTE 2.5 MM; 4 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, SAGE GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4 MM ABRADER STRAIGHT BURR; 4 MM ACROMIONIZER STRAIGHT BURR; 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS; 4 MM PORTAL STICK X 12 INCH 30 CM LONG; 4 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, MAROON, PACKAGED 6 PER BOX, STERILE; 4 MM SHOULDER ROD X 12 INCH 30 CM LONG; 4 MM STONECUTTER STRAIGHT BURR; 4.5 FULL RADIUS BONECUTTER BLADES, YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, CURVED, INCISOR CURVED BLADES, POWER/EP-1, LIME GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, FULL RADIUS, CURVE, CURVED BLADES, POWER/EP-1, YELLOW, CURVE LENGHTS 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, SYNOVATOR CURVED BLADES, POWER/EP-1, FOREST GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CUTTER STRAIGHT BLADE; 4.5 MM DILATOR; 4.5 MM FULL RADIUS STRAIGHT BLADE; 4.5 MM HELICUT STRAIGHT BURRS, POWER/EP-1, SLATE, 5000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, VIOLET, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR STRAIGHT BLADE; 4.5 MM LONG CURVED FULL RADIUS CONCAVE SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM LONG FULL RADIUS SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM OBTURATOR, CONICAL TIP; 4.5 MM ORBIT FULL RADIUS CURVED BLADE; 4.5 MM ORBIT INCIISOR PLUS CURVED BLADES, POWER/EP-1, POWER/EP-1, VIOLET, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERIL; 4.5 MM ORBIT INCISOR CURVED BLADE; 4.5 MM ORBIT SYNOVATOR CURVED BLADE; 4.5 MM RAZORCUT STRAIGHT BLADE; 4.5 MM SYNOVATOR STRAIGHT BLADE; 4.5 MM TURBOTRIMMER STRAIGHT BLADE; 4.5 MM TURBOWHISKER STRAIGHT BLADE; 4.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, FOREST GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 mm Incisor Plus Platinum Curved Blade; 4.5 mm Synovator Platinum Curved Blade; 4.5MM FULL RADIUS PLATINUM SERIES; 4.5MM INCISOR PLUS PLATINUM BLADE; 4.5MM SYNOVATOR PLATINUM SERIES; 4MM CANNULATED CAPTURED SCREW 32MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 34MM Stainless Stee; 4MM CANNULATED CAPTURED SCREW 38MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 42MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 44MM Stainless Steel; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 30MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 32MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 34MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 36MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 38MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 40MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 42MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 44MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 46MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 48MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 50MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 30MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 32MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 34MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 36MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 38MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 40MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 42MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 44MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 46MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 48MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 50MM; 4mm PLATINUM FLYER Blade; 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS; 5 MM CANNULATED DRILL; 5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, BLUE, LARGE DELRIN HANDLE; 5 MM FLEXIBLE DRILL; 5 MM HALF-ROUND RASP; 5.5 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, BRICK RED, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5 MM ABRADER STRAIGHT BURR; 5.5 MM ACROMIONIZER STRAIGHT BURR; 5.5 MM CANNULATED DRILL; 5.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 5.5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, RED, LARGE DELRIN HANDLE; 5.5 MM FULL RADIUS STRAIGHT BLADE; 5.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, TEAL, PACKAGED 6 PER BOX, STERILE; 5.5 MM INCISOR STRAIGHT BLADE; 5.5 MM OBTURATOR, CONICAL TIP, FOR CANNULAS WITH FLUID SEALS; 5.5 MM RAZORCUT STRAIGHT BLADE; 5.5 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, OLIVE, PACKAGED 6 PER BOX, STERILE; 5.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 5.5 MM STONECUTTER STRAIGHT BURR; 5.5 MM SYNOVATOR STRAIGHT BLADE; 5.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, MELON YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5MM FULL RADIUS PLATINUM SERIES; 5.5MM INCISOR PLUS PLATINUM SERIES; 5.5MM SYNOVATOR PLATINUM SERIES; 6 MM ENDOSCOPIC DRILL; 6 MM GRAFT SIZING TUBE; 6 MM OFFSET ENDOFEMORAL AIMER; 6 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6.5 MM CANNULATED DRILL; 6.5 MM CHISEL GUARD; 6.5 MM DILATOR; 6.5 MM ENDOSCOPIC DRILL; 6.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6.5MM DILATOR; 6MM DILATOR; 7 MM OFFSET ENDOFEMORAL AIMER; 7 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7.5 MM CANNULATED DRILL; 7.5 MM ENDOSCOPIC DRILL; 7.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7.5MM DILATOR; 7MM BICEPTOR TAP; 7MM DILATOR; 7MM ENDOSCOPIC DRILL XL; 7MM TENDON FORK; 8 MM ENDOSCOPIC DRILL XL; 8 MM PL TIBIAL AIMER POST; 8.5 MM CANNULATED DRILL; 8.5 MM DILATOR; 8.5 MM ENDOSCOPIC DRILL; 8.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 8.5MM DILATOR; 8MM BICEPTOR TAP; 8MM DILATOR; 8MM TENDON FORK; 9 MM ENDOSCOPIC DRILL XL; 9 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9.5 MM CANNULATED DRILL; 9.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 9.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9.5MM DILATOR; 90 DEGREE CURETTE, ANTERIOR LESION; 9MM BICEPTOR TAP; 9MM DILATOR; 9MM TENDON FORK; A-Tech ACL Sterilization Tray; A-Tech Controlled Flexion Guidewire; A-Tech Femoral Locator Handle; AC Powered Instrument Motor; ACCORD; ACCORD CABLE SYSTEM; ACCORD Cable System; ACCU-PASS STR SHTL BIG C STERILE BOX 1; ACCU-PASS SUTURE SHUTTLE 70 DEGREE; ACCU-PASS SUTURE SHUTTLE J-HOOK STERIL; ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE; ACCUPASS STR SHUTL MONOFIL -SEE72201361; ACCURIS; ACHIEVE CAS; ACL Bullet; ACL Closed Curette; ACL Disposables Guidewire Kit; ACL Disposables Kit; ACL Open Curette; ACL Tunnel Rasp; ACUFEX DIRECTOR ACL ELBOW AIMER; ACUFEX DIRECTOR ACL TIP AIMER; ACUFEX DIRECTOR ANGLED BULLET; ACUFEX DIRECTOR DRILL GUIDE. REQUIRES 1 AIMER AND 1 BULLET NOT INCLUDED; ACUFEX DIRECTOR PCL FEMORAL AIMER; ACUFEX DIRECTOR PCL SAFETY STOP; ACUFEX EXTRA ARTICULAR RECONSTRUCTION FEMORAL GUIDE; ACUFEX EXTRA ARTICULAR RECONSTRUCTION OFFSET GUIDE; ACUFEX Extra-Articular Reconstruction Fibular Guide; ACUFEX Extra-Articular Reconstruction Long Bullet; ACUFEX Extra-Articular Reconstruction Short Bullet; ACUFEX Extra-Articular Reconstruction System Tray; ACUFEX Extra-Articular Reconstruction Tibial Guide; ACUFEX Extra-Articular Retractor; ACUFEX GRAFTMASTER III PREPARATION BOARD; ACUFEX MTO PUNCH BASKET DUCKBILL UPBITER CURVED RIGHT PRO HANDLE; ACUFEX PINPOINT ADAPTER; ACUFEX PINPOINT BULLET 4 POINT - 6.5; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-6MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 6-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 7-8MM; ACUFEX PINPOINT DBL BNDL BULL SPT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-6MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 7-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-6MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 7-8MM; ACUFEX PINPOINT INSIDE-OUT HANDLE; ACUFEX PINPOINT OUTSIDE-IN AMR ARM LEFT; ACUFEX PINPOINT OUTSIDE-IN AMR ARM RT; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 10MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 6MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 8MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 9MM; ACUFEX PINPOINT SNGL BNDL GD 7MM; ACUFEX PUNCH BASKET CURVED RIGHT PRO HANDLE; ACUFEX PUNCH BASKET LEFT PRO HANDLE; ACUFEX PUNCH BASKET PRO RIGHT PRO HANDLE; ACUFEX PUNCH BASKET STRAIGHT PRO HANDLE; ACUFEX PUNCH BASKET UPBITER PRO HANDLE; ACUFEX PUNCH BASKET UPSWEPT PRO HANDLE; ACUFEX PUNCH OVAL STRAIGHT PRO HANDLE; ACUFEX PUNCH OVAL UPBITER PRO HANDLE; ACUFEX PUNCH SCISSOR STRAIGHT PRO HANDLE; ACUFEX PUNCH SCISSOR UPBITER PRO HANDLE; ACUFEX TRUNAV; ACUFEX TRUNAV RETROGRADE DRL 10.5MM; ACUFEX TRUNAV RETROGRADE DRL 10MM; ACUFEX TRUNAV RETROGRADE DRL 11.5MM; ACUFEX TRUNAV RETROGRADE DRL 11MM; ACUFEX TRUNAV RETROGRADE DRL 12MM; ACUFEX TRUNAV RETROGRADE DRL 6.5MM; ACUFEX TRUNAV RETROGRADE DRL 6MM; ACUFEX TRUNAV RETROGRADE DRL 7.5MM; ACUFEX TRUNAV RETROGRADE DRL 7MM; ACUFEX TRUNAV RETROGRADE DRL 8.5MM; ACUFEX TRUNAV RETROGRADE DRL 8MM; ACUFEX TRUNAV RETROGRADE DRL 9.5MM; ACUFEX TRUNAV RETROGRADE DRL 9MM; ACUFEX TUNNEL GAUGE; ACUFEX-PRO 3.4MM CUPPED GRASPR; ACUFEX-PRO NARROWLINE STR; ACUFEX-PRO NARROWLINE UPBITER; ACUFEX-PRO PITBULL GRASPER; ADVANSYS; ADVANSYS DLP; ADVANSYS MLP; ADVANSYS TTC; AETOS Shoulder System; AHTB UNIVERSAL HIP DISTRACTOR; AHTB WELL LEG HOLDER; AIMER ENDOFEMORAL 3MM OFFSET (BLUE); AIMER ENDOFEMORAL 4MM OFFSET (PURPLE); AIMER ENDOFEMORAL 5MM OFFSET (RED); AIMER TIBIAL PCL; AMBI; ANKLE ARTHROSCOPY ACCESSORY 2 UNITS; ANTHEM; ANTHEM Total Knee System; ANTHOLOGY; ANTHOLOGY HIP SYSTEM; ARO Osteotomy Guide Assembly; ARO Spacer Plate; ARTHRO-PIERCE STRAIGHT; ARTHROGARDE 4.5MM HIP CANNULA; ARTHROGARDE 5.5MM HIP CANNULA; ARTHROGARDE 5MM HIP CANNULA; ARTHROGARDE SLOTTLED CANNULA HIP; ARTHROPIERCE; ARTHROPIERCE 35 DEGREE UP; ARTHROPIERCE 45 DEG RIGHT; ARTHROPIERCE 45 DEGREE LEFT; ARTHROPIERCE INSTRUMENT CURVED LEFT; ARTHROPIERCE INSTRUMENT CURVED RIGHT; ARTHROPIERCE UTRATAPE; ARTHROPIERCE XL STRAIGHT; ARTHROSCOPIC LATARJET/BONE BLOCK LID; ARTHROSCOPIC LATARJET/BONE BLOCK TRAY; ARTHROSCOPIC NEEDLE STERILE; ASSEMBLY ENDOBUTTON INDICATOR; AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY 9.5 INCH LENGTH X 3 INCH WIDTH X 1.25 INCH HEIGHT; AWL STRAIGHT 3.8MM DISPOSABLE; AWL, INSERTION SITE MARKING, 45 DEGREES; Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361; Accu-pass suture shuttle 45 degree up, 7210425; Accu-pass suture shuttle 70 degree, Upbend, 72200419; Accu-pass suture shuttle J-hook; Accu-pass suture shuttle left 45 degree, 7210423; Accu-pass suture shuttle right 45 degree; Accu-pass suture shuttle, Big Curve; Accu-pass suture shuttle, crescent, 7210427; Accu-pass suture shuttle, straight, 7210426; Acufex Access Cart; Acute QC Strut and Components; Adaptor; Anatomic ACL Tray; Ankle Distractor; Ankle Distractor Strap; Anthology Hip Stems; Antrum Rasp; Arthroscopic needle, 72202825; Ascension; Ascension MCP; Ascension Modular Radial Head; Ascension NuGrip CMC Implant; Ascension PIP; Ascension Pyrocarbon Lunate; Ascension Pyrosphere; Ascension SPIP; Ascension Silicone MCP; Austin Moore; Awl; Awl straight 3.8mm, 72202986; Awl tapered 3.8mm; Awl, tap, driver, dilator; B-BOP; BANKART RASP; BHR; BI-GRIP PIN PULLER; BICEPTOR DRIVER; BIO-FIT; BIOLOX; BIORAPTOR INLINE DRILL GUIDE - OFFSET FISHMOUTH TIP 2.9 MM; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, CROWN TIP; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP; BIORAPTOR KNOTLESS INLINE OBTURATOR, BLUNT; BIORAPTOR TWIST DRILL, 2.9 MM INLINE; BIOSURE DRIVER; BIOSURE EASY TAP 10MM; BIOSURE EASY TAP 6MM; BIOSURE EASY TAP 7MM; BIOSURE EASY TAP 8MM; BIOSURE EASY TAP 9MM; BIOSURE RATCHET DRIVER; BIOSURE SYNC Inserter; BIOSURE TAP 10MM; BIOSURE TAP 6MM; BIOSURE TAP 7MM; BIOSURE TAP 8MM; BIOSURE TAP 9MM; BLADE 3.5 CURVED CONCAVE FULL RADIUS; BLADE 3.5MM ELITE FULL RADIUS; BLADE 4 ELITE ABRADER 6/BX; BLADE 5.5 FULL RADIUS ELITE DISPOSABLE; BLADE,4.5 BONECUTTER,FR,180MM LG,DSP; BLT ASSY. 4 POINT DIRECTOR; BLUNT NOSE JR. PUNCH; BOARD, PATIENT TRANSFER; BONE GRASPER; BONE TUNNEL PLUG; BONE TUNNEL PLUG NON-CANNULATED, LARGE 10-11 MM 3 PER PACKAGE; BONE TUNNEL PLUG NON-CANNULATED, SMALL 7-8 MM 3 PER PACKAGE; BONE TUNNEL PLUG XL 11-12 MM 3 PER PACKAGE; BUCK; BURR 4MM ABRADER 180MML DISPOSABLE (3; BURR 5.5MM ABRADER 180MML DISPOSABLE; Beath pin 2.4mm, 72202815; Beluga Retro; Bilok Instrument Sterilization Tray; Bilok ST Graft Expander; Bioblock; Biomotion Cannulated 1st MPJ Hemi System; Biosure 1.2mm x 18"", 72201201; Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile; Birmingham Hip; Blade, Sheath, Burr, Abrader, Incisor, Synovator, Acromionizer, Tubowhisker, Bonecutter, Acromioblaster, Notchblaster; Blunt Nose Junior; Bone Hook; Bone Tap; Brun; CALF STRAP EQUIPMENT RPLT AHTB; CALIBRATED DEPTH GAGE; CANN 5.5 WO/HOLES LTX FREE ORANGE; CANN DIAG RTTBL DBL VLV 4.5 ASCOPE; CANN DV ROT HF STORZ INT 6MM; CANN H.F. DGNST 6MM RTBL SGL VLV; CANN M.F. DGNST 6MM HIP DBL VLV; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE; CANNULA; CANNULA 2.9MM LONG WINDOW ASSEMBLY; CANNULA 2.9MM SHORT WINDOW; CANNULA 5.5MM OPER. W/STOPCOCK; CANNULA 5.5MM W/FINGER POST; CANNULA 6MM FMS 4MM AS W/O STOPCK; CANNULA 6MM FMS4MM ASCOPE W/STPCK; CANNULA CLEARTRAC 4.5 X 72MM THREADED; CANNULA CLEARTRAC SMOOTH 7 X 72MM; CANNULA CLEARTRAC THREADED 8.5 X 45MM; CANNULA CLEARTRAC THREADED 8.5 X 90MM; CANNULA ECTR; CANNULA FINGER POSTED 4.5MM; CANNULA FINGER POSTED 5.5MM; CANNULA FMS 2.7 LONG ASCOPE; CANNULA FMS SHORT 2.7 AS 3.8; CANNULA FOR 3.6 OPERATIVE SET; CANNULA INTEL NON-SCOPE 3MM; CANNULA MED FLOW ROT DBL VLV 5MM; CANNULA OPERATIVE 4.5MM NO DISATLHOLES; CANNULA OPERATIVE 5.5MM FINGERPOST; CANNULA OPERATIVE 5.5MM NO DISTAL HOLE; CANNULA OPERATIVE 5MM NO DIS HOLES; CANNULA SMOOTH FLEX 5.5 X 55MM; CANNULA SMOOTH FLEX 6.5 X 72MM; CANNULA SMOOTH FLEX 8 X 72MM; CANNULA THREADED DISP 8.5 X 72MM; CANNULA THREADED FLEX 5.5 X 45MM; CANNULA THREADED FLEX 6.5 X 72MM; CANNULA THREADED FLEX 8 X 90MM; CANNULATED OBTURATOR W/DELRIN 4.5MM; CANNULATED OBTURATOR W/DELRIN 5.5MM; CANNULATED OTBURATOR 8MM; CANNULATED SCREW; CANNULATED SCREWS; CANNULATED SCREWS CHS COMPRESSION HIP SCREW CONQUEST FN D-RAD PLATING SYSTEM EVOS PLATING SYSTEM; CAP-FIX Blade, Curved; CAP-FIX Blade, Curved, with Handle; CAP-FIX Blade, Curved, with Hip Pac; CAP-FIX Blade, Straight; CAP-FIX Blade, Straight, with Handle; CAP-FIX Blade, Straight, with Hip Pac; CAP-FIX SUTURE PASSER 45 DEG; CAP-FIX SUTURE PASSER 70 DEG; CAP-LIFT Cannula, 100mm; CAP-LIFT Cannula, 110mm; CAP-LIFT Cannula, 70mm; CAP-LIFT Cannula, 80mm; CAP-LIFT Cannula, 90mm; CAPTURE Cannulated Screw System; CARRIAGE REPLACEMENT KIT; CART PROCEDURE W. ISOL. TRANSFORMER; CART TRANSPORT SPIDER; CATALYSTEM Femoral Stems; CERAMIC FEMORAL HEAD; CHISEL GUARD; CHONDRAL PICK, LARGE, 20 DEGREE; CHONDRAL PICK, LARGE, 40 DEGREE; CHONDRAL PICK, SMALL, 20 DEGREE; CHONDRAL PICK, SMALL, 40 DEGREE; CHONDRAL PICK, SMALL, 90 DEGREE; CHS COMPRESSION HIP SCREW; CIRCLE SUTURE MENISCAL MENDER II; CLANCY 10 MM FLEXIBLE DRILL; CLANCY 10.5 MM FLEXIBLE DRILL; CLANCY 11 MM FLEXIBLE DRILL; CLANCY 12 MM FLEXIBLE DRILL; CLANCY 7.5 MM FLEXIBLE DRILL; CLANCY 9 MM FLEXIBLE DRILL; CLANCY 9.5 MM FLEXIBLE DRILL; CLANCY CURVED FEMORAL GUIDE, 42 DEGREE; CLEAR TRAC COMPLETE HIP CANNULA 7X110; CLEAR TRAC COMPLETE HIP CANNULA 8.5X110; CLEAR-TRAC CMPL. CANN. HIP OBT.8.5X110; CLEAR-TRAC CMPL.CANN. HIP OBT.7X110; CLEAR-TRAC DISPOSABLE STOPCOCK; CLEAR-TRAC MTO 5.5 MM X 72 MM REUSABLE OBTURATOR 4.3 MM CANNULATION; CLEAR-TRAC SCR CANN 8MM LTX FREE; CLEAR-TRAC THREADED CANNULA WITH OBTURATOR 5 MM X 76 MM, LATEX FREE, BOX OF 10; CLEARTRAC SCOPE/SHAVER CANNULA SMOOTH; COFIELD; COFIELD SHOULDER SYSTEM; COMPASS; COMPASS HINGE; CONQUEST FN; CONTOUR; CORACOID DRILLING GUIDE; CORACOID DRILLING OFFSETGUIDE 10MM; CORIOGRAPH Pre-Op Planning and Modeling Service; CPCS; CPCS Hip Stems; CROSSTRAC HIP GUIDE; CROSSTRAC HIP GUIDE BULLET; CURETTE CURVED 90 DEG; CURETTE OPEN 6MM 15 DEG; CURVED BLUNT DISSECTOR; CURVED ELEVATOR; CURVED INCISOR PLUS ELITE BL 4.5MM; CURVED LONG INCISOR PLUS ELITE BLADE; CURVED PROBE 3MM; Cadence Ankle Arthroplasty System; Cadence Total Ankle System; Calipers; Cannuflex 9"" Blunt Guidewire, 72202807; Cannula 5.5mm; Cannula Driver; Cannula set 4.5mm; Cannula set 5.5mm; Cannula set 7mm; Cannula, Obturator, Punch, Scissor, Suture cutter, Aimer, Gore smoother, Trephine adaptor, Guide, Knife; Cannula; post same as DOV, no holes; Cannulated Screw; Cannulated Switching Stick; Caps-Lock Cannula Driver; Caps-Lock Ultra; Carbon Modular Radial Head; Cement Tube with Suction Bypass; Cemented Round Patella with JRNY Pegs; Cemented Tibia Baseplate no Taper with JRNY Lock; Chisel; Chondral Pick; Chondral Pick Sterilization Tray; Circular fixation with balanced cable transport; Clamp; Clear-Trac Screw Cannula 7mm; Clear-Trac Screw Cannula 9mm; Clear-Trac Threaded Cannula 8mm x 76mm; Clear-Trac Threaded Cannula Kit 5mm ID, 76mm LG; Clear-Trac Threaded Cannula Kit, 8mm I.D., 76mm LG; Clear-Trac cannula Stopcock; Clear-Trac scope/shaver cannula; Clear-Trac scope/shaver cannula w/rib; Clearcut Suture Cutter; Closed Tendon Harvester; Cobb; Cove Point Pin; Crochet Hook; Crosstrac Flexible Passing Pin 13.50 x 2.4mm; Cuff Elevator; D-RAD; D-RAD PLATING SYSTEM; D-RAD SMART PACK; DART SUTURE PASSER; DELTA; DENYER RAIL CLAMP (LATERL DSTRCTR SYS); DENYER SUPINE RAIL CLAMPS 2; DETACHABLE OBTURATOR HANDLE ECTRA 2; DEUCE; DIA. 15MM CANNULA COVER; DIA. 15MM CANNULA TROCAR; DIA. 15MM CANNULA TUBE; DIAGNOSTIC CANNULAS 2.9MM; DILATOR; DILATOR 11-12MM BIOSURE SYNC; DILATOR 7-8MM BIOSURE SYNC; DILATOR 9-10MM BIOSURE SYNC; DIRECTOR PCL ELEVATOR WITH WIRE CATCHER; DISPOSABLE BL 4.5 ORBIT FR ELITE; DISPOSABLE BL 4.5MM CURVED FR ELITE (6); DISPOSABLE KNIFE; DISPOSABLE KNIFE HOOK STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE HOOK STRAIGHT 3 MM BOX OF 5, 10600; DISPOSABLE KNIFE ROSSETTE STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE SERRATED BANANA STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE SHARP TIP STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE V SHAPED; DISPOSABLE KNIFE V SHAPED, 10660; DISPOSABLE MIXING BOWL; DISSECTOR BLUNT CURVED ECTR; DISTRACTOR WARUPA DOUBLE 1.1MM&1.6MM; DOUBLE POSTERIOR GLENOID DRILL GUIDE; DPR SYSTEM; DRILL 2.6 MM BIORAPTOR 2.3 SUT ANC; DRILL 4.5MM SPADE TIP; DRILL 5.5MM SPADE TIP; DRILL ENDOBUTTON 4.5MM NON-CANN; DRILL FIXATION POSTERIOR STERILE BX OF 1; DRILL FLUTED 3MM WITH DEPTH STOP; DRILL GUIDE AC JOINT LEFT; DRILL GUIDE OFFSET; DRILL GUIDE PHALANGEAL EXTRA ARTICULAR; DRILL GUIDE PHALANGEAL LONG OFFSET; DRILL GUIDE PHALANGEAL SHORT OFFSET; DRILL GUIDE SLOTTED SPIKE TIP 2.3MM; DRILL RAPTORMITE 3 SUTURE ANCHOR; DRILL SURETAC IXC 8MM; DRILL TIP PASSING PIN 2.7 MM X 15 INCH, STERILE 6 PER BOX; DRIVER CANNULATED SCREW; DRIVER PIP MIDDLE PHALANX; DRIVER PIP PROXIMAL PHALANX; DRIVER PIP PROXIMAL PHALANX 10 DEGREE; DUCKBILL PUNCH BASKET UPBITER 1.5MM LOOP HANDLE; DUCKBILL PUNCH BASKET UPBITER CURVED LEFT 1.5 MM LOOP HANDLE; DUCKBILL PUNCH BASKET UPBITER CURVED RIGHT 1.5 MM LOOP HANDLE; DUCKLING PUNCH BASKET CURVED LEFT LOOP HANDLE; DUCKLING PUNCH BASKET CURVED RIGHT LOOP HANDLE; DUCKLING PUNCH BASKET ELEVATOR LOOP HANDLE; DUCKLING PUNCH BASKET STRAIGHT LOOP HANDLE; DUCKLING PUNCH BASKET UPBITER LOOP HANDLE; DUCKLING PUNCH BASKET UPSWEPT LOOP HANDLE; DYONICS 1/4 JCBS STL DRL SML BAT HND PC; DYONICS 2 MM FULL RADIUS BLADES, 7 CM LENGTH, BLUE, PACKAGED 6 PER BOX, STERILE; DYONICS 2 MM TURBOWHISKER BLADES, 7 CM LENGTH, YELLOW, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM ABRADER BURRS, 7 CM LENGTH, ORANGE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM BARREL BURRS, 7 CM LENGTH, PURPLE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM CUTTER BLADES, 7 CM LENGTH, BEIGE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM FULL RADIUS BLADES, 7 CM LENGTH, RED, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM INCISOR PLUS ELITE BLADES, 7 CM LENGTH, PEACH, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM TURBOWHISKER BLADES, 7 CM LENGTH, GREEN, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM ABRADER BURRS, 7 CM LENGTH, AQUA, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM FULL RADIUS BLADES, 7 CM LENGTH, PLUM, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM INCISOR PLUS ELITE BLADES, 7 CM LENGTH, SAGE GREEN, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM RAZORCUT BLADES, 7 CM LENGTH, PUMPKIN ORANGE, PACKAGED 6 PER BOX, STERILE; DYONICS 4MM ELITE ACROMIOBLASTER BURR; DYONICS 4MM ELITE ACROMIONIZER BURR(6); DYONICS 4MM ELITE NOTCHBLSTR ABRD BURR; DYONICS 4MM ELITE STONECUTTER BURR; DYONICS 5.5 FULL RADIUS BONECUTTER BLADES, ORANGE, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; DYONICS 5.5MM ELITE ABRADER BURR; DYONICS 5.5MM ELITE ACROMIOBLASTER BURR; DYONICS 5.5MM ELITE ACROMIONIZER BURR; DYONICS 5.5MM ELITE NOTCHBLSTR ABRD BURR; DYONICS 5.5MM ELITE STONECUTTER BURR; DYONICS 5/32 JACOBS STYLE DRL SML BATT; DYONICS KEYLESS SAGITTAL SW SML BT HNDPC; DYONICS MINI-MOTOR DRIVE, SUCTION LEVER, 10 FT 3 M CORD; DYONICS POWER CABLE ASSEMBLY; DYONICS POWERMAX ELITE HANDPIECE HAND-CONTROLLED WITH OPPOSITE-SIDE SUCTION LEVER; DYONICS POWERMAX ELITE HANDPIECE HAND-CONTROLLED WITH OPPOSITE-SIDE SUCTION LEVER REFURBISHED; DYONICS POWERMINI SMALL JOINT HANDPIECE WITH BLADE MULTI-POSITIONING, NO HAND CONTROLS, SUCTION LEVER, 10 FT 3 M CORD.; DYONICS SAGITTAL SAW W/KEY SML BAT HNDPC; DYONICS SYNTHS QUCK CON DRL SM BAT HNDPC; DYONICS WIRE DRVR SM BAT HANDPIECE; DYONICS ZIMMER HT RMR SML BAT HNDPC; DYOVAC KIT CLEANING BRUSHES FOR 5.2 MM SUCTION PUNCH, 10 PER BOX; DYOVAC SUCTION PUNCH 3.4MM STRAIGHT; DYOVAC SUCTION PUNCH 5.2MM STRAIGHT; Depth Gage; Depth Probe; DigiFuse Cannulated Intramedullary Fusion System; DigiFuse, TFS2, Capture, MBA, MetaSurg Subtalar, BOLD, HALLU-Lock, HALLU Plate, QUIX, SPIN, TIBIAXYS; Digital Goniometer; Disposable Knee Instruments; Doane; Drill Bit; Drill Tip Passing Pin; Drill for Q-FIX with Needles; Drill tip, passing pin w/graduation to 180mm; Driver; Dynomite 1.6mm drill & guide; ECHELON; ECHELON HIP SYSTEM; ECTRA HAND HOLDER/STERILIZATION TRAY WITH COVER; ELEVATOR COTTLE; ELEVATOR CURVED TEARDROP; ELITE MTO SHOULDER ELEVATOR BLUNT DOWN; ELITE MTO SHOULDER ELEVATOR BLUNT UP; ELITE MTO SHOULDER ELEVATOR DOWN; ELITE MTO SHOULDER ELEVATOR UP; ELITE PREMIUM ALLIGATOR GRASPER; ELITE PREMIUM COMBINATION GRASPER; ELITE PREMIUM CROCHET HOOK; ELITE PREMIUM KNOT MANIPULATOR; EMPERION; ENDER; ENDOBUTTON DEPTH PROBE; ENDOBUTTON HOLDER SCALE EXTENDER; ENDOFEMORAL AIMER, NO OFFSET; ENDOSCOPIC CANNULATED DRILL BIT, 4.5 MM, STERILE; ENDOSCOPIC FEMORAL AIM ARM 3MM OFFSET; ENDOSCOPIC FEMORAL AIM ARM 4MM OFFSET; ENDOSCOPIC FEMORAL GUIDE HANDLE; ENGAGE; ENGAGE Partial Knee System; EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH; EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS); EVOS; EVOS 1.8MM X 10MM LOCKING PEG T7; EVOS DISTAL RADIUS DORSAL PLATE 3H STANDARD TITANIUM 56MM; EVOS DISTAL RADIUS DORSAL PLATE 3H WIDE TITANIUM 58MM; EVOS DISTAL RADIUS INTERMEDIATE COLUMN PLATE 4H TITANIUM 54MM; EVOS DISTAL RADIUS RADIAL COLUMN PLATE 4H TITANIUM 57MM; EVOS DISTAL RADIUS VOLAR PLATE 10H RIGHT STANDARD 138MM; EVOS DISTAL RADIUS VOLAR PLATE 10H STANDARD TITANIUM 141MM; EVOS DISTAL RADIUS VOLAR PLATE 3H STANDARD 48MM; EVOS DISTAL RADIUS VOLAR PLATE 3H STANDARD TITANIUM 48MM; EVOS DISTAL RADIUS VOLAR PLATE 3H WIDE 48MM; EVOS DISTAL RADIUS VOLAR PLATE 3H WIDE TITANIUM 48MM; EVOS DISTAL RADIUS VOLAR PLATE 4H STANDARD 56MM; EVOS DISTAL RADIUS VOLAR PLATE 4H STANDARD TITANIUM 56MM; EVOS DISTAL RADIUS VOLAR PLATE 4H WIDE 56MM; EVOS DISTAL RADIUS VOLAR PLATE 4H WIDE TITANIUM 56MM; EVOS DISTAL RADIUS VOLAR PLATE 5H STANDARD 76MM; EVOS DISTAL RADIUS VOLAR PLATE 5H STANDARD TITANIUM 81MM; EVOS DISTAL RADIUS VOLAR PLATE 5H WIDE 78MM; EVOS DISTAL RADIUS VOLAR PLATE 5H WIDE TITANIUM 83MM; EVOS DISTAL RADIUS VOLAR PLATE 7H STANDARD 100MM; EVOS DISTAL RADIUS VOLAR PLATE 7H STANDARD TITANIUM 105MM; EVOS DISTAL RADIUS VOLAR PLATE 7H WIDE 100MM; EVOS DISTAL RADIUS VOLAR PLATE 7H WIDE TITANIUM 105MM; EVOS DISTAL ULNA PLATE 7H TITANIUM 34MM; EVOS PLATING SYSTEMS; EVOS PROXIMAL RADIAL SHAFT PLATE 5H L 95MM; EVOS Patella Plates; EVOS Pelvic and Acetabular System; EVOS RADIAL SHAFT PLATE 8H 98MM; EVOS TITANIUM 1.8MM X 10MM LOCKING PEG T7; EVOS TITANIUM 3.5MM X 10MM CORTEX SCREW T15 SELF-TAPPING; EVOS TITANIUM 3.5MM X 10MM LOCKING SCREW T15 SELF TAPPING; EVOS WRIST DORSAL WRIST SPANNING PLATE; EVac Bending Tool; Elevator Rasp; Endobutton Pin Passing 2.4mm Trocar; Endobutton drill tip, passing pin 2.4mm x 15; Endobutton drill tip, passing pin 2.7mm x 15; Endoscopic Cannula Drill Bit 4.5mm; Extractor; Extremities Guide, Universal; FAST-FIX 360 CURVED KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS; FAST-FIX 360 STRAIGHT KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS; FEMORAL AIMER; FEMORAL CANAL SUCTION ABSORBER; FERKEL 15 DEGREE ANTERIOR LESION CURETTE, 2.5 MM; FERKEL 15 DEGREE OPEN CURETTE, 2.5 MM; FERKEL 15 DEGREE OPEN CURETTE, 4 MM; FERKEL 30 DEGREE OPEN CURETTE, 2.5 MM; FERKEL MICROFRACTURE PICK 40 DEGREE; FERKEL MICROFRACTURE PICK 65 DEGREE; FERKEL MICROFRACTURE PICK 90 DEGREE; FIRSTPASS MINI Suture Passer; FIRSTPASS Suture Passer; FIXATION CERCLAGE; FIXATION STAPLE; FLEXIBLE DRILL; FLUID MAN EXT DIAG CANN W/INFLOW & VALVE; FLUID SEAL ADAPTOR; FLUSH SUTURE CUTTER; FLUSH SUTURE CUTTER XL; FOREFOOT; FULL RADIUS BONECUTTER 4.5MM PLATINUM; FULL RADIUS BONECUTTER 5.5MM PLATINUM; Face Shield; Fluid Barrier Boots,; Femoral Aimer; Femoral Heads; Femoral Locator; First Choice DRUJ; First Choice MUH; FirstPass Mini Suture Passer Left Curved; FirstPass Mini Suture Passer Right Curved; FirstPass Needle and Suture Capture; Fixation post drill, 72202879; Forefoot II; Freedom Wrist Arthroplasty System; GD WIRE NITINOL 1.2 X 45CM; GENESIS; GENESIS II; GENESIS II KNEE SYSTEM; GENESIS II OXINIUM; GENESIS II POROUS PLUS; GENESIS KNEE SYSTEM; GLENOID DRILL GUIDE LONG BULLET; GLENOID DRILL GUIDE SHORT BULLET; GRAFT SIZING BLOCK; GRAFT SIZING TUBE - 5.5MM; GRAFT SIZING TUBE - 5MM; GRAFT SIZING TUBE - 9.5MM; GRAFT SIZING TUBE -10.5MM; GRAFT SIZING TUBE -11.5MM; GRAFT SIZING TUBE -12.5MM; GRAFT SIZING TUBE -13.5MM; GRAFTMASTER ENDOBUTTON HOLDER; GRAFTMASTER II CUTTING STRIP; GRAFTMASTER II GRAFT PREP BRD.; GRAFTMASTER II SYSTEN TRAY; GRAFTMASTER III BTB HOLDER; GRAFTMASTER III CUTTING STRIP; GRAFTMASTER III SLIDING BASE 2; GRAFTMASTER III TENSIONING POST; GRAFTMASTER III TISSUE GRASPER 2; GRASPER ALLIGATOR MAX EXTENDED; GRASPER CUPPED 3.4MM EXTENDED 2.25; GRASPER EXTENDED 2.25; GRSPR ALGTR MAX; GRSPR ALGTR STR 2.7MM; GRSPR ALGTR UPBTR; GRSPR ATRMTC CANLTD TNSNR TIS; GRSPR ATRMTC TNSNR TIS; GRSPR CUPD 2.7MM; GRSPR CUPD 3.4MM; GRSPR FRCP LOOSEBODY PTBLL; GRSPR JT SM; GUHL NON-INVASIVE ANKLE DISTRACTOR STERILIZATION TRAY; GUIDE 2.3MM INLINE DRILL CROWN TIP; GUIDE 2.3MM INLINE DRILL F MOUTH TIP; GUIDE 2.3MM INLINE DRILL SPIKE TIP; GUIDE METATARSAL OSTEOTOMY; GUIDE WIRE 1.2MM X 9 BOX OF 5 STERILE; GUIDE WIRE 1.2MM X18 BX OF 5 STER.; GUIDE WIRE ALIGNER 45 MVECT; GUIDE WIRE ALIGNER 62 MVECT; GUIDE WIRE BEATH PIN 2.4 MM STERILE; GUIDE WIRE PCL 2.4MM X10; GUIDE WR 1.2MM X 12 BOX OF 5 STERILE; GUIDE, 4MM INLINE DRILL BIORAPTOR, HIP; GUIDEWIRE CANNFLEX 9 BLUNT TIP; Gelpi; Genesis Uni Knee System; Glenoid Holder; Graft Assist, Board; Graft Bar Drill; Graft Bar Holder; Graft Board Hook; Graft sizing tube; PCL two-tunnel template; Tensioning device; Graft preparation block; Graft, Base Lock",1978-02-22,362,2026-09-08,1,105,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221020279%22&limit=1
"MEDLINE INDUSTRIES, LP - Northfield",1417592,1417592,Three Lakes Drive,Northfield,IL,60093,United States,"Medline Industries, LP",1417592,Complaint file establishment; Repackager or relabeler; Specification developer,618,BSJ; BSK; BSO; BSP; BSY; BTA; BTC; BTM; BTQ; BTT; BTX; BWF; BYD; BYF; BYG; BYH; BYP; BYX; BYY; BYZ; BZA; BZB; BZD; BZE; BZO; CAE; CAF; CAI; CAN; CAT; CAZ; CBH; CCK; CCW; CCX; CDM; CEN; DQA; DQO; DRS; DRX; DSA; DSS; DTL; DWF; DWJ; DWL; DWP; DWS; DXC; DXN; DXQ; DXT; DZN; EAJ; EAX; EFL; EFN; EFQ; EFS; EFW; EGN; EHZ; EIR; EKT; EMF; EMG; EMH; EMI; EMJ; EMK; EML; EMM; EPP; EPY; EXI; EXN; EXX; EYB; EYH; EYI; EYJ; EYQ; EYR; EYZ; EZD; EZL; EZR; FAQ; FAX; FBM; FBS; FCL; FEG; FFH; FFN; FFO; FFQ; FGD; FGM; FGN; FHL; FHN; FHO; FHQ; FHX; FLK; FLL; FMA; FME; FMF; FMH; FMI; FMK; FMP; FMQ; FMR; FMW; FNJ; FNL; FNM; FNP; FNS; FNY; FOB; FOD; FOX; FOZ; FPA; FPF; FPY; FQL; FQM; FQZ; FRG; FRL; FRO; FRW; FSA; FSD; FSM; FTA; FTL; FTY; FWZ; FXE; FXG; FXN; FXP; FXX; FYA; FYC; FYD; FYF; FYH; FZF; FZM; FZO; FZP; FZQ; FZR; FZS; FZT; FZX; FZY; FZZ; GAA; GAB; GAC; GAD; GAE; GAF; GAG; GAI; GAT; GAX; GAZ; GBM; GBX; GCC; GCD; GCJ; GCX; GCY; GDF; GDG; GDH; GDI; GDJ; GDL; GDM; GDN; GDO; GDR; GDT; GDX; GDY; GEA; GEC; GEG; GEH; GEI; GEJ; GEN; GEO; GES; GFA; GFF; GFI; GFJ; GHY; GJW; GTY; GWX; GWY; GXY; GYB; GZT; GZX; HAE; HAO; HAS; HBA; HBG; HBT; HCF; HCY; HCZ; HDA; HDE; HDF; HDJ; HDK; HDL; HDQ; HEF; HFB; HFW; HFX; HGD; HGE; HGX; HGY; HHD; HHF; HIB; HIF; HMP; HMQ; HMR; HMX; HNA; HNC; HND; HNE; HNF; HNH; HNI; HNL; HNM; HNN; HNQ; HNR; HNW; HNX; HNY; HNZ; HOE; HOI; HOY; HRH; HRQ; HRR; HRS; HSS; HTC; HTD; HTF; HTJ; HTN; HTO; HTR; HTS; HTW; HTX; HTZ; HWA; HWB; HWC; HWI; HWJ; HWK; HWM; HWQ; HWT; HWW; HWX; HXB; HXD; HXE; HXG; HXL; HXO; HXP; HXS; HXW; HXX; HXY; HXZ; IFP; IKD; IKX; IKY; ILC; ILD; ILH; ILI; ILO; ILS; IMD; IME; IMM; IMP; IMR; INB; INF; INM; INN; INO; INP; IOD; ION; IOR; IOY; IPG; IPM; IPR; IPS; IQB; IQE; IQF; IQI; IQJ; IQK; ISA; ISR; ITG; ITJ; ITQ; ITW; ITX; JCB; JDR; JDZ; JEB; JEQ; JEX; JHI; JIL; JIN; JIO; JIR; JJB; JMA; JMT; JOJ; JOK; JOL; JOW; JQC; JRC; JRE; JSM; JXA; JYC; JYE; JYF; JYG; JYH; JYJ; JYL; JYO; JYQ; JYR; JYT; JYY; JYZ; JZB; JZE; JZF; JZY; KAD; KAE; KAJ; KAK; KAL; KAN; KAO; KAP; KAR; KAS; KAW; KAY; KBA; KBB; KBD; KBE; KBH; KBL; KBN; KBQ; KBR; KBS; KBZ; KCA; KCC; KCG; KCH; KCJ; KCP; KCT; KDC; KDD; KDP; KDQ; KDT; KEM; KES; KEW; KGB; KGC; KGN; KGO; KGX; KHE; KHR; KIA; KIC; KIK; KIZ; KJG; KKX; KME; KMF; KMI; KMJ; KMK; KMN; KMO; KNN; KNO; KNP; KNT; KNX; KOA; KOD; KOO; KOX; KPD; KPN; KQM; KQO; KQW; KSS; KST; KTC; KTD; KTE; KTF; KTG; KTN; KTZ; KXF; KXG; KYR; KYW; KYX; KYZ; LBJ; LCM; LCX; LDD; LDE; LFL; LGF; LGG; LGH; LHC; LHI; LIB; LIO; LJH; LJX; LKB; LLI; LRC; LRJ; LRO; LRP; LRR; LRW; LRY; LWF; LWG; LWH; LWK; LXG; LXH; LXI; LXZ; LYR; LYU; LYV; LYY; LYZ; LZA; LZB; LZC; LZH; MBI; MDM; MDR; MED; MEG; MGQ; MHW; MJG; MJI; MLY; MMK; MMP; MNK; MNL; MNR; MPN; MPO; MPQ; MQV; MRI; MRL; MRV; MSH; MTJ; MUI; NAB; NAC; NAD; NAE; NBH; NEC; NFT; NFV; NFW; NFY; NGG; NGL; NKC; NLF; NLM; NLQ; NNI; NNK; NNN; NNR; NNU; NOA; NOD; NWN; NXB; NXZ; NZD; NZU; OCT; OCX; OEA; OEV; OFP; OFR; OGG; OGV; OHI; OHO; OHR; OHY; OIE; OJH; OJJ; OJU; OKE; OMD; OOW; OPJ; OSI; OWL; OWX; OXQ; PIF; PIO; PRN; PSH; PTG; PTH; PTI; PTM; PUI; PWT; PXC; QAW; QBF; QDO; QKR; QPC; QQS; QSO; QSY; QTC; QUW; SCA,"Mask, Gas, Anesthetic; Cuff, Tracheal Tube, Inflatable; Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Catheters, Suction, Tracheobronchial; Pump, Portable, Aspiration (Manual Or Powered); Bag, Reservoir; Ventilator, Emergency, Manual (Resuscitator); Airway, Nasopharyngeal; Humidifier, Respiratory Gas, (Direct Patient Interface); Board, Arm (With Cover), Sterile; Spirometer, Therapeutic (Incentive); Condenser, Heat And Moisture (Artificial Nose); Mask, Oxygen, Low Concentration, Venturi; Mask, Oxygen; Drain, Tee (Water Trap); Mouthpiece, Breathing; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Trap, Sterile Specimen; Connector, Airway (Extension); Catheter, Nasal, Oxygen; Ventilator, Non-Continuous (Respirator); Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer; Set, Tubing And Support, Ventilator (W Harness); Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Circuit, Breathing (W Connector, Adaptor, Y Piece); Regulator, Pressure, Gas Cylinder; Cannula, Nasal, Oxygen; Anesthesia Conduction Kit; Device, Fixation, Tracheal Tube; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Laryngoscope, Rigid; Support, Patient Position; Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.); Dye-Indicator, Ph (Urinary, Non-Quantitative); Oximeter; Catheter, Intravascular, Diagnostic; Transducer, Blood-Pressure, Extravascular; Electrode, Electrocardiograph; Cable, Transducer And Electrode, Patient, (Including Connector); Clip, Vascular; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; System, Thermal Regulating; Stocking, Medical Support (To Prevent Pooling Of Blood In Legs); Dilator, Vessel, Surgical; Instruments, Surgical, Cardiovascular; Clamp, Vascular; System, Measurement, Blood-Pressure, Non-Invasive; Blood Pressure Cuff; Injector And Syringe, Angiographic; Instruments, Dental Hand; Apron, Leaded; Mirror, Mouth; Forceps, Dressing, Dental; Cotton, Roll; Gauze/Sponge, Internal; Unit, Oral Irrigation; Toothbrush, Manual; Scissors, Surgical Tissue, Dental; Evacuator, Oral Cavity; Scissors, Collar And Crown; Curette, Endodontic; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Forceps, Rongeur, Surgical; File, Bone, Surgical; Elevator, Surgical, Dental; Curette, Surgical, Dental; Chisel, Bone, Surgical; Chisel, Osteotome, Surgical; Splint, Nasal; Speculum, Ent; Device, Paste-On For Incontinence, Sterile; Support, Hernia; Probe, Rectal, Non-Powered; Catheter, Ureteral, Gastro-Urology; Table, Cysto, Non-Electrical; Adaptor, Ureteral Catheter; Holder, Ureteral Catheter; Garment, Protective, For Incontinence; Tourniquet, Gastro-Urology; System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile; Catheter, Straight; Catheter, Retention Type, Balloon; Cement, Stomal Appliance, Ostomy; Bag, Urine Collection, Leg, For External Use, Sterile; Bougie, Urological; Cannula And Trocar, Suprapubic, Non-Disposable; Sound, Metal, Interconnected; Forceps, Biopsy, Non-Electric; Tube, Double Lumen For Intestinal Decompression And/Or Intubation; Collector, Urine, Pediatric, For Indwelling Catheter; Clamp, Non-Electrical; Retractor, Self-Retaining; Speculum, Rectal; Catheter, Retention, Barium Enema With Bag; Probe And Director, Gastro-Urology; Retractor, Non-Self-Retaining; Scoop; Ligator, Hemorrhoidal; Pneumoperitoneum Needle; Holder, Needle, Gastroenterologic; Jelly, Lubricating, For Transurethral Surgical Instrument; Thermometer, Clinical Mercury; Continuous Measurement Thermometer; Depressor, Tongue, Non-Surgical; Gown, Examination; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Protector, Skin Pressure; Restraint, Protective; Device, Transfer, Patient, Manual; Cover, Mattress (Medical Purposes); Bed, Manual; Bed, Ac-Powered Adjustable Hospital; Mattress, Air Flotation, Alternating Pressure; Urinal; Ring Cutter; Basin, Emesis; Bedpan; Device, Occlusion, Umbilical; Stand, Infusion; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Bottle, Hot/Cold Water; Sheet, Burn; Stocking, Medical Support (For General Medical Purposes); Bandage, Elastic; Thermometer, Clinical Color Change; Wrap, Sterilization; Fiber, Medical, Absorbent; Dressing, Wound, Drug; Scale, Patient; Lift, Patient, Non-Ac-Powered; Binder, Abdominal; Tray, Surgical, Instrument; Light, Surgical, Accessories; Mesh, Surgical, Polymeric; Tape, Measuring, Rulers And Calipers; Operating Room Accessories Table Tray; Speculum, Non-Illuminated; Specula Accessories; Tape, Camera, Surgical; Cover, Shoe, Operating-Room; Mask, Surgical; Gown, Surgical; Gown, Isolation, Surgical; Apparatus, Exhaust, Surgical; Cap, Surgical; Splint, Extremity, Noninflatable, External, Sterile; Splint, Extremity, Inflatable, External; Stool, Operating-Room; Chisel, Surgical, Manual; Clip, Implantable; Clip, Removable (Skin); Contractor, Surgical; Curette, Surgical, General Use; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Marker, Skin; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Snare, Surgical; Spatula, Surgical, General & Plastic Surgery; Stapler, Surgical; Stripper, Vein, Reusable; Suture, Nonabsorbable, Synthetic, Polyethylene; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Urethral; Catheter, Irrigation; Dilator, Catheter; Connector, Catheter; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Needle, Suturing, Reusable; Needle, Aspiration And Injection, Reusable; Knife, Amputation; Applier, Surgical, Clip; Saw, Manual And Accessories; Staple, Removable (Skin); Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Cannula, Surgical, General & Plastic Surgery; Brush, Scrub, Operating-Room; Elevator, Surgical, General & Plastic Surgery; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Forceps, General & Plastic Surgery; File, Surgical, General & Plastic Surgery; Blade, Scalpel; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Hematocrit, Tube, Rack, Sealer, Holder; Pipette, Pasteur; Antigens, All Groups, Streptococcus Spp.; Fork, Tuning; Pinwheel; Electrode, Cutaneous; Media, Electroconductive; Retractor, Self-Retaining, For Neurosurgery; Instrument, Microsurgical; Rongeur, Manual; Instrument, Surgical, Non-Powered; Needle, Neurosurgical Suture; Neurosurgical Paddie; Drills, Burrs, Trephines & Accessories (Manual); Applier, Hemostatic Clip; Instrument, Ligature Passing And Knot Tying; Curette, Uterine; Forceps, Surgical, Gynecological; Forceps, Obstetrical; Hook, Fibroid, Gynecological; Speculum, Vaginal, Metal; Scissors, Umbilical; Scissors, Episiotomy; Retractor, Vaginal; Dilator, Cervical, Fixed Size; Binder, Breast; Forceps, Biopsy, Gynecological; Clamp, Umbilical; Clamp, Circumcision; Applicator, Vaginal; Amniotome; Pump, Breast, Powered; Pump, Breast, Non-Powered; Pad, Menstrual, Unscented; Remover, Intrauterine Device, Contraceptive, Hook-Type; Speculum, Vaginal, Nonmetal; Insufflator, Laparoscopic; Pad, Eye; Marker, Sclera; Marker, Ocular; Cannula, Ophthalmic; Spud, Ophthalmic; Specula, Ophthalmic; Spatula, Ophthalmic; Snare, Enucleating; Scissors, Ophthalmic; Ring, Ophthalmic (Flieringa); Retractor, Ophthalmic; Probe, Lachrymal; Needle, Ophthalmic Suturing; Knife, Ophthalmic; Hook, Ophthalmic; Forceps, Ophthalmic; Dilator, Lachrymal; Depressor, Orbital; Cystotome; Curette, Ophthalmic; Caliper, Ophthalmic; Spectacle, Magnifying; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Trephine, Manual, Ophthalmic; Hemostat; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Halter, Head, Traction; Pliers, Surgical; Forceps; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Rasp; Knife, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Corkscrew; Awl; Trephine; Osteotome; Passer; Template; Countersink; Tap, Bone; Probe; Clamp; Fork; Tamp; Mallet; Pusher, Socket; Instrument, Bending Or Contouring; Twister, Wire; Bender; Screwdriver; Brace, Drill; Cutter, Wire; Formalin, Neutral Buffered; Cable, Electrode; Aid, Transfer; Mattress, Flotation Therapy, Non-Powered; Utensil, Eating; Adaptor, Dressing; Splint, Hand, And Components; Sling, Arm; Pack, Hot Or Cold, Water Circulating; Adaptor, Hygiene; Pack, Hot Or Cold, Disposable; Pack, Hot Or Cold, Reusable; Footrest, Wheelchair; Cushion, Wheelchair; Device, Anti-Tip, Wheelchair; Attachment, Commode, Wheelchair; Scale, Platform, Wheelchair; Chair, With Casters; Chair, Adjustable, Mechanical; Chair, Positioning, Electric; Tips And Pads, Cane, Crutch And Walker; Components, Exercise; Exerciser, Non-Measuring; Wheelchair, Mechanical; Support, Arm; Shoe, Cast; Cover, Limb; Crutch; Cane; Belt, Wheelchair; Orthosis, Lumbar; Orthosis, Cervical-Thoracic, Rigid; Orthosis, Limb Brace; Splint, Clavicle; Orthosis, Cervical; Massager, Therapeutic, Electric; Band Or Belt, Pelvic Support; Bandage, Cast; Walker, Mechanical; Joint, Knee, External Brace; Joint, Ankle, External Brace; Transducer, Ultrasonic, Diagnostic; Detergent; Staple, Fixation, Bone; Mixer, Cement, For Clinical Use; Table, Surgical With Orthopedic Accessories, Manual; Toothbrush, Powered; Plier, Orthodontic; Visual, Pregnancy Hcg, Prescription Use; Method, Enzymatic, Glucose (Urinary, Non-Quantitative); Nitroprusside, Ketones (Urinary, Non-Quant.); Blood, Occult, Colorimetric, In Urine; Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.); Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric); Diazo (Colorimetric), Nitrite (Urinary, Non-Quant); Indicator, Physical/Chemical Sterilization Process; Scissors, Medical, Disposable; Catheter And Tip, Suction; Sleeve, Limb, Compressible; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Micro Pipette; Refractometer For Clinical Use; Culture Media, Non-Propagating Transport; Kit, Screening, Urine; Cannula, Ear; Chisel, Middle-Ear; Clamp, Ossicle Holding; Curette, Ear; Excavator, Ear; Gauge, Measuring; Hook, Microsurgical Ear; Knife, Ear; Loop, Wire; Nipper, Malleus; Pick, Microsurgical Ear; Rasp, Ear; Rod, Measuring Ear; Scissors, Ear; Spoon, Ear; Tube, Ear Suction; Knife, Laryngeal; Elevator, Ent; Forceps, Ent; Mobilizer, Ent; Probe, Ent; Retractor, Ent; Chisel, Nasal; Curette, Ethmoid; Curette, Nasal; Irrigator, Sinus; Knife, Nasal; Punch, Antrum; Punch, Nasal; Rasp, Nasal; Rongeur, Nasal; Scissors, Nasal; Snare, Nasal; Adenotome; Depressor, Metal Tongue, Surgical; Gag, Mouth; Knife, Tonsil; Needle, Tonsil Suturing; Punch, Adenoid; Snare, Tonsil; Tonsillectome; Bistoury, Tracheal; Dilator, Tracheal; Hook, Tracheal; Applicator, Ent; Syringe, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Regulator, Vacuum; Bottle, Collection, Vacuum; Container, Specimen Mailer And Storage, Sterile; Agent, Clearing; Coverslips, Microscope Slide; Slides, Microscope; Mask, Oxygen, Non-Rebreathing; Tube, Gastro-Enterostomy; Wound Dressing With Animal-Derived Material(S); Surgeon'S Gloves; Tape And Bandage, Adhesive; Reagent, Occult Blood; Absorber, Saliva, Paper; Cover, Cast; Cushion, Flotation; Hook, Bone; Dish, Tissue Culture; Tube, Tissue Culture; Drape, Surgical, Antimicrobial; Bedding, Disposable, Medical; Bandage, Liquid; Monitor, Bed Patient; Lubricant, Patient; Device, Intravascular Catheter Securement; Chair And Table, Medical; Binder, Elastic; Components, Wheelchair; Accessories, Wheelchair; Orthosis, Corrective Shoe; Tubes, Gastrointestinal (And Accessories); Collector, Urine, (And Accessories) For Indwelling Catheter; Surgical Instruments, G-U, Manual (And Accessories); Catheter, Urological; Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt; Solvent, Adhesive Tape; Strip, Temperature, Forehead, Liquid Crystal; Alarm, Conditioned Response Enuresis; Camera, Surgical And Accessories; Automated Urinalysis System; Goniometer, Nonpowered; Supplies, Blood-Bank; System, Blood Collection, Vacuum-Assisted, Manual; Bath, Sitz, Nonpowered; Orthosis, Abdominal; Trocar, Ent; Punch, Ent; Knife, Ent; System, Test, Infectious Mononucleosis; Caliper; Applicator, Absorbent Tipped, Non-Sterile; Applicator, Absorbent Tipped, Sterile; Bag, Ice; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Device, Vein Stabilization; Enzyme Immunoassay, Phencyclidine; Kit, Test, Pregnancy, Hcg, Over The Counter; Dc-Defibrillator, Low-Energy, (Including Paddles); Stethoscope, Manual; Instrument, Ultrasonic Surgical; Component, Cast; Instrument, Cast Application/Removal, Manual; Instrument, Cast Removal, Ac-Powered; Warmer, Irrigation Solution; Set, I.V. Fluid Transfer; Device, General Purpose, Microbiology, Diagnostic; Device, Specimen Collection; System, Irrigation, Urological; Test, Urine Leukocyte; Pad, Alcohol, Device Disinfectant; Bed, Therapeutic, Ac-Powered, Adjustable Home-Use; Instrument, Ent Manual Surgical; Disinfectant, Medical Devices; General Surgery Tray; Tray, Surgical; First Aid Kit With Drug; Scissors, General, Surgical; Punch, Surgical; Dilator, Nasal; Surgical Table Cushion; Counter, Sponge, Surgical; Razor, Surgical; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Orthopedic Manual Surgical Instrument; Guide, Drill, Ligament; Guard, Instrument; Helicobacter Pylori; Accessory, Surgical Apparel; Label Or Tag, Sterile; Latex Patient Examination Glove; Vinyl Patient Examination Glove; Polymer Patient Examination Glove; Finger Cot; Medical Glove, Specialty; Pump, Infusion, Enteral; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Binder, Medical, Therapeutic; Sterilant, Medical Devices; Syringe, Antistick; Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic; Dressing, Compression; Device, Percutaneous, Biopsy; Specimen/Tissue, Identification Orientation; Vapocoolant Device; Container, Sharps; Cover, Barrier, Protective; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Ventilatory Effort Recorder; Tissue Adhesive For The Topical Approximation Of Skin; Infant Heel Warmer (Chemical Heat Pack); Container, Specimen, Urine, Drugs Of Abuse, Over The Counter; Filler, Bone Void, Calcium Compound; Orthosis, Truncal/Orthosis, Limb; Scale, Sponge, Surgical, Electrically-Powered; Drink, Glucose Tolerance; Respirator, Surgical; Wax, Bone; Media, Coupling, Ultrasound; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Accessories, Arthroscopic; Bandage, Liquid, Skin Protectant; Test, Amphetamine, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Cannabinoid, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Methamphetamine, Over The Counter; Test, Opiates, Over The Counter; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Oximeter, Reprocessed; Laparoscope, General & Plastic Surgery, Reprocessed; Single-Use Reprocessed Ultrasonic Surgical Instruments; Container, Specimen, Non-Sterile; Container, Specimen Mailer And Storage, Non-Sterile; Crimper, Wire, Ent, Non-Sterile; Block, Cutting, Ent, Non-Sterile; Scissors, Wire Cutting, Ent, Non-Sterile; Device, Paste-On For Incontinence, Non-Sterile; Board, Arm (With Cover), Non-Sterile; Laparoscopic Bone Anchor Urethropexy Instrument Kit; Dispenser, Solid Medication; Dental Hygiene Kit; Stretcher, Patient Restraint; Collector, Urine, Powered, Non Indwelling Catheter; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Irrigation/Suction System; Non-Surgical Gown; Cardiopulmonary Resuscitation Aid Kit; Anesthesia Breathing Circuit Kit (Adult & Pediatric); Tracheobronchial Suction Catheter Kit; Humidifier Nebulizer Kit; Tracheostomy Cleaning Tray; Orthosis, Foot Drop; First Aid Kit Without Drug; Catheter Care Tray; Pill Crusher/Cutter; Urine Collection Kit (Excludes Hiv Testing); Orthopedic Tray; Burn Kit Without Drug; Skin Prep Tray; Port Introducer Kit; Cutaneous Tissue Adhesive With Mesh; Applicator For Rectal Suppository; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Bariatric Bed; Peripheral Catheter Insertion Kit; Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon; Dressing Change Tray; Gastrointestinal Tubes With Enteral Specific Connectors; Enteral Specific Transition Connectors; Pediatric Position Holder; Percutaneous Replacement Gastrostomy Tube Kit; Test, Methadone, Over The Counter; Test, Barbiturate, Over The Counter; Non-Coring (Huber) Needle; Syringe, Balloon Inflation, Exempt; Drape, Surgical, Exempt; Chemotherapy Spill Clean-Up Kit; Personal Protection Kit; Test, Tricyclic Antidepressants, Over The Counter; Test, Propoxyphene, Over The Counter; Fentanyl And Other Opioid  Protection Glove; Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua; Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection; Stapler, Skin; Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs; Hemostatic Wound Dressing Without Thrombin Or Other Biologics; Adult Portable Bed Rails For Medical Purposes; Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament; Multi-Analyte Respiratory Virus Antigen Detection Test",1; 2; N; U,"""Salt Airway S.A.L.T.""; 137075-Surgical SetUp CSTM; 145666-Dressing Change CSTM; 171415-O.R. KIT CSTM; 946240-Skin Prep CSTM; A10 Low-air-loss Mattress System; ABDOMINAL BINDER; ACCU-SORB; ACCU-THERM; ADAPTOR, DRESSING; AG+ Powder; AKTORmed; ANESTHESIA CIRCUIT; ANKLE; ANTI TIP; APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS; ARMBOARDS AND COVERS; Accu-Therm; Accu-Wrap; Accutouch Synthetic Exam Gloves; Addipak Unit Dose Vial; Alcohol Prep Pad; Alcohol Towelettes; Aloetouch Nitrile Glove; Aloetouch nitrile exam glove; Alterra 1000 Manual Long Term Care Bed; Alterra Hi-Low Bed; Alterra Maxx Long Term Care Bed; Anesthesiology Kits; AngelStat; Angiographic Control Syringe; Angiography Introducer Needle; Aplicare Lubricating Jelly; Aplicare Lubricating Jelly Bottles; Operand Lubricating Jelly; Aplicare Lubricating Jelly; Aplicare Lubricating Jelly Packets; Dover Lubricating Jelly; Operand Lubricating Jelly; Apollo Knotless Suture Anchor; Apollo Suture Anchor System; Apollo Suture Anchor System and Titan Screws; Applicator, Vaginal/Cervical; AquaPak Humidifier Adapters; Aquablation Therapy; Aquapak Humidifier Reservoir with Adaptor; Aquapak Nebulizer Reservoir with Adaptor; Aquapak Nebulizer; Aquapak Saline Reservoir; Aquapak Sterile Water Reservoir; Aquapak Sterile Humidifier Reservoirs; AzureGel Cushion; BEDDING; BERMAN AIRWAYS; BIOACTIVE Bone Graft Putty; BREATHING BAGS; BULKEE II; BULKEE LITE; Bagging limb adaptor; Ball Spike Pusher; Bandages; Basic Tracheostomy Care Kit; Bone Screw Fixation; Burn Sheet; CARING THERMOMETER KITS; COMPAT DUALFLO® Administration Sets; COMPAT DUALFLO® Enteral Feeding Pump; COMPAT ENTERAL FEEDING PUMP; COMPRECARES; COVERED YANKAUER; CUFFILL Cuff Pressure Regulator; CURAD; CURAD Antibacterial Bandage; CURAD Naturals; CURAD Performance Series; CURAD Powder-Free Textured Latex Exam Gloves; CURAD Soothe and Cool; CURAD Stretch Vinyl Exam Gloves; CURAD Wound Gel; Cardiovascular Kits; Carefusion Clipper Blade; Caring abdominal pads; Caring+; Cellasorb; Cellasorb Ag+; Centurion Basin Kit; Centurion Cuticle and Tissue Nippers; Centurion Forceps; Centurion Pathology Container; Centurion Scissors; Cision; CleanOp: bedding and cleaning supplies; Clinical Chemistry and Clinical Toxicology Kits; Clip, vascular / clip, implantable; CoFlex; CoFlex LF2; Comfort Flo; Comfort Flo Humidification System; Comfort Touch Foam Frame Headrest; ComfortGlide Air Sling; ComfortGlide Drypad; ComfortTemp Patient Warming System; Commode; Compat Enteral Delivery Sets; Concha Column; Concha Column; Concha Reservoir; ConchaPak; ConchaTherm Brackets; ConchaTherm III; ConchaTherm Thermistor Probes; Concha Nebulizer; ConchaPak; Convenience Trays & Kits CSTM; Convertors; CoreTemp Surgical Solution Warming System; Critical Response; CryoCube; Cryodose H; Cryodose TA; Cryodose V; Curad Cervical Collar; Curad Compression Hosiery; Curad Compression Hosiery; Medline / Curad Anti-Embolism Stockings; Curad Hot / Cold Therapy Water Bottle; DEXLOCK Knotless Anchor; DEXTACK; DEXTACK PUSH PEEK Suture Anchor; DEXTACK Suture Anchor; DISPOSABLE BEDDING; DJO LLC; DRAINBAG; DYNACOR; DYNACOR - CLOSED BA; DYNACOR - LEG BAG; DYNACOR - POOLE SUCTION TIP; DYNACOR AIRWAYS; DYNACOR CARING THERMOMETHER KITS; DYNACOR CONTAINERS; DYNACOR EAR; DYNACOR SUCTION CONNECTING TUBING; DenTips; Dental Kits; Dermasure Green Sterile Synthetic Polychloroprene Powder-Free Surgical Glove; Donjoy; Dry Skin Surgical Scrub Tray with Gauze, Premium Dry Surgical Scrub Tray; DuoCare; Dynacor Lubrication Gel; Dynacor Oxygen Connecting Tube; EAR; EAR ULCER SYRINGES; ENFit; EQUOS Ag; EXO-BAG; EXTREMITY SPLINT; Ear, Nose, and Throat Kits; Eclipse Surgical Drape; Ecolab Fluid Warmer; Electrosurgical Cords; Electrosurgical Pads; EntraFlo; EqualizeAire Plus Mattress System; Equos; Equos Wound Cleanser; Esmark; Essentials; Eudermic MP Latex Exam Glove; Exam Glove; Excel wheelchair; Extrasorb; Exuderm Low Profile (LP); Exuderm Satin; Exuderm Satin, Exuderm LP, Exuderm RCD / Medline Wound Dressing; FOOTREST; Feather Blades; FitGuard; FitGuard ES; FitGuard Touch Powder-Free Nitrile Exam Gloves; FitRight; FitRight ActivEdge Bladder Control Pads; FitRight ActivEdge Male Guard; FitRight ActivEdge Underwear; FitRight Booster Pad; FitRight Cloth-Like Adult Incontinence Briefs; FitRight Connect System (MSAPOD1, MSACHAR01); FitRight EasyFlex Brief; FitRight Extended Use Underpad; FitRight Extended Wear Underwear; FitRight Underwear; Fluid Warming and Surgical Slush; Foley Catheter Insertion Tray; Forceps; Fourflex; GELFIRST Gel Pre-Soak; GRIP ICE COMP WRAP CSTM 1377533; GUARDIAN; Gastroenterology-Urology Kits; Gemini; Gemini Bonded Sterilization Wrap; Gemini Sterilization Wrap; Gemini Titan Sterilization Wrap; General Hospital and Personal Use Kits; General and Plastic Surgery Kits; Gentac; Gentac EZ; Germ Shield Wound Gel; Gibeck Humid-Flo and Passive Kits; Gown; Guardian K1; Guardian Pediatric Wheelchair; Guardian wheelchair; HEATER, BREATHING SYSTEM W/WO CONTROLLER; HYPODERMIC; Harmony Breast Pump Kit; Heat and Moisture Exchanger; HeelMedix; Heelmedix Heel Protector / Wedge; Hemo-Force I; HubGuard; Hudson RCI; Hudson RCI AddiPak Unit Dose Vial; Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater; Hudson RCI Aquapak Nebulizer; Hudson RCI Circuit / Column Kits; Hudson RCI Comfort Flo; Hudson RCI Comfort Flo CubCannula; Hudson RCI Comfort Flo Nasal Cannula Infant; Hudson RCI Comfort Flo Nasal Cannula Premature; Hudson RCI Comfort Flo Plus Cannula Extra Small; Hudson RCI ConchaTherm Neptune; Hudson RCI Conventional Breathing Circuit with Filter; Hudson RCI Conventional Breathing Circuit with Nebulizer; Hudson RCI Dri-Tech Breathing Circuits; Hudson RCI Dri-Tech Breathing Circuits and Ventilator Accessory; Hudson RCI High Concentration Oxygen Mask; Hudson RCI Infant Dri-Tech Breathing Circuits; Hudson RCI Nasal Cannula; Hudson RCI Oxygen Supply Tubing Connector; Hudson RCI Triflo II Incentive Deep Breathing Exerciser; Humidifier; Hush-Slush Consoles; INFLATABLE SPLINT; INSTRUMENT ROLL; INVISISHIELD Drain Bag; ISO GARD Breathing Circuit Kit; IV POLE; Insufflation Tubing; IntraTemp Fluid Warming System; IntraTemp ThermaBasin; IntraVena Auto; IntraVena Shield; Kit, Screening, Urine-Urine Test Kit; Knee Support with Removable U-Buttress; Konig Bell Circumcision Clamp; Konig Hardy Bipolar Forceps; Konig Mogen Clamp; Konig Scoville-Greenwood Bipolar Forceps; LEG; LEG BAG AND LEG BAG STRAP; LEG BAG W/ STRAPS; LIFT CHAIR; LOW PROFILE DRAINAGE BAGS; Laparoscopic Insufflation Tubing; Lighted Ear Curettes; Lingeman; LiquiBand Secure; MARS-PRO; MAXXIM MEDICAL; MEDCREST - SURGEONS CAPS; MEDICAL GENERAL HOSPITAL; MEDICINE CAPS; MEDICINE CUPS; MEDLINE  Needle, hypodermic, single lumen - FMI; MEDLINE / CENTURION STERILE GRAVES VAGINAL SPECULUM; MEDLINE / CENTURION STERILE VAGINAL SPECULUM; MEDLINE ACCESSORIES, WHEELCHAIR - KNO; MEDLINE ADAPTOR, HYGIENE - ILS; MEDLINE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS; MEDLINE ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS - DTL; MEDLINE AHDOMINAL BINDER; MEDLINE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY - CAE; MEDLINE ANTI-EMBOLISM STOCKING; MEDLINE ANTI-REFLUX VALVE; MEDLINE APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED - GCX; MEDLINE APPLICATOR, VAGINAL - HGD; MEDLINE ATTACHMENT, COMMODE, WHEELCHAIR - INB; MEDLINE Accessories, operating-room, table (kit) - FWZ; MEDLINE Applicator for rectal suppository - OOW; MEDLINE BAG, RESERVOIR - BTC; MEDLINE BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE - FAQ; MEDLINE BELT, WHEELCHAIR - IQB; MEDLINE BINDER, ABDOMINAL - FSD; MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGICAL DRAPES; MEDLINE BLOOD PRESSURE CUFF; MEDLINE BLOOD PRESSURE MONITORS; MEDLINE BOARD, ARM (WITH COVER), STERILE - BTX; MEDLINE BOTTLE, COLLECTION, VACUUM - KDQ; MEDLINE CATHETER AND TIP, SUCTION - JOL; MEDLINE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS - DWF; MEDLINE CATHETER, INTRAVASCULAR, DIAGNOSTIC - DQO; MEDLINE CATHETER, RETENTION TYPE, BALLOON - EZL; MEDLINE CATHETER, UROLOGICAL - KOD; MEDLINE CHAIR, POSITIONING, ELECTRIC - INO; MEDLINE COLLECTOR, URINE, PEDIATRIC, FOR INDWELLING CATHETER - FFH; MEDLINE COMPONENTS, WHEELCHAIR - KNN; MEDLINE DECANTERS; MEDLINE DEVICE, ANTI-TIP, WHEELCHAIR - IMR; MEDLINE DEVICE, VEIN STABILIZATION - LBJ; MEDLINE DISPENSER, LIQUID MEDICATION - KYX; MEDLINE DRESSING, WOUND AND BURN, OCCLUSIVE - MGP; MEDLINE Dressing, wound, drug - FRO; MEDLINE EVACUATOR, ORAL CAVITY - EHZ; MEDLINE FOOTREST, WHEELCHAIR - IMM; MEDLINE GAUZE/SPONGE, INTERNAL - EFQ; MEDLINE General surgery tray (kit); MEDLINE INJECTOR AND SYRINGE, ANGIOGRAPHIC - DXT; MEDLINE LABEL OR TAG, STERILE; MEDLINE LUBRICANT, PATIENT - KMJ; MEDLINE MEDIA, ELECTROCONDUCTIVE - GYB; MEDLINE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) - BSP; MEDLINE Needle, hypodermic, single lumen; MEDLINE PNEUMOPERITONEUM NEEDLE; MEDLINE PREVENTION SURGICAL GOWNS; MEDLINE PROTECTOR, SKIN PRESSURE - FMP; MEDLINE Pad, menstrual, unscented - HHD; MEDLINE Patient examination glove, specialty - LCZ; MEDLINE Polymer patient examination glove - LZA; MEDLINE RONGEUR - HTX; MEDLINE SCALE, PLATFORM, WHEELCHAIR - INF; MEDLINE SILVERTOUCH FOLEY CATHETER; MEDLINE SPECULUM, VAGINAL, NONMETAL - HIB; MEDLINE SPLINT, EXTREMITY, INFLATABLE, EXTERNAL - FZF; MEDLINE SPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL, STERILE - FYH; MEDLINE SPLINT, NASAL - EPP; MEDLINE STAND, INFUSION - FOX; MEDLINE SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) - KOA; MEDLINE SYRINGE, ANTISTICK - MEG; MEDLINE SYRINGE, ENT - KCP; MEDLINE SYSTEM, IRRIGATION, UROLOGICAL - LGH; MEDLINE SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE - DXN; MEDLINE SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE - EYZ; MEDLINE Syringe, piston - FMF; MEDLINE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL - JEB; MEDLINE THERMOMETER, CLINICAL MERCURY - FLK; MEDLINE TRAY, SURGICAL - LRP; MEDLINE TUBE, ASPIRATING, FLEXIBLE, CONNECTING - BYY; MEDLINE TUBE, GASTRO-ENTEROSTOMY - KGC; MEDLINE TUBES, GASTROINTESTINAL (AND ACCESSORIES) - KNT; MEDLINE VENTILATORY EFFORT RECORDER - MNR; MEDLINE Vinyl patient examination glove - LYZ; MEDLINE  Latex patient examination glove - LYY; MEDLINE Container, sharps; MICROTEK DISPOSABLE BEDDING; Manifold, Stopcock, and Adapter; Manipler Skin Stapler; Marathon; Marathon XL; Matrix; Maxorb; Maxorb ES; Maxorb Extra; Maxorb II; Maxorb II Ag+; Med-Breathe; Med-Glide Patient Positioning Sheet; MedFix; MedFix EZ; MedGel EKG Resting Tab Electrode; MedStop; MediGuard Sense; Medigrip; Mediguard Nitrile Glove; Mediguard nitrile glove; Medline; Medline / CDS catheter care tray (kit); Medline / CDS orthopedic tray (kit); Medline / CDS skin prep tray (kit); Medline / CDS surgical instrument tray; Medline / CDS tracheostomy cleaning tray or kit; Medline / Curad Anti-Embolism Stockings; Medline / Eclipse / Aurora / Sirus surgical packs; Medline / Konig Adenotome; Medline / Konig Applicator, Absorbent Tipped, Non-Sterile; Medline / Konig Applicator, ENT; Medline / Konig Applier, Hemostatic Clip; Medline / Konig Applier, Surgical, Clip; Medline / Konig Apron, Leaded; Medline / Konig Awl; Medline / Konig Bender; Medline / Konig Bistoury, Tracheal; Medline / Konig Block, Cutting, ENT, Non-Sterile; Medline / Konig Bougie, Urological; Medline / Konig Brace, Drill; Medline / Konig Cannula and Trocar, Suprapubic, Non Disposable; Medline / Konig Cannula, Surgical, General & Plastic Surgery; Medline / Konig Catheter and Tip, Suction; Medline / Konig Chisel, Bone, Surgical; Medline / Konig Chisel, Osteotome, Surgical; Medline / Konig Clamp, Circumcision; Medline / Konig Clamp, Ossicle Holding; Medline / Konig Clamp, Surgical, General & Plastic Surgery; Medline / Konig Clamp, Vascular; Medline / Konig Clip, Removable (Skin); Medline / Konig Corkscrew; Medline / Konig Crimper, Wire, ENT, Non-Sterile; Medline / Konig Curette, Endodontic; Medline / Konig Curette, Ophthalmic; Medline / Konig Curette, Surgical, Dental; Medline / Konig Cutter, Surgical; Medline / Konig Cutter, Wire; Medline / Konig Cystotome; Medline / Konig Depressor, Metal, Tongue, Surgical; Medline / Konig Device, Percutaneous, Biopsy; Medline / Konig Dilator, Tracheal; Medline / Konig Dilator, Vessel, Surgical; Medline / Konig Elevator, ENT; Medline / Konig Elevator, Surgical, General & Plastic Surgery; Medline / Konig Excavator, Ear; Medline / Konig File, Bone, Surgical; Medline / Konig Forceps, General & Plastic Surgery; Medline / Konig Forceps, Rongeur, Surgical; Medline / Konig Fork, Orthopedic Fork; Medline / Konig Fork, Tuning; Medline / Konig Gag, Mouth; Medline / Konig Goniometer; Medline / Konig Guide, Needle, Surgical; Medline / Konig Hemorrhoidal Ligator; Medline / Konig Holder, Needle, Gastroenterologic; Medline / Konig Hook, Microsurgical Ear; Medline / Konig Hook, Tracheal; Medline / Konig Instrument, Bending or Contouring; Medline / Konig Instruments, Dental Hand; Medline / Konig Knife, Amputation; Medline / Konig Knife, Ophthalmic; Medline / Konig Knife, Tonsil; Medline / Konig Laparascope, General & Plastic Surgery; Medline / Konig Loop, Wire; Medline / Konig Marker, Ocular; Medline / Konig Mirror, Mouth; Medline / Konig Needle, Aspiration and Injection, Reusable; Medline / Konig Needle, Neurosurgical Suture; Medline / Konig Needle, Ophthalmic Suturing; Medline / Konig Needle, Suturing, Reusable; Medline / Konig Needle, Tonsil Suturing; Medline / Konig Osteotome; Medline / Konig Pliers, Surgical; Medline / Konig Probe; Medline / Konig Punch, Adenoid; Medline / Konig Punch, Nasal; Medline / Konig Punch, Surgical; Medline / Konig Razor, Surgical; Medline / Konig Remover, Intrauterine Device, Contraceptive, Hook-Type; Medline / Konig Retractor, Non-Self-Retaining; Medline / Konig Retractor, Vaginal; Medline / Konig Ring Cutter; Medline / Konig Scissors, Episiotomy; Medline / Konig Scissors, Orthopedic, Surgical; Medline / Konig Scissors, Surgical Tissue, Dental; Medline / Konig Scissors, Umbilical; Medline / Konig Scissors, Wire Cutting, ENT, Non-Sterile; Medline / Konig Screwdriver; Medline / Konig Snare, Nasal; Medline / Konig Snare, Tonsil; Medline / Konig Sound, Metal, Interconnected; Medline / Konig Specula Accessories; Medline / Konig Speculum, Non-Illuminated; Medline / Konig Speculum, Rectal; Medline / Konig Speculum, Vaginal, Metal; Medline / Konig Splint, Hand, and Components; Medline / Konig Spoon, Ear; Medline / Konig Spud, Ophthalmic; Medline / Konig Syringe, ENT; Medline / Konig Tamp; Medline / Konig Tonsillectome; Medline / Konig Tourniquet, Gastro-Urology; Medline / Konig Tray, Surgical, Instrument; Medline / Konig Trephine, Manual, Ophthalmic; Medline / Konig Trocar, ENT; Medline / Konig Twister, Wire; Medline /Konig Instrument, Cast Removal, AC-Powered; Medline 2-Ply Tissue/Poly Professional Towels; Medline 5-in-1 Connector; Medline 5-in-1 connector; Medline Abdominal Pad; Medline Adhesive Prep Mitt; Medline Adult Expandable Anesthesia Circuit; Medline Adult Water Trap; Medline Advantage 300 Therapeutic Homecare Foam Mattress; Medline Advantage Electrodes; Medline Advantage Mattress / Medline EqualizeAire Mattress; Medline Aerosol Tubing; Medline Airway Connector; Medline Alka-Wash; Medline Aluminum Commode Transport Shower Chair; Medline Amnio Hook; Medline Anesthesia Mask; Medline Anti-Fog Solution; Medline Antibacterial Bandage; Medline Arm Cradle Positioner; Medline Arm/Leg Elevated Foam Positioner; Medline Automatic Digital Blood Pressure Monitors; Medline Band Bag; Medline Bariatric Bed; Medline Basin Kit; Medline Bath Lift; Medline Baumgartner Needle Holder; Medline Bed Assist Bars; Medline Belted Briefs; Medline Biohazard Specimen Bag; Medline Biopsy Valve; Medline Biospy Tray; Medline Blood Collection Tube Holder; Medline Blood Pressure Cuff; Medline Blood Pressure Transducer; Medline Blunt Fill Needle; Medline Bone Tap; Medline Bone Tunnel Reamer, Cannulated Reamer; Medline Boot Covers; Medline Bordered Gauze; Medline Bordered Gauze Adhesive Island; Medline Breathing Circuit; Medline Burn And Wound Dressing; Medline Burn And Wound Dressing (OTC); Medline Cannulated Screws; Medline Cast Padding; Medline Casting Tape; Medline Catheter Connector; Medline Catheter Leg Strap; Medline Catheter Plug And Drain Tube Protector; Medline Catheter Tip Adapter; Medline Cautery Electrode (PTFE); Medline Cautery Tip Cleaner; Medline Chemo Spill Kit; Medline Christmas Tree Style Nut and Nipple Adapter; Medline Circumcision Clamp; Medline Classic Electrodes; Medline Clearpro Closed Suction Catheter; Medline Clipper Blade; Medline Comfort Glide / Med-Glide (positioning sheet); Medline Commode Bucket; Medline ConchaTherm 2000; Medline Connecting Tubing; Medline Convenience Trays & Kits CSTM; Medline Cotton Balls; Medline Cotton-Tipped Applicators; Medline Count Sheet Holder; Medline Coveralls; Medline Cushion / Medline Equagel Cushion; Medline Cushion / Medline Gel Overlay; Medline D407 Series Sleeved Suction Catheter Kit; Medline D409 Series Suction Catheter Kit; Medline DVT Therapy Compression; Medline DeLee Mucus Trap; Medline Debridement Tool; Medline Digital Rectal Thermometer Sheath; Medline Digital Thermometer Non-Lubricated Probe Sheath; Medline Disposable Electronic Thermometer Probe Cover; Medline Disposable Skin Stapler; Medline Disposable Tourniquet; Medline Disposable Underpads; Medline Distraction Pins; Medline Dome Bag; Medline Double / Single Basin Trays; Medline Double Mesh Strainer; Medline Drain Bag; Medline Drain Bag Strap; Medline Dressing Change Tray; Medline DriGo-HP Antibacterial Wicking Sheet; Medline Drill Guide; Medline Dual-Head Stethoscopes; Medline Dumbbells; Medline ENFit Connectors; Medline Ear Syringe; Medline Elastic Bandage; Medline Elastic Retention Netting; Medline Electrocautery Pencil; Medline Electrode; Medline Electrosurgical Pencil / Pad / Accessory; Medline Electrosurgical Tip; Medline Enteral Feeding Sets; Medline Epidural / Spinal Needles; Medline Epidural Catheter; Medline Equipment Cover; Medline Evacuator Kit; Medline Exam Shorts; Medline Examination Gown; Medline Exercise Ball; Medline Exercise Band; Medline Extension Set; Medline Extension Tubing; Medline External Catheter; Medline Eye Pad; Medline Eye Speculum; Medline Eye Spud; Medline Face Mask; Medline Finger Cot; Medline Fluid Administration Set; Medline Foley Catheter Securement Device; Medline Foley Catheter Temperature Sensing Interconnecting Cable; Medline Foley Catheterization Tray; Medline Forehead Thermometer Strip; Medline Formtex Undercast Padding; Medline Fresh Naturals Ostomy Drops; Medline Gas Sampling Lines; Medline Gemini Wrap; Medline General Surgery Tray; Medline Glide-On 3G Vinyl Examination Gloves; Medline Glide-On Vinyl Examination Gloves; Medline Gravity Cooler; Medline Green Ambidextrous PF Nitrile Exam Gloves With Colloidal Oatmeal USP (Tested For Use With Chemotherapy Drugs); Medline Hard Guedel Airway; Medline Head and Beard Cover; Medline Heel Raiser; Medline Hemo-Force DVT Compression Sleeve; Medline High Pressure Tubing; Medline Hudson Aerotee Model; Medline Hudson Breathing Mouthpiece; Medline Hudson Hand Held Nebulizer; Medline Hudson Low Concentration Oxygen Mask; Medline Hudson Micro Mist Nebulizer; Medline Hudson Neonatal Ventilator Circuit; Medline Hudson RCI AquaPak Bubble Prefilled Humidifiers; Medline Hudson RCI CORR-A-FLEX Corrugated Tubing; Medline Hudson RCI Face Tent; Medline Hudson RCI High-Concentration Oxygen Masks; Medline Hudson RCI Tee Adapter; Medline Hudson Side Draft Neb-U-Mist Nebulizer; Medline Hudson Smooth-Flo Circuit; Medline Humidifier Nebulizer Kit; Medline IBP Cable; Medline IV Armboard; Medline Ice Bag; Medline Indicator Tape; Medline Infant Resuscitation Kit; Medline Inflation Syringe; Medline Instant Cold Pack; Medline Instant Hot Pack; Medline Iodoform Packing Strip; Medline Irrigation Bottle; Medline Irrigation Syringe; Medline Irrigation Tray; Medline Isolation Gown; Medline Jackson Table Kit; Medline Keyboard Cover; Medline Knee/Body Positioning Strap; Medline Laceration Tray; Medline Leg Bag; Medline Level 4 Surgical Gown; Medline Level 4 Surgical Gown with Breathable Sleeves; Medline Lifter Sheet; Medline Light Handle Cover; Medline Limb Holder; Medline Liposuction Tubing; Medline Lubricating Jelly; Medline M/M Adapter; Medline Magnetic Instrument Mat; Medline Maternity Knit Underpants; Medline Mattress / Medline SupraDPS Mattress / Medline SupraAPL Mattress; Medline Mayo Stand; Medline Medicine Cup; Medline Mesh Underpants; Medline Microdissection Needle; Medline Midstream Collection Kit; Medline Mucus Trap; Medline Nasal Speculum; Medline Needle Counter; Medline Needle/Tube Protector; Medline Neuro Sponge; Medline Neutral Displacement Needle Free Connector; Medline Nitrile Exam Gloves; Medline Nitrile Examination Gloves, Blue, P-Free (Tested For Use With Chemotherapy And Fentanyl); Medline Nitrile Powder Free Examination Gloves (Tested For Use With Chemotherapy Drugs); Medline Non-Conductive Connecting Tubing; Medline Non-Surgical Isolation Gown; Medline O/R Scissors; Medline OPA/28; Medline OR Towels; Medline Open Suction Catheter; Medline Oral Care Bite Block; Medline Orbis Chemo Surgical Gown; Medline Orbis LVL 3 Surgical Gown; Medline Orbis Surgical Gown; Medline Oxygen Mask; Medline PICC Dressing Pack; Medline Pathology Container; Medline Patient Cables and Lead Wires; Medline Patient Lifts / Medline Patient Lift Slings; Medline Patient Position Support; Medline Patient Restraint Stretcher; Medline Pediatric Urine Collector; Medline Pediatric Wheelchair; Medline Perineal Cleansing Bottle; Medline Perineal Cold Pack; Medline Perineal Warm Pack; Medline Pill Crusher; Medline Plaster Casting Roll; Medline Platinum Electrodes; Medline Poly-Cath™ Red Polymer Urethral Catheter; Medline Poly-lined Drape; Medline Poly-lined Fenestrated Drape; Medline Port Access Tray; Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested For Use With Chemotherapy Drugs); Medline Precut Splint; Medline Pressure Monitoring Tubing; Medline Pressure Tubing and Accessories; Medline Procedure Gown; Medline Proxima; Medline Pulse Oximeter; Medline Quick Switch Valve With ENFit Connector; Medline Quick-Clear Wand; Medline Radial Compression Band; Medline Radiolucent Defibrillator Electrode Pads; Medline Raised Toilet Seat; Medline Razor; Medline ReNewal Reprocessed Carter-Thomason Needle-Point Suture Passer Instrument Set; Medline ReNewal Reprocessed Harmonic ACE+7 Shears; Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor; Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors; Medline Rectal Tube; Medline Reinforced Epidural Catheter; Medline Restore Sense Powder Free Nitrile Exam Gloves with maxOat+; Medline Restore Touch Nitrile Exam Gloves with Oatmeal; Medline Reusable Non-Sterile Back Surgical Table Covers; Medline Rollator; Medline Safety Insulin and TB Syringes; Medline Safety Lancets; Medline Scalpels; Medline Scleral Marker; Medline Scoop Curette; Medline SeeIV; Medline Set Up Cover; Medline Sharps Container; Medline Shoe Covers; Medline Silent Knight Pill Crusher; Medline Silicone Bulb Evacuator for Closed Wound Drainage; Medline Silicone Cautery Electrode; Medline Silicone Foley Catheter; Medline Single Patient Use Blood Pressure Cuff; Medline Single-Head Stethoscopes; Medline Skin Marker; Medline Skin Stapler; Medline Smoke Evacuation Pencil; Medline Smoke Evacuation Shroud; Medline Soft Casting Tape; Medline Specimen Container; Medline Specimen Trap; Medline Specula, Ophthalmic; Medline Sterile Foam Block Positioners; Medline Sterile Luer Lock Syringes; Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use With Chemotherapy Drugs); Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test For Use With Chemotherapy Drugs); Medline Sterilization Basket; Medline Sterilization Wrapper; Medline Stockinette; Medline Suction Canisters / Suction Canister Soft Liners; Medline Suction Catheter Kit; Medline Suction Catheter Mini Tray; Medline Suction Tubing; Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe; Medline Surgeon Cap; Medline Surgical Cap; Medline Surgical Clipper; Medline Surgical Drape; Medline Surgical Instrument; Medline Surgical Scrub Brush; Medline Surgical Shave Prep Tray; Medline Surgical Stapler; Medline Suture Boot; Medline Synthetic Undercast Padding; Medline Tape Measure; Medline Therapy Hand Putty; Medline Tongue Blade; Medline Tongue Depressor; Medline Toomey Irrigation Syringe; Medline Towel Clamps/Sponge Forceps; Medline Tracheobronchial Suction Catheter; Medline Tracheobronchial Suction Catheter Kit; Medline Tracheostomy Mask; Medline Transfer Bench; Medline Transfer or Gait Belt; Medline Transport Chair; Medline Triangular Graduate Container; Medline UNITE; Medline UNITE Ancillary Foot Recon Plates, Medline UNITE Ancillary Foot Recon Screws; Medline UNITE Ankle Fracture Plating System; Medline UNITE Ankle Fusion Plates; Medline UNITE Ankle Fusion Screws; Medline UNITE Autograft Harvester; Medline UNITE Burrs; Medline UNITE Calcaneal Fracture Plating System; Medline UNITE Extractor; Medline UNITE FORCECORD Implant and Probe Kit; Medline UNITE FORCEWEB Soft Tissue Reinforcement Device; Medline UNITE HS Fiber; Medline UNITE Joint Prep Kit; Medline UNITE Jones Fracture Screw System; Medline UNITE Komet Rasps; Medline UNITE Mini Plates And Screws; Medline UNITE REFLEX Dynamic Discs; Medline UNITE REFLEX Hybrid Nitinol Implant System; Medline UNITE REFLEX Nitinol Staple System; Medline UNITE Template; Medline UNITE® Ancillary Foot Recon Plating System – Countersink, Cannulated, Lisfranc; Medline UNITE® Digital Fusion Screw System; Medline UNITE® REFLEX® Nitinol Staple Kit; Medline Ultrasound Gel; Medline Undercast Padding; Medline Unite Bit, Drill; Medline Unite Depth Gauges; Medline Unite Fusion Reamer / Cone / Cup; Medline Unite Orthopedic Manual Surgical Instruemnt; Medline Unite Plate Bender; Medline Unite Screwdriver; Medline Unite Snap-Off Screws; Medline Universal Grounding Pad; Medline Urethral Catheter Holder; Medline Urethral Catheterization Tray; Medline Urinal; Medline Urinary Drain Bag; Medline Urine Analyzer; Medline Vacu-Line Suction Aspirator; Medline Ventilator Tubing; Medline Vessel Cannula; Medline Walker; Medline Waste Station; Medline Wipes; Medline Wound Drain; Medline Wound Drain Kit; Medline Wound Dressing; Medline Wytex Undercast Padding; Medline arterial needle; Medline bottle liner; Medline disposable laryngoscope blade; Medline electric bed; Medline hot/cold packs (disposable); Medline hot/cold packs (reusable); Medline limb cover; Medline rectal tube; Medline stopcock / manifold; Medline suction coagulator; Medline surgical kits/trays and CDS modules; Medline wheelchair; Medline yankauers / intracardiac suckers / suction accessories; Medline, Konig Dilator, Lachrymal; Medline/Centurion Sterile Bowl, Sterile Pitcher; Medline/Konig; Medline/Konig Anrtum Punch; Medline/Konig Bit, Drill; Medline/Konig Bone Hook; Medline/Konig Caliper; Medline/Konig Cannula, Ear; Medline/Konig Cannula, Ophthalmic; Medline/Konig Cardiovascular Surgical Instruments; Medline/Konig Carrier, Ligature; Medline/Konig Catheter Dilator; Medline/Konig Chisel, Middle-Ear; Medline/Konig Chisel, Nasal; Medline/Konig Clamp; Medline/Konig Clamp, Non-Electrical; Medline/Konig Collar and Crown Scissors; Medline/Konig Contractor, Surgical; Medline/Konig Curette; Medline/Konig Dental Dressing Forceps; Medline/Konig Dental Surgical Elevator; Medline/Konig Dilator, Cervical, Fixed Size; Medline/Konig Dissector, Surgical, General & Plastic Surgery; Medline/Konig Drills, Burrs, Trephines & Accessories (Manual); Medline/Konig ENT Probe; Medline/Konig Ear Knife; Medline/Konig Ear Scissors; Medline/Konig Electrosurgical, Cutting & Coagulation & Accessories; Medline/Konig Enucleating Snare; Medline/Konig Ethmoid Curette; Medline/Konig Forceps; Medline/Konig Forceps, Biopsy, Non-Electric; Medline/Konig Forceps, ENT; Medline/Konig Forceps, Ophthalmic; Medline/Konig Gastro-Urology Probe and Director; Medline/Konig Gauge, Depth; Medline/Konig General Use Surgical Curette; Medline/Konig Gouge, Surgical, General & Plastic Surgery; Medline/Konig Gynecological Biopsy Forceps; Medline/Konig Gynecological Surgical Forceps; Medline/Konig Hemostat; Medline/Konig Hook, Fibroid, Gynecological; Medline/Konig Hook, Surgical, General & Plastic Surgery; Medline/Konig Impactor; Medline/Konig Instrument Surgical Guide; Medline/Konig Instrument, ENT Manual Surgical; Medline/Konig Instrument, Microsurgical; Medline/Konig Instrument, Surgical, Non-Powered; Medline/Konig Insturment, Cast, Application/Removal, Manual; Medline/Konig Irrigator, Sinus; Medline/Konig Knife, ENT; Medline/Konig Knife, Nasal; Medline/Konig Knife, Orthopedic; Medline/Konig Lachrymal Probe; Medline/Konig Laryngeal Knife; Medline/Konig Ligature Passing and Knot Tying Instrument; Medline/Konig Mallet, Surgical, General & Plastic Surgery; Medline/Konig Manual Osteotome; Medline/Konig Manual Saw and Accessories; Medline/Konig Manual Surgical Chisel; Medline/Konig Manual Surgical Instruments; Medline/Konig Measuring Gauge; Medline/Konig Mobilizer, ENT; Medline/Konig Nasal Curette; Medline/Konig Nasal Rongeur; Medline/Konig Nipper, Malleus; Medline/Konig Non-Powered Rectal Probe; Medline/Konig Ophthalmic Hook; Medline/Konig Ophthalmic Retractor; Medline/Konig Orbital Depressor; Medline/Konig Orthodontic Plier; Medline/Konig Orthopedic Cutting Instrument; Medline/Konig Orthopedic Manual Surgical Instrument; Medline/Konig Passer; Medline/Konig Pick, Microsurgical Ear; Medline/Konig Pinwheel; Medline/Konig Rasp; Medline/Konig Rasp, Ear; Medline/Konig Rasp, Nasal; Medline/Konig Retractor, Self-Retaining, For Neurosurgery; Medline/Konig Reusable Vein Stripper; Medline/Konig Ring, Ophthalmic (Flieringa); Medline/Konig Rod, Measuring Ear; Medline/Konig Rongeur; Medline/Konig Rongeur, Manual",1977-12-29,357,2026-03-25,0,249,29,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221417592%22&limit=1
"Deroyal Industries, Inc.",1043214,1043214,200 Debusk LN.,Powell,TN,37849,United States,"DEROYAL INDUSTRIES, INC.",1044833,Complaint file establishment; Manufacturer; Repackager or relabeler; Specification developer,357,BSJ; BSO; BSP; BSY; BTA; BTC; BXB; BYG; BYX; BYY; BYZ; BZT; CAE; CAH; CAI; CAZ; CBH; CCK; CCX; DQO; DQX; DRE; DRI; DRS; DRX; DSS; DTL; DWE; DWF; DWH; DWJ; DWP; DWS; DXC; DXO; DXQ; DXT; DXZ; DYB; EBR; EFN; EFQ; EFW; EIC; EMD; EMX; EXM; EYC; EYH; EYQ; EZC; EZD; EZL; FAM; FCM; FCN; FDE; FEG; FGY; FHO; FHQ; FHX; FLL; FMA; FMF; FMG; FMH; FMI; FMP; FMQ; FMR; FMT; FMZ; FNL; FNY; FOB; FOD; FOK; FOS; FOZ; FPA; FPD; FPK; FPY; FQH; FQL; FQM; FRG; FRL; FRO; FRQ; FSA; FSD; FSM; FTA; FTD; FTY; FWZ; FXP; FXX; FXY; FYA; FYC; FYD; FZF; FZP; FZQ; FZT; FZZ; GAA; GAB; GAD; GAE; GAL; GAM; GAN; GAO; GAP; GAQ; GAR; GAT; GAW; GAX; GAZ; GBM; GBQ; GBW; GBX; GBZ; GCB; GCD; GCI; GCJ; GCX; GCY; GDF; GDG; GDI; GDJ; GDO; GDT; GDW; GDX; GDY; GDZ; GEA; GEI; GEJ; GEN; GES; GFA; GIM; GXY; GZJ; HAM; HBA; HBO; HBX; HCF; HDF; HET; HFG; HGE; HGI; HHD; HHM; HIB; HIF; HIO; HIS; HMP; HMT; HMX; HNC; HNN; HNR; HNY; HOE; HOY; HOZ; HRH; HRQ; HRX; HSP; HSS; HST; HTD; HXB; HXD; HXK; IKX; ILD; ILG; ILH; ILI; ILO; ILW; ILZ; IMD; IME; IMP; ION; IOY; IOZ; IPG; IPM; IPR; IPS; IPX; IPY; IQF; IQI; IQJ; IQK; IQQ; IRD; ISH; ITG; ITJ; ITQ; ITW; ITX; IYO; IZI; JAA; JCX; JKA; JOK; JOL; JRL; JSG; KCH; KCY; KDC; KDD; KDQ; KDT; KEW; KGN; KGO; KGX; KGY; KGZ; KHR; KID; KKX; KME; KMF; KMI; KMJ; KMK; KNF; KNP; KNT; KNX; KOD; KOE; KOX; KPD; KPE; KQM; KQZ; KRI; KSR; KWQ; KXF; KXG; KYR; KYS; KYW; KYX; KYZ; LDF; LIO; LIT; LJH; LKB; LKF; LMG; LRO; LRP; LRS; LRW; LRY; LWG; LWH; LWK; LXH; LYU; LYV; LYZ; LZA; LZC; MAV; MCY; MCZ; MDM; MEA; MGQ; MHW; MJC; MLS; MLT; MMP; MMZ; MNH; MNI; MNL; MPN; MPO; MQP; MRI; MTJ; NAB; NAC; NAD; NEC; NEW; NGT; NKB; NKC; NNI; NNW; NWV; OCT; ODP; OEQ; OEZ; OFA; OFP; OFX; OGJ; OGK; OGR; OHD; OHG; OHL; OHM; OIB; OJF; OJJ; OJK; OJS; OJT; OJU; OKH; OMP; OSV; OVN; OXQ; PEZ; PUI; PWU; PYB; QDO; QQS; SEL,"Mask, Gas, Anesthetic; Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Catheters, Suction, Tracheobronchial; Pump, Portable, Aspiration (Manual Or Powered); Bag, Reservoir; Exerciser, Powered; Mask, Oxygen; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Trap, Sterile Specimen; Stethoscope, Esophageal, With Electrical Conductors; Airway, Oropharyngeal, Anesthesiology; Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Anesthesia Conduction Kit; Device, Fixation, Tracheal Tube; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Support, Patient Position; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Dilator, Vessel, For Percutaneous Catheterization; Monitor, Line Isolation; Transducer, Blood-Pressure, Extravascular; Electrode, Electrocardiograph; Clip, Vascular; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Tubing, Pump, Cardiopulmonary Bypass; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Blade, Saw, Surgical, Cardiovascular; System, Thermal Regulating; Dilator, Vessel, Surgical; Instruments, Surgical, Cardiovascular; Clamp, Vascular; Transducer, Pressure, Catheter Tip; Blood Pressure Cuff; Injector And Syringe, Angiographic; Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene; Introducer, Catheter; Unit, Suction Operatory; Cotton, Roll; Gauze/Sponge, Internal; Toothbrush, Manual; Syringe, Periodontic, Endodontic, Irrigating; Hemostat, Surgical; Balloon, Epistaxis; Truss, Umbilical; Catheter, Upper Urinary Tract; Table, Cysto, Non-Electrical; Garment, Protective, For Incontinence; Catheter, Coude; Catheter, Straight; Catheter, Retention Type, Balloon; Sigmoidoscope And Accessories, Flexible/Rigid; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Urinary Drainage Collection Kit, For Indwelling Catheter; Laparoscopy Kit; Tube, Double Lumen For Intestinal Decompression And/Or Intubation; Cannula, Injection; Pneumoperitoneum Needle; Holder, Needle, Gastroenterologic; Jelly, Lubricating, For Transurethral Surgical Instrument; Continuous Measurement Thermometer; Depressor, Tongue, Non-Surgical; Syringe, Piston; Stopcock, I.V. Set; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Protector, Skin Pressure; Restraint, Protective; Device, Transfer, Patient, Manual; Warmer, Infant Radiant; Incubator, Neonatal; Bed, Ac-Powered Adjustable Hospital; Basin, Emesis; Bedpan; Device, Occlusion, Umbilical; Pad, Neonatal Eye; Catheter, Umbilical Artery; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Tube, Feeding; Tubing, Fluid Delivery; Sheet, Burn; Lavage, Jet; Stocking, Medical Support (For General Medical Purposes); Bandage, Elastic; Wrap, Sterilization; Fiber, Medical, Absorbent; Dressing, Wound, Drug; Tube, Levine; Lift, Patient, Non-Ac-Powered; Binder, Abdominal; Tray, Surgical, Instrument; Light, Surgical, Accessories; Lamp, Surgical; Tape, Measuring, Rulers And Calipers; Operating Room Accessories Table Tray; Cover, Shoe, Operating-Room; Mask, Surgical; Hood, Surgical; Gown, Surgical; Gown, Isolation, Surgical; Apparatus, Exhaust, Surgical; Splint, Extremity, Inflatable, External; Clip, Implantable; Clip, Removable (Skin); Cutter, Surgical; Marker, Skin; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Retractor; Snare, Surgical; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Absorbable, Synthetic; Suture, Nonabsorbable; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Urethral; Catheter, Continuous Irrigation; Catheter, Peritoneal; Catheter, Irrigation; Catheter, Cholangiography; Needle, Catheter; Connector, Catheter; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Removable (Skin); Staple, Implantable; Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Forceps, General & Plastic Surgery; Blade, Scalpel; Blade, Saw, General & Plastic Surgery, Surgical; Tubes, Vacuum Sample, With Anticoagulant; Electrode, Cutaneous; Stimulator, Nerve, Transcutaneous, For Pain Relief; Apparatus, Electrosurgical; Neurosurgical Paddie; Clip, Scalp; Instrument, Cranioplasty Material Forming; Instrument, Ligature Passing And Knot Tying; Speculum, Vaginal, Metal; Laparoscope, Gynecologic (And Accessories); Coagulator, Laparoscopic, Unipolar (And Accessories); Amniotome; Electrocautery, Gynecologic (And Accessories); Pad, Menstrual, Unscented; Sound, Uterine; Speculum, Vaginal, Nonmetal; Insufflator, Laparoscopic; Sampler, Amniotic Fluid (Amniocentesis Tray); Condom; Pad, Eye; Drape, Patient, Ophthalmic; Cannula, Ophthalmic; Specula, Ophthalmic; Knife, Ophthalmic; Forceps, Ophthalmic; Cystotome; Caliper, Ophthalmic; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Sponge, Ophthalmic; Trephine, Manual, Ophthalmic; Hemostat; Arthroscope; Splint, Traction; Halter, Head, Traction; Apparatus, Traction, Non-Powered; Forceps; Probe; Clamp; Holder, Needle; Orthopedic; Aid, Transfer; Adaptor, Dressing; Stocking, Elastic; Splint, Hand, And Components; Sling, Arm; Pack, Hot Or Cold, Water Circulating; Adaptor, Grooming; Accessories, Traction; Pack, Hot Or Cold, Disposable; Pack, Hot Or Cold, Reusable; Cushion, Wheelchair; Exerciser, Non-Measuring; Support, Arm; Splint, Abduction, Congenital Hip Dislocation; Shoe, Cast; Cover, Limb; Crutch; Cane; Orthosis, Rib Fracture, Soft; Orthosis, Lumbo-Sacral; Orthosis, Cervical-Thoracic, Rigid; Orthosis, Limb Brace; Splint, Clavicle; Orthosis, Cervical; Joint, Shoulder, External Limb Component; Joint, Elbow, External Limb Component, Mechanical; Component, External, Limb, Ankle/Foot; Bandage, Cast; Walker, Mechanical; Joint, Knee, External Brace; Joint, Ankle, External Brace; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; System, X-Ray, Fluoroscopic, Image-Intensified; Apparatus, Suction, Ward Use, Portable, Ac-Powered; Tubes, Vials, Systems, Serum Separators, Blood Collection; Scissors, Medical, Disposable; Catheter And Tip, Suction; Unit, Filter, Membrane; Culture Media, Non-Selective And Non-Differential; Hook, Tracheal; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Container, Specimen Mailer And Storage, Sterile; Slides, Microscope; Wound Dressing With Animal-Derived Material(S); Surgeon'S Gloves; Tape And Bandage, Adhesive; Bag, Intestine; Accessories, Catheter; Absorber, Saliva, Paper; Restraint, Wheelchair, Non-Protective; Drape, Surgical, Antimicrobial; Bedding, Disposable, Medical; Bandage, Liquid; Monitor, Bed Patient; Lubricant, Patient; Device, Intravascular Catheter Securement; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Orthosis, Corrective Shoe; Tubes, Gastrointestinal (And Accessories); Collector, Urine, (And Accessories) For Indwelling Catheter; Catheter, Urological; Dilator, Urethral; Solvent, Adhesive Tape; Strip, Temperature, Forehead, Liquid Crystal; Container, I.V.; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; Accessory Equipment, Cardiopulmonary Bypass; Container, Empty, For Collection & Processing Of Blood & Blood Components; Appliance, Fixation, Spinal Intervertebral Body; Applicator, Absorbent Tipped, Non-Sterile; Applicator, Absorbent Tipped, Sterile; Bag, Ice; Insoles, Medical; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Electrode, Pacemaker, Temporary; Device, Specimen Collection; Catheter, Angioplasty, Peripheral, Transluminal; System, Irrigation, Urological; Pad, Alcohol, Device Disinfectant; Cannula, Manipulator/Injector, Uterine; Agent, Absorbable Hemostatic, Non-Collagen Based; General Surgery Tray; Tray, Surgical; I.V. Start Kit; Scissors, General, Surgical; Punch, Surgical; Surgical Table Cushion; Counter, Sponge, Surgical; Razor, Surgical; Orthopedic Manual Surgical Instrument; Accessory, Surgical Apparel; Label Or Tag, Sterile; Vinyl Patient Examination Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; Syringe, Balloon Inflation; Wound Dressing Kit; Suture Removal Kit; Instrument, Manual, Surgical, General Use; Pump, Infusion, Pca; Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic; Dressing, Compression; Catheter, Urological (Antimicrobial) And Accessories; Labor And Delivery Kit; Pelvic Exam Kit; Cover, Barrier, Protective; Table, Cystometric, Electric; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Accessories, Cleaning Brushes, For Endoscope; Tissue Adhesive For The Topical Approximation Of Skin; Infant Heel Warmer (Chemical Heat Pack); Spinal Vertebral Body Replacement Device; Orthosis, Truncal/Orthosis, Limb; Wax, Bone; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Bandage, Liquid, Skin Protectant; Suture, Surgical, Absorbable, Polydioxanone; Saline, Vascular Access Flush; Thoracolumbosacral Pedicle Screw System; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Container, Specimen, Non-Sterile; Bag, Urine Collection, Leg, For External Use, Non-Sterile; Laparoscopic Accessories, Gynecologic; Anti Fog Solution And Accessories, Endoscopy; Intervertebral Fusion Device With Bone Graft, Cervical; Angiography/Angioplasty Kit; Cardiovascular Procedure Kit; Cardiovascular Surgical Instruments Tray; Anesthesia Breathing Circuit Kit (Adult & Pediatric); General Purpose Dental Tray; Nerve Block Tray; Orotracheal Intubation Guide Kit; Ear, Nose, And Throat Surgical Tray; Gynecological Laparoscopic Kit; Circumcision Tray; Pap Smear Kit; Cesarean Section Tray; Blood And Urine Collection Kit (Excludes Hiv Testing); Hysterectomy Kit; Burn Kit Without Drug; Eye Tray; Tourniquet Kit; Aspiration Tray; Skin Prep Tray; Body Fluids Barrier Kit; Negative Pressure Wound Therapy Powered Suction Pump; Insufflator, Endoscopic Vessel Harvesting; Suture Kit; Dressing Change Tray; Central Venous Catheter Dressing Change Kit; Drape, Surgical, Exempt; Clean-Up Kit; Minor Surgical Procedures Tray; Fentanyl And Other Opioid  Protection Glove; Stapler, Skin; Securement Wound Dressing For Reduction Of Infection",1; 2; 3; U,"Absorber, Saliva, Paper - DeRoyal; Accessories, Catheter - DeRoyal; Accessories, Cleaning Brushes, for Endoscope - DeRoyal; Accessories, Operating-Room, Table (Kit) - DeRoyal; Accessories, Traction - DeRoyal; Accessory Equipment, Cardiopulmonary Bypass - DeRoyal; Accessory Surgical Apparel - DeRoyal; Accessory, Surgical Apparel - DeRoyal; Adaptor, Dressing - DeRoyal; Adaptor, Grooming - DeRoyal; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal; Agent, Absorbable Hemostatic, Non-Collagen Based - DeRoyal; Aid, Transfer - DeRoyal; Airway, Oropharyngeal, Anesthesiology - DeRoyal; Amniotome - DeRoyal; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - DeRoyal; Anesthesia Breathing Circuit Kit (Adult & Pediatric) - DeRoyal; Anesthesia Conduction Kit - DeRoyal; Anesthesia Conduction Kit - Needle, Conduction, Anesthetic (w/wo Introducer) - DeRoyal; Angiography/Angioplasty Kit - DeRoyal; Anti Fog Solution and Accessories, Endoscopy - DeRoyal; Apparatus, Exhaust, Surgical - DeRoyal; Apparatus, Suction, Operating-Room, Wall Vacuum Powered - DeRoyal; Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal; Apparatus, Traction, Non-Powered - DeRoyal; Appliance, Fixation, Spinal Intervertebral Body - DeRoyal; Applicator, Absorbent Tipped, Non-Sterile - DeRoyal; Applicator, Absorbent Tipped, Sterile - DeRoyal; Applier, Surgical, Clip - DeRoyal; Arthroscope - DeRoyal; Aspiration Tray (Kit) - DeRoyal; BLOOD PRESSURE CUFF - DeRoyal; Bag, Ice - DeRoyal; Bag, Intestine - DeRoyal; Bag, Reservoir - DeRoyal; Bag, Urine Collection, Leg, For External Use, Non-Sterile - DeRoyal; Balloon, Epistaxis - DeRoyal; Bandage, Cast - DeRoyal; Bandage, Elastic - DeRoyal; Bandage, Liquid - DeRoyal; Bandage, Liquid, Skin Protectant - DeRoyal; Basin, Emesis - DeRoyal; Bed, Ac-Powered Adjustable Hospital - DeRoyal; BedPan - DeRoyal; Bedding Disposable, Medical - DeRoyal; Binder, Abdominal - DeRoyal; Blade, Saw, General & Plastic Surgery, Surgical - DeRoyal; Blade, Saw, Surgical,Cardiovascular; Blade, Scalpel - DeRoyal; Blood Pressure Cuff - DeRoyal; Blood and Urine Collection Kit (Excludes HIV Testing) - DeRoyal; Body Fluid Barrier Kit - DeRoyal; Bottle, Collection, Vacuum - DeRoyal; Burn Kit without Drug - DeRoyal; CLAMP - DeRoyal; Caliper, Ophthalmic - DeRoyal; Camera, Surgical and Accessories - DeRoyal; Cane - DeRoyal; Cannula Vial Access - DeRoyal; Cannula, Manipulator/Injector, Uterine - DeRoyal; Cannula, Ophthalmic - DeRoyal; Cannula, Surgical, General & Plastic Surgery - DeRoyal; Cannula, surgical, General & Plastic Surgery - DeRoyal; Cardiovascular Procedure Kit - DeRoyal; Cardiovascular Surgical Instruments Tray - DeRoyal; Carrier, Ligature - DeRoyal; Catheter Umbilical Artery - DeRoyal; Catheter and Tip, Suction - DeRoyal; Catheter, Angioplasty, Peripheral, Transluminal - DeRoyal; Catheter, Cannula and Tubing, Vascular, Cardiopulmonary By Pass - DeRoyal; Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - DeRoyal; Catheter, Cannula and Tubing, Vascular, Cardiopulmonary bypass - DeRoyal; Catheter, Cholangiography - DeRoyal; Catheter, Conduction, Anesthetic - DeRoyal; Catheter, Continuous Irrigation - DeRoyal; Catheter, Coude - DeRoyal; Catheter, Intravascular, Diagnostic - DeRoyal; Catheter, Intravascular, Therapeutic, Short-Term less than 30 days - DeRoyal; Catheter, Intravascular, Therapeutic, Short-term Less than 30 days - DeRoyal; Catheter, Intravascular, Therapeutic, Short-term less than 30 days - DeRoyal; Catheter, Intravascular, Therapeutic, short-term less than 30 days - DeRoyal; Catheter, Irrigation - DeRoyal; Catheter, Peritoneal - DeRoyal; Catheter, Retention Type, Balloon - DeRoyal; Catheter, Straight - DeRoyal; Catheter, Upper Urinary Tract - DeRoyal; Catheter, Urethral - DeRoyal; Catheter, Urological (Antimicrobial) and Accessories - DeRoyal; Catheter, Urological (antimicrobial) and Accessories - DeRoyal; Catheter, Urological - DeRoyal; Catheter,Urological - DeRoyal; Catheters, Suction, Tracheobronchial - DeRoyal; Central Venous Catheter Dressing Change Kit - DeRoyal; Cesarean Section Kit - DeRoyal; Circuit, Breathing (w Connector, Adaptor, Y Piece) - DeRoyal; Circumcision Tray - DeRoyal; Clamp, Surgical, General & Plastic Surgery - DeRoyal; Clamp, Vascular - DeRoyal; Clean-up Kit - DeRoyal; Clip, Implantable - Add; Clip, Implantable - DeRoyal; Clip, Removable (Skin)- DeRoyal; Clip, Scalp - DeRoyal; Clip, Vascular - DeRoyal; Coagulator, Laparoscopic, Unipolar (and accessories) - DeRoyal; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) - DeRoyal; Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal; Collector, Urine, (and Accessories) for Indwell Cath/ Tray, Catheteriz, Sterile Urethral, w/wo Catheter (kit)- DeRoyal; Component, External, Limb, Ankle/Foot - DeRoyal; Component, Traction, Non-Invasive - DeRoyal; Condom - DeRoyal; Connector, Catheter - DeRoyal; Container, Empty, for Collection & Processing of Blood & Blood Components - DeRoyal; Container, I V - DeRoyal; Container, I. V. - DeRoyal; Container, Liquid Medication, Graduated - DeRoyal; Container, Specimen Mailer and Storage, Sterile - DeRoyal; Container, Specimen, Non-Sterile - DeRoyal; Container, Specimen, Sterile - DeRoyal; Cotton, Roll - DeRoyal; Cover, Barrier, Protective - DeRoyal; Cover, Limb - DeRoyal; Cover, Shoe, Operating-room - DeRoyal; Crutch - DeRoyal; Culture Media, Non-Selective and Non-Differential - DeRoyal; Cushion, Wheelchair - DeRoyal; Cystotome - DeRoyal; DEROYAL THERMO-COLD S; Depressor, Tongue, Non-Surgical - DeRoyal; Device, Fixation, Tracheal Tube - DeRoyal; Device, Intravascular Catheter Securement - DeRoyal; Device, Occlusion, Umbilical - DeRoyal; Device, Specimen Collection - DeRoyal; Device, Transfer, Patient, Manual - DeRoyal; Dilator, Urethral Syringe, Balloon Inflation - DeRoyal; Dilator, Vessel, Surgical - DeRoyal; Dilator, Vessel, for Percutaneous Catheterization - DeRoyal; Dispenser, Liquid Medication - DeRoyal; Dissector, Surgical, General & Plastic Surgery - DeRoyal; Drape, Patient, Ophthalmic - DeRoyal; Drape, Surgical - DeRoyal; Drape, Surgical, Exempt - DeRoyal; Drape, surgical - DeRoyal; Dressing Change Tray - DeRoyal; Dressing, Compression - DeRoyal; Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic - DeRoyal; Dressing, Wound and Burn, Occlusive - DeRoyal; Dressing, Wound, Collagen - DeRoyal; Dressing, Wound, Drug - Burn, Hydrogel w/Drug and/or Biologic - DeRoyal; Dressing, Wound, Drug - DeRoyal; Dressing, Wound, Drug - DeRoyal / Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic - DeRoyal; Dressing, Wound, Hydrophilic - DeRoyal; Dressing, Wound, Occlusive - DeRoyal; Ear, Nose, and Throat Surgical Tray - DeRoyal; Electrocautery, Gynecologic (and Accessories) - DeRoyal; Electrode Electrocardiograph - DeRoyal; Electrode, Cutaneous - DeRoyal; Electrode, Pacemaker, Temporary - DeRoyal; Electrosurgical Cutting & Coagulation Accessories - DeRoyal; Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal; Electrosurgical, cutting & coagulation & accessories - DeRoyal; Exercise, Powered - DeRoyal; Exerciser, Non-Measuring - DeRoyal; Eye Tray - DeRoyal; FZT - Cutter, Surgical - DeRoyal; Fiber, Medical, Absorbent - DeRoyal; Filter, Bacterial, Breathing - Circuit - DeRoyal; Forceps - DeRoyal; Forceps, General & Plastic Surgery - DeRoyal; Forceps, Ophthalmic - DeRoyal; Garment, Protective, for Incontinence - DeRoyal; Gas Mask-Anesthesia - DeRoyal; Gastroenterology - Urology - DeRoyal; Gauze, Internal, X-ray Detectable - DeRoyal; Gauze/Sponge, Internal - DeRoyal; Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal; Gauze/Sponge, Nonresorbable for External Use - DeRoyal; General Purpose Dental Tray - DeRoyal; General Surgery Tray (Kit) - DeRoyal; General Surgery Tray - DeRoyal; General surgery tray - DeRoyal; Gown, Surgical - DeRoyal; Grounding Pad; Guide, Needle, Surgical - DeRoyal; Gynecological Laparoscopic Kit - DeRoyal; HRX Arthroscope GEI Electrosurgical, Cutting & coagulation & Accessories - DeRoyal; Halter, Head, Traction - DeRoyal; Handle, Scalpel - DeRoyal; Hemostat - DeRoyal; Hemostat, Surgical - DeRoyal; Holder, Needle, Gastroenterologic - DeRoyal; Holder, Needle; Orthopedic - DeRoyal; Hood, Surgical - DeRoyal; Hook, Surgical, General & Plastic Surgery - DeRoyal; Hook, Tracheal - DeRoyal; Hysterectomy Kit - DeRoyal; IMD - Pack, Hot or Cold, Disposable - DeRoyal; Incubator, Neonatal - Warmer, Infant Radiant - DeRoyal; Infant Heel Warmer (Chemical Heat Pack) - DeRoyal; Injector and Syringe Angiographic - DeRoyal; Injector and Syringe, Angiographic - DeRoyal; Insoles, Medical - DeRoyal; Instrument, Cranioplasty Material Forming - DeRoyal; Instrument, Ligature Passing & Knot Typing - DeRoyal; Instrument, Manual, Surgical, General Use - DeRoyal; Instrument, Surgical, Disposable - DeRoyal; Instruments, Surgical, Cardiovascular - DeRoyal; Insufflator, Laparoscopic - DeRoyal; Intervertebral Fusion Device with Bone Graft, Cervical - DeRoyal; Introducer, Catheter - DeRoyal; Jelly, Lubricating, For Transurethral Surgical Instrument - DeRoyal; Joint, Ankle, External Brace - DeRoyal; Joint, Elbow, External Limb Component, Mechanical - DeRoyal; Joint, Knee, External Brace - DeRoyal; Joint, Shoulder, External Limb Component - DeRoyal; Kit, I.V. Start - DeRoyal; Kit, Pelvic Exam - DeRoyal; Kit, Surgical Instrument, Disposable - DeRoyal; Kit, Wound Dressing - DeRoyal; Knife, Ophthalmic - DeRoyal; Label OR Tag, Sterile - DeRoyal; Labor and Delivery Kit - DeRoyal; Lamp, Surgical - DeRoyal; Laparoscope General and Plastic Surgery - DeRoyal; Laparoscope, General & Plastic Surgery - DeRoyal; Laparoscope, Gynecologic (and accessories) - DeRoyal; Laparoscopic Accessories, Gynecologic - DeRoyal; Laparoscopy Kit - DeRoyal; Laryngoscope, Endoscope - DeRoyal; Lavage, Jet - DeRoyal; Lift, Patient, Non-AC-Powered - DeRoyal; Light, Surgical, Accessories - DeRoyal; Lubricant, Patient - DeRoyal; MICROSCOPE SLIDES - DeRoyal; Marker, Skin - DeRoyal; Mask, Oxygen - DeRoyal; Mask, Surgical - DeRoyal; Medical Glove, Specialty - DeRoyal; Minor Surgical Procedures Tray - DeRoyal; Monitor, Bed Patient - DeRoyal; Monitor, Line Isolation - DeRoyal; Multidex; Needle, Aspiration and Injection, Disposable - DeRoyal; Needle, Catheter - DeRoyal; Needle, Conduction, Anesthetic (W/WO Introducer) - DeRoyal; Needle, Conduction, Anesthetic (W/WO Introducer)- DeRoyal; Needle, Conduction, Anesthetic (w/wo Introducer)- DeRoyal; Needle, Hypodermic, Single Lumen - DeRoyal; Needle, Suturing, Disposable - DeRoyal; Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal; Nepcell; Nerve Block Tray (Kit) - DeRoyal; Neurosurgical Paddie - DeRoyal; Orotracheal Intubation Guide Kit - DeRoyal; Ortho Manual Surgical Instrument - DeRoyal; Orthosis, Cervical - DeRoyal; Orthosis, Cervical - Thoracic, Rigid - DeRoyal; Orthosis, Corrective Shoe - DeRoyal; Orthosis, Limb Brace - DeRoyal; Orthosis, Lumbo-Sacral - DeRoyal; Orthosis, Rib Fracture, Soft - DeRoyal; Orthosis, Spinal Pedicle Fixation Orthosis, Spinal Pedicle Fixation, for Degenerative Disc Disease - DeRoyal; Orthosis, Truncal/Orthosis, Limb - DeRoyal; Oxygenator, Cardiopulmonary Bypass - DeRoyal; Pack, Hot and Cold, Disposable - DeRoyal; Pack, Hot or Cold, Reuseable - DeRoyal; Pack, Hot or Cold, Water Circulating - DeRoyal; Pad, Alcohol, Device Disinfectant - DeRoyal; Pad, Eye - DeRoyal; Pad, Menstrual, Unscented - DeRoyal; Pad, Neonatal Eye - DeRoyal; Pap Smear Kit - DeRoyal; Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal; Patch, Pledget and Intracardiac, PTTP, PTFE, Polypropylene - DeRoyal; Pneumoperitoneum Needle - DeRoyal; Polymer Patient Examination Glove - DeRoyal; Pro-II NPWT Powered Suction Pump, Collection canisters, hoses, Y-connectors & tubing, and foam/gauze dressings – DeRoyal; Probe - DeRoyal; Protector, Skin Pressure - DeRoyal; Pump, Portable, Aspiration (Manual or Powered) - DeRoyal; Punch, Surgical - DeRoyal; Razor, Surgical - DeRoyal; Restraint, Protective - DeRoyal; Restraint, Wheelchair, Non-Protective - DeRoyal; Retractor - DeRoyal; Saline, Vascular Access Flush - DeRoyal; Sampler, Amniotic Fluid (Amniocentesis Tray) - DeRoyal; Scalpel, One-Piece - DeRoyal; Scissors, General, Surgical - DeRoyal; Scissors, Medical, Disposable - DeRoyal; Sensostrip Temperature Sensor; Set, Administration, Intravascular - DeRoyal; Set, administration, intravascular - DeRoyal; Sheet, Burn - DeRoyal; Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal; Shoe, Cast - DeRoyal; Sigmoidoscope and Accessories, Flexible/Rigid - DeRoyal; Silver Alginate Cath Patch Dressing - DeRoyal; Skin Prep Tray (Kit)- DeRoyal; Sling, Arm - DeRoyal; Snare, Surgical - DeRoyal; Solvent, Adhesive Tape - DeRoyal; Sound, Uterine - DeRoyal; Specula, Ophthalmic - DeRoyal; Speculum, Vaginal, Metal - DeRoyal; Speculum, Vaginal, Nonmetal - DeRoyal; Spinal Vertebral Body Replacement Device - DeRoyal; Splint, Abduction, Congenital Hip Dislocation - DeRoyal; Splint, Clavicle - DeRoyal; Splint, Extremity, Inflatable, External - DeRoyal; Splint, Hand, and Components - DeRoyal; Splint, Traction - DeRoyal; Sponge, Ophthalmic - DeRoyal; Staple, Implantable - DeRoyal; Staple, Removable (Skin) - DeRoyal; Staple, Removeable (Skin) - DeRoyal; Stapler, Skin - DeRoyal; Stax; Stethoscope, Esophageal, with Electrical Conductors - DeRoyal; Stimulator, Nerve, Transcutaneous, For Pain Relief - DeRoyal; Stocking, Elastic - DeRoyal; Stocking, Medical Support (For General Medical Purposes) - DeRoyal; Stopcock, IV Set - DeRoyal; Streamway; Strip, Temperature, Forehead, Liquid Crystal - DeRoyal; Support, Arm - DeRoyal; Support, Patient Position - DeRoyal; Surgeon's Gloves; Surgeon's Gloves - DeRoyal; Surgical Drape - DeRoyal; Surgical Table Cushion - DeRoyal; Suture Kit - DeRoyal; Suture Removal Kit - DeRoyal; Suture, Absorbable, Synthetic - DeRoyal; Suture, Absorbable, Synthetic, Polyglycolic Acid - DeRoyal; Suture, Absorbable, Synthetic, Polyglycolic Acid - Suture, Absorbable, Synthetic - DeRoyal; Suture, Nonabsorbable - DeRoyal; Suture, Nonabsorbable, Silk - DeRoyal; Suture, Nonabsorbable, Synthetic, Polypropylene - DeRoyal; Suture, Surgical, Absorbable, Polydioxanone - DeRoyal; Syringe Piston - DeRoyal; Syringe, Irrigating (Non Dental) - DeRoyal; Syringe, Periodontic, Endodontic, Irrigating - DeRoyal; Syringe, Piston - DeRoyal; Syringe, Piston - Needle, Hypodermic, Single Lumen - DeRoyal; Syringe, balloon inflation - DeRoyal; Syringe, piston - DeRoyal; System, Imaging, Pulsed Echo, Ultrasonic - DeRoyal; System, Thermal Regulating - DeRoyal; System, X-Ray, Angiographic - DeRoyal; System, X-Ray, Fluoroscopic, Image-Intensified - DeRoyal; System, irrigation, Urological - DeRoyal; Table, Cysto, Non-Electrical - DeRoyal; Table, Cystometric, Electric - DeRoyal; Tape and Bandage, Adhesive - DeRoyal; Tape, Measuring, Rulers and Calipers - DeRoyal; Thermometer, Electronic, Clinical - DeRoyal; Thermometer, electronic, clinical - DeRoyal; Tissue Adhesive for the Topical Approximation of Skin - DeRoyal; Toothbrush, Manual - DeRoyal; Tourniquet Kit - DeRoyal; Tourniquet, Nonpneumatic - DeRoyal; Tourniquet, Pneumatic - DeRoyal; Transducer, Blood-Pressure, Extravascular - DeRoyal; Transducer, Pressure, Catheter Tip - DeRoyal; Transducer, Ultrasonic, Diagnostic - DeRoyal; Trap, Sterile Specimen - DeRoyal; Tray, Surgical - DeRoyal; Tray, Surgical, Instrument - DeRoyal; Trephine, Manual, Ophthalmic - DeRoyal; Triss. Umbilical - DeRoyal; Tube, Aspirating, Flexible, Connecting - DeRoyal; Tube, Double Lumen for Intestinal Decompression and/or Intubation - DeRoyal; Tube, Feeding - DeRoyal; Tube, Levine - DeRoyal; Tubes, Gastrointestinal (and Accessories) - DeRoyal; Tubes, Vacuum Sample, with Anticoagulant - DeRoyal; Tubes, Vials, Systems, Serum Separators, Blood Collection - DeRoyal; Tubing, Fluid Delivery - DeRoyal; Tubing, Noninvasive - DeRoyal; Tubing, Pressure and Accessories - DeRoyal; Tubing, Pump, Cardiopulmonary Bypass - DeRoyal; Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal; Unit, Filter, Membrane - DeRoyal; Unit, Suction Operatory - DeRoyal; Urinary Drainage Collection Kit, for Indwelling Catheter - DeRoyal; Vinyl Patient Examination Glove - DeRoyal; WRIST; Walker, Mechanical - DeRoyal; Warmer, Infant Radiant - DeRoyal; Wax, Bone - DeRoyal; Wire, Guide, Catheter - DeRoyal; Wrap, Sterilization - DeRoyal; Yankauer - DeRoyal; applier, Surgical, Clip - DeRoyal",1991-04-03,351,2025-11-21,0,51,2,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221043214%22&limit=1
Synthes GMBH,3000270450,3000270450,Industriestrasse 28,Selzach Solothurn,,2545 Selz.,Switzerland,SYNTHES GMBH / Synthes Produktions GmbH,9071542,Exporter to the US; Manufacturer,90,DZI; DZJ; DZL; EML; ETN; EZX; FQP; FZO; FZX; GDI; GDZ; GFF; GFG; GXN; GXQ; GZT; HAW; HBB; HBW; HRS; HRX; HSB; HSO; HSZ; HTD; HTN; HTO; HTQ; HTW; HTX; HTY; HWB; HWC; HWD; HWE; HWR; HWT; HWW; HWX; HXB; HXG; HXO; HXP; HXQ; HXX; JAQ; JDN; JDP; JDQ; JDS; JDW; JEC; JEY; KCT; KGS; KIH; KQW; KTT; KTW; KTZ; KWP; KWQ; LOD; LRP; LRY; LXH; LXT; MAX; MBI; MCV; MJG; MNH; MNI; MQN; MQP; MQV; MRW; NDN; NEI; NKB; NKG; NQW; OAR; ODP; OLO; OSH; OSN; OVD; OVE; PGM,"Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Screw, Fixation, Intraosseous; Chisel, Bone, Surgical; Stimulator, Nerve; Mesh, Surgical, Metal; Lamp, Operating-Room; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Dissector, Surgical, General & Plastic Surgery; Handle, Scalpel; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Plate, Cranioplasty, Preformed, Non-Alterable; Dura Substitute; Retractor, Self-Retaining, For Neurosurgery; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Fastener, Plate, Cranioplasty; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Saw; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Forceps; Washer, Bolt Nut; Reamer; Broach; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Driver, Prosthesis; Template; Countersink; Tap, Bone; Probe; Tamp; Pusher, Socket; Instrument, Bending Or Contouring; Crimper, Pin; Screwdriver; System, Applicator, Radionuclide, Remote-Controlled; Implant, Fixation Device, Spinal; Condylar Plate Fixation Implant; Cerclage, Fixation; Nail, Fixation, Bone; Pin, Fixation, Threaded; Component, Traction, Invasive; Plate, Bone; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Retention Device, Suture; Dispenser, Cement; Goniometer, Nonpowered; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Bone Cement; Tray, Surgical; Punch, Surgical; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Intervertebral Fusion Device With Bone Graft, Lumbar; Fastener, Fixation, Nondegradable, Soft Tissue; Spinal Pedicle Screw, Fixation, Appliance System; Device, Percutaneous, Biopsy; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; External Mandibular Fixator And/Or Distractor; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Cement, Bone, Vertebroplasty; Prosthesis, Condyle, Mandibular, Temporary; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Orthosis, Spine, Plate, Laminoplasty, Metal; Injector, Vertebroplasty (Does Not Contain Cement); Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Software For Diagnosis/Treatment; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Growing Rod System",1; 2; 3; U,"2.4/2.7mm VA-LCP Forefoot/Midfoot; 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES; 2.4mm Cannulated Compression Screw; 2.4mm Cannulated Screw; 2.4mm VA LCP Two Column Volar DR; 2.4mm Variable Angle LCP Volar Rim Distal Radius System; 3.5 / 4.5 MM LCP METAPHYSEAL PLATES; 3.5 MM LCP DISTAL HUMERUS SYSTEM; 3.5/4.5 LCP w/ Expanded Indications; 3.5mm LCP Hook Plates; 3.5mm Locking Attachment Plates; 3.5mm VA LCP Proximal TIbia Plate System; 3MM HEADLESS COMPRESSION SCREWS; 4.5 MM AND 6.5 MM HEADLESS COMPRESS; 4.5 MM LCP STRAIGHT RECONSTRUCTION; 6.5mm Midfoot Fusion Bolt; ALC Dynamized Fixation System; ANGLED BLADE PLATE; ANTERIOR CSLP SYSTEM; Ankle Trauma System; Anterior ISOLA System; Appliance Fix, Nail Blade Plate Com; BIT, DRILL; Bengal Stackable Cage System; BowTi Anterior Buttress Staple; CANNULATED FEMORAL NAIL; CLICK`X; CONCORDE Clear MIS Discectomy Device; Condylar Head Add-on-System; Cougar System; CrossOver Cross Connector; CrossOver System; DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS); DEPUY SYNTHES MAXFRAME AUTOSTRUT System; DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM; DHS-Troch Stabilizaiton Plate; DYNAMIC HIP SCREW; DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long; DePuy Synthes Cortex and Cannulated Screws; DePuy Synthes Femoral Neck System; DePuy Synthes Femoral Recon Nail System; DePuy Synthes MAXFRAME Multi-Axial Correction System; DePuy Synthes MatrixSTERNUM Fixation System; DePuy Synthes TFNA Augmentation System; DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) System; DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System; DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System; DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System; DePuySynthes Next Generation Hand System; Dental Bone Cutting Instruments; Depuy Synthes Variable Angle Locking Hand System - 1.3 mm and 2 mm Plates and Screws; Dispenser, Cement; EIN End Cap; ELASTIC INTRAMEDULLARY NAIL (EIN) E; ELBOW HINGE FIXATOR; EXTRACTOR; Expedium Anterior Spine System; Expedium SFX Cross Connector System; Expedium Spine System; FILLER, BONE VOID, CALCIUM COMPOUND; FRONTIER Anterior Scoliosis System; GONIOMETER; HA COATED SCHANZ SCREWS; HANDLE, SCALPEL; HINDFOOT ARTHRODESIS NAIL; ISOLA Spine System; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Irrigation clips; Jaguar Lumbar I/F Cage System; Kaneda Anterior Scoliosis System; Kaneda SR Anterior System; LCP; LCP CURVED PLATES; M-2 Anterior Plate System (Ocelot Stackable Cage System); MANDIBLE EXTERNAL FIXATOR; MATRIXRIB FIXATION SYSTEM; MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System; MAXFRAME Autostrut; MINI LENGTHENING APPARATUS; MIRS; MODIFICATION TO SYNTHES CERVIFIX SYSTEM; MODIFICATION TO SYNTHES MATRIX SYSTEM; MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK; MODULAR FOOT SYSTEM - 2.7 MM MODULE; MOUNTAINEER Laminoplasty System; Matrix RIB Fixation System; Matrix Sagittal Screws; MatrixORTHOGNATHIC Plating System; Monarch Spine System; Moss Miami Spine System; Mountaineer OCT Spinal System; Orthomesh; PEAK Anterior Compression Plate System; Pelvic C-Clamp; Plate fixation, bone; Posteromedial Proximal Tibia Plate; Profile Anterior Fixation System; SAW; SLIM-LOC Anterior Cervical Plate System; SMALL FRAGMENT DYNAMIC COMPRESSION; SMALL STATURE USS; SOCKET PUSHER; SPIKED WASHER; SS Elastic IM Nail; SUMMIT Bone Screw; SUMMIT Fixation System; SYMPHONY OCT System; SYNAPSE SYSTEM; SYNFIX Evolution; SYNFIX Lateral; SYNFIX-LR; SYNFIX-LR SPACER; SYNTHECEL DURA REPLACEMENT DEVICES; SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE; SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM; SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACR; SYNTHES (U.S.A.) UNIVERSAL SPINAL P; SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIV; SYNTHES (USA) 2.4 MM LCP WRIST PLATE; SYNTHES (USA) 2.4/2.7 MM LOCKING FO; SYNTHES (USA) 3.5MM CONICAL SCREWS; SYNTHES (USA) ALVEOLAR RIDGE DISTRA; SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM; SYNTHES (USA) CALVICLE HOOK PLATE; SYNTHES (USA) CLAVICLE HOOK PLATES; SYNTHES (USA) CONDYLAR HEAD ADD-ON; SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR; SYNTHES (USA) LARGE FRAGMENT LOCKIN; SYNTHES (USA) LATERAL ENTRY FEMORAL; SYNTHES (USA) LCP MODULAR FOOT PLATES; SYNTHES (USA) LCP PROXIMAL HUMERUS; SYNTHES (USA) LOW-PROFILE WRIST FIXATOR; SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES; SYNTHES (USA) MODULAR MINI FRAGMENT; SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM; SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM; SYNTHES (USA) TIBIAL NAIL SYSTEM EX; SYNTHES (USA) UNIV SPINE ROD/SACRAL; SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM; SYNTHES (USA) [SYNTHES] MINI EXTERN; SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS; SYNTHES 1.5MM/2MM ORTHOGNATHIC MA; SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM; SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM; SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM; SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM; SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM; SYNTHES AFS; SYNTHES ANTERIOR CERVICAL LOCKING P; SYNTHES ANTERIOR CSLP SYSTEM; SYNTHES ANTERIOR TENSION BAND (ATB); SYNTHES BUTTON PLATE; SYNTHES CERVIFIX/ AXON; SYNTHES CRANIAL FLAP TUBE CLAMP; SYNTHES CURVED RECONSTRUCTION PLATE; SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM; SYNTHES DUAL-OPENING USS; SYNTHES EXTERNAL FIXATION DEVICES,; SYNTHES HIGH TIBIAL OSTEOTOMY (HTO); SYNTHES LARGE FRAGMENT DYNAMIC COMP; SYNTHES LCP DISTAL TIBIA PLATES; SYNTHES LCP PROXIMAL HUMERUS PLATES; SYNTHES LCP PROXIMAL TIBIA PLATES L; SYNTHES LOCKING DISTAL RADIUS PLATI; SYNTHES MANDIBLE DISTRACTOR; SYNTHES MINI EXTERNAL FIXATOR; SYNTHES MODULAR FOOT SYSTEM; SYNTHES OC FUSION SYSTEM; SYNTHES PANGEA SYSTEM; SYNTHES PILON PLATE; SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM; SYNTHES RECONSTRUCTIVE PLATES `Y` P; SYNTHES REPROCESSED EXTERNAL FIXATI; SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF); SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM; SYNTHES SPINE PEDIATRIC ROD SYSTEM; SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM; SYNTHES SPINE UNIVERSAL SPINAL HOOK; SYNTHES STAINLESS STEEL MODULAR HAN; SYNTHES STERILE 4.5 MM CANNULATED SCREWS; SYNTHES STERNAL FIXATION SYSTEM; SYNTHES SYNAPSE TRANSCONNECTOR; SYNTHES SYNEX SPACER SYSTEM; SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM; SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR; SYNTHES UNIVERSAL SPINAL SYSTEM; SYNTHES USS; SYNTHES USS (10MM SIDE OPENING SCREWS; SYNTHES USS CONNECTORS; SYNTHES USS, CLICK`X, USS VAS, DUAL; SYNTHES VA LCP ANKLE TRAUMA SYSTEM; SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM; SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES); SYNTHES VECTRA SYSTEM; SYNTHES VECTRA-ONE SYSTEM; SYNTHES VECTRA-T SYSTEM; SYNTHES XRL; SYNTHES(USA) SYNTHES HYBRID EXTERNA; Set Screw for Ti Trochanteric Fixation Nail (TFN); Small Stature Ant. Cerv. Vertebral; Smooth threaded metallic bone fix; Spotlight Access System; Sterile 2.7mm recon Plates; Sternal Fixation System; Stimulator, Nerve; Summit SI OCT Spinal Fixation System; Suprapatellar Insertion Instruments; Surgical Bit; Surgical Punch; Surgical Titanium Mesh; SynCage Evolution Spacer; Synapse Occipital-Cervical-Thoracic (OCT) System; Synapse System, Synthes OC Fusion System; Synthecel Dura Repair, Synthecel Dura Onlay; Synthes (USA) 2.4mm Cortex Screw; Synthes (USA) VA-LCP 2-Col Narrow; Synthes 1.5mm Headless Comp. Screws; Synthes 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM; Synthes 2.7mm LCP Ulna Osteotomy Plate System; Synthes 3.5/4.5 Curved Narrow/Broad; Synthes 4.5mm VA-LCP Curved Condylar Plate System; Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins; Synthes 6 CoCr and CP Ti-3 Rods; Synthes 90 Degree Screwdriver; Synthes ASLS System; Synthes Air Pen Drive System; Synthes Angular Stable Locking Syst; Synthes Angular Stable Locking System; Synthes Cervifix System; Synthes ClampFix System; Synthes Cortical Screws; Synthes Curvilinear Distraction System; Synthes Graphic Case & Tray System; Synthes LCP Pediatric Plate System; Synthes Large Ex Fix, MR Cond.; Synthes Light Guide; Synthes Locking Hand Plates; Synthes Matrix MIS Rods; Synthes Matrix System; Synthes MatrixMANDIBLE Preformed Re; Synthes MatrixMANDIBLE Preformed Reconstruction Plates; Synthes MultiLoc Humeral Nailing System; Synthes Multiloc Proximal Humeral Nailing System; Synthes Navigable Pedicle Preparation Instruments; Synthes Neuro Plate and Screw System; Synthes Oracle Plate; Synthes Self Drilling Schanz Screws; Synthes Self-Drilling Schanz Screws; Synthes Sternal ZipFix System; Synthes Synapse 4 System; Synthes T-PAL Spacer; Synthes TFN Screw; Synthes Unreamed Humeral Nail; Synthes Zero-P; Synthes2.4 LCP Vol. Col. Dist. Radi; T-PAL; T-PAL Ti Spacer; TAMP; TAN Unreamed Femoral Nail; TAP; TITANIUM (TI) ALLOY HIGH TIBIAL OST; TITANIUM CANNULATED TIBIAL NAIL (TI; TITANIUM LOCKING PLATE SYSTEM; TOMOFIX OSTEOTOMY SYSTEM; TRAUMACEM"" V+ Injectable Bone Cement; TROCHANTERIC FIXATION NAIL (TFN); Titanium Distal Femoral Nail; Titanium TomoFix Medial High Tibia Plate Anatomical; TomoFix Medial Distal Femur Plates; TomoFix Medial High Tibia Pl. Small; Trochanter Stabilization Plate DHS; UNIVERSAL FEMORAL NAIL; UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM; USS; USS Iliosacral and Polyaxial System; USS VAS; USS-LINE EXTENSION; VBB System; VERTECEM II CEMENT KIT; VOLAR DISTAL RADIUS PLATE; VSP Spine System; Vertebroplasty Needle Kit; Vienna System; Viper 2 System; Viper F2 Facet Fixation System; Viper SAI; Viper System; ZERO-P NATURAL Plate; Zero-P VA; broach; burr; caliper; chisel; countersink; crimper; dissector; driver; guide; injector; instrument; nail, fixation, bone; plate; plate, fixation, bone; probe; reamer; rongeur; screw; screwdriver; starter; surgical instrument; tray, surgical",1981-02-24,350,2026-06-11,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223000270450%22&limit=1
Karl Storz Se & Co KG,3014342096,3014342096,Dr.-Karl-Storz-Str. 34,TUTTLINGEN Baden-Wurttemberg,,78532,Germany,KARL STORZ SE & CO KG,8010119,Specification developer,149,BTA; BYX; CAI; CAL; CBC; CCQ; CCW; DXC; DZN; EIA; ENZ; EOB; EOQ; EOX; EPT; EPY; EQH; EQJ; EQL; EQN; ERA; ERL; ETA; ETB; EWY; EZN; EZO; FAH; FAJ; FAM; FAS; FAX; FBK; FBN; FBO; FBQ; FCL; FCR; FCS; FCW; FCX; FCY; FCZ; FDC; FDF; FDI; FDS; FDZ; FEC; FEM; FEO; FEQ; FET; FFD; FFK; FFL; FFS; FGA; FGB; FGC; FHQ; FJL; FSM; FSR; FTA; FTS; FWF; FXF; GAZ; GBA; GCF; GCJ; GCM; GCT; GCX; GDC; GDI; GEA; GEI; GEX; GEY; GFF; GWG; GWX; GZX; HAO; HAW; HET; HFA; HGK; HIF; HIG; HIH; HIN; HJO; HKI; HMW; HPP; HRX; HWC; HWE; JOL; JOS; JYK; JYL; KAI; KAL; KBN; KCL; KCT; KGE; KMN; KNF; KNS; KNY; KOE; KOH; KQT; KTG; KYW; KYZ; LJH; LLZ; LMD; LQR; LRC; LXH; LYK; MDM; MNL; MOK; MQW; NBH; NKC; NTN; NVT; NWW; OAY; OCV; OCX; OCZ; ODA; ODB; OSV; OWN; PGW; PHT; PUI; PYO,"Pump, Portable, Aspiration (Manual Or Powered); Tubing, Pressure And Accessories; Circuit, Breathing (W Connector, Adaptor, Y Piece); Laryngoscope, Non-Rigid; Bottle, Collection And Trap, Breathing System (Uncalibrated); Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Laryngoscope, Rigid; Clamp, Vascular; Instruments, Dental Hand; Unit, Operative Dental; Telescope, Laryngeal-Bronchial; Nasopharyngoscope (Flexible Or Rigid); Bronchoscope (Flexible Or Rigid); Esophagoscope (Flexible Or Rigid); Microscope, Surgical; Speculum, Ent; Source, Carrier, Fiberoptic Light; Bur, Ear, Nose And Throat; Laryngostroboscope; Laryngoscope, Nasopharyngoscope; Otoscope; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Replacement, Ossicular Prosthesis, Total; Prosthesis, Partial Ossicular Replacement; Mediastinoscope, Surgical; Dilator, Catheter, Ureteral; Urethrotome; Dilator, Urethral, Mechanical; Cystoscope And Accessories, Flexible/Rigid; Sigmoidoscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Bougie, Urological; Endoscopic Injection Needle, Gastroenterology-Urology; Choledochoscope And Accessories, Flexible/Rigid; Cystourethroscope; Trocar, Gastro-Urology; Forceps, Biopsy, Non-Electric; Light Source, Photographic, Fiberoptic; Light, Catheter, Fiberoptic, Glass, Ureteral; Light Source, Fiberoptic, Routine; Insufflator, Automatic Carbon-Dioxide For Endoscope; Bulb, Inflation, For Endoscope; Tube, Smoke Removal, Endoscopic; Resectoscope, Working Element; Colonoscope And Accessories, Flexible/Rigid; Snare, Flexible; Gastroscope And Accessories, Flexible/Rigid; Attachment, Eyepiece, For Insertion Of Prescription Lens; Obturator, For Endoscope; Accessories, Photographic, For Endoscope (Exclude Light Sources); Lithotriptor, Ultrasonic; Pump, Air, Non-Manual, For Endoscope; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Evacuator, Bladder, Manually Operated; Lithotriptor, Electro-Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Image, Illumination, Fiberoptic, For Endoscope ; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Urethroscope; Holder, Needle, Gastroenterologic; Resectoscope; Tray, Surgical, Instrument; Light, Headband, Surgical; Light, Surgical, Accessories; Camera, Cine, Endoscopic, With Audio; Camera, Television, Endoscopic, Without Audio; Speculum, Illuminated; Tubing, Noninvasive; Catheter, Balloon Type; Proctoscope; Laparoscope, General & Plastic Surgery; Endoscope, Rigid; Light Source, Endoscope, Xenon Arc; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Table, Operating-Room, Electrical; Dissector, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Motor, Surgical Instrument, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Endoscope, Neurological; Fork, Tuning; Instrument, Microsurgical; Instrument, Surgical, Non-Powered; Neurological Stereotaxic Instrument; Laparoscope, Gynecologic (And Accessories); Amnioscope, Transabdominal (Fetoscope) (And Accessories); Endoscope, Fetal Blood Sampling (And Accessories); Insufflator, Laparoscopic; Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Coagulator-Cutter, Endoscopic, Bipolar (And Accessories); Biomicroscope, Slit-Lamp, Ac-Powered; Camera, Ophthalmic, Ac-Powered; Drape, Microscope, Ophthalmic; Headlamp, Operating, Battery-Operated; Arthroscope; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Catheter And Tip, Suction; Electrode, Electrosurgical; Holder, Ear Speculum; Hook, Microsurgical Ear; Mirror, Ent; Retractor, Ent; Gag, Mouth; Blower, Powder, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Forceps, Biopsy, Electric; Chair And Table, Medical; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Accessories, Catheter, G-U; Dilator, Urethral; Instrument, Manual, General Obstetric-Gynecologic; Evacuator, Gastro-Urology; Knife, Ent; Container, Liquid Medication, Graduated; Syringe, Irrigating (Non Dental); System, Irrigation, Urological; System, Image Processing, Radiological; System, Digital Image Communications, Radiological; Dislodger, Stone, Biliary; Instrument, Ent Manual Surgical; Orthopedic Manual Surgical Instrument; Angioscope; Instrument, Manual, Surgical, General Use; Accessories, Cleaning Brushes, For Endoscope; Vaginoscope And Accessories; Transilluminator, Fiber Optic; Accessories, Arthroscopic; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Led Light Source; Tubing And Tubing/Filter Fits; Hysteroscope Accessories; Light Source System, Diagnostic Endoscopic; Endoscope Holder; Endoscopic Irrigation/Suction System; Endoscopic Grasping/Cutting Instrument, Non-Powered; Endoscopic Central Control Unit; Endoscopic Contamination Prevention Sheath; Insufflator, Endoscopic Vessel Harvesting; Confocal Optical Imaging; Ear, Nose, And Throat Stereotaxic Instrument; Basin For Endoscope Reprocessing; Drape, Surgical, Exempt; Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use",1; 2; 3; f,"11274AB Flex Pediatric BRONCHOSCOPE; 11274AC Flex. CHOLEDOCHOSCOPE; 12G-SDI CABLE,; 26025UC HAMOU Elctrnc HYSTEROFLATOR; 300W Light Source, Non-flash; 495N Series Fibr Optic Light Cables; 7.5 Fr. Flexible CHOLEDOSCHOSCOPE; ADVANCED IMAGE AND DATA; AIDA Compact II System; AIDA w/ DICOM and HL7 Interface; ARTHRO PUMP; ARTHROPUMP DISP, Tubing Set; ARTHROPUMP Plus; AUTOCON II 200 Electrosurg Generat; AUTOCON II 400 Electrosurgical Gen.; AUTOCON III 400; Adaptors for Documentation; Adult/Pede VISCOUS Fluid Inject.Set; Arthroforce; Arthroscopic Telescopes; Autocon II 400 Electrosurgical Gen; BOUGIES and Dilators; Basin for endoscope reprocessing; Bipolar Coagulating Forceps; Bipolar Coagulation Electrodes; Bipolar Electrodes; Bipolar Electrotome; Bridges, Adaptors; Bronchoscope; Bronchoscopes; C-Cam; CALCULASE HOLMIUM LASE; CALCULASE HOLMIUM LASER; CALCULASE Holmium Laser & Acc.; CALCUSON; CALCUSPLIT; CALCUTRIPT Elctrohydraulc LITHR SYS; CCL Vaginal Extractor and Acc's; CHARDONNES Morcellation Knife; CLEARVISION Lens Irrigation System; CLICKLINE Scissors Inserts for single use; CMOS Endoscopes SSU; CMOS Video Rhino Laryngoscope; CMOS Video-Rhino-Laryngoscope System; CO2 ARTHROFLATOR; CO2 Endoflator; CO2 HYDROMAT Pump for Irrigation; CO2mbi LED SCB; Calculase II; Camera; Camera, ophthalmic, ac-powered; Carcinoma Gauges; Catheters; Catheters, MANDRIN, Plugs, Connect; Chair and Table, Medical; Cholangiography Set; Cleaning Brushes and kits; Cold Knife; Cold Knife Blades; Contact Microlaryngoscope; Continuous Flow Cystoscope; Continuous Flow RESECTOSCOPES; Cover; Cutting Loop Elctrodes Modification; Cystoscope 78FAJ, Fiberoptic 78GDB; DCI Endoscope; DCI VIDEO LARYNGOSCOPE; Dental Endoscopes; Dental Hand Instruments; Deployable Cardiovascular Clamp; Device Imaging Storage; Dilators, Reducers, Sleeves; Distending DIVERTICULOSCOPE; Drape; Drill; ENDOFLATOR +; ENDOFLATOR 40&50; ENDOMAT LC PUMP; ENDOMAT SELECT; ENDOSCOPE ACCESSORIES; ENDOSPINE Oper Tube & Telesc Bridge; ENDOTIP System; ENT Forceps, Scissors, and Punches; ENT Rigid Telescopes; ENT Stent Applicator Forceps; ENT Surgical Instrument; ENT/NEURO/OMF System and Accessory; EPIDUROSCOPE; EQUIMAT Model 203020 20; EQUIMAT, Model 203020 20; EYEPIECE ATTACHMENT FOR INS; Elec Endoflator, Model 264305 20; Electronic LAPAROFLATOR; Electronic LAPAROFLATOR (10 LPM); Electronic LAPAROFLATOR (20 LPM); Endoflator LC; Endomat Select; Endomat Select (Model Number: UP210); Endoscope; Endoscope Accessories; Endoscope Accessory; Endoscope Holder; Endoscopy Instrument; Esophagoscope and Accessories; FISCH TITANIUM MID; FISCH Titanium Mid Ear Prostheses; FLEX-X2; Fetoscopy Set; Fiber Optic Light Cables; Fiberscope; Flex-XC; Flex. HYSTEROSCOPE; Flexible CHOLEDOCHOSCOPE; Flexible CMOS Video-Cysto Urethroscope; Flexible Choledochoscope; Flexible HD Cysto-Urethroscope System; Flexible HD Video Rhino-Laryngoscope System; Flexible Hysteroscope, 10.5 Fr; Flexible Intubation Video Endoscope – Sterile (FIVE-S); Flexible Trocar Sleeves; Flexible Video Cysto-Urethroscope; Flexible Video-Uretero-Choledochoscope-System; Flexible Video-Uretero-Renoscope; Flexible Video-urethro-cystoscope; Fluid Light Cables; Forceps, ENDO/LAP; GAAB Rigid NEUROENDOSCOPES; GELET Uretero-Renoscope; GI CCU; General/Plastic Surgery Instruments; Grasping, Biopsy, and Spoon Forceps; H1 Camera Head; HAMOU ENDOMAT; HAMOU ENDOMAT Disposable Tubing Set; HARTMANN Ear Speculum; HD Mediastinoscope; HD View; HD-View; HEMPFLING Dilation Set; HOPKINS I/II Autoclavable Telescope; HOPKINS Telescopes; HOPKINS Telescopes for Arthroscopy; HYDROMAT, Model 263110 20; HYSTEROSCOPIC INSU; Headband; Headlight; Hysteromat II; Hysteroscope and accessories; IMAGE1; Image 1 SPIES; Image Processing System; Image1 S CCU, Image1 S 4U camera head; Infant Balloon VAGINOSCOPES; Instr Set Percut Discect/Nucleotomy; Instr, TX of Carpal Tunnel Syndrome; Instrument Tray; Instruments, Bipolar Coagulation; Insufflation Bulb; Insulated  Scissors & Rectal Snares; Insulated Biopsy Forceps; Insulated Biopsy Forceps, Grasping; Insulated Cannulae & Suction Tubes; Insulated Dissecting Cannulae; Insulated ELECTROSUGRICAL Instrum.; Intra-Handpieces & Accessories; Intubation Fiberscope; KARL STORZ BLADDER EVACUATOR; KARL STORZ Bipolar Resectoscopes with HF Cable; KARL STORZ Cholangiography Set; KARL STORZ Cysto-Urethro-Fiberscope; KARL STORZ ENDOVISION HYSTEROCAM; KARL STORZ ENDOVISION UROCAM; KARL STORZ Endoscopic Accessories for Urology; KARL STORZ Endoscopic ICG Imaging System; KARL STORZ FIBEROPTIC; KARL STORZ FLEXIBLE VIDEO-; KARL STORZ FORCEPS; KARL STORZ Fiber Telescopes for Urology; KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S; KARL STORZ Flexible Video Neuro-Endoscope; KARL STORZ Flexible Video-Neuro-Endoscope System; KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC); KARL STORZ HOPKINS Telescopes; KARL STORZ HYSTEROCAM; KARL STORZ ICG Imaging System; KARL STORZ ICG Imaging System with RUBINA Lens System; KARL STORZ ICG System; KARL STORZ Image1 S Camera Control Unit; KARL STORZ LARYNGOSCOPE; KARL STORZ Laryngoscopes and Accessories; KARL STORZ MODEL 28200C; KARL STORZ Mediastinoscopes and Instruments; KARL STORZ NAV1 Electromagnetic Navigation System; KARL STORZ NEEDLE HOLDERS; KARL STORZ OTOSCOPE; KARL STORZ PRESSURE T; KARL STORZ PULSAR II; KARL STORZ Ped. Cysto-Urethro-Fiberscope; KARL STORZ Pediatric Cysto-Urethro-Fiberscope; KARL STORZ SURGICAL CANNULA; KARL STORZ Shuntscope; KARL STORZ Trocars with Valve Seals; KARL STORZ Urological Laser Accessories; KARL STORZ VIDEO GASTROSCOPES; KARL STORZ VIDEO LOWER; KARL STORZ suction and irrigation system; KNIFE, ENT; KOH Needle Holders, Suture Forceps; KOH Needle Holders, Suturing Forcep; KS Lock; KSEA CLEARVISION II, MODEL 40334120; KSEA CLEARVISION LE; KSEA Monopolar Resectoscopes; KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE; Karl Storz Arthropump Power Irrigation/Suction Pump, Tubing; Karl Storz MegaFix-C Composite; Knives, Curettes; Knives,Curettes,Hooks,Needles; LAPAROCAM; LED Headlight KS70; LED light source; Laparoscope; Laproscope; Laproscopy; Laproscopy Insstruments; Large Joint Arthroscopy Set; Laryngoscope Accessories; Laser Accessories; Light Cable; Light Fountain 50 Watts; Light source system, diagnostic endoscopic; MAHNES Take-Apart Bipol Coag Forcep; MIrror; MOUTH GAG; MTP ARTHROUMP TUBING SET; MTP CLEARVISION Disp Tubing Set; MTP Disposable Trocar Valves; MTP Extraction Bags; MULTIDRIVE II Mini Shaver; MVM 3.3 MM MICROENDOSCOPE; MVM 3.3 MM Micro-Endoscope; MVM 7.5 French Flex. HYSTEROSCOPE; MVM 7.5 French Flex. URETEROSCOPE; Medi Pack; Medicine Cups; MegaFix Perforated Bioabsorbable; MegaFix-T Titanium Screw; Micro Surgical Instruments; Micro-Instrum. for Cochlear Implant; Microcast 4K Pro; Microcast HD Pro; Microsurgical Ear; Miniature Endoscope; Miniature Telescope for Urology; Model 27080 LITHOTRIPTOR System; Model 27086C Ultrasonic LITHOTRITE; Model 27224P Continuous Flow Pump; Modification to ENDOTIP System; Mono Ball/Needle/Loop Electrodes; Mono Coag Ball Electrodes; Mono Coag Needle Electrode; Mono Coag Needle, Loop Electrodes; Mono High Freq Cords; Mono Vaporization Electrodes; Monopolar Coagulating Electrodes; Monopolr Cord, Endoscpc Hi-Frequncy; N20 ENDOFLATOR; NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER); NEO; NEO IP; Nasopharyngo/Broncho/Tracheoscopes; Nasopharyngoscope; Navigation Panel Unit; Needles; Nephroscope, Adult & Pediatric; Neuro FIBERSCOPE; Neuro-Fiberscope; Neuroscope and Accessories; New Generation Trocars; Nonpowered neurosurgical instrument; OR1 SCB CONTROL; OTOSCOPE; Obstetrical and Gynecological Surgical Devices; Obturators, Cannula Sheaths; Operating LARYNGOSCOPES & Accs; Optical Mediastinoscope; Ortho Manual Surgical Instruments; Ped VANCAILLIE Take Apart Bip Instr; Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories; Percutaneous Foraminoscopy Set; Percutaneous Nephroscope System; Plastic Surgery Accessories; Powder Blower and Accessories; Power LED 175; Power LED 175 Light Fountain; Powered Laser Surgical Instrument; Powershaver System S2; Protoscopes, Sigmoidoscopes, Acc.; Puncture, Injction, ENDOSCPIC VERES; REMORGIDA Forceps; RETRACTOR; RHINO-PHARYNGO-LARYNGO FIBERSCOPE; Resectoscopes; Retractors,Probes,Dissectors,Hooks; Rhino-Laryngo-Bronco Fiberscope; Rigid Telescopes; Rotocut G1 Morcellator, Electromech; S-Pilot; SACHSE DRILL; SAWAHLE Electromech. Morcellator; SCB Interface Control #20090120; SCB Media Control; SCB-RUI (Realistic User Interface); SCB/CONMED ESU INTERFACE MODULE; SCB/Covidien Force Triad Interface Module; SCB/STERIS OR-Light Interface Box; SCB/VALLEY LAB Force FX Interface; SINGLE-USE TISSUE TRAP FILTER W/ADAPTER; SPIES 3D System; SSU Flexible Video-Uretero-Renoscope; STEINER Electromechanic Morcellator; SUPRALOOP; SYRINGE, IRRIGATING (NON DENTAL); Saphenous Vein Harvesting Set; Scalp Blood Collection Set; Scissors, ENDO/LAP; Semi-Rigid Micro-Endoscpes & Acc.; Semi-Rigid Micro-Endoscpes & Acces.; Semi-Rigid Microendoscope & Acc.; Semi-rigid Hysteroscope; Series 11274 Flex. URETEROSCOPE; Series 11274 Flexible Fiberscope; Shoulder Pro; Sialoendoscopes and Accessories; SilCut; SilGrasp; Slim Nasopharyngolaryngoscope; Smart Smoke Evacuation; Smoke Removal Tube; Snares; Speculum; Speculum, ENT; Spinoscope; Sterilization Trays; Stone Basket; Suction Catheters; Suction/Drainage Tubes, Cannulae; Suction/Irrigation Tubes; Sunction Tube; TAMBERGER-SACHASE INTRANASAL DRILL; THERMOFLATOR, Model 26 4320 20; TIPCAM; TIPCAM 1S 3D System; TIPCAM1 Rubina Video Endoscope System; TUBING; TUBING SET FOR LAPAROSCOPIC INSUFFL; Take Apart Rotating Grasping Forcep; Take Apart Suture Forceps; Take-Apart Bipolar Forceps; Take-Apart Forceps; Take-Apart Scissors; Tape and bandage, adhesive, adjustable closing mechanism, OTC use; Telepack +; Telescope Bridges & Adaptors; Telescopes Holders; Telescpes, Rigid/Mgnifying/KS VARIA; Thoracic Surgery Instruments; Trans-Nasal Esophagoscopes; Trocars, Cannulae and Sheaths; Tubing with Connector; Tuning Fork; Twin Transilluminator; UNIDRIVE II/II Plus & ENT Accessori; UNIDRIVE S III ENT; UNIDRIVE SIII System; UNIDRIVE Select System; UNIMAT 12; UNIMAT 45; UNIMAT Plus; URETERO-RENOSCOPES/URETEROSCOPE; UROMAT; UROPUMP Disposable Tubing Set; Unidrive SIII ENT; Unidrive Shaver ARTHROSCOPY Blades; Ureter Resectoscope; Ureteroscope and accessories, flexible/rigid; Uterine Manipulator; VACUSAFE TUBING SETS; VISCOUS Fluid Injection Set; VITOM; VOICE1 SCB R-UI Speech Control App; Vaporization Electrodes; Vascular Fiberscopes; Vein Discission; Video Flexible ENT Endoscope System; Video Gastroscopes; Video Lower G.I. Endoscope System; Wound Closure Instruments; XENON NOPPVA; Xenon 100; Xenon Light Source (175W) 201320-20; Xenon Light Source/Flash; Xenon Nova Light Source; Zero Wire; manual surgical instrument ENT",1978-06-20,343,2026-10-14,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014342096%22&limit=1
Cook Incorporated,1820334,1820334,750 Daniels Way,Bloomington,IN,47404,United States,"COOK, INC.",1820334,Complaint file establishment; Contract sterilizer; Manufacturer; Manufacturer for export; Specification developer,202,BSP; BSR; BTG; BTO; BTR; BTS; BWB; BWC; BYY; BZA; CBI; DPW; DQO; DQX; DQY; DRC; DRE; DTK; DTL; DWF; DWO; DWZ; DXE; DXF; DYB; EMF; EXB; EXD; EXG; EYB; EYI; EYJ; EYK; EYZ; EZB; EZL; EZN; FAD; FAJ; FAP; FAX; FBK; FBQ; FBW; FCG; FCL; FCN; FCS; FDI; FDX; FED; FEN; FEW; FEX; FFD; FFH; FFK; FFL; FFS; FFY; FGA; FGB; FGE; FGM; FGY; FHA; FHB; FHF; FHQ; FHR; FMI; FOZ; FPA; FSM; FSO; FTM; FTT; FZT; FZX; GAA; GAE; GAH; GAX; GAZ; GBA; GBM; GBO; GBP; GBW; GBX; GBZ; GCA; GCB; GCC; GCD; GCE; GCJ; GCY; GCZ; GDF; GEA; GED; GEE; GEI; GEJ; GEX; HAO; HCF; HCG; HDQ; HDR; HES; HET; HFC; HFE; HFF; HGE; HHM; HHO; HIO; HNW; HTD; HYA; ITX; IWJ; IWS; JCT; JDZ; JOH; JOL; JOP; JRL; KCG; KDC; KDD; KDQ; KET; KGC; KGY; KGZ; KIH; KJG; KNA; KNQ; KNS; KNT; KNW; KOA; KOB; KOD; KOE; KPY; KQT; KRA; KRD; KTI; KYZ; LIT; LJE; LJS; LJT; LKF; LLX; LQR; LRC; LRP; LRW; MAV; MDM; MFD; MIH; MIJ; MJG; MMX; MOV; MPB; MPR; MQE; MQF; MQG; MQH; MQJ; MQK; NAJ; NDN; NHC; NIN; NNX; NTN; NWT; NWV; NWW; OAR; OCY; OCZ; ODC; OQY; PDU; PGK; PNO; PRR; QCX,"Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Brush, Biopsy, Bronchoscope (Non-Rigid); Tube, Tracheostomy (W/Wo Connector); Tube, Tracheal (W/Wo Connector); Tube, Bronchial (W/Wo Connector); Forceps, Tube Introduction; Needle, Emergency Airway; Tube, Aspirating, Flexible, Connecting; Connector, Airway (Extension); Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector); Flowmeter, Blood, Cardiovascular; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Filter, Intravascular, Cardiovascular; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Needle, Biopsy, Cardiovascular; Device, Biopsy, Endomyocardial; Catheter, Embolectomy; Catheter, Septostomy; Introducer, Catheter; Knife, Surgical; Collector, Ostomy; Irrigator, Ostomy; Bag, Urine Collecting, Ureterostomy; Catheter, Ureteral, Gastro-Urology; Adaptor, Ureteral Catheter; Holder, Ureteral Catheter; Connector, Ureteral Catheter; System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile; Stylet For Catheter, Gastro-Urology; Catheter, Retention Type, Balloon; Dilator, Catheter, Ureteral; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Cystometric Gas (Carbon-Dioxide) On Hydraulic Device; Bougie, Urological; Endoscopic Injection Needle, Gastroenterology-Urology; Trocar, Gastro-Urology; Filiform And Filiform Follower; Biopsy Needle; Forceps, Biopsy, Non-Electric; Urinary Drainage Collection Kit, For Indwelling Catheter; Light, Catheter, Fiberoptic, Glass, Ureteral; Snare, Flexible; Endoscopic Cytology Brush; Endoscopic Access Overtube, Gastroenterology-Urology; Device, Cystometric, Hydraulic; Catheter, Malecot; Instrument, Catheter, Punch; Evacuator, Bladder, Manually Operated; Collector, Urine, Pediatric, For Indwelling Catheter; Lithotriptor, Electro-Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Image, Illumination, Fiberoptic, For Endoscope ; Adaptor, Bulbs, Miscellaneous, For Endoscope; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Stents, Drains And Dilators For The Biliary Ducts; Probe And Director, Gastro-Urology; Cannula, Injection; Clamp, Penile; Hook, Gastro-Urology; System, Evacuator, Fluid; Holder, Needle, Gastroenterologic; Needle, Gastro-Urology; Needle, Hypodermic, Single Lumen; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Tray, Surgical, Instrument; Microscope, Surgical, General & Plastic Surgery; Mesh, Surgical; Camera, Still, Surgical; Cutter, Surgical; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Snare, Surgical; Stylet, Surgical, General & Plastic Surgery; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Balloon Type; Catheter, Urethral; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Multiple Lumen; Catheter, Peritoneal; Catheter, Irrigation; Catheter, Cholangiography; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Needle, Catheter; Dilator, Catheter; Connector, Catheter; Adaptor, Catheter; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Retainer, Surgical; Guide, Needle, Surgical; Cannula, Surgical, General & Plastic Surgery; Brush, Dermabrasion, Manual; Brush, Biopsy, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Powered Laser Surgical Instrument; Instrument, Surgical, Non-Powered; Instrument, Ligature Passing And Knot Tying; Device, Neurovascular Embolization; Dilator, Cervical, Fixed Size; Cap, Cervical; Insufflator, Carbon-Dioxide, Uterotubal (And Accessories); Laparoscope, Gynecologic (And Accessories); Aspirator, Endocervical; Brush, Endometrial; Aspirator, Endometrial; Amniotome; Sound, Uterine; Screw, Fibroid, Gynecological; Sampler, Amniotic Fluid (Amniocentesis Tray); Dilator, Lachrymal; Forceps; Forceps, Wire Holding; Transducer, Ultrasonic, Diagnostic; System, Applicator, Radionuclide, Manual; Shield, Eye, Radiological; Prosthesis, Tracheal, Expandable; Mixer, Cement, For Clinical Use; Tube Tracheostomy And Tube Cuff; Catheter And Tip, Suction; Transducer, Ultrasonic; Unit, Filter, Membrane; Dilator, Tracheal; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Filters, Cell Collection, Tissue Processing; Tube, Gastro-Enterostomy; Bag, Intestine; Accessories, Catheter; Dispenser, Cement; Tube, Tissue Culture; Instrument, Manual, Specialized Obstetric-Gynecologic; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Surgical Instruments, G-U, Manual (And Accessories); Catheter, Suprapubic (And Accessories); Catheter, Urological; Dilator, Urethral; Shield, Protective, Personnel; Evacuator, Gastro-Urology; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Catheter, Angioplasty, Peripheral, Transluminal; Catheter, Nephrostomy; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Cannula, Manipulator/Injector, Uterine; Catheter, Sampling, Chorionic Villus; Dislodger, Stone, Biliary; Instrument, Ent Manual Surgical; Tray, Surgical; Scissors, General, Surgical; Syringe, Balloon Inflation; Instrument, Manual, Surgical, General Use; Cannula, Intrauterine Insemination; System, Endovascular Graft, Aortic Aneurysm Treatment; Needle, Tumor Localization; Device, Percutaneous, Biopsy; Device, Percutaneous Retrieval; Catheters, Salpingography; Catheter, Hemodialysis, Non-Implanted; Stent, Bladder, Fetal; Needle, Assisted Reproduction; Catheter, Assisted Reproduction; Accessory, Assisted Reproduction; Microtools, Assisted Reproduction (Pipettes); Micromanipulators And Microinjectors, Assisted Reproduction; Labware, Assisted Reproduction; Agents, Embolic, For Treatment Of Uterine Fibroids; Cement, Bone, Vertebroplasty; Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents); Stent, Renal; Device, Incontinence, Urosheath Type, Non-Sterile; Led Light Source; Endoscopic Cholangiogram Kit; Laparoscopic Accessories, Gynecologic; Hysteroscope Accessories; Injector, Vertebroplasty (Does Not Contain Cement); Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Grasping/Cutting Instrument, Non-Powered; Endoscope Channel Accessory; Intrauterine Tamponade Balloon; Catheter For Crossing Total Occlusions; Cannula, Injector, Uterine, Endometrial Biopsy; Catheter, Percutaneous, Cutting/Scoring; Feeding Tube Kit; Retrograde Intubation Set",1; 2; 3; U; f,"1,4 Layer Tissue Graft; ACROBAT 2 CALIBRATED TIP WIRE GUIDE; ACROBAT CALIBRATED TIP WIRE GUIDE; AQ HYDROPHILIC COATED DILATOR; AQ Hydrophilic Dual Lumen Ureteral Access Catheter; Advance Biliary Balloon Catheter; Advance, 14LP Low Profile PTA Balloon Dilatation Catheter; Aintree Intubation Catheter with Rapi-Fit Adapter; Amplatz Dilator; Amplatz Extra Stiff Whisker Wire Guide; Amplatz Extra Stiff Whisker Wire Guide Heparin Coated; Amplatz Extra Stiff Wire Guide; Amplatz Extra Stiff Wire Guide Heparin Coated; Amplatz Needle Holder; Amplatz Radiopaque TFE Sheath; Amplatz Renal Dilator Set; Amplatz Renal Introducer; Amplatz Stiff Wire Guide; Amplatz Support Wire Guide with Apex Curve; Amplatz Ultra Stiff Wire Guide; Amplatz Universal Drainage Catheter Ultrathane; Amplatz Ureteral Stent Set Ultrathane; Anesthetic Gel Adapter; Angled Tip Ureteral Catheter Set; Angled Tip Ureteral Catheter Set With Bentson PTFE Wire Guide; Angled Tip Ureteral Catheter with Bentson PTFE-Coated Wire Guide; Approach® CTO Micro Wire Guide; Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters; Arndt Pediatric Endobronchial Blocker Set With Spherical Balloon; Arterial Pressure Monitoring Set; Arterial Pressure Monitoring Set Nylon; Arterial Pressure Monitoring Set Urethane; Arterial Pressure Monitoring Tray; Arterial Pressure Monitoring Tray Nylon; Ascent AQ Ureteral Dilation Balloon; Aspiration Handle; Aspiration Needle Set; Aspiration Tube; Aurous Centimeter Sizing Catheter; Australian Mandril Wire Guide; BRONCHIAL BIOPSY BRUSH; BRONCHIAL BRUSH BIOPSY SET; Bakri Essential Postpartum Balloon; Ball Tip Fulgurating Electrode; Balloon Ureteral Dilator; Balloon Ureteral Dilator Set; Bander Ureteral Diversion Open-End Stent Set; Bander Ureteral Diversion Stent Set; Bander Ureteral Diversion Stent Set Wire Guide With Hydrophilic Coating; Bentson Wire Guide; Bentson Wire Guide 20cm Distal Flexibility with Softened Tip Heparin Coated; Biliary Drainage Catheter Ultrathane; Black Silicone Filiform Dbl Pigtail Ureteral Stent Set Wire Guide With Hydrophilic Coating; Black Silicone Filiform Double Pigtail Ureteral Stent Set; Black Silicone Filiform Double Pigtail Ureteral Stent Set Wire Guide With Hydrophilic Coating; Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set; Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray; Brush Biopsy Set; Bunegin-Albin Air Aspiration Set Polyethylene; CAGED BALLOON CATHE; CATHETER ACCESSORIES; CATHETER INSERTION FORCEPS; CHIBA DECOMPRESSION SET; CIAGLIA BLUE RHINO PERCUTAN; CODA BALLOON CATHETER; COOK Strange Bile Duct Stone Exploration Set; COONS DILATOR; COPE INTRODUCING DILATOR; CXI Support Catheter; Catheter for Use with Amplatz Renal Dilator Set; Central Venous Catheter Set; Central Venous Catheter Tray; Cervical Mucus Aspiration Set; Check-Flo Introducer; Check-Flo Performer Introducer; Check-Flo Performer Introducer Set Micropuncture® Radial Artery Access; Check-Flo® Adapter; Check-Flo® Adapter with Side-Arm and Stopcock; Clear Amplatz Sheath with Radiopaque Stripe; Common Bile Duct Exploration Set; Common Bile Duct Stent Set Laparoscopic; Cone Tip Ureteral Catheter; Cone Tip Ureteral Catheter with Open-End; Connecting Tube; Connecting Tube - Double Use With Cook Drainage Pouch; Connecting Tube - Single Use With Cook Drainage Pouch; Connecting Tubes; Connecting Tubes and Pressure Monit; Cook 810 Set; Cook Airway Exchange Catheter with Rapi-Fit Adapters; Cook Aspiration Unit; Cook CVC Double Lumen Power Injectable Central Venous Catheter Set; Cook CVC Double Lumen Power Injectable Central Venous Catheter Tray; Cook CVC Five Lumen Power Injectable Central Venous Catheter Set; Cook CVC Five Lumen Power Injectable Central Venous Catheter Tray; Cook CVC Single Lumen Central Venous Catheter Set; Cook CVC Triple Lumen Power Injectable Central Venous Catheter Tray; Cook CVC Triple Lumen Power-Injectable Central Venous Catheter Set; Cook Chorionic Villus Sampling Set; Cook Coagulator Probe; Cook Collect Evac; Cook Cope Loop Suprapubic Catheter Set; Cook Cystostomy Catheter Set; Cook Drainage Pouch Set; Cook Fallopian Tube Catheterization Wire Guide with Platinum Tip; Cook Injection Needle; Cook Retrograde Intubation Set; Cook Silicone Balloon HSG Catheter; Cook Silicone Balloon HSG Catheter With Closed End And Sideport; Cook Spectrum Central Venous Catheter Tray Power Injectable Double Lumen Minocycline/Rifampin Antibiotic Impregnated; Cook Spectrum Central Venous Catheter Tray Power Injectable Triple Lumen Minocycline/Rifampin Antibiotic Impregnated; Cook Spectrum Turbo-Ject PICC Set Minocycline/Rifampin Impregnated Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter; Cook Sterilization Case; Cook Turbo-Flo HD Hemodialysis Catheter Set Double Lumen Polyurethane; Cook Turbo-Flo HD Hemodialysis Catheter Tray Double Lumen Polyurethane; Cook Turbo-Flo HD Hemodialysis Catheter Tray Double Lumen Polyurethane Catheter; Cook-Cope Loop Nephrostomy Catheter; Cook-Cope Loop Nephrostomy Set; Cook® SP Tube Introducer Set; Cook® Spectrum® Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Power Injectable Triple Lumen; Coons Interventional Wire Guide; Cope Gastrojejunostomy Cannula; Cope Nephroureterostomy Stent Ultrathane; Cope Pediatric Gastrointestinal Suture Anchor; Cope Pediatric Gastrointestinal Suture Anchor Set; Cope Proximal Biliary Loop Catheter Ultrathane; Cope Proximal Biliary Loop Catheter Ultrathane,; Cup Biopsy Forcepts; Cystic Duct Introducer Set; DELTA WIRE GUIDE; DILATOR; DILATOR SET; DILATOR WITH AQ® HYDROPHILIC COATING; Deflectable Biopsy Set; Deflectable Brush Biopsy Set; Desilets-Hoffman Introducer Set; Desilets-Hoffman Introducer Set With Radiopaque Band; Dieckmann Intraosseous Infusion Needle 45 Degree Trocar; Dieckmann Intraosseous Infusion Needle 45 Degree Trocar - Pediatric Use (Less than 24 months); Disposable Cervical Dilators; Disposable Reuter Tip Deflecting Wire Guide; Disposable Stopcock; Disposable Trocar Needle; Disposable Two-Part Trocar Needle; Double Flexible Tipped Wire Guide; Dretler Ureteroscopy Stent Set; Dual Check Valve; Dual Lumen Ureteral Access Catheter; Dual Lumen Ureteral Catheter With AQ® Hydrophilic Coating; Dual Male Luer Lock Adapter; EMBO PREP KIT; ENDOVASCULAR DILATOR SET; EchoTip® Disposable Two-Part Trocar Needle; EchoTip®Skinny Needle® with Chiba Tip; Echotip® Open-End Ureteral Catheter; Elongated Cup Biopsy Forceps; Embryo Transfer Catheter; Emergency Transtracheal Airway Catheter; Endogo HD; Endoscopic Cap; Endoscopic Curved Needle Holder; Endoscopic Introducer/Extractor; Endoscopic Splash Shield; Endoscopic Tuohy Borst Adapter; Endosnare; Endovascular Dilator; Endovascular Dilator Coons Dilator; Endovascular Dilator Set Coons Dilator; Endovascular Dilator and Set; Enterostomy Suture Anchor Set; Entuit Gastrostomy Set; Entuit Gastrostomy Set with ENFit Connection; Entuit Secure Adjustable Gastrointestinal Suture Anchor Set; Entuit Secure Gastrointestinal Suture Anchor Set; Extra Large Check-Flo Introducer; FUSION LITHOTRIPSY EXTRACTION BASKET; FUSION WIRE GUIDE LOCKING DEVICE; Fair Urethral Stent; Fallopian Tube Catheterization Set; Fascial Incising Needle; Female Luer Lock Cap; Fiber Inspection Microscope; Filler Tubes, Various; Firlit-Kluge Urethral Stent; Firlit-Sugar Intermittent Catheter; Fixed Core Bentson Curved; Fixed Core Bentson Curved Wire Guide; Fixed Core Wire Guide Safe-T-J Curved Wire Guide; Fixed Core Wire Guide Safe-T-J‚ Curved; Fixed Core Wire Guide Safe-T-J‚ Curved Heparin Coated; Fixed Core Wire Guide Straight; Fixed Core Wire Guide Straight Heparin Coated; Flexi-Tip® Dual Lumen Ureteral Access Catheter; Flexi-Tip® Dual Lumen Ureteral Access Catheter With AQ® Hydrophilic Coating; Flexi-Tip® Ureteral Catheter (Left); Flexi-Tip® Ureteral Catheter (Right); Flexipet, Adjustable Handle Set; Flexor Parallel Rapid Release Ureteral Access Sheath with AQ Hydrophilic Coating; Flexor Ureteral Access Sheath with AQ Hydrophilic Coating; Flexor Vision; Flexor, Shuttle - SL Introducer with Tuohy-Borst Sidearm; Flexor, Tuohy-Borst Side-Arm Introducer Shuttle,-SL; Flushing Catheter; Foley Adapter/Connector; Foot Ureteroscopy Irrigation Pump; Frova Intubating Introducer with Rapi-Fit Adapters; Frova Intubating Introducer with Stiffening Cannula; Fuchs Endo-Needle Guide; Gastric Sizing Balloon Catheter; Gianturco Roehm Bird's Nest Vena Ca; Gift Catheter Set; Goldstein SonoBiopsy Catheter; Greene Renal Transplant Stent Set Wire Guide With Hydrophilic Coating; Guardia Access Embryo Transfer Catheter; Guardia Access Embryo Transfer Catheter With Internal Support Cannula; Guardia Access Malleable Obturator; Guardia Access Nano Embryo Transfer Catheter; Guardia AccessET Embryo Transfer Catheter; Guardia Obturator Malleable Adjustable Obturator; Guided Biliary Dilator Set; Gunther Tulip Vena Cava Filter Retrieval Set; HERCULES 3 STAGE BALLOON ESOPHAGEAL; HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL - PYLORIC - COLONIC; Hatter Flexible Cystoscopy Aspiration Tube; Heavy Double Flexible Tipped Wire Guide; Hilal Embolization Coil; Holmium Laser Fiber; Holmium Laser Fiber Multi Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems; Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems; Holmium Laser Safety Goggles and Glasses; Hysteroscopic Myoma Screw; Initial Placement Gastrostomy Set; Injekt Filiform Injection Needle; Insemi-Cath; Intratubal Transfer Set; Intrauterine Access Balloon Catheter; Jansen-Anderson Insemination Set; Kaye Nephrostomy Tamponade Balloon Catheter Set; Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set; Kidney Biopsy Brush; Kish Urethral Illuminated Catheter; Knot Pusher; Koyle Diaper Stent; Kumpe Access Catheter; Kwart Retro-Inject Ureteral Stent Set; Labcath; Laparoscopic Myoma Screw; Laser Ureteral Catheter; Lawson Retrograde Nephrostomy Wire Puncture Set; Lieberman Introducer; Liver Access and Biopsy Needle; Liver Access and Biopsy Needle Set; Luer Lock Cap; Lumax® Guiding Catheter; Lumax® Guiding Catheter/Guiding Coaxial Design; Lunderquiest Transhepatic Set; Lunderquist-Ring Torque Wire Guide; Lymphangiography Catheter; Lymphangiography Set; MAC-LOC MULTIPURPOS; MADDURI URETERAL STONE PUSHING CATHETER; MEMORY HARD WIRE BASKET; MEMORY SOFT WIRE BASKET; MReye Embolization Coil; MagniCore Precision Chiba iMRI Needle; MagniCore Precision Coaxial iMRI Needle; Malecot Nephrostomy Catheter/Stent Set; Margolin HSG Cannula; Markham Flexible Needle Guide; McLean-Ring Nasojejunal Feeding Tube Set; Melker Cuffed Emergency Cricothyrotomy Catheter Set - Percutaneous; Melker Cuffed Emergency Cricothyrotomy Catheter Set - Surgical; Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set; Micronester Embolization Coil; Micropuncture Introducer Set Push-Plus Design - STIFFENED CANNULA With Nitinol Wire Guide; Micropuncture Introducer Set Push-Plus Design STIFFENED CANNULA With Stainless Steel Wire Guide; Micropuncture Introducer Set Silhouette Transitionless; Micropuncture Introducer Set Silhouette Transitionless Design with Nitinol Wire Guide and EchoTip Needle; Micropuncture Introducer Set Silhouette Transitionless Push-Plus Design - STIFFENED CANNULA With Nitinol Wire Guide; Micropuncture Introducer Set Silhouette Transitionless Push-Plus Design - STIFFENED CANNULA With Stainless Steel Wire Guide; Micropuncture Introducer Set Silhouette Transitionless With Cope Platinum-Tipped Stainless Steel Wire Guide; Micropuncture Introducer Set Silhouette Transitionless With Nitinol Wire Guide; Micropuncture Introducer Set Silhouette Transitionless With Platinum-Tipped Stainless Steel Wire Guide; Micropuncture Introducer Set Silhouette Transitionless With Stainless Steel Wire Guide; Micropuncture Introducer Set With Cope Platinum-Tipped Stainless Steel Wire Guide; Micropuncture Introducer Set With Nitinol ST Wire Guide; Micropuncture Introducer Set With Nitinol Wire Guide; Micropuncture Introducer Set With Stainless Steel Wire Guide; Micropuncture Pedal Access Set Silhouette Transitionless - with Nitinol Wire Guide and Hemostatic Valve; Micropuncture® Introducer Set Silhouette® Transitionless Design with Nitinol Wire Guide and EchoTip® Needle; Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design - STIFFENED CANNULA With Nitinol Wire Guide; Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design - STIFFENED CANNULA With Stainless Steel Wire; Micropuncture® Introducer Set Silhouette® Transitionless Push-Plus™ Design With Nitinol Wire Guide; Micropuncture® Introducer Set Silhouette® Transitionless With Cope Platinum-Tipped Stainless Steel Wire Guide; Micropuncture® Introducer Set Silhouette® Transitionless With Nitinol Wire Guide; Micropuncture® Introducer Set Silhouette® Transitionless With Platinum-Tipped Stainless Steel Wire Guide; Micropuncture® Introducer Set Silhouette® Transitionless With Stainless Steel Wire Guide; Micropuncture® Introducer Set With Cope Platinum-Tipped Stainless Steel Wire Guide; Micropuncture® Introducer Set With Nitinol Wire Guide; Micropuncture® Introducer Set With Stainless Steel Wire Guide; Micropuncture® Pedal Access Set Silhouette® Transitionless - with Nitinol Wire Guide and Hemostatic Valve; Miller Double Mushroom Biliary Stent Set; Mitty Pollack Needle Set; Modified Novy Cornual Cannulation Set; Movable Core Wire Guide Tapered Tefcor Heparin Coated; Movable Core Wire Guide Tefcor; Multi-Sideport Catheter Infusion Set Dual Check Valve; N-Snare Stent Retriever; NCompass® Nitinol Stone Extractor; NYLON DILATOR; Nathanson Transcystic Bile Duct Stone Exploration Pack; Needle Catheter Combination; Nest VT Vitrification Device; Nester Embolization Coil; Newton Cerebral Wire Guide LLT; Newton Wire Guide LLT Taper; Newton Wire Guide LT Taper; Non-Toxic Syringe; Novy Corneal Cannulation Set; OBrien Suprapubic Peel-Away® Access Set; Odyssey Holmium Laser System; Offset Cervical Needle; One-Step Suprapubic Introducer; Onik-Cohen Percutaneous Access Set; Open-End Beveled Flexi-Tip® Ureteral Catheter; Open-End Flexi-Tip® Ureteral Catheter; Open-End Ureteral Catheter; Open-End Ureteral Catheter Sof-Flex®; Osteo-Force Connecting Tube; Osteo-Site® Bone Biopsy Needle; Osteo-Site® Bone Biopsy Needle Murphy M1M™; Osteo-Site® Bone Biopsy Needle Murphy M2™; Osteo-Site® Bone Biopsy Needle Set Murphy M2™; Ovum Aspiratiaon Needle with AQ Coating; Ovum Aspiration Needle; Pakter Curved Needle Set; Pediatric Flexor Ureteral Access Sheath; Pediatric Nephrostomy Stent Set; Pediatric Ureteral Catheter; Pediatric Urological Drain Bag; Peel Away Introducer; Peel-Away® Introducer; Peel-Away® Introducer Set; Percutaneous Entry Needle; Percutaneous Entry Set; Percutaneous Entry Set (EchoTip); Percutaneous Malecot Nephrostomy Catheter Set; Percutaneous Neonatal Pigtail Nephrostomy Set; Pigtail Ureteral Catheter Set; Pigtail Ureteral Catheter Set, Left; Pigtail Ureteral Catheter Set, Right; Pigtail Ureteral Catheter With Sof-Flex® AQ®; Pivet Guide Embryo Transfer Catheter Set; Polyethylene Catheter; Pursuit Balloon Dilation Catheter; ROADRUNNER WIRE GUIDE; Replacement O-Ring Set Use With K-MPH-1000; Retracta Detachable Embolization Coil; Retrograde Intubation Set; Reuter Tip Deflecting Wire Guide; Rhapsody® H-30® Holmium Laser System; Ring Biliary Drainage Set; Ring Biliary Duct Drainage Catheter Polyethylene; Ring Biliary Duct Drainage Catheter Ultrathane; Ring Transjugular Intrahepatic Access Set; Roadrunner Biliary Wire Guide; Roadrunner Extra Support Wire Guide; Roadrunner PC Wire Guide Nimble; Roadrunner PC Wire Guide Nimble Floppy; Roadrunner PC Wire Guide The Firm; Roadrunner PC Wire Guide The Firm LT; Rosch-Uchida Transjugular Liver Access Set; Rosen Curved Wire Guide; Rosen Curved Wire Guide Heparin Coated; Rosen Curved Wire Guided; Round Tip Ureteral Catheter (Left); Round Tip Ureteral Catheter (Right); Royal Flush Plus High-Flow Catheter; Royal Flush® Catheter; Rutner Universal Wedge Catheter; STANDARD WIRE GUIDE; Safety Wire Guide Introducer; Salle Intraoperative Pyeloplasty Stent Set With 3cm Stylet; Salle Intraoperative Pyeloplasty Stent Set With 6cm Stylet; San Antonio Stopcock; Seidmon Antegrade AQ® Stent Set; Selective Salpingography Catheter; Selikowtiz Ureteroscopic Knife; Side Arm Adapter; Side-Arm Adapter - Male Luer Lock and Touhy-Borst Adapter; Silhouette® Transitionless Peel-Away® Introducer; Silicone Rectal Balloon; Skinny Needle; Skinny Needle® with Chiba Tip; Sling Cutter; Sof-Flex, Double Pigtail Ureteral Stent Set Wire Guide with Hydrophilic Coating; Sof-Flex® Double Pigtail Ureteral Stent Set; Sof-Flex® Multi-Length Ureteral Stent Set; Sof-flex Loop Suprapubic Catheter Set; Soft-Pass EchoTip Embryo Transfer Catheter; Soft-Pass EchoTip Embryo Transfer Catheter Set; Soft-Pass Embryo Transfer Catheter Set; Soft-Pass™ Embryo Mock Transfer Catheter Set; Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip; Soules Intrauterine Insemination Catheter; Spectrum Central Venous Catheter Set Double Lumen Polyurethane Minocycline/Rifampin Antibiotic Impregnated; Spectrum Central Venous Catheter Set Triple Lumen Polyurethane Minocycline/Rifampin Antibiotic Impregnated; Spectrum Central Venous Tray Double Lumen Polyurethane Catheter Minocycline/Rifampin Impregnated; Spectrum Central Venous Tray Five Lumen Polyurethane Catheter Minocycline/Rifampin Impregnated; Spectrum Central Venous Tray Minocycline/Rifampin Impregnated Double Lumen Polyurethane Catheter; Spectrum Central Venous Tray Triple Lumen Polyurethane Catheter Minocycline/Rifampin Impregnated; Spiral Tip Ureteral Access Catheter; Stamey Percutaneous Loop TURP Suprapubic Catheter Set; Stamey Percutaneous Suprapubic Catheter Set; Steam Sterilization Tray; Stonebreaker Pneumatic Lithotripter; Straight Forming Wire; Stylet Catheter Combination; Surgical Urine Drain Pouch Set; Surgisis and Surgisis ES; TFE Catheter; TFE Coated Amplatz Ultra Stiff Wire Guide - Catheter Exchange; TFE Coated Curved Amplatz Ultra Stiff Wire Guide - Catheter Exchange; TFE Sheathed Needle; THE WEB EXTRACTION BASKET; TIGER TOURNIQUET; TRACER METRO DIRECT WIRE GUIDE; Tao Brush I.U.M.C. Endometrial Sampler; Taylor Gel Adapter; Tissue Bag Introducer; Tornado Embolization Coil; Tornado Embolization Microcoil; Transmyometrial Embryo Transfer Catheter; TriForce Peripheral Crossing Set; Tuohy-Borst Adapter; Turbo-Flo PICC Set Polyurethane Peripherally Inserted Central Venous Catheter; Two Part Needle; UPJ Occlusion Balloon Catheter Set; Ultrathane Endoureterotomy Stent Set; Ultrathane® Nephrostomy Set With Mac-Loc®; Ultrathane® Suprapubic Set With Mac-Loc®; Ultraxx Nephrostomy Balloon Set; Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath with Radiopaque Stripe; Ultraxx Nephrostomy Balloon Set with TFE Sheath; Ultraxx Nephrostomy Balloon with TFE Sheath; Universa 2-Way Silicone Foley Catheter; Universa 3-Way Silicone Folly Catheter; Universa Firm Ureteral Stent Set with Hydrophilic Coating; Universa Firm Ureteral Stent Set with Hydrophilic Coating and Monofilament Tether; Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating; Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating and Monofilament Tether; Universal Check Flo Adapter; Universal Check-Flo® Adapter; Ureteral Dilation Balloon; Ureteral Dilator; Ureteral Dilator Set; Ureteral Dilator Set Dilators With AQ, Hydrophilic Coating; Ureteral Dilator With AQ, Hydrophilic Coating; Ureteral Dilator With AQ, Hydrophilic Coating With Modified Taper; Ureteral Meatotomy Knife; Ureteral TFE Dilator; Ureteral TFE Dilator Set; Ureteroscopy Irrigation System; Urethral Dilator Set; Urethral Meatal Dilator; UroStream Hydrophilic Wire Guide; Vacuum Syringe; Vas Reapproximator Set; VentriClear II Ventricular Drainage Catheter; VersaTube Tapered Tracheostomy Tube with Disposable Inner Ca; Wayne Pleural Drainage Set; Weinmann Tracheostomy Exchange Set; Weinmann-Multi Tracheostomy Exchange Set; Whistle Tip Ureteral Catheter; Whistle Tip Ureteral Catheter (Left); Whistle Tip Ureteral Catheter (Right); White Sizing Catheter; Williams Cystoscopic Injection Needle; Wittich Nitinol Stone Basket; ZENITH® AAA ILIAC PLUG WITH THE H&L-B ONE SHOT¿ INTRODUCER SYSTEM; Zaontz Urerthral Stent",1977-12-31,334,2024-03-25,4,95,14,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221820334%22&limit=1
"Zimmer, Inc.",1822565,1000220733,1800 W. Center Street,Warsaw,IN,46580,United States,"ZIMMER, INC.",1822565,Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,141,CCX; EAY; EFQ; ETN; FSM; FTY; FZO; FZW; FZX; FZY; GAD; GDG; GDH; GEA; GEF; GEG; GEY; GFA; GFC; GFD; GXH; HRR; HRS; HRY; HSB; HSD; HSH; HSN; HSO; HST; HSX; HSZ; HTC; HTD; HTF; HTH; HTJ; HTN; HTO; HTQ; HTR; HTS; HTT; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWD; HWE; HWJ; HWK; HWL; HWM; HWN; HWO; HWP; HWQ; HWR; HWT; HWW; HWX; HXC; HXD; HXG; HXI; HXL; HXN; HXO; HXP; HXQ; HXS; HXW; HXX; HXY; HXZ; HYA; ILZ; ITG; JDB; JDC; JDI; JDJ; JDL; JDQ; JDS; JDW; JDY; JDZ; JWH; KCY; KIH; KIK; KIL; KMC; KRO; KRR; KTT; KTZ; KWA; KWI; KWL; KWP; KWS; KWT; KWY; KWZ; KXA; LLZ; LPH; LWJ; LXH; LYS; LZN; LZO; MBF; MBH; MBV; MDM; MEH; MLR; MRA; NBH; NDG; NJD; NJL; NRA; NTG; OIY; OOG; OQG; OQH; OQI; PAO; PBF; PBI; PHX; PKC; QHE,"Support, Patient Position; Light, Fiber Optic, Dental; Gauze/Sponge, Internal; Stimulator, Nerve; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Expander, Surgical, Skin Graft; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Applier, Staple, Surgical,; Elevator, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Driver, Surgical, Pin; Dermatome; Device, Surgical, Cryogenic; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented); Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Saw; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Curette; Protractor; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Knife, Orthopedic; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Set, Hollow Mill; Osteotome; Instrument, Compression; Skid, Bone; Punch, Femoral Neck; Passer; Driver, Prosthesis; Template; Countersink; Tap, Bone; Wrench; Clamp; Tamp; Passer, Wire, Orthopedic; Mallet; Applier, Cerclage; Pusher, Socket; Instrument, Bending Or Contouring; Crimper, Pin; Twister, Wire; Bender; Screwdriver; Brace, Drill; Cutter, Wire; Forceps, Wire Holding; Accessories, Traction; Bandage, Cast; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Cerclage, Fixation; Nail, Fixation, Bone; Pin, Fixation, Threaded; Evacuator, Vapor, Cement Monomer; Mixer, Cement, For Clinical Use; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Tourniquet, Pneumatic; Dispenser, Cement; Hook, Bone; Positioner, Socket; Prosthesis, Hip, Semi-Constrained,  Composite/Metal; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Appliance, Fixation, Spinal Interlaminal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Femoral, Resurfacing; System, Image Processing, Radiological; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Bone Mill; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Instrument, Manual, Surgical, General Use; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Sterilizer, Chemical; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented; Accessories, Arthroscopic; Washer, Bolt, Nut, Non-Spinal, Metallic; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing; Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing; Prosthesis, Ankle, Uncemented, Non-Constrained; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Knee Arthroplasty Implantation System; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Orthopaedic Surgical Planning And Instrument Guides; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Shoulder Arthroplasty Implantation System",1; 2; 3; U,"(Bigliani/Flatow) Shoulder; (Ti-6Al-4V Alloy, CP Grade Titanium; 3 Dose Compact Mixer; 3.5MM PLATES AND SCREWS-4936 PLATES; 4835 SCREWS; APR & APRII Press-Fit Universal Hip; APR Acetabular Insert; APR Hip Sys & Natural-Hip for Uncem; APR Hip Sys w/Cal-Coated Can Str Ti; ATS Cyclindrical Cuff, Single Port/Dual Bladder; ATS Cylindrical Cuff, Dual Port/Dual Bladder; ATS Cylindrical Cuff, Dual Port/Single Bladder; ATS Cylindrical Cuff, Single Port/Single Bladder; ATS Tourniquet Systems; AVL HINGE KNEE SYSTEM; AXIA L2L Radial Heads (CoorsTek Medical); Acetabular Liners and Constrained Liners; Advance 1115 Bars; Affixus Natural Nail System Humeral Nail; Affixus Retrograde Femoral Nailing System; Affixus Tibial Nailing System - 4mm screws; Affixus Tibial and Antegrade Femoral Nailing System; Air Dermatome Handpiece; Air Dermatome II Hose; Allen Med Cement Plugs, Z Poly Plug; Alliance Augmented Glenoid; Alliance Glenoid; Alpha System; Alumina Ceramic Fem Heads- 28,32mm; Anatomical Shoulder Combined System; Apollo Knee Femoral Component; Apollo Knee Tibial Baseplate/Knee T; Apollo Rev/Constrained Knee Sys; Ascendent Acetabular System; Astel Non-backed Acetabular Cup; Augment Off-Axis Instrument System; Avenir Complete Hip System; Avenir Complete Hip System, Size 0 Coxa Vara; Avenir Muller Stem; BAYONET IMPACTOR HANDLE; BDH Bipolar Femoral Component A3; BIOMET COBALT-CHROME FEMORAL COMPONENTS; BLUNT DISTRACTOR; BONE HARVESTER; BONE REMOVAL TREPHINE; BOX OSTEOTOME; Bag Hook; Basket; Battery Powered System, accessories, and attachments; Bed Cradle; Beta Hip Prosthesis; Bi-Articular II Hip Device; Bigliani/Flatow 56mm Humeral Heads; Bigliani/Flatow Shoulder (Japan Cast Offset Heads); Bilateral Clamp Assembly; Biomet Knee Joint Replacement Prostheses; Bipolar Hip Device; Body Aligners; Bohler Braun Leg Splint; Bohler-Steinmann Pin Holder; Bone Screw; Brady Splint Assembly and Balanced Suspension System; Breakaway Nozzle; Bunker Foot Piece with Pulley; C/M Total Elbow, Model 32-8105; C/M Total Elbow, Model 8105 Series; C/M Total Elbow, New Hinge Pin; CAS PSI Knee System; CAS PSI Shoulder; CERVICAL BONE IMPACTOR; CLS Brevius Stem with Kinectiv Technology; CO-CR-MO Alloy Femoral; COMPREHENSIVE REVERSE SHOULDER; COMPRESSOR; CONTINUUM KNEE SYSTEM (CKS); COUNTERSINK; COUNTERSINK TAMP; CPT 12/14 Hip, Model 00-8114-040/50; CPT Hip System; CPT Stainless Steel Hip; CR (Augmentable) & Constrained; CRIMPER; Cable Ready; Cable-Ready Cable Cable Button; Cable-Ready Cable Grip System; Cable-Ready Cable Grip System; Cable-Ready Bone Plate System; Cable-Ready Cable Grip System; GTR and 1.8mm Cerclage Cables; Cable-Ready Cable Grip System; Pin and Needle System; Canvas Slings; Cast Elevators; Cast Iron Traction Weight; Casting Splints; Collarless Polished Taper Hip Pros; Compact Vacuum Cement Mixing System; Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplaste, Comprehensive Mini Baseplate; Comprehensive Reverse Shoulder - HA Glenosphere Baseplates; Comprehensive Reverse Shoulder System; Comprehensive Segmental Revision System(SRS); Comprehensive® Convertible Glenoid - Vivacit-E Liner; Continuum Trilogy IT Act. Sys; Continuum and Trilogy IT 40mm Shells; Continuum and Trilogy IT Acetabular Systems; Converge Acetabular System; Coonrad III Total Elbow; Coonrad/Morrey Elbow Cement Restric; Corb TM Counterrotating Biopsy Needle; Corstren Compression Tube & Plate; Curette; DERMATONE-AIR OR ELECTRIC POWERED; DISPOSABLE MIXING BOWL; Dermacarrier II Skin Graft Carrrier; Dermatome Autoclave Case; Dermatome Hose; Dermatome Screwdriver; Derotator; Dicosola Rope Holder; Drill guide; Dual Mobility-Longevity and Vivacit E Polyethylene Hip Bearings; Dual Port, Dual Bladder, cuff with PLC and protective sleeve; Dual Port, Single Bladder cuff with PLC and protective sleeve; Dual Port/Dual Bladder Disposable Cuff; Dual Port/Single Bladder Contour Lge Thigh Cuff; Dual Port/Single Bladder Disposable Cuff; Durasul Bipolar; EXTRAMEDEDULLARY TI; Endplate Rasp; Epsilon Durasul Constrained Act Lin; Exo-Static Traction Kit with Water Weight; FEMORAL BROACH; FEMORAL STEM BROACH; FREEDOM CONSTRAINED LINERS; FastFrame Externa Fixation System-Distal Radius; FastFrame External Fixation System-Ankle Spanning; FastFrame External Fixation System-Knee Spanning, Damage Control; Fiberglass Splinting; Finger Grip; Fitmore Hip Stem; Flex-Foam Traction Strips; Foot Bracket; Foot Exerciser Assembly; Foot Exerciser Pad; Foot Support; Foot Support Sling; Full Length Sling; Fuson Bone Plug, Radiopaque; G7 ACETABULAR SYSTEM-LTF Zimmer Design Control; G7 Acetabular System; G7 Revision Acetabular System; G7® Vivacit-E® Freedom® Constrained Liner; GIGLI SAW PASSER; Gamma System; Gas Plasma Sterilization; Gender Solutions Natural Knee Flex; Gender Solutions Natural-Knee Flex; Guide Pin; Guide Tube; HAMMR; HARRINGTON PROTRACTOR; HG Multilock w/Ti-Nidium; HGP Total Hip; HOLLOW MILL SET; HYDROFERA FEMORAL WICK; Harris/Galante Porous w/Calcicoat; Heavy Duty Pulley; Heel Rest; Herbert Bone Screw; Herbert/Whipple,Herbert and Herbert Mini Bone Screw; Heritage Hip System; Hill Rom 840 Poster; Hill Rom CareAssist Bed Brackets; Hill Rom CareAssist Traction Complete; Hill Rom T/C Bed Brackets; Hill Rom T/C Traction Frame; Hill-Rom Advanta II Bed Brackets; Hill-Rom Patient Helper; Hose with CPC connector; Hoses; ICLH (FREEMAN) ANKLE; INTRODIGITATOR; ITST Intertrochanteric/Subtrochante; ITST Intertrochanteric/Subtrochanteric Fixation System; IV Bar/Post; IV Pole / Rollstand; Identity Revision Humeral Stems; Identity Shoulder System; Insall/Burstein Fiber Metal Condyla; Insall/Burstein II Modular Total Kn; Insall/Burstein II Tibial Wedges; Inter-Op Acetabular Sys.-Dursul Ace; Inter-Op Durasul Act Inserts.CoCr F; Inter-Op HA Porous Act. HA/CSTi; Inter-Op Porous Protrusio Shell w/s; Inter-Op Porous Rev Shell w/ Sealab; Intermedics Bone Screw; Intermedics High Tibial Osteotomy S; Intramedullary Nail System; Iovera Smart Tip (1X90MM), 5-Pack; Iovera Smart Tip (3X8.5MM), 5-Pack; Iovera Smart Tip, Stimulating (1X180MM), 5-Pack; Iovera Smart Tip, Stimulating (1X90MM), 5-Pack; Iovera System; Keels; Kirschner Wire Tractor; Kodel Ring Pad; L.M.S. SELF-DETACHA; LIGHT CABLE; Laminectomy Arm Cradles; Locking Plate System; Longevity IT 22 Elevated, Offset, Oblique Liners; Longevity IT Constrained Liners; Longevity IT Crosslinked Poly comptability w Metasul; Longevity IT Elevated Liners, Continuum, Trilogy IT Acet. Sy; Longevity IT XLPE Elevated Liners; Luer Adaptors; Luque Segmental Spinal Instrumentat; M/L Taper Hip Prosthesis; MALLORY/HEAD TOTAL HIP SYSTEM; MBK Mobile Bearing Knee; MGII Porous Cobalt-Chrome Fem Comp; MGII Porous Total Knee System; MONOMER EVACUATIONG BOWL; MOST Options System; Magna-Fx Cannulated Screw Fixation System; Mallet; Meshgraft II; Meshgraft II Dermatome with Ratchet; Meshgraft II Ratchet Handle; Miami Protrusio Ring; Miller/Galante Precoat Unicomp Knee; Miller/Galante Precoated Total Knee; Mini-Clips; Mobile Traction Unit-Com Pact and Hook Kit; Mod. to Z Peri Locking Plates; Modification to M/G Precoat Unicomp; Modula Options for Severe Bone Loss; Modular Acetabular Shell II; Modular Calcar Replacement; Modular Oncology Sys Technology; Modular Unipolar; Moore Hip Prosthesis, PMMA Coated; MotionLoc Screw for NCB Polyaxial Locking Plate System; Multi-Cradle Positioner; Mutiple; NCB; NCB Periprosthetic Femur Polyaxial; NCB Poly Locking Plate, Z ULS3.5 Ti; NCB Polyaxial Locking Plate System; NCB® Cable Button; NCB® Periprosthetic Femur Plate System; NCB® Polyaxial Locking Plate System; NCB® Straight Narrow Shaft Plate; NKII Unicompartmental Knee Sys; Natural-Hip CoCr Offset Stem; Natural-Hip Porous Stem w/Offset; Natural-Knee Congruent Tibial Inser; Natural-Knee II; Natural-Knee II Cem Mod Tib Basepla; Natural-Knee II Constrained Knee Sy; Natural-Knee II Posterior Stabilize; Natural-Knee II Revision Fem Spacer; Natural-Knee II Sys Durasul Tibial; Natural-Knee II System; Natural-Knee Revision; Natural-Knee Tib Baseplate/All Poly; Nelson Finger Exerciser; Nerve Root Retractors; New Zimmer Shoulder System; NexGen 9mm Articular Surface; NexGen Complete Knee Solution; NexGen Crosslinked Polyethylene; NexGen Cruciate Retaining; NexGen Gender Sol. Female (GSF) Fem; NexGen LPS Flex Mobile Bearing Knee; NexGen LPS-Flex Mobile Bearing Knee; NexGen LPS-Flex Porous, GSF Porous; NexGen LPS-Flex Prolong Art Surface; NexGen Legacy Posterior Stabilized; NexGen MIS Modular Tibial; NexGen MIS Tibial Component; NexGen Porous, HA/TCP Uncem Fem. &; NexGen Porous, Uncem Fem & Tib Base; NexGen Prolong All-Poly Patella; NexGen Rotating Hinge Knee; NexGen Trabecular Metal Tibial Tray; Next Generation Knee System; Non-Sterile ZPS Compression,Reconstruction, Symphseal Plates and Forte Screws; Non-Sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers; O.R. Donuts; OR Head Positioner; ORTHOPEDIC SALVAGE SYSTEM- OSS; OSCILLATING SAW BLADE; OSTEOTOME; OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM; OsseoFit Stemless Shoulder System; Osteotome; PSN Valgus Alignment Guide; Patient Helper System; Patient Helper Total Care Bed; Patient Specific Planning Solution™ Bone Models; Pearson Attachment; Pearson Attachments, Brady; Peri Locking Plates & Screw Series2; Peri Locking Plates & Screw, Mod 23; Peri Locking Plates, 2358 Series; Peri Locking Plates, Screws 2358, 2; Periarticular Locking Plates and Screws, 2357 and 2359 series; Persona Knee System-CPS; Persona Natural Tibia Baseplates Size J and Instrumentation; Persona OsseoTi 3-Peg Patella; Persona Partial Knee System; Persona Personalized Knee System TiNidium CR Femurs; Persona Personalized Knee System TiNidium PS Femur; Persona Personalized Knee System-PPS; Persona Porous Plasma Spray PPS Femurs; Persona Revision Knee System; Persona Revision Knee System Femoral Metaphyseal Cones; Persona Revision SoluTion™ Femoral Components; Persona TM Porous Natural Tibia, Vivacit -E Patella and Articular Surfaces; Persona the Personalized Knee System; Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs); Persona™ Personalized Knee System; Polyester Pile Knee Sling; Positioner, Socket; Posterior Stabilized Apollo Knee Sy; Premier-Total Hip; Procedure Pack; Prolong Highly Crosslinked Poly Cru; Protective sleeve for  Disposable Cuff; RECIPROCATING SAW BLADE; REDUCED SIZE ONCOLOGY SALVAGE SYSTEM; RETRACTOR; RETRACTOR CASE; RIM Flare Acetabular Component; RONGUER; Radiolucent Splint X-Wide; Raps; Rasp; Ratcheting  Deflection Beam Wrench; Retrofit Kit; Ring Pad; Ring Strap; Rush Medullary Pins; S-Hook; SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM; SCREW DEPTH GAUGE; SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM; SOFT GRAFT TAMP; STABLECUT; STRAIGHT; SUPER BOWL; Sand Weight Bag; Serrated Clips; Signature ONE System; Signature ONE System-Shoulder; Signature™ ONE System; Single Port, Single Bladder cuff with PLC and protective sleeve; Single Port/Dual Bladder Disposable Cuff; Single Port/Dual Bladder Disposable Cuff with PLC; Single Port/Single Bladder Contour Lge Thigh Cuff; Single Port/Single Bladder Disposable Cuff; Songer Cable System; Splint Pad Ring; Spreader Bars; Spreader Blocks; St. Joseph Bed Cradle; Stand Base; Starter; Stem Extensions and Intercalary Seg; Stockinette; Strap Clamps; Stryker MPS Bars; Sulzer Orthopedics Fluted Stems; Supracondylar Intramedullary Nail; Suture Wires and Wire Loops; T/C Free Staning Frame Assy; TIBIAL BROACH; TM Acetabular Revision Sys. Cage; TM Acetabular Sys Cem Const Liner; TM Coupled Tibial Cones; TRABECULAR METAL K; Tank Holder; Thomas Leg Splint; Thomas Leg Splint, Pediatric; Tibial Spacer for NK II Cem Modular; Trabecular Metal Acetabular Revision System; Trabecular Metal Primary Hip Prosth; Trabecular Metal Revision Shell Lin; Traction Bars, Clamps, Trapezes, Pulleys and  Wall Bumpers; Traction Cord; Traction Finger Apparatus; Traction Strap Kit; Trilogy AB; Trilogy Acet Sys Large Head Liner; Trilogy Acet. Shell & Liners 36mm; Trilogy Acetabular Comp. 7mm Offset; Trilogy Acetabular Sys, 46mm Large; Trilogy Acetabular Sys, Constrained; Trilogy Acetabular System; Trilogy Longevity Constrained Liner; Trilogy Longevity Crosslinked Poly; Trochanter Antegrade Femoral Nails; Ulnar Nerve Protectors; Ultra battery powerd system, accessories, and attachments; Unicondylar Interpostitional Spacer; Universal Locking Sys 2.7mm Plates; Universal Locking Sys, 3.5mm Pl & S; Universal Sterilization Case; Universal Traction Boot; VANGUARD 360 REVISION KNEE SYSTEM; VERSA-DIAL HUMERAL HEAD PROSTHESIS; Vanguard Complete Knee System; Vanguard PSRP Cases; Various Trays; VerSys Beaded Fullcoat Bowed Revisi; VerSys Beaded Hip Prosthesis; VerSys Beaded Midcoat Low Head Cent; VerSys Cemented Revision/Calcar; VerSys Fiber Metal Taper Hip Pros; Versa-Fx Femoral Fixation System; Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System; Versacare Bed Brackets; Versacare Frame Kit - Balk; Versacare Patient Helper; Vinyl Pad Half Ring; Vivacit-E Vitamin E Highly Crosslinked Liners; WIRE TAMP; Weight Carrier; White Felt Padding; Width Plate; X-PSI Knee System; XtraFix External Fixation System 11mm Blue; XtraFix External Fixation System, XtraFix Small External Fixation System; XtraFix Small External Fixation System; Z Dermatome Blade; Z M/L Taper Hip Pros w/Calcicoat Ce; Z M/L Taper Hip Pros w/Kinectiv Tec; Z M/L Taper Hip Pros w/Modular Neck; Z M/L Taper Hip Prosthesis; Z Peri Locking Plate Distal Humeral; Z Segmental Sys Variable Stiffness; Z TM Modular Acetabular System; Z Trabecular Metal Humeral Stem; Z Trabecular Metal Humeral Stem 6mm; Z Trabecular Metal Modular Acet. Sy; Z Trabecular Metal Reverse Shoulder; Z ULS 3.5mm Locking Plates and Scre; Z1 Cemented Hip System; Z1 Hip System; ZCA All-Poly Acetabular Cup; ZCA All-Poly Acetabular Cups; ZCA All-Poly Act Cup, Snap-In 8005; ZCH Alpha System; ZIMMER BONE CEMENT INJECTOR; ZIMMER BRACE; ZIMMER CEMENT DISPENS; ZMR Hip System; ZMR Hip System-Porous Revision; ZMR Hip System-Revision Taper; ZMR Hip System-XL, 9921,9922, 9923; ZNN CM Instruments; ZNN Piriformis Fossa and Greater; ZNN Retrograde Femoral Nail; ZNN Sys Tibial Nail; ZNN System Tibial Nail and Stainless Steel Tibial Nail-Modification; ZULS 2.7mm Locking Plates and Screw; Zim Clip; Zim-Flex Cast Tape; Zimcode Buck's Extension System; Zimcode Foot Rest; Zimcode Traction Weight Bag; Zimmer; Zimmer Air Dermatome II Handpiece; Zimmer Allofit IT; Zimmer Anatomic Hip System; Zimmer Anatomic II Hip Prosthesis; Zimmer Biomet; Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head; Zimmer Biomet Ceramic Heads; Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Hume; Zimmer Biomet Select Ceramic Heads; Zimmer Biomet X Series; Zimmer Derm II Width Plate; Zimmer Dermatome AN; Zimmer Dermatome Blade; Zimmer Dermatome II Blade; Zimmer Dermatome II Screwdriver; Zimmer Distal Radius Plating System; Zimmer Guide Wire Devices; Zimmer Kirschner Wires and Steinmann Pins; Zimmer Knee Joint Replacement Prosthesis MR Labeling; Zimmer Knee Prosthesis; Zimmer M/DN Intramedullary Fixation System; Zimmer M/L Taper Hip Pros, 7711 Ser; Zimmer M/L Taper Hip Prosthesis; Zimmer M/L Taper with Kinective Technology MR Labeling; Zimmer Maxera Hip Cup; Zimmer MotionLoc Screw for NCB Polyaxial Locking Plate-New Indications; Zimmer MotionLoc Screw for Periarticular Locking Plate System; Zimmer Natural Nail System; Zimmer NexGen Tibial and Femoral Augments; Zimmer Nexel Total Elbow; Zimmer Nexel Total Elbow Ulnar Cement Diverter; Zimmer Nexel Total Elbow, Coonrad/Morrey Total Elbow; Zimmer PSI Knee; Zimmer PSI Shoulder; Zimmer PSI Shoulder System; Zimmer Patellofemoral Joint Prosthe; Zimmer Peri Locking Plate Sys, Mode; Zimmer Periarticular Locking Plate System; Zimmer Periarticular Locking Plate System-sterile; Zimmer Periarticular Plating System; Zimmer Periarticular Screws; Zimmer Persona 14x +30mm Tapered Stem Extension; Zimmer Persona Knee System; Zimmer Persona Personalized Knee System; Zimmer Persona Personalized Knee System-Kinematic Alignment; Zimmer Persona Personalized Knee System-Medial Congruent; Zimmer Persona TM Femorals; Zimmer Persona Ti Alloy Femorals; Zimmer Plates and Screws (ZPS)-Sterile 2.7mm Cortical Screws; Zimmer Plates and Screws System (ZPS) Non-sterile Plates and Screws; Zimmer Plates and Screws System (ZPS)-Non-Sterile Plates; Zimmer Plates and Screws System (ZPS)-Non-sterile ZPS; Zimmer Plates and Screws System-Screws only Sterile; Zimmer Power-Mix Vacuum Cement Mixing System; Zimmer Seg Prox Fem Com Small Stem; Zimmer Segmental System; Zimmer Segmental System Proximal Femoral Component; Zimmer Segmental System TM Prox Tib. Comp. TM Prox  Fem Comp; Zimmer Segmental System XT Components; Zimmer Segmental System, Trabecular Metal Stem Collar, 25mm O.D., 00-5852-040-25; Zimmer Segmental System, Trabecular Metal Stem Collar, 30mm O.D., 00-5852-040-30; Zimmer Segmental System, Trabecular Metal Stem Collar, 30mm O.D., 00-5852-041-30; Zimmer Segmental System, Trabecular Metal Stem Collar, 35mm O.D., 00-5852-040-35; Zimmer Segmental System, Trabecular Metal Stem Collar, 35mm O.D., 00-5852-041-35; Zimmer Skin Graft Mesher; Zimmer Skin Graft Mesher with Autoclave case and Rachet Handle; Zimmer TM Ankle; Zimmer TM Reverse Shoulder Liners Vivacit-E Liners; Zimmer Trabecular Metal Reverse Should Sytem, Non Porous Humeral Stems; Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid; Zimmer Trabecular Metal Reverse Shoulder System-MRI labeling; Zimmer Trabecular Metal Shoulder System; Zimmer Trabecular Metal Total Ankle; Zimmer Unicompartmental Knee Sys; Zimmer Unicompartmental Knee System Vivacit-E Articular Surface; Zimmer Vacuum Foot Pumps; Zimmer, Inc. Hip Joint Prostheses MR Labeling I; ZimmerBiomet; trabecular metal acetabular augments; trabecular metal tibial and femoral cones",1978-01-06,330,2026-09-24,1,267,3,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221822565%22&limit=1
Roche Diagnostics GMBH,9610126,3002806559,Sandhofer Strasse 116,MANNHEIM Baden-Wurttemberg,,D-68305,Germany,Roche Diagnostics Operations Inc.,9039767,Exporter to the US; Manufacturer; Repackager or relabeler; Specification developer,273,CBT; CDD; CDM; CDP; CDQ; CDS; CDT; CDX; CDZ; CEC; CEK; CEM; CEN; CEO; CEP; CET; CEW; CFJ; CFL; CFN; CFP; CFR; CFT; CGA; CGJ; CGN; CGX; CGZ; CHH; CHI; CHL; CHN; CHP; CHW; CIC; CIG; CIT; CIX; CIZ; CJC; CJE; CJW; CJX; CKA; CKG; CZP; CZW; DAD; DAH; DAO; DAP; DBF; DBI; DCF; DCK; DCN; DDG; DDR; DEB; DEL; DEM; DER; DEW; DFC; DHA; DHR; DHX; DIC; DIF; DIH; DIO; DIP; DIS; DJG; DJR; DKB; DKJ; DKZ; DLB; DLJ; DLZ; DML; DOP; DPM; GGF; GGN; GGZ; GHH; GHS; GIO; GJS; GKA; GKF; GKR; GLY; GTQ; JCC; JFJ; JFP; JFT; JFY; JGJ; JGQ; JGS; JHN; JHR; JHS; JHY; JIF; JIH; JIL; JIN; JIO; JIQ; JIR; JIS; JIT; JIX; JIY; JJB; JJE; JJF; JJH; JJT; JJX; JJY; JKC; JKD; JKR; JLS; JLW; JLX; JMG; JMM; JMO; JMT; JPZ; JQB; JQP; JQW; JRE; JTA; JTW; JXM; JXN; JXO; JZG; JZJ; JZO; JZW; KEM; KHE; KHG; KHP; KHQ; KHS; KLB; KLI; KLP; KLR; KLS; KLT; KNK; KQO; KRZ; KXS; KXT; LAF; LAN; LAO; LAR; LAS; LBR; LBS; LBZ; LCM; LCP; LCQ; LDJ; LDP; LEG; LEH; LFM; LFR; LFT; LFW; LFX; LFZ; LGD; LGI; LGJ; LGQ; LGS; LIP; LJX; LKL; LOJ; LOL; LOM; LPS; LPT; LSL; LTJ; LTK; LXG; LZG; MAQ; MKT; MKW; MKZ; MLM; MMI; MOI; MOJ; MQM; MRG; MRR; MSW; MTF; MTG; MXJ; MYF; MYR; MZA; MZE; MZF; MZO; MZP; NBC; NBW; NDW; NDY; NEO; NHG; NHX; NIG; NJT; NQD; NQX; NSU; NTM; OAV; OCC; OIU; OOI; OQO; OUG; OVK; OWD; OZE; OZN; PAB; PDJ; PGX; PMT; PPM; PQO; PQQ; PRI; PSL; QCH; QEP; QJR; QKO; QKP; QLC; QLX; QSE; QVP; QWH; SEI; SET; SJM,"Arterial Blood Sampling Kit; Radioassay, Vitamin B12; Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.); Radioimmunoassay, Total Triiodothyronine; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Electrode, Ion Specific, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Total Thyroxine; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Dye-Indicator, Ph (Urinary, Non-Quantitative); Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Olive Oil Emulsion (Turbidimetric), Lipase; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Radioimmunoassay, Human Growth Hormone; Method, Nephelometric, Immunoglobulins (G, A, M); Radioimmunoassay, Immunoreactive Insulin; Hexokinase, Glucose; Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph; Immunochemical, Ceruloplasmin; Radioimmunoassay, Estradiol; Titrimetric With Edta And Indicator, Calcium; Cresolphthalein Complexone, Calcium; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Bromcresol Green Dye-Binding, Albumin; Radioimmunoassay, Androstenedione; Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Bromcresol Purple Dye-Binding, Albumin; Acid Phosphatase, Disodium Phenylphosphate; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Radioimmunoassay, Acth; Iga, Antigen, Antiserum, Control; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Gamma Globulin, Antigen, Antiserum, Control; Igm (Mu Chain Specific), Antigen, Antiserum, Control; Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; System, Test, C-Reactive Protein; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Alpha-2-Macroglobulin, Antigen, Antiserum, Control; Lipoprotein X, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Alpha-1-Lipoprotein, Antigen, Antiserum, Control; Igg, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Radioimmunoassay, Lsd (125-I); Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Nad-Nadh, Specific Reagent For Alcohol Enzyme Method; Mass Spectrometer, Clinical Use; Columns, Liquid Chromatography; Acid Hematin; Plasma, Coagulation Control; Oxyhemoglobin; Fibrin Split Products; Assay, Carboxyhemoglobin; Tube, Collection, Capillary Blood; Test, Time, Prothrombin; Abnormal Hemoglobin Quantitation; Instrument, Hematocrit, Automated; System, Hemoglobin, Automated; Oximeter To Measure Hemoglobin; Antistreptolysin - Titer/Streptolysin O Reagent; Ph Buffer; Catalytic Methods, Amylase; Electrode, Ion Specific, Calcium; Fluorometric, Cortisol; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Turbidimetric, Total Protein; Electrode, Ion Specific, Sodium; Turbidimetric Method, Lipoproteins; Radioimmunoassay, Immunoglobulins (D, E); Differential Rate Kinetic Method, Cpk Or Isoenzymes; Colorimetric Method, Cpk Or Isoenzymes; Enzymatic Method, Ammonia; Flame Photometry, Lithium; Method, Enzymatic, Glucose (Urinary, Non-Quantitative); Nitroprusside, Ketones (Urinary, Non-Quant.); Blood, Occult, Colorimetric, In Urine; Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.); Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Analyzer, Chemistry, Micro, For Clinical Use; Clinical Sample Concentrator; Enzyme Controls (Assayed And Unassayed); Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate); Radioimmunoassay, C-Peptides Of Proinsulin; Radioimmunoassay, Calcitonin; Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Radioimmunoassay, 17-Hydroxyprogesterone; Radioimmunoassay (Two-Site Solid Phase), Ferritin; Column Chromatography & Color Development, Hydroxyproline; Ferrozine (Colorimetric) Iron Binding Capacity; Diazo (Colorimetric), Nitrite (Urinary, Non-Quant); Colorimetric Method, Gamma-Glutamyl Transpeptidase; Kinetic Method, Gamma-Glutamyl Transpeptidase; Calculator/Data Processing Module, For Clinical Use; Station, Pipetting And Diluting, For Clinical Use; Refractometer For Clinical Use; Monitor, Microbial Growth; System, Transport, Aerobic; Enzyme Immunoassay, Benzodiazepine; Enzyme Immunoassay, Propoxyphene; Enzyme Immunoassay, Cocaine; System, Test, Beta-2-Microglobulin Immunological; Prealbumin, Antigen, Antiserum, Control; System, Test, Thyroid Autoantibody; Nephelometer; Agent, Clearing; Reagent, Occult Blood; Whole Blood Hemoglobin Determination; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzymatic, Carbon-Dioxide; Radioimmunoassay, Tobramycin; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Amikacin Serum Assay; Enzyme Immunoassay, Lidocaine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Automated Urinalysis System; Calibrator For Hemoglobin And Hematocrit Measurement; Radioimmunoassay, Methaqualone; Enzyme Immunoassay, Digoxin; Gas Chromatography, Methamphetamine; Enzyme Immunoassay, N-Acetylprocainamide; Enzyme Immunoassay, Methotrexate; Enzyme Immunoassay, Procainamide; Drug Specific Control Materials; Ldl & Vldl Precipitation, Hdl; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Quinidine; Enzyme Immunoassay, Phencyclidine; Assay, Glycosylated Hemoglobin; Fluorescent Immunoassay Gentamicin; Enzyme Immunoassay, Cannabinoids; Colorimetry, Acetaminophen; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Immunoassay, Digitoxin; Glucose Dehydrogenase, Glucose; Fluorescent Immunoassay, Primidone; Fluorescence Polarization Immunoassay, Tobramycin; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Fluorescence Polarization Immunoassay, Carbamazepine; Fluorescence Polarization Immunoassay, Amibacin; Fluorescence Polarization Immunoassay, Phenobarbital; Fluorescence Polarization Immunoassay, Theophylline; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Test, Urine Leukocyte; Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control; Kit, Test,Alpha-Fetoprotein For Testicular Cancer; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Urinary Homocystine (Nonquantitative) Test System; System, Test, Urinary Methylmalonic Acid; Dna-Reagents, Neisseria; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Pump, Infusion, Insulin; Kit, Dna Detection, Human Papillomavirus; Hepatitis Viral B Dna Detection; Cyclosporine; Dna Probe, Nucleic Acid Amplification, Chlamydia; Enzyme Immunoassay, Tracrolimus; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free); Bilirubin (Total And Unbound) In The Neonate Test System; System, Test, Vitamin D; System, Test, Low Density, Lipoprotein; System, Test, Thyroglobulin; Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2; Test, Donor, Syphilis, Antigens, Treponemal; Test, Equipment, Automated Bloodborne Pathogen; Test, Donor, Cmv; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus; Test, Natriuretic Peptide; System, Test, Blood Glucose, Over The Counter; Assay, Porphyrin, Spectrophotometry, Lithium; Test, Cystatin C; System, Test, Osteocalcin; Enzyme Immunoassay, Cortisol, Salivary; Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp); System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Immunohistochemistry Reagents And Kits; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen; Instrumentation For Clinical Multiplex Test Systems; Antigen, Inflammatory Response Marker, Sepsis; Mycophenolic Acid Test System; Respiratory Virus Panel Nucleic Acid Assay System; Test, Epithelial Ovarian Tumor Associated Antigen (He4); Real Time Nucleic Acid Amplification System; Herpes Simplex Virus Nucleic Acid Amplification Assay; Medical Device Data System; Cytokeratin Fragments 21-1 Eia Kit; Somatic Gene Mutation Detection System; Influenza A And Influenza B Multiplex Nucleic Acid Assay; C. Difficile Toxin Gene Amplification Assay; Cytomegalovirus (Cmv) Dna Quantitative Assay; Hemoglobin A1c Test System; Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; General Purpose Reagent; Anti-Müllerian Hormone Test System; Data Acquisition Software; Procalcitonin Assay; 25-Oh-Vitamin D Mass Spectrometry Test System; Assayed Quality Control Material For Clinical Microbiology Assays; Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections; Reagents, 2019-Novel Coronavirus Nucleic Acid; Reagent, Coronavirus Serological; Coronavirus Antigen Detection Test System.; Interleukin 6; Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna; Alzheimer’S Disease Pathology Assessment Test; Sars-Cov-2 Serology Test; Prognostic Test For Development Or Progression Of Preeclampsia; Qualitative And Quantitative Hepatitis B Virus Antibody Assays; Immunoassay Blood Test For Amyloid Pathology Assessment; SJM",1; 2; 3; N; U,"10X SSC; 579-2-RSA Dynamic Interface v1.1; 713-2-cobase 8100 v1.5; 770-1-CCM-AOB v1.1; ?-Amylase EPS ver.2; ?-Glutamyltransferase ver.2 - Standardized against IFCC / Szasz; ?-Glutamyltransferase ver.2-Standardized against IFCC/Szasz; A/C Inform II Base Unit Kit; A1CD, cobas c 503; A1CX3, 200T, cobas c 503; A1CX3, 500T, cobas c 503; A2M Calibrator Kit; A2M Reagent Kit; A2M Serum Control Kit; AAGP Gen.2, 100Tests, cobas c, Integra; AAGP Gen.2, 150Tests, cobas c 701; AAGP2, 100T, cobas c 503; AAT Gen.2, 100Tests, cobas c, Integra; AAT Gen.2, 150Tests, cobas c 701; AAT2, 200T, cobas c 503; ABUS ONLINE LSD CAL/CTRL PK; ABUSCREEN ONLINE FOR METHAQUALONE; ABUSCREEN ONLINE OPIATES 300 / 2000; ACCU-CHECK INFORM II US 50CT 72/CS F2; ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM; ACCU-CHEK INFORM II CNTRL US 6/CS; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD),; ACCU-CHEK Inform II Blood Glucose Monitoring System; ACCU-CHEK Inform II Control Solutions; ACCU-CHEK Inform II Linearity Test Kit; ACCU-CHEK Inform II Meter; ACCU-CHEK Inform II Meter Kit + RF; ACCU-CHEK Inform II System; ACCU-CHEK Inform II Test Strip; ACCU-CHEK SPIRIT; ACCU-HEK LINEARITY KIT U.S.; ACCUCHEK INSTANT PLUS CHOLESTEROL; ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM; ACCUCHEK INSTANT PLUS GLUCOSE; ACCUTREND CHOLESTEROL CONTROL 2 LEVEL; ACCUTREND PLUS METER ONLY KIT, MG/DL; ACET2 150 Tests, cobas c, Integra 400; ACET2 Calibrator; ACET2 calibrator; ACET2, 500Tests, cobas c503; ACTH CC 3 Elecsys; ACTH CC3 Elecsys; ACTH CS Elecsys; ACTH Elecsys E2G 100; ACTH Elecsys cobas e 100; AFP CalCheck; AFP CalSet II; AFP Elecsys E2G 100 V2; AFP Elecsys E2G 300; AFP Elecsys E2G 300 V2; AFP Elecsys cobas e 100 V1.1; AFP Elecsys cobas e 100 V2; AFP Elecsys cobas e 200; AFP Elecsys cobas e 200 V2; AFP G2 CS Elecsys V2.1; AFP G2 CS Elecsys V3; ALB BCG Gen.2, 300Tests, cobas c, Int.; ALB BCG Gen.2, 750Tests cobas c701; ALB BCP 400Tests cobas c701; ALB BCP, 225Tests, cobas c 501,311; ALB2, 750T, cobas c 503; ALBP, 500T, cobas c 503; ALBT2, 500T, cobas c 503; ALDOLASE; ALDOLASE TC UV-TEST 100ML; ALK PHOS Liquid; ALKALINE PHOSPHATASE; ALP IFCC Gen.2 L, 400T, cobas c, Int.; ALP IFCC Gen.2 S, 200T, cobas c, Int.; ALP IFCC Gen.2, 1050Tests cobas c701; ALP IFCC Gen.2, 200T, cobas c111; ALP2 Alkaline Phosphatase acc to IFCC Gen.2 (1100 tests); ALP2, 1100T, cobas c pack green; ALT 1100Tests cobas c 701; ALTL/PYP, 275Tests, cobas c; ALTP , 450Tests, cobas c503; ALTP2, 1450T, cobas c pack green; ALTP2, 800T, cobas c 503; AMH CC 5 Elecsys; AMH CS Elecsys; AMH CS Elecsys V2; AMH Elecsys E2G 100; AMH Elecsys E2G 100 V2; AMH Elecsys cobas e 100; AMH Elecsys cobas e 100 V2; AMH PC Elecsys; AMIK Gen.2, 200Tests, cobas c 503; AMIKM, 150Tests, cobas Integra; AMMON/ETH/CO2 ABNORM CTRL; AMMON/ETH/CO2 NORMAL CTRL; AMMONIA/ETHANOL/CO2 CAL; AMMONIA/ETHANOL/CO2 CALIBRATORs; AMMONIA/ETHANOL/CO2 Controls; AMPHETAMINES II; AMPHETAMINES II ASSAY; AMPLILINK Software Version 3.4; AMPS2, 850T, cobas c 503; AMY-P, 200Tests, cobas c, Integra; AMY-P, 450T, cobas c 503; AMYL Gen.2, 300Tests, cobas c, Integra; AMYL Gen.2, 750Tests cobas c701; AMYL-P 600Tests cobas c701; AMYL2, 750T, cobas c 503; APO A TQ 100Tests cobas c701; APO B TQ 150Tests cobas c701; APOAT, 100Tests, cobas c, Integra; APOAT, 250T, cobas c 503; APOB TINA-QUANT a Unisys; APOBT, 250T, cobas c 503; ASLO Gen2, 200T, cobas c pack green; ASLO Gen2, 400Tests, cobas c701/702; ASLO TQ, 400Tests, cobas c701; ASLO TZ, 150Tests, cobas c; ASO, 100Tests, cobas Integra; AST 1100Tests cobas c 701; AST/GOT 400T cobas c 111; ASTP, 500T, cobas c 503; ASTP2, 1450T, cobas c pack green; ASTP2, 800T, cobas c 503; ASTPM, 740Tests, cobas c 701; ATRX CM Rabbit Polyclonal Antibody; AUTO QC MODUL cobas b 221=Roche OMNI S; AVENIO Edge System; AVENIO MILLISECT System; AVL 9180 ELECTROLYTE ANALYZER; AVL CA++ ELECTRODE; AVL CL- ELECTRODE; AVL K+ ELECTRODE; AVL LI+ ELECTRODE; AVL NA+ ELECTRODE; Abuscreen Online Opiates; Accelerator I 1 x 100ML; Accu-Chek 360° Diabetes Management System Professional; Accu-Chek Care; Accu-Chek Care (HCP); Accu-Chek Smart Pix Software; AccuChek Instant Plus Dual Testing System; Accutrend Chol, 25T.; Acetaminophen; Acetaminophen Gen.2; Acetaminophen Gen.2 Assay; AcfS Detection Robot; AcfS L&D Equipment Installation Bundle; AcfS Library Robot; Acid Wash Solution; Acid wash Solution 2x1,8 L; Acid wash Solution 2x2 L; Activator for cobas c,Integra,c111; Add-On Buffer Unit; Alanine Aminotransferase acc. to IFCC II; Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation; Albumin BCG 400T Cobas c111; Albumin BCP; Albumin Gen.2; Aldolase Assay; Aliquot Tip Loader; Alk Phos; Alkaline phosphatase acc. to IFCC Gen.2; Alu Positive Control Probe II; Amikacin; Amikacin MAB; Ammonia; Ammonia II; Amphetamines Gen. 2; Amplification Kit; Androstenedione CC5 Elecsys; Androstenedione CS Elecsys; Androstenedione Elecsys E2G 100; Androstenedione Elecsys cobas e 100; Anti-CCP Elecsys E2G 100; Anti-CCP Elecsys cobas e 100; Anti-CCP PC Elecsys; Anti-CD43 (L60) Mouse Monoclonal Primary Antibody; Anti-CMV Elecsys E2G 9 x 300; Anti-CMV PC Elecsys; Anti-CMV PC Release Elecsys; Anti-Chromogranin A (LK2H10) Primary Antibody; Anti-Cytokeratin (CAM 5.2) Mouse Monoclonal Primary Antibody; Anti-HAV G2 Elecsys E2G 300; Anti-HAV G2 Elecsys,cobas e100; Anti-HAV G2 PC Elecsys; Anti-HAV IgM Elecsys E2G 300; Anti-HAV IgM Elecsys cobas e 100; Anti-HAV IgM Elecsys, cobas e; Anti-HAV IgM PC Elecsys; Anti-HBc Elecsys cobas e 100 V2.1; Anti-HBc G2 Elecsys E2G 100 V2; Anti-HBc G2 Elecsys E2G 300; Anti-HBc G2 Elecsys E2G 300 V2; Anti-HBc G2 Elecsys cobas e 100 V2; Anti-HBc G2 PC Elecsys; Anti-HBc IgM Elecsys E2G 300; Anti-HBc IgM Elecsys cobas e 100; Anti-HBc IgM PC Elecsys; Anti-HBe Elecsys E2G 300; Anti-HBe Elecsys cobas e 100; Anti-HBe PC Elecsys; Anti-HBs CC 3 Elecsys; Anti-HBs Elecsys E2G 300; Anti-HBs Elecsys cobas e; Anti-HBs Elecsys cobas e 100; Anti-HBs G2 Elecsys E2G 300 V2; Anti-HBs G2 Elecsys cobas e 100 V2; Anti-HBs PC Elecsys; Anti-HCV Elecsys cobas e 100; Anti-HCV G2 Elecsys E2G 300 V2; Anti-HCV G2 Elecsys cobas e 100; Anti-HCV G2 Elecsys cobas e 100 V2; Anti-HCV G2 Elecsys cobas e 200; Anti-HCV G2 Elecsys cobas e 200 V2; Anti-HCV II; Anti-HCV PC Elecsys; Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody; Anti-SARS-CoV-2 Elecsys E2G 300; Anti-SARS-CoV-2 Elecsys cobas e 200; Anti-SARS-CoV-2 PC Elecsys; Anti-SARS-CoV-2 S CC5 Elecsys; Anti-SARS-CoV-2 S CS Elecsys; Anti-SARS-CoV-2 S Elecsys E2G 300; Anti-SARS-CoV-2 S Elecsys cobas e 200; Anti-SARS-CoV-2 S PC Elecsys; Anti-Sars CoV-2 Elecsys E2G 300; Anti-Sars CoV-2 Elecsys cobas e 200; Anti-Sars CoV-2 PC Elecsys; Anti-TG CS Elecsys; Anti-TG Elecsys 100 V5; Anti-TG Elecsys CS V2; Anti-TG Elecsys E2G 100 V2; Anti-TG Elecsys E2G 300; Anti-TG Elecsys E2G 300 V2; Anti-TG Elecsys cobas e 100 V4; Anti-TPO CS Elecsys; Anti-TPO Elecsys E2G 300; Anti-TPO Elecsys cobas e 100 V3; Anti-TSHR CC 3 Elecsys; Anti-TSHR CS Elecsys V2; Anti-TSHR Elecsys E2G 100 V2; Anti-TSHR Elecsys E2G 300; Anti-TSHR Elecsys E2G 300 V2; Anti-TSHR Elecsys cobas e 100 V2; Anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody; Anti-p504s (SP116) Rabbit Monoclonal Primary Antibody; Anti-p53 (Bp53-11) Primary Antibody; Antibody Diluent; Antibody Dilution Buffer; Antigen Excess Reagent; Ariosa Tecan Detection Robot; Ariosa Tecan Library Robot; Aspartate Aminotransferase (AST)(S GOT); Aspartate Aminotransferase acc. to IFCC II; Aspartate Aminotransferase acc. to IFCC with pyridoxal phosphate activation; AssayTip/AssayCup tray; Avenio Millisect System 2; B-CrossLaps CC5 Elecsys; B-CrossLaps/serum CS Elecsys; B-CrossLaps/serum Elecsys E2G 100; B-CrossLaps/serum Elecsys E2G 100 V2; B-CrossLaps/serum Elecsys cobas e 100 V2; B-Gate Interface; B2MG TQ(a), 140Tests cobas c; B2MG TQ(a), 140Tests cobas c 701/702; B2MG, 150T, cobas c 503; BARB, 850Tests, cobas c503; BASIC WASH 2x2 L; BCM for cobas 8100; BENZ, 850T, cobas c 503; BENZ2, 850T, cobas c pack green; BIL-D Gen.2, 500Tests cobas c 701,702; BIL-D JK 800Tests cobas c 701, US; BIL-T Gen.3, 1050T, cobas c pack green; BIL-T Gen.3, 250T, cobas c,Integra; BIL-T Gen.3, 250Tests cobas c,Integra; BIL-T Gen.3, 400Tests cobas c 111; BIL-T Gen.3, 600T, cobas c 701,702; BIL-T Gen.3, 600Tests cobas c 701,702; BILT3, 1050T, cobas c 503; BenchMark Special Stains Deparaffinization Solution (10X); BenchMark Special Stains Liquid Coverslip; Benchmark Special Stains Cleaning Kit; Bicarbonate Liquid; Bilirubin Direct Gen. 2; Bilirubin Total Gen.3; BlankCell Elecsys,cobas e; Bluing Reagent; Broocresol Purple Dye Binding, Albumin; Bulk Loader Module for p512/612; Bulk Loader for cobas p 471; C-Peptide Assay; C-Peptide CS Elecsys; C-Peptide Elecsys E2G 100; C-Peptide Elecsys cobas e 100; C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM; C-REACTIVE PROTEIN HIGH SENSITIVE TEST SYSTEM; C-Reactive Proetin Gen.3; C-Reactive Protein; C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS); C.F.A.S. HBA1C; C.F.A.S. LIPIDS; C.F.A.S. PRODUCTS; C.F.A.S.PROTEINS IN URINE/CSF; C.f.a.s Cystatin C; C3C Gen.2, 150Tests, cobas c 701; C3C-2, 150T, cobas c 503; C3c, 100Tests, cobas c, Integra; C4 Gen.2, 150Tests, cobas c 701; C4-2, 150T, cobas c 503; CA 125 CC 3 Elecsys; CA 125 G2 CS Elecsys; CA 125 G2 Elecsys E2G 100 V1; CA 125 G2 Elecsys E2G 300; CA 125 G2 Elecsys cobas e 100; CA 15-3 G2 CS Elecsys; CA 15-3 G2 Elecsys E2G 100 V1; CA 15-3 G2 Elecsys E2G 300; CA 15-3 G2 Elecsys cobas e 100; CA 15-3 Test System; CA 19-9 CS Elecsys; CA 19-9 CS Elecsys,cobas e; CA 19-9 Elecsys E2G 100 V1; CA 19-9 Elecsys E2G 300; CA 19-9 Elecsys cobas e 100; CA 19-9 Elecsys,cobas e; CA, Gen.2, 300Tests, cobas c,Integra; CA, Gen.2, 400Tests, cobas c111; CA2, 1500T, cobas c 503; CALCIUM GEN. 2; CALCIUM-ELECTRODE - ALFA WASSERMANN; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE; CALIBRATOR FOR AUTOMATED SYSTEMS; CAPILLARY TUBES 115 uL; CAPILLARY TUBES 200 uL; CARB, 200Tests, cobas Integra; CARB4 100 Tests, cobas c; CARB4, 500T, cobas c 503; CC-XS Meter cpl.; CCM AOB sw ver 13; CCM Address Extension Unit; CCM Backend Connection Unit; CCM Bidirectional Interface; CCM Vertical Elevator Unit; CCM Vertical Overhead Conveyor Unit (1m); CCM Vertical Power Box Unit; CCM Vertical Turntable Unit; CCM cobas c 513 Connection Unit; CD SW multilingual_software_2.1.1; CD SYSTEM SW p 512 SP 2.1.1; CD SYSTEM SW p 612 SP 2.1.1; CD117(EP10) Rabbit Monoclonal PAB; CD68 (SP251v18) Rabbit Monoclonal Antibody; CD8 (SP239) Rabbit Monoclonal PAB; CEA CS Elecsys V2; CEA Elecsys E2G 300; CEA Elecsys cobas e 100; CEA Elecsys cobas e 200; CEA Elecsys,cobas e; CERU 150Tests cobas c 701; CERU, 200T, cobas c 503; CERULOPLASMIN; CFAS CYSTATIN C GEN2; CFAS DAT QUAL PLUS; CFAS DAT QUALITATIVE PLUS CLINICAL; CHE Gen.2, 200Tests, cobas c, Integra; CHE2, 1050T, cobas c 503; CHEMSTRIP 10 MD TEST STRIPS; CHEMSTRIP 10 UA TRAY 30 DISP; CHEMSTRIP 5 OB TEST STRIPS; CHEMSTRIP 7 TEST STRIPS; CHEMSTRIP MICRAL URINE TEST STRIPS; CHOL HiCo Gen.2, 2100Tests, cobas c701; CHOL HiCo Gen.2, 400Tests, cobas c, Int.; CHOL2, 2600T, cobas c 503; CHOLINESTERASE TEST SYSTEM; CHOLINESTERASE TEST SYSTEM PRODUCTS; CINtec Wash Buffer (10X); CK 200 Tests, cobas c/Integra; CK 200Tests; CK 200Tests, cobas c111; CK, 1000T, cobas c pack green; CK, 500Tests, cobas c503; CK-MB 100T c111; CK-MB CS Elecsys V4; CK-MB CS Elecsys V4 E2G; CK-MB Elecsys E2G 100; CK-MB Elecsys cobas e 100 V4; CK-MB STAT CS Elecsys V4; CK-MB STAT Elecsys cobas e 100 V4; CLAS Systems; CLEANING KIT for CL-  ELECTRODE; CLEANING SOLUTION 988-4 (125 ML); CLEANING SOLUTION FOR AVL COMPACT II; CLOT CATCHER [250 PC]; CMV IgG Elecsys E2G 300; CMV IgG Elecsys E2G 300 V2; CMV IgG Elecsys cobas e 100; CMV IgG Elecsys cobas e 100 V2; CMV IgG PC Elecsys; CMV IgM Elecsys E2G 300; CMV IgM Elecsys cobas e 100; CMV IgM PC Elecsys; CO2, 200T cobas c 111; CO2-L 1100 Tests cobas c701; CO2-L 700Tests cobas c701; CO2-L, 2300T, cobas c pack green; CO2-L, 250Tests, cobas c503; COAGUCHEK XS Meter [CC-XS]; COAGUCHEK XS PLUS CARE KIT; COAGUCHEK XS PLUS SYSTEM; COAGUCHEK XS PST CARE KIT; COAGUCHEK XS PT CONTROLS; COAGUCHEK XS PT TEST 2X24 STRIPS; COAGUCHEK XS PT TEST 6 STRIP; COAGUCHEK XS SYSTEM; COAGUCHEK XS SYSTEM PRODUCTS; COBAS 4800 Test System; COBAS 8000 C 502 MODULE CU; COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST; COBAS AmpliPrep/COBAS TaqMan HBV Test, version 2; COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2; COBAS C 111 ANALYZER; COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY; COBAS ELECSYS ANTI-TPO; COBAS ELECSYS PROLACTIN II CALSET; COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS; COBAS INTEGRA AMIKACIN MAB; COBAS INTEGRA ANALYZER PRODUCTS; COBAS INTEGRA CARBON DIOXIDE ASSAY; COBAS INTEGRA CHOLESTEROL GEN. 2; COBAS INTEGRA COCAINE II 200; COBAS INTEGRA CREATININE PLUS VER.2 ASSAY; COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM; COBAS INTEGRA ISE ETCHER 6 x 11ML; COBAS INTEGRA ISE SOL.1. 6 x 17,5 ML; COBAS INTEGRA ISE SOLUTION 2. 6 x 9,5 ML; COBAS INTEGRA ISE SOLUTION 3. 6 x 9,5ML; COBAS INTEGRA LSD 200; COBAS INTEGRA METHADONE II 200; COBAS INTEGRA ONLINE DAT II COCAINE II; COBAS INTEGRA ONLINE DAT II METHADONE II; COBAS INTEGRA OPIATES 300/2000 200T; COBAS INTEGRA PROPOXYPHENE 200; COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II; COBAS INTEGRA REAGENT CASSETTES; COBAS INTEGRA SYSTEM; COBAS P612 PRE-ANALYTICAL SYSTEM W/O CCM; COBAS READY TOTAL PROTEIN REAGENT; COBAS TAQMAN HBV TEST; COBAS TaqMan 48 Analyzer; COBAS TaqMan HBV Test For Use With The High Pure System; COBAS TaqMan HIV-1 Test version 2 For Use With The High Pure System; COBAS U411 TEST SYSTEM; COBAS-FP REAGENTS FOR TOBRAMYCIN; COC Gen.2, 850Tests, cobas c503; CONA, 100Tests, cobas c503; CONFIRM Anti-CD34 (QBEnd/10) Mouse Monoclonal Primary Antibody; CONFIRM MART-1/melan A (A103) 250 test; CONFIRM Negative Control Rabbit Ig; CONFIRM anti-ALK1 (ALK01) Primary Antibody; CONFIRM anti-CD15 (MMA) Mouse Monoclonal Primary Antibody; CONFIRM anti-CD20 (L26) Primary Antibody; CONFIRM anti-CD23 (SP23) Rabbit Monoclonal Primary Antibody; CONFIRM anti-CD3 (2GV6) Rabbit Monoclonal Primary Antibody; CONFIRM anti-CD30 (Ber-H2) Primary Antibody; CONFIRM anti-CD4 (SP35) Rabbit Monoclonal Primary Antibody; CONFIRM anti-CD45, LCA (RP2/18) Primary Antibody; CONFIRM anti-CD5 (SP19) Rabbit Monoclonal Primary Antibody; CONFIRM anti-CD56 (123C3) Mouse Monoclonal Primary Antibody; CONFIRM anti-CD68 (KP-1) Primary Antibody; CONFIRM anti-CD79a (SP18) Rabbit Monoclonal Primary Antibody; CONFIRM anti-CD8 (SP57) Rabbit Monoclonal Primary Antibody; CONFIRM anti-CD99 (O13) Mouse Monoclonal Primary Antibody; CONFIRM anti-Calretinin (SP65) Rabbit Monoclonal Primary Antibody; CONFIRM anti-Cytokeratin (AE1) Primary Antibody; CONFIRM anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody; CONFIRM anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody; CONFIRM anti-Desmin (DE-R-11) Primary Antibody; CONFIRM anti-EGFR (5B7) Rabbit Monoclonal Primary Antibody; CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody; CONFIRM anti-Epidermal Growth Factor Receptor (3C6) Primary Antibody; CONFIRM anti-HER-2/neu (4B5) Primary Antibody; CONFIRM anti-Kappa Rabbit Polyclonal Primary Antibody; CONFIRM anti-Keratin (34?E12) Mouse Monoclonal Primary Antibody; CONFIRM anti-Ki-67 (30-9); CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody; CONFIRM anti-LMO2 (1A9-1) Mouse Monoclonal Primary Antibody; CONFIRM anti-Lambda Rabbit Polyclonal Primary Antibody; CONFIRM anti-MART-1/melan A (A103) Mouse Monoclonal Primary Antibody; CONFIRM anti-MITF (C5/D5) Mouse Monoclonal Primary Antibody; CONFIRM anti-MSH6 (44) Mouse Monoclonal; CONFIRM anti-Melanosome (HMB45) Mouse Monoclonal Primary Antibody; CONFIRM anti-PAX5 (SP34) Rabbit Monoclonal Primary Antibody; CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Antibody; CONFIRM anti-S100 (4C4.9) Primary Antibody; CONFIRM anti-S100 (Polyclonal) Primary Antibody; CONFIRM anti-Synaptophysin (SP11) Rabbit Monoclonal Primary Antibody; CONFIRM anti-Thyroid Transcription Factor-1 (8G7G3/1) Mouse Monoclonal Primary Antibody; CONFIRM anti-Topoisomerase IIa (JS5B4) Rabbit Monoclonal Primary Antibody; CONFIRM anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody; CONFIRM anti-Tyrosinase (T311) Mouse Monoclonal Primary Antibody; CONFIRM anti-Vimentin (V9) Primary Antibody; CONFIRM anti-Vimentin (Vim 3B4) Primary Antibody; CONFIRM anti-bcl-2 (124) Mouse Monoclonal Primary Antibody; CONFIRM anti-p53 (DO-7) Primary Antibody; CONFIRM anti-p53 (DO7) Primary Antibody; CONTROL SET AMPHETAMINE 1000; CONTROL SET AMPHETAMINE 500; CONTROL SET DAT CLINICAL; CONTROL SET DAT I; CONTROL SET DAT II; CONTROL SET DAT III; CONVEYOR 1 Unit; CONVEYOR 2 Unit; CONVEYOR 3 Unit; CONVEYOR 4 Unit; CREAJ Gen.2, 1500Test, cobas c701; CREAJ Gen.2, 2500Test, cobas c503; CREAJ Gen.2, 700Test, cobas c, Integra; CREP Gen.2, 250Tests, cobas c, Integra; CREP Gen.2, 600Tests, cobas c701; CREP2, 600T, cobas c 503; CRP Gen.4 250Tests cobas c501/INT; CRP Gen.4 500Tests cobas c701/702; CRP Gen.4, 200Tests cobas c111; CRP HS 100T cobas c111; CRP LX HS, 300Tests, cobas c, Integra; CRP N Control 5x0,5ML; CRP T CONTROL N PRODUCTS; CRP3, 500T, cobas c 503; CRP3, 500T, cobas c pack green; CRP4, 500T, cobas c 503; CRP4, 850T, cobas c pack green; CRPHS 250Tests cobas c 701; CRPHS, 600T, cobas c 503; CYSC2, 250T, cobas c 503; CYSTATIN C GEN2 CONTROL SET; CalCheck Androstenedione; CalCheck Anti-SARS-CoV-2 S; CalCheck IGFBP-3; CalCheck Vitamin D total II; CalCheck Vitamin D total III; CalChecks ?-Amyloid (1-42) II; CalChecks Phospho-Tau (181P); CalSet ?-Amyloid (1-42) II; CalSet Androstenedione; CalSet Anti-SARS-CoV-2 S; CalSet Anti-TSHR; CalSet Cortisol III Urine; CalSet FT4 IV; CalSet IGF-1; CalSet IGFBP-3; CalSet Phospho-Tau (181P); CalSet Phospho-Tau (181P) Plasma; CalSet Total-Tau; CalSet Troponin T Gen 5; CalSet Vials Elecsys,cobas e; CalSet Vitamin D total II; CalSet Vitamin D total III; Calcitonin CC 5 Elecsys; Calcitonin CS Elecsys; Calcitonin CS Elecsys V2; Calcitonin Elecsys E2G 100; Calcitonin Elecsys E2G 100 V2; Calcitonin Elecsys cobas e 100; Calcitonin Elecsys cobas e 100 V2; Calcium Gen.2; Calcium Gen.2, 2250Tests, cobas c 701; Calibration strip UA; Calibrator b2-MICROGLOBULIN; Calibrator for Automated Systems CK-MB; Cardiac C-Reactive Protein (Latex) High Sensitive; Carry-over Needle Assessment; Cell Check Elecsys,cobas e; Cell Conditioning Solution (CC1); Cell Conditioning Solution (CC2); Cell Set cobas C311; Cell Wash Solution I/NaOH-D 2x1.9L; Ceruloplasmin; Cfas CK.MB 3x1ML; Cfas Cystatin C; Cfas DAT Qual Plus Calibrator; Cfas HbA1c, 3x2ml; Cfas Lipids 3x1ML; Cfas Lipids 5x5ML; Cfas MYO, 3x1ml; Cfas PAC 3x1ML; Cfas Proteins; Chemstrip 10; Chemstrip 10 SG 100 Str.; Chemstrip 10 UA; Chemstrip 10 UA 100 Str.; Chemstrip 10 w/SG; Chemstrip 2 GP; Chemstrip 2 GP 100 Str. 1 St; Chemstrip 2 LN 100 Str.; Cholesterin 400T cobas c 111; Cholesterol Bio; Cholesterol Gen.2; Cl-ELECTRODE- ALFA WASSERMANN; Clean Cell M 2x2L Elecsys, cobas e; CleanCell Elecsys,cobas e; CleanCell M 2x2 L Elecsys,cobas e; Cleaner Basisch cobas c111; Clot Catcher Pro [100 PCS]; CoaguChek Link Tier 1; CoaguChek Link Tier 2; CoaguChek Link Tier 3; CoaguChek Vantus; CoaguChek XS 24 ct strip; CoaguChek XS 24 tests USA; CoaguChek XS 6 tests International (en); CoaguChek XS 6 tests USA (en); CoaguChek XS PT Test Strips; CoaguChek XS Plus System; CoaguChek XS Pro System; CoaguChek® XS Plus system; Coaguchek Link; Coaguchek XS Pro Systems; Cobas 6000 Connection Unit; Cobas 8000 Connection Unit; Cobas Integra Albumin (ALB-T) (Turbidimetric); Cobas Integra Digoxin (DIG) modification; Cobas Integra HbA1c; Cocaine; Comm Server 1.11.3725; ConKit cobas BLIM to p x71; Control Set DAT 1; Control Set DAT 2; Control Set DAT 3; Control-Set b2-MICROGLOBULIN; ControlSet Vials Elecsys,cobas e; Controlset RF II; Copan MSwab Collection, Transport and Preservation System; Cortisol CS Elecsys; Cortisol Elecsys cobas e; Cortisol Elecsys cobas e 100; Cortisol G2 CS Elecsys; Cortisol G2 Elecsys E2G 300; Cortisol G2 Elecsys cobas e 100; Cortisol II CalSet; Cortisol III Elecsys E2G 100; Cortisol III Elecsys E2G 300; Cortisol III Urine CS Elecsys; Cortisol Urine PC Elecsys; Crea PAP 200T cobas c111; Creatine Kinase; Creatinin Jaffe 400T c111; Creatinine Jaffe Gen.2; Creatinine Plus Ver. 2; Cyfra 21-1 CC5 Elecsys; Cyfra 21-1 CS Elecsys V2; Cyfra 21-1 Elecsys E2G 300; Cyfra 21-1 Elecsys cobas e 100; Cystatin C Control Set Gen.2; Cystatin C Gen. 2; Cystatin C TQ Gen.2, 225T, cobas c 701; Cystatin C TQ Gen.2, 225T, cobas c,INT; D BILI, 350T, cobas c503; D-DIMER CONTROL I/II; D-Dimer Calibrator; D-Dimer, 100 Tests, cobas c, Integra; D-Dimer, 100Tests, cobas c503; DEPROTEINIZER (125 ML); DHEA-S CS Elecsys; DHEA-S Elecsys E2G 100; DHEA-S G2 CS Elecsys; DHEA-S G2 Elecsys E2G 100; DHEA-S G2 Elecsys cobas e 100; DHEAS CS Elecsys,cobas e; DIG, 500Tests, cobas c503; DIGOXIN, 250Tests, cobas c, Integra; DNA AWAY; Data Innovations Instrument Manager; Digital LC Analyzer; Digital LC Partitioning Engine; Digital LightCycler® Analyzer; Digital LightCycler® DNA Master Kit; Digital LightCycler® Partitioning Fluid; Digital LightCycler® RNA Master Kit; Digoxin CS Elecsys; Digoxin CS Elecsys, cobas e; Digoxin Elecsys E2G 100; Digoxin Elecsys cobas e 100; Digoxin Elecsys, cobas e; Diluent MultiAssay E2G; Diluent MultiAssay Elecsys,cobas e; Diluent Universal E2G; Direct Bilirubin; Driver Framework 3.1.8915; ECL-LC; ECL-LC, BV-CLEAN Plus, 1000ml; ECL-LC, BV-DILUENT, 250ml; ECL-LC, BV-GLO Plus, 1000ml; ECL-LC, BV-SANITIZE, 100ml; ECL-LC, BV-STORE, 250ml; ELECSYS ACTH CALSET; ELECSYS AFP; ELECSYS AFP CALSET II; ELECSYS AFP GEN 2 RACKPACK; ELECSYS ANTI-CCP CALCHECK KIT; ELECSYS ANTI-HCV II IMMUNOASSAY; ELECSYS ANTI-HCV IMMUNOASSAY; ELECSYS ANTI-TG ASSAY; ELECSYS ANTI-THSR; ELECSYS ANTI-TPO; ELECSYS ANTI-TPO CALSET; ELECSYS ANTI-TSHR IMMUNOASSAY; ELECSYS C-PEPTIDE ASSAY; ELECSYS C-PEPTIDE CALSET; ELECSYS CA 125 Gen.2 CS; ELECSYS CA 125 II CALSET; ELECSYS CA 15-3 TEST SYSTEM; ELECSYS CA 19-9 IMMUNOASSAY/CALSET; ELECSYS CALCITONIN; ELECSYS CEA; ELECSYS CK-MB IMMUNOASSAY; ELECSYS CK-MB STAT IMMUNOASSAY; ELECSYS CMV IGG IMMUNOASSAY; ELECSYS CORTISOL TEST SYSTEM; ELECSYS DHEA-S CALSET; ELECSYS DIGOXIN; ELECSYS FERRITIN PRODUCTS; ELECSYS FOLATE GEN 3 CALCHECK KIT; ELECSYS FOLATE RBC; ELECSYS FOLATE RBC CALSET; ELECSYS FSH CALCHECK; ELECSYS FT3; ELECSYS HBSAG CONFIRMATORY; ELECSYS HCG AND BETA TEST SYSTEM; ELECSYS HCG STAT II CALSET; ELECSYS HCG TEST SYSTEM; ELECSYS HCG+BETA CALSET II; ELECSYS HE4 CALCHECK 5; ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4; ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV; ELECSYS HSV-2 IGG IMMUNOASSAY; ELECSYS IGE II IMMUNOASSAY; ELECSYS INSULIN; ELECSYS INSULIN CALSET; ELECSYS LH ASSAY; ELECSYS LH CALSET II; ELECSYS MYOGLOBIN ASSAY; ELECSYS N-MID OSTEOCALCIN; ELECSYS OSTEOCALCIN CALCHECK; ELECSYS OSTEOCALCIN CALSET; ELECSYS PARATHYROID HORMONE TEST SYSTEM; ELECSYS PRECICONTROL ANTI-HBS; ELECSYS PRECICONTROL ANTI-HCV; ELECSYS PRECICONTROL CALCITONIN; ELECSYS PRECICONTROL CMV IGG; ELECSYS PRECICONTROL HBEAG; ELECSYS PRECICONTROL TUMOR; ELECSYS PRECICONTROL TUMOR MARKER; ELECSYS PROBNP II; ELECSYS PROBNP II CALSET; ELECSYS PROBNP II STAT IMMUNOASSAY; ELECSYS PROGESTERONE; ELECSYS PROLACTIN; ELECSYS PROLACTIN ASSAY; ELECSYS PTH TEST SYSTEM; ELECSYS RUBELLA IGG IMMUNOASSAY; ELECSYS SAP BUFFER; ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY; ELECSYS SERUM IMMUNOASSAY; ELECSYS SHBG CALSET; ELECSYS T-UPTAKE ASSAY; ELECSYS T3; ELECSYS T4 ASSAY; ELECSYS TESTOSTERONE CALSET II; ELECSYS TOTAL PSA; ELECSYS TOXO IgG Immunoassay; ELECSYS TROPONIN T; ELECSYS TSH ASSAY; ELECSYS TSH CALSET W/MODELS; ELECSYS VITAMIN B12 CALSET GEN 2; ELECSYS® HBEAG; ELECTRODE ISE CHLOR STARLYTE III, [AW]; ELECTRODE ISE LITHIUM; ELECTRODE ISE POTASSIUM; ELECTRODE ISE SODIUM; ELECTRODE REFERENCE ISE (0980); ELECTRODE, ISE REF, STARLYTE III, [AW]; ELECTRODE, ISE, CHLORIDE; ELECTRODE, ISE, POTASSIUM; ELECTRODE, ISE, POTASSIUM, [ALFA W]; ELECTRODE, ISE, SODIUM, [ALFA W]; ELECTROLYTE ANALYZER W/O STARTERKIT 9180; ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5; ELECYS IGE ASSAY; ELECYSYS SHBG; EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY; ETOH2, 150T, cobas c 503; ETOH2, 850T, cobas c 503; EVO ADDITIONAL E MODULE; EZ Prep Concentrate (10X); Eco Detergent; EcoTergent; EcoTergent, cobas c503; Elecssys proBNP II Immunoassay; Elecsys 2010; Elecsys ?-Amyloid (1-42) CSF II; Elecsys ?-CrossLaps CalCheck; Elecsys ACTH; Elecsys ACTH CalCheck; Elecsys ACTH Calset; Elecsys ACTH Immunoassay; Elecsys AFP; Elecsys Androstenedione; Elecsys Anti-CCP CalCheck; Elecsys Anti-CCP Products; Elecsys Anti-CMV; Elecsys Anti-HAV II; Elecsys Anti-HAV IgM; Elecsys Anti-HAV IgM and PreciContr; Elecsys Anti-HBCIG; Elecsys Anti-HBc II; Elecsys Anti-HBc IgM; Elecsys Anti-HBe; Elecsys Anti-HBs II; Elecsys Anti-HCV II; Elecsys Anti-HCV PC; Elecsys Anti-SARS-CoV-2; Elecsys Anti-SARS-CoV-2 S; Elecsys Anti-TPO CalCheck; Elecsys Anti-TSHR; Elecsys Anti-Tg; Elecsys Anti-Tg CalCheck; Elecsys B-CrossLaps/serum; Elecsys BRAHMS PCT; Elecsys Beta-Amyloid (1-42) CSF II; Elecsys Brahms PCT; Elecsys C-Peptide; Elecsys C-Peptide CalCheck 5; Elecsys CA 125 II; Elecsys CA 125 II Assay; Elecsys CA 125 II CalCheck; Elecsys CA 15-3; Elecsys CA 15-3 II; Elecsys CA 15-3 II CalCheck 5; Elecsys CA 19-9 CalCheck 5; Elecsys CEA CalCheck 5; Elecsys CEA Calset; Elecsys CK-MB; Elecsys CK-MB CalCheck 5; Elecsys CK-MB STAT; Elecsys CK-MB STAT Immunoassay; Elecsys CMV IgG; Elecsys CMV IgM; Elecsys CMV IgM Immunoassay; Elecsys CYFRA 21-1; Elecsys CYFRA 21-1 CalCheck 5; Elecsys CYFRA 21-1 CalSet; Elecsys CalCheck FT 3; Elecsys CalCheck T-Uptake; Elecsys CalCheck Testosterone; Elecsys Calcitonin; Elecsys Calcitonin CalCheck 5; Elecsys Calcitonin Calcheck 5; Elecsys Calcitonin Calset; Elecsys Cortisol; Elecsys Cortisol II; Elecsys Cortisol III; Elecsys DHEA-S; Elecsys DHEA-S CalCheck 5; Elecsys DHEA-S II; Elecsys Digoxin; Elecsys Digoxin CS; Elecsys Digoxin CalCheck 5; Elecsys Digoxin CalSet; Elecsys Digoxin Immunoassay; Elecsys Estradiol; Elecsys Estradiol Assay; Elecsys Estradiol III; Elecsys Estradiol III CalCheck; Elecsys Estradiol III CalSet; Elecsys FSH; Elecsys FT3 Assay; Elecsys FT3 III; Elecsys FT3 III CalSet; Elecsys FT4 CalCheck; Elecsys FT4 G2 CS; Elecsys FT4 II Assay; Elecsys FT4 II CalSet; Elecsys FT4 IV; Elecsys Ferritin CalCheck 5; Elecsys Folate III; Elecsys Folate III Assay; Elecsys Folate III CalCheck; Elecsys Folate III CalSet; Elecsys Folate RBC CalCheck; Elecsys Folate gen 3 products; Elecsys HBeAg; Elecsys HBsAg Confirmatory Test; Elecsys HBsAg II; Elecsys HBsAg II Auto Confirm; Elecsys HBsAg II quant II RxDx; Elecsys HBsAgII; Elecsys HCG; Elecsys HCG STAT CalCheck 5; Elecsys HCG STAT CalSet II; Elecsys HCG Test System; Elecsys HCG and Beta; Elecsys HE4 CalCheck 5; Elecsys HIV Duo; Elecsys HIV combi PT; Elecsys HSV-1 IgG; Elecsys HSV-2 IgG; Elecsys IGFBP-3; Elecsys IL-6; Elecsys IgE; Elecsys IgE CalCheck 5; Elecsys IgE II; Elecsys Insulin; Elecsys Insulin Assay; Elecsys Insulin CalCheck 5; Elecsys LH; Elecsys LH CalCheck 5; Elecsys Myoglobin; Elecsys Myoglobin CalCheck 5; Elecsys Myoglobin Immunoassay; Elecsys N-MID Osteocalcin CalCheck 5; Elecsys PCT CalCheck 5; Elecsys PTH; Elecsys PTH CalCheck 5; Elecsys PTH STAT; Elecsys Phospho-Tau (181P) CSF; Elecsys Phospho-Tau (181P) Plasma; Elecsys Phospho-Tau (217P) Plasma; Elecsys PlG; Elecsys PlGF; Elecsys PreciControl ACTH; Elecsys PreciControl Anemia; Elecsys PreciControl Anti-HAV IgM; Elecsys PreciControl CMV IgG; Elecsys PreciControl CMV IgM; Elecsys PreciControl Cardiac II; Elecsys PreciControl Rubella IgG; Elecsys PreciControl Troponin; Elecsys PreciControl Universal; Elecsys PreciControl Varia 3; Elecsys Precicontrol Cardiac II; Elecsys ProBNP II Stat; Elecsys Progesterone Assay; Elecsys Progesterone III; Elecsys Progesterone III CalCheck 5; Elecsys Progesterone III CalSet; Elecsys Prolactin II; Elecsys Prolactin II CalCheck 5; Elecsys RBC Folate Hemolysing Reagent; Elecsys Rubella IgG CalCheck 5; Elecsys Rubella IgG PreciControl; Elecsys Rubella IgM; Elecsys Rubella IgM Assay & Control; Elecsys Rubella IgM Control; Elecsys SHBG CalCheck 5; Elecsys SYSCLEAN; Elecsys Syphilis; Elecsys T-Uptake CalSet; Elecsys T3; Elecsys T3 CalCheck 5; Elecsys T4; Elecsys T4 CalCheck 5; Elecsys T4 CalSet; Elecsys TSH; Elecsys TSH CalCheck 5; Elecsys TSH CalSet; Elecsys Tacrolimus; Elecsys Testosterone II; Elecsys Testosterone II Assay & CS; Elecsys Testosterone II Calset; Elecsys Tg II; Elecsys Total-Tau CSF; Elecsys Toxo IgG CalCheck 5; Elecsys Troponin Gen 5 CalCheck 5; Elecsys Troponin I CalCheck 5; Elecsys Troponin I Calset; Elecsys Troponin I STAT; Elecsys Troponin I STAT CALSET; Elecsys Troponin I products; Elecsys Troponin T CalCheck 5; Elecsys Troponin T Gen 5; Elecsys Troponin T Gen 5 CalSet; Elecsys Troponin T Gen 5 STAT Assay; Elecsys Troponin T Gen 5 STAT CalSet; Elecsys Troponin T STAT; Elecsys Troponin T STAT Assay; Elecsys Troponin T STAT CS; Elecsys Vitamin B12; Elecsys Vitamin B12 CalCheck; Elecsys Vitamin B12 G2; Elecsys Vitamin D; Elecsys Vitamin D CalCheck 5; Elecsys Vitamin D Calcheck 5; Elecsys Vitamin D assay, Elecsys Vitamin D CalSet,; Elecsys Vitamin D total II; Elecsys Vitamin D total III; Elecsys free PSA; Elecsys free PSA Test System; Elecsys hCG; Elecsys hGH; Elecsys hGH CalCheck 5; Elecsys proBNP II; Elecsys proBNP II CalCheck 5; Elecsys proBNP II CalSet; Elecsys proBNP II Calset; Elecsys proBNP II STAT; Elecsys proBNP II STAT CalSet; Elecsys proBNP II STAT Immunoassay; Elecsys sFLT-1; Elecsys total PSA; Elecsys total PSA - 100 test kit; Elecsys total PSA - 200 test kit; Elecsys total PSA CalCheck; Elecsys total PSA Test System; Electrode Chloride Cl/ISE (0980); Endogenous Biotin Blocking Kit; Estradiol G3 CS Elecsys; Estradiol G3 Elecsys E2G 300; Estradiol G3 Elecsys cobas e 100; Ethanol Gen.2; FERR Gen.4, 250Tests cobas c; FERR Gen.4, 650Tests cobas c 701; FERR4, 400T, cobas c 503",1983-06-01,307,2026-10-20,22,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229610126%22&limit=1
Medos International Sarl,3008114965,3008114965,Chemin-Blanc 38,Le Locle Neuchatel,,2400,Switzerland,Medos International SARL,10031083,Specification developer,139,BZN; DQO; DQX; DQY; DYB; EOB; ETN; EZX; FCW; FEM; FMF; FOX; FQH; FSM; FST; FSX; FWF; FZO; FZT; FZX; FZY; GAA; GAB; GAC; GAD; GAM; GAS; GAT; GCJ; GCX; GDF; GDG; GDI; GDX; GDZ; GEA; GEF; GEG; GEI; GFG; GWM; GZT; HAW; HAX; HCF; HCG; HNX; HRS; HRX; HTC; HTD; HTE; HTF; HTJ; HTN; HTO; HTQ; HTR; HTS; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWE; HWJ; HWK; HWM; HWN; HWR; HWT; HWX; HXB; HXC; HXG; HXK; HXW; HXX; IQK; JAK; JDN; JDQ; JDR; JDW; JDZ; JEB; JEC; JOL; JXG; KCT; KDD; KGG; KIH; KQM; KRA; KRD; KTZ; KWP; KWQ; LRJ; LWG; LXH; LYC; MAI; MAX; MBI; MDM; MED; MJG; MJN; MNH; MNI; MOF; MQP; MQV; MRW; NBH; NDN; NEW; NJE; NKB; NKG; NOV; NQW; NRY; OAR; ODP; OLO; OSH; OVD; PDQ; PGM; PLR; PML; QEW; QJP; SGU,"Cart, Emergency, Cardiopulmonary (Excluding Equipment); Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Introducer, Catheter; Nasopharyngoscope (Flexible Or Rigid); Stimulator, Nerve; Mesh, Surgical, Metal; Light Source, Fiberoptic, Routine; Accessories, Photographic, For Endoscope (Exclude Light Sources); Syringe, Piston; Stand, Infusion; Lavage, Jet; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Light, Surgical, Connector; Camera, Television, Endoscopic, Without Audio; Chisel, Surgical, Manual; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Scalpel, One-Piece; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Applier, Staple, Surgical,; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Bit, Surgical; Device, Monitoring, Intracranial Pressure; Retractor, Self-Retaining, For Neurosurgery; Neurological Stereotaxic Instrument; Tong, Skull For Traction; Instrument, Ligature Passing And Knot Tying; Device, Neurovascular Embolization; Depressor, Orbital; Plate, Fixation, Bone; Arthroscope; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Knife, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Instrument, Compression; Driver, Prosthesis; Template; Tap, Bone; Probe; Wrench; Tamp; Holder, Needle; Orthopedic; Bender; Screwdriver; Orthosis, Cervical; System, X-Ray, Tomography, Computed; Implant, Fixation Device, Spinal; Cerclage, Fixation; Staple, Fixation, Bone; Pin, Fixation, Threaded; Mixer, Cement, For Clinical Use; Table, Surgical With Orthopedic Accessories, Manual; Component, Traction, Invasive; Catheter And Tip, Suction; Shunt, Central Nervous System And Components; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations; Dispenser, Cement; Camera, Surgical And Accessories; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Caliper; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Disinfectant, Medical Devices; Surgical Table Cushion; Orthopedic Manual Surgical Instrument; Bone Grafting Material, Synthetic; Fastener, Fixation, Biodegradable, Soft Tissue; Intervertebral Fusion Device With Bone Graft, Lumbar; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Sterilant, Medical Devices; Device, Percutaneous, Biopsy; Catheter, Intravascular Occluding, Temporary; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Guide, Wire, Catheter, Neurovasculature; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Suture, Surgical, Absorbable, Polydioxanone; Intracranial Neurovascular Stent; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Anchor, Suture, Bone Fixation, Metallic; Orthosis, Spine, Plate, Laminoplasty, Metal; Catheter, Thrombus Retriever; Injector, Vertebroplasty (Does Not Contain Cement); Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Neurosurgical Nerve Locator; Growing Rod System; Spinal Vertebral Body Replacement Device - Cervical; Bone Cement, Posterior Screw Augmentation; Peripheral Mechanical Thrombectomy With Aspiration; Catheter, Percutaneous, Neurovasculature; Neurovascular Liquid Embolic Agent",1; 2; 3; U; f,"ABSOLUTE; ACL GRAFT KNIVES; ACORN; AEGIS Anterior Lumbar Plate System; AETI System; ALC; ALC Dynamized Fixation System; ARTHROSCOPE (MULTIPLE BRANDS); Agility 10, Agility 14, Agility 16 Steerable Guidewire; Anterior ISOLA Spine System; Arthroscope; Arthroscopic Instruments; Arthroscopy Tubing; BENGAL STACKABLE CAGE SYSTEM; BENGAL Stackable Cage System; BENGAL System; BIOCRYL; BIOKNOTLESS; BOWTI; BOWTI Anterior Buttress Staple Spinal System; BREMER; BRISTOW LATARJET; Bengal Stackable Cage System; Bengal System, Bengal Stackable Cage System, Devex System, Ocelot Stackable Cage System; Bengal System, Concorde Bullet Spine System; Biointrafix; Bremer Classic II Halo Vest System; Bremer Halo System; CEREBASE DA Guide Sheath; CERENOVUS Aspiration Tubing Set; CERENOVUS Large Bore Catheter; CEREPAK Detachable Coil Systems; CHARITE; CHIA PERCPASSER; CIDEX Activated Dialdehyde Solution; CIDEX OPA Concentrate; CIDEX OPA Solution; CIDEXPLUS® 28 Day Solution; CLEARFIX; CMW - Confidence High Viscosity Spinal Cement; CODMAN Integrated Bipolar Cord And Tubing Set; CODMAN Microcoil Delivery System; CONCORDE; CONCORDE BULLET Lumbar Interbody System; CONCORDE BULLET SPINAL SYSTEM; CONCORDE Bullet Spinal System; CONCORDE LIFT; CONCORDE LIFT System; CONCORDE Lift System; CONCORDE SYSTEM; CONCORDE® Bullet Lumbar Interbody System; CONCORDE® Curve Lumbar Interbody System; CONCORDE® Inline Lumbar Interbody System; CONDUIT Instruments; CONDUIT Lateral Switch Plate; CONFIDENCE; CONFIDENCE SPINAL CEMENT SYSTEM; CONFIDENCE™ High Viscosity Spinal Cement; COR; COUGAR; COUGAR LATERAL CAGE SYSTEM; COUGAR LS Lateral Cage System; COUGAR System; CROSSNAV Disc Preparation and Interbody Instruments; CROSSNAV Navigation Enabled Instruments; CROSSNAV Navigation Enabled Instruments and Universal Navigation Adaptor Set (UNAS); Certas Plus Electronic Tool Kit; Certas Plus Programmable Valve; Certas Programmable Valve; Certas Therapy Management System; Codman Floor Stand; Concorde Bullet Lumbar Interbody System, Concorde Inline Lumbar Interbody System, Cougar System; Concorde Curve Spinal System; Concorde Inline Spinal System; Concorde LS Lateral Interbody Instrument System; Conduit; Confidence Spinal Cement System; Cougar LS Lateral Cage System; Cougar LS Lateral Cage System, Leopard System; Cougar System; CrossOver Cross Connectors; DELTAMAXX Microcoil Delivery System; DISCOVERY; DISCOVERY Screw System; DYNACORD Suture; DYNATAPE Suture; DePuy Mitek Instrument; DePuy PULSE Thoracolumbar Screw System; DePuy Pulse Anterior Cervical Plate System; DePuy Pulse Cervical Cage System; DePuy Pulse Lumbar Cage System; DePuy Pulse Thoracolumbar Screw System; Deltamaxx 18 Microcoil System; Devex Mesh System; Discectomy Navigation Ready Instruments; Dispenser, Cement; E-Z Link Cross Connectors; EAGLE PLUS ANTERIOR CERVICAL PLATE SYSTEM; EAGLE PLUS MICRO ACP SYSTEM; EAGLE Plus Anterior Cervical Plate System; EAGLE Plus Micro Anterior Cervical Plate System; ELECTROSURGICAL SYSTEM; EXPEDIUM; EXPEDIUM 4.5MM SPINE SYSTEM; EXPEDIUM Anterior Spine System; EXPEDIUM Fenestrated Screw System; EXPEDIUM SFX Cross Connectors; EXPEDIUM Spine System; EXPEDIUM Spine System/Synapse System; EXPEDIUM VERSE Spine System; EXPEDIUM Verse Fenestrated Screws; EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods; EXPRESSEW; Elevator; EnPower Control Cable and Connecting Cable; Endoscope Couplers; Endoscopes; Enterprise Vascular Reconstruction Device and Delivery System; Envoy (DA) Distal Access Guiding Catheter; Envoy DA Guiding Catheter; Envoy Distal Access (DA) Guiding Catheter; Envoy Guiding Catheter; Envoy Guiding Catheters; Expedium; Expedium Anterior Spine System; Expedium Fenestrated Screw System; Expedium Osteotomy; Expedium Powered Instruments; Expedium Spine System; Expedium Spine System, Viper System; Expedium Spine System, Viper System, Viper 2 System; F.A.S.T. SYSTEM SED AND CXD; FASTIN RC; FMS; FMS Interface Cable Duo/Solo; FMS VUE II Fluid Management and Tissue Debridement System; FMS VUE system; FRONTIER Anterior Scoliosis System; Free Needle Loop; GALAXY G3 Mini Microcoil Delivery System; GII; GLOSAIR 600 Area Decontamination System; GRYPHON; GRYPHON Anchors with DYNACORD Suture; GRYPHON Flex; GRYPHON PEEK; GRYPHON X Anchor; GRYPHON™ Flex Knotless Biocomposite Anchor; GRYPHON™ Flex Knotless PEEK Anchor; Gryphon; Gryphon BR; Gryphon PEEK; HEALIX; HEALIX ADVANCE; HEALIX ADVANCE Anchor with DYNATAPE Suture; HEALIX ADVANCE Anchors with DYNACORD Suture; HEALIX ADVANCE BR WITH PERMACORD; HEALIX ADVANCE KNOTLESS; HEALIX ADVANCE Knotless; HEALIX ADVANCE PEEK; HEALIX ADVANCE PEEK ANCHORS WITH PERMACORD; HEALIX ADVANCE SP BIOCOMPOSITE Anchor; HEALIX ADVANCE SP PEEK Anchor; HEALIX ADVANCE Self-Punching; HEALIX AWL; HEALIX BR; HEALIX PEEK; HEALIX TI™ 3 SUTURE ANCHOR with DYNACORD™; HEALIX TI™ ANCHOR with DYNACORD™; HEALIX TI™ ANCHOR with DYNACORD™ AND NEEDLES; HEALIX TRANSTEND; HEALIX TRANSTEND Anchor; HEALIX TRANSTEND PEEK; HEALIX Ti; HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture; HEALKIX BR; HEALOS FX; Healix Advance; Healix Advance Anchors with Dyna+Tape Sutures; Healix Advance Knotless; IDEAL; INTRAFIX; ISOLA Spine System; Impactor; Intrafix Advance; Isola and Expedium Growing Spine Systems; KANEDA Anterior Scoliosis System; KANEDA SR Anterior Spinal System; KNOT PUSHER; LEOPARD SYSTEM; LUPINE; Laparoscopes; Latarjet; Light Adaptor; Light Guide; MICRO QUICKANCHOR; MICROFIX; MICROFIX QUICKANCHOR; MICRUS ASCENT OCCLUSION BALLOON CATHETER; MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM; MICRUS COURIER ENZO MICROCATHETER 0190; MICRUS COURIER MICROCATHETERS; MICRUS MICROCATHETER; MICRUS MICROCATHETER ""COURIER PRE-SHAPED"", MODELS MPS170045-; MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00; MICRUS MICROCATHETER, MODEL COURIER 270; MICRUS MICROCOIL DELIVERY SYSTEM; MICRUS MICROCOIL DELIVERY SYSTEM, MDS03; MICRUS MICROCOIL SYSTEM; MICRUS MICROCOIL SYSTEM ""CASHMERE-CERECYTE"", MODEL CRC; ""CAS; MICRUS MICROCOIL SYSTEM ""PRESIDIO-18"", MODEL PC4; MICRUS MICROCOIL SYSTEM, ""CASHMERE"" MODEL SRC; MICRUS MICROCOIL SYSTEM, ""DELTAPAQ 10 CERECYTE"", MODEL CDF; MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT; MICRUS MICROCOIL SYSTEMS; MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR; MICRUS MICROCOLI SYSTEM, ""DELTAPLUSH"", MODELS CPL, DPL; MICRUS MODIFIED MICROCOIL 18-SYSTEM, ""CERECYTE"", MODEL CSP &; MICRUS MODIFIED MICROCOIL SYSTEM, ""CERECYTE""; MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01; MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3 FILL, and GALAXY G3 XSFT Microcoil Delivery System; MILAGRO; MILAGRO ADVANCED; MILAGRO BR; MINI QUICKANCHOR PLUS; MINILOK; MITEK TIGHT-N Tendon Docking Anchor; MONARCH Spine System; MOSS; MOSS MIAMI Spine System; MOUNTAINEER; MOUNTAINEER OCT SPINAL SYSTEM; MOUNTAINEER OCT Spinal System; MULTIPLE CANNULAE; MULTIPLE SUTURE GRASPER; Micrus Ascent Occlusion Balloon Catheter; Micrus Microcoil Delivery System; Milagro Advance; Milagro Advance Interference Screw; Milagro Advance PEEK; Milagro Interference Screw; Monarch System; Moss Miami; Moss Miami Spine System; Moss Miami System; Mountaineer OCT Spinal System; Multiple Guides; N/A; Navigation Enabled Instruments; OCELOT; OCELOT® Stackable Cage System; OCT Spinal Fixation System; OMNICUT; OMNISPAN; ORBIT GALAXY G2 Microcoil Delivery System; ORTHOCORD; OVB1 Camera Control Unit  TCK1 Camerahead; OVS1 Video System; Opticage Expandable Interbody Fusion Device; Orbit Galaxy G2 Microcoil Delivery System; Orthocord; PEAK ACP; PEEK; PERIPHERAL GUIDING SHEATH; PERMATAPE; PIPELINE; PIPELINE II ACCESS SYSTEM; PROFILE PLATE SYSTEM; PULSE; PULSE Anterior Cervical Plate System; PUREVUE; Peak Anterior Compression Plate System; Periosteal Elevator; Permaloop Suture; Permatape Suture; Pipeline Access System; Profile Anterior Fixation System; Profile Anterior Thoracolumbar Plate System Distractor; Prowler EX Microcatheter; Prowler Infusion Catheter with pre-shaped tips; Prowler Plus Infusion Catheter; Prowler Select (10, 14, and Plus) Infusion Catheters; Prowler Select LP ES Microcatheter; Prowler Select Plus Microcatheter; Prowler XS Microcatheter; QUICKANCHOR; RESTORE; RIGIDFIX; RIGIDFIX CURVE; ReVive PV Thrombectomy Device; Revive (PV) Thrombectomy Device; Revive Peripheral VasculatureThrombectomy Device; RigidFix PLA; RigidLoop; RigidLoop Adjustable; Rigidloop; Rigidloop Cortical Fixation System XL; Rigidloop Disposable Kit; Rigidloop Titanium Button; Robotic Integration Instruments; SFX SNAP-FIT CROSS CONNECTOR; SKYLINE ANTERIOR CERVICAL PLATE SYSTEM; SKYLINE Anterior Cervical Plate System; SKYLINE Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System; SLIM LOC; SPOTLIGHT; SUMMIT Fixation System; SUMMIT SI OCT Spinal Fixation System; SUTURE CUTTER; SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM; SYMPHONY - GDS; SYMPHONY Navigation Ready Instruments; SYMPHONY OCT; SYMPHONY OCT System; Sentio MMG; Sentio MMG Gen2; Sinuscope; Spectra (Micrusfram, Deltafill, Deltaxsft, Galaxy G3, Galaxy G3 XSFT, Galaxy G3 mini) Microcoil Delivery System; Spotlight Access System; Stackable Cage System; Suction Instrument; Super Anchor - Orthocord; Surgical Positioning Board; Surgical Titanium Mesh System; Suture Graspers; Symphony; Symphony Navigation Ready Instruments, Universal Navigation Adaptor Set; TELIGEN; TELIGEN CART Assembled; TELIGEN System Instruments; TELIGEN System Navigation Ready Indications; TELIGEN System Navigation Ready Instruments; TELIGEN System Peripheral Motor Nerve Stimulation Indications; TIMX; Teligen; Teligen System; The XTool Device; TiMX; TiMX Low Back System; Transit Infusion Catheter; Transit/Rapid Transit/Prowler Infusion Catheter; TriALTIS; TriALTIS™ Spine System; Truespan Meniscal Repair System; Trufill DCS Orbit Detachable Coil System; Trufill DCS Syringe; Trufill N-Butyl Cyanoacrylate (N-Bca) Liquid Embolic System; Tube Set, Shaver Blades, Cutter, Cutter Shaver, Burr, Hand Control Interface, Foot Pedal, Tube Set.; UNIPLATE; UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM; UNIPLATE Anterior Cervical Plate System; UNIVERSAL NAVIGATION ADAPTOR SET; Uniplate 2 Anterior Cervical Plate System; Universal Navigation Adaptor Set; VAPR; VAPR 3, LD and LP Suction Electrodes; VAPR Tripolar Suction electrode; VAPR VUE Radiofrequency System; VBR Spinal System; VELYS™ Active Robotic Assistance; VERSALOK; VIPER; VIPER 2; VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS; VIPER Fenestrated Screw System; VIPER PRIME; VIPER PRIME Fenestrated Screws; VIPER PRIME™; VIPER Prime Screws; VIPER System; Versalok Pre-packed W/Orthocord; Viper  System; Viper 2 Spine System; Viper F2 Facet Fixation System; Viper F2 Facet Fixation System bit, drill; Viper Prime; Viper Spine System; Viper System; X-MESH; X-MESH EXPANDABLE CAGE SYSTEM; X-MESH® Expandable Cage System; YOGA Microcatheter; duo+ and solo; instrument, compression",2009-12-16,323,2026-05-26,1,2,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008114965%22&limit=1
Integra LifeSciences Corporation,3003418325,3003418325,1100 Campus Road,Princeton,NJ,08540,United States,Integra LifeSciences Corporation,9004007,Complaint file establishment; Manufacturer for export; Specification developer,429,BTO; BWB; BWN; CAN; CCW; CCX; DQR; DWF; DWP; DWS; DXC; DYX; DZA; DZC; DZN; DZP; EAX; ECB; ECS; EEA; EEF; EFB; EFH; EFK; EFL; EFN; EGD; EGN; EGS; EGZ; EHJ; EHM; EHY; EHZ; EID; EIF; EIG; EIK; EIL; EIR; EIS; EIX; EIY; EJB; EJE; EJG; EJI; EJL; EJR; EJY; EJZ; EKB; EKC; EKF; EKG; EKH; EKI; EKJ; EKK; EKL; EKM; EKP; EKR; EKS; EKT; EKW; ELA; ELR; EMB; EMD; EMF; EMG; EMH; EMI; EMJ; EMK; EML; EMN; EMO; EMP; EMQ; EMS; EMX; EOB; EPY; EQH; EQJ; ERA; ERL; EXX; EYR; EZB; FBQ; FBX; FCL; FCW; FDE; FFN; FFO; FFQ; FFR; FFY; FGM; FGN; FGY; FHA; FHI; FHL; FHN; FHQ; FKC; FMA; FMF; FNS; FNY; FPX; FQM; FRG; FRO; FSE; FSM; FSR; FST; FTL; FTM; FTX; FTY; FWC; FWZ; FXE; FXG; FZO; FZQ; FZR; FZS; FZT; FZW; FZX; FZY; FZZ; GAA; GAB; GAC; GAD; GAF; GAH; GAI; GAL; GAM; GAP; GBX; GBY; GCB; GCJ; GCM; GCY; GDF; GDG; GDH; GDI; GDJ; GDL; GDM; GDN; GDO; GDR; GDX; GDZ; GEA; GEC; GEG; GEH; GEI; GEJ; GEN; GEO; GES; GFD; GFI; GFJ; GWG; GWI; GWM; GWX; GWY; GWZ; GXQ; GYC; GYK; GZT; GZX; HAE; HAO; HAW; HBA; HBD; HBE; HBF; HBG; HBL; HBM; HBO; HBR; HBT; HCA; HCF; HCY; HCZ; HDA; HDC; HDF; HDJ; HDK; HDL; HDM; HDQ; HDX; HER; HET; HFB; HGE; HGN; HHF; HHK; HHM; HHW; HJH; HKY; HMX; HMZ; HNA; HNB; HNC; HND; HNF; HNG; HNH; HNI; HNK; HNL; HNM; HNN; HNQ; HNR; HNW; HNX; HNY; HNZ; HOE; HOY; HPN; HPP; HRH; HRQ; HRT; HRW; HTC; HTD; HTE; HTF; HTJ; HTP; HTR; HTS; HTT; HTW; HTX; HTY; HTZ; HWA; HWJ; HWK; HWM; HWO; HWQ; HWR; HWT; HXB; HXD; HXG; HXI; HXK; HXL; HXR; HXS; HXX; HXY; HXZ; HYA; IKD; ILH; ITG; IWZ; IYE; JDW; JEP; JEX; JOJ; JXG; JXI; JYC; JYD; JYE; JYF; JYG; JYH; JYJ; JYK; JYL; JYM; JYO; JYP; JYQ; JYT; JYW; JYY; JYZ; JZA; JZB; JZD; JZE; JZF; JZY; KAC; KAD; KAE; KAI; KAJ; KAK; KAL; KAM; KAN; KAO; KAP; KAQ; KAR; KAS; KAW; KAX; KAY; KAZ; KBA; KBB; KBC; KBD; KBE; KBG; KBH; KBJ; KBL; KBM; KBN; KBQ; KBR; KBS; KBT; KBW; KBX; KBZ; KCB; KCC; KCF; KCG; KCH; KCJ; KCP; KCT; KDG; KGN; KGX; KHJ; KIK; KNF; KQW; KTE; KTF; KTG; KTI; KTZ; KYG; KYT; KYW; KYZ; LBK; LDE; LFL; LGG; LGH; LKG; LMF; LPG; LQY; LRC; LRP; LRW; LRY; LXH; LXM; LYA; LYC; LYS; MDD; MDM; MGR; MJI; MMO; MUJ; MXP; MZY; NNP; NNR; NNU; NOC; NOK; NQR; NWT; NWV; OGH; OGR; OJG; OWV; OXH; OXK; PGW; PIY; PNZ; PSQ; QGK; SEL,"Tube, Tracheostomy (W/Wo Connector); Forceps, Tube Introduction; Table And Attachments, Operating-Room; Regulator, Pressure, Gas Cylinder; Laryngoscope, Rigid; Support, Patient Position; Cannula, Catheter; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Dilator, Vessel, Surgical; Instruments, Surgical, Cardiovascular; Clamp, Vascular; Lock, Wire, And Ligature, Intraoral; Drill, Dental, Intraoral; Wire, Orthodontic; Instruments, Dental Hand; Instrument, Diamond, Dental; Mirror, Mouth; Unit, Syringe, Air And/Or Water; Pusher, Band, Orthodontic; Plate, Base, Shellac; Clamp, Rubber Dam; Handpiece, Air-Powered, Dental; Paper, Articulation; Forceps, Articulation Paper; Forceps, Dressing, Dental; Cotton, Roll; Wax, Dental, Intraoral; Scissors, Surgical Tissue, Dental; Handpiece, Contra- And Right-Angle Attachment, Dental; Holder, Film, X-Ray; Disk, Abrasive; Strip, Polishing Agent; Tray, Impression, Preformed; Evacuator, Oral Cavity; Syringe, Restorative And Impression Material; Accessories, Retractor, Dental; Retractor, All Types; Carver, Wax, Dental; Gauge, Depth, Instrument, Dental; Scissors, Collar And Crown; Remover, Crown; Probe, Periodontic; Instrument, Filling, Plastic, Dental; Handle, Instrument, Dental; Frame, Rubber Dam; Forceps, Rubber Dam Clamp; Syringe, Cartridge; Bur, Dental; Agent, Polishing, Abrasive, Oral Cavity; Pliers, Operative; Knife, Margin Finishing, Operative; Explorer, Operative; Excavator, Dental, Operative; Instrument, Contouring, Matrix, Operative; Condenser, Amalgam And Foil, Operative; Carver, Dental Amalgam, Operative; Carrier, Amalgam, Operative; Burnisher, Operative; Spreader, Pulp Canal Filling Material, Endodontic; Point, Silver, Endodontic; Gutta-Percha; Reamer, Pulp Canal, Endodontic; Plugger, Root Canal, Endodontic; File, Pulp Canal, Endodontic; Curette, Endodontic; Broach, Endodontic; Instrument, Hand, Calculus Removal; Post, Root Canal; Zinc Oxide Eugenol; Hemostat, Surgical; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Forceps, Rongeur, Surgical; File, Bone, Surgical; Elevator, Surgical, Dental; Curette, Surgical, Dental; Chisel, Bone, Surgical; Scaler, Periodontic; Knife, Periodontic; Marker, Periodontic; Hoe, Periodontic; Curette, Periodontic; Balloon, Epistaxis; Nasopharyngoscope (Flexible Or Rigid); Speculum, Ent; Source, Carrier, Fiberoptic Light; Bur, Ear, Nose And Throat; Otoscope; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Probe, Rectal, Non-Powered; Tourniquet, Gastro-Urology; Stylet For Catheter, Gastro-Urology; Trocar, Gastro-Urology; Sound, Urethral, Metal Or Plastic; Forceps, Biopsy, Non-Electric; Light Source, Fiberoptic, Routine; Laparoscopy Kit; Clamp, Non-Electrical; Retractor, Self-Retaining; Speculum, Rectal; Device, Locking, For Intestinal Clamp; Adaptor, Bulbs, Miscellaneous, For Endoscope; Probe And Director, Gastro-Urology; Retractor, Non-Self-Retaining; Cannula, Injection; Clamp, Penile; Ring, Laparotomy; Scoop; Ligator, Hemorrhoidal; Holder, Needle, Gastroenterologic; Clamp, Cannula; Depressor, Tongue, Non-Surgical; Syringe, Piston; Ring Cutter; Basin, Emesis; Strip, Adhesive, Closure, Skin; Bandage, Elastic; Wrap, Sterilization; Dressing, Wound, Drug; Table, Operating-Room, Manual; Tray, Surgical, Instrument; Light, Headband, Surgical; Light, Surgical, Fiberoptic; Mesh, Surgical, Polymeric; Mesh, Surgical; Mirror, General & Plastic Surgery; Tape, Measuring, Rulers And Calipers; Camera, Television, Surgical, With Audio; Operating Room Accessories Table Tray; Speculum, Non-Illuminated; Specula Accessories; Chisel, Surgical, Manual; Clip, Removable (Skin); Contractor, Surgical; Curette, Surgical, General Use; Cutter, Surgical; Expander, Surgical, Skin Graft; Guide, Surgical, Instrument; Hammer, Surgical; Marker, Skin; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Spatula, Surgical, General & Plastic Surgery; Stylet, Surgical, General & Plastic Surgery; Stripper, Vein, Reusable; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Catheter, Irrigation; Catheter, Eustachian, General & Plastic Surgery; Needle, Catheter; Laparoscope, General & Plastic Surgery; Endoscope, Rigid; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Needle, Suturing, Reusable; Needle, Aspiration And Injection, Reusable; Knife, Amputation; Applier, Surgical, Clip; Saw, Manual And Accessories; Scalpel, One-Piece; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Brush, Scrub, Operating-Room; Elevator, Surgical, General & Plastic Surgery; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Forceps, General & Plastic Surgery; File, Surgical, General & Plastic Surgery; Blade, Scalpel; Dermatome; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Endoscope, Neurological; Discriminator, Two-Point; Device, Monitoring, Intracranial Pressure; Fork, Tuning; Pinwheel; Percussor; Dura Substitute; Electrode, Cortical; Instrument, Shunt System Implantation; Retractor, Self-Retaining, For Neurosurgery; Instrument, Microsurgical; Rongeur, Manual; Instrument, Surgical, Non-Powered; Neurological Stereotaxic Instrument; Neurosurgical Paddie; Handpiece (Brace), Drill; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Compound, Powered); Drills, Burrs, Trephines & Accessories (Manual); Holder, Head, Neurosurgical (Skull Clamp); Headrest, Neurosurgical; Clip, Scalp; Rack, Clip; Applier, Hemostatic Clip; Catheter, Ventricular; Instrument, Ligature Passing And Knot Tying; Curette, Uterine; Forceps, Surgical, Gynecological; Forceps, Obstetrical; Tenaculum, Uterine; Speculum, Vaginal, Metal; Scissors, Umbilical; Scissors, Episiotomy; Retractor, Vaginal; Packer, Uterine; Dilator, Cervical, Fixed Size; Dilator, Vaginal; Pelvimeter, External; Laparoscope, Gynecologic (And Accessories); Forceps, Biopsy, Gynecological; Amniotome; Stethoscope, Fetal; Remover, Intrauterine Device, Contraceptive, Hook-Type; Curette, Suction, Endometrial (And Accessories); Sound, Uterine; Pessary, Vaginal; Loupe, Binocular, Low Power; Tonometer, Manual; Cannula, Ophthalmic; Trabeculotome; Spud, Ophthalmic; Spoon, Ophthalmic; Specula, Ophthalmic; Spatula, Ophthalmic; Scissors, Ophthalmic; Rongeur, Lachrymal Sac; Ring, Ophthalmic (Flieringa); Retractor, Ophthalmic; Probe, Trabeculotomy; Probe, Lachrymal; Needle, Ophthalmic Suturing; Knife, Ophthalmic; Hook, Ophthalmic; Forceps, Ophthalmic; Dilator, Lachrymal; Depressor, Orbital; Cystotome; Curette, Ophthalmic; Caliper, Ophthalmic; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Magnet, Permanent; Headlamp, Operating, Battery-Operated; Trephine, Manual, Ophthalmic; Hemostat; Stripper, Surgical; Dynamometer, Nonpowered; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; File; Rasp; Knife, Orthopedic; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Awl; Trephine; Osteotome; Skid, Bone; Passer; Driver, Prosthesis; Template; Probe; Clamp; Tamp; Passer, Wire, Orthopedic; Holder, Needle; Orthopedic; Mallet; Spatula, Orthopedic; Twister, Wire; Screwdriver; Brace, Drill; Cutter, Wire; Forceps, Wire Holding; Cable, Electrode; Splint, Hand, And Components; Bandage, Cast; Film, Radiographic; Accelerator, Linear, Medical; Pin, Fixation, Threaded; Retainer, Matrix; Plier, Orthodontic; Indicator, Physical/Chemical Sterilization Process; Shunt, Central Nervous System And Components; Cuff, Nerve; Cannula, Ear; Chisel, Mastoid; Chisel, Middle-Ear; Clamp, Ossicle Holding; Curette, Ear; Excavator, Ear; Gauge, Measuring; Holder, Ear Speculum; Hook, Microsurgical Ear; Inserter, Myringotomy Tube; Knife, Ear; Knife, Myringotomy; Loop, Wire; Pick, Microsurgical Ear; Press, Vein; Rasp, Ear; Rod, Measuring Ear; Rongeur, Mastoid; Scissors, Ear; Snare, Ear; Spoon, Ear; Tube, Ear Suction; Knife, Laryngeal; Tube, Laryngectomy; Elevator, Ent; Forceps, Ent; Mirror, Ent; Mobilizer, Ent; Probe, Ent; Retractor, Ent; Cannula, Sinus; Chisel, Nasal; Curette, Ethmoid; Curette, Nasal; Gouge, Nasal, Ent; Irrigator, Sinus; Knife, Nasal; Punch, Antrum; Punch, Ethmoid; Punch, Nasal; Rasp, Frontal-Sinus; Rasp, Nasal; Rongeur, Nasal; Saw, Nasal; Scissors, Nasal; Snare, Nasal; Trocar, Sinus; Adenotome; Curette, Adenoid; Depressor, Metal Tongue, Surgical; Dissector, Tonsil; Gag, Mouth; Knife, Tonsil; Needle, Tonsil Suturing; Punch, Adenoid; Punch, Tonsil; Screw, Oral; Screw, Tonsil; Snare, Tonsil; Tube, Tonsil Suction; Bistoury, Tracheal; Dilator, Esophageal, Ent; Dilator, Tracheal; Hook, Tracheal; Applicator, Ent; Syringe, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Chisel (Osteotome); Wound Dressing With Animal-Derived Material(S); Tape And Bandage, Adhesive; Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material); Hook, Bone; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Goniometer, Nonpowered; Trocar, Ent; Punch, Ent; Knife, Ent; Bronchoscope Accessory; Caliper; Device, Irrigation, Ocular Surgery; Light, Examination, Medical, Battery Powered; Container, Liquid Medication, Graduated; Syringe, Irrigating (Non Dental); Neurosurgical Ultrasonic Instruments; Stethoscope, Manual; Instrument, Ultrasonic Surgical; Instrument, Cast Application/Removal, Manual; Instrument, Cast Removal, Ac-Powered; Port & Catheter, Implanted, Subcutaneous, Intraventricular; Agent, Absorbable Hemostatic, Collagen Based; Material, Dressing, Surgical, Polylactic Acid; Locator, Root Apex; Instrument, Ent Manual Surgical; Tray, Surgical; Scissors, General, Surgical; Punch, Surgical; Orthopedic Manual Surgical Instrument; Manipulator, Plunger-Like Joint; Splint, Intranasal Septal; Bone Grafting Material, Synthetic; Bone Mill; Device, Dermal Replacement; Instrument, Manual, Surgical, General Use; Dressing, Wound And Burn, Interactive; Specimen/Tissue, Identification Orientation; Tray, Surgical, Ent; System, Planning, Radiation Therapy Treatment; Bone Particle Collector; Graft, Vascular, Stainless Steel Tunneler; Die, Wire Bending, Ent, Non-Sterile; Block, Cutting, Ent, Non-Sterile; Scissors, Wire Cutting, Ent, Non-Sterile; Splint, Extremity, Non-Inflatable, External, Non-Sterile; Material, External Aesthetic Restoration, No Adhesive; Sealant, Dural; Endoscopic Cholangiogram Kit; Laparoscopic Accessories, Gynecologic; Laryngoscope Kit; Ear, Nose, And Throat Surgical Tray; Neurological Tray; Mesh, Surgical, Collagen, Diaphragmatic Hernia; Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery; Mesh, Surgical, Collagen, Large Abdominal Wall Defects; Ear, Nose, And Throat Stereotaxic Instrument; Stainless Steel Instrument, Shunt System Implantation; Eustachian Tube Balloon Dilation Device; Intracardiac Patch Or Pledget, Biologically Derived; Balloon, Nasal Airway; Securement Wound Dressing For Reduction Of Infection",1; 2; 3; U,"225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710; 33-31;33-31A;33-31AA;33-31AA-P/25;33-31A-P/25;33-31B;33-31-P/25;33-32;33-32-P/25;33-33;33-33-SH;33-34;33-34-P/25; 33-34-SH;33-35;33-35-SH;33-36;33-36-SH;33-37;33-38; 33-52;33-53;33-54;33-55;33-57; 4-110;4-111;4-112;4-112B;4-115;4-115C;4-120;4-121;4-122;4-123;4-125;4-310;4-311;4-312;4-312B;4-315;4-315C;4-320;4-321; 4-322;4-323;4-325;4610;4611;4615; 5-700;5-702;5801;5803;5804; 5-800; 730410; 730411; 730412; 730413; 730414; 730510; 730511; 730512; 730610; 730611; 730612; 730613; 730614; ACCLARENT PIVOT Balloon Dilation Systems; ACCLARENT SE Inflation Device; ASX9/100; ASX9/130; ASX9/70; AURORA Evacuator + Coag; AURORA Surgiscope System; Acclarent; Acclarent AERA Eustachian Tube Balloon Dilation System; Acclarent ENT Navigation System; Acclarent Inflation Device; Acclarent Navwire Sinus Navigation Guidewire; Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System; Acclarent Relieva Ultirra® Nav Sinus Balloon Catheter; Accudrain External CSF Drainage Sys; Alleghany CSF External Drainage Sys; Arkis CerebroFlo EVD Catheter; Arkis Galea Elevator; Arkis Precision Tunneler; Arkis Subcutaneous Guideware; Arkis Subcutaneous Guidewire; Arkis Tunneling Guidewire; Articodent; Auragen Cortical Electrodes; Aurora Evacuator; Aurora Surgiscope System; BUDDE Halo Retractor System; Bactiseal Barium Striped Catheters; Bactiseal Catheters; Bactiseal Clear EVD Catheter Set; Bactiseal EVD Catheter Sets:; Bactiseal Endoscopic Ventricular Catheter; Beauty Pink; BioMend Absorbable Collagen Membrane; Biomend Extend Absorbable Collagen Membrane; Biopatch; Blade P4596; Braden Reservoir; BulkNet; CABLES; CODMAN® ICP EXPRESS®; CARB-BITE; CARB-EDGE; CARDIO-GRIP; CATHETER PROBES AND KIT; CODMAN BACTISEAL EVD CATHETER SET; CODMAN BICOL Collagen Sponge; CODMAN Bipolar Cords; CODMAN CERTAS PLUS PROGRAMMAGLE VALVE SYSTEM; CODMAN CERTAS Plus Electronic Tool Kit; CODMAN Cranio-blade; CODMAN Craniotomy Kit (consisting of Disposable Perforator, Cranio-blade, & Wire Pass Drill); CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT; CODMAN DISPOSABLE SCALP CLIP APPLIER; CODMAN Disposable ICP Kits; CODMAN Disposable Perforators; CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters; CODMAN EDS 3 - CSF External Drainage System; CODMAN EDS 3 - CSF External Drainage System no Catheter; CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II); CODMAN HAKIM SHUNT SYSTEMS; CODMAN Integrated Bipolar Cord And Tubing Set; CODMAN LEROY Scalp Clip Applier Forceps; CODMAN MALIS Mirror Finish Bipolar Forceps; CODMAN MICROSENSOR Skull Bolt Kits; CODMAN Mirror Finish Bipolar Forceps; CODMAN Peel-Away Catheter Introducer; CODMAN RANEY Scalp Clip Forceps; CODMAN RHOTON Mirror Finish Bipolar Forceps; CODMAN Spetzler Mirror Finish Bipolar Forceps; CODMAN VPV SYSTEM, MODEL 82-3192; CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps; CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps; CODMAN Wire Pass Drill; CODMAN® ACCU-FLO® Straight Connector; CODMAN® BACTISEAL® Clear EVD Catheter; CODMAN® BACTISEAL® Clear with Barium Stripe Catheter Kit; CODMAN® BACTISEAL® Ventricular Catheter and Distal Catheter Kit; CODMAN® Disposable Catheter Passer; CODMAN® GHAJAR GUIDE® Ventriculostomy Kit; CODMAN® HAKIM® Precision Fixed Pressure Valve; CODMAN® HAKIM® Precision Fixed Pressure Valve with SIPHONGUARD® Device; CODMAN® HAKIM® Programmable Valve; CODMAN® HAKIM® Programmable Valve with SIPHONGUARD® Device; CODMAN® HAKIM® Programmable Valve; CODMAN® MEDOS® Ventricular Catheter; CODMAN® HAKIM® Valve Programmer; CODMAN® HOLTER®; CODMAN® HOLTER®; HOLTER®; CODMAN® MICROSENSOR® Ventricular Catheter Kit With ICP Sensor; CODMAN® SCHWARTZ Clamp Forceps; CODMAN® SCOTT Ventricular Cannula (Disposable); CODMAN® YASARGIL Mirror Finish Bipolar Forceps; CRW; CRW Biopsy Plus; CRW Precision Arc Steriotactic System; CRW Precision Arc Sterotactic System; CRW-1 System; CSF Reservoirs; CUSA Clarity 23 kHz Single-Sided Bone Tip; CUSA Clarity 23kHz CEM Nosecone; CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA; CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA; CUSA EXCEL Ultrasonic Surgical Aspirator System; CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602; CUSA® Clarity 23 kHz Expanded CEM Nosecone; CUSA® Clarity 23 kHz Extended Laparoscopic Tip; CUSA® Clarity 23 kHz Standard Laparoscopic Tip; Carb-N-Sert; Cardio-Grip; Cardion"" for Pericardial Repair; Cath Strip; Ceram-A-Grip; CereLink ICP Extension Cable 826845; CereLink ICP Monitor 826820; CereLink ICP Monitor. CereLink ICP Extension Cable; CereLink ICP Replacement Battery 826824; CereLink ICP Replacement Power Supply 826822; CereLink ICP Sensor; CerebroFlo EVD Catheter; Certas Plus Programmable Valve; Codman Accessories Bolt Kit; Codman Accessories Cables; Codman Accessories Cranial Access Kit; Codman Accessories Drill Kit; Codman Accessories ICP Transducer Basic Kit; Codman Accessories Interface Control Unit Kit; Codman Accessories Neuro Monitor; Codman Accessories Ventricular Kit; Codman Bactiseal Endoscopic Ventricular Catheter; Codman Bactiseal Ventricular Catheter; Codman CRAK Kit; Codman Certas Plus Programmable Valves; Codman Certas Toll Kit; Codman Disposable Perforators; Codman Double Lumen Skull Bolt; Codman Electrosurgical Foot Pedal; Codman Electrosurgical Generator; Codman External Drainage System II; Codman HAKIM PROGRAMMABLE VALVE SYSTEM; Codman Hakim Precision Fixed Pressure Valves; Codman Hakim Programmable Valves; Codman Instrument Tray; Codman IsoCool Bipolar Forceps; Codman Leroy Raney Scalp Bulk; Codman Leroy Raney Scalp Clips; Codman Leroy Scalp Clip Adult; Codman Leroy Scalp Clips Pediatric; Codman Microsensor; Codman Microsensor Basic Kit; Codman Microsensor Intracranial Pressure Transducer and Accessories; Codman Microsensor Metal Skull Bolt Kit; Codman Microsensor Plastic Skull Bolt Kit; Codman Microsensor Ventricular Catheter Kit; Codman Microsensor Ventricular Catheter Kit With Tuohyborst Adapter; Codman Raney Scalp Clips; Codman Raney Scalp Clips Bulk; Codman Single Lumen Skull Bolt; Codman Subarachnoid Screw; Codman Surgical Pattie and Strip; Codman Surgical Patties; Codman Ventricular Needles; Codman® Electrosurgical Interconnecting Cable; Codman® Electrosurgical lrrigator; CollaCote Absorbable Collagen Wound Dressing; CollaPlug Absorbable Collagen Wound Dressing; CollaTape Absorbable Collagen Wound Dressing; Compriband; Contour-Flex Valve and Shunt System; Cosgrove Depth Electrode Kit; Covidien Air Assisted Sprayer; Covidien Flow Regulator; Curity; Cyclops Multi-Angle Endoscope; Cyst Puncture Catheter Kits; Cytal Burn Matrix; Cytal Wound Matrix 1-Layer; Cytal Wound Matrix 2-Layer; Cytal Wound Matrix 3-Layer; Cytal Wound Matrix 6-Layer; Cytal® Wound Matrix Cytal® Burn Matrix; DURAGEN PLUS ADHESION BARRIER MATRIX; Depth Electrodes; Diamond; DirectLink ICP Extension Cable; DirectLink ICP Module; Disposable Shunt Passer; DuraGen Dural Graft Matrix; DuraGen Plus Dural Regeneration Matrix; DuraGen Secure Dural Regeneration Matrix; DuraGen XS Dural Regeneration Matrix; DuraSeal Dural Sealant; DuraSeal Exact Dural Sealant; DuraSorb Monofilament Mesh; Durepair Dura Regeneration Matrix; Dusor Elastic Bandage; Edwards Barbaro Syringo Shunt Syste; Endoscopic Ventricular Catheter; Equi-Flow Valve and Shunt Systems; Essential Shunt Kits; EvenWet; Extended Tip Applicator; External CSF Drainage Systems; External Corotid Shunts; First Aid Adhesive Bandages; Fixott-Everett Grid (for x-ray film); Flex-R; Flexible EEG Cables; Flexoplast; GENERAL INSTRUMENT; Galea Elevator; Gentrix Surgical Matrix; Gentrix Surgical Matrix Hiatal; Gentrix Surgical Matrix Plus; Gentrix Surgical Matrix Thin; Gentrix"" Surgical Matrix Thick; Gill-Thomas Cosman GTC Dental Tray; Gravity Compensating Accessory; Grid Electrodes; Grip Deep; GripLite; HAKIM MICRO PROGRAMMABLE VALVE SYSTEM; HAKIM PRECISION VALVE SYSTEM; HAKIM PROGRAMMABLE VALVE SYSTEM; HV Valve System; Hakim Percision Valve System; HeliCote Absorbable Collagen Wound Dressing; HeliMend Absorbable Collagen Membrane; HeliMend Advanced Absorbable Collagen Membrane; HeliPlug Absorbable Collagen Wound Dressing; HeliTape Absorbable Collagen Wound Dressing; Helistat Absorbable Collagen Hemostatic Sponge; Helitene Absorbable Collagen Hemostatic Agent; Hermetic; Hermetic External CSF Drainage Syst; Hermetic Lumbar Catheters; Hermetic Plus External CSF Drainage; Hi-5; Horizontal-Vertical Lumbar Valve System; ICB/ASX15; ICP Catheter; INTEGRA Bilayer Matrix Wound Dressing; INTEGRA Bilayer Wound Matrix; INTEGRA Dermal Regeneration Template; INTEGRA Flowable Wound Matrix; INTEGRA Matrix Wound Dressing; INTEGRA Meshed Dermal Regeneration Template; INTEGRA Wound Matrix; INTEGRA Wound Matrix (Thin); Inject-R-Fill; Inspira Air Balloon Dilation System; Integra; Integra Allograft Wedge Impactor Instrument; Integra Allograft Wedge Instrument Set; Integra Allograft Wedge Instrument Tray Assembly; Integra Allograft Wedge Sizer Instrument; Integra Anti-Rotation Peg Holder; Integra Cranial Access Kit; Integra DP Valve Systems; Integra Dermal Regeneration Template Single Layer; Integra Dermal Regeneration Template Single Layer Thin; Integra Disposable Filters 775-200; Integra Drainage Accessory Kit; Integra Flexible EEG Cable; Integra Flow Regulating Valve; Integra Flow Regulating Valve Low Flow; Integra Flow Regulator; Integra Gravity Compensating Accessory; Integra Horizontal-Vertical Lumbar Valve System; Integra Jarit; Integra LED Surgical Headlight; Integra LICOX PT02 Monitor; Integra Licox Pt02 Monitor Accessories; Integra Luxtec DLX UltraLite Pro; Integra Luxtec DLX UltraLite Pro Camera System; Integra Luxtec MLX 300 Watt Xenon Light; Integra Luxtec UltraLitePro; Integra Meshed Bilayer Wound Matrix; Integra Meshed Dermal Regeneration Template (OUS); Integra MicroFrance; Integra Miltex; Integra Omni-Tract Surgical Retractor Systems; Integra Omnigraft Dermal Regeneration Matrix; Integra Padgett; Integra Reservoirs; Integra Retention Plate 775-212-INT; Integra Ruggles Redmond; Integra Stainless Steel Peritoneal Introducer; Integra Straight Ventricular Catheter; Integral Drainage Set; Integral Lumbar Drainge Set; Integral Ventricular Drainge Set; Integral Ventricular Reservoir; Integra® Duo LED Surgical Headlight System; Jarit; Jarit Rigid Endoscopes; Jarit Star; Jarit Super; Jarit Supercut; LCM-2-Linac Couch-Mount System; LICOX BRAIN OXYGEN MONITORING SYSTEM; Liberator; Licox IMC Complete Neuromonitoring; Licox IT2 Complete Brain Tunneling; Light Guide Cable Adapters; Lightning; LimiTorr Volume Limiting Drainage; Loop Canulator / Canulator; LumbarTrak; Luxtec Fiber Optic Cables; Luxtec Light Sources; Luxtec MLX Light Source; MAYFIELD; MAYFIELD 2 Skull Clamp; MAYFIELD Skull Clamp; METIS; MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYP; Malleable Tunneler; Maurice Worldwide Shunt System; Mayfield; Mayfield 2000 Radiolucent Skull Cla; Mayfield A-2000 Skull Clamp; Mayfield Adult Disposable Skull Pin; Mayfield Base Unit; Mayfield Base Unit Adaptors; Mayfield Child Disposable Skull Pin; Mayfield Composite Series Skull Clamp; Mayfield Infinity Skull Clamp; Mayfield Infinity XR2 MR Skull Clamp; Mayfield Infinity XR2 Skull Clamp; Mayfield MR/CT Skull Clamp; Mayfield MR/X-Ray Skull Clamp; Mayfield Radiolucent Disposable Skull Pins; Mayfield Radiolucent Skull Clamp; Mayfield Titanium Skull Pins Dispos; Mayfield Titanium Skull Pins Reusab; MediHoney 100%; MediHoney Alginate; MediHoney Honeycolloid; Medihoney; Medihoney Dressing with Active Hone; Medihoney Gel Dressings; Medihoney Honeycolloid Dressing; Medihoney Wound and Burn Dressing; MicroFrance; MicroMatrix; MicroMatrix Flex; MicroMatrix® UBM Particulate; MicroMyst Applicator; Miltex; Miltex Apex Root Locator; Miltex Cryosolutions; Miltex Loupes LED Light Unit; Mishler Valve Systems; MoniTorr CSF External Drainage Syst; MoniTorr ICP External CSF Drainage; MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System; Mor-Flex; Moyco; Multi-Purpose Valves; NG Strip; NPH Low Flow Valve; Nashold Biopsy Needle - Disposable; Nashold Biopsy Needle - Single Use; Nasostat; NeuraGen 3D; NeuraGen Nerve Guide; NeuraWrap Nerve Protector; NeuroSight Arc Software; OSVII; OSVII Low Flow Lumbar Valve; OSVII Lumbar Valve System; OSVII and OSV Low Pro Valve Systems; On-Off Flushing Valves; Onyx-Flex; Onyx-H; Onyx-R; OraFOAM Absorbable Collagen Hemostatic Sponge; OraMem Absorbable Collagen Membrane; OraMem Sustained Absorbable Collagen Membrane; OraPlug Absorbable Collagen Wound Dressing; OraTape Absorbable Collagen Wound Dressing; Padgett; Padgett Finger Splint; Padgett Hand Splint; Padgett Sheen Grid; Padgett by Miltex; Patient Monitor Interface Cables; Peritoneal Introducer and Sheath; Petit-Point; Petit-Pt; Polypropylene Burr Hole Reservoir; Polypropylene Connectors; Precise; Precision; Pressure Bandage; PriMatrix; PriMatrix AG; Primacare; Primer Unna Boot; Probe 8""; Pudenz Cardiac Catheters; Pudenz Catheters; Pudenz Flushing Valve; Pudenz In-line Valve Systems; Pudenz Peritoneal Catheter; Pudenz Valves; RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE; RMH Integrator; Redmond; Relieva Circa Ethmoid Punch; Relieva Flex Guide Catheter; Relieva Luma Light Guide Cable 2; Relieva Luma Sentry Sinus Illumination System; Relieva Sidekick LP; Relieva Spin Balloon Sinuplasty System; Relieva SpinPlus Balloon Sinuplasty System; Relieva Tract Balloon Dilation System; Relieva Ultirra Sinus Balloon Catheter; Relieva Vortex 2; Revize Collagen Matrix; Revize-X Collagen Matrix; Right Angle Catheters; Right Angle Guide; Roto-Cam; Roto-Lok; Ruggles; Ruggles-Red; Ruggles-Redmond; SCHWARTZ VESSEL CL; STDSTEAM; STERILE STD LPV WITH RIGHT ANGLE; SUCTION RESERVOIR KIT; SUTURABLE DURAGEN DURAL REGENERATION METRIX; Scout® Multi-Sinus Dilation System; Shur Strip; Silitone; SiphonGuard TM CSF Control Device; Spectra A; Spectra F; Spetzler Lumbar Peritoneal Shunt Systems; Spetzler Lumbar-Peritoneal System; Stockingnette; Straight Ventricular Catheter; Strip Electrodes; Subcutaneous Guidewire; Subdural Drainage Catheter Kits; Sundt Shunt; SurgiMend -e Collagen Matrix; SurgiMend 1 Collagen Matrix; SurgiMend 2 Collagen Matrix; SurgiMend 3 Collagen Matrix; SurgiMend 4 Collagen Matrix; SurgiMend MP; SurgiMend PRS Collagen Matrix; SurgiMend PRS Meshed Collagen Matrix; Surgilast; Suritube; Suturable DuraGen Dural Regenration Matrix; Suture Strip; T Electron; TCC-EZ®; TEW Cranial /Spinal Retractor Syste; TISSUEMEND; TRAUMA CATHETER, VENTRICULAR CATHETER SET; Tactile Tone; Tarbell-Loeffler Cosman Pediatric F; Tardie; TenoGlide Tendon Protector; Thompson; Tri-R Post; TruDi NAV Cable; TruDi NAV Suction; TruDi NAVWIRE; TruDi Navigation System; TruDi Probe; TruDi Shaver Blade; TruDi® Curette; Tunneling Guidewire; UC Strip; UltraLite; UltraLite Plus; Ultralite; VENTRICULAR DRAINAGE SYSTEM; Ventricular Antichamber; Ventricular Catheter Accessory Kits; White Cross; Wing-Grip; Wound Measuring Kit; XKnife 5; Xcision",1981-02-24,317,2026-06-23,5,124,7,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003418325%22&limit=1
"Warsaw Orthopedic, Inc.",1824199,1824199,2500 Silveus Xing,Warsaw,IN,46582,United States,"Medtronic, Inc.",2112641,Manufacturer; Manufacturer for export; Repackager or relabeler,85,DZE; EQJ; ETN; EZX; FSM; FSZ; FTY; FZX; GAD; GDF; GDG; GDH; GDI; GEI; GEY; GWF; HBE; HRR; HRS; HRX; HTC; HTD; HTE; HTJ; HTO; HTS; HTW; HTZ; HWA; HWB; HWE; HWJ; HWK; HWM; HWN; HWR; HWT; HWX; HXB; HXC; HXD; HXG; HXL; HXP; HXQ; HXW; HXX; HXZ; JDI; JDK; JDN; JDQ; JDR; JEY; KDG; KIH; KWF; KWI; KWP; KWQ; LRN; LXH; MAX; MJO; MNH; MNI; MQP; MQV; MRW; NBH; NDN; NEK; NKB; NKG; NQP; NQW; NVR; ODP; OLO; OSH; OUR; OVD; OVE; PGM; PML,"Implant, Endosseous, Root-Form; Bur, Ear, Nose And Throat; Stimulator, Nerve; Mesh, Surgical, Metal; Tray, Surgical, Instrument; Light, Surgical, Carrier; Tape, Measuring, Rulers And Calipers; Guide, Surgical, Instrument; Retractor; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Ac-Powered; Stimulator, Electrical, Evoked Response; Drills, Burrs, Trephines & Accessories (Simple, Powered); Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Arthroscope; Pliers, Surgical; Forceps; Elevator; Gauge, Depth; Reamer; Knife, Orthopedic; Bit, Drill; Instrument, Cutting, Orthopedic; Impactor; Extractor; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Instrument, Compression; Driver, Prosthesis; Template; Tap, Bone; Probe; Wrench; Clamp; Tamp; Mallet; Instrument, Bending Or Contouring; Crimper, Pin; Bender; Screwdriver; Cutter, Wire; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Cement Restrictor; Implant, Fixation Device, Spinal; Cerclage, Fixation; Staple, Fixation, Bone; Plate, Bone; Chisel (Osteotome); Dispenser, Cement; Prosthesis, Finger, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Wire, Surgical; Orthopedic Manual Surgical Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Posterior Metal/Polymer Spinal System, Fusion; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Growing Rod System; Bone Cement, Posterior Screw Augmentation",1; 2; 3; U,", MOTORS; ACPii Atlantis Cervial Plate; AFFINITY; ANTERIOR CERVICAL PLATE SYSTEM; ARCHITEX; ARTHROSCOPE; ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS"" Anterior Cervical Plate System; ATLANTIS- Anterior Cervical Plate System; AXIS Fixation; Aspen; Atlantis Translational Plate; Atlantis Vision Anterior Cervical; Atlas Cable; Atlas Cable System Ti; BIT DRILLS; BONE HOOK; BONE MILL; BONE SCREW RULER; BONE TAP; BRYAN Cervical Disc; BRYANCervical Disc System; Bard-Parker; Basis Vetebral Body Spacers; Bipolar forcep; Bone Graft Washer; CAPSTONE PTC™ SPINAL SYSTEM; CAPSTONE Spinal System; CCD Spine System; CD 4.5 Crosslink Plates; CD 5.5mm Set Screws; CD Anterior Spinal System; CD Cannulated Screw; CD Central Rod; CD Cobalt Chrome; CD Eclipse Screws; CD Engage Cap; CD Engage Components; CD Engage Plate; CD Engage Y Parts; CD HA Coated; CD HORIZON; CD HORIZON ESSENCE; CD HORIZON ESSENTIALS™ Spinal System; CD HORIZON Growth Rod Conversion Set; CD HORIZON Longitude 2 Instruments and Rods; CD HORIZON Multiaxial screw; CD HORIZON SOLERA SPINAL SYSTEM; CD HORIZON SOLERA Spinal System; CD HORIZON SOLERA""; CD HORIZON SPINAL SYSTEM; CD HORIZON SPIRE(TM) Z Spinal System; CD HORIZON Solera 5.5/6; CD HORIZON Spinal System; CD HORIZON Spinal System SDS Pre-Bent Rods; CD HORIZON Spinal System SOLERA; CD HORIZON Spinal System, CD HORIZON ESSENTIALS"" Spinal System; CD HORIZON Threaded Rods; CD HORIZON VOYAGER Extended Tab Screws; CD HORIZON(R) Spinal System; CD HORIZONSPINAL SYSTEM; CD HORIZONSpinal System; CD HORIZON™ Spinal System; CD HORIZON® Fenestrated Screw Set; CD HORIZON® SOLERA® Spinal System; CD HORIZON® Spinal System; CD Horizan Eclipse M8 Screws; CD Horizan M8 Screws; CD Horizan Spinal Ti Spinal System; CD Horizon 3.2/4.5 Connectors; CD Horizon 3.5 Rods; CD Horizon 4.5 Cannulated Screws; CD Horizon 6.35 Crosslink Plates; CD Horizon Advanta; CD Horizon Antares Spinal System; CD Horizon Ballast"" Spinal System; CD Horizon Eclipse; CD Horizon Eclipse Screws; CD Horizon Ilio Sacral; CD Horizon Legacy 4.5; CD Horizon Legacy 6.35 Ti; CD Horizon M8 M10 Reduction Hooks; CD Horizon MAS Design Enhancement; CD Horizon Minor Mod; CD Horizon Reduction; CD Horizon SMA Staple; CD Horizon Set Screws; CD Horizon Solera 5.5/6 Sagittal Adjusting Screws; CD Horizon Solera HA Screws; CD Horizon Spinal System; CD Horizon Spinal System MAS; CD Horizon Spinous Plate; CD Horizon TAH Pedicle Hooks; CD Horizon Ti; CD Horizon- Spinal System; CD Horizon-Spinal System/ CD Horizon SOLERA; CD HorizonSpinal System; CD Horizon™ Astute™ Spinal System; CD Horizon™ ModuLeX™ Spinal System; CD Horizon™ Spinal System; CD Horizon® Spinal System; CD Ilio Sacral Screws; CD Instrumentation; CD LIBERTY POSTERIOR SPINCAL SYSTEM; CD M8 RMAS; CD Modified Set Screws; CD Modified Sextant II Instruments; CD Perc Trauma; CD Roller Burnished/Shot Peened Rod; CD Sextant II Reduction; CD Sextant Instruments; CD Spinal System; CD Spinal System for DDD TI; CD Spine Implants for DTT #3; CD Spire Spikes; CD Staples and Screws; CDH Legacy 5.5; CDH Solera 4.75; CEMENT; CLYDESDALE Spinal System; COLORADO 2 Spinal Sys 6.35 Rods and; COLORADO 2 Spinal System; COLORADO II Spinal System SS; COLORADO II Spinal System Ti; CRESCENT™ SPINAL SYSTEM; CRESCENT™ SPINAL SYSTEM TITANIUM; CRESENT Ti Spinal System; CROSSLINK Axial & CROSSLINK Offset; CROSSLINK Plate Non Grooved; Capstone Spinal System; Catalyft PL Expandable Interbody System; Catalyft™ PL Expandable Interbody System; Cement Restrictor; Cotrel-Dubousset Spinal System; DIVERGENCE Anterior Cervical Fusion System; DIVERGENCE(TM) Anterior Cervical Fusion System; DIVERGENCE-L"" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM; DRILL BIT (ORTHOPEDIC MA; DRILL GUIDES; DRILLS; Danek Infant System; Danek Plate and Screw System; Danek Precision Rod Set; Danek Unit Rod; DanekScope Micro-Endo Systems; Drill; Introducer Tool; Dyan-Lok Anterior Posterior Plating; Dyna-Lok Classic; Dyna-Lok PLUS Spinal System; Dyna-Lok Plate and Screw; Dyna-Lok Rods Bolts Connectors; Dyna-Lok Ti Spinal System; Dyna-lok/Danek Plate Screw; Dynamic Compression Shape Memory; EEA TAID; ELEVATE"" Spinal System; ELEVATE™ SPINAL SYSTEM; ELEVATOR; ENT); Equation Fixation System; Expandable Cage; FORCEPS (MANUAL INSTRU; Fuse Spinal System; Fuse Spinal System/ PLIF Titanium Cage; GDLH Posterior Spinal System; GRIP CLIP - CLIP; GUIDE WIRES (PINS); Galaky Spinal system; General Instrument; Guide Pin; Introducer Tool; HOLDER NEEDLE; HOLDER, NEEDLE; Hydrosorb CR; IB3D™ PL Spinal System; ICAL INST); INFINITY™ OCT System; INFINITY™ Occipitocervical Upper Thoracic System; INFUSE BONEGRAFT/ LT-CAGE Lumbar TF; INTERFIX Device (TIBFD); KYPHON Cement Delivery System; KyphX Bone Filler Device; KyphX Latitude Curette; KyphX Osteointroducer; LAA Selection Guide; LAMINOPLASTY; LT CAGE PEEK; Legacy 6.35 SS; Lever Screwdriver; Liberty Anterior System; Liberty Spinal System; Loop Spinal System/ TLIF- Cage; MAST QUADRANT™ Retractor System; MASTERGRAFT PUTTY; MEROCEL SPONGE; METRx Endoscope; METRx Microscope; MICRO-FRANCE; MODIFICATION TO TENOR SPINAL SYSTEM-PLATES; MSB PYRAMESH® Implant System; MSD Silo Spinal System; MULTIPLE (CHISELS; MULTIPLE (DEPTH GAUGES); MULTIPLE (DRIVER-EXTRACTORS); MULTIPLE (ORTHOPEDIC CLAMPS); MULTIPLE (ORTHOPEDIC OSTEOTOMES); MULTIPLE (ORTHOPEDIC REAMERS); MULTIPLE (SCISSORS); MULTIPLE (SURGICAL MALLETS); MULTIPLE FORCEPS; MULTIPLE TWIST; MUTIPLE TYPES OF BURS; Manual surgical instrument for general use; Medtronic Dissector Tool; Medtronic General Instrument; Medtronic Reusable Instrument; Multi Axial Screw System; Multiple High Speed systems; NAVIGATED INFINITY™ Instruments; NETTERVILLE LARYNGOLOPLASTIC STAGE; NIM; NIM SPINE SYSTEM; Navigated Vertex Select Drill Bit; Navigated Vertex Select Tap; Navigated Vertex Select Threaded Driver; ORION Anterior Cervical; ORTHOPEDIC (ORTHOPEDIC MANUAL SURG; ORTHOPEDIC MANUAL SURGICAL INSTRUM; OSTEOTOMES); Orfil Spine Fixation system; Orion Anterior Cervical Plate; PASS LP Spinal System; PEEK Prevail Cervical Interbody Dev; PEEK Previal Cervical Interbody Dev; PERIMETER C SPINAL SYSTEM; PERIMETER® C; PIVOX"" Oblique Lateral Spinal System; PLATE; POWEREASE; PRESTIGE Cervical Disc; PRESTIGE LP Cervical Disc System; PRESTIGECervical Disc; PROBE (ORTHOPEDIC MANU; PYRAMID +4 Anterior Lumbar Plate S; Peek Rod; Perimeter Interbody Fusion Device; Perimeter TI; Premier Anterior Cervical Plate; Pyramesh C; Pyramesh Implant System; Pyramid +4 Anterior Lumbar Plate; Pyramid Non-constrained Cover Plate; Pyramid Tapered Shank Bone Screw; RETRACTOR; RIALTO"" SI FUSION SYSTEM; RIALTO™ SI Fusion System; ROD BENDER; RONGEUR; RadiaLux™; Radio-Opaque Scale; SCREWDRIVER; SOLID SPHERE; SOVEREIGN Spinal System; SPINAL INTERVERTEBRAL FUSION; SPINE; SURGICAL DRIVE SYSTEM; Sextant Percutaneous; Sovereign; Soveriegn Spinal System; Spacekeeper; Spinal System; Straight Tip Radiance Illumination System; Symmetrix™ L Spinal System; T2 Sceptor Universal Endcleats; T2 Sinal System; T2 TXVBR; TACOMA Sacral Fixation System; TEMPLATE; TENOR SPINAL SYSDYNA-LOK PLUS Plate; TENOR Spinal System; TOWEL; TSRH; TSRH 3D Connectors; TSRH 3Dx 90 Degree Offset Connector; TSRH CROSSLINK Axial and Offset Pl; TSRH Central Post Hooks; TSRH Chromaloy Plus Precut Contoured Rods; TSRH Cobalt Chrome Rods; TSRH Crosslink System; TSRH Expanded Pedicle Screw; TSRH Hook Holder; TSRH L Rod Connector; TSRH Lateral Offset Plate; TSRH Offset and Slide Loading Hooks; TSRH Open Head Bone Screw; TSRH Osteogrip; TSRH SENTRY Posterior Spinal System; TSRH SENTRY VA Screws; TSRH Sacral Screw Central Post; TSRH Sentry Anterior/Posterior Spin; TSRH Silo; TSRH Spinal System; TSRH Spinal System 3D Connectors an; TSRH Spinal System 4.5 Screws; TSRH Spinal System Anterior L Plate; TSRH Spinal System MPA Screws; TSRH Spinal System Prebent/precut r; TSRH Spinal System RP; TSRH Spinal System S Rods and Unit Rods; TSRH Spinal system Crosslink Plates; TSRH TC 3D MPA Screw; TSRH TC Splined Connectors & Screws; TSRH TC Threaded Screws; TSRH Top Tightening T-Bolt; Tenor Spinal System; Thoracolumbosacral pedicle screw system; Threaded Cement Restrictor Ti; Ti Cement Restrictor; Tissue Approximating Forceps; Titanium GDLH Posterior Spinal Syst; Titanium TSRH SpinalSystem; Townley Pedicle Screw; Townley Transfacetpedicular Screw; Transverse Oct Spinal Fixation; Transverse Spinal Fixation; Tray, Surgical, Instrument; UCSS Non-Cannulated; VENTURE™ Anterior Cervical Plate System; VERTE-STACK(TM)SPINAL SYSTEM; VERTEBROPLASTY; VERTEX; VERTEX CROSSLINKS Reconstruction System; VERTEX Reconstruction System; VERTEX SELECT Reconstruction System; VERTEX® Reconstruction System; Vantage Bolts; Vantage Plates; Variable Angle Screw; Venture Cervical Plate; Verte-Span Components; Verte-Span Lift VB; Verte-Stack Capstone Peek; Verte-Stack Perimeter Peek; Verte-Stack Telamon Ti; Vertex Adjustable Plate; Vertex Cannulated Screw; Vertex Crosslinks; Vertex Keel Plate; Vertex Lateral Connectors; Vertex Max; Vertex OC MAS, Rods, Hooks; Vertex Occipital Components; Vertex Reconstruction Occipital; Vertex Reconstruction System; WRENCH; Wave D- Spinal System; Wave O Spinal System; Wire Caddy; Wire Nest; ZEVO Anterior Cervical Plate System; ZPlate II; Zephir Anterior Cervical Plate; Zephir Anterior Cervical Plate System; Zplate Anterior Fixation System; instrument tray; spinal system",1978-02-15,313,2026-07-17,6,6,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221824199%22&limit=1
Siemens Healthcare Diagnostics Inc.,2517506,2517506,"500 GBC DR, PO Box 6101",Newark,DE,19714,United States,SIEMENS HEALTHCARE DIAGNOSTICS INC.,9096044,Complaint file establishment; Contract manufacturer; Manufacturer; Manufacturer for export; Specification developer,160,CDD; CDP; CDQ; CDT; CDZ; CEC; CEK; CEM; CEO; CEP; CEW; CFJ; CFQ; CFR; CFT; CGJ; CGN; CGS; CGX; CGZ; CHH; CHI; CIC; CIG; CIT; CJE; CJO; CJW; CKA; CKE; CZW; DAD; DAP; DBF; DBI; DCF; DCN; DDG; DDR; DDS; DEM; DHA; DHB; DHX; DIC; DIF; DIH; DIO; DIP; DIS; DJD; DJG; DJR; DKB; DKE; DKJ; DKN; DKZ; DLB; DLF; DLI; DLJ; DLZ; DMJ; DML; DNI; GHH; GTQ; JFJ; JFL; JFM; JFY; JGJ; JGS; JHC; JHM; JHR; JHS; JHT; JHX; JHY; JIF; JIH; JIS; JIT; JIW; JIX; JIY; JJB; JJE; JJF; JJQ; JJY; JLS; JLW; JMG; JMO; JQB; JQP; JXM; JXN; JZJ; KHO; KHP; KHQ; KHS; KLB; KLI; KLQ; KLR; KLS; KLT; KNK; KXS; KXT; LAF; LAG; LAN; LAO; LAR; LAS; LBS; LBZ; LCD; LCM; LCP; LCR; LDJ; LDO; LDP; LEG; LEH; LFG; LFH; LFI; LFM; LOJ; LTJ; LTK; LXG; MKW; MLM; MMI; MOI; MQM; MRG; MRR; MTF; MTG; NBC; NDR; NDW; NGA; NIG; NQD; NRP; OAV; OUF; PDJ; PRI,"Radioassay, Vitamin B12; Radioimmunoassay, Total Triiodothyronine; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Radioimmunoassay, Immunoglobulins (G, A, M); Hexokinase, Glucose; Radioimmunoassay, Prolactin (Lactogen); Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Cresolphthalein Complexone, Calcium; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes; Bromcresol Purple Dye-Binding, Albumin; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Acid Phosphatase, Thymolphthale Inmonophosphate; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; System, Test, C-Reactive Protein; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Prealbumin, Fitc, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Radioallergosorbent (Rast) Immunological; System, Test, Carcinoembryonic Antigen; Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Primidone; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Reagents, Test, Tetrahydrocannabinol; Colorimetry, Salicylate; Radioimmunoassay, Barbiturate; Enzyme Immunoassay, Amphetamine; Radioimmunoassay, Lsd (125-I); Enzyme Immunoassay, Ethosuximide; Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase; Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Test Reagents For Ethyl Alcohol; Nad-Nadh, Specific Reagent For Alcohol Enzyme Method; Liquid Chromatography, Amphetamine; Fibrin Split Products; Antistreptolysin - Titer/Streptolysin O Reagent; Catalytic Methods, Amylase; Ph Rate Measurement, Carbon-Dioxide; Enzymatic Method, Bilirubin; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Electrode, Ion Specific, Sodium; Acid, Uric, Uricase (Oxygen Rate); Colorimetric Method, Lipoproteins; Radioimmunoassay, Immunoglobulins (D, E); Differential Rate Kinetic Method, Cpk Or Isoenzymes; Chromatographic Separation, Cpk Isoenzymes; Fluorometric Method, Cpk Or Isoenzymes; Colorimetric Method, Cpk Or Isoenzymes; Enzymatic Method, Ammonia; Flame Photometry, Lithium; Calibrator, Primary; Calibrator, Secondary; Calibrator, Surrogate; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Analyzer, Chemistry, Micro, For Clinical Use; Colorimeter, Photometer, Spectrophotometer For Clinical Use; Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Radioimmunoassay (Two-Site Solid Phase), Ferritin; Ferrozine (Colorimetric) Iron Binding Capacity; Kinetic Method, Gamma-Glutamyl Transpeptidase; Calculator/Data Processing Module, For Clinical Use; Enzyme Immunoassay, Benzodiazepine; Enzyme Immunoassay, Propoxyphene; Prealbumin, Antigen, Antiserum, Control; Fluorometer, For Clinical Use; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzymatic, Carbon-Dioxide; Radioimmunoassay, Tobramycin; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Radioimmunoassay, Amikacin; Enzyme Immunoassay, Lidocaine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Radioimmunoassay, Methaqualone; Enzyme Immunoassay, Digoxin; Gas Chromatography, Methamphetamine; High Pressure Liquid Chromatography, Methamphetamine; Enzyme Immunoassay, N-Acetylprocainamide; Enzyme Immunoassay, Methotrexate; Enzyme Immunoassay, Procainamide; Drug Specific Control Materials; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Quinidine; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Assay, Glycosylated Hemoglobin; Fluorescent Immunoassay, Tobramycin; Enzyme Immunoassay, Cannabinoids; Enzymatic Radiochemical Assay, Tobramycin; Colorimetry, Acetaminophen; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Radioimmunoassay, Tricyclic Antidepressant Drugs; U.V. Spectrometry, Tricyclic Antidepressant Drugs; High Pressure Liquid Chromatography, Tricyclic Antidepressant Drugs; Enzyme Immunoassay, Digitoxin; Kit, Test,Alpha-Fetoprotein For Testicular Cancer; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Cyclosporine; Enzyme Immunoassay, Tracrolimus; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; Bilirubin (Total And Unbound) In The Neonate Test System; System, Test, Vitamin D; System, Test, Low Density, Lipoprotein; Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; Test, Natriuretic Peptide; Enzyme Immunoassay, Inhibin-A; Assay, Porphyrin, Spectrophotometry, Lithium; Test, Follicle Stimulating Hormone (Fsh), Over The Counter; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Sirolimus Test System; Mycophenolic Acid Test System; Everolimus Immunoassay; Hemoglobin A1c Test System; Procalcitonin Assay",1; 2; 3; U,"ADVIA; ADVIA 1650 HDL CHOLESTEROL ASSAY; ADVIA Centaur NT proBNPII (PBNPII); ADVIA Centaur NT-proBNP (PBNP); ADVIA Chemistry; ADVIA Chemistry A1c_E Pretreatment Buffer Kit; ADVIA Chemistry A1c_E Reagent (2x150 Kit); ADVIA Chemistry A1c_E Reagent (4x300 Kit); ADVIA Chemistry ALP_2 Calibrator; ADVIA Chemistry Albumin BCP (ALBP); ADVIA Chemistry Albumin BCP CAL (ALBP CAL); ADVIA Chemistry Cystatin C_2 Calibrator; ADVIA Chemistry DBIL_2; ADVIA Chemistry Enzymatic Creatinine_3 (ECre3); ADVIA Chemistry Enzymatic Hemoglobin A1c Calibrator (A1c_E CAL); ADVIA Chemistry Enzyme 1 Calibrator (ENZ 1 CAL); ADVIA Chemistry Enzyme 2 Calibrator (ENZ 2 CAL); ADVIA Chemistry Enzyme 3 Calibrator (ENZ 3 CAL); ADVIA Chemistry HAPT; ADVIA Chemistry HbA1c Denaturant Reagent (HbA1c Denat); ADVIA Chemistry LAC; ADVIA Chemistry LDLP; ADVIA Chemistry LDPL; ADVIA Chemistry Lipase; ADVIA Chemistry Lithium_2 (LITH_2); ADVIA Chemistry Salicylate (SAL); ADVIA Chemistry TBIL_2; ADVIA Chemistry TP; ADVIA Chemistry TP_c; ADVIA Chemistry Total Bilirubin_2 (TBIL_2); ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL); ADVIA® Chemistry Toxicology Calibrators; ADVIA® Chemistry Toxicology Controls; Advia Centaur with StreamLAB; Aliquot Wheel Assembly; Aptio Automation System; Atellica CH 930 Analyzer; Atellica CH 930 Analyzer (Fully Refurbished); Atellica CH A-LYTE IMT Cleaner; Atellica CH A-LYTE Integrated Multisensor (IMT Na K CI); Atellica CH A1c_3 Calibrator (A1c_3 CAL); Atellica CH A1c_EZ PRE; Atellica CH Acetaminophen (Acet); Atellica CH Acetaminophen (AcetC); Atellica CH Acetaminophen 2 (ACTM); Atellica CH Acetaminophen 2 (ACTMC); Atellica CH Alanine Aminotransferase (ALT); Atellica CH Alanine Aminotransferase P5P (ALTPLc); Atellica CH Albumin BCP (AlbP); Atellica CH Albumin BCP Calibrator (AlbP CAL); Atellica CH Alkaline Phosphatase, Concentrated (ALP_2c); Atellica CH Alkaline Phosphatase_2 Calibrator (ALP_2 CAL); Atellica CH Alpha-1-Antitrypsin 2 (AAT2); Atellica CH Ammonia (Amm); Atellica CH Amphetamines (Amp); Atellica CH Amphetamines (AmpC); Atellica CH Anti-Streptolysin-O_2 (ASO_2); Atellica CH Anti-Streptolysin-O_3 (ASO_3); Atellica CH Barbiturates (BrbC); Atellica CH Benzodiazepines (Bnz); Atellica CH Benzodiazepines (BnzC); Atellica CH Bilirubin Calibrator (BILI CAL); Atellica CH Brb; Atellica CH CHEM III Calibrator (CHEM III CAL); Atellica CH Cannabinoids THC (Thc); Atellica CH Cannabinoids THC (ThcC); Atellica CH Carbamazepine (Carb); Atellica CH Carbon Dioxide, Concentrated (CO2_c); Atellica CH Check Reagent (CHK); Atellica CH Chemistry Calibrator (CHEM CAL); Atellica CH Cholinesterase_2 (CHE_2); Atellica CH Cleaner; Atellica CH Cocaine Metabolite (Coc); Atellica CH Cocaine Metabolite (CocC); Atellica CH Conditioner; Atellica CH Creatinine_3 (Crea3); Atellica CH Cystatin C Calibrators (CysC CAL); Atellica CH DRUG CAL (DRUG CAL); Atellica CH DRUG CAL II; Atellica CH Diazo Direct Bilirubin (D_DBil); Atellica CH Diazo Total Bilirubin (D_TBil); Atellica CH Digoxin (Dgn); Atellica CH Diluent; Atellica CH Direct Bilirubin 2 (DBil_2); Atellica CH EMPTY; Atellica CH EMPTY1; Atellica CH EMPTY2; Atellica CH ENZ 1 Calibrator (ENZ 1 CAL); Atellica CH ENZ 2 Calibrator (ENZ 2 CAL); Atellica CH ETOH; Atellica CH Ecstasy (Xtc); Atellica CH Ecstasy (XtcC); Atellica CH Enzymatic Creatinine_2 (ECre_2); Atellica CH Enzymatic Creatinine_3 (ECre3); Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Atellica CH Enzymatic Hemoglobin A1c_E Calibrator (A1c_E CAL); Atellica CH Ethyl Alcohol (EtohC); Atellica CH Gamma-Glutamyl Transferase_2 (GGT_2); Atellica CH Gentamicin (Gent); Atellica CH HA1c_E High Volume Bottles (5); Atellica CH HA1c_E High Volume Conversion Kit; Atellica CH HA1c_E High Volume Labels (50); Atellica CH HDL Cholesterol (HDLC); Atellica CH HDLC Calibrator (HDLC CAL); Atellica CH Haptoglobin_2 (Hapt_2); Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2); Atellica CH IMT Diluent (IMT Diluent); Atellica CH IMT Dilution Check (IMT Dilution Check); Atellica CH IMT Standard A (IMT Standard A); Atellica CH IMT Standard B + Salt Bridge (IMT Standard B + Salt Bridge); Atellica CH Iron3 (Iron_3); Atellica CH LDL Cholesterol (LDLC); Atellica CH LDL Cholesterol Calibrator (LDLC CAL); Atellica CH LIDO Assay; Atellica CH Lac_3; Atellica CH Lactate Dehydrogenase L-P (LDLP); Atellica CH Lamp Coolant (LC); Atellica CH Lid Keying Feature; Atellica CH Liquid Specific Protein Calibrators (LSP CAL); Atellica CH Lithium_2 (LITH_2); Atellica CH Methadone (Mdn); Atellica CH Methadone (MdnC); Atellica CH Microalbumin_2 Calibrator (?ALB_2 CAL); Atellica CH Mycophenolic Acid (MPA); Atellica CH Opiates (Op); Atellica CH Opiates (OpC); Atellica CH Oxycodone (OXYC); Atellica CH Oxycodone Assay; Atellica CH Phencyclidine (Pcp) Assay; Atellica CH Phencyclidine (PcpC); Atellica CH Phenobarbital (Phnb); Atellica CH Phenytoin (Phny); Atellica CH Prealbumin (PALB); Atellica CH Procainamide (PROC); Atellica CH Propoxyphene (Ppx); Atellica CH Protein 1 Calibrator (PROT1 CAL); Atellica CH Protein 2 Calibrator (PROT2 CAL); Atellica CH Reagent Probe Cleaner 1 (RPC1); Atellica CH Reagent Probe Cleaner 2 (RPC2); Atellica CH Reagent Probe Cleaner 4 (RPC4); Atellica CH Revised C-Reactive Protein Assay (RCRP); Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL); Atellica CH Salicylate (Sal); Atellica CH Salicylate (SalC); Atellica CH Special Chem CAL (SPCL CHEM CAL); Atellica CH Tacrolimus; Atellica CH Theophylline (Theo); Atellica CH Tobramycin (Tob); Atellica CH Total Bilirubin_2 (TBIL_2); Atellica CH Total Bilirubin_2 (TBil_2); Atellica CH Total Iron Binding Capacity (TIBC); Atellica CH Total Protein_2 (TP_2); Atellica CH Toxicology Calibrator (TOX CAL); Atellica CH Triglyceride_2 (Trig_2); Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Atellica CH Urinary/Cerebrospinal Fluid Protein Calibrator (UCFP CAL); Atellica CH Urine Albumin (UAlb); Atellica CH Urine Albumin Calibrator (UAlb CAL); Atellica CH Valproic Acid (VPA); Atellica CH Vancomycin (Vanc) Assay; Atellica CH Wash; Atellica CH Water Bath Additive (WBA); Atellica CI Analyzer; (Model 1900); Atellica CI Dilution Cuvette Segments; Atellica CI Reaction Cuvette Segments; Atellica Data Manager (ADM); Atellica Direct Connect for CI; Atellica Direct Load; Atellica IM 1300 Analyzer; Atellica IM 1300 Analyzer (Fully Refurbished); Atellica IM 1600 Analyzer; Atellica IM 1600 Analyzer (Fully Refurbished); Atellica IM Acid; Atellica IM Acid/Base; Atellica IM Ancillary Seal Kit; Atellica IM Base; Atellica IM Cleaner; Atellica IM NT proBNPII (PBNPII); Atellica IM NT-proBNP (PBNP); Atellica IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL); Atellica IM Wash; Atellica Japan Enzymatic Creatinine (ECreJ) Pack; Atellica Rack Handler; Atellica® CH N-acetylprocainamide (NAPA); Atellica® Connect; Atellica® Connect SE; CentraLink; Clinitek Novus Pro 12; DM Vista LDI; Dimension / Dimension Vista Lipase Calibrator (LIP); Dimension ACTMN Flex; Dimension AHDL Cal; Dimension AHDL Flex; Dimension ALB Flex; Dimension ALDL Cal; Dimension ALDL Flex; Dimension ALPI Cal; Dimension ALPI Calibrator; Dimension ALPI Flex; Dimension ALTI Flex; Dimension AMM Flex; Dimension AMPH Flex; Dimension AMY Flex; Dimension Aspartate Aminotransferase Flex; Dimension B12 Flex; Dimension BARB Flex; Dimension BENZ Flex; Dimension BUN Flex; Dimension C3 Flex; Dimension C4 Flex; Dimension CA Flex; Dimension CCRP Cal; Dimension CCRP Flex; Dimension CHEM I Cal; Dimension CHEM II Cal; Dimension CHK Flex; Dimension CHOL Cal; Dimension CHOL Flex; Dimension CKI Flex; Dimension CKI-MBI Cal; Dimension COC Flex; Dimension CRBM Flex; Dimension CSA Cal; Dimension CSA Flex; Dimension CTNI Cal; Dimension CTNI Flex; Dimension Chemistry III Calibrator; Dimension Chemistry Wash; Dimension Creatinine Flex reagent cartridge; Dimension Cuvette Cartridge; Dimension DBI Flex; Dimension DGNA Flex; Dimension DGTX Flex; Dimension Drug Cal; Dimension Drug Cal II; Dimension Drugs of Abuse Neg Ctrl; Dimension Drugs of Abuse Pos Ctrl; Dimension ECO2 Flex; Dimension ECRE Flex; Dimension ENZ 1 Cal; Dimension ETOH Flex; Dimension EXL 200 integrated chemistry system; Dimension EXL High-Sensitivity Troponin I (TNIH) Assay; Dimension EXL LOCI BRAHMS Procalcitonin (PCT); Dimension EXL LOCI BRAHMS Procalcitonin Calibrator (LOCI PCT CAL); Dimension EXL LOCI High-Sensitivity Troponin I Calibrator (LOCI TNIH CAL); Dimension EXL with LM and STM Ready; Dimension EXL with LM integrated chemistry system; Dimension EXTC Flex; Dimension EZCR Flex; Dimension Empty Flex; Dimension Enzyme II Cal; Dimension Enzyme Verifier; Dimension Everolimus Assay; Dimension Everolimus Calibrator; Dimension FERR Cal; Dimension FERR Flex; Dimension FOL Flex; Dimension FPSA Flex; Dimension FT3 Flex; Dimension FT4 Flex; Dimension GENT Flex; Dimension GGT Flex; Dimension Glucose Flex; Dimension HCG Cal; Dimension HCG Flex; Dimension Hemoglobin A1c Assay; Dimension IBCT Cal; Dimension IBCT Flex; Dimension IGA Flex; Dimension IGG Flex; Dimension IGM Flex; Dimension IMT Probe Cleaner; Dimension IRON Cal; Dimension IRON Flex; Dimension LA Flex; Dimension LDI Flex; Dimension LHCG Flex; Dimension LI Flex; Dimension LIDO Flex; Dimension LIPL Cal; Dimension LMMB Flex; Dimension LNTP Flex; Dimension LOCI Anemia Calibrator; Dimension LOCI B-type Natriuretic Peptide Calibrator; Dimension LOCI Free Thyroxine Flex reagent cartridge (LOCI FT4L); Dimension LOCI N-Terminal Pro-Brain Natriuretic Peptide Flex reagent cartridge; Dimension LOCI NTP Cal; Dimension LOCI TNI Cal; Dimension LOCI Thyroid Cal; Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (LOCI TSHL); Dimension LOCI VITD Cal; Dimension LOCI Vitamin B12 Flex; Dimension LOCI Vitamin D Total Assay; Dimension LTNI Flex; Dimension Lipase Flex; Dimension MALB Cal; Dimension MALB Flex; Dimension MBI Flex; Dimension METH Flex; Dimension MG Flex; Dimension MMB Cal; Dimension MMB Flex; Dimension MPAT Cal; Dimension MPAT Flex; Dimension MPAT Flex (DF215); Dimension MYO Cal; Dimension MYO Flex; Dimension NAPA Flex; Dimension NTP Flex; Dimension OPI Flex; Dimension Oxycodone (OXY) Flex Reagent Cartridge; Dimension PALB Cal; Dimension PALB Flex; Dimension PBNP Cal; Dimension PBNP Flex; Dimension PCHE Flex; Dimension PCHE Verifier; Dimension PCP Flex; Dimension PHNO Flex; Dimension PROC Flex; Dimension PTN Flex; Dimension RCRP Cal; Dimension RCRP Flex; Dimension Reaction Vessels; Dimension Reagent Probe Cleaner; Dimension RxL (with or without HM); Dimension RxL Max (with or without HM); Dimension RxL Max with HM & STM; Dimension SAL Cal; Dimension SAL Flex; Dimension SIRO Cal; Dimension SIRO Flex; Dimension Salt Bridge Solution; Dimension Sample Cups with Lids; Dimension Sample Diluent; Dimension Sample Probe Cleaner; Dimension Small Sample Container; Dimension Special Protein Cal; Dimension T/F PSA Cal; Dimension T4 Cal; Dimension T4 Flex; Dimension TBI Flex; Dimension TBI/DBI Cal; Dimension TGL Flex; Dimension THC Flex; Dimension THEO Flex; Dimension THY Cal; Dimension TNI Flex; Dimension TOBR Flex; Dimension TP Flex; Dimension TP/ALB Cal; Dimension TPSA Flex; Dimension TRNF Flex; Dimension TU Cal; Dimension TU Flex; Dimension Tacrolimus Calibrator; Dimension Tacrolimus Flex reagent cartridge; Dimension Thyroid Stimulating Hormone Flex; Dimension UCFP Cal; Dimension UCFP Flex; Dimension URCA Flex; Dimension VALP Flex; Dimension VANC Flex; Dimension Vista 1500 System; Dimension Vista A1AT Flex; Dimension Vista ACTM Flex; Dimension Vista AFP Flex; Dimension Vista ALB Flex; Dimension Vista ALPI Cal; Dimension Vista ALPI Flex; Dimension Vista ALTI Flex; Dimension Vista AMPH Flex; Dimension Vista AMY Flex; Dimension Vista ASL Flex; Dimension Vista AST Flex; Dimension Vista Ammonia Flex; Dimension Vista BARB Flex; Dimension Vista BENZ Flex; Dimension Vista BHCG Cal; Dimension Vista BHCG Flex; Dimension Vista BILI Cal; Dimension Vista CA Flex; Dimension Vista CEA Flex; Dimension Vista CHEM 2 Cal; Dimension Vista CHEM 4 Cal; Dimension Vista CHOL Flex; Dimension Vista CO2 Flex; Dimension Vista COC Flex; Dimension Vista CRBM Flex; Dimension Vista CTNI Sample Diluent; Dimension Vista Chemistry 1 Calibrator; Dimension Vista Chemistry 3 Calibrator; Dimension Vista Creatinine Flex Reagent Cartridge (CRE2); Dimension Vista DBIL Flex; Dimension Vista DGTX Flex; Dimension Vista DRUG 1 Cal; Dimension Vista DRUG 2 Cal; Dimension Vista Drug 4 Cal; Dimension Vista ENZ 1 Cal; Dimension Vista ETOH Flex; Dimension Vista EXTC Cal; Dimension Vista EXTC Flex; Dimension Vista Enzymatic Creatinine Calibrator (ECREA CAL); Dimension Vista Estradiol Flex (E2); Dimension Vista FERR Flex; Dimension Vista FOL Flex; Dimension Vista FT3 Flex; Dimension Vista FT4 Flex; Dimension Vista GENT Flex; Dimension Vista GGT Flex; Dimension Vista GLU Flex; Dimension Vista HAPT Flex; Dimension Vista HDLC Flex; Dimension Vista Hemoglobin A1c Assay; Dimension Vista High-Sensitivity Troponin I (TNIH) Assay; Dimension Vista High-Sensitivity Troponin I Calibrator (TNIH Cal); Dimension Vista IRON Cal; Dimension Vista IRON Flex; Dimension Vista LDLC Flex; Dimension Vista LIDO Flex; Dimension Vista LIPID Cal; Dimension Vista LITH Flex; Dimension Vista LOCI 1 Cal; Dimension Vista LOCI 6 Calibrator; Dimension Vista LOCI 7 Calibrator; Dimension Vista LOCI B-type Natriuretic Peptide Calibrator; Dimension Vista LOCI B-type Natriuretic Peptide Flex reagent cartridge; Dimension Vista LOCI CA 125 Flex; Dimension Vista LOCI CA 15-3 Flex; Dimension Vista LOCI CA 19-9 Flex; Dimension Vista Lipase Flex; Dimension Vista METH Flex; Dimension Vista MYO Cal; Dimension Vista MYO Flex; Dimension Vista Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge; Dimension Vista Multi 1 Sample Diluent (MULTI 1 SDIL); Dimension Vista OPI Flex; Dimension Vista Oxycodone (OXY) Flex Reagent Cartridge; Dimension Vista PBNP Cal; Dimension Vista PBNP Flex; Dimension Vista PCHE Flex; Dimension Vista PCP Flex; Dimension Vista PHOS Flex; Dimension Vista PREALB Flex; Dimension Vista PROC Flex; Dimension Vista PTN Flex; Dimension Vista Progesterone Calibrator; Dimension Vista SAL Flex; Dimension Vista T4 Flex; Dimension Vista TBIL Flex; Dimension Vista THC Flex; Dimension Vista THEO Flex; Dimension Vista TIBC Cal; Dimension Vista TIBC Flex; Dimension Vista TOBR Flex; Dimension Vista TP Flex; Dimension Vista TRIG Flex; Dimension Vista TSH Flex; Dimension Vista TU Flex; Dimension Vista Testosterone Calibrator; Dimension Vista Thyroxine/Thyronine-Uptake Calibrator; Dimension Vista Total Testosterone Flex reagent cartridge; Dimension Vista UCFP Cal; Dimension Vista UCFP Flex; Dimension Vista UDAT CON (Pos); Dimension Vista UDAT Cal; Dimension Vista UDAT Con (Neg); Dimension Vista URCA Flex; Dimension Vista VALP Flex; Dimension Vista VANC Flex; Dimension Vista sALB Flex reagent cartridge (sALB); Dimension Vista/EXL MULTI 2 SDIL; Dimension Vista® Acid Clean Flex® reagent cartridge; Dimension Vista® Aliquot Plates; Dimension Vista® Barcode Labels; Dimension Vista® CHK Flex® reagent cartridge; Dimension Vista® Cuvette Wash Solution; Dimension Vista® Cuvettes; Dimension Vista® Empty Flex® reagent cartridge; Dimension Vista® Empty Vials Kit; Dimension Vista® LOCI Reaction Vessels; Dimension Vista® Magnesium Flex® reagent cartridge; Dimension Vista® Mass CKMB Isoenzyme Calibrator; Dimension Vista® Phenobarbital Flex® reagent cartridge; Dimension Vista® Reagent Probe Cleaner; Dimension Vista® Sample Cups; Dimension Vista® Sample Probe Cleaner; Dimension Vista® Small Sample Container (SSC); Dimension Vista® System (500, 1000T, 3000T); Dimension Vista® System Diluent; Dimension Vista® Urea Nitrogen Flex® reagent cartridge; Dimension Xpand (with or without HM); Dimension Xpand Plus (with or without HM); Dimension/Dimension Vista CTNI Sample Diluent; Dimension/Dimension Vista Enzyme Diluent; Dimension® HM; Dimension® Phosphorus Flex® reagent cartridge; Dimension® Reagent Management System for EXL; EDM; EDMS Software System; Emi II Plus Methadone Assays; Emit 2000 CSA Sample Pretreat Rgt; Emit 2000 Carbamazepine Assay; Emit 2000 Carbamazepine Cals; Emit 2000 Cyclosporine Neg Cal; Emit 2000 Cyclosporine Specific Asy; Emit 2000 Cyclosporine Specific Cal; Emit 2000 Digoxin Assay; Emit 2000 Digoxin Cals; Emit 2000 Gentamicin Plus Assay; Emit 2000 Gentamicin Plus Cals; Emit 2000 N-Acetylprocainamide Assay; Emit 2000 N-Acetylprocainamide Assy; Emit 2000 N-Acetylprocainamide Cals; Emit 2000 Phenobarbital Assay; Emit 2000 Phenobarbital Cals; Emit 2000 Phenytoin Assay; Emit 2000 Phenytoin Cals; Emit 2000 Procainamide Assay; Emit 2000 Procainamide Cals; Emit 2000 Quinidine Assay; Emit 2000 Quinidine Cals; Emit 2000 Siro/Tacro Sample Pretrea; Emit 2000 Sirolimus Assay; Emit 2000 Sirolimus Calibrators; Emit 2000 Tacrolimus Assay; Emit 2000 Tacrolimus Cal; Emit 2000 Tacrolimus Sample Pretrea; Emit 2000 Theophylline Assay; Emit 2000 Theophylline Cals; Emit 2000 Tobramycin Assay; Emit 2000 Tobramycin Calibrators; Emit 2000 Valproic Acid Assay; Emit 2000 Valproic Acid Cals; Emit 2000 Vancomycin Assay; Emit 2000 Vancomycin Cals; Emit Amikacin Assay; Emit Antiepileptic Drug Cal Set; Emit Caffeine Assay; Emit Caffeine Control; Emit Cal B Level 1 (cutoff); Emit Cal B Level 2 (high); Emit Cal Level 0 (Neg); Emit Cal/Controls Levels 0-5; Emit Ethosuximide Assay; Emit Ethyl Alcohol Cal; Emit Ethyl Alcohol High Control; Emit Ethyl Alcohol Low Control; Emit Ethyl Alcohol Negative Cal; Emit II Plus Amphetamine Assays; Emit II Plus Amphetamines Assay; Emit II Plus Barbiturate Assay; Emit II Plus Benzodiazepine Assay; Emit II Plus Benzodiazepine Assays; Emit II Plus Buprenorphine Assay; Emit II Plus Cannabinoid Assay; Emit II Plus Cannabinoid Assays; Emit II Plus Cocaine Metabolite Assay; Emit II Plus Ecstasy Assay; Emit II Plus Ethyl Alcohol Assay; Emit II Plus Ethyl Alcohol Assays; Emit II Plus Methadone Assay; Emit II Plus Methaqualone Assay; Emit II Plus Methaqualone Assays; Emit II Plus Opiate Assay; Emit II Plus Opiate Assays; Emit II Plus Oxycodone Assay; Emit II Plus Oxycodone Negative Control 100; Emit II Plus Oxycodone Negative Control 300; Emit II Plus Oxycodone Positive Control 100; Emit II Plus Oxycodone Positive Control 300; Emit II Plus Phencyclidine Assay; Emit II Plus Phencyclidine Assays; Emit II Plus Propoxyphene Assay; Emit II Plus Propoxyphene Assays; Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2, Level 3, Level 4; Emit II Plus Specialty Drug Control Negative; Emit II Plus Specialty Drug Control Positive; Emit II Plus Specialty Multi Drug Calibrator/Control Level 1; Emit II Plus Specialty Multi Drug Calibrator/Control Level 2; Emit II Plus Specialty Multi Drug Calibrator/Control Level 3; Emit II Plus Specialty Multi Drug Calibrator/Control Level 4; Emit LSD Assays; Emit LSD Cals (10 ml); Emit LSD Control Level I; Emit LSD Control Level II; Emit Lidocaine Assay; Emit Primidone Assay; Emit dau Amphetamine Class Assay; Emit tox Acetaminophen Assay; Emit tox Acetaminophen Calibrators; Emit tox Salicylic Acid Assay; Emit tox Salicylic Acid Calibrators; Emit tox Serum Barbiturate Assay; Emit tox Serum Benzodiazepine Assay; Emit tox Serum Calibrators (Negative, Low, and Medium); Emit tox Serum Tricyc Antidep Assay; Emit tox Serum Tricyc Antidep Cal; IMMULITE 2000 / XPi Probe Cleaning Kit; IMMULITE 2000 / XPi Probe Wash Module; IMMULITE 2000 Chemiluminescent Substrate Module; IMMULITE 2000 Immunoassay System; IMMULITE 2000 Phenobarbital (PHE); IMMULITE 2000 Systems Allergen Tube Caps; IMMULITE 2000 Systems Allergen Tube Septum; IMMULITE 2000 Systems Diluent Tube Caps; IMMULITE 2000 Systems Diluent Tubes; IMMULITE 2000 Systems Microsampling Tube Caps; IMMULITE 2000 Systems Reaction Tubes; IMMULITE 2000 T4 (TT4); IMMULITE 2000 Total T3 (T3); IMMULITE 2000 XPi Immunoassay System; IMMULITE 2000 XPi System Sample Cup Nesting; IMMULITE Probe Cleaning Kit; IMMULITE Probe Wash Module; IMMULITE® / IMMULITE® 1000 FSH; IMMULITE® 2000 FSH; IMMULITE® 2000 FSH Sample Diluent; IMMUUTE 2000 Systems Microsampling Tubes; Ictotest; MAGIC LITE LH LUTEN; MAGIC LITE T UPTAKE REFERENCE SERUM; MAGIC LITE T3 100 TEST KIT; N Antiserum to Human Prealbumin; N Latex ASL; POCcelerator; Purified Water Diluent; QuikLYTE IMT (Na+/K+/Cl-); QuikLYTE IMT Std A; QuikLyte IMT Diluent Check; QuikLyte IMT Flush Solution; QuikLyte IMT Sample Diluent; QuikLyte IMT Std B; RAPIDComm; Reagent Management System; SCS CKMB CalPak; SCS CKMB DilPak; SCS CTNI DilPak; SCS Cannula (BD); SCS Cannula (Sarstedt); SCS Cannula (Terumo); SCS MYO CalPak; SCS MYO TestPak; SCS Pipette Tips; SCS Printer Paper; SCS Rotors; SCS Sample Cup; SCS Waste Bin Liner; Sample Transfer Module; Sample Transfer Module Aliquot Segment; Sample Transfer Module Kit for EXL; Sample Transfer Module Pipette Tips; Stratus CS Acute Care BHCG CalPak; Stratus CS Acute Care BHCG TestPak; Stratus CS Acute Care CCRP CalPak; Stratus CS Acute Care CCRP TestPak; Stratus CS Acute Care CKMB CalPak; Stratus CS Acute Care CKMB TestPak; Stratus CS Acute Care CTNI CalPak; Stratus CS Acute Care CTNI TestPak; Stratus CS Acute Care DDMR CalPak; Stratus CS Acute Care DDMR TestPak; Stratus CS Acute Care MYO CalPak; Stratus CS Acute Care MYO TestPak; Stratus CS Acute Care PBNP CalPak; Stratus CS Acute Care PBNP TestPak; Stratus CS Acute Care PBNPM CalPak; Stratus CS Analyzer; Stratus CS BHCG CalPak; Stratus CS BHCG TestPak; Stratus CS CTNI CalPak; Stratus CS D-Dimer TestPak DDMRE; Stratus CS DDMR CalPak; Stratus CS DDMR DilPak; Stratus CS DDMR TestPak; Syva Emit 2000 Mycophenolic Acid Assay; Syva Emit 2000 Mycophenolic Acid Calibrators; Syva Emit 2000 Mycophenolic Acid Controls; Syva Emit Disopyramide Assay; Syva Emit II Plus 6-Acetylmorphine Assay; Syva Emit II Plus 6-Acetylmorphine Cals/Controls Level 1-4; Syva Emit Methotrexate Assay; Syva RapidTest d.a.u AMP; Syva RapidTest d.a.u. 10 mAMP/OPI/COC/THC/PCP/BZO/BAR/MDN/TCA/AMP; Syva RapidTest d.a.u. 3 THC/COC/OPI; Syva RapidTest d.a.u. 4 THC/OPI/COC/AMP; Syva RapidTest d.a.u. 5 mAMP/OPI/COC/THC/PCP; Syva RapidTest d.a.u. BAR; Syva RapidTest d.a.u. BZO; Syva RapidTest d.a.u. COC; Syva RapidTest d.a.u. MDN; Syva RapidTest d.a.u. OPI; Syva RapidTest d.a.u. TCA; Syva RapidTest d.a.u. THC; Syva RapidTest d.a.u. mAMP; UniPOC; V-Lyte Diluent; V-Lyte Dilution Check; V-Lyte Integrated Multisensor; V-Lyte Standard A; V-Lyte Standard B; VITROS Chemistry Products CAFFN Reagent Kit BOX/200T; VITROS Chemistry Products CAL KIT 26; VITROS Chemistry Products Calibrator Kit 11 box/1 set/6 btls; VITROS Chemistry Products Calibrator Kit 12 box/1 set/6 btls; VITROS Chemistry Products Calibrator Kit 13 box/1 set/6 btls; VITROS Chemistry Products Calibrator Kit 14 box/1 set/6 btls; Vista CKI Flex; Vista DGTX Cal; Vista DIGXN Flex; Vista ECREA Flex; Vista ENZ 6 Cal; Vista ENZ5 Cal; Vista Enzyme 2 Calibrator; Vista FPSA Flex; Vista FSH Flex; Vista LA Flex; Vista LH Flex; Vista LOCI 4 Cal; Vista LOCI 8 Calibrator; Vista LOCI Progesterone Flex (LOCI PROG); Vista MBI Flex; Vista Prolactin Flex (LOCI PRL); Vista TPSA Flex; Vista VB12 Flex; eDM Lite",1995-04-18,303,2026-07-24,3,180,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222517506%22&limit=1
"Smith & Nephew, Inc.",3007366790,3007282753,3303 E Holmes Rd,Memphis,TN,38118,United States,"Smith & Nephew, Inc.",1020279,Manufacturer,113,FNS; FQH; FSM; FTY; FZO; FZP; FZX; FZY; GAD; GDG; GEA; GEY; GFA; GFG; HAB; HAW; HRS; HRY; HSB; HSD; HST; HSX; HTC; HTD; HTE; HTF; HTJ; HTN; HTO; HTQ; HTR; HTW; HTX; HTY; HWA; HWB; HWC; HWE; HWJ; HWK; HWM; HWQ; HWR; HWT; HWX; HXC; HXD; HXG; HXJ; HXL; HXP; HXR; HXS; HXW; HXX; HXZ; HYA; IPR; IXG; JDG; JDI; JDJ; JDO; JDQ; JDR; JDS; JDW; JDY; JDZ; JOL; JWH; KAZ; KGS; KIH; KIK; KIL; KQW; KRO; KRQ; KRR; KTT; KTZ; KWH; KWI; KWL; KWS; KWY; KWZ; KYJ; LPH; LRY; LWJ; LXH; LXT; LYU; LZN; LZO; LZY; MBH; MBL; MBV; MEH; NAB; NDG; NEU; NJD; NPJ; OIY; OLO; OOG; OQG; OSN; PBF,"Ring Cutter; Lavage, Jet; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Clip, Implantable; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Hook, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Bit, Surgical; Saw, Powered, And Accessories; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Passer; Driver, Prosthesis; Template; Tap, Bone; Wrench; Clamp; Tamp; Staple Driver; Mallet; Instrument, Bending Or Contouring; Spatula, Orthopedic; Twister, Wire; Bender; Screwdriver; Cutter, Wire; Forceps, Wire Holding; Crutch; Phantom, Anthropomorphic, Radiographic; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Evacuator, Vapor, Cement Monomer; Mixer, Cement, For Clinical Use; Catheter And Tip, Suction; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Rasp, Frontal-Sinus; Retention Device, Suture; Dispenser, Cement; Hook, Bone; Positioner, Socket; Goniometer, Nonpowered; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Finger, Constrained, Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Punch, Surgical; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Accessory, Surgical Apparel; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Gauze / Sponge,Nonresorbable For External Use; Washer, Bolt, Nut, Non-Spinal, Metallic; Marker, Radiographic, Implantable; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Stereotaxic Instrument; Knee Arthroplasty Implantation System; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Software For Diagnosis/Treatment; Orthopaedic Surgical Planning And Instrument Guides",1; 2,"1.5 MM TENDON DRILL PIN; 1.5mm Guidewire, 12"", 72202189; 1.6MM DRILL & GUIDE DYNOMITE 2; 1.8MM DRILL & GUIDE SPYROMITE/MINI 2; 10 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10.5 MM CANNULATED DRILL; 10.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 10.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10MM DILATOR; 11 MM GRAFT SIZING TUBE; 11 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11.5 MM CANNULATED DRILL; 11.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 11.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11MM DILATOR; 12 MM GRAFT SIZING TUBE; 12 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 12.5 MM CANNULATED DRILL; 12.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 12MM DILATOR; 13 MM GRAFT SIZING TUBE; 13 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 13.5 MM CANNULATED DRILL; 14 MM GRAFT SIZING TUBE; 2 MM FULL RADIUS MINI BLADES, POWER/EP-1, BLUE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE; 2.4MM PASSING PIN WITH CALIBRATION MARKS; 2.6 MM TWIST DRILL BIT FOR 2.3 ANCHOR; 2.6MM DRILL & GUIDE RAPTORMITE 3; 2.7 MM DILATOR; 2.7 MM X 15 INCH 38 CM DRILL-TIP PASSING PIN, NON-STERILE 6 PER PACKAGE; 2.9 MM ABRADER MINI BURRS, POWER/EP-1, ORANGE, PACKAGED 6 PER BOX, STERILE; 2.9 MM BARREL ABRADER MINI BURRS, POWER/EP-1, PURPLE, PACKAGED 6 PER BOX, STERILE; 2.9 MM CUTTER MINI BLADES, POWER/EP-1, BEIGE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2.9 MM FULL RADIUS MINI BLADES RED, POWER/EP-1, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 3.2MM DRILL & GUIDE RAPTORMITE 3.7; 3.5 MM ABRADER MINI BURRS, POWER/EP-1, AQUA, PACKAGED 6 PER BOX, STERILE; 3.5 MM CUTTER STRAIGHT BLADE; 3.5 MM DILATOR; 3.5 MM FULL RADIUS BLADE; 3.5 MM FULL RADIUS CURVED, CONCAVE, 8 CM MINI BLADES, POWER/EP-1, PLUM, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM HEX DRIVER, 2 MM CANNULATION; 3.5 MM INCISOR PLUS, 8 CM MINI BLADES, POWER/EP-1, SAGE GREEN, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM INCISOR STRAIGHT BLADE; 3.5 MM RAZORCUT STRAIGHT BLADE; 3.5 MM RAZORCUT, 8 CM MINI BLADES, POWER/EP-1, PUMPKIN/ORANGE, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 mm Bonecutter Platinum Blade; 3.5MM INCISOR PLUS PLAT BLD; 3.5MM SYNOVATOR PLAT BLD; 4 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, SAGE GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4 MM ABRADER STRAIGHT BURR; 4 MM ACROMIONIZER STRAIGHT BURR; 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS; 4 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, MAROON, PACKAGED 6 PER BOX, STERILE; 4 MM STONECUTTER STRAIGHT BURR; 4.5 FULL RADIUS BONECUTTER BLADES, YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, CURVED, INCISOR CURVED BLADES, POWER/EP-1, LIME GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, FULL RADIUS, CURVE, CURVED BLADES, POWER/EP-1, YELLOW, CURVE LENGHTS 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, SYNOVATOR CURVED BLADES, POWER/EP-1, FOREST GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CUTTER STRAIGHT BLADE; 4.5 MM DILATOR; 4.5 MM FULL RADIUS STRAIGHT BLADE; 4.5 MM HELICUT STRAIGHT BURRS, POWER/EP-1, SLATE, 5000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, VIOLET, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR STRAIGHT BLADE; 4.5 MM LONG CURVED FULL RADIUS CONCAVE SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM LONG FULL RADIUS SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM ORBIT FULL RADIUS CURVED BLADE; 4.5 MM ORBIT INCIISOR PLUS CURVED BLADES, POWER/EP-1, POWER/EP-1, VIOLET, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERIL; 4.5 MM ORBIT INCISOR CURVED BLADE; 4.5 MM ORBIT SYNOVATOR CURVED BLADE; 4.5 MM RAZORCUT STRAIGHT BLADE; 4.5 MM SYNOVATOR STRAIGHT BLADE; 4.5 MM TURBOTRIMMER STRAIGHT BLADE; 4.5 MM TURBOWHISKER STRAIGHT BLADE; 4.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, FOREST GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 mm Incisor Plus Platinum Curved Blade; 4.5 mm Synovator Platinum Curved Blade; 4.5MM FULL RADIUS PLATINUM SERIES; 4.5MM INCISOR PLUS PLATINUM BLADE; 4.5MM SYNOVATOR PLATINUM SERIES; 4MM CANNULATED CAPTURED SCREW 32MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 34MM Stainless Stee; 4MM CANNULATED CAPTURED SCREW 38MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 42MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 44MM Stainless Steel; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 30MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 32MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 34MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 36MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 38MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 40MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 42MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 44MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 46MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 48MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 50MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 30MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 32MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 34MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 36MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 38MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 40MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 42MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 44MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 46MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 48MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 50MM; 4mm PLATINUM FLYER Blade; 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS; 5 MM CANNULATED DRILL; 5.5 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, BRICK RED, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5 MM ABRADER STRAIGHT BURR; 5.5 MM ACROMIONIZER STRAIGHT BURR; 5.5 MM CANNULATED DRILL; 5.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 5.5 MM FULL RADIUS STRAIGHT BLADE; 5.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, TEAL, PACKAGED 6 PER BOX, STERILE; 5.5 MM INCISOR STRAIGHT BLADE; 5.5 MM RAZORCUT STRAIGHT BLADE; 5.5 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, OLIVE, PACKAGED 6 PER BOX, STERILE; 5.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 5.5 MM STONECUTTER STRAIGHT BURR; 5.5 MM SYNOVATOR STRAIGHT BLADE; 5.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, MELON YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5MM FULL RADIUS PLATINUM SERIES; 5.5MM INCISOR PLUS PLATINUM SERIES; 5.5MM SYNOVATOR PLATINUM SERIES; 6 MM ENDOSCOPIC DRILL; 6 MM GRAFT SIZING TUBE; 6 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6.5 MM CANNULATED DRILL; 6.5 MM DILATOR; 6.5 MM ENDOSCOPIC DRILL; 6.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6.5MM DILATOR; 6MM DILATOR; 7 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7.5 MM CANNULATED DRILL; 7.5 MM ENDOSCOPIC DRILL; 7.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7.5MM DILATOR; 7MM BICEPTOR TAP; 7MM DILATOR; 7MM ENDOSCOPIC DRILL XL; 7MM TENDON FORK; 8 MM ENDOSCOPIC DRILL XL; 8.5 MM CANNULATED DRILL; 8.5 MM DILATOR; 8.5 MM ENDOSCOPIC DRILL; 8.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 8.5MM DILATOR; 8MM BICEPTOR TAP; 8MM DILATOR; 8MM TENDON FORK; 9 MM ENDOSCOPIC DRILL XL; 9 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9.5 MM CANNULATED DRILL; 9.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 9.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9.5MM DILATOR; 9MM BICEPTOR TAP; 9MM DILATOR; 9MM TENDON FORK; A-Tech ACL Sterilization Tray; A-Tech Controlled Flexion Guidewire; A-Tech Femoral Locator Handle; AC Powered Instrument Motor; ACCORD; ACCORD CABLE SYSTEM; ACCORD Cable System; ACCU-PASS STR SHTL BIG C STERILE BOX 1; ACCU-PASS SUTURE SHUTTLE 70 DEGREE; ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE; ACCUPASS STR SHUTL MONOFIL -SEE72201361; ACCURIS; ACHIEVE CAS; ACL Bullet; ACL Closed Curette; ACL Disposables Guidewire Kit; ACL Disposables Kit; ACL Open Curette; ACL Tunnel Rasp; ACUFEX GRAFTMASTER III PREPARATION BOARD; ACUFEX TRUNAV; ACUFEX TRUNAV RETROGRADE DRL 10.5MM; ACUFEX TRUNAV RETROGRADE DRL 10MM; ACUFEX TRUNAV RETROGRADE DRL 11.5MM; ACUFEX TRUNAV RETROGRADE DRL 11MM; ACUFEX TRUNAV RETROGRADE DRL 12MM; ACUFEX TRUNAV RETROGRADE DRL 6.5MM; ACUFEX TRUNAV RETROGRADE DRL 6MM; ACUFEX TRUNAV RETROGRADE DRL 7.5MM; ACUFEX TRUNAV RETROGRADE DRL 7MM; ACUFEX TRUNAV RETROGRADE DRL 8.5MM; ACUFEX TRUNAV RETROGRADE DRL 8MM; ACUFEX TRUNAV RETROGRADE DRL 9.5MM; ACUFEX TRUNAV RETROGRADE DRL 9MM; ADVANSYS; ADVANSYS DLP; ADVANSYS MLP; ADVANSYS TTC; AHTB UNIVERSAL HIP DISTRACTOR; AHTB WELL LEG HOLDER; AMBI; ANTHEM; ANTHEM Total Knee System; ANTHOLOGY; ANTHOLOGY HIP SYSTEM; ARO Osteotomy Guide Assembly; ARO Spacer Plate; ARTHROPIERCE XL STRAIGHT; ARTHROSCOPIC LATARJET/BONE BLOCK LID; ARTHROSCOPIC LATARJET/BONE BLOCK TRAY; ARTHROSCOPIC NEEDLE STERILE; ASSEMBLY ENDOBUTTON INDICATOR; AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY 9.5 INCH LENGTH X 3 INCH WIDTH X 1.25 INCH HEIGHT; AWL STRAIGHT 3.8MM DISPOSABLE; Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361; Accu-pass suture shuttle 45 degree up, 7210425; Accu-pass suture shuttle 70 degree, Upbend, 72200419; Accu-pass suture shuttle left 45 degree, 7210423; Accu-pass suture shuttle right 45 degree; Accu-pass suture shuttle, Big Curve; Accu-pass suture shuttle, crescent, 7210427; Accu-pass suture shuttle, straight, 7210426; Acute QC Strut and Components; Adaptor; Anatomic ACL Tray; Ankle Distractor; Ankle Distractor Strap; Anthology Hip Stems; Antrum Rasp; Arthroscopic needle, 72202825; Ascension; Austin Moore; Awl; Awl straight 3.8mm, 72202986; Awl tapered 3.8mm; Awl, tap, driver, dilator; B-BOP; BHR; BI-GRIP PIN PULLER; BIO-FIT; BIOLOX; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP; BIOSURE DRIVER; BLADE 3.5 CURVED CONCAVE FULL RADIUS; BLADE 3.5MM ELITE FULL RADIUS; BLADE 4 ELITE ABRADER 6/BX; BLADE 5.5 FULL RADIUS ELITE DISPOSABLE; BLADE,4.5 BONECUTTER,FR,180MM LG,DSP; BOARD, PATIENT TRANSFER; BUCK; BURR 4MM ABRADER 180MML DISPOSABLE (3; BURR 5.5MM ABRADER 180MML DISPOSABLE; Beath pin 2.4mm, 72202815; Beluga Retro; Bilok Instrument Sterilization Tray; Bilok ST Graft Expander; Biosure 1.2mm x 18"", 72201201; Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile; Birmingham Hip; Blade, Sheath, Burr, Abrader, Incisor, Synovator, Acromionizer, Tubowhisker, Bonecutter, Acromioblaster, Notchblaster; Blunt Nose Junior; Bone Hook; Bone Tap; Brun; CALF STRAP EQUIPMENT RPLT AHTB; CALIBRATED DEPTH GAGE; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE; CANNULATED SCREW; CANNULATED SCREWS; CANNULATED SCREWS CHS COMPRESSION HIP SCREW CONQUEST FN D-RAD PLATING SYSTEM EVOS PLATING SYSTEM; CAP-FIX SUTURE PASSER 45 DEG; CAP-FIX SUTURE PASSER 70 DEG; CAP-LIFT Cannula, 100mm; CAP-LIFT Cannula, 110mm; CAP-LIFT Cannula, 70mm; CAP-LIFT Cannula, 80mm; CAP-LIFT Cannula, 90mm; CARRIAGE REPLACEMENT KIT; CATALYSTEM Femoral Stems; CERAMIC FEMORAL HEAD; CHS COMPRESSION HIP SCREW; CLANCY 10 MM FLEXIBLE DRILL; CLANCY 9 MM FLEXIBLE DRILL; COFIELD; COFIELD SHOULDER SYSTEM; COMPASS; COMPASS HINGE; CONQUEST FN; CONTOUR; CORIOGRAPH Pre-Op Planning and Modeling Service; CPCS; CPCS Hip Stems; CURVED INCISOR PLUS ELITE BL 4.5MM; CURVED LONG INCISOR PLUS ELITE BLADE; Calipers; Cannuflex 9"" Blunt Guidewire, 72202807; Cannula Driver; Cannulated Screw; Cannulated Switching Stick; Caps-Lock Cannula Driver; Caps-Lock Ultra; Cement Tube with Suction Bypass; Cemented Round Patella with JRNY Pegs; Cemented Tibia Baseplate no Taper with JRNY Lock; Chisel; Chondral Pick; Chondral Pick Sterilization Tray; Circular fixation with balanced cable transport; Clamp; Clearcut Suture Cutter; Closed Tendon Harvester; Cobb; Cove Point Pin; Crochet Hook; Cuff Elevator; D-RAD; D-RAD PLATING SYSTEM; D-RAD SMART PACK; DART SUTURE PASSER; DELTA; DENYER RAIL CLAMP (LATERL DSTRCTR SYS); DENYER SUPINE RAIL CLAMPS 2; DEUCE; DIRECTOR PCL ELEVATOR WITH WIRE CATCHER; DISPOSABLE BL 4.5 ORBIT FR ELITE; DISPOSABLE BL 4.5MM CURVED FR ELITE (6); DISPOSABLE MIXING BOWL; DISTRACTOR WARUPA DOUBLE 1.1MM&1.6MM; DPR SYSTEM; DRILL 4.5MM SPADE TIP; DRILL 5.5MM SPADE TIP; DRILL ENDOBUTTON 4.5MM NON-CANN; DRILL FIXATION POSTERIOR STERILE BX OF 1; DRILL FLUTED 3MM WITH DEPTH STOP; DRILL GUIDE PHALANGEAL EXTRA ARTICULAR; DRILL GUIDE PHALANGEAL LONG OFFSET; DRILL GUIDE PHALANGEAL SHORT OFFSET; DRILL RAPTORMITE 3 SUTURE ANCHOR; DRILL TIP PASSING PIN 2.7 MM X 15 INCH, STERILE 6 PER BOX; DRIVER CANNULATED SCREW; DRIVER PIP MIDDLE PHALANX; DRIVER PIP PROXIMAL PHALANX; DRIVER PIP PROXIMAL PHALANX 10 DEGREE; DYONICS 1/4 JCBS STL DRL SML BAT HND PC; DYONICS 2 MM FULL RADIUS BLADES, 7 CM LENGTH, BLUE, PACKAGED 6 PER BOX, STERILE; DYONICS 2 MM TURBOWHISKER BLADES, 7 CM LENGTH, YELLOW, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM ABRADER BURRS, 7 CM LENGTH, ORANGE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM BARREL BURRS, 7 CM LENGTH, PURPLE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM CUTTER BLADES, 7 CM LENGTH, BEIGE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM FULL RADIUS BLADES, 7 CM LENGTH, RED, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM INCISOR PLUS ELITE BLADES, 7 CM LENGTH, PEACH, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM TURBOWHISKER BLADES, 7 CM LENGTH, GREEN, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM ABRADER BURRS, 7 CM LENGTH, AQUA, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM FULL RADIUS BLADES, 7 CM LENGTH, PLUM, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM INCISOR PLUS ELITE BLADES, 7 CM LENGTH, SAGE GREEN, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM RAZORCUT BLADES, 7 CM LENGTH, PUMPKIN ORANGE, PACKAGED 6 PER BOX, STERILE; DYONICS 4MM ELITE ACROMIOBLASTER BURR; DYONICS 4MM ELITE ACROMIONIZER BURR(6); DYONICS 4MM ELITE NOTCHBLSTR ABRD BURR; DYONICS 4MM ELITE STONECUTTER BURR; DYONICS 5.5 FULL RADIUS BONECUTTER BLADES, ORANGE, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; DYONICS 5.5MM ELITE ABRADER BURR; DYONICS 5.5MM ELITE ACROMIOBLASTER BURR; DYONICS 5.5MM ELITE ACROMIONIZER BURR; DYONICS 5.5MM ELITE NOTCHBLSTR ABRD BURR; DYONICS 5.5MM ELITE STONECUTTER BURR; DYONICS 5/32 JACOBS STYLE DRL SML BATT; DYONICS KEYLESS SAGITTAL SW SML BT HNDPC; DYONICS MINI-MOTOR DRIVE, SUCTION LEVER, 10 FT 3 M CORD; DYONICS POWER CABLE ASSEMBLY; DYONICS POWERMAX ELITE HANDPIECE HAND-CONTROLLED WITH OPPOSITE-SIDE SUCTION LEVER; DYONICS POWERMAX ELITE HANDPIECE HAND-CONTROLLED WITH OPPOSITE-SIDE SUCTION LEVER REFURBISHED; DYONICS POWERMINI SMALL JOINT HANDPIECE WITH BLADE MULTI-POSITIONING, NO HAND CONTROLS, SUCTION LEVER, 10 FT 3 M CORD.; DYONICS SAGITTAL SAW W/KEY SML BAT HNDPC; DYONICS SYNTHS QUCK CON DRL SM BAT HNDPC; DYONICS WIRE DRVR SM BAT HANDPIECE; DYONICS ZIMMER HT RMR SML BAT HNDPC; Depth Gage; Depth Probe; Digital Goniometer; Disposable Knee Instruments; Doane; Drill Bit; Drill Tip Passing Pin; Drill for Q-FIX with Needles; Drill tip, passing pin w/graduation to 180mm; Driver; Dynomite 1.6mm drill & guide; ECHELON; ECHELON HIP SYSTEM; ECTRA HAND HOLDER/STERILIZATION TRAY WITH COVER; ELEVATOR COTTLE; EMPERION; ENDER; ENDOBUTTON DEPTH PROBE; ENDOBUTTON HOLDER SCALE EXTENDER; ENDOSCOPIC CANNULATED DRILL BIT, 4.5 MM, STERILE; ENGAGE; ENGAGE Partial Knee System; EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH; EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS); EVOS; EVOS 1.8MM X 10MM LOCKING PEG T7; EVOS DISTAL RADIUS DORSAL PLATE 3H STANDARD TITANIUM 56MM; EVOS DISTAL RADIUS DORSAL PLATE 3H WIDE TITANIUM 58MM; EVOS DISTAL RADIUS INTERMEDIATE COLUMN PLATE 4H TITANIUM 54MM; EVOS DISTAL RADIUS RADIAL COLUMN PLATE 4H TITANIUM 57MM; EVOS DISTAL RADIUS VOLAR PLATE 10H RIGHT STANDARD 138MM; EVOS DISTAL RADIUS VOLAR PLATE 10H STANDARD TITANIUM 141MM; EVOS DISTAL RADIUS VOLAR PLATE 3H STANDARD 48MM; EVOS DISTAL RADIUS VOLAR PLATE 3H STANDARD TITANIUM 48MM; EVOS DISTAL RADIUS VOLAR PLATE 3H WIDE 48MM; EVOS DISTAL RADIUS VOLAR PLATE 3H WIDE TITANIUM 48MM; EVOS DISTAL RADIUS VOLAR PLATE 4H STANDARD 56MM; EVOS DISTAL RADIUS VOLAR PLATE 4H STANDARD TITANIUM 56MM; EVOS DISTAL RADIUS VOLAR PLATE 4H WIDE 56MM; EVOS DISTAL RADIUS VOLAR PLATE 4H WIDE TITANIUM 56MM; EVOS DISTAL RADIUS VOLAR PLATE 5H STANDARD 76MM; EVOS DISTAL RADIUS VOLAR PLATE 5H STANDARD TITANIUM 81MM; EVOS DISTAL RADIUS VOLAR PLATE 5H WIDE 78MM; EVOS DISTAL RADIUS VOLAR PLATE 5H WIDE TITANIUM 83MM; EVOS DISTAL RADIUS VOLAR PLATE 7H STANDARD 100MM; EVOS DISTAL RADIUS VOLAR PLATE 7H STANDARD TITANIUM 105MM; EVOS DISTAL RADIUS VOLAR PLATE 7H WIDE 100MM; EVOS DISTAL RADIUS VOLAR PLATE 7H WIDE TITANIUM 105MM; EVOS DISTAL ULNA PLATE 7H TITANIUM 34MM; EVOS PLATING SYSTEMS; EVOS PROXIMAL RADIAL SHAFT PLATE 5H L 95MM; EVOS Patella Plates; EVOS Pelvic and Acetabular System; EVOS RADIAL SHAFT PLATE 8H 98MM; EVOS TITANIUM 1.8MM X 10MM LOCKING PEG T7; EVOS TITANIUM 3.5MM X 10MM CORTEX SCREW T15 SELF-TAPPING; EVOS TITANIUM 3.5MM X 10MM LOCKING SCREW T15 SELF TAPPING; EVOS WRIST DORSAL WRIST SPANNING PLATE; EVac Bending Tool; Elevator Rasp; Endobutton Pin Passing 2.4mm Trocar; Endobutton drill tip, passing pin 2.4mm x 15; Endobutton drill tip, passing pin 2.7mm x 15; Endoscopic Cannula Drill Bit 4.5mm; Extractor; Extremities Guide, Universal; FEMORAL CANAL SUCTION ABSORBER; FIRSTPASS Suture Passer; FIXATION CERCLAGE; FIXATION STAPLE; FOREFOOT; FULL RADIUS BONECUTTER 4.5MM PLATINUM; FULL RADIUS BONECUTTER 5.5MM PLATINUM; Face Shield; Fluid Barrier Boots,; Femoral Aimer; Femoral Heads; Femoral Locator; Fixation post drill, 72202879; Forefoot II; GD WIRE NITINOL 1.2 X 45CM; GENESIS; GENESIS II; GENESIS II KNEE SYSTEM; GENESIS II OXINIUM; GENESIS II POROUS PLUS; GENESIS KNEE SYSTEM; GRAFT SIZING BLOCK; GRAFT SIZING TUBE - 5.5MM; GRAFT SIZING TUBE - 5MM; GRAFT SIZING TUBE - 9.5MM; GRAFT SIZING TUBE -10.5MM; GRAFT SIZING TUBE -11.5MM; GRAFT SIZING TUBE -12.5MM; GRAFT SIZING TUBE -13.5MM; GRAFTMASTER ENDOBUTTON HOLDER; GRAFTMASTER II CUTTING STRIP; GRAFTMASTER II GRAFT PREP BRD.; GRAFTMASTER II SYSTEN TRAY; GRAFTMASTER III BTB HOLDER; GRAFTMASTER III CUTTING STRIP; GRAFTMASTER III SLIDING BASE 2; GRAFTMASTER III TENSIONING POST; GRAFTMASTER III TISSUE GRASPER 2; GUHL NON-INVASIVE ANKLE DISTRACTOR STERILIZATION TRAY; GUIDE METATARSAL OSTEOTOMY; GUIDE WIRE 1.2MM X 9 BOX OF 5 STERILE; GUIDE WIRE 1.2MM X18 BX OF 5 STER.; GUIDE WIRE BEATH PIN 2.4 MM STERILE; GUIDE WIRE PCL 2.4MM X10; GUIDE WR 1.2MM X 12 BOX OF 5 STERILE; GUIDEWIRE CANNFLEX 9 BLUNT TIP; Gelpi; Genesis Uni Knee System; Glenoid Holder; Graft Assist, Board; Graft Bar Drill; Graft Bar Holder; Graft Board Hook; Graft sizing tube; PCL two-tunnel template; Tensioning device; Graft preparation block; Graft, Base Lock; Graft, Suture Clamp; Graft, Tissue Clamp; Graftologer Tray; Guide; Guide wire 2mm, 15"", 7207222; Guide-TRAC; Guidewire 1.5mm x 229mm; Guidewire 2.4mm Drill Tip, guide wire, 12"", 7207221; Guidewire Aimer; Guidewire, Nitinol 1.2mm x 45cm; HALLU LOCK; HALLU-FIX; HALLU-LOCK; HALLU-REAM; HAMMER; HAMMER SLAP DILATOR SYSTEM; HANDLE MODULAR; HARMONY; HEALICOIL Knotless Drill, 4.75mm, 72205308; HEIDELBERG; HEWSON; HEX-FIX; HIGH VISIBILITY SHEATH 4 MM ABRADER BURR; HIGH VISIBILITY SHEATH 4 MM BARREL BURR; HIGH VISIBILITY SHEATH 4 MM FLAT TOP BURR; HIGH VISIBILITY SHEATH 5.5 MM ABRADER BURR; HIGH VISIBILITY SHEATH 5.5 MM BARREL BURR; HIGH VISIBILITY SHEATH 5.5 MM FLAT TOP BURR; HIP Tray; HUDSON DRILL; HUDSON REAMER; HUMERAL STAPLE; HYSTEROSCOPE SET STERILIZATION TRAY. INCLUDES SILICONE MAT, COVER, 12 POSTS, 12 TIE-DOWNS, POST REMOVAL TOO; HYSTEROSCOPE SET STERILIZATION TRAY. INCLUDES SILICONE MAT, COVER, 12 POSTS, 12 TIE-DOWNS, POST REMOVAL TOOL; Half Pin; Hammerhead Rotary Punch; Hammerhead Rotary Scissor; Handheld Instrument Sterilization Tray, Small; Hibbs; Hohmann; Hoke; Hook; I.CO.S.; I.CO.S. XL; ILIZAROV; ILIZAROV External Fixator; IMHS; INCISOR PLUS ELITE BL 4.5MM DSPL DYO PW; INCISOR PLUS ELITE BLADE 3.5MM DSPL DYO; INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX; INCISOR PLUS ELITE LONG 4.5MM; INLINE DRILL BIT 2.7 MM, SUITABLE FOR USE WITH BIORAPTOR 2.9 MM ANCHORS FOR SOFT BONE; INLINE DRILL BIT 2.9 MM, SUITABLE FOR USE WITH KINSA ANCHOR AND BIORAPTOR 2.9 MM ANCHORS; INTERFIT; INTERTAN; INTRAMEDULLARY HIP SCREW SYSTEM; INTRETAN MAX Hip Fracture Nail System; INVIS; IPP-ON; Image Guided Surgical Instruments for Hip Applications; Impactor; Insert Trials; Inserter Tip; Integra; Intermediate; Intramedullary Nailing System; JET-VAC; JET-X; JET-X Fixator; JET-X HALF PIN; JOURNEY; JOURNEY BCS and II Knee Systems; JOURNEY II CR Knee System; JOURNEY II Uni Knee System; JOURNEY II Unicompartmental Knee System; JOURNEY II XR Bi-Cruciate Retaining Knee System; JOURNEY KNEE SYSTEM; JOURNEY PFJ System; JOURNEY Uni Knee System; Jaws Great White Grasper; Jaws Retro Junior Grasper; Jaws Retro Toothed Grasper; Jaws Tigar Shark Grasper; Journey II Mid-Level Tibial Inserts; Journey II UK Knee System; K-WIRE; K-WIRES; K-wire; KFN; KIRSCHNER; KIRSCHNER WIRE; KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR; KIT AHTB RETRFIT HARDWARE WELL LEG HOLDR; KNEE FUSION NAIL; KNEE HOLDER; KNOT PUSHER XL; Knee Fusion Nail; LABELS FOR RING MODULE; LANDMARK Total Knee System; LARGE INSERTER DSP; LARGE QWIX; LARGE TENDON STRIPPER, CLOSED, 7.4 MM I.D. X 13.5 INCH WORKING LENGTH; LEGION; LEGION Finned Tib Wedge Sz 20mm Left; LEGION Finned Tib Wedge Sz2 10mm Left; LEGION Finned Tib Wedge Sz2 10mm Right; LEGION Finned Tib Wedge Sz2 15mm Left; LEGION Finned Tib Wedge Sz2 15mm Right; LEGION Finned Tib Wedge Sz2 20mm Left; LEGION Finned Tib Wedge Sz2 20mm Right; LEGION Finned Tib Wedge Sz3 10mm Left; LEGION Finned Tib Wedge Sz3 10mm Right; LEGION Finned Tib Wedge Sz3 15mm Left; LEGION Finned Tib Wedge Sz3 15mm Right; LEGION Finned Tib Wedge Sz3 20mm Right; LEGION Finned Tib Wedge Sz4 10mm Left; LEGION Finned Tib Wedge Sz4 10mm Right; LEGION Finned Tib Wedge Sz4 15mm Left; LEGION Finned Tib Wedge Sz4 15mm Right; LEGION Finned Tib Wedge Sz4 20mm Left; LEGION Finned Tib Wedge Sz4 20mm Right; LEGION Finned Tib Wedge Sz5 10mm Left; LEGION Finned Tib Wedge Sz5 10mm Right; LEGION Finned Tib Wedge Sz5 15mm Left; LEGION Finned Tib Wedge Sz5 15mm Right; LEGION Finned Tib Wedge Sz5 20mm Left; LEGION Finned Tib Wedge Sz5 20mm Right; LEGION Finned Tib Wedge Sz6 10mm Left; LEGION Finned Tib Wedge Sz6 10mm Right; LEGION Finned Tib Wedge Sz6 15mm Left; LEGION Finned Tib Wedge Sz6 15mm Right; LEGION Finned Tib Wedge Sz6 20mm Left; LEGION Finned Tib Wedge Sz6 20mm Right; LEGION Finned Tib Wedge Sz7 10mm Left; LEGION Finned Tib Wedge Sz7 10mm Right; LEGION Finned Tib Wedge Sz7 15mm Left; LEGION Finned Tib Wedge Sz7 15mm Right; LEGION Finned Tib Wedge Sz7 20mm Left; LEGION Finned Tib Wedge Sz7 20mm Right; LEGION Finned Tib Wedge Sz8 10mm Left; LEGION Finned Tib Wedge Sz8 10mm Right; LEGION Finned Tib Wedge Sz8 15mm Left; LEGION Finned Tib Wedge Sz8 15mm Right; LEGION Finned Tib Wedge Sz8 20mm Left; LEGION Finned Tib Wedge Sz8 20mm Right; LEGION INSERTS WITH JRNY LOCK; LEGION KNEE SYSTEM; LEGION Porous CR Narrow Femoral Components; LEGION Total Knee System; LINEAR INSTRUMENTS 15-UNIT STERILIZATION TRAY; LOCKING WRENCH; LOOP TIP GUIDEWIRE; Lane; Large Goniometer; Large QWIX; Large Sterilization Tray; Legion Hinge Total; Ligament Tunnel Drill; Lobster Claw Suture Retriever; Long Probe; MALLET WITH NYLON ENDS; MANUAL INSTRUMENT TRAY; MATRIX; MAVERICK External Fixation System; MAVERICK MINI; MAVERICK Mini External Fixation System; MAXI; MDF; MENISCAL ROOT REPAIR INSTRUMENTS PACK; META-NAIL; MIA; MINI-OPEN ARTHRO ASSIST LATARJET BB LID; MINI-OPEN ARTHRO ASSIST LATARJET BB TRAY; MIS HIP STEM; MOD; MOSAICPLASTY COMPLETE SYSTEM 19 INCH LENGTH X 9 INCH WIDTH X 2 INCH HEIGHT; MOTOR DRIVE UNIT HAND CNTRL PWRMX EL; MOTOR DRIVE UNIT NON-HAND CNTL PWRMX; MRI Phantom; MSS; MTO 12.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; MTO 2.6 FLUTED DR W/2.5 SHORT DEPTH STOP; MTO 5.5 MM FULL RADIUS SHAVER BLADES, 18 CM; MTO AWL-DIL TF ULTRA 5.5/6.5 CORTICAL; MTO AWL-DILATOR TF ULTRA 4.5 CORTICAL; MTO BLADE 4.5 SHARP INCISR PLUS DSPL DYO; MTO BLADE SYNOVATOR/INCISOR 4.5 DSPL DYO; MTO DRILL BIT CANNULATED AC JOINT 4.5; MTO GUIDE WIRE AC JOINT 2.4 MM; MTO GUIDEWIRE THREADED 1.5MM X 45CM; MTO TWINFIX ULTRA 5.5 FOR 5.5 CANNULA; MTO,4.5MM TURBOCUTTER II,(6/BX); MTO,SCRW DRVR,LOCKING, 2.5MM HEX, CANN; Mallet; Manta; Marlin; MegaMouth Grasper; Meniscal Lift; Meniscal Rasp; Metal Screw Driver Shaft; Modular Calcar Replacement; Modular Rail System; Multi-Sizing Block; N8TIVE ACL Curette; N8TIVE ACL Depth Gage; N8TIVE ACL Disposables Kit; N8TIVE ACL Femoral Drill; N8TIVE ACL Femoral Drill Guide Trocar; N8TIVE ACL Femoral Tamp; N8TIVE ACL Graft Sizing Block; N8TIVE ACL Implant Extractor; N8TIVE ACL Slotted Mallet; N8TIVE ACL Tamp Extender; N8TIVE ACL Tendon Harvester; N8TIVE ACL Tibial Button Impactor; N8TIVE ACL Tibial Dilator; N8TIVE ACL Tibial Drill; N8TIVE ACL Tibial Sheath Inserter; N8TIVE ACL Tibial Tamp; N8TIVE ACL Tunnel Rasp; NAVITRACK; NEER; NEER 3 SHOULDER SYSTEM; NEWDEAL; OPEN CURETTE 4.5MM XL; OPEN CURETTE 6MM REVERSE CUT XL; OPERA; OPTI-FIX; OR30; OR3O Dual Mobility Liners; OR3O Dual Mobility System; ORTHOMATCH; OSTEORAPTOR TWIST DRILL 2.45 MM; OVAL SIZING TUBE/DILATOR; OXINIUM; OXINIUM DH; OXINIUM FEMORAL HEAD; Other External Fixation; PANTA; PANTA NAIL; PASSING PIN DRILL TIP 2.7 MM X 15 INCH GRADUATIONS TO 180 MM; PASSING PIN, 3 MM, SPADE TIP; PATELLO-FEMORAL KNEE PROSTHESIS; PCL Guidewire, 7207284; PCL TWIN TUNNEL TEMPLATE; PERI-LOC; PERI-LOC PERIARTICULAR AND VARIABLE- ANGLE LOCKED PLATING (VLP) SYSTEMS; PERI-LOC PLATING SYSTEM; PERINEAL POST; PIN DRIVER FOR 7505 DRILL/REAMER; PLIERS, COMPACTION, 9mm; POLARCUP; POLARSTEM; POROUS PLUS; POWERMINI SMALL JOINT HANDPIECE WITH BLADE MULTI-POSITIONING, HAND CONTROLS, SUCTION LEVER, 10 FEET 3 M CORD.; POWERPULSE; PROFIX; PROFIX KNEE SYSTEM; PROFIX OXINIUM; PROMOS; Parham; Passing Pin Puller; Passing pin Spade tip 3mm, 72202814; Pediatric; Pin Cutter; Pin Puller; Piranha Arthroscopic Rongeur; Piranha Junior; Platform; Platinum Handpiece; Pliers; Pliers, Compaction, 9MM; Point to Elbow, ACL Arm; Point to Point, ACL Arm; Porous Patella and Porous Tibia Baseplate; PowerMax Elite, hand control; Power moter drive; Probe; QWIX; R3; R3 ANTEVERTED LINER TRAIL 36MM X 50MM +4; R3 ANTEVERTED LINER TRIAL 28MM X 44MM +4; R3 ANTEVERTED LINER TRIAL 28MM X 46MM +4; R3 ANTEVERTED LINER TRIAL 28MM X 48MM +4; R3 ANTEVERTED LINER TRIAL 28MM X 50MM +4; R3 ANTEVERTED LINER TRIAL 28MM X 52MM +4; R3 ANTEVERTED LINER TRIAL 28MM X 54MM +4; R3 ANTEVERTED LINER TRIAL 28MM X 56MM +4; R3 ANTEVERTED LINER TRIAL 28MM X 58MM +4; R3 ANTEVERTED LINER TRIAL 28MM X 60MM +4; R3 ANTEVERTED LINER TRIAL 32MM X 46MM +4; R3 ANTEVERTED LINER TRIAL 32MM X 48MM +4; R3 ANTEVERTED LINER TRIAL 32MM X 50MM +4; R3 ANTEVERTED LINER TRIAL 32MM X 52MM +4; R3 ANTEVERTED LINER TRIAL 32MM X 54MM +4; R3 ANTEVERTED LINER TRIAL 32MM X 56MM +4; R3 ANTEVERTED LINER TRIAL 32MM X 58MM +4; R3 ANTEVERTED LINER TRIAL 32MM X 60MM +4; R3 ANTEVERTED LINER TRIAL 32MM X 62MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 52MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 54MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 56MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 58MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 60MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 62MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 64MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 66-70MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 72-74MM +4; R3 ANTEVERTED LINER TRIAL 36MM X 76-80MM +4; R3 ANTEVERTED LINER TRIAL 40MM X 54MM +4; R3 ANTEVERTED LINER TRIAL 40MM X 56MM +4; R3 ANTEVERTED LINER TRIAL 40MM X 58MM +4; R3 ANTEVERTED LINER TRIAL 40MM X 60MM +4; R3 ANTEVERTED LINER TRIAL 40MM X 62MM +4; R3 ANTEVERTED LINER TRIAL 40MM X 64MM +4; R3 ANTEVERTED LINER TRIAL 40MM X 66-70MM +4; R3 ANTEVERTED LINER TRIAL 40MM X 72-74MM +4; R3 ANTEVERTED LINER TRIAL 40MM X 76-80MM +4; R3 ANTEVERTED LINER TRIAL 44MM X 60MM +4; R3 ANTEVERTED LINER TRIAL 44MM X 62M +4; R3 ANTEVERTED LINER TRIAL 44MM X 64MM +4; R3 ANTEVERTED LINER TRIAL 44MM X 66-70MM +4; R3 ANTEVERTED LINER TRIAL 44MM X 72-74MM +4; R3 ANTEVERTED LINER TRIAL 44MM X 76-80MM +4; R3 ANTEVERTED XLPE LINER 28MM X 44MM +4; R3 ANTEVERTED XLPE LINER 28MM X 46MM +4; R3 ANTEVERTED XLPE LINER 28MM X 48MM +4; R3 ANTEVERTED XLPE LINER 28MM X 50MM +4; R3 ANTEVERTED XLPE LINER 28MM X 52MM +4; R3 ANTEVERTED XLPE LINER 28MM X 54MM +4; R3 ANTEVERTED XLPE LINER 28MM X 56MM +4; R3 ANTEVERTED XLPE LINER 28MM X 58MM +4; R3 ANTEVERTED XLPE LINER 28MM X 60MM +4; R3 ANTEVERTED XLPE LINER 32MM X 46MM +4; R3 ANTEVERTED XLPE LINER 32MM X 48MM +4; R3 ANTEVERTED XLPE LINER 32MM X 50MM +4; R3 ANTEVERTED XLPE LINER 32MM X 52MM +4; R3 ANTEVERTED XLPE LINER 32MM X 54MM +4; R3 ANTEVERTED XLPE LINER 32MM X 56MM +4; R3 ANTEVERTED XLPE LINER 32MM X 58MM +4; R3 ANTEVERTED XLPE LINER 32MM X 60MM +4; R3 ANTEVERTED XLPE LINER 32MM X 62MM +4; R3 ANTEVERTED XLPE LINER 36MM X 50MM +4; R3 ANTEVERTED XLPE LINER 36MM X 52MM +4; R3 ANTEVERTED XLPE LINER 36MM X 54MM +4; R3 ANTEVERTED XLPE LINER 36MM X 56MM +4; R3 ANTEVERTED XLPE LINER 36MM X 58MM +4; R3 ANTEVERTED XLPE LINER 36MM X 60MM +4; R3 ANTEVERTED XLPE LINER 36MM X 62MM +4; R3 ANTEVERTED XLPE LINER 36MM X 64MM +4; R3 ANTEVERTED XLPE LINER 36MM X 66-70MM +4; R3 ANTEVERTED XLPE LINER 36MM X 72-74MM +4; R3 ANTEVERTED XLPE LINER 36MM X 76-80MM +4; R3 ANTEVERTED XLPE LINER 40MM X 54MM +4; R3 ANTEVERTED XLPE LINER 40MM X 56MM +4; R3 ANTEVERTED XLPE LINER 40MM X 58MM +4; R3 ANTEVERTED XLPE LINER 40MM X 60MM +4; R3 ANTEVERTED XLPE LINER 40MM X 62MM +4; R3 ANTEVERTED XLPE LINER 40MM X 64MM +4; R3 ANTEVERTED XLPE LINER 40MM X 66-70MM +4; R3 ANTEVERTED XLPE LINER 40MM X 72-74MM +4; R3 ANTEVERTED XLPE LINER 40MM X 76-80MM +4; R3 ANTEVERTED XLPE LINER 44MM X 60MM +4; R3 ANTEVERTED XLPE LINER 44MM X 62MM +4; R3 ANTEVERTED XLPE LINER 44MM X 64MM +4; R3 ANTEVERTED XLPE LINER 44MM X 66-70MM +4; R3 ANTEVERTED XLPE LINER 44MM X 72-74MM +4; R3 ANTEVERTED XLPE LINER 44MM X 76-80MM +4; R3 Acetabular System; R3 Large Head Liners; RADIAL HEAD PROSTHESIS; RAIL; RASP DOUBLE ENDED",1978-02-22,302,2026-09-08,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223007366790%22&limit=1
"Depuy Orthopaedics, Inc.",1818910,1818910,700 Orthopaedic DR.,Warsaw,IN,46582,United States,"DePuy Synthes, Inc.",1818910,Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,132,BWN; CGX; FSM; FTM; FTY; FXP; FXZ; FYA; FYE; FZO; FZX; FZY; GAD; GCX; GCY; GDH; GEG; GEN; GEY; GFA; GFJ; HAB; HAW; HNF; HRS; HRY; HSB; HSD; HSN; HSO; HST; HSX; HTC; HTD; HTF; HTJ; HTN; HTO; HTP; HTQ; HTR; HTT; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWE; HWJ; HWK; HWM; HWN; HWR; HWT; HWX; HXC; HXD; HXG; HXI; HXK; HXO; HXX; HXY; HXZ; HYA; JAC; JDB; JDC; JDI; JDJ; JDL; JDQ; JDW; JDY; JDZ; JEB; JEC; JOL; JWH; KCY; KIH; KIJ; KIK; KQW; KRO; KRR; KTT; KTZ; KWA; KWI; KWL; KWS; KWT; KWY; KWZ; KXH; KYJ; KYK; LLZ; LOD; LPH; LRN; LRY; LSA; LWJ; LXH; LYS; LYU; LZN; LZO; LZY; MBB; MBD; MBF; MBH; MDM; MEH; MRA; NJL; NPJ; NRA; OIY; OLO; OOG; OVO; PAO; PHX; PKC; QBO; QIH,"Table And Attachments, Operating-Room; Alkaline Picrate, Colorimetry, Creatinine; Tray, Surgical, Instrument; Mesh, Surgical; Tape, Measuring, Rulers And Calipers; Cover, Shoe, Operating-Room; Helmet, Surgical; Gown, Surgical; Dress, Surgical; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Gouge, Surgical, General & Plastic Surgery; Elevator, Surgical, General & Plastic Surgery; Forceps, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Mallet, Surgical, General & Plastic Surgery; Saw, Powered, And Accessories; Neurological Stereotaxic Instrument; Scissors, Ophthalmic; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Saw; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Pliers, Surgical; Forceps; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; File; Broach; Rasp; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Instrument, Compression; Driver, Prosthesis; Template; Tap, Bone; Wrench; Clamp; Tamp; Passer, Wire, Orthopedic; Holder, Needle; Orthopedic; Pusher, Socket; Screwdriver; Brace, Drill; Cutter, Wire; Forceps, Wire Holding; System, X-Ray, Film Marking, Radiographic; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Cerclage, Fixation; Pin, Fixation, Threaded; Evacuator, Vapor, Cement Monomer; Mixer, Cement, For Clinical Use; Table, Surgical With Orthopedic Accessories, Manual; Component, Traction, Invasive; Catheter And Tip, Suction; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Tourniquet, Pneumatic; Dispenser, Cement; Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment; Hook, Bone; Goniometer, Nonpowered; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Cradle, Patient, Radiologic; Prosthesis, Finger, Constrained, Polymer; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite; System, Image Processing, Radiological; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Wire, Surgical; Punch, Surgical; Vise, Bench, Surgical; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Bone Mill; Accessory, Surgical Apparel; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Bone Cement, Antibiotic; Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Instrument, Manual, Surgical, General Use; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Stereotaxic Instrument; Knee Arthroplasty Implantation System; Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Instruments Designed For Press-Fit Osteochondral Implants; Automated Radiological Image Processing Software",1; 2; 3,"ACCESSORY; ACE MARKIII ASSEMBLY; AMK (Knee); AMK (knee); AML ( hip); AML (hip); AML Hip; AML Hip Prosthesis; AML, Duraloc (hip); ARICULATED TENSION DEVICE SYNTHES TEN; ASphere (hip), M-Spec; ATTUNE Medial Stabilized Fixed Bearing Insert; ATTUNE Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP Technology; ATTUNE REV FB INSERT IMPACTOR; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 5; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 6; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 7; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 8; ATTUNE REVISION BOSS AND STEM ADAPTOR TRIAL EXTRACTOR; ATTUNE REVISION FEMORAL IM ADAPTOR; ATTUNE REVISION FEMORAL STRAIGHT STEM WRENCH; ATTUNE REVISION RP BASE TRIAL SIZE 10; ATTUNE REVISION RP BASE TRIAL SIZE 2; ATTUNE REVISION RP BASE TRIAL SIZE 3; ATTUNE REVISION RP BASE TRIAL SIZE 4; ATTUNE REVISION RP BASE TRIAL SIZE 5; ATTUNE REVISION RP BASE TRIAL SIZE 6; ATTUNE REVISION RP BASE TRIAL SIZE 7; ATTUNE REVISION RP BASE TRIAL SIZE 8; ATTUNE REVISION RP BASE TRIAL SIZE 9; ATTUNE REVISION RP CONICAL REAMER; ATTUNE REVISION RP INSERT TRIAL SIZE 3 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 8MM; ATTUNE REVISION RP STEM ADAPTOR TRIAL; ATTUNE REVISION SOLID RP INSERTS SIZE 3-4 CASE; ATTUNE REVISION SOLID RP INSERTS SIZE 5-6 CASE; ATTUNE REVISION SOLID RP INSERTS SIZE 7-8 CASE; ATTUNE REVISION TIBIAL BASE TRIAL EXTRACTOR; ATTUNE REVISION TIBIAL BROACH 29MM; ATTUNE REVISION TIBIAL BROACH 37MM; ATTUNE REVISION TIBIAL BROACH 45MM; ATTUNE REVISION TIBIAL BROACH 53MM; ATTUNE REVISION TIBIAL BROACH 61MM; ATTUNE REVISION TIBIAL BROACH 69MM; ATTUNE REVISION TIBIAL BROACH CADDY; ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - ATTUNE SLEEVE WEDGE; ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - BASE ATTACHMENT; ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - DRIVER; ATTUNE REVISION TIBIAL SLEEVE TRIAL 29MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 37MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 45MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 53MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 61MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 69MM; ATTUNE Revision CRS Rotating Platform Insert Size 3 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 8 mm; ATTUNE Revision Tibial Base Rotating Platform Size 10 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 2 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 3 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 4 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 5 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 6 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 7 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 8 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 9 Cemented; ATTUNE Revision Tibial Sleeve 29 mm Cemented; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 29 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 37 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 45 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 53 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 61 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 69 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 29 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 37 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 45 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 53 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 61 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 69 mm; ATTUNE® Revision Knee System; Accessories/Attachmnts to AC Powered Motors for Joint Recon; Acclaim; Acclaim (elbow); Actis (hip); Agility (Ankle); Agility (ankle); Alinity c Creatinine Reagent Kit (LN 07P9920, 07P9930); Allo-Grip; Alvine (ankle); Apex (hip); Arthropor, S-Rom (hip); Articul/eze (hip); Articuleze (hip); Attune; Attune (Knee); Attune (knee); Attune (knee), AOX; BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL; Bantam (hip), Endurance (hip), ERS (elbow), Synatomic (knee), Global (shoulder), Self-Centering (hip), ACS (hip); Bengal; Bone Punch, Tibial Punch, Femoral Punch, Acetabular Punch; Bone Screw; Bone Screw Nut; Brooker external fix frame; Burr, Orthopedic; C-Stem (hip); CAS; CAS (hip); CATHETER AND TIP; CEMENT; CEMENT MONOMER (MULTIPLE BRANDS); CHARNLEY TROCHANTER HOLDERS; CI (hip); COMplete Acetabular Hip System; CORAIL HIP (LANDANGER); CREATININE (LN 3L81-22, 3L81-32, 3L81-23, 3L81-33); CUPTIMIZE™ Advanced; Caliper Instruments (Joint Recon); Cathcart (hip), Articul/eze; Cement Restrictor; Change in pkg of UHMWPE components for Multicup, Ogee, cement restrictor, AMK poly tib & patella & tib insert, Synatomic; Charnley; Clamp for Joint Recon; Concorde; Contour knee; Control Cable; Coordinate (knee); DELTA XTEND Reverse Shoulder System; Darwin (knee), PFC Sigma; Darwin (knee), TC3, PFC Sigma; DePuy GLOBAL UNITE Platform Shoulder System; DePuy GLOBAL UNITE Shoulder System; Delta (Shoulder); Delta (hip); Delta (shoulder); Delta Xtend (shoulder); Duraloc (hip); Duraloc (hip), Enduron; Duraloc (hip), Marathon; Duraloc (hip), Solution; Duraloc (hip), Solution, Sector, Profile, Bantam; EVACUATOR; Endurance (hip); Enduron, Hylamer; Expedium; F2, Fenning (hip); FOOTSWITCH; FOR CLINICAL USE (MULTIPLE BRANDS); Fixator; Focus (hip); General Accessories; Global (Shoulder); Global (shoulder); Global Advantage; Global Advantage (shoulder); Global Advantage Shoulder; Global FX Shoulder; Global Shoulder; Global Unite (shoulder); Global Unite Platform Shoulder System Short Stem; Gouge instrumnts for Joint Recon; Gription (hip); Guide, Surgical, Instrument; HELMET; HOLDER, NEEDLE; Hi-Marc; Hip Screw; Hip ball; IM Nail; IM Rod; INHANCE Shoulder System; Impactor Instruments (Joint Recon); Instrument Retractors; Instrument file for Joint Recon; Joing Recon Forceps, Wire Holding; Joint Ortho Tamp Instrument; Joint Recon Awl instruments; Joint Recon Bone Hook Instrument; Joint Recon Curettes; Joint Recon Cutting Instrument; Joint Recon Hammers; Joint Recon Mallet instruments; Joint Recon Passer Wire; Joint Recon Surgical instrument motors and accessories/attachments; Joint Recon instrument -chisel, surgical, manual; Joint Reconstruction wire cutters; JointPoint; Kamvac Suction; Kar (hip); Kyle captured Screw; LCS Complete; LCS Uni (knee); LCS, New Jersey Total Knee; LOW PROFILE HALO VEST ASSEMBLY; LPS; LPS (Limb Preservation System); LPS Metaphyseal Sleeve; LPS, Orthogenesis; LPS, Universal (knee); Lere; Life Liner; Life Liners; M-Spec (Hip); METAPHYSEAL SLEEVES (Knee- PFC, SIGMA, S-ROM, LPS, LPS); MIXER; Marathon (hip), Duraloc; Microlock (knee), PFC; Mitek ELEVATOR; Neuflex (finger); Noiles (knee); OPERATING-ROOM (MULTIPLE BRANDS); OR table attachments; OR vacuum apparatus; ORTHOPAEDIC TRACTION ACCESSORY; Orthopaedic DRILL; Orthopaedic EXTRACTOR; Orthopaedic GUIDE; Orthopaedic REAMER; Orthopaedic TAP; PFC  SIGMA KNEE SYSTEM; PFC (Knee); PFC (hip); PFC (knee); PFC Knee; PFC MODULAR PLUS OFFSET TIBIAL TRAY; PFC Modular Total Knee System; PFC SIGMA POROUS MODULAR KEEL TIBIAL TRAY; PFC Sigma (knee); PFC Sigma (knee), Darwin; PFC Sigma Patella; PINNACLE ALTRX (Hip); PINNACLE DUOFIX® Acetabular Cup; PINNACLE Dual Mobility; PNEUMATIC (MULTIPLE BRANDS); POWER CONSOLE; PUSHER; Pilon Plate; Pinnacle; Pinnacle (hip); Pinnacle AltrX; Pinnacle Hip; Pinnacle Liner - Hip; Pinnacle, Gription (hip); Pinnacle, Marathon (hip); Prism (Mixing Bowl); Prodigy (hip); Profile; Profile (hip); Prostalac (hip); Protrusio; Punch, Surgical; RASP; Rasp for Joint Recon; Reclaim (hip); Repel; Repel Gloves; Restore; Rongeur for Joint Recon; Rongeur surgical instrument; S Rom (hip); S Rom, Noiles (knee); S-ROM; S-ROM Hip System; S-ROM NOILES PS TOTAL KNEE SYSTEM (ALL POLYETHYLENE); S-Rom (hip); S-Rom (hip), Articul/eze, M-Spec; S-Rom Proximal Sleeves -Hip; S-Rom, Delta (hip); S-Rom, Noiles (knee); SAW; SHOE; SIGMA HIGH PERFORMANCE PARTIAL KNEE SYSTEM [GCK]; SIGMA KNEE PROSTHESIS; SOCKET; SOLUTION SYSTEM HIP PROSTHESIS; SURGICAL APPAREL (MULTIPLE BRANDS); Screwdrivers for Joint Recon; Self-Centering Hip; Sigma (knee); Sigma (knee), Bannister, Darwin; Sigma High Performance (Knee); Sigma PS 150; Sigma, Bannister (knee); Sm. IM Rod; Smartset (bone cement); Solution System Hip Prosthesis; Sterile View; Sterilization change for: AMK (knee), AML (hip), Preservation (knee), Enduron (hip), Hylamer (knee), Duraloc (hip),; Strickland; Summit (hip); Summit DuoFix Hip Prosthesis; Summit Duofix (hip); Summit FX (hip); Summit Hip System; Summit, Titan (hip); Synatomic (knee); Synatonic (knee); TELIGEN; TRUMATCH Personalized Solutions; Trephine; Tri-Lock (hip); Tri-Lock, BPS (hip); Triflange (hip); TruMatch (instruments); Ultima (hip); VACU-MIX PUMP; VAPOR; VARIOUS TYPES OF HAMMERS; Viper; Viper Prime; Vision (hip) AML; Vision, Solution (hip); WILLIAMS GAUGES; WILLIAMS MICROSURGERY SAW; Wire Cable (joints); X-Ray Cushion; ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP; blade; bone screw; broach, wire cutter, prosthesis driver, extractor, file, femoral neck punch, reamer, screwdriver, tamp wrench, etc.; cannulated bone screw; chisel, instrument guide, hammer, mallet, osteotome, rasp, retractor, saw, calipers; compression instrument for Joint Recon; drill instrument; forcep instrument; forearm nail; guides; instrument tray, instrument case; intermedullary nail; joint recon Goniometers, nonpowered; measuring; power; rasp instrument; reamer instrument; saw; spine instrument; stem (hip); surgical instrument; surgical instrument motor; suture washer; tape, measuring, rulers and calipers for Joint Recon; templates; threaded screw; traction; traction pin; various broach instruments; various cement dispensers; various general plier instruments; various osteotome general instruments; various prosthesis drivers; wire tension clamp; wrenches for Joint Recon; x ray positioner",1977-12-22,295,2026-06-25,5,86,2,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221818910%22&limit=1
Boston Scientific Corporation,1000121056,1000121056,8 Industrial Dr,Coventry,RI,02816,United States,Boston Scientific Corporation,9912058,Manufacturer; Manufacturer for export; Specification developer,127,BTG; DQO; DQX; DQY; DRA; DRE; DRF; DSA; DTL; DXF; DXO; DYB; EOQ; ESW; EZB; EZN; FAD; FAE; FAJ; FBK; FBN; FCG; FCL; FDF; FDI; FDT; FDX; FED; FEQ; FET; FFA; FFK; FFL; FFY; FGA; FGB; FGE; FGX; FQH; GBM; GBO; GBZ; GCA; GCB; GCC; GCJ; GEI; GEX; GXI; IKD; IWP; JCT; KDQ; KGZ; KNQ; KNS; KNT; KOD; KOE; KQM; KQT; KRA; KRD; KTI; KYZ; LIT; LJE; LOX; LPB; LQC; LQR; LWS; LZC; MAF; MAV; MCW; MCX; MDM; MIR; MJN; MQR; MUM; NGV; NIN; NIO; NIP; NIQ; NIU; NJE; NTE; NTN; NVY; NWT; NWX; OAD; OAE; OCW; OCX; OCY; ODC; ODD; ODG; OFK; OHD; ONU; OTM; OTN; OTO; PAH; PCU; PID; PIF; PKL; PNB; PPN; PTL; PTM; PTS; PWI; PWJ; QAN; QEW; QEY; QEZ; QKJ; QTD; QZI,"Brush, Biopsy, Bronchoscope (Non-Rigid); Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Dilator, Vessel, For Percutaneous Catheterization; Catheter, Electrode Recording, Or Probe, Electrode Recording; Cable, Transducer And Electrode, Patient, (Including Connector); Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Catheter, Septostomy; Transducer, Pressure, Catheter Tip; Introducer, Catheter; Bronchoscope (Flexible Or Rigid); Prosthesis, Esophageal; Stylet For Catheter, Gastro-Urology; Dilator, Catheter, Ureteral; Stent, Ureteral; Prosthesis, Penile; Cystoscope And Accessories, Flexible/Rigid; Endoscopic Injection Needle, Gastroenterology-Urology; Choledochoscope And Accessories, Flexible/Rigid; Biopsy Needle; Forceps, Biopsy, Non-Electric; Colonoscope And Accessories, Flexible/Rigid; Snare, Flexible; Duodenoscope And Accessories, Flexible/Rigid; Endoscopic Cytology Brush; Endoscopic Access Overtube, Gastroenterology-Urology; Pump, Air, Non-Manual, For Endoscope; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Tube, Drainage, Suprapubic; Lithotriptor, Electro-Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Adaptor, Bulbs, Miscellaneous, For Endoscope; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Stents, Drains And Dilators For The Biliary Ducts; Snare, Non-Electrical; Lavage, Jet; Catheter, Urethral; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Cholangiography; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Needle, Catheter; Dilator, Catheter; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Probe, Radiofrequency Lesion; Cable, Electrode; Radiographic Protective Glove; Prosthesis, Tracheal, Expandable; Bottle, Collection, Vacuum; Accessories, Catheter; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Catheter, Urological; Dilator, Urethral; Camera, Surgical And Accessories; Evacuator, Gastro-Urology; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Catheter, Angioplasty, Peripheral, Transluminal; Catheter, Nephrostomy; Catheters, Transluminal Coronary Angioplasty, Percutaneous; Cardiac Ablation Percutaneous Catheter; Lithotriptor, Biliary Mechanical; Dislodger, Stone, Biliary; Implantable Cardioverter Defibrillator (Non-Crt); Medical Glove, Specialty; Stent, Coronary; Syringe, Balloon Inflation; Catheter, Peripheral, Atherectomy; Catheter, Coronary, Atherectomy; Instrument, Manual, Surgical, General Use; Shunt, Portosystemic, Endoprosthesis; Catheter, Intravascular Occluding, Temporary; Stent, Colonic, Metallic, Expandable; Stent, Metallic, Expandable, Duodenal; System, Appendage Closure, Left Atrial; Stent, Renal; Stent, Iliac; Stent, Superficial Femoral Artery; Coronary Drug-Eluting Stent; Stent, Superficial Femoral Artery, Drug-Eluting; Intracranial Neurovascular Stent; Temporary Carotid Catheter For Embolic Capture; Led Light Source; Permanent Defibrillator Electrodes; Endoscopic Cholangiogram Kit; Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation; Endoscopic Tissue Approximation Device; Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscope Channel Accessory; Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula; Endoscopic Ultrasound System, Gastroenterology-Urology; Percutaneous Atrial Catheter Kit; Gynecological Laparoscopic Kit; Drug-Eluting Peripheral Transluminal Angioplasty Catheter; Mesh, Surgical, For Stress Urinary Incontinence, Male; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator; Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling; Pancreatic Stent, Covered, Metallic, Removable; Esophageal Dilator Balloon With Or Without Electrode Sensors; Gastrointestinal Tubes With Enteral Specific Connectors; Hemostatic Metal Clip For The Gi Tract; Biliary Stent System For Benign Strictures; Percutaneous Catheter, Ultrasound; Wire, Guide, Catheter, Exempt; Syringe, Balloon Inflation, Exempt; Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt; Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse; Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence; Stent, Iliac Vein; Peripheral Mechanical Thrombectomy With Aspiration; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter; Stent, Central Venous; Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",1; 2; 3; U; f,"AngioJet Spiroflex Thrombecotmy Set; AngioJet Spiroflex VG Thrombectomy Set; AngioJet Ultra 5000A Console; AutoElite Thrombectomy System Console; Blazer II HTD Temperature Ablation Catheter; Blazer II Temperature Ablation Catheter; Blazer II XP Temperature Ablation Catheter; Blazer Open-Irrigated Ablation Catheter; Blazer Prime HTD Temperature Ablation Catheter; Blazer Prime XP Temperature Ablation Catheter; Blazer Solid-Tip Ablation Cather Cable, Sterile Cable; Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable; Cable IntellaTip MiFi OI to Maestro 4000; Cable IntellaTip MiFi XP Sterile Cable; Cable, IntellaNav Ablation Catheter; Cable, IntellaTip MiFi OI; Cable, Maestro 4000; Connector Tools; ELUVIA Drug-Eluting Vascular Stent System; ENDOTAK RELIANCE; ENDOTAK RELIANCE G; ENDOTAK RELIANCE S; ENDOTAK RELIANCE SG; Electrophysiology Cable Non-Sterile Cable; Electrophysiology Cable Sterile Cable; Emerge PTCA Dilatation Catheter; Emerge Push PTCA Dilatation Catheter; Endovive Securi-T Percutaneous Replacement Gastrostomy Tube; Epic Vascular Self-Expanding Stent System; Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter; Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit; Express SD Renal/Biliary Premounted Stent System; FARAPOINT Pulsed Field Ablation Catheter; FARASTAR AAMI Recoding System Module ECG Output Module; FARASTAR AAMI Recording System Module ECG Trunk Cable; FARASTAR AAMI Snap Cable R/L; FARASTAR AAMI Snap Cable V Set; FARASTAR Cable Set; FARASTAR Catheter Connection Cable; FARASTAR EGM Cable; FARASTAR EGM to EP Recording System Cable (FARAPOINT); FARASTAR Gen 2 Catheter Connection Cable; FARASTAR IEC Recording System Module ECG Output Module; FARASTAR IEC Recording System Module ECG Trunk Cable; FARASTAR IEC Snap Cable C Set; FARASTAR IEC Snap Cable R/L; FARASTAR Inter-Connection Box; FARASTAR Mapping System Module; FARASTAR Mapping System Module ABL Output to Signal Station ABL Input Cable FARASTAR to OPAL HDx; FARASTAR Mapping System Module Auxiliary Cable; FARASTAR Mapping System Module BNC-Phono Cable; FARASTAR Mapping System Module Back Patch Cable; FARASTAR Mapping System Module Back Patch Cable Male; FARASTAR Pulsed Field Ablation Generator; FARASTAR Recording System Module; FARASTAR Recording System Module Catheter Pin Cable; FARASTAR Recording System Module ECG Output to Signal Station ECG Input Cable FARASTAR to OPAL HDx; FARASTAR Recording System Module EGM Input Module; FARASTAR Recording System Module EGM Output to Singal Station EGM Input Cable FARASTAR to OPAL HDx; FARASTAR Stimulation Module Cable; FARASTAR Stimulation Module Female Cable; FARASTAR Stimulation Module Male Cable; FARASTAR Stimulation Module Y-Cable Long; FARASTAR Stimulation Module Y-Cable Short; FARAWAVE Nav Pulsed Field Ablation Catheter; FARAWAVE Pulsed Field Ablation Catheter; Flexima Nephrostomy Catheter System; Flexima Nephrostomy Catheter System Kit; Flexima Nephrostomy Catheter System Kit with Dissolving Tip; Flexima Nephrostomy Catheter System with Dissolving Tip; Flextome Cutting Balloon Microsurgical Dilatation Device; Gateway PTA Dilatation Catheter; INTELLAGEN Catheter Adapter Cable 0.3 Meter; INTELLAGEN ECG Connection Cable 3 Meter; INTELLAGEN Foot Pedal; INTELLAGEN Foot Pedal Extension Cable 7 Meter; INTELLAGEN Grounding Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 1 Meter; INTELLAGEN Irrigation Pump Connection Cable 10 Meter; INTELLAGEN Irrigation Pump Connection Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 5 Meter; INTELLAGEN Irrigation Pump Kit; INTELLAGEN RF Generator Kit; INTELLAGEN Remote Control Connection Cable 10 Meter; INTELLAGEN Remote Control Connection Cable 15 Meter; INTELLAGEN Remote Control Connection Cable 25 Meter; INTELLAGEN Remote Control Connection Cable 30 Meter; INTELLAGEN Remote Control Kit; INTELLAGEN Serial Communication Cable 15 Meter; INTELLAGEN Serial Communication Cable 3 Meter; INTELLAGEN Serial Communication Cable 5 Meter; INTELLAGEN Tubing Set; Innova Vascular Self-Expanding Stent System; IntellaNav MiFi Open-Irrigated Ablation Catheter; IntellaNav MiFi XP Temperature Ablation Catheter; IntellaNav Open-Irrigated Ablation Catheter; IntellaNav ST Ablation Catheter; IntellaNav StablePoint Ablation Catheter; IntellaNav StablePoint Catheter Cable; IntellaNav XP Temperature Ablation Catheter; IntellaTip MiFi Filter Module RF Frequency Filter; IntellaTip MiFi Open-Irrigated Ablation Catheter; IntellaTip MiFi Reference Cable Non-Sterile Electrophysiology Cable; IntellaTip MiFi XP Temperature Ablation Catheter; JINRO Pigtail Nephrostomy Catheter; JINRO Pigtail Nephrostomy Catheter Kit; JINRO Pigtail Nephrostomy Catheter Placement Kit; Lead Adapter; Lead Cap Kit; Lead Pulling Tip; Lead Repair Kit; Lead Stylets; Maestro 4000 Controller, RF Cardiac Ablation Controller; Maestro 4000 Pod, 100W, RF Cardiac Ablation Pod, 100W; Maestro 4000 RF Cardiac Ablation Controller; Maestro 4000 RF Cardiac Ablation Pod 100; Maestro 4000 Remote Control; Maestro Foot Switch; Maestro Remote Control Cable; Malecot Nephrostomy Catheter Set; MetriQ Foot Switch; MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set; MetriQ Pump Irrigation Pump; NC Emerge PTCA Dilatation Catheter; NaviGuide Percutaneous Access Needle; Non-Sterile Cable; Non-Sterile Cable (Controller to Pump or Remote Control); OPAL HDx Connection Box - MAESTRO; OPAL HDx Connection Box - MAESTRO STABLEPOINT; OPAL HDx Connection Box INTELLAGEN; OPAL HDx Connection Box INTELLAGEN STABLEPOINT; POLARx Cryoablation Balloon Catheter; POLARx FIT Cryoablation Balloon Catheter; Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip; Percuflex Locking Loop Nephrostomy Catheter; Percuflex Locking Loop Nephrostomy Catheter with Fader Tip; Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit; Percutaneous Access Needle; Percutaneous Access Needle with Echogenic Tip; Percutaneous Access Set; Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System; REBEL Platinum Chromium Coronary Stent System; RELIANCE 4-FRONT Defibrillation Lead; RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint; ROTAPRO Advancer Burr Advancing Device; ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; ROTAPRO Rotational Atherectomy System Console Kit; ROTAWIRE Drive and wireClip Torquer Extra Support; ROTAWIRE Drive and wireClip Torquer Floppy; Ranger Paclitaxel-Coated PTA Balloon Catheter; Re-entry Malecot Nephrostomy Catheter Set; Rhythmia HDx Ablation Connection Box; Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN; Rhythmia HDx Ablation Connection Box - for INTELLAGEN; Rhythmia HDx Ablation Connection Box Maestro; Rhythmia Mapping System IntellaNav CB - Maestro; RotaLink Advancer Catheter Advancing Device; RotaLink Burr Exchangeable Burr Catheter; RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; RotaWire and wireClip Torquer Extra Support; RotaWire and wireClip Torquer Floppy; Rotablator Dynaglide Foot Pedal; Rotablator Rotational Atherectomy System Console Kit; Rotaglide Lubricant; SMARTFREEZE Catheter Extension Cable; SMARTFREEZE Cryo-Cable; SMARTFREEZE Cryo-Console; SMARTFREEZE Cryo-Console Foot Switch; SMARTFREEZE Diaphragm Movement Sensor; SMARTFREEZE Inter-Connection Box; SMARTFREEZE Remote Control; SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System; Suture Sleeve Accessory; TLA Introducer Needle and Sheath Set; Trapezoid RX Wireguided Retrieval Basket; VENOUS WALLSTENT Self-Expanding Stent; VTC Nephrostomy Catheters System; VTC Nephrostomy Catheters System Kit; WALLSTENT Endoprosthesis Self-Expanding Stent; WALLSTENT RP Endoprosthesis Self-Expanding Stent; WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device; wireClip Torquer",1983-09-09,270,2026-09-03,21,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221000121056%22&limit=1
Siemens Healthineers AG,3004977335,3004977335,SIEMENSSTRASSE 1 -OR- Rittigfeld 1,FORCHHEIM Bavaria,,91301,Germany,Siemens Healthineers AG,8010024,Complaint file establishment; Contract manufacturer; Exporter to the US; Manufacturer; Specification developer,45,CCK; DQA; DQK; DRQ; DRT; DSI; DSJ; DSK; DXN; EGZ; FLL; ITY; IXA; IXR; IYO; IZH; IZI; IZL; IZO; IZZ; JAA; JAK; KGI; KPR; KRB; LHN; LLZ; LMC; LNH; LNS; MHX; MLD; MOS; MQB; MUA; MUE; MUJ; NWE; OEB; OMV; OTE; OWB; OXO; QAS; QIH,"Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Oximeter; Computer, Diagnostic, Programmable; Amplifier And Signal Conditioner, Transducer Signal; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Detector And Alarm, Arrhythmia; Alarm, Blood-Pressure; Computer, Blood-Pressure; System, Measurement, Blood-Pressure, Non-Invasive; Holder, Film, X-Ray; Continuous Measurement Thermometer; Assembly, Tube Housing, X-Ray, Diagnostic; Cassette, Radiographic Film; Table, Radiographic, Tilting; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Mammographic; System, X-Ray, Angiographic; System, X-Ray, Mobile; Generator, High-Voltage, X-Ray, Diagnostic; Table, Radiographic, Non-Tilting, Powered; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Tomography, Computed; Densitometer, Bone; System, X-Ray, Stationary; Probe, Thermodilution; System, Radiation Therapy, Charged-Particle, Medical; System, Image Processing, Radiological; Camera, Multi Format, Radiological; System, Nuclear Magnetic Resonance Imaging; Lithotriptor, Extracorporeal Shock-Wave, Urological; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Monitor, St Segment With Alarm; Coil, Magnetic Resonance, Specialty; Solid State X-Ray Imager (Flat Panel/Digital Imager); Bone Sonometer; Full Field Digital, System, X-Ray, Mammographic; System, Planning, Radiation Therapy Treatment; Colon Computed Tomography System, Computer Aided Detection; Lung Computed Tomography System, Computer-Aided Detection; Ultrasonic Body Composition Analyzer; Digital Breast Tomosynthesis; Interventional Fluoroscopic X-Ray System; Image-Intensified Fluoroscopic X-Ray System, Mobile; Radiological Computer-Assisted Triage And Notification Software; Automated Radiological Image Processing Software",1; 2; 3,"3D CT Reconstruction Software; 3D-ANGIO; ADMIRE; ADMIRE Quantitative Dose Reduction; AI Rad Companion (Musculoskeletal); AI-Rad Companion (Cardiovascular); AI-Rad Companion (Engine); AI-Rad Companion (Pulmonary); ANZAI AZ-733 RESPIRATORY GATING SYSTEM; ARCADIS ORBIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE); ARTIS Q MODULAR ANGIOGRAPHIC SYSTEM; ARTIS Q.ZEN MODULAR ANGIOGRAPHIC SYSTEM; ARTIS ZEE / ZEEGO WITH SW VC14; ARTIS ZEE AND ZEEGO; ARTIS ZEE/ZEEGO SW VC21 (with CARE claims); ARTIS genio floor (VE50B); ARTIS icono (VE2); ARTIS icono (VE2) System; ARTIS icono (VE21); ARTIS icono (VE23); ARTIS icono (VE30A); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS icono (VE40A) (floor); ARTIS icono Biplane (VE50B); ARTIS icono Ceiling (VE50B); ARTIS icono Floor (VE50B); ARTIS icono.explore floor (VE50B); ARTIS one Edition X; ARTIS pheno; ARTIS pheno (VE2); ARTIS pheno (VE21); ARTIS pheno (VE30A); ARTIS pheno (VE40A); ARTIS pheno (VE50B); AX WORKSTATION DR-VIEWER SOFTWARE OPTION; AX Workstation; AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM); AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM; AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM; AXIOM LUMINOS DRF; AXIOM SIRESKOP SD; AZ-733 Respiratory Gatinn System; AZ-733VI Respiratory Gating System; Additional Pixium 2430 EZ-C; Additional Pixium 3543 EZ-C; Admire; Angiolux Family; Arcadis Avantic; Arcadis Varic; ArtPix Mobile EZ2GO; Artis; Artis One; Artis One Angiographic System; Artis Q and Artis Q.zen; Artis zee / zeego; Artis zee with CSX 10 Detector VC21; Artis zeego with CSX 10 Detector VC21; Athlon Family; CALCIUM SCORING; CHRONON Family; CIARTIC Move (VB10); COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY; Cios Alpha; Cios Alpha (SW VA30); Cios Alpha (VA30G); Cios Alpha VA10; Cios Alpha VA20; Cios Connect; Cios Flow; Cios Fusion; Cios Spin; Cios Spin (VA30); Cios Spin (VA30G); Cios Spin (VA31A); DIGITAL IMAGING SYSTEM (BSR); DURA Family; Drystar AXYS; Dyna CT; EchoS Family; EchoSK and EchoSGyn modules for EchoS Family devices; Extended Field of View (FoV) Software Package; FAST DE Results for Twin Beam Data post processing application; FAST DE Results for Twin Beam Data post processing application for Definition AS/AS+; FAST DE Results for Twin Beam Data post processing application for Definition Edge; FLUOROSPOT COMPACT; Gigalix Family; IN SPACE 3D; INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY; Insight BD; Inspace 4D; KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7); Kenex Mobile Cassett Holder; LEONARDO SYNGO CARDIOLOGY WORKSTATION; LITHOSKOP; LUMINOS Q.namix R; LUMINOS Q.namix T; LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY; Lithotriptor; Low Dose Lung Cancer Screening; Low Dose Lung Cancer Screening for Siemens Computed Tomography (CT) Systems.; Luminos Agile; Luminos Agile (Max); Luminos Agile Max; Luminos Lotus Max; Luminos dRF Max; LungCARE CT software package; MAMMOMAT 300 AND MAMMOMAT 3000; MAMMOMAT B.brilliant; MAMMOMAT B.brilliant with Tomosynthesis Option; MAMMOMAT INSPIRATION; MAMMOMAT INSPIRATION PRIME; MAMMOMAT Revelation; MAMMOMAT Revelation (VC20); MAMMOREPORT SOFTCOPY WORKSTATION; MAMMOVISTA B.smart; MAMMOVISTA B.smart VB70; MOBILETT Elara Max (SW VF10); MOBILETTE XP AND MOBILETT XPHYBRID; MODIFICATION TO SYNGO INSPACE 4D; MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS; MODULARIS VARIOSTAR; MODULTH SLK; MR VB10 software upgrade; MULTIX Impact; MULTIX Impact C; MULTIX Impact E; MULTIX Impact E VB20; MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE; Mammomat Fusion; Mammomat Fusion with Stereotactic Biopsy; Mammomat Inspiration with Tomosynthesis option; Mammomat Revelation with Tomosynthesis option; Megalix Cat Family; Megalix Cat Plus Family; Megalix Family; Mindray Patient Monitoring System; Mobilett Impact; Mobilett Mira; Mobilett Mira Max; Multitom Rax; Multitom Rax with True2scale Body Scan Option; Multix Fusion; Multix Fusion Max; Multix Fusion Max w/SW VF10; Multix Fusion VA30 and VA40; NAEOTOM Alpha with SOMARIS/10 syngo CT VB10; NAEOTOM Alpha with SOMARIS/10 syngo CT VB20; NAEOTOM Alpha, Scan&GO with SOMARIS/10 syngo CT VA40; NAEOTOM Alpha, Scan&GO with SOMARIS/10 syngo CT VA50; NAEOTOM Alpha.Peak with SOMARIS/10 syngo CT VB20; NAEOTOM Alpha.Prime with SOMARIS/10 syngo CT VB20; NAEOTOM Alpha.Prime with SW SOMARIS/10 syngo CT VB20; NAEOTOM Alpha.Pro with SOMARIS/10 syngo CT VB20; NAEOTOM Alpha.Pro with SW SOMARIS/10 syngo CT VB20; NAEOTOM Alpha/NAEOTOM Alpha.Peak with SW SOMARIS/10 syngo CT VB20; NEWCOR; OPDIMA; OPTIPHOS Family; OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS; Opti Family; Optilix Family; Optitop Family; P40 MoW-100G; PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE; POLYSTAR; Pie Medical CAAS Workstation; Polydoros A100 Family; Polydoros ACX; Polydoros F / Polydoros R Family; Polydoros RF Family; Polydoros RFX; Pulmo CT with Reference Database for the SOMATOM Plus and Plus 4; RAY Family; S3P-Monoblock; SAFIRE; SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS; SIREMOBILE C06; SIREPHOS Family; SMB Family; SOMATOM CARE CONTRAST CT; SOMATOM CT Systems with VC50 SW - SOMATOM Perspective, SOMATOM Scope/Scope Power and SOMATOM Emotion 16; SOMATOM Confidence with SOMARIS/7 syngo CT VB20; SOMATOM Confidence with SOMARIS/7 syngo CT VB30; SOMATOM Confidence® RT Pro; SOMATOM DEFINITION; SOMATOM DEFINITION EDGE; SOMATOM DEFINITION FLASH; SOMATOM DEFINITION, MODEL AS/AS+; SOMATOM Definition AS Open; SOMATOM Definition AS Open VA48; SOMATOM Definition AS Open with SOMARIS/7 syngo CT VB20; SOMATOM Definition AS Open with SOMARIS/7 syngo CT VB30; SOMATOM Definition AS/AS+; SOMATOM Definition AS/AS+ with SOMARIS/7 syngo CT VB20; SOMATOM Definition AS/AS+ with SOMARIS/7 syngo CT VB30; SOMATOM Definition Confidence; SOMATOM Definition Edge; SOMATOM Definition Edge VA48 software; SOMATOM Definition Edge with SOMARIS/7 syngo CT VB20; SOMATOM Definition Edge with SOMARIS/7 syngo CT VB30; SOMATOM Definition Edge, SOMATOM Definition AS/AS+; SOMATOM Definition Flash; SOMATOM Definition Flash with SOMARIS/7 VA48; SOMATOM Definition Flash with SOMARIS/7 syngo CT VB20; SOMATOM Definition Flash with SOMARIS/7 syngo CT VB30; SOMATOM Definition Flash with Stellar Detector; SOMATOM Drive; SOMATOM Drive with SOMARIS/7 syngo CT VB20; SOMATOM Drive with SOMARIS/7 syngo CT VB30; SOMATOM Edge Plus; SOMATOM Edge Plus with SOMARIS/7 syngo CT VB20; SOMATOM Edge Plus with SOMARIS/7 syngo CT VB30; SOMATOM Emotion 16; SOMATOM Emotion 6; SOMATOM Flash DS; SOMATOM Force; SOMATOM Force with SOMARIS/7 syngo CT VB20; SOMATOM Force with SOMARIS/7 syngo CT VB30; SOMATOM On.site with software version SOMARIS/10 syngo CT VB10; SOMATOM P30 CT SYSTEMS ( Emotion MS- multislice); SOMATOM P45; SOMATOM P47; SOMATOM Perspective; SOMATOM Perspective (with syngo® CT VC30-easyIQ version); SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10; SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB20; SOMATOM Project P68; SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE; SOMATOM RESPIRATORY GATING; SOMATOM SENSATION 64 AND SENSATION CARDIAC; SOMATOM Scope (with syngo® CT VC30-  easyIQ version); SOMATOM Scope Power (with syngo® CT VC30-easyIQ version); SOMATOM X.ceed; SOMATOM X.ceed with SOMARIS/10 syngo CT VA40; SOMATOM X.ceed with SOMARIS/10 syngo CT VB10; SOMATOM X.cite; SOMATOM X.cite with SOMARIS/10 syngo CT VA 30; SOMATOM X.cite with SOMARIS/10 syngo CT VA40; SOMATOM X.cite with SOMARIS/10 syngo CT VB10; SOMATOM X.cite, with SOMARIS/10 syngo CT VA30 (Update); SOMATOM go. Now, with SOMARIS/10 syngo CT VA30 (Update); SOMATOM go. Open Pro, with SOMARIS/10 syngo CT VA30 (Update); SOMATOM go.All; SOMATOM go.All with SOMARIS/10 syngo CT VA40; SOMATOM go.All with SOMARIS/10 syngo CT VB10; SOMATOM go.All with SOMARIS/10 syngo CT VB20; SOMATOM go.All, with SOMARIS/10 syngo CT VA30; SOMATOM go.All, with SOMARIS/10 syngo CT VA30 (Update); SOMATOM go.Now; SOMATOM go.Now with SOMARIS/10 syngo CT VA40; SOMATOM go.Now with SOMARIS/10 syngo CT VB10; SOMATOM go.Now with SOMARIS/10 syngo CT VB20; SOMATOM go.Now, with SOMARIS/10 syngo CT VA30; SOMATOM go.Open Pro with SOMARIS/10 syngo CT VA40; SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB10; SOMATOM go.Open Pro with SOMARIS/10 syngo CT VB20; SOMATOM go.Open Pro, with SOMARIS/10 syngo CT VA30; SOMATOM go.Sim with SOMARIS/10 syngo CT VA40; SOMATOM go.Sim with SOMARIS/10 syngo CT VB10; SOMATOM go.Sim with SOMARIS/10 syngo CT VB20; SOMATOM go.Sim, with SOMARIS/10 syngo CT VA30; SOMATOM go.Sim, with SOMARIS/10 syngo CT VA30 (Update); SOMATOM go.TOP; SOMATOM go.Top with SOMARIS/10 syngo CT VA40; SOMATOM go.Top with SOMARIS/10 syngo CT VB10; SOMATOM go.Top with SOMARIS/10 syngo CT VB20; SOMATOM go.Top, with SOMARIS/10 syngo CT VA30; SOMATOM go.Top, with SOMARIS/10 syngo CT VA30 (Update); SOMATOM go.Up; SOMATOM go.Up with SOMARIS/10 syngo CT VA40; SOMATOM go.Up with SOMARIS/10 syngo CT VB10; SOMATOM go.Up with SOMARIS/10 syngo CT VB20; SOMATOM go.Up, with SOMARIS/10 syngo CT VA30; SOMATOM go.Up, with SOMARIS/10 syngo CT VA30 (Update); STRATON Family; SYNGO BODY PERFUSION-CT; SYNGO CIRCULATION; SYNGO CIRCULATION SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY; SYNGO CT ONCOLOGY SOFTWARE PACKAGE; SYNGO DUAL ENERGY SOFTWARE PACkage; SYNGO INSPACE 4D; SYNGO SINGLE SOURCE DUAL ENGERY; SYNGO VOLUME PERFUSION-CT NEURO; SYNGO, CT BONE READING; SYNGO, CT CARDIAC FUNCTION; SYNGO. PLAZA VA20A; SYNGO.MR SPECTRO ENGINE SYNGO.MR SPECTRO SVS SYNGO.MR SPECTRO CSI SYNGO.MR SPECTRO EXTENSION; Scan&GO; Scan&GO Software with SOMARIS/10 syngo CT VA40; Scan&GO with SOMARIS/10 syngo CT VA 30; Scan&GO, with SOMARIS/10 syngo CT VA30 (Update); Scan&Go; Scan&Go, with SOMARIS/10 syngo CT VA30; Sensis; Sensis Lite; Sensis Vibe; Sensis Vibe Combo (VD15B); Sensis Vibe Hemo (VD15B); Siemens SOMATOM Definition AS/AS+ with  software version syngo ® VA48 (SOMARIS/7 VA48); Siremobil Compact; Siremobil Compact L; Sliding Gantry Option for CT Devices; Somatom Definition AS Open (Somaris/7 VA46A); Somatom Definition with software version SOMARIS/7 VA44; Somatom Drive; Somatom Force; Somatom Perspective 16 & 32 slice config; Syngo Carbon Clinicals; Syngo Colonography; Syngo LUNG CAD; Syngo.CT Lung CAD; TILTING BUCKY TABLE; TOP ACOM STATION; TR Family; U04 endourological R/F system; UROSKOP OMNIA; UROSKOP Omnia Max; Uroskop; Uroskop Omnia Max; VA11; VA21J; VB20 Extended Functionality; VB20 Twin Beam; VUZE System; Vectron Family; X-Leonardo; YSIO X.pree; YSIO X.pree (VA20); Ysio; Ysio Max; Ysio Max Rad X-ray system (modular system of X-Ray); iMAR software; iterative Metal Artifact Reconstruction Software; software version SOMARIS/8 VB50; sungo.CT Pulmo 3D; syngo Aortic ValveGuide Software; syngo Application Software; syngo Application Software (VD11); syngo Application Software (VD20); syngo Application Software (VE21); syngo Application Software (VE30A); syngo Application Software (VE40C); syngo Application Software (VE51); syngo Application Software VD11; syngo CT Dual Energy; syngo Carbon Clinicals (VA41); syngo Carbon Enterprise Access (VA40A); syngo Carbon Space (VA20A); syngo Carbon Space (VA30A); syngo Dual Energy with extended functionality; syngo DynaPBV Body Software; syngo Dynamics; syngo Dynamics Version VA30; syngo Neuro DSA CT; syngo Neuro PBV CT; syngo Neuro PBV IR; syngo Perfusion-CT; syngo True D; syngo Virtual Cockpit (VB10A); syngo X-Workplace SW VD10; syngo application software version VD20; syngo dual energy; syngo expert I; syngo mMR General; syngo' Dual Energ with extended functionality; syngo. CT Dynamic Anglo; syngo. CT Vascular Analysis; syngo. plaza VB10A; syngo.Breast care; syngo.CT Applications; syngo.CT Brain Hemorrhage; syngo.CT Brain Hemorrhage (VB80); syngo.CT Brain Quantification (SOMARIS/8 VB80); syngo.CT CaScoring; syngo.CT CaScoring SOMARIS/8 VB50; syngo.CT CaScoring with software SOMARIS/8 VB40; syngo.CT Cardiac Function; syngo.CT Cardiac Planning; syngo.CT Colonography - Software Package with Extended Functionality; syngo.CT Coronary Analysis; syngo.CT Coronary Cockpit (VC10); syngo.CT Dental; syngo.CT Dual Energy; syngo.CT Dual Energy (VB10); syngo.CT Dual Energy (VB71); syngo.CT Dual Energy (VB80); syngo.CT Dual Energy (VC10); syngo.CT Extended Functionality; syngo.CT LVO Detection (VB80); syngo.CT Liver Analysis; syngo.CT Lung CAD; syngo.CT Lung CAD (VD20); syngo.CT Lung CAD (VD30); syngo.CT Myocardial Perfusion; syngo.CT Neuro Perfusion; syngo.CT Single Source Dual Energy; syngo.CT Single Source Dual Energy (VB10); syngo.CT Single Source Dual Energy (twin beam); syngo.CT Skull Unfolding; syngo.CT Vascular Analysis; syngo.CT View&GO; syngo.Interventional; syngo.MR Applications; syngo.MR Applications (VB80); syngo.MR Applications with new software version SMR VB40A; syngo.MR Brain; syngo.MR BreVis; syngo.MR Cardiology; syngo.MR General; syngo.MR General VB20; syngo.MR Neurology; syngo.MR Oncology; syngo.MR Vascular; syngo.RT Image Suite; syngo.mMR General; syngo.via (Version VB40A); syngo.via (version VB10A); syngo.via RT Image Suite; syngo.via RT Image Suite (VB70); syngo.via RT Image Suite (VB80); syngo.via VA20 (with Alpha Algorithm); syngo.via View&GO (VA20A); syngo.via View&Go (VA30A); syngo.via View&Go (VA40A); syngo.via Webviewer; syngo® Volume Perfusion-CT Body; syngo®.plaza",2003-03-26,290,2026-09-25,1,1,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004977335%22&limit=1
"Cardinal Health 200, LLC",1423537,3001236905,3651 Birchwood Drive,Waukegan,IL,60085,United States,"Cardinal Health 200, LLC",9028292,Complaint file establishment,483,BSY; BTO; BTX; BWN; BYX; BYY; BYZ; CAI; CBH; CBT; CCK; CCX; DQA; DQO; DQX; DRC; DRO; DRS; DRX; DSA; DSF; DTL; DWF; DWL; DWS; DXC; DXN; DYB; DYN; DZM; EBO; ECI; EFN; EFQ; EFW; EHZ; EIC; ERY; EXB; EXJ; EXM; EXR; EYC; EYQ; EYX; EYY; EYZ; EZC; EZD; EZL; FAQ; FCE; FCM; FCN; FDE; FEG; FFG; FFP; FGM; FHQ; FKG; FLK; FLL; FMA; FMF; FMG; FMH; FMI; FMJ; FMP; FNY; FOD; FOK; FOS; FOX; FOZ; FPA; FPK; FQM; FRG; FRI; FRL; FRN; FRO; FRQ; FRZ; FSD; FSM; FSY; FTA; FTL; FTY; FWZ; FXP; FXX; FYA; FYC; FYF; FZP; FZT; FZX; FZZ; GAA; GAB; GAD; GAL; GAM; GAO; GAP; GAQ; GAR; GAT; GAW; GAX; GAZ; GBM; GBQ; GBS; GBW; GBX; GBZ; GCD; GCJ; GCX; GCY; GDF; GDG; GDJ; GDO; GDT; GDX; GDY; GDZ; GEA; GEC; GEI; GEN; GES; GFA; GIM; GXY; GZJ; HAO; HCC; HCY; HDF; HED; HFB; HFX; HGP; HHD; HHK; HHT; HIB; HIF; HIO; HMP; HMT; HMW; HMX; HNC; HNF; HRQ; HTD; HWE; HXB; HXD; HXK; HXZ; IKD; ILG; IMD; IME; IPM; ITG; JEB; JKA; JOK; JOL; JOW; JQC; JYA; KAE; KCY; KDC; KDD; KDH; KDQ; KDT; KGO; KGW; KGX; KGY; KGZ; KIZ; KJG; KKX; KME; KMF; KMJ; KMK; KNT; KNW; KNX; KNY; KOA; KOD; KOX; KPE; KQM; KQZ; KST; KXF; KYP; KYR; KYW; KYX; KYZ; LDQ; LJS; LKB; LRJ; LRO; LRP; LRQ; LRS; LRW; LWE; LWH; LWK; LXG; LYU; LYY; LZA; LZC; LZH; MAC; MCY; MCZ; MDM; MEG; MFY; MGQ; MHW; MIA; MJG; MKJ; MLN; MLS; MLT; MMK; MMP; MNL; MPO; MUI; MYK; NAB; NAC; NAD; NAE; NNI; NWI; NWN; NWP; NWT; NWU; NXA; NXZ; NYC; NYD; NYE; NYF; NYG; NYH; OEA; OEQ; OER; OES; OET; OEU; OEV; OEX; OEZ; OFA; OFB; OFC; OFE; OFF; OFG; OFH; OFI; OFJ; OFK; OFL; OFM; OFN; OFO; OFP; OFQ; OFR; OFS; OFT; OFU; OFV; OFW; OFX; OFY; OFZ; OGA; OGB; OGC; OGD; OGE; OGF; OGG; OGH; OGI; OGJ; OGK; OGL; OGP; OGQ; OGR; OGS; OGT; OGU; OGV; OGW; OHC; OHD; OHE; OHF; OHG; OHH; OHL; OHM; OHO; OHR; OHZ; OIA; OIB; OIC; OID; OIE; OII; OIJ; OIL; OIN; OIO; OIP; OJA; OJF; OJG; OJH; OJJ; OJK; OJR; OJS; OJT; OJU; OJV; OJW; OKE; OKF; OKG; OKH; OKI; OKU; OKV; OKW; OKX; OKY; OKZ; OMP; OPJ; OVN; OWL; OXQ; PAD; PEV; PEZ; PFU; PIF; PIN; PIO; PKD; PKE; PKF; PNR; POQ; POR; POZ; PPA; PPB; PPC; PPD; PPE; PPF; PPG; PPH; PPI; PPJ; PPK; PPL; PPO; PPP; PPQ; PPR; PQD; PQE; PRM; PRP; PRQ; PRR; PRT; PRU; PRV; PRW; PRY; PRZ; PSA; PSB; PSC; PSD; PSG; PSI; PSJ; PSK; PSP; PUI; PVL; PVM; PVO; PVP; PVS; PVT; PVU; PVV; PVW; PVX; PVY; PWL; PWM; PWO; PWT; PWU; PWY; PWZ; PXB; PXC; PXD; PXF; PXG; PXI; PXJ; PXK; PXM; PXN; PXO; PXP; PXQ; PXS; PXU; PXV; PXW; PXX; PXY; PXZ; PYC; PYD; PYE; PYF; PYG; PYH; PYI; PYJ; PYK; PYL; PZG; QDO; QGA; QPC; SDV,"Catheters, Suction, Tracheobronchial; Tube, Tracheostomy (W/Wo Connector); Board, Arm (With Cover), Sterile; Table And Attachments, Operating-Room; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Trap, Sterile Specimen; Circuit, Breathing (W Connector, Adaptor, Y Piece); Device, Fixation, Tracheal Tube; Arterial Blood Sampling Kit; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Support, Patient Position; Oximeter; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Trocar; Pacemaker, Cardiac, External Transcutaneous (Non-Invasive); Transducer, Blood-Pressure, Extravascular; Electrode, Electrocardiograph; Cable, Transducer And Electrode, Patient, (Including Connector); Recorder, Paper Chart; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Stocking, Medical Support (To Prevent Pooling Of Blood In Legs); Instruments, Surgical, Cardiovascular; Clamp, Vascular; System, Measurement, Blood-Pressure, Non-Invasive; Introducer, Catheter; Mouthpiece, Saliva Ejector; Needle, Dental; Denture Repair Kit; Band, Elastic, Orthodontic; Cotton, Roll; Gauze/Sponge, Internal; Toothbrush, Manual; Evacuator, Oral Cavity; Syringe, Periodontic, Endodontic, Irrigating; Drape, Surgical, Ent; Collector, Ostomy; Device, Incontinence, Urosheath Type, Sterile; Truss, Umbilical; Urinometer, Mechanical; Catheter, Upper Urinary Tract; Garment, Protective, For Incontinence; Drape, Pure Latex Sheet, With Self-Retaining Finger Cot; Drape, Urological, Disposable; System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile; Catheter, Coude; Catheter, Straight; Catheter, Retention Type, Balloon; Bag, Urine Collection, Leg, For External Use, Sterile; Enema Kit; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Urinary Drainage Collection Kit, For Indwelling Catheter; Laparoscopy Kit; Tube, Double Lumen For Intestinal Decompression And/Or Intubation; Device, Urine Flow Rate Measuring, Non-Electrical, Disposable; Dilator, Rectal; Probe And Director, Gastro-Urology; Holder, Needle, Gastroenterologic; Tray, Start/Stop (Including Contents), Dialysis; Thermometer, Clinical Mercury; Continuous Measurement Thermometer; Depressor, Tongue, Non-Surgical; Syringe, Piston; Stopcock, I.V. Set; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Manometer, Spinal-Fluid; Protector, Skin Pressure; Basin, Emesis; Device, Occlusion, Umbilical; Pad, Neonatal Eye; Catheter, Umbilical Artery; Stand, Infusion; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Tubing, Fluid Delivery; Bandage, Elastic; Wrap, Sterilization; Scale, Stand-On, Patient; Fiber, Medical, Absorbent; Pump, Infusion; Dressing, Wound, Drug; Tube, Levine; Device, Patient Transfer, Powered; Binder, Abdominal; Tray, Surgical, Instrument; Light, Surgical, Ceiling Mounted; Light, Surgical, Accessories; Mesh, Surgical, Polymeric; Tape, Measuring, Rulers And Calipers; Operating Room Accessories Table Tray; Cover, Shoe, Operating-Room; Mask, Surgical; Gown, Surgical; Gown, Isolation, Surgical; Cap, Surgical; Clip, Implantable; Cutter, Surgical; Guide, Surgical, Instrument; Marker, Skin; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Retractor; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Urethral; Catheter, Continuous Irrigation; Catheter, Ventricular, General & Plastic Surgery; Catheter, Peritoneal; Catheter, Irrigation; Catheter, Cholangiography; Connector, Catheter; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Removable (Skin); Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Brush, Scrub, Operating-Room; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Blade, Scalpel; Blade, Saw, General & Plastic Surgery, Surgical; Tubes, Vacuum Sample, With Anticoagulant; Electrode, Cutaneous; Stimulator, Nerve, Transcutaneous, For Pain Relief; Instrument, Surgical, Non-Powered; Device, Biofeedback; Curette, Uterine; Speculum, Vaginal, Metal; Douche Apparatus, Vaginal, Therapeutic; Forceps, Biopsy, Gynecological; Clamp, Circumcision; Electrode, Circular (Spiral), Scalp And Applicator; Pad, Menstrual, Unscented; Curette, Suction, Endometrial (And Accessories); Spatula, Cervical, Cytological; Speculum, Vaginal, Nonmetal; Insufflator, Laparoscopic; Sampler, Amniotic Fluid (Amniocentesis Tray); Pad, Eye; Drape, Patient, Ophthalmic; Drape, Microscope, Ophthalmic; Cannula, Ophthalmic; Specula, Ophthalmic; Scissors, Ophthalmic; Hemostat; Forceps; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Probe; Clamp; Holder, Needle; Orthopedic; Cutter, Wire; Cable, Electrode; Stocking, Elastic; Pack, Hot Or Cold, Disposable; Pack, Hot Or Cold, Reusable; Cover, Limb; Bandage, Cast; Table, Surgical With Orthopedic Accessories, Manual; Tubes, Vials, Systems, Serum Separators, Blood Collection; Scissors, Medical, Disposable; Catheter And Tip, Suction; Sleeve, Limb, Compressible; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Scissors, Wire Cutting, Ent, Sterile; Forceps, Ent; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration; Bottle, Collection, Vacuum; Container, Specimen Mailer And Storage, Sterile; Surgeon'S Gloves; Ring (Wound Protector), Drape Retention, Internal; Tape And Bandage, Adhesive; Bag, Intestine; Accessories, Catheter; Dish, Tissue Culture; Tube, Tissue Culture; Drape, Surgical, Antimicrobial; Bedding, Disposable, Medical; Bandage, Liquid; Lubricant, Patient; Device, Intravascular Catheter Securement; Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Collector, Urine, (And Accessories) For Indwelling Catheter; Accessories, Catheter, G-U; Surgical Instruments, G-U, Manual (And Accessories); Catheter, Urological; Solvent, Adhesive Tape; Container, I.V.; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; System, Blood Collection, Vacuum-Assisted, Manual; Applicator, Absorbent Tipped, Non-Sterile; Snake Bite Suction Kit; Bag, Ice; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); LDQ; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Pad, Alcohol, Device Disinfectant; Disinfectant, Medical Devices; General Surgery Tray; Tray, Surgical; Tracheostomy And Nasal Suctioning Kit; I.V. Start Kit; Scissors, General, Surgical; Bone Marrow Collection/Transfusion Kit; Counter, Sponge, Surgical; Razor, Surgical; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Accessory, Surgical Apparel; Latex Patient Examination Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; Pump, Infusion, Enteral; Decontamination Kit; Wound Dressing Kit; Suture Removal Kit; Instrument, Manual, Surgical, General Use; Syringe, Antistick; Endothelial Cell Harvesting Kit; Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic; Dressing, Compression; Needle, Spinal, Short Term; Device, Percutaneous, Biopsy; Automated External Defibrillators (Non-Wearable); Electrode, Electrocardiograph, Multi-Function; Labor And Delivery Kit; Pelvic Exam Kit; Container, Sharps; Cover, Barrier, Protective; Accessories, Cleaning Brushes, For Endoscope; Infant Heel Warmer (Chemical Heat Pack); Media, Coupling, Ultrasound; Kit, Cord Blood Collection; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Container, Specimen, Non-Sterile; Electrosurgical Electrode Kit; Laparoscopic Bone Anchor Urethropexy Instrument Kit; Suprapubic Cystostomy Catheter Kit; Endoscopic Cholangiogram Kit; Endoscope Introducer Kit; Tracheotomy Care Kit; Dental Hygiene Kit; Dental Prophylaxis Kit; Endodontic Kit; Fixture Mount Kit; Gingival Retraction Kit; Lapping Tool Kit; Plaque Disclosing Kit; Non-Surgical Gown; Angiography/Angioplasty Kit; Angioscopic Valvulotome Kit; Cardiac Catheterization Kit; Cardioplegia Solution Administration Kit; Cardiopulmonary Bypass Catheter Kit; Cardiopulmonary Resuscitation Aid Kit; Cardiovascular Catheter Sheath Introducer Kit; Cardiovascular Procedure Kit; Cardiovascular Surgical Instruments Tray; Catheter Guide Wire Kit; Catheter Introducer Kit; Central Venous Blood Pressure Kit; Central Venous Catheter Tray; Ct Biopsy Tray; Digital Angiography Tray; Laser Blood Flow Kit; Lead Introducer Kit; Percutaneous Atrial Catheter Kit; Percutaneous Sheath Introducer Kit; Phlebotomy Blood Collection Kit; Winged Intravenous Catheterization Kit; Airway Suction Kit; Anesthesia Breathing Circuit Kit (Adult & Pediatric); Anesthesia Kit; Tracheobronchial Suction Catheter Kit; Tracheal Suction Set; Spinal Epidural Anesthesia Kit; Spinal Anesthesia Kit; Regional Anesthesia Kit; Restorative Instrument And Component Tray; General Purpose Dental Tray; Dental Implant Surgical Tray; Blood Specimen Collection Kit (Excludes Hiv Testing); Brachial Plexus Anesthesia Kit; Caudal Anesthesia Kit; Continuous Brachial Plexus Block Tray; Custom Anesthesia Tray; Epidural Anesthesia Kit; Glossopharyngeal Anesthesia Kit; Humidifier Nebulizer Kit; Laryngoscope Kit; Nasal Endotracheal Tube Holder Kit; Nerve Block Tray; Orotracheal Intubation Guide Kit; Oxygen Administration Kit; Cricothyrotomy Kit; Ear Irrigation Kit; Ear, Nose, And Throat Surgical Tray; Myringotomy Procedure Kit; Oral Irrigation Kit; Pierced Ear/Entry Cleaning Tray; Tracheostomy Cleaning Tray; Tracheostomy Kit; Obstetrical Vacuum Delivery Kit; Gynecological Laparoscopic Kit; Forensic Evidence Sexual Assault Kit; Culdocentesis Kit; Circumcision Tray; Breast Pump Kit; Pap Smear Kit; Cesarean Section Tray; First Aid Kit Without Drug; Catheter Care Tray; Urine Transport Kit (Excludes Hiv Testing); Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing); Blood And Urine Collection Kit (Excludes Hiv Testing); Blood Alcohol Kit (Excludes Hiv Testing); Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing); Urine Collection Kit (Excludes Hiv Testing); Arthrogram Tray; Biopsy Needle Guide Kit; Discography Kit; Prostate Seeding Kit; Radiographic Contrast Tray; Radiology-Diagnostic Kit; Intravenous Extension Tubing Set; Hysterectomy Kit; Neurological Tray; Orthopedic Tray; Burn Kit Without Drug; Eye Tray; Vacuum Powered Body Fluid Collection Kit; Tourniquet Kit; Aspiration Tray; Skin Prep Tray; Single Use Instrument Tray; Shave Prep Kit; Port Introducer Kit; Body Fluid Disposal Kit; Body Fluid Clean Up Kit; Body Fluids Barrier Kit; Emergency Response Safety Kit; Emergency Obstetrical Kit; Obstetrical Kit; Seminal Fluid Collection Kit; Trocar Kit; Cytology Kit; Endometrial Sampling Kit; Negative Pressure Wound Therapy Powered Suction Pump; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Suture Kit; Peripheral Catheter Insertion Kit; Dressing Change Tray; Chest Drainage Kit; Dialysis Administration Kit; Central Venous Catheter Dressing Change Kit; Tissue Processing Kit; Gastrointestinal Tubes With Enteral Specific Connectors; Kidney Perfusion Kit; Enteral Specific Transition Connectors; Laceration Tray; Laparoscopic Cholecystectomy Kit; D And C Tray; Enteral Syringes With Enteral Specific Connectors; Blood Transfusion Kit; Parenteral Administration Kit; Biopsy Needle Kit; Bladder Irrigation Kit; Foley Catheter Kit (Excludes Hiv Testing); Male External Catheterization Kit (Excludes Hiv Testing); Universal Drainage Tray; Nephroscope Set; Urinary Irrigation Kit; Urinary Drainage Collection Kit; Single Needle With Uni-Directional Pump Kit; Hemodialysis Tray (Not A Start/Stop Kit); Peritoneal Dialysis Administration Kit; Peritoneal Dialysis Tubing Kit; Single Needle (Co-Axial Flow) Dialysis Kit; Multi-Lumen Hemodialysis Catheterization Kit; Disposable Joint Aspiration/Injection Kit; Transtibial Anterior Cruciate Ligament Kit; Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures; Blood Specimen Collection Convenience Kit (Excludes Hiv); Ostomy Care Kit; Enteral Administration Kit (Adult & Pediatric); Balloon Gastrostomy Tube Kit; Esophageal Dilator Kit; Feeding Tube Kit; Gastric Irrigation And Aspiration Kit; Gastric Lavage Kit (Adult Or Pediatric Use); Gastro-Urology Biopsy Kit; Gastrointestinal Tube Kit; Gastrostomy Jejunostomy Feeding Tube Kit; Gastrostomy Tube Kit; Laparoscopic Jejunostomy Kit; Nasogastric Feed Tube Kit; Nasogastric-Gastrojejunal Kit; Laparoscopic Gastrostomy Kit; Percutaneous Endoscopic Gastrostomy Kit; Perineal Irrigation Kit; Rectal Dilator Kit; Replacement Gastrostomy Feeding Catheter Tray; Intracranial Pressure & Temperature Monitoring Kit; Drape, Surgical, Exempt; Endoscopic Shunt Placement Kit; Endoscopic Ventricular Catheter Placement Kit; Lumbar Drainage Catheter Kit; Neurological Test Kit; Fetal Blood Sampling Kit (Excludes Hiv Testing); Maternity Kit; Obstetrical Anesthesia Kit; Paracervical Anesthesia Kit; Pudendal Anesthesia Kit; Vaginal Examination Tray; Vasovasostomy Set; Oral Surgery Tray; Admission Kit (Patient Utensil); Blood Administration Kit; Chemotherapy Spill Clean-Up Kit; Clean-Up Kit; Lumbar Puncture Tray (Adult & Pediatric); Mid-Stream Collection Kit; Percutaneous Introducer Kit; Personal Protection Kit; Prep Kit; Sitz Bath Kit; Spill Kit; Thoracentesis Tray; Umbilical Catheter Insertion Tray; Vascular Access Port Kit; Vomitus Clean-Up Kit; Basic Set-Up Tray; Bone Marrow Biopsy Tray; Breast Biopsy / Localization Tray; Burn Dressing Tray; Cholecystectomy Kit; Fluid Drainage Tray; General Purpose Instrument Tray; Herniorraphy Kit; Incision Tray; Irrigation Kit (Wounds); Laparascopic Sphincterotomy Kit; Paracentesis Tray; Pelviscopy Kit; Staple Removal Kit; Sterile Puncture Tray; Suction Catheter Kit; Surgical Retractor Kit; Thoracic Catheter Insertion Tray; Ulcer Wound Tray; Venous Ulcer Kit; Wound Drainage Kit; Surgical Eye Tray; Fentanyl And Other Opioid  Protection Glove; Penile Implant Surgical Accessories; Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection; Clinical Electronic Thermometer",1; 2; 3; N; U,CARDINAL HEALTH NITRILE EXAMINATION GLOVES EXTENDED CUFF; Stainless Steel Tongue Cleaner,1977-12-23,276,2026-09-02,1,83,5,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221423537%22&limit=1
DePuy Synthes Sales,3034676720,3034676720,75 Fruit St,Bridgewater,MA,02324,United States,SYNTHES (USA) Products LLC,2520274,Repackager or relabeler,130,DZI; DZJ; DZK; DZL; EML; ERL; FDG; FEM; FMF; FSM; FST; FTY; FZO; FZT; FZX; FZY; GAA; GAB; GAD; GAT; GDG; GDH; GDI; GDJ; GDZ; GEA; GEY; GFA; GFC; GFF; GFG; GWO; GXL; GXP; GXQ; GXR; GZT; HBE; HBG; HBW; HRS; HRX; HSB; HST; HTC; HTD; HTE; HTF; HTJ; HTN; HTO; HTQ; HTR; HTT; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWE; HWJ; HWK; HWM; HWN; HWR; HWT; HWW; HWX; HXB; HXC; HXD; HXG; HXI; HXL; HXP; HXQ; HXS; HXW; HXX; HXZ; JDO; JDP; JDQ; JDR; JDS; JDW; JEC; JEY; JTQ; JWH; KCT; KDD; KIH; KIK; KQW; KTT; KTW; KTZ; KWI; KWL; KWP; KWQ; KWY; LOD; LRP; LXH; LXT; LZO; MAI; MBI; MDM; MEH; MNH; MNI; MOQ; MQN; MQV; NDG; NEI; NKB; NKG; NOV; OAT; OLO; OSH; OSN; OUR; QYM,"Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Wire, Fixation, Intraosseous; Screw, Fixation, Intraosseous; Chisel, Bone, Surgical; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Retractor, Fiberoptic; Accessories, Photographic, For Endoscope (Exclude Light Sources); Syringe, Piston; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Retractor; Suture, Nonabsorbable, Synthetic, Polyethylene; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Driver, Surgical, Pin; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Plate, Cranioplasty, Preformed, Alterable; Screwdriver, Skullplate; Methyl Methacrylate For Cranioplasty; Dura Substitute; Cover, Burr Hole; Retractor, Self-Retaining, For Neurosurgery; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Manual); Fastener, Plate, Cranioplasty; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Apparatus, Traction, Non-Powered; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Instrument, Compression; Driver, Prosthesis; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Tamp; Passer, Wire, Orthopedic; Mallet; Instrument, Bending Or Contouring; Crimper, Pin; Twister, Wire; Bender; Screwdriver; Cutter, Wire; Device, Fixation, Proximal Femoral, Implant; Condylar Plate Fixation Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Component, Traction, Invasive; Plate, Bone; Bath, Incubators/Water, All; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Dispenser, Cement; Hook, Bone; Goniometer, Nonpowered; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Bone Cement; Tray, Surgical; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Battery, Replacement, Rechargeable; External Mandibular Fixator And/Or Distractor; Filler, Bone Void, Calcium Compound; Washer, Bolt, Nut, Non-Spinal, Metallic; Prosthesis, Condyle, Mandibular, Temporary; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Anchor, Suture, Bone Fixation, Metallic; Implant, Endosseous, Orthodontic; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Software For Diagnosis/Treatment; Sacroiliac Joint Fixation; Ophthalmic Needle",1; 2,"2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM; 2.4/2.7mm VA-LCP Forefoot/Midfoot; 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES; 2.4mm VA LCP Volar DR Plates; 2.4mm VA-LCP Intercarpal Fusion System; 2.7/3.5 LCP Distal Fibula Plates; 2.7/3.5 VA-LCP Anterior Clavicle Plate Sytem; 2.7MM LCP ULNA OSTEOTOMY SYSTEM; 2.7mm VA LCP Clavicle Plate System; 3.5 MM LCP DISTAL HUMERUS SYSTEM; 3.5/4.5 LCP w/ Expanded Indications; 3.5mm Distal Tibia T Plates; 3.5mm LCP Hook Plate; 3.5mm Locking Attachment Plates; 4.5 VA-LCP Curved Condylar System; 4.5mm/6.5mm Headless Comp. Screws; 6.5mm Midfoot Fusion Bolt; ANGLED BLADE PLATE; ARICULATED TENSION DEVICE SYNTHES TEN; AWL; Additional VIPER PRIME™ screws with fenestrations; Akros Fibulink™ Syndesmosis Repair Kit; Ankle Trauma; Aspiration; BONE FORCEPS STANDARD SET; BROACH; Burr, Orthopedic; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY; CMFD Mandible; COUNTERSINK; COUNTERSINK (MULTIPLE BRANDS); CURETTE; Caliper; ChronOS BMA; DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS); DEPUY SYNTHES MAXFRAME AUTOSTRUT System; DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM; DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY; DYNACORD Suture; DYNAMIC HIP SCREW; DYNATAPE Suture; DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System); DePuy Synthes 2mm Quick Insertion Screws; DePuy Synthes 3.5 mm Intrapelvic Acetabular System; DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System; DePuy Synthes 4 Mm And 4.5 Mm Cortex Screws, DePuy Synthes 2.4 Mm Cannulated Screws, DePuy Synthes 3.5 Mm And 4 Mm C; DePuy Synthes Femoral Neck System; DePuy Synthes Femoral Recon Nail System; DePuy Synthes MatrixNEURO Reconstruction Mesh; DePuy Synthes MatrixSTERNUM Fixation System; DePuy Synthes Maxillofacial Portfolio - MR Conditional; DePuy Synthes Plates And Screws Portfolio; DePuy Synthes Sterilization Container System; DePuy Synthes TFNA Augmentation System; DePuy Synthes Tibial Nail Advanced; DePuy Synthes Trauma Orthopedic Plates And Screws; DePuy Synthes Trauma Screws; DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) System; DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System; DePuy Synthes Variable Angle Locking Hand System (1.3 mm and 2 mm Plates  and Screws); DePuy Synthes Variable Angle Locking Patella Plating System; Dental Bone Cutting Instruments; Depuy Synthes Retrograde Femoral Nail Advanced System; Depuy Synthes Retrograde Femoral Nail Advanced System and DePuy Synthes Locking Screws for Medullary Nails, 5 mm; Drill Bits & Taps; EMPHASYS Femoral Stems; EXPEDIUM SPINE SYSTEM; EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM; EXPEDIUM SYSTEM, VIPER SYSTEM; EXPEDIUM Spine System/Synapse System; EXPEDIUM VERSE SPINE SYSTEM; EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM; EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System; Elevator; GAB - NEEDLE, SUTURING, DISPOSABLE; GII QUICKANCHOR PLUS; GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE; GONIOMETER; GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY; GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor; Guide, Surgical, Instrument; HAMMERLOCK 2; HEALIX ADVANCE Anchor with DYNACORD Suture; HEALIX ADVANCE Anchor with DYNATAPE Suture; HEALIX ADVANCE KNOTLESS Anchor; HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchor; HOHMANN RETRACTOR; Hammertoe Continuous Compression Implant; Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor,; Hook; IMPACTOR; INSTRUMENT SET FOR ANGLED BLADE; INSTRUMENT SET FOR RE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE; LCP RADIAL HEAD PLATING SYSTEM; LIGHT, SURGICAL, FIBEROPTIC; LOCKING CONDYLAR PLATE (LCP) SYSTEM; MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM); MAXFRAME Autostrut; MAXILLARY DISTRACTOR; MEDULLARY INSTRUMENT SET; MERLIN SPINE SYSTEM; MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD; MITEK MICRO QUICKANCHOR; MITEK MINI QUICKANCHOR PLU; MODIFICATION TO EXPEDIUM SPINE SYSTEM; MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM; MODIFICATION TO: EXPEDIUM SPINE SYSTEM; MODULAR FOOT SYSTEM - 2.7 MM; MONARCH SPINE SYSTEM; MR Conditional; Manual surgical instrument; MatrixORTHOGNATHIC Plating System; MatrixRIB Fixation System; MatrixWAVE MMF System; Maxframe; Mini Superhawk Suture Anchor System; NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY; Navigation Enabled Instruments; Orthopedic manual surgical instrument; PIPELINE II ACCESS SYSTEM; POSITIONING PLATE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER; PROXIMAL FEMORAL NAIL (PFN) SYSTEM; Periarticular Prox Humerus Plates; Posteromedial Proximal Tibia Plate; RAM; RASP; REAMER; RONGEUR; Radial Head Prosthesis; Rapid Resorb. Cranial Clamp; Responsive Arthroscopy Suture Anchor System; Robotic Integration Instruments; SCREWDRIVER; SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM; SMALL FRAGMENT DYNAMIC COMPRESSION; SMF STAINLESS STEEL BONE SCREWS; SMF TITANIUM (TI) ALLOY BONE SCREWS; SUTURE PASSER; SYMPHONY™ OCT System; SYN VA LCP ELBOW SYS MEDIAL & POSTERLAT DISTAL HUMERUS PLT; SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE; SYNTHES (USA) 1/1.22 MM CRANIOFAC; SYNTHES (USA) 2.4/2.7 MM LOCKING FO; SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP; SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES; SYNTHES (USA) 3.5 MM BROAD LCP & 4.; SYNTHES (USA) 3.5/4.5MM LCP MEDIAL; SYNTHES (USA) 3.5MM CONICAL SCREWS; SYNTHES (USA) CANNULATED TITANIUM H; SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM; SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM; SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM; SYNTHES (USA) DDHS/DCS SYSTEM MODIF; SYNTHES (USA) DISTAL FEMUR PLATE (D; SYNTHES (USA) DISTAL RADIUS PLATE S; SYNTHES (USA) ELASTIC INTRAMEDULLAR; SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION; SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE; SYNTHES (USA) ELECTRIC PEN DRIVE SY; SYNTHES (USA) EXTERNAL FIXATION COM; SYNTHES (USA) EXTERNAL MULTI VECTOR; SYNTHES (USA) HYDROXYAPATITE (HA) C; SYNTHES (USA) IMF SCREWS; SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP); SYNTHES (USA) LATERAL ENTRY FEMORAL; SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM; SYNTHES (USA) LCP MODULAR FOOT PLAT; SYNTHES (USA) LCP PROXIMAL FEMUR HO; SYNTHES (USA) LCP PROXIMAL FEMUR PL; SYNTHES (USA) LCP PROXIMAL HUMERUS; SYNTHES (USA) LCP WRIST FUSION PLAT; SYNTHES (USA) MIDFACE DISTRACTOR; SYNTHES (USA) MIDFACIAL SYSTEM; SYNTHES (USA) MODULAR MINI FRAGMENT; SYNTHES (USA) NEURO PLATE AND SCREW; SYNTHES (USA) RATCHETING DISTRACTOR; SYNTHES (USA) REAMER IRRIGATOR AS; SYNTHES (USA) RETROGRADE/ANTEGRADE; SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM; SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM; SYNTHES (USA) STERNAL RECONSTRUCTIO; SYNTHES (USA) TIBIAL NAIL SYSTEM EX; SYNTHES (USA) TROCHANTER STABILIZ; SYNTHES (USA) TROCHANTER STABILIZAT; SYNTHES (USA) VARIABLE ANGLE-LOCKIN; SYNTHES (USA) [SYNTHES] MINI EXTERN; SYNTHES (USA) [SYNTHES} PERI-PROSTH; SYNTHES 1.3 MM SELF-DRILLING SCREW; SYNTHES 1.5MM TI BROW LIFT SCREW; SYNTHES 1.5MM/2MM ORTHOGNATHIC MA; SYNTHES 1/1.2 MM PLUSDRIVE SCREWS; SYNTHES 2 MM LOCKING PLATE SYSTEM; SYNTHES 2.4 MM CANNULATED SCREW; SYNTHES 3.5 MM LOW PROFILE PELVIC R; SYNTHES 3.5MM CORTEX SCREWS; SYNTHES 3.5MM TITANIUM LCP PROXIMAL; SYNTHES 4 AND 5 MM LOCKING SCRE; SYNTHES 4.5 MM TITANIUM LCP PROXIMA; SYNTHES 4MM TITANIUM (TI.) LOCKIN; SYNTHES 5/7.3 MM CANNULATED LOCKI; SYNTHES 6.5 MM CANNULATED SCREW; SYNTHES 7/7.3 MM CANNULATED SCREW; SYNTHES ADOLESCENT LATERAL ENTRY FE; SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM; SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS); SYNTHES ANTERIOR CERVICAL LOCKING P; SYNTHES CANNULATED ANGLE BLADE PLAT; SYNTHES CERVIFIX/ AXON; SYNTHES DORSAL DISTAL RADIUS PLATE; SYNTHES ELASTIC INTRAMEDULLARY NAIL; SYNTHES EXTERNAL FIXATION DEVICES,; SYNTHES EXTERNAL MIDFACE DISTRACTOR; SYNTHES HINDFOOT ARTHRODESIS NAIL S; SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM; SYNTHES LARGE FRAGMENT DYNAMIC COMP; SYNTHES LCP DIAPHYSEAL-METAPHYSEAL; SYNTHES LCP DISTAL FEMUR PLATES; SYNTHES LCP DISTAL TIBIA PLATES; SYNTHES LCP PEDIATRIC PLATE SYSTEMS; SYNTHES LCP PROXIMAL HUMERUS PLATES; SYNTHES LCP PROXIMAL TIBIA PLATE; SYNTHES LCP PROXIMAL TIBIA PLATES L; SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT; SYNTHES LOW PROFILE RECONSTRUCTION; SYNTHES MANDIBLE EXTERNAL FIXATOR; SYNTHES MANDIBULAR MODULAR FIXATION; SYNTHES MATRIXMANDIBLE PLATE AND SC; SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES; SYNTHES MAXILLOFACIAL TITANIUM MICR; SYNTHES MIDFACE DISTRACTOR; SYNTHES MODULAR FOOT SYSTEM; SYNTHES MULTILOC HUMERAL NAILING SYSTEM; SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM; SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY; SYNTHES PROXIMAL HUMERAL NAIL; SYNTHES RECONSTRUCTIVE PLATES `Y` P; SYNTHES RIB FIXATION SYSTEM; SYNTHES SIMPLE SMALL EXTERNAL FIXAT; SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM; SYNTHES SPIRAL BLADE FOR HUMERAL NA; SYNTHES STAINLESS STEEL MODULAR HAN; SYNTHES STERILE 3 MM CANNULATED S; SYNTHES STERILE 3.5 MM AND 4 MM C; SYNTHES STERNAL FIXATION SYSTEM; SYNTHES STERNAL ZIPFIX SYSTEM; SYNTHES TITANIUM (TI) ALLOY HIGH TI; SYNTHES TITANIUM DIASTAL FEMORAL NA; SYNTHES TOMOFIX OSTEOTOMY SYSTEM; SYNTHES TRANSLATING MAXILLARY DISTR; SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM; SYNTHES(U.S.A.) ANTERIOR SPINAL PLA; SYNTHS ONE-THIRD TUBULAR DCL PLATE; Staple; Suprapatellar; SyntheCel; Synthes (USA) 2.4 VA-LCP 2-Col Narr; Synthes 1.5mm Mini Fragment LCP Sys; Synthes 2.4 LCP Vol. Col. Distal Ra; Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System; Synthes 3.5/4.5 Curved Narrow/Broad; Synthes 3.5mm LCP Clavicle Plate Sy; Synthes 3.5mm VA-LCP Proximal Tibia Plate; Synthes 4.5mm VA-LCP Curved Condylar Plate System; Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins; Synthes 90 Degree Screwdriver; Synthes Cortex Screws; Synthes Craniofacial Plate & Screw; Synthes Curvilinear Distraction System; Synthes Distraction Osteogenesis Sy; Synthes Hybrid External Fixator; Synthes Large Ex Fix MR Conditional; Synthes MATRIXMANDIBLE SUBCONDYLAR; Synthes Self-Drilling Schanz Screw; Synthes SyntheCel Dura Replacement Devices; Synthes USA RIA System; Synthes graphic case & tray system; Synthes(USA) 3.5mm Low Profile Cortical Screw; TITANIUM CANNULATED TIBIAL NAIL (TI; TITANIUM MOSS MIAMI SPINAL SYSTEM; TORQUE LIMITING ATTACHMENT; TRAUMACEM™ V+ Injectable Bone Cement; TRAYS AND RACKS.; Tamp; Terumo Injection Filter Needle (NF-3013RBKE05M); TomoFix Medial Distal Femur Plates; Tomofix; Trauma Screw; Tray, Surgical; TriLEAP Plating System; UNIVERSAL NAVIGATION INSTRUMENTS; VARIOUS TYPES AND; VARIOUS TYPES OF CASES; VARIOUS TYPES OF GUIDES; VARIOUS TYPES OF HAMMERS; VARIOUS TYPES OF IMPACTORS; VARIOUS TYPES OF MANUAL; VIPER 2 SYSTEM; VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS; VIPER PRIME navigated inserter; VIPER PRIME™ Screws with Fenestrations; VIPER PRIME™ additions to the VIPER® System; VIPER SYSTEM, EXPEDIUM SYSTEM; VOLAR DISTAL RADIUS PLATE; WAGNER RESURFACE INSTRUMENT SET; WATER BATH TRAY; WIRE INSTRUMENT SET; WIRE PASSER; WRENCH; accessories, photographic, for endoscope; battery; bender; bit; blade; bur; cannula; chisel; clamp; cutter, surgical; cutter, wire; dispenser; dissector, surgical, general & plastic surgery; drill kit; driver; ePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm); gauge; hook; instrument; instrument, surgical, orthopedic, ac-powered motor and accessory/attachment; mandibular fiaxtion; measuring; osteotome; plate; pliers; power; probe; retractor; screw; screwdriver, skullplate; spine instrument; tap; traction; trephine",1978-03-16,274,2025-10-14,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223034676720%22&limit=1
"Highridge Medical, LLC",3012447612,3012447612,10225 Westmoor Dr,Westminster,CO,80021,United States,"Highridge Medical, LLC",9061535,Manufacturer; Specification developer,112,BWN; DZK; FDG; FEM; FSM; FST; FTY; FZO; FZT; FZX; FZY; GAC; GAD; GCX; GCZ; GDF; GDG; GDI; GDJ; GDZ; GEA; GEI; GEN; GEO; GEY; GFA; GFC; GFI; GWG; GXP; HAB; HAO; HAW; HRS; HRX; HTC; HTD; HTE; HTF; HTJ; HTO; HTR; HTW; HTX; HTZ; HWA; HWB; HWC; HWD; HWJ; HWK; HWM; HWN; HWT; HWW; HWX; HXB; HXC; HXD; HXG; HXI; HXL; HXP; HXR; HXS; HXW; HXX; HXZ; JDQ; JOL; KET; KIH; KIK; KNW; KQW; KTZ; KWP; KWQ; LMN; LOE; LOF; LRP; LRY; LXH; LYC; MAX; MBP; MBS; MJO; MNH; MNI; MQP; MQV; MRW; NKB; NKG; NQW; NWI; OAR; ODP; OIS; OJV; OLO; OSH; OVD; OVE; OWI; PEK; PGM; PHM; QHP; QLQ,"Table And Attachments, Operating-Room; Wire, Fixation, Intraosseous; Retractor, Fiberoptic; Accessories, Photographic, For Endoscope (Exclude Light Sources); Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Rasp, Surgical, General & Plastic Surgery; Retractor; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Retainer, Surgical; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; File, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Driver, Surgical, Pin; Osteotome, Manual; Endoscope, Neurological; Methyl Methacrylate For Cranioplasty; Saw, Powered, And Accessories; Instrument, Surgical, Non-Powered; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Arthroscope; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Reamer; Rasp; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Awl; Trephine; Osteotome; Instrument, Compression; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Tamp; Passer, Wire, Orthopedic; Mallet; Instrument, Bending Or Contouring; Spatula, Orthopedic; Twister, Wire; Bender; Screwdriver; Cutter, Wire; Cerclage, Fixation; Catheter And Tip, Suction; Filters, Cell Collection, Tissue Processing; Dispenser, Cement; Hook, Bone; Instrument, Biopsy; Goniometer, Nonpowered; Caliper; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses; Stimulator, Invasive Bone Growth; Stimulator, Bone Growth, Non-Invasive; Tray, Surgical; Punch, Surgical; Orthopedic Manual Surgical Instrument; Bone Grafting Material, Synthetic; Intervertebral Fusion Device With Bone Graft, Lumbar; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Filler, Bone Void, Non-Osteoinduction; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Orthosis, Spine, Plate, Laminoplasty, Metal; Electrosurgical Electrode Kit; Injector, Vertebroplasty (Does Not Contain Cement); Intervertebral Fusion Device With Bone Graft, Cervical; Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation; Single Use Instrument Tray; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Bone Fixation Cerclage, Sublaminar; Spinous Process Plate; Growing Rod System; Intervertebral Fusion Device With Bone Graft, Thoracic; Vertebral Body Tethering System; Manual Instruments Designed For Use With Total Disc Replacement Devices",1; 2; 3; N; U,"Chisel; Clamp; FlareHawk; FlareHawk Interbody Fusion System; FlareHawk11/TiHawk11; HD Lumbar Interbody System; Hive™ Stand-alone Anterior Lumbar Interbody System; Integrity Implants Navigated Instruments; LineSider Spinal System; Passer, Wire, Orthopedic; Surgical Tray; TM-400; Toro-L Interbody Fusion System; Virage Navigation; Virage® OCT Spinal Fixation System; Vista-S; Vital Navigation; Vital Spinal Fixation System; Vitality® Spinal Fixation System; bipolar forceps",2004-02-27,260,2025-05-21,10,18,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012447612%22&limit=1
"Globus Medical, Inc.",3030412764,3030412764,4670 E. Shelby DR,Memphis,TN,38118,United States,"GLOBUS MEDICAL, INC.",9056090,Manufacturer,76,BSK; BTR; BXM; ETN; FMF; FST; FTL; GAD; GEI; GEY; GFF; GWF; HAW; HRS; HSB; HSX; HTN; HTW; HWA; HWC; HWE; IKN; INK; JAA; JDG; JDI; JDO; JDQ; JDS; JDZ; JWH; KWL; KWP; KWQ; KWY; LLZ; LPH; LWJ; LXH; LZO; MAX; MAY; MBH; MBI; MBL; MJO; MNH; MNI; MQP; MQV; MRW; NDN; NKB; NKG; NQP; NQW; ODP; OIY; OLO; OQG; OQH; OQI; OSH; OUR; OVD; OVE; OWB; OWI; PDQ; PEK; PGM; PHM; PLR; PML; QHP; QLQ,"Cuff, Tracheal Tube, Inflatable; Tube, Tracheal (W/Wo Connector); Stimulator, Nerve, Ac-Powered; Stimulator, Nerve; Syringe, Piston; Light, Surgical, Fiberoptic; Mesh, Surgical, Polymeric; Retractor; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Stimulator, Electrical, Evoked Response; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Washer, Bolt Nut; Bit, Drill; Impactor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Electromyograph, Diagnostic; Stretcher, Wheeled, Powered; System, X-Ray, Fluoroscopic, Image-Intensified; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Nail, Fixation, Bone; Mixer, Cement, For Clinical Use; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; System, Image Processing, Radiological; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Cement, Bone, Vertebroplasty; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Posterior Metal/Polymer Spinal System, Fusion; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Cervical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Stereotaxic Instrument; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Interventional Fluoroscopic X-Ray System; Bone Fixation Cerclage, Sublaminar; Neurosurgical Nerve Locator; Spinous Process Plate; Growing Rod System; Intervertebral Fusion Device With Bone Graft, Thoracic; Spinal Vertebral Body Replacement Device - Cervical; Bone Cement, Posterior Screw Augmentation; Vertebral Body Tethering System; Manual Instruments Designed For Use With Total Disc Replacement Devices",1; 2; 3; N; U,"ACP; ACTIFY 3D; ACTIFY Uni; ALIF Buttress Plate; ANTHEM; APX; AUTOBAHN; AffiX; Affix; Archon; Armada; AttraX; BASE; BIOLOX DELTA; BIT, DRILL; Bendini; Brigade; CALIBER TPS Spacers; COALITION TPS Spacers; CORBEL; CREO; Caliber Additional Implants; Camber; CoRoent; Coalesce; Cohere; DUAL TAPER WEDGE; DuraPro; ET Tube; Embrace; FORTIFY; FORTIFY I-R TPS Corpectomy Spacer; FORTIFY-R TPS Corpectomy Spacer; FORTRESS; FORTRESS-Plus; Forceps; FormaGraft; Foundation; GENflex2; GSB Global Spinal Balance; Globus Medical Manual Surgical Instruments; Gradient; Growth Rod; HEDRON; Halo; HeliX; Helix; INDEPENDENCE MIS; INDEPENDENCE SPACER; INDEPENDENCE TPS Spacers; InstaFill; InterContinental Plate-Spacer; KINEX; LeVerage; LessRay; MAS PLIF; MESH Implants; MLX; MaXcess; Modulus; Modulus Expandable; Monolith; NIKO TPS Corpectomy Spacer; NVJJB; NVM5; Navigation Instruments; NuVaLine; ONVOY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; PATRIOT TPS Spacers; PCM; PEEK Corpectomy; PRECEPT; PRECICE; PROCLASS; PROFORM; PROGENY; PROTRACT; PROVEN Gen-Flex; PROVIDENT; PROVIDENT II; PULSE; Precept; Proven Gen-Flex; QUARTEX; REFLECT; RELINE; RETAIN RADIOLUCENT SPACER; REVLOK Fenestrated; RIB LINK; RISE¿ Spacer; Radian; Retractor; Rod Registration Frame; SABLE; SECURE®-C Cervical Artificial Disc; SI-LOK; SIGNIFY; SILC; STRETTO; SUSTAIN R TPS Spacers; SUSTAIN RADIOLUCENT SPACER; Simplify; SpheRx; Stimulation/Dissection Instruments; StruXure; TENSOR; TLX; TRANSITION STABILIZATION SYSTEM; TRIVANCE; TraVerse; Traverse; Triad Facet; VERZA; VersaTie; VuePoint; X-Core; XLIF Decade Plate; XLIF Stimulating Electrode; XLP Lateral Plate; XLX; XPAND CORPECTOMY SPACER; XPAND RADIOLUCENT CORPECTOMY; XPand-R TPS Corpectomy Spacer; ZYFUSE",2003-08-19,262,2026-08-04,3,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223030412764%22&limit=1
Medacta International SA,3005180920,3005180920,Strada Regina,Castel San Pietro Ticino,,6874,Switzerland,Medacta International SA,10024526,Complaint file establishment; Exporter to the US; Foreign private label distributor; Manufacturer; Repackager or relabeler; Specification developer,109,EMF; FDG; FLE; FRG; FSM; FTY; FWX; FZO; FZS; FZX; GAA; GAC; GAD; GAT; GDF; GDG; GEA; GEG; GET; GEY; GFF; GZT; HAW; HRT; HRX; HSD; HSX; HTD; HTE; HTF; HTJ; HTN; HTO; HTR; HTW; HTX; HTY; HWA; HWB; HWC; HWD; HWE; HWJ; HWM; HWP; HWQ; HWX; HXB; HXD; HXX; JDI; JDK; JDQ; JDR; JDW; JDY; JDZ; JWH; KIH; KQZ; KRO; KRR; KWL; KWP; KWQ; KWS; KWT; KWY; KWZ; LLZ; LOD; LPH; LXH; LZN; LZO; LZY; MAI; MAX; MBB; MBF; MBH; MBI; MDM; MEH; MNH; MNI; MQV; NBH; NDN; NKB; NKG; NPJ; OAR; OCJ; ODP; OLO; ONN; OUR; OVD; OVE; PBF; PHX; PML; PQC; PUI; QHE; QSD; QSR; SBF,"Knife, Surgical; Retractor, Fiberoptic; Sterilizer, Steam; Wrap, Sterilization; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Table, Operating-Room, Mechanical; Chisel, Surgical, Manual; Curette, Surgical, General Use; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Suture, Nonabsorbable, Synthetic, Polyethylene; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Elevator, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Pneumatic Powered; Motor, Surgical Instrument, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Retractor, Self-Retaining, For Neurosurgery; Neurological Stereotaxic Instrument; Stripper, Surgical; Arthroscope; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Rasp; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Osteotome; Punch, Femoral Neck; Passer; Tap, Bone; Probe; Clamp; Screwdriver; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Cement Restrictor; Cerclage, Fixation; Staple, Fixation, Bone; Pin, Fixation, Threaded; Evacuator, Vapor, Cement Monomer; Mixer, Cement, For Clinical Use; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Dispenser, Cement; Component, Traction, Non-Invasive; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; System, Image Processing, Radiological; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Orthopedic Manual Surgical Instrument; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Intervertebral Fusion Device With Bone Graft, Lumbar; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Filler, Bone Void, Calcium Compound; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Injector, Vertebroplasty (Does Not Contain Cement); Spinal Channeling Instrument, Vertebroplasty; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Intraoperative Orthopedic Joint Assessment Aid; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Orthopaedic Surgical Planning And Instrument Guides; Shoulder Prosthesis, Reverse Configuration; Bone Cement, Posterior Screw Augmentation; Pedicle Screw Placement Guide; Drape, Surgical, Exempt; Shoulder Arthroplasty Implantation System; Posterior Cervical Screw Placement Guide; Sacroiliac Screw Placement Guide; Orthopedic Augmented Reality",1; 2,"3DMetal Diaphyseal Femoral Cones; 3DMetal Tibial Cones; 9604UK Gaston sleeve; AMIS K Long; AMIS Table; AMIStem H;; AMIStem and Quadra - Line Extension; AMIStem-C; AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared; AMIStem-P Short Neck; ATLAS; AcTiFlip , GFS Ultimate Hip; Access kit; ActiFlip; Advanced MyHip Planner; Arthroscopic Instruments; Awl; B-Screw; Bone Tap; Bone screw starter; BonePrep kit; Cannula System; Carefusion Shadow Line System; Cement Injector; Cement Obturator; Cement mixing system; Chisel; Clamp; Coated Hip Implants; Constrained Liner; Cortical Fixation Systems; Curette; DM Converter – TiN coated; DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR; Depth Gauge; Drill Bit; Elevator; Endo Head; Evolis Total Knee System; Extractor; FairFix Adjustable Button System; FairFix Adjustable Button System Extension; FairFix QT Adjustable Button; Fairfix Adjustable Button System; Fastener, Fixation, Nondegradable, Soft Tissue; GFS; GFS BTB; GFS Ultimate; GMK - Line Extension; GMK 3D Metal Tibial Tray; GMK 3D Metal Tibial Tray Extension; GMK Extension; GMK Full PE Tibial Components; GMK Hinge; GMK Hinge, GMK Revision; GMK Narrow; GMK Resurfacing Patella Size 4; GMK Revision & Hinge Extension - TiNbN Coating; GMK Revision SC Liners; GMK Revision extension; GMK Short Stem; GMK Sphere; GMK Sphere & GMK SpheriKA Cementless; GMK Sphere - Kinematic Alignment; GMK Sphere E-CROSS CR Tibial Inserts, GMK Sphere E-CROSS Flex Tibial Inserts and GMK Sphere E-CROSS Resurfacing Patella; GMK Sphere Extension; GMK Sphere Revision; GMK Sphere Tibial Inserts; GMK Total Knee System; GMK Total Knee System - GMK Revision Hybrid Liners; GMK Total Knee System - TiNbN Coating; GMK Total Knee System- Revision; GMK-Femoral Distal Augmentations; GMK-SPHERE Spherika Femurs and Tibial Trays Plus; GRAFT FIXATION SYSTEM; Gaston; General orthopedic instruments; Glenoid Reconstruction System; Glenoid Reconstruction System – Full Wedge Baseplate; HS SutureTape; Humeral Eccentric Reverse Metaphysis; IMT Motorized broach; Image Processing; Impactor; Injector Instrumentation; Intradisk; K-Wire; Renova Spine Kyphoplasty Kirschner Guide; KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY; Knotless AP Suture Anchors; Knotless PEEK and PEEK CF Push-In Suture Anchor; Lateralized Glenosphere; Ligament Staple; M-ARS ACL: Anatomic Ribbon Surgery System; M-Vizion Femoral Revision System; M-Vizion Femoral Revision System Extension; M-Vizion Monobloc; M.U.S.T Pedicle Screw System; M.U.S.T. Combined Set Screws; M.U.S.T. Extension; M.U.S.T. MINI Posterior Cervical Screws System; M.U.S.T. MINI Posterior Cervical Screws System Extension; M.U.S.T. Midline Cortical (MC) Screw System; M.U.S.T. Mini Extension; M.U.S.T. Mini Posterior Cervical Screw System; M.U.S.T. Pedicle Screw Extension and Long Tab Implants; M.U.S.T. Pedicle Screw System; M.U.S.T. Pedicle Screw System - Extension; M.U.S.T. Pedicle Screw System – Extension; M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System; MITI TITANIUM SUTURE ANCHOR; MOTO Lateral; MOTO PFJ System; MOTO Parital Knee System; MOTO Partial Knee System Extension; MOTO™ Partial Knee & MOTO PFJ Systems Extension; MPACT Extension; MPACT Extension - Face Changing Liners; MSS - Humeral reverse liners extension; MSS – Monobloc stem; Manual Orthopedic Instruments; MasterLoc; MasterLoc™ Stem Extension; MasterLoc™ Stem: Lateralized Plus; Mbrace Cable; Mecta-C; Mecta-C Cervical Plate; Mecta-C Stand Alone; Mecta-C Stand Alone Extension; Mecta-C TiPEEK; Mecta-C TiPEEK with titanium markers; Mecta-C with titanium markers; MectaBone-G; MectaBone-P; MectaBone-P Injection System; MectaBone-P LV; MectaCer BIOLOX forte Femoral Heads; MectaCer Biolox Delta Heads; MectaFix CL Fixation Button with Continuous Loop; MectaLIF; MectaLIF 3D Metal; MectaLIF 3D Metal Anterior; MectaLIF Anterior; MectaLIF Anterior Extension; MectaLIF Anterior Lag; MectaLIF Anterior Simple; MectaLIF Anterior Stand Alone; MectaLIF Anterior Stand-Alone; MectaLIF Extension; MectaLIF Posterior Extension; MectaLIF TiPEEK; MectaLIF Transforaminal; MectaLIF Transforaminal TiPEEK; MectaLock All-Suture Anchors; MectaLock PEEK® Suture Anchor; MectaLock Suture Anchor Extension; MectaLock TI Triple Loaded Suture Anchor; MectaLock Ti Suture Anchor; MectaQTH; MectaScope System; MectaScrew Extension; MectaScrew PEEK®; MectaTap TI Suture Anchor; Mectacem-X; Mectacem-X (With Gentamicin); Mectacer Biolox Option Heads; Mectaplug PE II; Medacta Anatomic Shoulder Prosthesis; Medacta Bipolar Heads; Medacta Bone Screws; Medacta Shoulder System; Medacta Shoulder System - Reverse; Medacta Shoulder System Short Humeral Diaphysis; Medacta Shoulder System: Threaded Glenoid Baseplate; Medacta Total Hip Prosthesis - AMIStem C, Quadra C SN; Medacta Total Hip System; Medacta Versafitcup CC Trio; Meta + Cement; Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System; Mfinity Femoral System; MiniMAX; Mpact 3D Metal Foam; Mpact 3D Metal Implants Extension - DMLS Technology; Mpact 3D Metal Implants and Augments 3D Metal; Mpact 3D Metals Augments; Mpact Acetabular System; Mpact Constrained Liner; Mpact DM Converter; Mpact Double Mobility System; Mpact Extension; Mpact® 3D Metal Implants - DMLS Technology; Mpres Neck Preserving Stem; MyHip Planner & Verifier; MyKnee Cutting Blocks; MyKnee PPS-Pin Positioners; MyKnee R Pin Positioners; MyKnee UNI-ST; MyPAO Guides; MyPAO Planning Report; MyPAO SA guides; MyShoulder Planner; MyShoulder™ Placement Guides; MySpine Cervical Guides; MySpine Pedicle Screw Placement Guides; MySpine Pedicle Screw Placement Guides - LP; MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MyS; MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments; MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides; MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides; MySpine Unilateral Guides; MySpine WebPlanner & MyBalance; NextAR Hip Platform; NextAR Spine; NextAR TSA Platform; NextARTM Shoulder Platform; NextAR™ RSA Platform; NextAR™ Spine; NextAR™ Spine Platform; NextAR™ TKA Platform; NextAR™ TKA Platform My Knee PPS; ORTHOPEDIC DISPOSABLE SURGICAL NEEDLE; OrthoButton CL; Osteotome; PAO Cortical Screw; PEEK CF PUSH-IN SUTURE ANCHOR; PEEK CF PUSH-IN SUTURE ANCHORS; PPEK CF INTERFERENCE SCREW; PULLUP Adjustable Juxtacortical Fixation Device; Passer; PowerKnot High Strength Sutures; PowerSuture; Probe; Punch; Quadra C; Quadra C stems; Quadra H Stems, Quadra C Stems; Quadra H and R; Quadra R Stems; Quadra S Stems; Quadra S and H Stems; Quadra-P; Rasp; Reamer; Retractor; Reverse Shoulder; Rongeur; SLiK Anchors; SLiK Fix Screw; SMS Cementless Stem; STD Size Wire Case & Tray; Screwdriver; SecureFix Meniscus Repair; Shoulder System - TiNbN Coating; SnugFit; SnugFit All-Suture Anchor; SnugFit All-Suture Anchor Extension; Spinal Instrument; Sterilization tray; Sterilization trays; Stripper; Surgical Instrument; Surgical Instrument - Elevator; Surgical Instrument - Hook; Surgical Instrument Tray; Surgical Instrument, AC-Powered; Surgical Manual Instrument; Suture; Synd-EZ SS; Synd-EZ Ti; TWIST PEEK SUTURE ANCHOR; Titanium Interference Screw; Titanium Interference Screws; Total Hip Prosthesis System ¿ CoCr Line Extension; Traction Instrument; Treu GmbH k-wire; Twist AP Suture Anchors; V-LOX PEEK CF SUTURE ANCHOR; V-LOX TITANIUM SUTURE ANCHOR; V-lox Titanium Suture Anchors and Miti Suture Anchors; Vacuum Pump; Versacem and DM HC Liners; Versafit Cup Double Mobility Family; Versafitcup CC Trio - Additional Liners; Versafitcup CC Trio extension; Versafitcup DM Highcross HXUMWPE; X-Twist Biocomposite Suture Anchor; X-Twist PEEK Suture Anchor; eLIBRA; iMNS Medacta Navigation System",2008-02-11,264,2026-09-17,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223005180920%22&limit=1
Medacta International SA,3008110533,3008110533,Via Alla Rossa 6,Rancate Ticino,,6862,Switzerland,Medacta International SA,10024526,Complaint file establishment; Exporter to the US; Foreign private label distributor; Manufacturer; Repackager or relabeler; Specification developer,109,EMF; FDG; FLE; FRG; FSM; FTY; FWX; FZO; FZS; FZX; GAA; GAC; GAD; GAT; GDF; GDG; GEA; GEG; GET; GEY; GFF; GZT; HAW; HRT; HRX; HSD; HSX; HTD; HTE; HTF; HTJ; HTN; HTO; HTR; HTW; HTX; HTY; HWA; HWB; HWC; HWD; HWE; HWJ; HWM; HWP; HWQ; HWX; HXB; HXD; HXX; JDI; JDK; JDQ; JDR; JDW; JDY; JDZ; JWH; KIH; KQZ; KRO; KRR; KWL; KWP; KWQ; KWS; KWT; KWY; KWZ; LLZ; LOD; LPH; LXH; LZN; LZO; LZY; MAI; MAX; MBB; MBF; MBH; MBI; MDM; MEH; MNH; MNI; MQV; NBH; NDN; NKB; NKG; NPJ; OAR; OCJ; ODP; OLO; ONN; OUR; OVD; OVE; PBF; PHX; PML; PQC; PUI; QHE; QSD; QSR; SBF,"Knife, Surgical; Retractor, Fiberoptic; Sterilizer, Steam; Wrap, Sterilization; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Table, Operating-Room, Mechanical; Chisel, Surgical, Manual; Curette, Surgical, General Use; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Suture, Nonabsorbable, Synthetic, Polyethylene; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Elevator, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Pneumatic Powered; Motor, Surgical Instrument, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Retractor, Self-Retaining, For Neurosurgery; Neurological Stereotaxic Instrument; Stripper, Surgical; Arthroscope; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Rasp; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Osteotome; Punch, Femoral Neck; Passer; Tap, Bone; Probe; Clamp; Screwdriver; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Cement Restrictor; Cerclage, Fixation; Staple, Fixation, Bone; Pin, Fixation, Threaded; Evacuator, Vapor, Cement Monomer; Mixer, Cement, For Clinical Use; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Dispenser, Cement; Component, Traction, Non-Invasive; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; System, Image Processing, Radiological; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Orthopedic Manual Surgical Instrument; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Intervertebral Fusion Device With Bone Graft, Lumbar; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Filler, Bone Void, Calcium Compound; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Injector, Vertebroplasty (Does Not Contain Cement); Spinal Channeling Instrument, Vertebroplasty; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Intraoperative Orthopedic Joint Assessment Aid; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Orthopaedic Surgical Planning And Instrument Guides; Shoulder Prosthesis, Reverse Configuration; Bone Cement, Posterior Screw Augmentation; Pedicle Screw Placement Guide; Drape, Surgical, Exempt; Shoulder Arthroplasty Implantation System; Posterior Cervical Screw Placement Guide; Sacroiliac Screw Placement Guide; Orthopedic Augmented Reality",1; 2,"3DMetal Diaphyseal Femoral Cones; 3DMetal Tibial Cones; 9604UK Gaston sleeve; AMIS K Long; AMIS Table; AMIStem H;; AMIStem and Quadra - Line Extension; AMIStem-C; AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared; AMIStem-P Short Neck; ATLAS; AcTiFlip , GFS Ultimate Hip; Access kit; ActiFlip; Advanced MyHip Planner; Arthroscopic Instruments; Awl; B-Screw; Bone Tap; Bone screw starter; BonePrep kit; Cannula System; Carefusion Shadow Line System; Cement Injector; Cement Obturator; Cement mixing system; Chisel; Clamp; Coated Hip Implants; Constrained Liner; Cortical Fixation Systems; Curette; DM Converter – TiN coated; DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR; Depth Gauge; Drill Bit; Elevator; Endo Head; Evolis Total Knee System; Extractor; FairFix Adjustable Button System; FairFix Adjustable Button System Extension; FairFix QT Adjustable Button; Fairfix Adjustable Button System; Fastener, Fixation, Nondegradable, Soft Tissue; GFS; GFS BTB; GFS Ultimate; GMK - Line Extension; GMK 3D Metal Tibial Tray; GMK 3D Metal Tibial Tray Extension; GMK Extension; GMK Full PE Tibial Components; GMK Hinge; GMK Hinge, GMK Revision; GMK Narrow; GMK Resurfacing Patella Size 4; GMK Revision & Hinge Extension - TiNbN Coating; GMK Revision SC Liners; GMK Revision extension; GMK Short Stem; GMK Sphere; GMK Sphere & GMK SpheriKA Cementless; GMK Sphere - Kinematic Alignment; GMK Sphere E-CROSS CR Tibial Inserts, GMK Sphere E-CROSS Flex Tibial Inserts and GMK Sphere E-CROSS Resurfacing Patella; GMK Sphere Extension; GMK Sphere Revision; GMK Sphere Tibial Inserts; GMK Total Knee System; GMK Total Knee System - GMK Revision Hybrid Liners; GMK Total Knee System - TiNbN Coating; GMK Total Knee System- Revision; GMK-Femoral Distal Augmentations; GMK-SPHERE Spherika Femurs and Tibial Trays Plus; GRAFT FIXATION SYSTEM; Gaston; General orthopedic instruments; Glenoid Reconstruction System; Glenoid Reconstruction System – Full Wedge Baseplate; HS SutureTape; Humeral Eccentric Reverse Metaphysis; IMT Motorized broach; Image Processing; Impactor; Injector Instrumentation; Intradisk; K-Wire; Renova Spine Kyphoplasty Kirschner Guide; KOMET SURGICAL BUR GENERAL & PLASTIC SURGERY; Knotless AP Suture Anchors; Knotless PEEK and PEEK CF Push-In Suture Anchor; Lateralized Glenosphere; Ligament Staple; M-ARS ACL: Anatomic Ribbon Surgery System; M-Vizion Femoral Revision System; M-Vizion Femoral Revision System Extension; M-Vizion Monobloc; M.U.S.T Pedicle Screw System; M.U.S.T. Combined Set Screws; M.U.S.T. Extension; M.U.S.T. MINI Posterior Cervical Screws System; M.U.S.T. MINI Posterior Cervical Screws System Extension; M.U.S.T. Midline Cortical (MC) Screw System; M.U.S.T. Mini Extension; M.U.S.T. Mini Posterior Cervical Screw System; M.U.S.T. Pedicle Screw Extension and Long Tab Implants; M.U.S.T. Pedicle Screw System; M.U.S.T. Pedicle Screw System - Extension; M.U.S.T. Pedicle Screw System – Extension; M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System; MITI TITANIUM SUTURE ANCHOR; MOTO Lateral; MOTO PFJ System; MOTO Parital Knee System; MOTO Partial Knee System Extension; MOTO™ Partial Knee & MOTO PFJ Systems Extension; MPACT Extension; MPACT Extension - Face Changing Liners; MSS - Humeral reverse liners extension; MSS – Monobloc stem; Manual Orthopedic Instruments; MasterLoc; MasterLoc™ Stem Extension; MasterLoc™ Stem: Lateralized Plus; Mbrace Cable; Mecta-C; Mecta-C Cervical Plate; Mecta-C Stand Alone; Mecta-C Stand Alone Extension; Mecta-C TiPEEK; Mecta-C TiPEEK with titanium markers; Mecta-C with titanium markers; MectaBone-G; MectaBone-P; MectaBone-P Injection System; MectaBone-P LV; MectaCer BIOLOX forte Femoral Heads; MectaCer Biolox Delta Heads; MectaFix CL Fixation Button with Continuous Loop; MectaLIF; MectaLIF 3D Metal; MectaLIF 3D Metal Anterior; MectaLIF Anterior; MectaLIF Anterior Extension; MectaLIF Anterior Lag; MectaLIF Anterior Simple; MectaLIF Anterior Stand Alone; MectaLIF Anterior Stand-Alone; MectaLIF Extension; MectaLIF Posterior Extension; MectaLIF TiPEEK; MectaLIF Transforaminal; MectaLIF Transforaminal TiPEEK; MectaLock All-Suture Anchors; MectaLock PEEK® Suture Anchor; MectaLock Suture Anchor Extension; MectaLock TI Triple Loaded Suture Anchor; MectaLock Ti Suture Anchor; MectaQTH; MectaScope System; MectaScrew Extension; MectaScrew PEEK®; MectaTap TI Suture Anchor; Mectacem-X; Mectacem-X (With Gentamicin); Mectacer Biolox Option Heads; Mectaplug PE II; Medacta Anatomic Shoulder Prosthesis; Medacta Bipolar Heads; Medacta Bone Screws; Medacta Shoulder System; Medacta Shoulder System - Reverse; Medacta Shoulder System Short Humeral Diaphysis; Medacta Shoulder System: Threaded Glenoid Baseplate; Medacta Total Hip Prosthesis - AMIStem C, Quadra C SN; Medacta Total Hip System; Medacta Versafitcup CC Trio; Meta + Cement; Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System; Mfinity Femoral System; MiniMAX; Mpact 3D Metal Foam; Mpact 3D Metal Implants Extension - DMLS Technology; Mpact 3D Metal Implants and Augments 3D Metal; Mpact 3D Metals Augments; Mpact Acetabular System; Mpact Constrained Liner; Mpact DM Converter; Mpact Double Mobility System; Mpact Extension; Mpact® 3D Metal Implants - DMLS Technology; Mpres Neck Preserving Stem; MyHip Planner & Verifier; MyKnee Cutting Blocks; MyKnee PPS-Pin Positioners; MyKnee R Pin Positioners; MyKnee UNI-ST; MyPAO Guides; MyPAO Planning Report; MyPAO SA guides; MyShoulder Planner; MyShoulder™ Placement Guides; MySpine Cervical Guides; MySpine Pedicle Screw Placement Guides; MySpine Pedicle Screw Placement Guides - LP; MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MyS; MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments; MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides; MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides; MySpine Unilateral Guides; MySpine WebPlanner & MyBalance; NextAR Hip Platform; NextAR Spine; NextAR TSA Platform; NextARTM Shoulder Platform; NextAR™ RSA Platform; NextAR™ Spine; NextAR™ Spine Platform; NextAR™ TKA Platform; NextAR™ TKA Platform My Knee PPS; ORTHOPEDIC DISPOSABLE SURGICAL NEEDLE; OrthoButton CL; Osteotome; PAO Cortical Screw; PEEK CF PUSH-IN SUTURE ANCHOR; PEEK CF PUSH-IN SUTURE ANCHORS; PPEK CF INTERFERENCE SCREW; PULLUP Adjustable Juxtacortical Fixation Device; Passer; PowerKnot High Strength Sutures; PowerSuture; Probe; Punch; Quadra C; Quadra C stems; Quadra H Stems, Quadra C Stems; Quadra H and R; Quadra R Stems; Quadra S Stems; Quadra S and H Stems; Quadra-P; Rasp; Reamer; Retractor; Reverse Shoulder; Rongeur; SLiK Anchors; SLiK Fix Screw; SMS Cementless Stem; STD Size Wire Case & Tray; Screwdriver; SecureFix Meniscus Repair; Shoulder System - TiNbN Coating; SnugFit; SnugFit All-Suture Anchor; SnugFit All-Suture Anchor Extension; Spinal Instrument; Sterilization tray; Sterilization trays; Stripper; Surgical Instrument; Surgical Instrument - Elevator; Surgical Instrument - Hook; Surgical Instrument Tray; Surgical Instrument, AC-Powered; Surgical Manual Instrument; Suture; Synd-EZ SS; Synd-EZ Ti; TWIST PEEK SUTURE ANCHOR; Titanium Interference Screw; Titanium Interference Screws; Total Hip Prosthesis System ¿ CoCr Line Extension; Traction Instrument; Treu GmbH k-wire; Twist AP Suture Anchors; V-LOX PEEK CF SUTURE ANCHOR; V-LOX TITANIUM SUTURE ANCHOR; V-lox Titanium Suture Anchors and Miti Suture Anchors; Vacuum Pump; Versacem and DM HC Liners; Versafit Cup Double Mobility Family; Versafitcup CC Trio - Additional Liners; Versafitcup CC Trio extension; Versafitcup DM Highcross HXUMWPE; X-Twist Biocomposite Suture Anchor; X-Twist PEEK Suture Anchor; eLIBRA; iMNS Medacta Navigation System",2008-02-11,264,2026-09-17,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008110533%22&limit=1
Conmed Corporation,1320894,3001451571,525 French Rd,Utica,NY,13502,United States,CONMED CORPORATION,1317214,Complaint file establishment; Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler,113,BTG; BYX; BYY; BZQ; CCX; DQA; DQK; DRG; DRX; DSA; DSB; DWG; EOQ; FBM; FCG; FCL; FCW; FDI; FDX; FEC; FED; FEH; FGE; FGX; FGY; FHN; FHO; FMF; FMP; FOX; FPA; FRG; FRN; FSM; FWZ; FXM; FXR; FXX; FYD; FZQ; GAA; GAT; GAZ; GBW; GCA; GCJ; GCL; GCT; GCX; GCY; GDT; GEA; GEE; GEF; GEI; GEN; GET; GFG; GXY; HAM; HBT; HES; HET; HFG; HGI; HIF; HIH; HRS; HRX; HTN; HTY; HWC; HWE; IKD; JOS; KCT; KDQ; KGE; KGX; KMK; KNF; KNQ; KNS; KNT; KPL; KQM; KQZ; KTI; LDD; LDR; LKF; LMB; LQR; LWG; MAI; MBI; MGP; MKJ; MND; MNK; MNL; NAE; NKC; NOD; NTN; OCT; OCX; OCY; ODC; ODD; OWW; OWY; QQS,"Brush, Biopsy, Bronchoscope (Non-Rigid); Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Monitor, Breathing Frequency; Support, Patient Position; Oximeter; Computer, Diagnostic, Programmable; Transmitters And Receivers, Physiological Signal, Radiofrequency; Electrode, Electrocardiograph; Cable, Transducer And Electrode, Patient, (Including Connector); Plethysmograph, Impedance; Electrosurgical Device; Bronchoscope (Flexible Or Rigid); Cannula And Trocar, Suprapubic, Non-Disposable; Biopsy Needle; Forceps, Biopsy, Non-Electric; Light Source, Fiberoptic, Routine; Snare, Flexible; Endoscopic Cytology Brush; Obturator, For Endoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Electrode, Flexible Suction Coagulator; Stents, Drains And Dilators For The Biliary Ducts; Snare, Non-Electrical; Cannula, Injection; Ligator, Hemorrhoidal; Pneumoperitoneum Needle; Syringe, Piston; Protector, Skin Pressure; Stand, Infusion; Set, Administration, Intravascular; Wrap, Sterilization; Pump, Infusion; Tray, Surgical, Instrument; Operating Room Accessories Table Tray; Camera, Still, Endoscopic; Holder, Camera, Surgical; Mask, Surgical; Apparatus, Exhaust, Surgical; Clip, Removable (Skin); Needle, Aspiration And Injection, Disposable; Suture, Nonabsorbable, Synthetic, Polyethylene; Tubing, Noninvasive; Catheter, Peritoneal; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Laparoscope, General & Plastic Surgery; Esophagoscope, General & Plastic Surgery; Light Source, Endoscope, Xenon Arc; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Staple, Removable (Skin); Cannula, Surgical, General & Plastic Surgery; Brush, Biopsy, General & Plastic Surgery; Applier, Staple, Surgical,; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Motor, Surgical Instrument, Pneumatic Powered; Bit, Surgical; Electrode, Cutaneous; Apparatus, Electrosurgical; Applier, Hemostatic Clip; Insufflator, Carbon-Dioxide, Uterotubal (And Accessories); Laparoscope, Gynecologic (And Accessories); Coagulator, Laparoscopic, Unipolar (And Accessories); Electrocautery, Gynecologic (And Accessories); Insufflator, Laparoscopic; Hysteroscope (And Accessories); Plate, Fixation, Bone; Arthroscope; Washer, Bolt Nut; Pin, Fixation, Smooth; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Cable, Electrode; Electrode, Electrosurgical; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Bottle, Collection, Vacuum; Forceps, Biopsy, Electric; Tape And Bandage, Adhesive; Device, Intravascular Catheter Securement; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Colonic Irrigation System; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; Bronchoscope Accessory; Dc-Defibrillator, Low-Energy, (Including Paddles); Controller, Infusion, Intravascular, Electronic; Cannula, Manipulator/Injector, Uterine; Device, Digital Image Storage, Radiological; Dislodger, Stone, Biliary; Surgical Table Cushion; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Dressing, Wound And Burn, Occlusive; Automated External Defibrillators (Non-Wearable); Ligator, Esophageal; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Board, Arm (With Cover), Non-Sterile; Led Light Source; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscope Channel Accessory; Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula; Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon; Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Stapler, Skin",1; 2; 3; U,"1 Liter Pressure Infusor; 1000 SES; 10K, Linvatec; 3 Liter Pressure Infusor; 4K UHD Monitor; ABC; ABC Flex Probes; ABC Footswitch; ABC Handpieces/Accessories; ABC Laparoscopic Probe; ABCFlex Flexible Endoscopy Probes; ADVANTAGE 2; AIR SAFE; AUTOCLAVABLE TRAY; Accessory Electrode; Ace 25 Biliary Guidewire; Adult Arm Support with Cover; Aer Defense; AirSeal; AirSeal Robotic Solution; AirSeal dV Solution; AirSeal iFS System; AirSeal® Bifurcated Filtered Tube Set; AirSeal® Cannula Cap; Airsoft Patient Positioner; Altrus; American Dilation System; Anchor Bag-Alone; Anchor Tissue Retrieval System; Anchor Tissue Retrieval System by CONMED; Apollo Papillotomes; Argo Knotless; Argo Knotless Anchor Kit; Argo Knotless GENESYS Anchor Kit; Argo Knotless Genesys Anchors; Arthoscopy ES Electrode; Arthroscopic Energy System; Articulating Arm; Asp-Irrator; AspenVAC ULPA/Charcoal Filter; Axcess Papillotomes; BADGER CANNULATED; BADGER DRILL BIT; BIO INSTABILITY INTRUMENT TRAY; BIOANCHOR INSTRUMENT TRAY; BRAINSTREAM Disposable Deep Cup EEG Electrodes; BULLSEYE TRAY; Backpads Strippers; Ball Electrodes; Beamer; Beamer AVEO Backwards Combability Cable; Beamer AVEO™ Electrosurgical Generator, Beamer AVEO™ Argon Module, Beamer AVEO™ Cart, Beamer AVEO™ Wired Foot Pedal; Beamer AVEO™ FILTER INTEGRATED ARGON PROBES, Beamer AVEO™ FILTER INTEGRATED ARGON SIDEFIRE PROBE; Beamer Argon Snare Probe; Bend A Beam; BiCap Superconductor; BiCapIII; Big Yank; BioBrace Extra-Articular Ligament Augmentation Kit; BioBrace Reinforced Implant; BioBrace® Reinforced Implant; Bipolar Coagulating Forceps; Bipolar Cord; Bite Block, Conmed; Blue Bullet; Bone Fixation; Bovie; Broncho; Brush Cytology; Buffalo Filter; C-SERTER; CANNUAL SHAFT; CANNULA; CANNULA TIP; CONMED Argo Knotless® Anchor; CONMED CrystalView; CONMED Laparoscopic Electrode; CONMED Laparoscopic Scissors; COOLING BIN; CORE; CORE E3; CRUCIATE RECONST; CUFFLINK; Camera Head Eyecup; Camera Holder; Camera and Console; Channel Master; Child Arm Support with Cover; CleanGuard; CleanGuide; Clear Guard; Clear Trace; Clearsite; Cleartrace, Profile, Suretrace, Positrace; Cleartrode, Softrace; Clearvac; Clearview; CoLink; ConMed; ConMed 1000 Smoke Evacuator Sys.; ConMed 1200 Smoke Evacuator Sys.; ConMed Irrigation Nozzle; ConMed Mixing and Delivery Kit; ConMed Stealth Electrode; ConMed Tens Electrode; Conmed Suction Coag; Contour Meniscus Arrow; Core; Core Dynamics; Core Gold; Core Trumpet; CrosFT Knotless; D Series; DetachaPort; DetachaTip; DetachaTip Instrument Tray; Detachatip III; Dflex; Dispersive Electrode Adapter; Dispersive Electrode Adapters; Disposable Bipolar Cable; Disposable Bipolar Cord; Disposable Bite Block; Disposable Microbiology Brush; Dual 1 Liter Pressure Infusor; Dual Tank Gauge; DuraGlide; Dynatrace, Snaptrace, e-Trode, Softrace; E9000 BUR; E9000 BUR RACK; ECOM; EDGE Bi-Polar Arthroscopic RF System; EDGE S.A.F.E.; ESU Footswitch; EZLink; Electrode Cable; Electronic Light Guide; Electrosurgical Handpiece; Eliminator; Eliminator PET Balloon Dilitation; Endoscopic Overtube; Entake Standard & Safety PEG System; EntriPort Surgical Trocar System; Exactrace; Examine; Excalibur; Excel; ExoShape; Expose Retractor; Extended Blade Electrosurgical Electrode; FIT Biliary Stone Balloon; FIXATION STRAP; FOREARM STRAP; FSR/SRS Series; FUMOVAC; FX Wire Advance; Fastrace, Heartbeat, VTrace; Flextip; FloVac; FloVac Handcontrolled suction; Foot Control; Footcontrol - Bipolar Forceps; Footcontrol Bipolar Forceps; Footswitch, Bipolar; Forcep Accessories; Frazier; GRAFIX GRAFT INSTRUMENT TRAY; Genesys Matryx; GoldVac; GoldVac Slim; Goldline handpieces/Pencils; Grasper; Gynecare Versascope; HALL; HALL DRILL REAM ATTACHMENT; HALL SERIES 3 OSCILLATOR; HD CARTRIDGE SCOPE; HD EYECUP CARTRIDGE LAPAROSCOPE; HD EYECUP LAPAROSCOPE; HD EYECUP SCOPE; HD Monitor; HOSE ASSEMBLY; HOSE HANDLERS; HP Pin Index Yoke 1m; HP Pin Index Yoke with Gauge 1m; HSW Laparoscopy Set; Hand-Trol; HandStand; Handcontrol - Bipolar Forceps; Handcontrol Bipolar Forceps; Harmony AIR; HarmonyAIR; Harrel; HelixAR; HelixAR ABC System; Holster; Huggables; HyfreVAC; Hyfrecator; Hyfrecator #733; Hyfrecator 2000 ESU and Accessories; Hyfrecator Reusable Pencil; Hyfrecator, Electrolase; IMPACT DRILL BIT; INFINITY; INSTABILITY TRAY; INSTRUMENT CASE; Infant Arm Support with Cover; Infinity; Infinity AIM; Infusor Compressor; Instatrace; Introducer Accessory; Invisatrace; LEG STABILIZER; LaparoLight; LaparoVue; LaseADAPT; Linvatec; Linvatec light source; LocaLisa; Looking Glass Shelf; Looking Glass™; Loop Electrosurgical Electrode; Loop Excision Electrode; Loop Excision Electrodes; Low Impact; MENISCUS INSTRUMENT TRAY; MEP-1; MICRO 100 TUBING; MICROCHOICE; MICROFREE; MICROLINK; MICROMITE DRILL; MICROMITE INSTRUMENT TRAY; MIN-REVO DRILL BIT; MINI DRIVER HANDPIECE; MINI-REVO; MINOS HANDPIECE; Maciol Lap Suture Set; MacroLyte Dispersive Electrode; Macrolyte; MicroLink; MicroSafe; Microlap Introducer; Monopolar Cable; Monopolar Forceps; Mounting Brackets; Multi-Link; NITROGEN HOSE; Nakao Spider-Net Retrieval Device; Needle Electrosurgical Electrode; Needle Tip Cytology Brush; Neotrode; Neptune; Next Generation X Wire Guidewire; OR-VAC; OSTEON HOSE; OnePort; Optimizer; Optimumm; OrthoVAC; PADPRO MULTI-FUNCTION ELECTRODES; PINN ACL DROSSPIN; PLUMEPORT; POPLOK DRILL BIT; POWERPRO; POWERPROMAX DRIVER ATTACHMENT; PadPro; Paradigm; PenAdapt; Phoenix; Pin Index Yoke Mounted Valve; Pinn-ACL; Pinn-ACL TRAY; Pivotal Graspers; PlumeGuard; PlumePen; PlumePort; PlumeSafe X5 Smoke Management System; PlumeVac; PowerPro Attachments; Powerpoint Pencil; Precisor; Pro2 Plus Oximeter System; Proforma; Proforma HF; Puncture Closure Device; QUIKLINK; R Series; R2; RCR INSTRUMENT TRAY; RETRACTOR GUARD; REVO DRILL BIT; Reflex; Reflex Staple Extractor; Reusable Bipolar Cord; Reusable Bipolar Forceps; Reusable Dispersive Electrode; Reusable Grounding Pad Cable; Reusable Grounding Pad Cables; Reusable Pediatric Dispersive Electrode; SAGITTAL SAW; SENTINEL DRILL BIT; SHE SHA; SHUTT MASTER SET; SMARTNAIL; SMARTPIN; SMARTPIN DRILL BIT; STABILIZER BALL; STRESS POST; Sabre Genesis; Scope Saver Bite Block; Select One; SelectOne; SelectOne Universal Plus; Singular; SkyVac; SmartNail; Smartnail; Smartpin; Smoke Evacuator Accessories; Smoke Plume; Smoke Shark; SnapEvac; SnapTrace; Softee; Stackhouse; Stat 2 Pumpette; Stat2; Steigmann-Goff; Stieg-Mann Goff; Stiegmann-Goff Bandito; Straight Blade Electrosurgical Electrode; StrykeVac; Suction Connecting Tubing; Sure Shot; SureTrace; Surefit; Surgairtome II BUR GUARD; SurgiQuest Laparoscope; Surgical Camera; Surgical Laser Mask; Switching Valve w/ hoses and mounting bracket; System 2450 ESU and Accessories; System 5000 ESU and accessories; System 7550 ABC ESU; T.U.R. Cable; TRACTION TOWER; TUNNEL DILATOR; TUR/Endoscopic Cable; TeleVac; Thermogard; Tip Cleaner; Totaltrace; Touch Glass; TroGard; TroGard Finesse; TruShot with Y-Knot; True HD 3MOS Camera System; ULTRAFIX DRILL; ULTRAFIX INSTRUMENT TRAY; UNIVERSAL CABLE; UNIVERSAL HOSE; UPPERARM STRAP; UltraPower; Ultratrace; Universal Cart Strap; Universal Modular Base Cart; Universal Modular Cart Cord Wraps; Universal Plus; Universal Plus ABC; Universal Plus ES; V-Trace; VARIOUS ENDOSCOPIC PROB; VCARE; VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator); VCARE Plus; VCare Dx; VCare Dx Plus; VENI-GARD SECUREMENT DEVICES; VP1003 Video Extended Length Tray (RADEL); VP1005 Video Tray Single Level (RADEL); VP1006 Video Arthroscope Tray (RADEL); VP1007 Video Laparoscope Tray (RADEL); Vacuum hose holder stand; Valve with Hoses and Mounting Bracket; Veni-Gard; Veni-Gard/Neoderm; Versa-Stim; Viking; ViroSafe; ViroVac; VisiClear; VueTip; Wang; Wang, Garg; Whistle; XO BUTTON HOLDER; Y-KNOT DRILL BIT; Y-KNOT FLEX DRILL BIT; Y-Knot; Y-Knot OneStep Anchor; Y-Knotless™ Flex Anchors; YKnot TruShot; ZONE SPECIFIC INSTRUMENT TRAY; Zone Specific AIM; cable; core; eLUma; iFS Cart 6"" Bottle with Valve; iFS Cart with Valve; iFS Cart with Valve and two Bottle Racks; iFS House Gas Switching Valve; linvatec; puddle vac; smokeSTAR",1992-06-27,258,2026-05-30,1,37,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221320894%22&limit=1
"Depuy Spine, Inc.",1526439,1526439,325 Paramount Drive,Raynham,MA,02767,United States,"DePuy Spine, Inc.",1526439,Complaint file establishment; Repackager or relabeler; Specification developer,108,BZN; EZX; FMF; FQH; FSM; FSQ; FST; FTY; FWZ; FZO; FZX; FZY; GAA; GAB; GAC; GAD; GCX; GCZ; GDF; GDG; GDI; GEA; GEY; GFC; GFI; GZT; HAO; HAW; HAX; HRR; HRS; HRX; HTC; HTD; HTE; HTF; HTJ; HTN; HTO; HTQ; HTS; HTW; HTX; HTZ; HWA; HWB; HWC; HWE; HWJ; HWK; HWM; HWN; HWP; HWR; HWT; HWX; HXB; HXC; HXD; HXG; HXK; HXP; HXW; HXX; HXZ; IQF; IQK; JDN; JDQ; JDW; JDZ; JEB; JEC; JOL; KQM; KQW; KTW; KTZ; KWP; KWQ; LOD; LWG; LXG; LXH; LXT; LYC; MAX; MCV; MDM; MJG; MNH; MNI; MQP; MQV; MRW; NDN; NKB; NKG; NPM; NQW; ODP; OLO; OSH; OUR; OVD; PDQ; PGM; PML,"Cart, Emergency, Cardiopulmonary (Excluding Equipment); Mesh, Surgical, Metal; Syringe, Piston; Lavage, Jet; Tray, Surgical, Instrument; Light, Surgical, Instrument; Light, Surgical, Fiberoptic; Tape, Measuring, Rulers And Calipers; Operating Room Accessories Table Tray; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Retainer, Surgical; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Driver, Surgical, Pin; Osteotome, Manual; Retractor, Self-Retaining, For Neurosurgery; Instrument, Surgical, Non-Powered; Neurological Stereotaxic Instrument; Tong, Skull For Traction; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Arthroscope; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Knife, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Instrument, Compression; Punch, Femoral Neck; Driver, Prosthesis; Template; Tap, Bone; Probe; Wrench; Clamp; Tamp; Holder, Needle; Orthopedic; Instrument, Bending Or Contouring; Bender; Screwdriver; Cutter, Wire; Orthosis, Cervical-Thoracic, Rigid; Orthosis, Cervical; Implant, Fixation Device, Spinal; Cerclage, Fixation; Pin, Fixation, Threaded; Mixer, Cement, For Clinical Use; Table, Surgical With Orthopedic Accessories, Manual; Component, Traction, Invasive; Catheter And Tip, Suction; Camera, Surgical And Accessories; Goniometer, Nonpowered; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Bone Cement; Surgical Table Cushion; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Bone Grafting Material, Synthetic; Intervertebral Fusion Device With Bone Graft, Lumbar; Spinal Pedicle Screw, Fixation, Appliance System; Instrument, Manual, Surgical, General Use; Device, Percutaneous, Biopsy; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Cement, Bone, Vertebroplasty; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Bone Grafting Material, Animal Source; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Neurosurgical Nerve Locator; Growing Rod System; Bone Cement, Posterior Screw Augmentation",1; 2; 3; U,"ACROMED; ADS Bone Nail; AEGIS; ALC Dynamized; Ace  Halo; Ace Halo; Ace Halo Measuring Tape; Ace Halo Vest System; Ace Halo Vest System, Bremer Halo System; Ace Halo Vest System, Bremer Halo system; Aegis; Anterior ISOLA System; Anterior ISOLA Spine System; Kaneda Anterior Scoliosis System;; BENGAL; BENGAL System; BOWTI; Bengal; Bengal Stackable Cage System; Bengal, Bengal Stackable, Concorde Bullet, Concorde Inline, Cougar, Cougar LS Lateral; BowTi; Bremer Halo; Bremer Positioning Pad; Bremer table accessories; CELLECT BONE MARRO; CHARITE; CONCORDE; CONCORDE BULLET SPINAL SYSTEM; CONCORDE Bullet Spinal System; CONCORDE System; CONDUIT Cages; FIBERGRAFT BG Putty; CONDUIT HL LLIF; CONDUIT Instruments; CONDUIT Switch Plate; CONFIDENCE High Viscosity Spinal Cement; CONFIDENCE SPINAL CEMENT SYSTEM; COUGAR; COUGAR LATERAL CAGE SYSTEM; COUGAR System; CROSSNAV Disc Preparation and Interbody Instruments; CROSSNAV Navigation Enabled Instruments; CROSSNAV Navigation Enabled Instruments and Universal Navigation Adaptor Set (UNAS); Cellect Graft Preparation; Concorde Bullet; Concorde Inline Spinal System; Concorde System; Pipeline Access System; Mountaineer OCT Spinal System; X-MESH Expandable Cage System; Conduit; Confidence; Confidence Bone Cement; Confidence High Viscosity Cement; Confidence Ultra High; Cougar; Cougar LS Lateral Cage System; CrossOver; DEVEX; DEVEX System; DISCOVERY; DOC Ventral; DOC Ventral Cervical Stabilization System; DePuy Pulse Lumbar Cage System; Devex Mesh System; Discovery; Discovery Bone Screws; E-Z Link; E-Z X System; EAGLE; EAGLE PLUS ANTERIOR CERVICAL PLATE SYSTEM; EAGLE PLUS MICRO ACP SYSTEM; EAGLE/SWIFT; EIT Cellular Titanium ALIF Cages; EIT Cellular Titanium Cages; EIT Cellular Titanium Cervical Cage; EIT Cellular Titanium LLIF Cages; EIT Cellular Titanium Lumbar Cage - T/PLIF; EIT Cellular Titanium PLIF Cages; EIT Cellular Titanium TLIF Cages; EXPEDIUM; EXPEDIUM Spine System; EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws); EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods; Emerging Implant Technologies GmBH Instruments; Emerging Implant Technologies GmbH Trays; Expedium; Expedium 4.5; Expedium Anterior; Expedium Anterior Spine System Driver, Case, Caddy, Lid, Tray or Rod Reducer; Expedium Fenestrated Screw Systems; Expedium Powered Instruments; Expedium Powered Instruments, ELLIPTICAL HANDLE, T-HANDLE, RATCHETING; Expedium SFX; Expedium SFX Cross Connector System Case, Tray, Lid, Caddy, Name Plate, Handle, Label, Inserter, Shaft or Plate Ruler; Expedium SFX Cross Connector System Stabilizer or Bender; Expedium Spinal System; Expedium Spine System; Expedium Spine System Bender, Forceps, Cutter, Pan, Alignment Fork, Quick Stick Frame, Modular Clamp or Tap; Expedium Spine System Case, Caddy, Lid, Tray, Laminar Finder, Thoracic Facet Finder, Shaft, Sleeve, Tap or Guide; Expedium Spine System Feeler, Wire Cutter, Compressor, Distractor or Pusher; Expedium Spine System Guide, DI Reduction Tube for Clip-on, Rod Stabilizer, Pedicle Screw Sizer or Pedicle Finder; Expedium Spine System Inserter, Probe, Handle, Tap, SI Clip-On Reduction Device Clip Assembly with Pins, Driver orSleeve; Expedium Spine System Rod Approximator, Flex. Clipon Reduction device clip, Facilitator or DI Clip-On Reduction Device; Expedium Spine System Stabilizer, Tab Key, Tab remover, Reduction Clip, Pedicle Finder, Hook Starter or Rotator; Expedium Spine System Tab Key, Tab remover, Lamina/Transverse Process Starter, Elevator, Rongeur or Gage; Expedium Spine System Wire Cutter; Expedium Spine System, Viper System; Expedium Spine System; Viper 2 System; Cougar LS Lateral Interbody Instrument System;; Expedium Spine system; Expedium, Synapse; Expedium, Viper, Viper 2; FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute; FIBERGRAFT Aeridyan Matrix Bone Graft Substitute; FIBERGRAFT BG Matrix Bone Graft Substitute; FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE; FIBERGRAFT BG Putty Bone Graft Substitute; FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix B; FRONTIER; Free Needle Loop; GPS Advanced; 5 cc GPS Advanced Cannula; GPS Advanced; GPS Advanced Cannula; HEALOS Dental; HEALOS Dental Bone Graft Replacement; HEALOS FX; Healos; Healos II  Bone Graft Substitute; I/F CAGE; IN MOTION; ISOLA; ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS; ISOLA Pediatric; ISOLA Spine System Holder; ISOLA Spine System Rod Cutter; ISOLA Spine System; Universal ALIF Instrument Set; Cage Weasel Instruments; Monarch Spine System; Bengal Stackable Cage; JAGUAR; Jaguar; KANEDA PLATE DRIVER; KANEDA SPREADER; KEYSTONE; Kaneda; Kaneda SR; LEOPARD System; Leopard; M-2 Anterior Plate; M-2 Plate; MONARCH; MOSS; MOSS MIAMI Spine System; MOUNTAINEER; MOUNTAINEER Laminoplasty System; MOUNTAINEER OCT, SUMMIT SI OCT, SYMPHONY OCT, SUMMIT Fixation System; Manual Calibrated Navigation Handle for Use with Brainlab; Monarch; Monarch 6.35; Monarch Spine System; Monarch Spine System Distractor, Clamp, Compressor, Rocker, Holder, Rod-template or Pusher; Monarch Spine System Probe, Handle, Bender, Driver, Screwdriver, Rod Template or Wrench; Moss; Moss Intradiscal Instruments; Moss Miami Spine System; Concorde System; X-MESH Expandable Cage System; Moss Miami; Moss Miami Magnum; Moss Miami Magnum Spine System Feeler; Moss Miami Spine System; Moss Miami Spine System Clamp, Compressor, Distractor, or Remover; Moss Miami Spine System Pusher; Mountaineer OCT; Mountaineer OCT Spinal System; N/A; OCELOT; OCT Spinal Fixation System; Ocelot; Ocelot Stackable Cages; PEAK; PIPELINE; PIPELINE II ACCESS SYSTEM; PLIF-SG; PULSE; Peak; Pipeline; Pipeline Access System; Profile; Robotic Integration Instruments; SABER LUMBAR I/F CAGE SYSTEM; SCREW REMOVER; SIJF Cannulated Screw; SKYLINE; SKYLINE ANTERIOR CERVICAL PLATE SYSTEM; SKYLINE® Anterior Cervical Plate System; SLIM-LOC; SOF'WIRE; SPOTLIGHT; SUMMIT; SUMMIT SI OCT Spinal Fixation System; SWIFT; SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM; SYMPHONY GRAFT DELIVERY SYSTEM; SYMPHONY Navigation Ready Instruments; SYMPHONY OCT System; SYMPHONY Open but Unused; SYRINGE CONNECTOR; Skyline; Songer Cable; Spotlight Access System; Spotlight PL; Suction Instrument; Summit; Summit OCT; Surgical Titanium Mesh; Symphony; T.L.I.F.; TELIGEN; TELIGEN CART Assembled; TELIGEN CART assembled; TELIGEN System Instruments; TELIGEN System Navigation Ready Indications; TELIGEN System Navigation Ready Instruments; TELIGEN System Peripheral Motor Nerve Stimulation Indications; TIMX; TLIF SG Instruments Vertebral Spreader; TLIF SG Instruments; PLIF SG Instruments; Anterior I/F Cage; Bengal System;; Teligen System; TiMX; TiMX Low Back; TriALTIS; TriALTIS™ Spine System; UNIPLATE; UNIPLATE 2 ACP System; UNIPLATE ACP System; Uniplate; Universal ALIF Instrument Set; Universal Navigation Instruments; University Plate; VBR Spinal System; VELYS™ Active Robotic Assistance; VERTIGRAFT; VG2; VG2 Cervical Instruments; Universal ALIF Instrument Set; Surgical Titanium Mesh;; VIPER; VIPER Fenestrated Screw Systems; VIPER PRIME; VIPER PRIME Screws with Fenestrations; VIPER Prime; VIPER Prime, VIPER PRIME Fenestrated, EXPEDIUM Verse Fenestrated; VIPER System; VIPER2; VSP; VSP ALUMINUM CONTO; VSP PLATE BENDER; VSP SCREW (END) CUTTER; VSP SCREW EXTRACTOR; VSP System; Vertebroplastic Radiopaque Bone Cement; Viper; Viper 2; Viper F2 Facet Fixation System; Viper System; Viper System Post, Tap, Handle or Cap; Viper System Screw Extension, Closed, Tray, Case, Caddy, Lid, Driver, Screwdriver, Tap, Wrench, Tightener or Shaft; Viper2 System; WALLIE-HEINIG OSTEOTOMES; X-MESH; X-MESH EXPANDABLE CAGE SYSTEM",1987-05-17,258,2026-05-26,1,15,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221526439%22&limit=1
Arthrex Distribution Hub EMEA B.V.,3016851379,3016851379,Amperestraat 9,Venlo Limburg,,5928 PE,Netherlands,"ARTHREX, INC.",1220287,Exporter to the US,83,BWN; BZN; DXJ; FEI; FLE; FMF; FRG; FRO; FSM; FWB; FWL; FWZ; FZW; GAB; GAP; GAS; GAT; GAZ; GCJ; GEI; GFA; GFF; HAB; HRS; HRX; HSB; HSD; HST; HSX; HTD; HTJ; HTN; HTO; HTW; HTY; HTZ; HWC; HWE; HWT; HXB; HXD; HXJ; IQG; IZI; JDI; JDQ; JDR; JQC; JQO; JWH; KGS; KQM; KQX; KQZ; KRR; KWD; KWS; KWY; KYZ; LLZ; LRY; LXH; LXI; LZB; MAI; MBF; MBH; MBI; MBP; MDM; MHW; MNU; MQV; NAC; NBH; OIY; ORG; OUG; PHX; PKC; PLF; QHE; QHQ,"Table And Attachments, Operating-Room; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Display, Cathode-Ray Tube, Medical; Instrument, Special Lens, For Endoscope; Sterilizer, Steam; Syringe, Piston; Wrap, Sterilization; Dressing, Wound, Drug; Tray, Surgical, Instrument; Camera, Television, Surgical, Without Audio; Camera, Cine, Endoscopic, Without Audio; Operating Room Accessories Table Tray; Expander, Surgical, Skin Graft; Needle, Suturing, Disposable; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Tubing, Noninvasive; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Saw, Powered, And Accessories; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Forceps; Gauge, Depth; Washer, Bolt Nut; Reamer; Bit, Drill; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Template; Probe; Clamp; Staple Driver; Adaptor, Holder, Syringe; System, X-Ray, Angiographic; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Cerclage, Fixation; Staple, Fixation, Bone; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Balance, Analytical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Retention Device, Suture; Camera, Surgical And Accessories; Goniometer, Ac-Powered; Component, Traction, Non-Invasive; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Syringe, Irrigating (Non Dental); System, Image Processing, Radiological; Punch, Surgical; Orthopedic Manual Surgical Instrument; Guide, Drill, Ligament; Finger Cot; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Instrument, Manual, Surgical, General Use; Dressing, Compression; Staple, Absorbable; Filler, Bone Void, Calcium Compound; Dressing, Wound, Hydrophilic; Accessories, Arthroscopic; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Platelet And Plasma Separator For Bone Graft Handling; Medical Device Data System; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Bone Wedge; Shoulder Arthroplasty Implantation System; Total Shoulder Arthroplasty System",1; 2; U,"ACCIN Bipolar Head System; ACCIN Patellofemoral System; ACCIN Total Knee System; ACCIN Uni-Knee System; ACL TightRope; ACL TightRope Double Bundle; AESCULAP STERILCONTAINER SYSTEM; ANATOEMIC PROSTHESIS; ARTHREX ANATOEMIC P; ARTHROERESIS IMPLANT; ARTHROSCOPY LEG HOLDER; ARTHROSCOPY PUMP; Adaptor, Holder, Syringe; Apparatus, Traction, Non-Powered; Arthrex Ankle Fusion Plating System; Arthrex BioComposite SutureTak; Arthrex BioSuture; Arthrex Biocomposite Transfix; Arthrex Compression Plates; Arthrex Distal Extremity Plate System; Arthrex FiberTak Suture Anchors; Arthrex Fracture Plates; Arthrex Fracture Plates and Screws; Arthrex Fracture System; Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi; Arthrex Graft-Anchor; Arthrex Knotless SutureTak Anchor; Arthrex Low Profile Screws; Arthrex MicroSuture Anchors; Arthrex Mini TightRopes; Arthrex Minimally Invasive Ankle Fusion Plate; Arthrex PCL TightRope; Arthrex Plates, Screws, and Staples; Arthrex PushLock; Arthrex PushLock Tenodesis Anchor; Arthrex Pushlock; Arthrex RetroFusion Screw  Smooth or Threaded Metallic Bone Fixation Fastener; Arthrex Suture; Arthrex SwiveLock Anchors; Arthrex Tibial  GraftBolt; Arthrex Tibial GraftBolt; Arthrex Univers Apex; Arthrex Univers CA Heads; Arthrex Univers II Glenoid Components; Arthrex Univers II Shoulder Prosthesis; Arthrex iBalance BiCompartmental Arthroplasty System; Arthrex iBalance Patella Implant, Dome; Arthrex iBalance TKA System; Arthroscope; Arthroscope  Sheath; Arthroscopes; BI-CORTICAL BIO-POST AND WASHER; BIO-ABSORBABLE CORKSCREW; BIO-BUTTON; BIO-COMPRESSION SCREW; BIO-CORKSCREW FT; BIO-FASTAK SUTURE ANCHOR; BIO-PIN; BIO-POST AND WASHER; BIOCOMPOSITE; BIOCOMPOSITE INTERFERENCE SCREW; BIOCOMPOSITE SUTURE ANCHORS; Balance, Analytical; Bio-Composite SutureTak; Biosync; Biosync Bone wedge; CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO; CHONDRAL DART; COBE Angel Whole Blood Separation System; COMPRESSION STAPLE; CONTAINER SYSTEM; CONTINUOUS WAVE III; CORKSCREW ANCHORS; Camera Heads; Camera, Television, Surgical, Without Audio; Clamp; Component, Traction, Non-Invasive; DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER; DOUBLE SYRINGE (ACP) SYSTEM; Dressing, Compression; Dual Wave Pump; Elastic bandage; FASTAK SUTURE ANCHOR; FIBERTAPE; FIBERWIRE BUTTON REPAIR KIT; FINGERSHIELD; Fastener, Fixation, nondegradable, soft tissue; FiberStitch Implant; FiberTak DR; FiberTape; FiberWire; Fiberstick; Fracture Plates & Screws; HATRIC; HUMERAL FRACTURE PLATE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT; INTERFERENCE SCREW; INTERFERENCE SCREWS; Instrument, Special Lens, For Endoscope; Instrument, manual, surgical, general use; Knee Joint Patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; LOW PROFILE PLATE AND SCREW SYSTEM; Laproscopes; MENISCAL CINCH; MENISCAL DART, DARTSTICK,; MINI BIO-ANCHOR; MINI TIGHTROPE; Metallic Bone Fixation; Mini TightRope CMC; Nonabsorbable poly(ethylene terephthalate) Surgical Suture; OPES ELECTRODES AND ACCESSORIES; ORTHOPEDIC MANUAL INSTRUMENTS; OSTEOTOMY PLATE; OSTEOTOMY SYSTEM; Orthopedic Template; PARS Needle; PROSTOP PLUS; PROWICK; PUSHLOCK; RETROBUTTON; RF device, blade, hook; SHAVER BLADES; SHAVER SYSTEM; SHOULDER HOLDER; Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis; Shoulder joint metal/ polymer semi-constrained cemented prosthesis; Single/multiple component metallic bone fixation appliances and accessories; Stimublast; Sutter CURIS RF Generator; Syringe, Irrigating (Non Dental); Syringe, piston; TAK FAMILY; TENODESIS FAMILY; TRIM-IT FAMILY; Table Attachments, Operating-Room; Thrombinator System for use with the Arthrex Angel Concentrated Platelet Rich Plasma (PRP)System; UNIVERS FRACTURE; UNIVERS II; UNIVERS SHOULDER; Univers II; Univers Revers Shoulder Prosthesis System; VARIOUS BURS; VARIOUS IMPLANTS; VARIOUS INSTRUMENTS; Viscogel/Viscospray; WASHER; bone void filler; cart, emergency, cardiopulmonary; display, cathode-ray tube, medical; drill bit; fixation pin; fixation plate; iBalance; knee joint patellofemorotibial polymer/metal/polymer semi-constrained; orthopedic manual instrument; saw blade; single/ multiple component metallic bone fixation appliances and accessories; smooth or threaded metallic bone fixation fastener",1994-01-27,255,2024-07-25,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223016851379%22&limit=1
Boston Scientific Limited,9681260,3002806565,Ballybrit Business Park,GALWAY Galway(County),,'--,Ireland,Boston Scientific Corporation,9912058,Manufacturer; Specification developer,107,BTG; DQO; DQX; DQY; DRA; DRF; DSA; DTL; DXO; DYB; EOQ; ESW; EZB; EZN; FAD; FAE; FBK; FBN; FCG; FCL; FDF; FDI; FDT; FDX; FED; FEQ; FET; FFA; FFK; FGB; FGE; FGX; FQH; GBM; GBO; GBZ; GCA; GCB; GCJ; GEI; GEX; IKD; IWP; JCT; KGZ; KNQ; KNS; KNT; KOD; KOE; KQM; KRA; KRD; KTI; KYZ; LIT; LJE; LOX; LPB; LQC; LQR; LZC; MAF; MAV; MCX; MDM; MIR; MJN; MQR; MUM; NGV; NIM; NIN; NIO; NIP; NIQ; NIU; NJE; NTN; NWT; NWX; OAD; OAE; OCW; OCY; ODC; ODD; ODG; ONU; OOB; OTN; PAH; PCU; PIF; PKL; PNB; PNO; PTM; PTS; PWI; QAN; QEW; QEY; QEZ; QKJ; QTD; QZI,"Brush, Biopsy, Bronchoscope (Non-Rigid); Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Catheter, Electrode Recording, Or Probe, Electrode Recording; Cable, Transducer And Electrode, Patient, (Including Connector); Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Transducer, Pressure, Catheter Tip; Introducer, Catheter; Bronchoscope (Flexible Or Rigid); Prosthesis, Esophageal; Stylet For Catheter, Gastro-Urology; Dilator, Catheter, Ureteral; Stent, Ureteral; Prosthesis, Penile; Endoscopic Injection Needle, Gastroenterology-Urology; Choledochoscope And Accessories, Flexible/Rigid; Biopsy Needle; Forceps, Biopsy, Non-Electric; Colonoscope And Accessories, Flexible/Rigid; Snare, Flexible; Duodenoscope And Accessories, Flexible/Rigid; Endoscopic Cytology Brush; Endoscopic Access Overtube, Gastroenterology-Urology; Pump, Air, Non-Manual, For Endoscope; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Tube, Drainage, Suprapubic; Lithotriptor, Electro-Hydraulic; Ureteroscope And Accessories, Flexible/Rigid; Stents, Drains And Dilators For The Biliary Ducts; Snare, Non-Electrical; Lavage, Jet; Catheter, Urethral; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Cholangiography; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Needle, Catheter; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Cable, Electrode; Radiographic Protective Glove; Prosthesis, Tracheal, Expandable; Accessories, Catheter; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Catheter, Urological; Dilator, Urethral; Camera, Surgical And Accessories; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Catheter, Angioplasty, Peripheral, Transluminal; Catheter, Nephrostomy; Catheters, Transluminal Coronary Angioplasty, Percutaneous; Cardiac Ablation Percutaneous Catheter; Lithotriptor, Biliary Mechanical; Dislodger, Stone, Biliary; Medical Glove, Specialty; Stent, Coronary; Syringe, Balloon Inflation; Catheter, Coronary, Atherectomy; Instrument, Manual, Surgical, General Use; Shunt, Portosystemic, Endoprosthesis; Catheter, Intravascular Occluding, Temporary; Stent, Colonic, Metallic, Expandable; Stent, Metallic, Expandable, Duodenal; System, Appendage Closure, Left Atrial; Stent, Carotid; Stent, Renal; Stent, Iliac; Stent, Superficial Femoral Artery; Coronary Drug-Eluting Stent; Stent, Superficial Femoral Artery, Drug-Eluting; Intracranial Neurovascular Stent; Led Light Source; Endoscopic Cholangiogram Kit; Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation; Endoscopic Tissue Approximation Device; Endoscopic Guidewire, Gastroenterology-Urology; Endoscope Channel Accessory; Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula; Endoscopic Ultrasound System, Gastroenterology-Urology; Drug-Eluting Peripheral Transluminal Angioplasty Catheter; Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling; Pancreatic Stent, Covered, Metallic, Removable; Gastrointestinal Tubes With Enteral Specific Connectors; Hemostatic Metal Clip For The Gi Tract; Biliary Stent System For Benign Strictures; Catheter, Percutaneous, Cutting/Scoring; Syringe, Balloon Inflation, Exempt; Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt; Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse; Stent, Iliac Vein; Peripheral Mechanical Thrombectomy With Aspiration; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter; Stent, Central Venous; Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",1; 2; 3; U; f,"AGENT Paclitaxel-Coated Balloon Catheter; AngioJet Spiroflex Thrombecotmy Set; AngioJet Spiroflex VG Thrombectomy Set; AngioJet Ultra 5000A Console; AutoElite Thrombectomy System Console; Blazer II HTD Temperature Ablation Catheter; Blazer II Temperature Ablation Catheter; Blazer II XP Temperature Ablation Catheter; Blazer Open-Irrigated Ablation Catheter; Blazer Prime HTD Temperature Ablation Catheter; Blazer Prime XP Temperature Ablation Catheter; Blazer Solid-Tip Ablation Cather Cable, Sterile Cable; Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable; Cable IntellaTip MiFi OI to Maestro 4000; Cable IntellaTip MiFi XP Sterile Cable; Cable, IntellaNav Ablation Catheter; Cable, IntellaTip MiFi OI; Cable, Maestro 4000; Carotid WALLSTENT Monorail Endoprosthesis; ELUVIA Drug-Eluting Vascular Stent System; Electrophysiology Cable Non-Sterile Cable; Electrophysiology Cable Sterile Cable; Epic Vascular Self-Expanding Stent System; Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter; Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit; Express LD Iliac/Biliary Stent System; Express SD Renal/Biliary Premounted Stent System; FARAPOINT Pulsed Field Ablation Catheter; FARASTAR AAMI Recoding System Module ECG Output Module; FARASTAR AAMI Recording System Module ECG Trunk Cable; FARASTAR AAMI Snap Cable R/L; FARASTAR AAMI Snap Cable V Set; FARASTAR Cable Set; FARASTAR Catheter Connection Cable; FARASTAR EGM Cable; FARASTAR EGM to EP Recording System Cable (FARAPOINT); FARASTAR Gen 2 Catheter Connection Cable; FARASTAR IEC Recording System Module ECG Output Module; FARASTAR IEC Recording System Module ECG Trunk Cable; FARASTAR IEC Snap Cable C Set; FARASTAR IEC Snap Cable R/L; FARASTAR Inter-Connection Box; FARASTAR Mapping System Module; FARASTAR Mapping System Module ABL Output to Signal Station ABL Input Cable FARASTAR to OPAL HDx; FARASTAR Mapping System Module Auxiliary Cable; FARASTAR Mapping System Module BNC-Phono Cable; FARASTAR Mapping System Module Back Patch Cable; FARASTAR Mapping System Module Back Patch Cable Male; FARASTAR Pulsed Field Ablation Generator; FARASTAR Recording System Module; FARASTAR Recording System Module Catheter Pin Cable; FARASTAR Recording System Module ECG Output to Signal Station ECG Input Cable FARASTAR to OPAL HDx; FARASTAR Recording System Module EGM Input Module; FARASTAR Recording System Module EGM Output to Singal Station EGM Input Cable FARASTAR to OPAL HDx; FARASTAR Stimulation Module Cable; FARASTAR Stimulation Module Female Cable; FARASTAR Stimulation Module Male Cable; FARASTAR Stimulation Module Y-Cable Long; FARASTAR Stimulation Module Y-Cable Short; FARAWAVE Nav Pulsed Field Ablation Catheter; FARAWAVE Pulsed Field Ablation Catheter; Flexima Nephrostomy Catheter System; Flexima Nephrostomy Catheter System Kit; Flexima Nephrostomy Catheter System Kit with Dissolving Tip; Flexima Nephrostomy Catheter System with Dissolving Tip; Flextome Cutting Balloon Microsurgical Dilatation Device; INTELLAGEN Catheter Adapter Cable 0.3 Meter; INTELLAGEN ECG Connection Cable 3 Meter; INTELLAGEN Foot Pedal; INTELLAGEN Foot Pedal Extension Cable 7 Meter; INTELLAGEN Grounding Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 1 Meter; INTELLAGEN Irrigation Pump Connection Cable 10 Meter; INTELLAGEN Irrigation Pump Connection Cable 3 Meter; INTELLAGEN Irrigation Pump Connection Cable 5 Meter; INTELLAGEN Irrigation Pump Kit; INTELLAGEN RF Generator Kit; INTELLAGEN Remote Control Connection Cable 10 Meter; INTELLAGEN Remote Control Connection Cable 15 Meter; INTELLAGEN Remote Control Connection Cable 25 Meter; INTELLAGEN Remote Control Connection Cable 30 Meter; INTELLAGEN Remote Control Kit; INTELLAGEN Serial Communication Cable 15 Meter; INTELLAGEN Serial Communication Cable 3 Meter; INTELLAGEN Serial Communication Cable 5 Meter; INTELLAGEN Tubing Set; Innova Vascular Self-Expanding Stent System; IntellaNav MiFi Open-Irrigated Ablation Catheter; IntellaNav MiFi XP Temperature Ablation Catheter; IntellaNav Open-Irrigated Ablation Catheter; IntellaNav ST Ablation Catheter; IntellaNav StablePoint Ablation Catheter; IntellaNav StablePoint Catheter Cable; IntellaNav XP Temperature Ablation Catheter; IntellaTip MiFi Filter Module RF Frequency Filter; IntellaTip MiFi Open-Irrigated Ablation Catheter; IntellaTip MiFi Reference Cable Non-Sterile Electrophysiology Cable; IntellaTip MiFi XP Temperature Ablation Catheter; JINRO Pigtail Nephrostomy Catheter; JINRO Pigtail Nephrostomy Catheter Kit; JINRO Pigtail Nephrostomy Catheter Placement Kit; Maestro 4000 Controller, RF Cardiac Ablation Controller; Maestro 4000 Pod, 100W, RF Cardiac Ablation Pod, 100W; Maestro 4000 RF Cardiac Ablation Controller; Maestro 4000 RF Cardiac Ablation Pod 100; Maestro 4000 Remote Control; Maestro Foot Switch; Maestro Remote Control Cable; Malecot Nephrostomy Catheter Set; MetriQ Foot Switch; MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set; MetriQ Pump Irrigation Pump; NaviGuide Percutaneous Access Needle; Non-Sterile Cable; Non-Sterile Cable (Controller to Pump or Remote Control); OPAL HDx Connection Box - MAESTRO; OPAL HDx Connection Box - MAESTRO STABLEPOINT; OPAL HDx Connection Box INTELLAGEN; OPAL HDx Connection Box INTELLAGEN STABLEPOINT; POLARx Cryoablation Balloon Catheter; POLARx FIT Cryoablation Balloon Catheter; Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip; Percuflex Locking Loop Nephrostomy Catheter; Percuflex Locking Loop Nephrostomy Catheter with Fader Tip; Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit; Percutaneous Access Needle; Percutaneous Access Needle with Echogenic Tip; Percutaneous Access Set; Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System; REBEL Platinum Chromium Coronary Stent System; RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint; Ranger Paclitaxel-Coated PTA Balloon Catheter; Re-entry Malecot Nephrostomy Catheter Set; Rhythmia HDx Ablation Connection Box; Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN; Rhythmia HDx Ablation Connection Box - for INTELLAGEN; Rhythmia HDx Ablation Connection Box Maestro; Rhythmia Mapping System IntellaNav CB - Maestro; SMARTFREEZE Catheter Extension Cable; SMARTFREEZE Cryo-Cable; SMARTFREEZE Cryo-Console; SMARTFREEZE Cryo-Console Foot Switch; SMARTFREEZE Diaphragm Movement Sensor; SMARTFREEZE Inter-Connection Box; SMARTFREEZE Remote Control; SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System; TLA Introducer Needle and Sheath Set; Trapezoid RX Wireguided Retrieval Basket; VENOUS WALLSTENT Self-Expanding Stent; VTC Nephrostomy Catheters System; VTC Nephrostomy Catheters System Kit; WALLSTENT Endoprosthesis Self-Expanding Stent; WALLSTENT RP Endoprosthesis Self-Expanding Stent; WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device",1983-09-09,231,2026-09-03,22,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229681260%22&limit=1
Teleflex LLC (NADC),3010041511,3010041511,11245 N Distribution Cove,Olive Branch,MS,38654,United States,Teleflex,9062981,Manufacturer; Repackager or relabeler,463,BRW; BSO; BSP; BSR; BTO; BWB; BYY; CAC; CAE; CAL; CAZ; CCX; DQO; DQT; DQX; DQY; DRB; DRC; DSP; DSS; DTI; DWO; DWP; DWQ; DWS; DWX; DXC; DXE; DXT; DXZ; DYB; EAX; EBA; EFQ; EHJ; EIB; EIG; ELA; EMD; EME; EMF; EMG; EMH; EMI; EMK; EML; EMM; EOQ; EOX; EPE; EPY; EQH; EQN; ERA; EWY; EXX; EYR; EZB; EZM; FAT; FAX; FBM; FBP; FBX; FCG; FCL; FCO; FCT; FCY; FCZ; FDE; FDG; FDZ; FEA; FEI; FEN; FFN; FFO; FFP; FFQ; FFR; FFY; FGM; FGN; FGO; FGS; FGY; FHA; FHH; FHI; FHL; FHN; FHQ; FKC; FLK; FLL; FMF; FMG; FMH; FMI; FMK; FMP; FNS; FNY; FOB; FOD; FOZ; FPA; FPD; FPF; FQH; FQM; FQP; FSM; FSR; FSW; FSX; FSY; FTA; FTD; FTX; FTY; FTZ; FWZ; FXE; FXF; FXM; FYA; FZO; FZP; FZQ; FZR; FZS; FZT; FZW; FZX; FZY; GAB; GAC; GAD; GAF; GAH; GAI; GAL; GAM; GAN; GAO; GAP; GAQ; GAR; GAS; GAT; GAW; GAZ; GBP; GBS; GBW; GBX; GBZ; GCA; GCB; GCC; GCD; GCE; GCJ; GCT; GCX; GCY; GDF; GDG; GDH; GDI; GDJ; GDM; GDN; GDO; GDR; GDW; GDX; GDY; GDZ; GEA; GEC; GEG; GEI; GEJ; GEN; GEO; GES; GFA; GFB; GFI; GFJ; GWX; GWY; GZT; GZX; HAE; HAM; HAO; HBG; HBI; HBO; HBQ; HBR; HBT; HCF; HCH; HCY; HCZ; HDA; HDC; HDE; HDF; HDG; HDH; HDJ; HDK; HDL; HDQ; HDX; HER; HFB; HFW; HFX; HGC; HGI; HHF; HHK; HHM; HIF; HJB; HKF; HLF; HLN; HMQ; HMR; HMX; HNA; HNC; HND; HNE; HNF; HNG; HNH; HNI; HNJ; HNK; HNL; HNN; HNP; HNQ; HNR; HNW; HNX; HNY; HNZ; HOB; HOC; HOD; HOE; HOF; HOY; HOZ; HPQ; HRH; HRP; HRQ; HRR; HRS; HRT; HSO; HTC; HTD; HTF; HTJ; HTP; HTR; HTS; HTT; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWI; HWJ; HWK; HWM; HWQ; HWT; HWW; HWX; HXB; HXC; HXD; HXE; HXG; HXI; HXK; HXL; HXP; HXQ; HXS; HXW; HXX; HXY; HXZ; ITX; IYN; IYO; JDC; JDR; JDW; JEK; JOH; JOK; JOL; JXS; JXT; JXX; JYA; JYC; JYD; JYE; JYG; JYH; JYJ; JYK; JYL; JYM; JYO; JYP; JYQ; JYR; JYT; JYY; JYZ; JZA; JZB; JZD; JZE; JZF; JZY; KAC; KAD; KAE; KAG; KAI; KAJ; KAK; KAL; KAM; KAN; KAO; KAP; KAQ; KAR; KAS; KAT; KAW; KAX; KAY; KAZ; KBA; KBB; KBC; KBD; KBE; KBH; KBJ; KBK; KBL; KBM; KBN; KBQ; KBS; KBT; KBZ; KCA; KCB; KCC; KCD; KCF; KCG; KCH; KCI; KCJ; KCP; KCT; KDC; KDD; KDG; KDQ; KGS; KGX; KGZ; KIK; KKX; KMK; KNQ; KNT; KNW; KOA; KOH; KPY; KQT; KRA; KTE; KTF; KTG; KTR; KYZ; LDF; LFJ; LGG; LJS; LJT; LKF; LQR; LRC; LRP; LRW; LRY; LXG; LXH; MAB; MAI; MAV; MCW; MDM; MDZ; MEB; MGP; MGZ; MIJ; MNK; MNL; MPB; MSD; MWS; MXY; MZY; NEW; NFK; NWT; NWV; OBJ; OCW; OFK; OGR; OVN; OXC; PAD; PEW; POZ; PPO; PYC; PYH; QEW; QQS,"Protector, Dental; Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Tube, Tracheostomy (W/Wo Connector); Forceps, Tube Introduction; Tube, Aspirating, Flexible, Connecting; Apparatus, Autotransfusion; Airway, Oropharyngeal, Anesthesiology; Laryngoscope, Non-Rigid; Anesthesia Conduction Kit; Support, Patient Position; Catheter, Intravascular, Diagnostic; Occluder, Catheter Tip; Wire, Guide, Catheter; Catheter, Percutaneous; Stylet, Catheter; Trocar; System, Balloon, Intra-Aortic And Control; Clip, Vascular; Sizer, Heart-Valve, Prosthesis; Needle, Biopsy, Cardiovascular; Dilator, Vessel, Surgical; Stripper, Vein, External; Instruments, Surgical, Cardiovascular; Stripper, Artery, Intraluminal; Clamp, Vascular; Catheter, Embolectomy; Injector And Syringe, Angiographic; Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene; Introducer, Catheter; Mirror, Mouth; Light, Surgical Headlight; Gauze/Sponge, Internal; Disk, Abrasive; Syringe, Irrigating (Dental); Retractor, All Types; Instrument, Hand, Calculus Removal; Hemostat, Surgical; Punch, Biopsy, Surgical; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Forceps, Rongeur, Surgical; File, Bone, Surgical; Curette, Surgical, Dental; Chisel, Bone, Surgical; Chisel, Osteotome, Surgical; Bronchoscope (Flexible Or Rigid); Esophagoscope (Flexible Or Rigid); Brush, Cleaning, Tracheal Tube; Speculum, Ent; Source, Carrier, Fiberoptic Light; Laryngoscope, Nasopharyngoscope; Otoscope; Mediastinoscope, Surgical; Probe, Rectal, Non-Powered; Tourniquet, Gastro-Urology; Stylet For Catheter, Gastro-Urology; Dilator, Esophageal (Metal Olive) Gastro-Urology; Bougie, Esophageal, And Gastrointestinal, Gastro-Urology; Bougie, Urological; Cannula And Trocar, Suprapubic, Non-Disposable; Telescope, Rigid, Endoscopic; Sound, Urethral, Metal Or Plastic; Biopsy Needle; Forceps, Biopsy, Non-Electric; Box, Battery, Rechargeable; Headlight, Fiberoptic Focusing; Bulb, Inflation, For Endoscope; Tube, Smoke Removal, Endoscopic; Laparoscopy Kit; Retractor, Fiberoptic; Attachment, Eyepiece, For Insertion Of Prescription Lens; Attachment, Teaching, For Endoscope; Instrument, Special Lens, For Endoscope; Device, Cystometric, Hydraulic; Clamp, Non-Electrical; Retractor, Self-Retaining; Dilator, Rectal; Speculum, Rectal; Device, Locking, For Intestinal Clamp; Adaptor, Bulbs, Miscellaneous, For Endoscope; Probe And Director, Gastro-Urology; Retractor, Non-Self-Retaining; Dislodger, Stone, Flexible; Carrier, Sponge, Endoscopic; Cannula, Injection; Clamp, Penile; Crusher, Spur, Colostomy; Ring, Laparotomy; Scoop; Ligator, Hemorrhoidal; Holder, Needle, Gastroenterologic; Clamp, Cannula; Thermometer, Clinical Mercury; Continuous Measurement Thermometer; Syringe, Piston; Stopcock, I.V. Set; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Protector, Skin Pressure; Ring Cutter; Basin, Emesis; Bedpan; Device, Occlusion, Umbilical; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Tube, Feeding; Bottle, Hot/Cold Water; Lavage, Jet; Bandage, Elastic; Lamp, Operating-Room; Tray, Surgical, Instrument; Light, Headband, Surgical; Light, Surgical, Endoscopic; Light, Surgical, Connector; Light, Surgical, Ceiling Mounted; Light, Surgical, Accessories; Lamp, Surgical; Mirror, General & Plastic Surgery; Tape, Measuring, Rulers And Calipers; Locator, Magnetic; Operating Room Accessories Table Tray; Speculum, Non-Illuminated; Speculum, Illuminated; Camera, Still, Endoscopic; Gown, Surgical; Chisel, Surgical, Manual; Clip, Implantable; Clip, Removable (Skin); Contractor, Surgical; Curette, Surgical, General Use; Cutter, Surgical; Expander, Surgical, Skin Graft; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Suturing, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Spatula, Surgical, General & Plastic Surgery; Stylet, Surgical, General & Plastic Surgery; Stripper, Vein, Reusable; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Absorbable, Synthetic; Suture, Nonabsorbable; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tubing, Noninvasive; Catheter, Multiple Lumen; Catheter, Ventricular, General & Plastic Surgery; Catheter, Peritoneal; Catheter, Irrigation; Catheter, Cholangiography; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Needle, Catheter; Dilator, Catheter; Connector, Catheter; Adaptor, Catheter; Laparoscope, General & Plastic Surgery; Light Source, Endoscope, Xenon Arc; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Needle, Aspiration And Injection, Reusable; Knife, Amputation; Applier, Surgical, Clip; Saw, Manual And Accessories; Staple, Implantable; Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Brush, Scrub, Operating-Room; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Forceps, General & Plastic Surgery; File, Surgical, General & Plastic Surgery; Blade, Scalpel; Blade, Saw, General & Plastic Surgery, Surgical; Head, Surgical, Hammer; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Fork, Tuning; Pinwheel; Retractor, Self-Retaining, For Neurosurgery; Instrument, Microsurgical; Rongeur, Manual; Apparatus, Electrosurgical; Instrument, Surgical, Non-Powered; Drills, Burrs, Trephines & Accessories (Manual); Illuminator, Fiberoptic, Surgical Field; Clip, Scalp; Instrument, Clip Removal; Rack, Clip; Applier, Hemostatic Clip; Instrument, Ligature Passing And Knot Tying; Clip, Aneurysm; Curette, Uterine; Forceps, Surgical, Gynecological; Forceps, Obstetrical; Tenaculum, Uterine; Hook, Fibroid, Gynecological; Speculum, Vaginal, Metal; Speculum, Vaginal, Metal, Fiberoptic; Needle, Cerclage, Gynecological; Scissors, Umbilical; Scissors, Episiotomy; Retractor, Vaginal; Dilator, Cervical, Fixed Size; Dilator, Vaginal; Pelvimeter, External; Forceps, Biopsy, Gynecological; Clamp, Umbilical; Clamp, Circumcision; Clamp, Uterine; Electrocautery, Gynecologic (And Accessories); Remover, Intrauterine Device, Contraceptive, Hook-Type; Curette, Suction, Endometrial (And Accessories); Sound, Uterine; Insufflator, Laparoscopic; Instrument, Measuring, Corneal Radius; Mirror, Headband, Ophthalmic; Device, Measuring, Lens Radius, Ophthalmic; Gauge, Lens, Ophthalmic; Marker, Sclera; Marker, Ocular; Cannula, Ophthalmic; Spud, Ophthalmic; Specula, Ophthalmic; Spatula, Ophthalmic; Snare, Enucleating; Scissors, Ophthalmic; Rongeur, Lachrymal Sac; Ring, Ophthalmic (Flieringa); Retractor, Ophthalmic; Punch, Corneo-Scleral; Probe, Trabeculotomy; Probe, Lachrymal; Knife, Ophthalmic; Introducer, Sphere; Hook, Ophthalmic; Forceps, Ophthalmic; Dilator, Lachrymal; Depressor, Orbital; Cystotome; Curette, Ophthalmic; Clamp, Muscle, Ophthalmic; Clip, Iris Retractor; Clamp, Eyelid, Ophthalmic; Caliper, Ophthalmic; Burr, Corneal, Manual; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Sponge, Ophthalmic; Headlamp, Operating, Ac-Powered; Trephine, Manual, Ophthalmic; Pen, Marking, Surgical; Hemostat; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Stripper, Surgical; Saw; Pliers, Surgical; Forceps; Curette; Gauge, Depth; File; Rasp; Knife, Orthopedic; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Corkscrew; Awl; Trephine; Osteotome; Passer; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Fork; Tamp; Passer, Wire, Orthopedic; Holder, Needle; Orthopedic; Mallet; Instrument, Bending Or Contouring; Crimper, Pin; Twister, Wire; Bender; Screwdriver; Brace, Drill; Cutter, Wire; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Prosthesis, Elbow, Constrained, Cemented; Staple, Fixation, Bone; Pin, Fixation, Threaded; Forceps, Biopsy, Bronchoscope (Rigid); Tube Tracheostomy And Tube Cuff; Scissors, Medical, Disposable; Catheter And Tip, Suction; Block, Cutting, Ent, Sterile; Crimper, Wire, Ent, Sterile; Forceps, Wire Closure, Ent, Sterile; Scissors, Wire Cutting, Ent, Sterile; Cannula, Ear; Chisel, Mastoid; Chisel, Middle-Ear; Curette, Ear; Excavator, Ear; Gauge, Measuring; Holder, Ear Speculum; Hook, Microsurgical Ear; Inserter, Myringotomy Tube; Knife, Ear; Knife, Myringotomy; Loop, Wire; Nipper, Malleus; Pick, Microsurgical Ear; Rasp, Ear; Rod, Measuring Ear; Rongeur, Mastoid; Scissors, Ear; Snare, Ear; Spoon, Ear; Tube, Ear Suction; Knife, Laryngeal; Tube, Laryngectomy; Elevator, Ent; Forceps, Ent; Holder, Speculum, Ent; Mirror, Ent; Mobilizer, Ent; Probe, Ent; Retractor, Ent; Cannula, Sinus; Chisel, Nasal; Curette, Ethmoid; Curette, Nasal; Gouge, Nasal, Ent; Irrigator, Sinus; Knife, Nasal; Perforator, Antrum; Punch, Antrum; Punch, Ethmoid; Punch, Nasal; Rasp, Frontal-Sinus; Rasp, Nasal; Rongeur, Nasal; Saw, Nasal; Scissors, Nasal; Snare, Nasal; Adenotome; Curette, Adenoid; Curette, Salpingeal; Depressor, Metal Tongue, Surgical; Dissector, Tonsil; Gag, Mouth; Knife, Tonsil; Punch, Adenoid; Punch, Tonsil; Snare, Tonsil; Tonsillectome; Tube, Tonsil Suction; Bistoury, Tracheal; Bougie, Esophageal, Ent; Dilator, Esophageal, Ent; Dilator, Tracheal; Hook, Tracheal; Trocar, Tracheal; Applicator, Ent; Syringe, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Chisel (Osteotome); Bottle, Collection, Vacuum; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Hook, Bone; Drape, Surgical, Antimicrobial; Device, Intravascular Catheter Securement; Dilator, Esophageal; Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Surgical Instruments, G-U, Manual (And Accessories); Instrument, Manual, General Obstetric-Gynecologic; Shield, Protective, Personnel; Evacuator, Gastro-Urology; Catheter, Continuous Flush; Trocar, Ent; Punch, Ent; Knife, Ent; Tube, Aspirating, Bronchoscope, Rigid; Syringe, Irrigating (Non Dental); Electrode, Pacemaker, Temporary; Catheter, Subclavian; Instrument, Cast Application/Removal, Manual; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Cannula, Manipulator/Injector, Uterine; Dislodger, Stone, Biliary; Instrument, Ent Manual Surgical; Tray, Surgical; Scissors, General, Surgical; Punch, Surgical; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Orthopedic Manual Surgical Instrument; Marker, Cardiopulmonary Bypass (Vein Marker); Fastener, Fixation, Biodegradable, Soft Tissue; Syringe, Balloon Inflation; Catheter, Peripheral, Atherectomy; Instrument, Manual, Surgical, General Use; Cleaners, Medical Devices; Pump, Infusion, Elastomeric; Dressing, Wound And Burn, Occlusive; Valvulotome; Needle, Tumor Localization; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Catheter, Hemodialysis, Non-Implanted; Catheter, Hemodialysis, Implanted; Stabilizer, Heart; Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal; Graft, Vascular, Stainless Steel Tunneler; Suture, Surgical, Absorbable, Polydioxanone; Kit, Repair, Catheter, Hemodialysis; Endoscopic Cholangiogram Kit; Laparoscopic Accessories, Gynecologic; Catheter, Ultrasound, Intravascular; Endoscopic Tissue Approximation Device; Percutaneous Atrial Catheter Kit; Ear, Nose, And Throat Surgical Tray; Suture Kit; Mesh, Surgical, Absorbable, Staple Line Reinforcement; Chest Drainage Kit; Implantable Transprostatic Tissue Retractor System; Biopsy Needle Kit; Multi-Lumen Hemodialysis Catheterization Kit; Paracentesis Tray; Surgical Retractor Kit; Peripheral Mechanical Thrombectomy With Aspiration; Stapler, Skin",1; 2; U,"(K792088); , GEN; 12 Fr Heparin Two-Lumen Hemodialysis Catheterization Kit/Set; 12 Fr. Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter; 14 Fr Two-Lumen Hemodialysis Catheterization Kit/Set; 3mm Xcel; 5mm Biozip; 5mm Biozip Hss; 6.5mm Biozip; 6.5mm Biozip Hss; ACULUX-PILLING; ADAPT LAPAROSCOPIC; ADAPT UNIVERSAL LAPAROSCOPIC PORT,; ADENOID; ADENOTOME; ANTRUM; AORTIC OCCLUDER; APH IOOP; APPARATUS; ARROW Radial Artery Catheterization Set with Integral Needle Protection; ARROWg+ard Evolution Antimicrobial Pressure Injectable PICC; ARROW® FlexBlock Continuous Peripheral Nerve Block Kits; ASPIRATING; ATOMIZERS; Abdominal Paracentesis Kit; Antecubital Central Venous Catheterization Kit with Heparin-Coated Catheter; Arrow; Arrow Access Tray; Arrow Catheter Clamp for 5, 6, 7 and 8 Fr. Catheters; Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter; Arrow Central Venous Catheterization Kit; Arrow Continuous Nerve Block Needle; Arrow Continuous Peripheral Nerve Block Kit; Arrow Echogenic Introducer Needle; Arrow Epidural Anesthesia Kit; Arrow FlexBlock Continuous Periphearl Nerve Block Kits; Arrow Glidethru Peel-Away Sheath/Dilator Introducer; Arrow JACC; Arrow Jugular Puncture Kit; Arrow Large Bore Multi-lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter; Arrow MAC(TM) Two-Lumen Central Venous Access Kit; Arrow MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Non-Absorbable Silk Suture; Arrow OnControl Bone Marrow Biopsy System (Model Number 9401-OnControl Power Driver); Arrow PICC; Arrow PICC Powered by Arrow VPS Stylet; Arrow PSI; Arrow Peripheral Inserted Central Catheter; Arrow Peripherally Inserted Central Catheter; Arrow Peritoneal Lavage Catheterization Kit; Arrow Pressure Injectable Central Venous Catheterization Kit; Arrow Pressure Injectable PICC; Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Radial Artery; Arrow Seldinger Arterial Catheterization Device; Arrow Select Kits; Arrow SharpsAwayII¿ Locking Disposal Cup; Arrow Simplicity Micro-Introducer Set; Arrow Single Shot Epidural Anesthesia Kit; Arrow StimuCath® Continuous Nerve Block Set; Arrow Stimulator Adapter Cable; Arrow Surgical Drape; Arrow Thoracentesis Kit; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis Set; Arrow Twin-Cath(R) 20/22 Multiple-Lumen Peripheral Catheter; Arrow UserGard(R) Needle-Free Injection Hub; Arrow VPS G4 System; Arrow VPS System, VPS Bedside procedure Kit and VPS Stylet component; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clark™ VectorFlow™ Antegrade Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Replacement Hub Set; Arrow-Johans¿ ECG Adapter for Right Atrial Electrocardiography; Arrow-Tretola Over-The-Wire PTD; Arrow-Tretola PTD; ArrowADVANTAGE5 Pressure Injectable Peripherally Inserted Central Catheter; Arrow™ Large Volume Paracentesis Kit; Arrow™ OnControl™ Powered Bone Access System; Arrow® 0.2 Micron Flat Epidural Filter; Arrow® 10 mL Luer-Slip Loss of Resistance Syringe; Arrow® 5 mL Luer-Lock Loss of Resistance Syringe; Arrow® 5 mL Luer-Slip Loss of Resistance Syringe; Arrow® Arterial Catheterization Set; Arrow® BiPolar Pacing Catheters; Arrow® Emergency Infusion Device - EID¿; Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter; Arrow® Epidural Needle; Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath; Arrow® Sheath Adapter with Cath-Gard® Catheter Contamination Shield; Arrow® SnapLock™ Catheter/Syringe Adapter; Arrow® Temporary Pacing Catheters,; Arrow® TransRadial Arterial Access Device; Arrow® TransRadial Artery Access Kit; Arrow® Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set; Arrow® Wedge Pressure Catheter,; Autofuser; BATTERY; BED PAN RUBBER ROUND; BETHEA SHEET HOLDER; BIPOLAR CORDS; BISTOURY; BITE BLOCK; BITEGARD ORAL PHARYNGEAL BITE BLOCK; BONDEK; BONDEK SYNTHETIC ABSO; BONE FIXATION PLATE; BOUGIE; BOX; BULBS; Barron, Tucker, McGivney; Becton Dickinson Syringe; Beere Evolution; BightForceTM; Bite Gard; Bite-Gard Oral Bite Block; Bizmo PICC; Bondek; Bondek Plus; CALCULUS REMOVAL; CANNULA; CANNULA EAR; CARDIOPULMONARY BYPASS; CARRIER LAHEY; CATHETER SPIGOTS; CENTIMETER SUBTRACTION; CERCLAGE; CG+ Arrow PICC Powered by Arrow VPS; CG+ Arrow PICC Powered by Arrow VPS Stylet; CG+Arrow PICC powered by Arrow VPS Stylet; CHAMBER IRRIGATORS; CHISEL OSTEDTOME; CLAMP; CLEANING; CLIP; COLD WATER BOTTLES; COLOSTOMY; CONMED; CONNECTING; CONTRACTOR; CORNEAL RADIUS; COTTONY II, Silky II, Polydek,; CRUSHER; CUNNINGHAM PENILE CLAMP; CURETTE; Cannon Hemodialysis Catheter; Cannon II Plus; Cannon II Plus Replacement Hub Set; Cannon II Plus; Edge; Canyons Wound Irrigation System; Catheter Hemodialysis; Cleaning Brush; Clip Appliers.; Cottony; Cottony II, Silky II Polydek; DA VINCI; DEKNATEL; DEPTH; DIATEK CANNON-CATHETER; DUET SUTURE ANCHOR; DUET W/HI-FI; Deklene; Deklene Maxx; Deknatel; Deknatel Thoracic; Deknatel Trocar; Deknatel®, Deklene®, Deklene® Maxx™, Capio; Deknatel®, Tevdek®, Capio, LSI, Niceloop, Polydek®, NextStich®, silky, Cottony; Disposable Aortic Punch; Drape surgical; E SUTURES; ECTIVE EYEWEAR AND POST-MYDRIATIC; EF-05510N: FILTER COMPONENT NRFit GVS; EFx; ENDO5; ENT MANUAL SURGICAL; ESOPHAGEAL; ETHMOID; EVACUPAK; EWALD STOMACH SYSTEM; EXTRACTOR; EZ-Stabilizer; Edge; Elcam Stopcock; Embolectomy Catheter; Encapsulon Epidural Catheter; Enfuse, Entube, various; Esmarch Bandage; Evolution Broken Screw Remover; Extension Tubing; External Fixation Devices; FACE; FIBEROPTIC; FILIFORMS; FLEXIBLE; FOLLOWERS; FOR ENDOSCOPE; FORCEPS; FRONTAL-SINUS; Foosin Silk Suture; Force Fiber; GASTRO-UROLOGY; GEN/PLASTIC SURGERY; GENERAL AND PLASTIC SURGERY; GENERAL OBSTETRIC-GENECOLOGIC; GENERAL OBSTETRIC-GYNECOLOGIC; GENERAL OBSTETRIC-GYNECOLOGIC MANU; GERY; GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG; GRAFT RING; Gertie Marx; Guide Wire - Lake Region; HEADBAND; HEEL RING CUSHION; HEM O LOCK LIGATION CLIPS; HEMOCLIP; HEMOCLIP AUTOMATIC CLIPS MEDIUM; HEMOCLIP Ligating Clip Med/Lrg; HEMOLOCK; HEMOLOK; HEMOLOK Ligating Clips & Cartridges; HEMOLOK SMX Ligating Clip Polymer; HEMOSTAT; HOLDER, NEEDLE; HOLDERS; HORIZON; HOT WATER BOTTLE; HUDSON BURR BITS; Hem-O-Clip Plus, Hem-O-Lok,; Hem-o-lok; Hem-o-lok Plus; Hem-o-lok PurplePlus; Hemoclip; Hemoclip Plus; Hemolok; High Flow Fluid Administration Set; Horizon; Horizon Ligating Clips, Titanium; Horizon, Hem-O-Clip Traditional,; Hudson Bite-Guard; Hudson RCI; Hudson RCI Temperature Indicator; IMPACT W/HI-FI; IMPACTOR; INC'D POST MYDRIATIC EYEWEAR; INSTR RACKS AND HOLDERS; INSTRUMENT RACKS AND HOLDERS; INTRADUCER; INTRAVASCULAR CATHETER SECUREMENT; INTRODUCER; INTRODUCER NEEDLE; INTRODUCERS; IRIS RETRACTOR; IRRIGATING; Infant Feeding Tube; Introducer Catheter; Introducer Catheter with Rotator Lock; Intubation Stylet; Inview; JINOTTI DUAL PURPOSE CATHETER; Jehle Catheters; KMEDIC; LAPAROTOMY; LARYNGEAL; LARYNGECTOMY; LASTIC SURGERY; LEBSCHE STERNUM KNIFE; LENS RADIUS; LIGATURE CARRIER; LIGHT; LMA Classic; LMA Classic Excel; LMA Fastrach; LMA Fastrach ETT; LMA Fastrach ETT SU; LMA Flexible; LMA Flexible SU; LMA Gastro Cuff Pilot; LMA ProSeal; LMA Supreme; LMA Unique; LOCKING PLATES; Laparoscope, general & plastic surgery; Ligation Clips; Liver Biopsy Kit; MAGIL FORCEPS; MAGNET HOLLINGER; MALONEY AND HURST; MALONEY AND HURST BOUGIE; MANUAL CAST REMOVAL INSTRUMENTS; MEASURING TAPES; METAL OR PLASTIC; METAL OR PLASTIC URETHRALS; MICRO BULLDOG; MICROSURGICAL EAR; MIDLINE CATHETERS; MINI-SAHARA; MISCELLANEOUS; MONODEK; MULTIIPLE; MULTIPLE A-C POWERED; MULTIPLE ADENOID CURETTES; MULTIPLE ADENOID PUNCHES; MULTIPLE ADENOTOME; MULTIPLE AMPUTATION KNIFES; MULTIPLE AMPUTATION KNIVES; MULTIPLE ANEURYSM CLIPS; MULTIPLE ANTRUM PERFORATORS; MULTIPLE ANTRUM PUNCHES; MULTIPLE BED PANS; MULTIPLE BENDING PLATES; MULTIPLE BONE FILES; MULTIPLE BONE HOOKS; MULTIPLE BONE TAPS; MULTIPLE CALCULUS REM; MULTIPLE CANNULA CLAMPS; MULTIPLE CARDIOVASC; MULTIPLE CATHETER ACCESSORIES; MULTIPLE CATHETER ADAPTORS; MULTIPLE CATHETER CONNECTORS; MULTIPLE CATHETER INTRODUCERS; MULTIPLE CATHETER TI; MULTIPLE CEILING MOUNTED; MULTIPLE CLINICAL; MULTIPLE COLLECTIONS SYSTEMS; MULTIPLE COLOSTOMY SPUR CRUSHERS; MULTIPLE CONNECTOR SURGICAL LIGHTS; MULTIPLE CORNEAL RADIU; MULTIPLE CORONARY; MULTIPLE COUNTERSINKS; MULTIPLE CURETTES; MULTIPLE DENTAL PROTECTORS; MULTIPLE DEPTH GAUGES; MULTIPLE DISPOSABL; MULTIPLE DISPOSABLE SURGICAL INSTRU; MULTIPLE DRILL BITS; MULTIPLE DRILL BRACES; MULTIPLE EMESIS BASINS; MULTIPLE ENDOSCOPI; MULTIPLE ENDOSCOPIC SPONGE CARRIERS; MULTIPLE ENDOSCOPIC STILL CAMERAS; MULTIPLE ENDOSCOPIC SURGICAL LIGHTS; MULTIPLE ENT APPLICATORS; MULTIPLE ENT ESOPHAGEAL BOUGIES; MULTIPLE ENT ESOPHAGEAL DILATORS; MULTIPLE ENT FORCEPS; MULTIPLE ENT MANUAL; MULTIPLE ENT MIRRORS; MULTIPLE ENT NASAL GOUGES; MULTIPLE ENT PROBES; MULTIPLE ENT RETRACTORS; MULTIPLE ENT SPECULUM HOLDERS; MULTIPLE ENT SPECULUMS; MULTIPLE EPISIOTOMY SCISSORS; MULTIPLE ESOPHAGEAL (METAL O; MULTIPLE ETHMOID CURETTES; MULTIPLE ETHMOID PUNCHES; MULTIPLE EXTERNAL PELVIMETER; MULTIPLE EXTERNAL VEIN STRIPPERS; MULTIPLE EYEPIECE ATTACHMENT FO; MULTIPLE FIBEROPTIC; MULTIPLE FIBEROPTIC RETRACTOR; MULTIPLE FLEXIBLE AN; MULTIPLE FLEXIBLE CONNE; MULTIPLE FLEXIBLE STONE DISLODGER; MULTIPLE FORCEPS; MULTIPLE FRONTAL SINUS RASPS; MULTIPLE GASTRO-UROLOG; MULTIPLE GASTRO-UROLOGY ESOPHAG; MULTIPLE GASTRO-UROLOGY TOURNIQUETS; MULTIPLE GEN. PURPOSE LAB EQ; MULTIPLE GENERAL; MULTIPLE GENERAL AND PLAST; MULTIPLE GENERAL US; MULTIPLE GENERAL USE SUR; MULTIPLE GYNECOLOG; MULTIPLE GYNECOLOGI; MULTIPLE HEMORRHOIDAL LIGATOR; MULTIPLE ILLUMINATED SPECULUM; MULTIPLE INFLATION; MULTIPLE INTERNAL GAUZE-SPONGES; MULTIPLE INTRALUMIN; MULTIPLE INTRAVASCULAR CA; MULTIPLE IRIS RETRACTOR CLIPS; MULTIPLE IRRIGATING; MULTIPLE IRRIGATING DENTAL SYRINGES; MULTIPLE LACHRYMAL DILATORS; MULTIPLE LACHRYMAL PROBES; MULTIPLE LACHRYMAL SAC RONGEUR; MULTIPLE LAPAROTOMY RINGS; MULTIPLE LARYNGEAL KNIFES; MULTIPLE LARYNGECTOMY TUBES; MULTIPLE LIGATURE; MULTIPLE LIGATURE PASSING; MULTIPLE LOCKING DEVICE; MULTIPLE LUMEN CATHETHERS; MULTIPLE MAGNETIC LOCATORS; MULTIPLE MANUAL CAST APPLICATION-RE; MULTIPLE MANUAL CORNEAL BURRS; MULTIPLE MANUAL INSTRUMENTS; MULTIPLE MANUAL SURGICAL CHISELS; MULTIPLE METAL FIBERO; MULTIPLE METAL OR PL; MULTIPLE MISCELLANEOUS AD; MULTIPLE MOUTH MIRRORS; MULTIPLE NASAL CHISELS; MULTIPLE NASAL CURETTES; MULTIPLE NASAL KNIFES; MULTIPLE NASAL PUNCHES; MULTIPLE NASAL RASPS; MULTIPLE NASAL RONGEUR; MULTIPLE NASAL SAWS; MULTIPLE NASAL SCISSORS; MULTIPLE NASAL SNARES; MULTIPLE NASOPHARYNGOS; MULTIPLE NEEDLE HOLDERS; MULTIPLE NON-DISPOSABLE SUP; MULTIPLE NON-ILLUMINATED SPECULUM; MULTIPLE NON-POWERED RECTAL PROBES; MULTIPLE NON-SELF-R; MULTIPLE NONINVASIVE TUBINGS; MULTIPLE OCCLUSIVE WO; MULTIPLE OPERATING; MULTIPLE OPERATING ROOM ACCESSORIES; MULTIPLE OPHTHALMI; MULTIPLE OPHTHALMIC CALIPERS; MULTIPLE OPHTHALMIC CANNULAS; MULTIPLE OPHTHALMIC CURETTES; MULTIPLE OPHTHALMIC EYE SHIELDS; MULTIPLE OPHTHALMIC EYELID CLAMPS; MULTIPLE OPHTHALMIC FORCEPS; MULTIPLE OPHTHALMIC HOOKS; MULTIPLE OPHTHALMIC KNIFES; MULTIPLE OPHTHALMIC LENS; MULTIPLE OPHTHALMIC LENS GAUGES; MULTIPLE OPHTHALMIC MUSCLE CLAMPS; MULTIPLE OPHTHALMIC RETRACTORS; MULTIPLE OPHTHALMIC SPATULAS; MULTIPLE OPHTHALMIC SPECULAS; MULTIPLE OPHTHALMIC SPONGES; MULTIPLE OPHTHALMIC SPUDS; MULTIPLE ORTHOPEDI; MULTIPLE ORTHOPEDIC; MULTIPLE ORTHOPEDIC BONE TAPS; MULTIPLE ORTHOPEDIC COUNTERSINKS; MULTIPLE ORTHOPEDIC DRILL BRACES; MULTIPLE ORTHOPEDIC KNIFES; MULTIPLE ORTHOPEDIC NEEDLE HOLDERS; MULTIPLE ORTHOPEDIC PASSERS; MULTIPLE ORTHOPEDIC TAMPS; MULTIPLE OSTEOTOME CHISELS; MULTIPLE OTOSCOPES; MULTIPLE PASSERS; MULTIPLE PERITONEAL CATHETERS; MULTIPLE PERSONNEL PROTECTIVE SHIEL; MULTIPLE PUNCHES; MULTIPLE RASPS; MULTIPLE RECHARGEABLE BATTERY BOXES; MULTIPLE RECTAL DILATOR; MULTIPLE RETRACTORS; MULTIPLE REUSABLE ASPIRAT; MULTIPLE REUSABLE VEIN STRIPPERS; MULTIPLE RIGID BRONCH; MULTIPLE RIGID BRONCHO; MULTIPLE RING CUTTERS; MULTIPLE RONGEURS; MULTIPLE RULERS AND CALIPERS; MULTIPLE SALPINGEAL CURETTE; MULTIPLE SAWS; MULTIPLE SCELERA MARKERS; MULTIPLE SCISSORS; MULTIPLE SCOOPS; MULTIPLE SELF RETAINING R; MULTIPLE SKIN PRESSURE PROTECTORS; MULTIPLE SMOKE REMO; MULTIPLE SPECIAL LENS IN; MULTIPLE STAINLESS STEE; MULTIPLE STAINLESS STEEL; MULTIPLE STERILE ABSORABLE SUTURES; MULTIPLE STERILE WIR; MULTIPLE STERILE WIRE; MULTIPLE SUCTION APPARATUS; MULTIPLE SUCTION CATHETERS AND TIPS; MULTIPLE SURGICAL BIOPSY PUNCHES; MULTIPLE SURGICAL BONE CHISELS; MULTIPLE SURGICAL CONTRACTORS; MULTIPLE SURGICAL CUTTERS; MULTIPLE SURGICAL FIELD; MULTIPLE SURGICAL GOUGE; MULTIPLE SURGICAL HEADBAND LIGHTS; MULTIPLE SURGICAL HEADLIGHT LIGHTS; MULTIPLE SURGICAL HEMOSTATS; MULTIPLE SURGICAL INSTRUMENT GUIDES; MULTIPLE SURGICAL INSTRUMENT TRAYS; MULTIPLE SURGICAL KNIFES; MULTIPLE SURGICAL LAMPS; MULTIPLE SURGICAL LIGHT ACCESSORIES; MULTIPLE SURGICAL MARKING PENS; MULTIPLE SURGICAL ME; MULTIPLE SURGICAL NEEDLE GUIDES; MULTIPLE SURGICAL PLIERS; MULTIPLE SURGICAL PUNCHES; MULTIPLE SURGICAL RONGEUR FORCEPS; MULTIPLE SURGICAL STRIPPERS; MULTIPLE SURGICAL TRAYS; MULTIPLE SURGICAL VESSEL DILATORS; MULTIPLE SUTURE RETENTION DEVICES; MULTIPLE TAMPS; MULTIPLE TEACHING ATTACHMENT FOR EN; MULTIPLE TEMPORARY; MULTIPLE TONSIL DISSECTORS; MULTIPLE TONSIL KNIFES; MULTIPLE TONSIL PUNCHES; MULTIPLE TONSIL SNARES; MULTIPLE TONSILLECTOMES; MULTIPLE TRACHEAL BISTOURY; MULTIPLE TRACHEAL DILATORS; MULTIPLE TRACHEAL HOOKS; MULTIPLE TRACHEAL T; MULTIPLE TRACHEAL TROCAR; MULTIPLE TYPES OF SURGICAL PLIERS; MULTIPLE UMBILICAL; MULTIPLE UMBILICAL SCISSORS; MULTIPLE UROLOGICAL BOUGIES; MULTIPLE VACUUM COLLECTION BOTTLES; MULTIPLE VAGINAL RETRACTORS; MULTIPLE VASCULAR CLAMPS; MULTIPLE VASCULAR CLIPS; MULTIPLE VEIN MARKERS; MULTIPLE WRENCHES; MULTIPLE, AUTOTRANSFUISON BAG; MULTIPLE, AUTOTRANSFUSION BAG; MULTIPLES; MYOWIRE-ATEMPORARY CARDIAC PACING W; Marked Spring-Wire Guide with Arrow Advancer; Martins Bandage; McKenzie V Clips; MiniLap; Mouth Gag; Multiple Trephines; NEW HYDROPHILIC COATING FOR WIRE GUIDES; NEXTSTITCH; NO SCALPEL VASECTOMY INSTRUMENTS; NON-SELF-RETAINING; NONP; NONPOWERED; NarrowFlex® Intra-Aortic Balloon (IAB) Catheter; NarrowFlex® Intra-Aortic Balloon (IAB) System; NextStep; NextStep Antegrade; NextStep Retrograde; NextStep Retrograde (femoral lengths); NextStep Retrograde Replacement Hub Set; NextStep Retrograde for femoral lengths; Nonabsorb Polypropylene Synthetic; OBSERVER SCOPE; OPCAB; OPCAB 3 IN 1 CLEARSITE; OPCAB IRRIGATION SYSTEM; OPEDIC; OPHTHALMIC (FLIERINGA); OPHTHALMIC (INCLUDING SUNLAMP PROT; OPTHAMEND; ORTHODEK; ORTHOP.; OTOSCOPE; Oberto Mouth prop; OrthoTape; PERFORATOR; PERITONEAL CATHETER; PERITONEAL#GENERAL AND PLASTIC SUR; PICC with Chlorag+ard Technology; PICK; PILLING; PILLING MICRO ANASTOMOSIS; PILLING WECK M-20 DISPOSABLE AUTOMA; PINEHOLE; PLASTIC SURGERY MIRRORS; PLASTIC SURGERY SURGICAL CLAMPS; PLASTIC SURGERY SURGICAL DISSECTOR; PLASTIC SURGERY SURGICAL HOOKS; PLASTIC SURGERY SURGICAL RASPS; PLASTIC SURGERY SURGICAL SPATULAS; PLASTIC SURGERY SURGICAL STYLETS; PLEUR EVAC A6000 ADULT/PED CHEST DRAINAGE; PLEUR EVAC CHEST DRAINAGE SYSTEM; PLEUR-EVAC; PLEUR-EVAC CHEST DRAINAGE SYSTEM; PLEUR-EVAC(R) A-8000--ADULT/PEDIATR; PLEUR-EVAC(R) A-8020--INFANT CHEST; PLUER-EVAC; PNEUMONECTOMY; POLYETHYLENE SYNTHETIC NONABSORBABL; POLYPROP, POLYETHYLE NYLON AND SILK; POLYPROPYLENE SYNTHETIC NONABSORBAB; POLYSORB SYNTHETIC ABSORBABLE SUTUR; PORTABLE; PROBE; PROBE AND DIRECTOR; Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter; Percutaneous Cavity DRAI; Percutaneous Cavity Drainage Catheterization Set/Kit; Percutaneous Cavity Drainage Catheterization Set/Kit; Percutaneous Sheath Introducers; Percuvance; Percuvance Percutaneous Surgical System; Percuvance(TM) Percutaneous Surgical System; Peripherally Inserted central catheter (PICC) with Blue Flex Tip; Peripherally inserted central catheter (PICC) Product with Blue Flex Tip and integral needle protection; Pilling; Pilling Esophageal Bougies; Pleur-evac; Pleur-evac Sahara® Plus Continuous Reinfusion Autotransfusion System; Pneumothorax Kit; Pneumothorax Set; Polydek; Polyglycolytic Acid Absorbable Sutr; Polyglytone 6211 Synthetic Absorb; PurplePlus; R SCOPE; RADIOLOGY; RASP; RECHARGEABLE; RECTAL SPECULUMS; RETRACTOR; RING; RONGEUR; RUBBER LATEX AND PVC TUBING; RULE; Raney Scalp Clips; Rusch Asherman Chest Seal; Rusch Esmark Bandage; Rusch Greenspec Laryngoscope Handle; Rusch Lite Laryngoscope Kit; S-02200-010: FILTER COMM: .2 MICRON FLAT, GVS; S-02200-010N: FILTER COMM: 0.2. MICRON FLAT NRFit, GVS; S-FIBRE; SALPINGEAL; SAPH IOOP; SAPH LIFE; SAPHLOOP; SAW; SCOOP; SELF-RETAINING AND ACCESSORIES; SHERIDAN; SINGLE PATIENT USE; SINUS IRRIGATOR; SL INSTRUMENTS; SPECIAL LENS; SPROTTE NEEDLE; SPUR; STAINLESS STEEL SUTURE NEEDLES; STRIPPER; STYLET; SUCTION TUBE CATHETE; SURG-I-BAND; SURGICAL HAMMER; SURGICAL HEADLIGHT; SURGICAL HOOK FOR ENT; SURGICAL STRIPPERS; SnapLock™ Clamp Fastener; Spring Wire Guide; Sprotte Needle; SpyGlass Discover Imager II IOC Catheter; Stainless Steel, Multifiloment,; Standard Precision Bougie Device; Standard Staple-Line Reinforcement; Standard Tapered Bougie, 38 Fr (STB38); Standard Trocar; Stapler, Skin; StimuCath (19 Ga); Suction Tube; Suction catheter with saline; Super Arrow Flex (SAF) PSIs; Super Arrow-Flex® Percutaneous Sheath Introducer Set; Suture; TAUT; TAUT BALLOON CATHETER; TAUT INSUFFLATION NEEDLE; TFX Introducer Needle; TONSILLECTOME; TOUPHY NEEDLE; TRACHEAL TUBE; TREPHINE; TROCAR; Taut; Teleflex; Tevdek; Tevdek II; Thermistor Probe; Titan SGS; Titan SGS Tapler with Titan SGS Standard Staple-Line Reinforcement; Transseptal Super ArrowFlex PSI; Trial Rods; Tube, tracheostomy (w/wo connector); Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; ULTRABRAID; URETHRAL; UltraCath Continuous Nerve Block Catheter; UltraCath Continuous Nerve Block Kit; UroLift 2 ATC Advanced Tissue Control System, UL2 ATC; UroLift 2 System; UroLift Advanced Tissue Control (ATC) System; UroLift System Procedure Kit Sterilization Tray; UroLift System UL400; VARIOUS BONE FIXATION FASTENERS; VARIOUS, CUTTING BLOCKS; VARIOUS, TUBE TRACHEOSTOMY AND TUBE CUFF; VARIOUS, VENTRICULAR NEEDLES; VEIN; VPS Rhythm Device with TipTracker Technology; VPS Vascular Positioning System; Valvulotome; VectorFlow Antegrade Chronic Hemodialysis Catheter; VectorFlow Retrograde Chronic Hemodialysis Catheter; VectorFlow Retrograde Replacement Hub Set; Vesocclude; Vesolock; WECK; WECK EFX; WECK VISTA; WECKVISTA; WRENCH; Weck; Weck Auto Endo5 Hem-o-lok Ligating Clip Applier; Weck EFx Facial Closure System; Weck Hem-O-Lock Clip Remover; Weck Hem-O-Lock Endo Clip Remover; Weck Raney Scalp Clip Appliers; Weck Reusable Obturator; Weck Vista; Weck, Hem-o-lok, Hemolok; Weck, Horizon, Hemoclip Traditional, Hemoclip Plus; Weck®, Hem-o-lok®, Auto Endo5®; You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; and Monofiliment Sutures; bipolar electosurgical forcep; various clip appliers",1992-08-03,253,2025-07-03,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010041511%22&limit=1
Covidien,1219930,1219930,60 Middletown Ave,North Haven,CT,06473,United States,Covidien llc,1282497,Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,74,BWA; FAJ; FBQ; FEB; FER; FGE; FHM; FHO; FMF; FOD; FZP; FZX; GAB; GAD; GAG; GAL; GAM; GAP; GAQ; GAR; GAT; GAW; GCI; GCJ; GDH; GDJ; GDO; GDT; GDW; GEF; GEI; GET; GEX; HBI; HBQ; HCF; HDA; HET; HIG; HIH; HTD; HWC; IZD; JDR; JDW; JOH; JOL; KCT; KDD; KDW; KKX; KNT; KNW; KOA; LFL; LIT; LJS; LJT; LMG; MAI; MBI; MCA; MCN; MNL; MPN; NQR; NWW; OCT; OCW; ORQ; OVN; OXC; PUI; SCV,"Unit, Electrosurgical And Coagulation, With Accessories; Cystoscope And Accessories, Flexible/Rigid; Trocar, Gastro-Urology; Accessories, Cleaning, For Endoscope; Anoscope And Accessories; Stents, Drains And Dilators For The Biliary Ducts; Apparatus, Suturing, Stomach And Intestinal; Pneumoperitoneum Needle; Syringe, Piston; Device, Occlusion, Umbilical; Clip, Implantable; Guide, Surgical, Instrument; Needle, Suturing, Disposable; Retractor; Stapler, Surgical; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Removable (Skin); Staple, Implantable; Applier, Staple, Surgical,; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Pneumatic Powered; Powered Laser Surgical Instrument; Illuminator, Fiberoptic, Surgical Field; Instrument, Clip Removal; Instrument, Ligature Passing And Knot Tying; Forceps, Obstetrical; Laparoscope, Gynecologic (And Accessories); Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Forceps; Screw, Fixation, Bone; Probe, Uptake, Nuclear; Staple, Fixation, Bone; Pin, Fixation, Threaded; Tube Tracheostomy And Tube Cuff; Catheter And Tip, Suction; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Container, Specimen Mailer And Storage, Temperature Controlled, Sterile; Drape, Surgical, Antimicrobial; Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Surgical Instruments, G-U, Manual (And Accessories); Instrument, Ultrasonic Surgical; Catheter, Angioplasty, Peripheral, Transluminal; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Agent, Absorbable Hemostatic, Non-Collagen Based; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Tape, Surgical, Internal; Barrier, Absorbable, Adhesion; Accessories, Cleaning Brushes, For Endoscope; Tissue Adhesive For The Topical Approximation Of Skin; Sealant, Dural; Hysteroscope Accessories; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Tissue Approximation Device; Mesh, Surgical, Deployer; Suture Kit; Mesh, Surgical, Absorbable, Staple Line Reinforcement; Drape, Surgical, Exempt; Modular Electromechanical Surgical System",1; 2; 3; U,"4 Calibration Insert; 8 TRUCLEAR Sheath; 9 TRUCLEAR Obturator; ACUCLIP; ANTI-FOG; AS Meniscal; ATLAS; AUTO SUTURE ENDO CATCH SPECIMAN BAG; AUTOSUTURE ENDOSCOPIC CLAMP; AbsorbaTack; AbsorbaTack 30x; Absorbatack; AccuMesh; Appose Skin Staplers; ArthroPort; Auto Suture; Autosonix; BLUNTGRIP - SURGIGRIP; Biosyn; Blunt Tip Trocars; Bluntport; Bralon & Surgidac; CHEMOSITE TUNNELER; CLIP IMPLANTABLE; Caprosyn; Chemosite; Clearify; Clearify Trocar Wipe; Clip Applier; Coated Electrodes; ConcordeMultifire Premium skin stapler; Cool-Tip Generator; DG Surgilene Suture; DUET with Tri-Staple; Dermalon & Surgilon; Dexon; Divider One-step Sealing, Nano-coated (LF1930T); Doubletime Trocar; Drape; DuraSeal Spine; Duraseal; EEA Hemorrhoid stapler and Accessor; EEA OrVil; EEA Stapler; EEA Surgical Stapler; EEA TAID; EEA'M Circular Stapler with Tri-Staple"" Technology; EGIA AVM; EGIA Radial Reload; EGIA Tristaple Reloads; EGIA Ultra Black; EGIA Ultra Stapler; ENDO BAG; ENDO CATCH; ENDO CLOSE; ENDO GIA ROTICULATOR Staplers; ENDO LUNG; ENDO MINI-RETRACT; ENDO MINI-SHEARS; ENDO PADDLE RETRACT; ENDO PEANUT; ENDO SHEARS; ENDO SLIDE; ENDO STITCH; ENDO TA; Edge Blade Electrode, (3” (, 7.62 cm), E1450G and E1450GNSB; Edge Blade Electrode, (4"", (10.16 cm), E1450-NSB; Edge Blade Electrode, (6.5"" (, 16.51 cm), E1450-6 and E1450-6NSB; Edge Coated Blade Extended Electrode, ( 4"" , (10.16 cm), E1450-4; Edge Hex-locking Blade Electrode, (2.5” (, 6.35 cm), E1450X and E1450XNSB; Edge Insulated Blade Electrode, (2.75"", (7 cm), E1455; Edge Insulated Blade Electrode, (4"", (10.16 cm), E1455-4 and E1455-4NSB; Edge Insulated Blade Electrode, (6.5"", (16.51 cm), E1455-6 and E1455-6NSB; Edge Insulated Blade Electrode, Safety Sleeve (2.75"", (7 cm), E1455NSB; Edge Insulated Blade Electrode, Safety Sleeve, (2.75"" (, 7 cm), E1455B; Edge Insulated Blade Electrode, Safety Sleeve, (2.75"", (7 cm), E1455BNSB; Edge Insulated Blade Electrode, Safety Sleeve, (4"" (, 10.16 cm), E1455B4; Edge Insulated Blade Electrode, Safety Sleeve, (4"", (10.16 cm), E1455B-4NSB; Edge Insulated Needle Electrode, (2.8"", (7.2 cm), E1465; Edge Insulated Needle Electrode, (2.8"", (7.2 cm), E1465NSB; Edge Insulated Needle Electrode, 6.5"" (16.51 cm), E1465-6; Edge Insulated Needle Electrode, Safety Sleeve, (2.8"", (7.2 cm), E1465B and E1465BNSB; Edge Insulated Needle Electrode, Safety Sleeve, (4"", (10.16 cm), E1465B-4; Edge Needle Electrode, (2.8"" (, 7.2 cm), E1452; Edge Needle Electrode, (2.8"", (7.2 cm), E1452NSB; Edge Needle Electrode, (6.5"" (, 16.51 cm), E1452-6; Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDBNSB; Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HGNSB; Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450H; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HDBNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HGNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2450HS; Edge™ Pencil Blade Electrode, Holster, E2250H; Edge™ Pencil Blade Electrode, Holster, E2250HNSB; Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350H; Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350HDB; Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HS; Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HSNSB; Electrodes; Elite hysteroscope mini- refurbished; Elite hysteroscope plus - refurbished; Endo Clip III; Endo Clip MultApplier; Endo Clip lll; Endo GIA Extra Long Adapter; Endo GIA Pancreas Indication; Endo GIA Reinforced Reload Tristaple Technology; Endo GIA Reload; Endo GIA™ Gray Articulating Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo Lube; Endo Universal 65; Extended Tip Applicator; Extra View Sterile Balloons; Ez-Tack; FRED; Force FX; Force FX™ Electrosurgical Generator 8C, Force FX-8C; Force FX™ Electrosurgical Generator 8CAS Autobipolar, Force FX-8CAS; Force FX™ Electrosurgical Generator 8CS, Force FX-8CS; Force TriVerse; GIA PREMIUM; GIATM Stapler with Tri-StapleTM Technology; GIA™ Stapler with Tri-Staple™ Technology; GYN-Pump PH304; GastriSail™ Gastric Positioning System; Gastrisail; General Non-Sterile Surgical Inst; Gut; Gynecology Instrument Tray; Hugo™ Robotically Assisted Surgery (RAS) System; Hysteroscopic Outflow Tubes Set; ILA GIA Staplers; ILA, EEA, LDS reusable staplers; ILAN; IO+ Port; IRRIGATION SYSTEM; Indermil; LIGATURE PASSING AND KNOT TYING; Laparascopic Electrodes w/Retractab; Laparoscope; Lapro-Clip; Laproclip; Laproclip remover; Lectrovac, Valleylab Models; LigaSure; LigaSure Advance; LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider Nano-coated, LF4418; LigaSure Maryland Jaw Thoracic Sealer; LigaSure™ Blunt Tip Laparoscopic Sealer/Divider, LF1644; LigaSure™ Blunt Tip Open Sealer/Divider Nano-coated, LF1823; LigaSure™ Blunt Tip Open Sealer/Divider, LF1623; LigaSure™ Blunt Tip, Laparoscopic Sealer/Divider Nano-coated, LF1837 and LF1844; LigaSure™ Exact Dissector Nano-coated, LF2019; LigaSure™ Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Nano-coated, LF1937 and LF1944; LigaSure™ Maryland Jaw Open Sealer/Divider One-step Sealing, Nano-coated, LF1923; LigaSure™ Retractable L-Hook Laparoscopic Sealer/Divider, LF5637 and LF5644; LigaSure™ Tissue Fusion Footswitch, Purple, LS0300; LigaSure¿ Atlas; LigaSure¿ Impact; LigaSure¿ V; MIBB SITE MARKER; MINI STEP; MULTAPPLIER; MULTAVAC; MaxTack™ Motorized Fixation Device; Maxon; McKesson Skin Staplers 35 REGULAR; McKesson Skin Staplers 35 WIDE; Micro-Needle Electrodes, E16XX; Miniport; Minisite; Minisite Biopsy; Minisite Bipolar Forceps; Minisite Blunt probe; Model E2515 Electrosurgical Accesso; Monosof; NanoCross Elite; Navigator Copilot; Navigator™ GPS; Novafil & Vascufil; Ogden Anchore; Ogden Suture Anchor; One Step; Open Step; PDB; PDB Sterile Balloon; POLY GIA; Paramount Mini; Poly Surgiclip; Polyester Tape; Polyhesive II Patient Return Electr; Polyhesive Patient Return Electrode; Polypropylene Suture; Polysorb; Polysorb™ Coated Braided Absorbable Suture; Premium Mulitfire TA; Premium Poly CS; Premium Surgiclip; Premium-SurgiClip III; Protack; Purple Radial Reload; Purstring; REM patient return electrode cord; ROTICULATOR ENDO DISSECT - ENDO GRASP; ROTICULATOR ENDO MINI-SHEARS; Radial Expandable; ReliaCatch; ReliaMax; ReliaTack; ReliaTack Fixation Device - Deep Purchase Absorbable Tacks; Reusable Handswitching Pencil; SD Suture Anchor; SFS Stapler; SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS; SHILEY PEDIATRIC TRACHEOS; SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS; SILS; SILS Articulating Hand Instruments; SILS PORT; SILS Port; SILS Port 15mm; SILS Procedure Kit; SILS Stitch; SPACEMAKER; STAT Tack; SURGINEEDLE; SURGIPORT; SURGIPORT SPIRAL SLEEVE; SURGIWAND; Signet; Signia Circular Adapters, Tri-Staple 2 Circular Reloads; Signia Small Diameter Reload; Signia Stapler; Signia"" Four-Bay Smart Charger; SigniaTM Circular Adapters; Signia™ Loading Units Tri-staple 2 and Tri-staple 2.4 45mt and 60vt; Signia™ Small Diameter Reloads; Signia™ Sterilization Tray; Smoke Evacuation Attachment for Ele; Sofsilk; Sonicision 26cm dissector (SCD26); Sonicision 28 cm dissector (SCD48); Sonicision™ Battery Charger, CBCA; Sonicision™ Cordless Ultrasonic Dissector; Sonicision™ Cordless Ultrasonic Dissector (5 mm - 13 cm); Sonicision™ Cordless Ultrasonic Dissector (5 mm - 26 cm); Sonicision™ Cordless Ultrasonic Dissector (5 mm - 48 cm); Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 13 cm, SCDA13; Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 26 cm, SCDA26; Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 39 cm, SCDA39; Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 48 cm, SCDA48; Sonicision™ Reusable Battery Insertion Guide, SCBIGA; Sonicision™ Reusable Battery Pack, SCBA; Sonicision™ Reusable Generator; Sonicision™ Reusable Generator, SCGAA; Sonicision™ Torque Wrench; Spacekeeper; Spray Gel; Spray Shield; Stainless Steel Sutures; Step; Stratis ST Absorbable; Stratis ST Non-Absorbable; Stratus Nonabsorbable ACL Fixation; SurgiGut; SurgiPro II; SurgiSleeve Extra Small Wound Protector; SurgiSleeve Wound Protector; SurgiTie; Surgiclip""; Surgiport; Surgipro; Surgisleeve Wound Protector; Surgiwand II; Surgiwip; Suture Convenience Kit; TRUCLEAR Calibration Insert 2.9; TRUCLEAR Calibration Insert 4; TRUCLEAR Control Unit; TRUCLEAR Footswitch; TRUCLEAR Handpiece; TRUCLEAR INCISOR"" Plus Tissue Removal Device; TRUCLEAR INCISOR"" Tissue Removal Device; TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS; TRUCLEAR Obturator; TRUCLEAR Operative Hysteroscope; TRUCLEAR Operative Hysteroscope 5; TRUCLEAR Operative Hysteroscope 5C; TRUCLEAR Operative Hysteroscope 5C- Refurbished/Service; TRUCLEAR Operative Hysteroscope 8; TRUCLEAR Operative Hysteroscope 8- Refurbished/Service; TRUCLEAR Sheath 5.6; TRUCLEAR Sheath 5C; TRUCLEAR Sheath 9; TRUCLEAR Tissue Removal System; TRUCLEAR ULTRA MINI Tissue Removal Device; TRUCLEAR ULTRA Plus Tissue Removal Device; Tacker System; Tan and Black Radial Reload; Thoracoport; TiCron; Tissue Approximating Forceps; Topical Tissue Adhesive; Topical Tissue Adhesives; Trexon™ Monofilament Synthetic Absorbable Suture; Tri-StapleTM 2 Circular Reloads; Tri-Staple™ 2 Intelligent Cartridges; Tri-Staple™ 2 Reloads; Tri-staple 2 Reinforced Reload; Tri-staple 2™ Reloads; TriMax; TriTis 12 mm Non-Absorbable; TriTis Absorbable; TriTis Non-Absorbable; TruClear Diagnostic Sheath Duo; TruClear Elite Hysteroscope Mini; TruClear Elite Hysteroscope Mini (includes insert); TruClear Elite Hysteroscope Plus; TruClear Elite Hysteroscope Plus (includes insert); TruClear Hysteroscope Duo; TruClear Operative Sheath Duo; Umbilical Tape; V-LOC NA; V-Loc; V-Loc 180; V-Loc 180 4-0; V-Loc 90; V-Loc Reloads; VERSAPORT; VERSASEAL; VITAL VUE ILLUMINATION; Valleylab Monopolar Footswitch; Valleylab REM patient return electrode cord; Valleylab Suction Coagulator; Valleylab ™ Laparoscopic Handset, Four-Function, E2750 and E2750NSB; Valleylab™ Angled Micro-Needle Electrode, 45 degree, 1 cm from tip, 3 cm, E1653; Valleylab™ Angled Micro-Needle Electrode, 45 degree, 3 mm from tip, 3 cm, E1652; Valleylab™ Argon Handset, E2520H; Valleylab™ Argon Tungsten Sharp Needle Electrode, E2532; Valleylab™ Button Switch Pencil Holster, E2516H, E2516HGNSB, and E2516HNSB; Valleylab™ Button Switch Pencil Holster, Smoke Attachment, E2516HS; Valleylab™ Button Switch Pencil Needle Electrode, Holster, E2516HDA; Valleylab™ Button Switch Pencil, E2516, E2516GNSB, and E2516NSB; Valleylab™ Cord Clamp ERBE™, Reusable 15/ (4.6 m), E0560E; Valleylab™ Flexible Argon Electrode Coagulation Only, E2530-3; Valleylab™ Flexible Argon Electrode Coagulation Only, E2530-6; Valleylab™ Flexible Laparoscopic Argon Electrode Coagulation Only, E2530-28; Valleylab™ Insulated Micro-Needle Electrode, 9 cm, E1654B; Valleylab™ Laparoscopic Argon Blade Electrode Retractable, E2580-28; Valleylab™ Laparoscopic Argon Blunt Needle Electrode Retractable, E2583-28; Valleylab™ Laparoscopic Argon Modified Flat L Electrode Retractable, E2581-28; Valleylab™ Laparoscopic Argon Sharp Needle Electrode Retractable, E2582-28; Valleylab™ Laparoscopic Curved Spatula Electrode, Hollow, 28 cm, E2781-28; Valleylab™ Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Holes, 28 cm, E2781R-28ASP; Valleylab™ Laparoscopic Cylindrical Electrode, Hollow, 28 cm, E2786-28; Valleylab™ Laparoscopic Flat L-Hook Electrode, Hollow, 28 cm, E2784-28; Valleylab™ Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Holes, 28 cm, E2784R-28ASP; Valleylab™ Laparoscopic Straight Spatula Electrode, Hollow, 28 cm, E2780-28; Valleylab™ Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Holes, 28 cm, E2782R-28ASP; Valleylab™ Laparoscopic Wire J-hook Electrode, 28 cm, E2782-28; Valleylab™ Laparoscopic Wire L-Hook Electrode, Retractable Aspiration Holes, 28 cm, E2783R-28ASP; Valleylab™ Laparoscopic Wire L-Hook Electrode, Retractable Aspiration Holes, 36 cm, E2783R-36ASP; Valleylab™ Laparoscopic Wire L-hook Electrode, Hollow, 28 cm, E2783-28; Valleylab™ Monopolar Footswitch, E6008B; Valleylab™ Monopolar Footswitch, E6008L; Valleylab™ Non-REM Polyhesive™ Patient Return Electrode, E7506; Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7508; Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7509; Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7509B; Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, E7507; Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, E7507DB; Valleylab™ REM Polyhesive™ Neonatal Patient Return Electrode, E7512; Valleylab™ REM™ Patient Return Electrode Cord, Reusable, 15' (4.6 m), E0560; Valleylab™ Rocker Switch Pencil ERBE, Reuseable, E2100E; Valleylab™ Rocker Switch Pencil Holster, E2515H, E2515HDB, E2515HDBNSB, E2515HGNSB, and E2515HNSB; Valleylab™ Rocker Switch Pencil Holster, Smoke Attachment, E2515HS and E2515HSNSB; Valleylab™ Rocker Switch Pencil Needle Electrode, Holster, E2515HDA and E2515HDANSB; Valleylab™ Rocker Switch Pencil Reusable, E2100; Valleylab™ Rocker Switch Pencil, E2515, E2515NSB, and E2515GNSB; Valleylab™ Solid Laparoscopic Curved Spatula Electrode, Solid, 36 cm, E2771-36; Valleylab™ Solid Laparoscopic Curved Spatula Electrode, Solid, 45 cm, E2771-45; Valleylab™ Solid Laparoscopic Electrode, Flat L-Hook Solid, 36 cm, E2774-36; Valleylab™ Solid Laparoscopic Electrode, Wire J-Hook Solid, 36 cm, E2772-36; Valleylab™ Solid Laparoscopic Electrode, Wire L-Hook Solid, 36 cm, E2773-36; Valleylab™ Solid Laparoscopic Electrode, Wire L-Hook Solid, 45 cm, E2773-45; Valleylab™ Solid Laparoscopic Straight Spatula Electrode, Solid, 36 cm, E2770-36; Valleylab™ Straight Micro-Needle Electrode, 2 cm, E1650; Valleylab™ Straight Micro-Needle Electrode, 3 cm, E1651; Valleylab™ Suction Coagulator, E2608-6; Valleylab™ Suction Coagulator, E3305; Valleylab™ Suction Coagulator, E3310 and E3310NSB; Valtrac Purse String; Veriset; VersaOne optical trocar with fixation balloon cannula VersaOne universal fixation balloon cannula; VersaOne™ 5mm bladed trocar; VersaOne™ Bladed and Bladeless Trocars; VersaOne™ Bladeless Trocar; VersaOne™ Bladeless and Optical 15mm; VersaOne™ Reusable Positioning Trocar System; Versaport; Versaport Bladeless; Versaport Bladeless Optical Trocar; Versaport RPF; Versaport V2; Versaport V2 Bladeless Optical Trocar; Versastep; Versastep V2; Visiport; iDrive Powered Stapling System; iDrive Ultra; iDrive Ultra Sterilization Tray",1992-06-29,251,2026-07-01,1,74,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221219930%22&limit=1
Howmedica Osteonics Corp,2249697,3003070421,325 Corporate DR.,Mahwah,NJ,07430,United States,STRYKER CORP.,1811755,Contract manufacturer; Contract sterilizer; Manufacturer; Specification developer,63,FSM; FTY; FWP; FZO; FZX; FZY; GAD; GWO; HRS; HRY; HSD; HSX; HTD; HTF; HTO; HTW; HTZ; HWA; HWB; HWC; HWJ; HWR; HWT; HXC; HXD; JDC; JDG; JDI; JDJ; JDK; JDL; JDQ; JWH; KKY; KRO; KRR; KWA; KWI; KWL; KWS; KWY; KWZ; LGE; LOD; LPH; LRN; LWJ; LXH; LYT; LZN; LZO; MAY; MBB; MBH; MBL; MEH; MJT; MRA; NBH; NJD; NPJ; OIY; PHX,"Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Prosthesis, Chin, Internal; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Plate, Cranioplasty, Preformed, Alterable; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Forceps; Curette; Reamer; Bit, Drill; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Awl; Driver, Prosthesis; Template; Wrench; Clamp; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Prosthesis, Hip, Cement Restrictor; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Cerclage, Fixation; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Wire, Surgical; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Fixation Accessory; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Bone Cement, Antibiotic; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented; Accessories, Arthroscopic; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Shoulder Prosthesis, Reverse Configuration",1; 2; 3,".; 1.3MM X 35.6CM NITINOL GUIDE WIRE; 1.9MM OBTURATOR; 1.9MM SPEEDLOCK PENCIL TIP OBTURATOR; 1.9MM TROCAR; 100MM DRAIN CANNULA; 10MM DRAIN CANNULA; 10mm SUBFIX TRIAL; 11.5mm SUBFIX TRIAL; 135 mm Reusable Slat, SE Retr, 10 Pack; 155 mm Reusable Slat, SE Retr, 10 Pack; 175mm Reusable Slat, SE Retr, 10 Pack; 2-0 Knot Pusher/Suture Cutter; 2.1MM BLUNT NOSE DOWN ASSY; 2.1MM BLUNT NOSE LEFT ASSY; 2.1MM BLUNT NOSE RIGHT ASSY; 2.1MM BLUNT NOSE STRAIGHT ASSY; 2.1MM BLUNT NOSE UP ASSY; 2.3MM  OBTURATOR; 2.3MM AUTOCLAVABLE BLUNT TIP OBTURATOR WITH SPEED-LOCK; 2.3MM AUTOCLAVABLE PENCIL TIP OBTURATOR WITH SPEED-LOCK; 2.3MM AUTOCLAVABLE TROCAR FOR 2.9MM CANNULA WITH SPEED-LOCK; 2.3MM TROCAR; 2.5MM GRASPER ASSY; 2.5MM SCISSORS ASSY; 2.7MM BLUNT NOSE STRAIGHT ASSY; 2.7MM BLUNT NOSE UP ASSY; 2.7MM NORROW PUNCH; 2.7MM OBTURATOR; 2.7MM SCOPE BRIDGE; 2.7MM SPEEDLOCK PENCIL TIP OBTURATOR; 2.7MM TROCAR; 2.8MM  TWO ROTATING STOPCOCKS; 2.8MM CANNULA WITH 1 FIXED STOPCOCK; 2.8MM CANNULA WITH 1 ROTATING STOPCOCK; 2.8MM CANNULA WITH 2 ROTATING STOPCOCKS; 2.9MM AUTOCLAVABLE CANNULA, 1 ROTATING STOPCOCK W/SPEEDLOCK; 2.9MM CANNULA WITH 1 ROTATING STOPCOCK; 206-716 w/2 small sculps/pkg; 234-112-100 VersiQuad Halo Retractor; 266-719-000 PKG, WESSINGER ROD (SMALL); 266-720-000 PKG, WISSINGER ROD (LARGE); 266-721-000 PKG. WISSINGER HANDLE, SE3; 3.2MM CANNULA WITH 1 FIXED STOPCOCK; 3.2MM CANNULA WITH 1 ROTATING STOPCOCK; 3.2MM CANNULA WITH 2 FIXED STOPCOCKS; 3.2MM SPEEDLOCK PENCIL TIP OBTURATOR; 3.4MM 30 LEFT MENISCAL PUNCH; 3.4MM 30 RIGHT MENISCAL PUNCH; 3.4MM HIP GRASPER; 3.4MM HIP PUNCH - STRAIGHT; 3.4MM LOOSEBODY GRASPER W/ RATCHET; 3.4MM NARROW PUNCH-15° UP; 3.4MM NORROW PUNCH; 3.5MM FORMULA SERIES, SMALL JOINT CUTTER CANNULA; 3.5MM SWITCHING STICK; 3.9mm Omega Drill; 3.9mm Omega Tap; 3.9mm Omega and 4.75mm AlphaVent Awl; 3910-500-582, ICONIX DC Guide for 2.3mm anchor; 3910-500-583, ICONIX DC Obturator for 2.3mm anchor; 3MM DBL SLEEVE 80MM TROC/ASSY; 3mm PREDRILL ASSEMBLY LONG; 3mm PREDRILL ASSEMBLY SHORT; 4.4MM HIP OBTURATOR CANNULATED; 4.4MM HIP TROCAR CANNULATED; 4.6 X 200 MM CANNULA, 1 FIXED STOPCOCK; 4.6 X 200 MM CANNULA, 1 FIXED STOPCOCK, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK; 4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS AT 95°; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS AT 95°, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS AT 95°; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS AT 95°, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS, NO DISTAL HOLES; 4.75mm AlphaVent Punch Tap; 4.75mm AlphaVent Tap; 4.75mm AlphaVent and Omega Awl; 4.75mm AlphaVent and Omega Drill; 4.75mm Omega Tap; 4MM CANNULA WITH 1 ROTATING STOPCOCK; 4MM CANNULA WITH 2 FIXED STOPCOCKS; 4MM CANNULA WITH 2 ROTATING STOPCOCKS; 4MM CANNULATED SWITCHING STICK; 4MM DBL SLVE 180MM TROC/ASSY; 4MM X 24 SWITCHING STICK; 4MM, 30 HIP ARTHOSCOPE (HIPSCOPE); 4mm DBL SLEEVE 150mm TROC/ASSY; 4mm PREDRILL ASSEMBLY EXTRA SHORT; 4mm PREDRILL ASSEMBLY LONG; 4mm PREDRILL ASSEMBLY SHORT; 5.5MM CANNULATED SWITCHING STICK; 5.5MM SLOTTED CANNULA; 5.5mm AlphaVent Tap; 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill; 5.8 CANNULA, 2 ROTATING STOPCOCKS FOR 4MM LONG ARTHROSCOPE; 5.8MM CANNULA, 1 FIXED STOPCOCK; 5.8MM CANNULA, 2 FIXED STOPCOCKS; 5.8MM CANNULA, 2 ROTATING STOPCOCKS; 5.8MM HIPSCOPE CANNULA, 2 ROTATING STOPCOCKS; 5MM CANNULA 1 ROT SPEEDLOCK; 5MM CANNULA 2 ROT STCK (SPEEDLOCK); 5mm PREDRILL ASSEMBLY EXTRA SHORT; 5mm PREDRILL ASSEMBLY LONG; 5mm PREDRILL ASSEMBLY SHORT; 5mm SPANNER WRENCH; 6.5MM CANNULATED SWITCHING STICK; 6.5MM SLOTTED CANNULA; 6.5MM X 75MM CANNULATED OBTURATOR ASSY.; 6.5MM X 90MM CANNULATED OBTURATOR ASSY.; 6.5mm SUBFIX TRIAL; 6mm PREDRILL ASSEMBLY EXTRA SHORT; 6mm PREDRILL ASSEMBLY LONG; 6mm PREDRILL ASSEMBLY SHORT; 7MM SPANNER WRENCH; 7mm SPANNER WRENCH; 8MM X 75MM CANNULATED OBTURATOR ASSY.; 8MM X 90MM CANNULATED OBTURATOR ASSY.; 8mm SUBFIX TRIAL; 90 mm Reusable Slat, SE Retr, 10 Pack; 9mm SUBFIX TRIAL; A 2 DRILL BRACE W/O CHUCK; A 4 4MM CHUCK; A 5 T-WRENCH; A 51 T WRENCH W/35 EXTENSION; ACCOLADE DISTAL SPACER; ACL Workstation; ADAPTOR SPEED LOCK SYRINGE; ADM MDM Acetabular Systems; ADM MDM Insert; AEQ FRAC LONG SUP IMP ENS; AEQ FRAC SUPPORT DE BRAS; AEQ FRACT GR AXE LIAISON; AEQ FRACT MESUREUR AMOVIB; AEQ FRACT NM FANT TIG; AEQ IMPACTEUR DE PROTHESE; AEQ TIGE FRA LG FANT; AEQ USA FANT CALO; AEQUALIS; AEQUALIS FRACTURE; AEQUALIS RESURFACING HEAD; AEQUALIS REVERSED; AGM 6 6MM CHUCK; ALEUTIAN Interbody Systems Trays; ALL TORNIER FORCEPS INSTRUMENTS; ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS); ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE; ANCHORAGE CP LAPIDUS TEMPLATE; ANCHORAGE CP MTP PIVOTING DRILL GUIDE; ANCHORAGE CP MTP TEMPLATE; ANCHORAGE CP POLYAXIAL DRILL GUIDE; ANCHORAGE CP UTILITY TEMPLATE; ANCHORAGE FIXATION PIN; ANCHORAGE FIXED DRILL GUIDE 2.5MM; ANCHORAGE FIXED DRILL GUIDE 2MM; ANCHORAGE INSTRUMENTS RACK (LEVEL 1); ANCHORAGE INSTRUMENTS RACK (LEVEL 2); ANCHORAGE INSTRUMENTS RACK COVER; ANCHORAGE PLATE BENDER; ANCHORAGE PLATE GRIPPER; ANTEVERSION GUIDE; AO HANDLE - LENGTH 135MM; AO Quick Coupling with Elastosil Handle; AO/JACOBS QUICK RELEASE APEX CHUCK 3mm; AO/JACOBS QUICK RELEASE APEX CHUCK 4mm; AO/JACOBS QUICK RELEASE APEX CHUCK 5mm; AO/JACOBS QUICK RELEASE APEX CHUCK 6mm; APEX DRILL BRACE - 3/4/5/6mm; APEX DRILL GUIDE HANDLE; APEX TRAY BASE; APEX TRAY LID; APEX TRAY LOWER INSERT; APEX TRAY UPPER INSERT; ATP Disc Prep; AWL; AXSOS ADAPTOR FOR TORQUE TESTER T20; AXSOS ADAPTOR FOR TORQUE TESTER T8/T15; AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK; Accolade C Femoral Stem; Accolade C Hip Stems; Accolade Hfx Hip Stems; Accolade Hip System; Accolade II Hip Stems; Accolade II System Instrumentation; AccoladeThV'-J I-Iip Stern Series; Aequalis Fracture; Aequalis Reversed Fracture; Aequalis Reversed II; Aequalis"" Ascend"" Flex; Aequalis"" Fx2; Aequalis"" Instrument; Aequalis"" PerFORM; Aequalis"" Retractor Shoulder System; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; All OrthoHelix Orthopedic Manual Surgical Instruments; All Tornier Instruments, Cutting, Orthopeadic; All Tornier Orthopeadic Manual Surgical Instruments (exempt); Aluminum Lid - Universal; Anato Hip Stem; Anato Hip System Instrumentation; Anatomic Express Tray; Anato¿ Hip System; Anato¿ Hip System Instrumentation; Angeld Farabeuf clamp; Angled Ruler; Artisan Bone Plug; Artisan Bone Plug; UHR Bipolar Component; Artisan Bone Plug; Universal Cement Restrictor; Asnis® III Cannulated Screw System; Asnis® PRO Cannulated Screw System; Associated instrumentation; Avon Patella-Femoral Joint; Avon Patellofemoral Replacement - femoral and patellar components; AxSOS; AxSOS 3; AxSOS 3 AF System and AxSOS 3 Ti System, Plate; AxSOS 3 Ankle Fusion; AxSOS 3 Ti; BARREL REAMER ASSEMBLY STAND; BIOCOMPRESSION WRENCH 15mm TUBE; BIOCOMPRESSION WRENCH 20mm TUBE; BIOCOMPRESSION WRENCH 25mm TUBE; BLUNT TIP OBTURATOR; BLUNT TIP OBTURATOR FOR 2.8MM CANNULA; BLUNT TIP OBTURATOR FOR 2.9MM CANNULA; BLUNT TIP OBTURATOR FOR 3.2 CANNULA; BLUNT TIP OBTURATOR FOR 4MM CANNULA; BLUNT TIP OBTURATOR FOR 4MM LONG ARTHROSCOPE; BUR CANNULA 5MM; BioPrep Cement Obturator; BioZip System; Biolox Delta Heads; Bioprep Cement Restrictor; Biosteon Wedge Interference Screw System; Bixcut Reamers; Bixcut, IM Reamer; Bone Plug Extractor; BriteField Depth Gauge; Broach and Inserter Handle; C-Taper Alumina Heads; C-Taper Biolox Delta Ceramic Heads; C-Taper Femoral Head; C-Taper Femoral Heads; CANNULA 4MM; CANNULA 4MM W/2 ROTATING STOPCOCKS; CANNULA 6.5 1 FXD STCK (SPEED-LOCK); CANNULA 6.5MM 1 ROT STCK (SPEED-LOCK); CANNULA 6.5MM 2 FXD STCKS (SPEED-LOCK); CANNULA 6.5MM 2 ROT STCKS (SPEED-LOCK); CANNULA PLUG; CANNULA, 2.8MM; CANNULA, 2.8MM  ONE FIXED STOPCOCK; CANNULA, 2.8MM  ONE ROTATING STOPCOCK; CANNULA, 2.8MM  TWO FIXED STOPCOCKS; CANNULA, 3.2MM  ONE FIXED STOPCOCK; CANNULA, 3.2MM  ONE ROTATING STOPCOCK; CANNULA, 3.2MM  TWO FIXED STOPCOCKS; CANNULA, 3.2MM  TWO ROTATING STOPCOCKS; CANNULA, 4MM ONE FIXED STOPCOCK; CANNULA, 4MM SPEEDLOCK TWO FIXED STOPCOCKS; CANNULATED OBTROCAR FOR 4.6 X 200 MM CANNULA; CANNULATED OBTURATOR FOR 4.6 X 200 MM CANNULA; CANNULATED PENCIL TIP OBTURATOR FOR LONG 5.8MM SCOPE SHEATH; CANNULATED TROCAR FOR 4.6 X 200 MM CANNULA; CANYON Retractor Systems Trays; CAPRI Corpectomy Cage System Trays; CASPIAN Spinal System Trays; CAYMAN Plate System Trays; CDH Hip Stem; CHESAPEAKE Stabilization System Trays; CLAMP; CMI; CMI Delivery Clamp; CMI Mesuring Cannula; CURETTE; CURSOR; CURVED HIP BLADE, SHARP TIP; CURVED HIP PROBE; CUTTER & BUR TRAY; CUTTER CANNULA 4.5MM; CUTTER CANNULA W/ HOLE 5MM; CUTTER CANNULA W/HOLE 4.5MM; CUTTER/ BUR CANNULA 5.6MM; CUTTER/BUR CANNULA (W/HOLE) 5.6MM; CUTTING SCREWDRIVER 4.5; CYLINDRICAL BUSH HOLDER; CalcLock manual surgical instruments; Cannulated Countersink with AO Fitting; Cannulated Drill with AO Fitting; Cannulated Drill ø 2,7/3.5mm with AO Fitting; Cannulated Screwdriver with AO Fitting; Cannulated Screwdriver with Elastosil Handle; Cannulated Tap with AO Fitting; Capsule Punch; Cascadia Interbody System; Cement Plug; Centrax; Ceramic C-Taper Femoral Head; Ceramic V40™ Femoral Head; Champion Shoulder Instrumentation; CinchLock; Citation Hip Stem; Citation TMZF Hip Stems; Cobra Suture Passer, Capture; Cobra Suture Passer, Hook; Colored Plugs; Constrained Acetabular Insert; Trident Crossfire 0 deg Polyethylene Insert; Counterbore Drill; Cross-Screw System; Curettes; Cut Guide; DENALI Spinal System Trays; DEPTH GAUGE; DEPTH GAUGE (DISTAL RADIUS); DEPTH GAUGE (HAND); DISPOSABLE CEMENT SCULPS; DJD II STORAGE CASE; DRAIN CANNULA 70MM; DRAIN CNLA 70MM W/ 2ND; DRILL BIT; DRILL GUIDE; DRILL GUIDE BLOCK COMPACT 4 HOLE; DRILL GUIDE BLOCK COMPACT PERI 4 HOLE; DRILL GUIDE BLOCK HII 10 HOLE; DRILL GUIDE BLOCK HII 5 HOLE; DRILL GUIDE BLOCK MONOTUBE 4 HOLE; DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE; DRILL GUIDE LOCK II 2.5; DRILL SLEEVE; Dall Miles Cable Grip System Implants; Dall Miles Cable System; Dall Miles System; Depth Gauge (Foot/Elbow/Distal Fib); Direct Anterior Instruments; Direct Measuring Gauge; Distal Femoral Growing Prosthesis; Dome Hole Plug; Double Drill Guide ø 2,0/3,5mm; Drill Bit; Drill Bit ø 2,0 x 150mm; Drill Guide Non Sterile; Drill Sleeve; Dual-sided Baseplate Centering Guide; Duracon Knee System; EASY CLIP ANGLED DRILL GUIDE SIZE 15; EDINTRAK II; ENDOTRAC ECTR; ENDOTRAC EPF/ EGR; EVEREST Spinal System Trays; EXTRACTOR; Eccentric 10 Degree Cup Insert Crossfire; Edgelock manual surgical instruments; Eiberg Retractor, Standard; Eiberg Retractor, Standard, Long; Eikon LT Adapt SE 135 mm, Wide Retractor; Eikon LT Adapt SE 135mm Retractor; Eikon LT Adapt SE 135mm, Teeth Retractor; Eikon LT Adapt SE 155 mm, Wide Retractor; Eikon LT Adapt SE 155 mm,Wide,Teeth Retr; Eikon LT Adapt SE 155mm Retractor; Eikon LT Adapt SE 155mm, Teeth Retractor; Eikon LT Adapt SE 175 mm, Wide Retractor; Eikon LT Adapt SE 175 mm,Wide,Teeth Retr; Eikon LT Adapt SE 175mm Retractor; Eikon LT Adapt SE 175mm, Teeth Retractor; Eikon LT Adapt SE 90 mm, Wide Retractor; Eikon LT Adapt SE 90 mm, Wide Teeth Retr; Eikon LT Adapt SE 90mm Retractor; Eikon LT Adapt SE 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide, Teeth Retractor; Eikon LT Adapt, 135 mm; Eikon LT Adapt, 135 mm, Teeth; Eikon LT Adapt, 135 mm, Wide; Eikon LT Adapt, 135 mm, Wide, Teeth; Eikon LT Adapt, 175 mm; Eikon LT Adapt, 175 mm, Teeth; Eikon LT Adapt, 90 mm; Eikon LT Adapt, 90 mm, Teeth; Eikon LT Adapt, 90 mm, Wide; Eikon LT Adapt, 90 mm, Wide, Teeth; Eikon LT FF 135mm Retractor; Eikon LT FF 135mm, Wide Retractor; Eikon LT FF 175mm Retractor; Eikon LT FF 90mm Retractor; Eikon LT FF 90mm, Wide Retractor; Eikon LT FF Replacement Screw; Eikon LT Fixed Frame Retractor, 135mm Eval; Eikon LT Fixed Frame Retractor, 135mm Wide Eval; Eikon LT Fixed Frame Retractor, 90mm Eval; Eikon LT Fixed Frame Retractor, 90mm Wide Eval; Eikon LT Retractor, 135 mm; Eikon LT Retractor, 135 mm, Narrow; Eikon LT Retractor, 135 mm, Narrow Teeth; Eikon LT Retractor, 135 mm, Sweetheart; Eikon LT Retractor, 135 mm, Teeth; Eikon LT Retractor, 135 mm, Wide; Eikon LT Retractor, 135 mm, Wide, Teeth; Eikon LT Retractor, 175 mm; Eikon LT Retractor, 175 mm, Teeth; Eikon LT Retractor, 40 mm, Extra Narrow; Eikon LT Retractor, 40 mm, Narrow; Eikon LT Retractor, 50 mm; Eikon LT Retractor, 50 mm, Teeth; Eikon LT Retractor, 90 mm; Eikon LT Retractor, 90 mm, Narrow; Eikon LT Retractor, 90 mm, Narrow Teeth; Eikon LT Retractor, 90 mm, Teeth; Eikon LT Retractor, 90 mm, Wide; Eikon LT Retractor, 90 mm, Wide, Teeth; Eikon LT Retractor, A-N, 35 mm & 50 mm; Eikon LT Retractor, Rich, 40mm x 38mm; Eikon LT Retractor, Rich, 60mm x 45mm; Eikon LT Retractor, Rich, 80mm x 60mm; Eikon LT SL Sterilization Tray; Eikon LT Sterilization Tray; Elastosil T-Handle with AO Coupling; Endotrac; Exeter 2.5 mm Intramedullary Plug, orthopaedic accessory; Exeter Acetabular; Exeter Acetabular System; Exeter Centralizer, orthopaedic accessory; Exeter Femoral Heads; Exeter Hip Stem; Exeter Hip System; Exeter Hip System Instrumentation; Exeter IM Plug; Exeter Related Instrumentation; Exeter V40 Femoral Stem; Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads; Exeter X3 RimFit All Poly Cup; Exeter X3 RimFit Cup; Express Humeral Stem Extractor; Express Insert; Extractor; Extractor Rod; Extractor for Screws; FEMORAL CANAL BRUSH, STANDARD; FIXOS 4 MV DEPTH GAUGE; FOREFOOT SET; FORMULA 180 SHAVER (HAND CONTROL); FORMULA SHAVER (HAND CONTROL); FUNNEL; Farabeuf clamp; Flex Shoulder System; FlexStick Passer; FlowPort II; GAP Acetabular System; GAP II Acetabular System; GLENOID PLANER; GLICK HIP KIT TRAY; GMRS; GMRS System; GUIDE FOR HALF-PINS; Gap II Shell; General; General Instruments; Glenoid Retractor; Glenoid pin guide; Global Modular Replacement System; Graft box body; Graft box compression screw; Graft box locking screw; Graft box washer; Graft box wedge; Graft container; Graft extractor; Graft sizer; Guide Wire; Guide Wire Pusher; Guide Wire Ruler; Guide Wire Targeter; Guide Wire Targeter - Crown; Guide Wire Targeter - Sleeve; Guide Wire, Threaded; HII 7mm T-WRENCH / 5+6mm SOCKET; HII COMPACT 5mm WRENCH/3&4mm SOCKET; HII COMPACT GUIDE BLOCK W/AO; HII COMPACT MRI STORAGE CASE BASE; HII COMPACT MRI STORAGE CASE LID; HII COMPACT MRI STORAGE CASE UPPER INSERT; HII COMPACT STORAGE CASE BASE; HII COMPACT STORAGE CASE LID; HII COMPACT STORAGE CASE UPPER INSERT; HII MICRO 2mm PIN DRIVER; HII MICRO DRILL GUIDE ASSEMBLY; HII MICRO NUT DRIVER; HII MICRO STORAGE CASE BASE; HII MICRO STORAGE CASE DRILL BIT HOLDER; HII MICRO STORAGE CASE LID; HII MICRO STORAGE CASE LOWER INSERT; HII MICRO STORAGE CASE UPPER INSERT; HII MRI TRAY BASE; HII MRI TRAY LID; HII MRI TRAY LOWER INSERT; HII TRAY BASE; HII TRAY LID; HII TRAY LOWER INSERT; HII TRAY UPPER INSERT; HIP  SUTURE GRASPER; HIP 4MM CANNULA; HIP 4MM CANNULA, WITH DISTAL HOLES; HIP 5.5MM CANNULA; HIP 5.5MM CANNULA, WITH DISTAL HOLES; HIP 5MM CANNULA; HIP 5MM CANNULA, WITH DISTAL HOLES; HIP BITER, 15°  UP; HIP BITER, STRAIGHT; HIP BRIDGE, DUAL FIXED STOPCOCKS; HIP BRIDGE, DUAL ROTATING STOPCOCKS; HIP BRIDGE, SINGLE ROTATING STOPCOCK; HIP BRIGE, SINGLE FIXED STOPCOCK; HIP CANNULA - 4.5MM; HIP CANNULA - 5.6MM; HIP CANNULA - 5MM; HIP CURETTE, 20°; HIP GRASPER, LEFT; HIP GRASPER, RIGHT; HIP GRASPER, STRAIGHT; HIP KNOT PUSHER; HIP OBTROCAR FOR 4MM CANNULA; HIP OBTROCAR FOR 5.5MM CANNULA; HIP OBTROCAR FOR 5MM CANNULA; HIP OBTURATOR (CANNULATED) - 5.6MM; HIP OBTURATOR (CANNULATED) - 5MM; HIP OBTURATOR (CANNULATED) 4.5MM; HIP OBTURATOR FOR 4MM CANNULA; HIP OBTURATOR FOR 5.5MM CANNULA; HIP OBTURATOR FOR 5MM CANNULA; HIP PROBE, 90°; HIP RASP, 30° UP; HIP SUTURE PASSER ,LEFT; HIP SUTURE PASSER, 35° UP; HIP SUTURE PASSER, RIGHT; HIP SUTURE PASSER, STRAIGHT; HIP TISSUE LIBERATOR, 20°; HIP TROCAR ( CANNULATED) - 4.5MM; HIP TROCAR (CANNULATED) -  5MM; HIP TROCAR (CANNULATED) - 5.6MM; HIP TROCAR FOR 4MM CANNULA; HIP TROCAR FOR 5.5MM CANNULA; HIP TROCAR FOR 5MM CANNULA; HLS KNEETEC; HLS NOETOS; HLS UNI EVOLUTION; HM MINI 4 SPANNER WRENCH; HOFFMANN LRF INFO BOARD; HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT; HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY; HOFFMANN LRF RATCHET WRENCH - HEX 10; HOFFMANN LRF SPANNER WRENCH - 5 mm; HOFFMANN LRF SPANNER WRENCH - 7/10 mm; HOFFMANN LRF TELES. STRUT WRENCH; HOFFMANN LRF THUMBWHEEL - HEX 10; HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS; HOFFMANN LRF UNIVERSAL COMPONENTS INSERT; HOFFMANN LRF UNIVERSAL COMPONENTS TRAY; HOFFMANN LRF WIRE BOLT WRENCH; HOFFMANN LRF WIRE TENS. NOSE - LONG; HOFFMANN LRF WIRE TENS. NOSE - SHORT; HOFFMANN LRF WIRE TENSIONER; HOFFMANN XPRESS SILICON MAT; HOFFMANN XPRESS SILICON THUMBWHEEL; HOFFMANN XPRESS SPANNER WRENCH; HOFFMANN XPRESS STORAGE CASE BASE; HOFFMANN XPRESS STORAGE CASE INSERT; HOFFMANN XPRESS STORAGE CASE LID; HOFFMANN XPRESS TORQUE WRENCH; HOFFMANN3 TRAY FOR STANDARD COMPOMENTS; HOLDING FORCEPS; HOLDING SPANNER 4.5; HOLE PLUGS; HOWMEDICA MIX KIT I TM 10PK; Hammer, Surgical; Hip Needle; Hoffmann LRF; Hoffmann LRF System, Insert; Hoffmann LRF System, Instrument; Hoffmann LRF System, Ruler; Hoffmann LRF System, Wire Tensioner; Hoffmann LRF System, Wrench; Holding Sleeve; Humeral Express Tray; Humeral Intercalary System; ICONIX All Suture Anchor System; IMN Instruments Percutaneous guide wire inserter; IMN Instruments Self-Holding Screwdriver T20; IMPACTOR; INBONE; INCLINED DRILL GUIDE SCREW EZ18; INCLINED DRILLING GUIDE + SCREW EZ20; INFINITY; INFLOW/OUTFLOW CANNULA; INSTRUMENT TRAY BASE 4.5; INSTRUMENT TRAY LID FIXOS; INTERMEDIATE PROSTHESIS HOLDER LEFT; INTERMEDIATE PROSTHESIS HOLDER RIGHT; INTRAMEDULLARY BRUSH STANDARD 14MM OD; Iconix DC Guide for 1.4mm anchor; Iconix DC Obturator for 1.4mm anchor; Impactor, Orthopedic Manual Surgical Instrument; Insertion Sleeve for Guide Wire; Insignia Hip Stem; Insignia Instruments; Instrument Guides; Instrumentation; Inter-Lock System; Intraosseous Fixation system manual surgical instruments; Invuity A-N, 35mm & 50mm Extra Narrow Re; Invuity A-N, 35mm & 50mm Extra Narrow Retractor; Invuity A-N, 35mm & 50mm Narrow Retracto; Invuity A-N, 35mm & 50mm Narrow Retractor; Invuity Breisky 130mm; Invuity Breisky 170mm; Invuity Deaver 25mm Wide Retractor; Invuity Deaver 38mm Wide Retractor; Invuity St. Marks 11 in Retractor; Invuity St. Marks 9 in Retractor; JA FANTOME CALOTTE; Jaw Clamp Large Offset Curved; Jaw Clamp Large offset Straight; Jaw Clamp Std Long; Jaw Clamp Std Short; Jaw Clamp offset Overbite; Jaw Clamp offset Underbite; Jaw Clamp, Curved Offs. Counterclockwise; Jaw Clamp, Overbite Counterclockwise; Jaw Clamp, Std Offset Counterclockwise; Jaw Clamp, Std Short Counterclockwise; Jaw Clamp, Std, Long Counterclockwise; Jaw Clamp, Underbite Counterclockwise,; Jungbluth Clamp, Narrow; Jungbluth Clamp, Wide; K-TEK BASIC CLAMP, EU/UK; K-TEK BASIC CLAMP, US; K-TEK SELECT BLADE CLAMP, EU; K2M General Instruments; KTEK ROUND POST CLAMP, US; KTEK SELECT BLADE CLAMP, US; KW BENDING IRON ICS; Kerboull Acetabular Cross Plate; Kinematic Knee System; Kinemax  Knee; Kinemax Knee; Kinemax Knee System; Kinemax Plus Knee System; Knotilus+ 2.4X11.3mm Drill, Hard Bone; Knotilus+ 2.4x11.3mm Drill; Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip; Knotilus+ 2.4x8.9mm Drill, Hip; Knotilus+ 2.9x12.5mm Drill; Knotilus+ 2.9x12.5mm Drill, Hard Bone; Knotilus+ 2.9x12.5mm Drill, Hard Bone, Hip; Knotilus+ 2.9x12.5mm Drill, Hip; Knotilus+ 2.9x15.5mm Drill; Knotilus+ 2.9x15.5mm Drill, Hard Bone; Knotilus+ Bullet Tip Obturator, Cannulated; Knotilus+ Bullet Tip Obturator, Cannulated, Hip; Knotilus+ Crown Tip Guide; Knotilus+ Crown Tip Guide, Hip; Knotilus+ Fishmouth Tip Guide; Knotilus+ Fork Tip Guide, Hip; Knotilus+ Offset Tip Guide; Knotilus+ Pencil Tip Obturator; Knotilus+ Pencil Tip Obturator, Hip; LFIT V40 Femoral Heads; LID FOR INSTRUMENT TRAY; LID FOR PLATE RACK - COMPRESSION PLATES; LID FOR PLATE RACK - GENERIC; LID FOR PLATE RACK - SPECIAL PLATES; LITe BIO Delivery System - Sterilization Tray and Lid; LONG HIP KNIFE HANDLE; Lag Screw Sleeve; Large AO Coupling - Hall Fitting; M/T TRIAX LNG HANDLE WRENCH BLUE; M/T TRIAX LNG HANDLE WRENCH RED; M/T TRIAX LNG HANDLE WRENCH YELLOW; MANUAL ARTHROSCOPIC ACCESSORIES; MANUAL DRILL BIT; MDM Acetabular Liner; MDM Hip System Instrumentation; MEDPOR CI; MEDPOR Customized Implant Kit; MESA Spinal System Trays; MICROFRACTURE PICK, STRAIGHT; MILITARY EXTERNAL FIXATION CASE; MONOTUBE TRIAX YELLOW CASE; MRH System; MRS SYstem; Mainstay Zip Anchor System; Mako Instrument Trays; MaxLock Extreme manual surgical instruments; Meniscal Transplant Set; Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini; MicroFX OCD; MicroFX™; Mini MaxLock manual surgical instruments; Modular Glenoid Surface Trial; Modular Humeral Head Trial; Modular Humeral Head Trial Post; Modular Replacement System; Modular Rotating Hinge Knee; Morse Taper Head; Muller Acetabular Cup; Multiple Drill Guide; NAPA Access System; NEEDLE GUIDE; NUR CANNULA 6MM; NanoTack; NanoTack Flex; Navigated Spine Instruments Trays; Navigation Instruments Trays; OBLONG DRILL GUIDE DIAMETER 2MM; OBTROCAR FOR 4.6 X 200 MM CANNULA; OBTURATOR 2.8MM; OBTURATOR 4.5MM; OBTURATOR 4MM BLUNT TIP; OBTURATOR 4MM PENCIL TIP; OBTURATOR 5.6MM; OBTURATOR 5MM; OBTURATOR 5MM SPEED LOCK CANNULA; OBTURATOR 6.5; OBTURATOR 6MM; OBTURATOR FOR 10MM DRAIN CANNULA; OBTURATOR FOR 3.2MM 30° A/C J-LOCK ARTHROSCOPE; OBTURATOR FOR 4.6 X 200 MM CANNULA; OBTURATOR FOR 5.8MM SPEED-LOCK CANNULA - BLUNT TIP; OBTURATOR FOR 5.8MM SPEED-LOCK CANNULA - PENCIL TIP; OBTURATOR FOR 70MM DRAIN CANNULA; OBTURATOR SE-4; ODC Hip Stem; OMEGA PLUS 145 DRILL GUIDE INSERT; OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-NEUTRAL; OMEGA PLUS DRILL GUIDE HANDLE; OMEGA PLUS HEAD; OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm; OMEGA PLUS LAG SCREW ADAPTER; OMEGA PLUS SCREW EXTRACTION BOLT; OMEGA PLUS SUPRACONDYLAR DRILL GUIDE; OMEGA PLUS SUPRACONDYLAR PIN GUIDE; OMEGA PLUS TAP GUIDE 4.5mm; OMEGA PLUS TAP GUIDE 6.5mm; OMEGA PLUS TRIAL PLATE 150; OMEGA+ BARREL REAM ASSY SHORT; OMEGA+ PIN W/THREAD 2.8X230MM; OMEGA+ VAR ANGLE GUID REPL KIT; OMNIFLEX; ORTHOPEDIC MANUAL; OSTEONICS; OSTEONOICS; OZARK Cervical Plate System Trays; OmniFIt Acetabular System; OmniFIt EON Hip Stem; OmniFit Acetabular Inserts; OmniFit Acetabular System; OmniFit Bone Screw; OmniFit Constrained Acetabular Insert; OmniFit Crossfire Inserts; OmniFit HFx Hip Stem; OmniFit Head/Neck Hip Stem; OmniFit Hip Stem; OmniFit Hip System; OmniFit Knee System; OmniFit-C Hip Stem; OmniFlex Hip System; Omnifit 20 degree Series I insert; Omnifit Crossfire 10 deg Series II Insert; Omniflex Hip System; Opening Guide; Opening Reamer; Opening Sleeve; Orthinox V40 Femoral Heads; Orthopaedic Manual Instrumentation; Osteocolock Acetabular System; Osteolock Acetabular System; Osteolock Screws; Osteonics Constrained Acetabular Liner; Overdrill for 4.5mm Screws, AO; PATELLAR CUTTER; PCA  Constrained Liner; PCA Acetabular System; PCA Duration Insert; PCA Femoral Head; PCA Femoral Heads; PCA Head; PCA Knee System; PEDIATRIC CORTICAL REAMER; PENCIL TIP OBTURATOR FOR 2.8MM CANNULA; PENCIL TIP OBTURATOR FOR 2.8MM J-LOCK CANNULA; PENCIL TIP OBTURATOR FOR 2.9MM CANNULA; PENCIL TIP OBTURATOR FOR 3.2MM CANNULA; PENCIL TIP OBTURATOR FOR 4MM CANNULA; PENCIL TIP OBTURATOR FOR 4MM LONG ARTHROSCOPE; PIN CUTTER / HA PINS; PIP Starter Awl; PKG, 3.4MM CLAW RANGEUR; PKG, 3.4MM HOOK SCISSORS, 30 DEG LEFT; PKG, ARTHROSCOPY ACCESS ARTHROSCOPE TRAY; PKG, ARTHROSCOPY ACCESS HARDWARE XL TRAY; PKG, ARTHROSCOPY ACCESS TRAY LID; PKG. , 2.7 BIG BITE PUNCH - 30 DEG. LEFT; PKG. , 3.4MM SOFT TISSUE GRASPER; PKG. , 3.4MM TIP BITER - 45 DEG RIGHT; PKG. 2.7MM MICRO SCISSOR PUNCH; PKG. 2.7MM SOFT TISSUE GRASPER; PKG. 2.7MM SOFT TISSUE GRASPER W/RATCHET; PKG. 3.4MM HOOK SCISSORS RIGHT; PKG. 3.4MM MICRO SCISSOR PUNCH; PKG. 3.4MM SCOOP JAW PUNCH-STRAIGHT; PKG., 2.7MM BIG BITE PUNCH - 15 DEG UP; PKG., 2.7MM BIG BITE PUNCH - 30 DEG. RIGHT; PKG., 2.7MM BIG BITE PUNCH - STRAIGHT; PKG., 2.7MM BIG BITE PUNCH - UPSHAFT; PKG., 3.4MM BACKBITER; PKG., 3.4MM BIG BITE PUNCH - 15 DEG UP; PKG., 3.4MM BIG BITE PUNCH - 30 DEG LEFT; PKG., 3.4MM BIG BITE PUNCH - 30 DEG RIGHT; PKG., 3.4MM BIG BITE PUNCH - STRAIGHT; PKG., 3.4MM BIG BITE PUNCH - UPSHAFT; PKG., 3.4MM SCOOP JAW PUNCH 30 DEG LEFT; PKG., 3.4MM SCOOP JAW PUNCH 30 DEG RIGHT; PKG., 3.4MM SOFT TISSUE GRASPER WITH RATCHET; PKG., 3.4MM TIP BITER - 45 DEG LEFT; PKG., 4MM GRASPER; PKG., PUMP CANNULA, 5.8MM W/ 1 ROTATIONG STOPCOCK; PKG.,3.4 HOOK SCISSORS STRAIGHT; PKG.,3.4 ROTARY PUNCH-90° LEFT; PKG.,3.4 ROTARY PUNCH-90° RIGHT; PKG.,3.4MM GRASPER; PKG.,3.4MM MINISCAL CRESCENT PUNCH; PKG.3.4MM MENISCAL CRESCENT PUNCH; PLANER; PLATE BENDING IRONS; PLUG SPEEDLOCK CANNULA; PRO Plating System; PRO-TOE; PROTRACTOR; PYRENEES Cervical Plate System Trays; Pangea Femur Reconstruction System Bender; Pangea Femur Reconstruction System K-Wire; Pangea Femur Reconstruction System Tray; Pangea Platform; Pangea T-Handle; Parallel Guide for ø 1,4mm/2mm Wires; Perc. Double Wire Guide; PeriPROTM Femur; Phoenix; Plastic Tray; Polymer Implant; Posterior TLIF; Precision Hip Stem; Premise Acetabular System; Proximal Cement Spacer; Q Pedicle Instruments; Quick Release Driver Hall Fitting; RACK FOR OPEN WEDGE PLATES (LEVEL 2); RACK FOR PLP UTILITY/MTP (LEVEL 2); RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2); RAS System Instrumentation; RAVINE Access System Trays; RED & BLUE INTL M/T CASE; REDUCTION HANDLES B & R CLAMPS; REPLACEMENT COMPONENTS; REPLACEMENT KNOB FOR DRILL BRACE; RESECTION GUIDE; RETRACTOR; RING DRIVER 4.5; ROTARY BRIDGE SE4; ReUnion; ReUnion RFX; ReUnion RSA; ReUnion RSA. ReUnion RFX, ReUnion TSA; ReUnion Shoulder System; ReUnion TSA; Reduction Tray; Reduction Tray Insert for Jaw Clamps; Reduction Tray Insert for Weber Clamps; Reduction Tray generic Insert; Reliance Hip Stem; Restoration ADM Acetabular System; Restoration ADM and MDM System; Restoration ADM/MDM Instrumentation; Restoration Acetabular Augments; Restoration Acetabular Ring; Restoration Acetabular Wedge Augments; Restoration Anatomic Acetabular Shell; Restoration Anatomic Shell; Restoration Anatomic Shell and RAS Instrumentation; Restoration HA Calcar Hip Stem; Restoration HA Hip Stem; Restoration Hip Stem; Restoration MDM Acetabular System; Restoration Modular Hip Stem System; Restoration Modular Hip System; Restoration Modular Hip System, Plasma Distal Stem, Bowed; Restoration Modular Instrument Trays; Restoration Modular System; Restoration Modular Total Hip System implants - proximal bodies and distal stems; Restoration Modular Trials; Restoris MCK; Restoris MCK Femoral Component; Restoris MCK Knee System; Restoris MCK Patella Resurfacing Round Dome; Restoris MCK Patellofemoral Component; Restoris MCK Tibial Baseplate; Restoris MCK Tibial Onlay Insert; Restoris MCK X3 Tibial Onlay Insert; Restoris MCK X3 Unicondylar Tibial Insert; Retractor; Reunion Fracture System; Reusable Awl; Reusable Slat for Eikon LT Adapt Smoke Evacuation 135 mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 155mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 175mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 90mm Retractor, 10 Pack; Reverse Express Tray; SAHARA Stabilization System Trays; SALTO TALARIS; SALTO XT; SCR Unicompartmental Knee; SCREW CADDY FOR 2 / 2.5 FIXO TRAY; SCREW RACK ANCHORAGE; SCREW RACK WS + CS (2MM+3.5MM); SCREW TRAY 4.5; SCREW-HOLDING FORCEPS FIXOS; SCREWDRIVER HANDLE; SET ANCILLARY IMPLANT SUBTALAR; SET SCREW FOR HUMERUS AIMING BLOCK; SET SCREW FOR TIBIA AIMING BLOCK; SILICONE MAT; SLOTTED HIP CANNULA -133 MM (LONG); SLOTTED HIP CANNULA -70 MM (SHORT); SMALL JOINT BRIDGE (2.3MM-2.7MM); SMALL JOINT CANNULA; SMALL JOINT CAP; SMALL JOINT OBTURATOR-3.5MM; SMALL JOINT TROCAR 3.5MM; SMALL JOINTS PROBE 30 DEG ASSY; SMALL JOINTS PROBE 90 DEG ASSY; SMALL JOINTS PROBE STRAIGHT ASSY; SMALL RULER FOR MEASUREMNET; SMALL SWIVEL JOINT; SMART TOE 1 INSTRUMENT KIT; SPARE SET SCREW HUMERUS TS AIMING BLOCK; SPARE SHAFT TEMP. PLATE HOLDER; SPEED-LOCK BRIDGE 2 ROTATING STOPCOCKS; SPEED-LOCK BRIDGE, 1 ROTATING STOPCOCK; SPEED-LOCK BRIDGE, 2 ROTATING STOPCOCKS; SPIKE SCREW INSERTER FOR 4.5MM SCREWS; SPS BENDING SLEEVE - SLOTTED STEEL; STANDARD BENDING SLEEVE; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM; STERNUM SAW REPLACEMENT GUIDE; STRAIGHT FEMORAL CANAL BRUSH; STRAIGHT HIP BLADE, BLUNT TIP; STRAIGHT HIP BLADE, SHARP TIP; STRYKER 2-0 KNOT PUSHER/SUTURE CUTTER AND SLOTTED CANNULA SET; STRYKER DYONICS ADAPTOR BRIDGE, ONE ROTATING STOPCOCK; STRYKER DYONICS ADAPTOR BRIDGE, TWO ROTATING STOPCOCKS; STRYKER DYONICS FLUID SEAL ADAPTOR; SUBFIX INSERTION INSTRUMENT; SUPERSCOPE SYRINGE LOCK SCOPE BRIDGE,1 FIXED SPCK; SUTURE CUTTER",1992-11-23,240,2026-08-06,2,226,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222249697%22&limit=1
"Medtronic Sofamor Danek Usa, Inc.",3003120897,3003120897,4340 Swinnea Road,Memphis,TN,38118,United States,"Medtronic, Inc.",2112641,Manufacturer; Manufacturer for export; Remanufacturer; Repackager or relabeler; Specification developer,122,DXT; DXY; EQJ; ETN; EZW; FMF; FMH; FSM; FSZ; FTY; FZO; FZT; FZX; FZY; GAD; GDG; GDI; GEA; GEI; GET; GEY; GWF; GXD; GXI; GXZ; HAW; HBB; HBE; HRR; HRX; HTC; HTD; HTE; HTF; HTJ; HTO; HTQ; HTR; HTS; HTW; HTX; HTZ; HWA; HWB; HWE; HWI; HWJ; HWK; HWM; HWN; HWR; HWT; HWX; HXB; HXC; HXD; HXG; HXK; HXL; HXP; HXQ; HXT; HXW; HXX; HXZ; JDZ; KCT; KDG; KIH; KRA; KRG; KTZ; KWP; KWQ; LGW; LKK; LRN; LRP; LWP; LWS; LXH; MAX; MBX; MHY; MJO; MNH; MNI; MPW; MQP; MRW; NBH; NDN; NEK; NHL; NIK; NKB; NKE; NKG; NPZ; NQO; NQP; NQW; NVN; NVY; NVZ; ODP; OLO; OSH; OSR; OUR; OVD; OVE; OWI; PGM; PJS; PLR; PML; PNJ; QON; QPT; QRB; SGS,"Injector And Syringe, Angiographic; Implantable Pacemaker Pulse-Generator; Bur, Ear, Nose And Throat; Stimulator, Nerve; Stimulator, Electrical, Implantable, For Incontinence; Syringe, Piston; Container, Specimen, Sterile; Tray, Surgical, Instrument; Light, Surgical, Carrier; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Hook, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Pneumatic Powered; Motor, Surgical Instrument, Ac-Powered; Stimulator, Electrical, Evoked Response; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Electrode, Needle; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Drills, Burrs, Trephines & Accessories (Simple, Powered); Scissors, Orthopedic, Surgical; Arthroscope; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Reamer; Broach; Rasp; Knife, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Corkscrew; Awl; Trephine; Osteotome; Instrument, Compression; Driver, Prosthesis; Template; Tap, Bone; Probe; Wrench; Clamp; Tamp; Holder, Needle; Orthopedic; Mallet; Instrument, Bending Or Contouring; Crimper, Pin; Tape, Orthopedic; Bender; Screwdriver; Cutter, Wire; Mixer, Cement, For Clinical Use; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Chisel (Osteotome); Dispenser, Cement; Catheter, Continuous Flush; Programmer, Pacemaker; Caliper; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Pump, Infusion, Implanted, Programmable; Wire, Surgical; Tray, Surgical; Implantable Pulse Generator, Pacemaker (Non-Crt); Implantable Cardioverter Defibrillator (Non-Crt); Orthopedic Manual Surgical Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Stimulator, Thalamic, Epilepsy, Implanted; Stimulator, Electrical, Implanted, For Parkinsonian Tremor; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction; Spinal Vertebral Body Replacement Device; System, Facet Screw Spinal Device; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction; Stimulator, Electrical, Implanted, For Parkinsonian Symptoms; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D); Thoracolumbosacral Pedicle Screw System; Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P); Posterior Cervical Screw System; Bone Grafting Material, Dental, With Biologic Component; Prosthesis, Spinous Process Spacer/Plate; Posterior Metal/Polymer Spinal System, Fusion; Orthosis, Spine, Plate, Laminoplasty, Metal; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes; Permanent Defibrillator Electrodes; Pulse Generator, Permanent, Implantable; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Pacemaker/Icd/Crt Non-Implanted Components; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Bone Fixation Cerclage, Sublaminar; Growing Rod System; Stimulator, Electrical, Implanted, For Essential Tremor; Spinal Vertebral Body Replacement Device - Cervical; Bone Cement, Posterior Screw Augmentation; Leadless Pacemaker; Implanted Electrical Device Intended For Treatment Of Fecal Incontinence; Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence; Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy; Deep Brain Stimulation For The Treatment Of Dystonia",1; 2; 3; U,", MOTORS; ACPii Atlantis Cervial Plate; AEX Generator Refurbished; ANTERIOR CERVICAL PLATE SYSTEM; ARTHROSCOPE; ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology; ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS"" Anterior Cervical Plate System; ATLANTIS- Anterior Cervical Plate System; AURORA EV-ICD™ MRI SURESCAN™ SW041; Access Review Therapy Controller; Access Therapy Controller; Accurian™; Activa PC Neurostimulator; Activa Parkinsons Control Therapy; Activa RC Neurostimulator; Activa SC Neurostimulator; Activa Tremor Control Therapy; Adapta; Adapta L; Adapta S; Adapter Cable; Adaptor Extender Kit; Adaptor Kit; Advisa DR; Advisa DR MRI SureScan; Advisa SR MRI SureScan; Altaviva™ Clinician Kit; Altaviva™ Clinician Programmer Kit; Altaviva™ Neurostimulator; Altaviva™ Patient Programmer Kit; Amplia MRI CRT-D SureScan; Amplia MRI Quad CRT-D SureScan; Analyzer Adapter; Analyzer Cable; Anatomic Peek; Anatomic Peek PTC Cervical Fusion System Cage; Ankle Band; Anteralign Spinal System with Titan nanolOCk; Anteralign™ Spinal System with Titan NanoLOCK™ Surface Technology Navigated Instruments; Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology; Aquamantys 2.3 Bipolar Sealer (23-113-1);; Aquamantys Epidural Vein Sealer (23-121-1); Aquamantys Mini EVS 3.4 Epidural Vein Sealer (23-314-1); Aquamantys SBS 5 Sheathed Bipolar Sealer (23-312-1); Ascenda Catheter; Aspen; Atlantis Vision Anterior Cervical; Atlas Cable; Atrion Inflation Syringe; Attesta DR MRI; Attesta L DR MRI; Attesta S DR MRI; Attesta SR MRI; Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator; Azure S DR MRI; Azure S SR MRI; Azure XT DR MRI; Azure XT SR MRI; BIT DRILLS; BONE HOOK; BONE MILL; BONE SCREW RULER; BONE TAP; BRYAN Cervical Disc; BRYANCervical Disc System; Bard-Parker; Bipolar forcep; Bone Cement HV-R w/Mixer - US; Brava; Brava Quadripolar CRT-D; CAPSTONE CONTROL PTC Spinal System; CAPSTONE CONTROL Spinal System; CAPSTONE PTC SPINAL SYSTEM; CAPSTONE Spinal System; CAPSTONE-L SPINAL SYSTEM; CD Cannulated Screw; CD HORIZON ESSENCE; CD HORIZON ESSENTIALS™ Spinal System; CD HORIZON Fenestrated Screw Set; CD HORIZON Growth Rod Conversion Set; CD HORIZON Longitude 2 Instruments and Rods; CD HORIZON SEXTANT II Spinal System; CD HORIZON SOLERA Spinal System; CD HORIZON SPIRE(TM) Z Spinal System; CD HORIZON Spinal System; CD HORIZON Spinal System, CD HORIZON ESSENTIALS"" Spinal System; CD HORIZON VOYAGER""; CD HORIZON(R) Spinal System; CD HORIZONSPINAL SYSTEM; CD HORIZON™ Spinal System; CD HORIZON® Fenestrated Screw Set; CD HORIZON® SOLERA® Spinal System; CD HORIZON® Spinal System; CD Horizon Ballast"" Spinal System; CD Horizon MAS Design Enhancement; CD Horizon SMA Staple; CD Horizon Solera 5.5/6 Sagittal Adjusting Screws; CD Horizon Spinal System; CD Horizon Spinal System ; CD Horizon Mazor Modulex Spinal System; CD HorizonSpinal System; CD Horizon™ Astute™ Spinal System; CD Horizon™ ModuLeX™ FNS Screw Set; CD Horizon™ ModuLeX™ Spinal System; CD Horizon™ Modular 5.5/6mm Spinal System; CD Horizon™ Spinal System; CD Horizon® Spinal System; CD LIBERTY POSTERIOR SPINCAL SYSTEM; CD Modified Sextant II Instruments; CD Perc Trauma; CD Sextant II Reduction; CD Sextant Instruments; CD Spire Spikes; CEMENT; CLYDESDALE Spinal System; CORKSCREW; CORNERSTONE PSR Cervical Fusion System; CRESCENT Vertebral Body Spacer; CRESENT Ti Spinal System; Cannula; Introducer tool; CapSure Lead; CapSure VDD-2 Lead; CapSureFix MRI SureScan Lead; Capstone Control; Capstone Control™ Spinal System; Capstone Spinal System; CardioSight Reader; CareLink Encore Programmer; CareLink Encore Programmer RF Head; CareLink Express Mobile System - Android; CareLink Express Mobile System - iOS; CareLink Express Monitor; CareLink Network Software; CareLink Programmer RF Head; CareLink SmartSync Azure Astra Application; CareLink SmartSync Base 24970A; CareLink SmartSync Common Application iOS; CareLink SmartSync PSA Application; CareLink SmartSync Patient Connector 24967; CareLink SmartSync Power Cord 249705; CareLink SmartSync Power Supply 249701; CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025; CareLink Wireless Network Adapter Card; Catalyft PL Expandable Interbody System; Catalyft™ LS Expandable Interbody System; Catalyft™ PL Expandable Interbody System; Centerpiece Plate Fixation System; Chisel, Surgical, Manual; Claria MRI CRT-D; Claria MRI Quad CRT-D; Clydesdale Spinal System; Cobalt DR MRI Surescan; Cobalt HF CRT-D MRI SureScan; Cobalt HF Quad CRT-D MRI SureScan; Cobalt VR MRI Surescan; Cobalt XT DR MRI Surescan; Cobalt XT HF CRT-D MRI SureScan; Cobalt XT HF Quad CRT-D MRI SureScan; Cobalt XT VR MRI Surescan; Compia MRI CRT-D SureScan; Compia MRI Quad CRT-D SureScan; Concerto ICD; Concerto II CRT-D; Consulta DF4 ICD; Consulta ICD; Container; Crescent Spinal System Interbody F; Crome DR MRI Surescan; Crome HF CRT-D MRI SureScan; Crome HF Quad CRT-D MRI SureScan; Crome VR MRI Surescan; Curette; DBS Extension Kit; DF-1 Port Pin Plug; DIVERGENCE Anterior Cervical Fusion System; DIVERGENCE(TM) Anterior Cervical Fusion System; DIVERGENCE-L"" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM; DRILL BIT (ORTHOPEDIC MA; DRILL GUIDES; DRILLS; Danek Unit Rod; Disposable EPG Cover; Disposable Pouch; Drill; Introducer Tool; Dyna-lok/Danek Plate Screw; ECG Cable; ECG Output Adapter; ECG Port Plug; EEA TAID; ELEVATE"" Spinal System; ELEVATOR; ENDOSKELETON TC; ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD); ENDOSKELETON(R) TAS; ENDOSKELETON(R) TL INTERBODY FUSION DEVICE; ENDOSKELETON® TA nanoLOCK® Surface Technology; ENT); EZ Anchor; EnTrust ICD; Endoskeleton TAS Plate; Endoskeleton TCS Interbody Fusion Device; Endoskeleton TCS System; Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device; Endoskeleton® TAS Hyperlordotic Interbody Fusion Device And Endoskeleton® TCS Interbody Fusion Device; Endoskeleton® TAS Interbody Fusion Device; Epsila EV™ MRI SureScan™ extravascular lead; Epsila EV™ Sternal Tunneling Tool; Epsila EV™ Transverse Tunneling Tool; Evera; Evera MRI S DR SureScan; Evera MRI S VR; Evera MRI XT DR SureScan; Evera MRI XT VR SureScan; Evera S DR; Evera S VR; Evera XT DR; Evera XT VR; Expandable Cage; FORCEPS (MANUAL INSTRU; Fuse Spinal System; Fuse Spinal System/ PLIF Titanium Cage; GRIP CLIP - CLIP; GUIDE WIRES (PINS); General Instrument; General Instruments; GoldenEye Micro-Magnetic Tracking; Guide Pin; Introducer Tool; HOLDER NEEDLE; HOLDER, NEEDLE; HV-R Bone Cement US; HourGlass Vertebral Body Spacer; IB3D™ PL Spinal System; ICAL INST); INFINITY™ OCT System; INFINITY™ Occipitocervical Upper Thoracic System; INFUSE BONEGRAFT Tibial Fracture; INFUSE BONEGRAFT/ LT-CAGE Lumbar TF; INFUSE BONGRAFT for Oral Max; IS-1 Port Pin Plug Kit; InCheck Patient Assistant; Inceptiv™ Implantable Neurostimulator; Inceptiv™ LT Implantable Neurostimulator; Indura 1P Catheter; Inflate FX Fracture Management Inflatable Bone Tamp; Injex BiWing Anchor; Injex Bumpy Anchor; Instrument Command Library (ICL)Device Command Library (DCL); Integrated Diagnostics Data Calculation Module Model 5242; Intellis™ Pro Implantable Neurostimulator; Intellis™ with AdaptiveStim™ Implantable Neurostimulator; InterStim II Neurostimulator; InterStim II Sacral Nerve Stim; InterStim Micro™ Implantable Neurostimulator; InterStim Neurostimulator; InterStim Sacral Nerve Stimulation; InterStim Therapy System; InterStim iCon Patient Programmer; InterStim iCon Programmer; InterStim™ SureScan™ MRI leads; InterStim™ X Implantable Neurostimulator; Intercept™; Intrinsic ICD; Itrel 4 Neurostimulation System; Itrel 4 Neurostimulator; Itrel EZ Programmer; KYPHON Cement Delivery System; KyphX Bone Filler Device; KyphX Latitude Curette; KyphX Osteointroducer; Kyphon; Kyphon Anchor Facet Screw System; Kyphon Exact Inflatable Bone Tamp; Kyphon Express Inflatable Bone Tamp; Kyphon HV-R Fenestrated Screw Cement; Kyphon Inflation Syringe; Kyphon Mixer; Kyphon VuE Bone Cement and Kyphon Mixer Pack; Kyphon Xpander II Inflatable Bone Tamp; Kyphon Xpede Bone Cement; LAA Selection Guide; LAMINOPLASTY; LEGEND Power Adapter; Lead Analyzer; Lever Screwdriver; Liberty Spinal System; Loop Spinal System/ TLIF- Cage; MAST QUADRANT™ Retractor System; MEDTRONIC REUSABLE INSTRUMENTS FOR USE WITH THE IPC POWEREASE"" SYSTEM; MEROCEL SPONGE; METRx Endoscope; METRx Microscope; MICRO-FRANCE; MSB-Perimeter System; MULTIPLE (CHISELS; MULTIPLE (DEPTH GAUGES); MULTIPLE (DRIVER-EXTRACTORS); MULTIPLE (ORTHOPEDIC CLAMPS); MULTIPLE (ORTHOPEDIC OSTEOTOMES); MULTIPLE (ORTHOPEDIC REAMERS); MULTIPLE (SCISSORS); MULTIPLE (SURGICAL MALLETS); MULTIPLE FORCEPS; MULTIPLE TWIST; MUTIPLE TYPES OF BURS; Manual surgical instrument for general use; Marksman; Marquis DR ICD; Marquis VR ICD; Maximo DR ICD; Maximo II CRT-D; Maximo II DR; Maximo II VR; Maximo VR ICD; Medtronic CareLink Monitor; Medtronic CareLink Programmer; Medtronic Dissector Tool; Medtronic General Instrument; Medtronic Longevity; Medtronic Reusable Instrument; Medtronic Reusable Instruments; Medtronic Transportation/Sterilization Cassettes; Medtronic Transportation_Sterilization Cassettes; Micra AV TPS; Micra AV2 TPS; Micra TPS; Micra Transcatheter Pacemaker System; Micra VR2 TPS; Multiple High Speed systems; MyCareLink Patient Monitor; N'Vision Programmer; N'Vision Software Application Card; NAVIGATED INFINITY™ Instruments; NETTERVILLE LARYNGOLOPLASTIC STAGE; NIM; NIM Eclipse; NIM SPINE SYSTEM; NO 8 HEXALOBE STRAIGHT DRIVER; Navigated Anterolateral Disc Prep Insturments; Navigated CD HORIZON SOLERA Screwdrivers and Taps; Navigated Disc Prep Instruments; Navigated Elevate Spinal System; Navigated Vertex Select Drill Bit; Navigated Vertex Select Tap; Navigated Vertex Select Threaded Driver; ORION Anterior Cervical; ORTHOPEDIC (ORTHOPEDIC MANUAL SURG; ORTHOPEDIC MANUAL SURGICAL INSTRUM; OSTEOTOMES); OsteoCool"" Cart Stand; OsteoCool"" Desk Stand; OsteoCool"" Independent Thermocouple; OsteoCool"" Pump and Pump Cable; OsteoCool"" RF Ablation Probe Kit; OsteoCool"" RF Ablation System Generator; OsteoCool™ 2 RF Ablation System; Osteocool"" Connector Hub; PASS LP Spinal System; PEAK PlasmaBlade 3S (Model Number: PS210-030S, PS210-030S-SP, PS210-030SE); PEAK PlasmaBlade Needle (Model Number: PS200-001, PS200-001-SP, PS200-001E, PS200-001SPE); PEAK PlasmaBlade Tonsil (PS300-001, PS300-001E, PS300-003, SP300-003E); PEEK Previal Cervical Interbody Dev; PERIMETER INSERTER; PERIMETER Interbody Fusion Device; PIVOX"" Oblique Lateral Spinal System; PLATE; POWEREASE; POWEREASE System; POWEREASE System Working Ends; PRESTIGE LP Cervical Disc System; PRESTIGECervical Disc; PROBE (ORTHOPEDIC MANU; Patient Cable; Patient Programmer; Percept™ PC BrainSense™; Percept™ RC Rechargeable Neurostimulator with BrainSense™ Technology; Perimeter Interbody Fusion Device; Pisces-Quad Compact Lead; Pisces-Quad Plus Lead; PrimeAdvanced Neurostimulator; PrimeAdvanced SureScan MRI Neurostimulator; Primo MRI DR SureScan; Primo MRI VR SureScan; Prodigy IPG; Program Interface Cable; Protecta CRT-D; Protecta DR; Protecta VR; Protecta XT CRT-D; Protecta XT DR; Protecta XT VR; PumpSynchroMed™ Clinician Programmer; Pyramid +4 Anterior Lumbar Plate; Pyramid Non-constrained Cover Plate; Pyramid Tapered Shank Bone Screw; RETRACTOR; RIALTO™ SI Fusion System; ROD BENDER; RONGEUR; RadiaLux™; Radio-Opaque Scale; Rasp; Recharging Dock; Relia IPG; RestoreAdvanced Neurostimulator; RestoreAdvanced SureScan MRI Neurostimulator; RestorePrime Neurostimulator; RestoreSensor Neurostimulator; RestoreSensor SureScan MRI Neurostimulator; RestoreUltra Neurostimulator; RestoreUltra SureScan MRI Neurostimulator; Resume II Lead; Resume TL Lead; Revo MRI SureScan; Robotic Graft Delivery Instruments; SCREWDRIVER; SHILLA(TM) Growth Guidance System; SHILLA™ Growth Guidance System; SOVEREIGN Spinal System; SOVEREIGN™ SPINAL SYSTEM; SPINE; STEALTH AXIS™; SURGICAL DRIVE SYSTEM; Secura DR; Secura VR; SenSight™; Sensia DR IPG; Sensia IPG; Service Kit; Sextant Percutaneous; Slap Hammer; Sovereign; Sovereign Spinal System; Soveriegn Spinal System; Spacekeeper; Specify Lead; Specify SureScan MRI Lead; Sphera DR MRI; Sphera L DR MRI; Sphera SR MRI; Spinal System; Sprint Quattro Lead; Sprint Quattro MRI SureScan Lead; Sprint Quattro Secure Lead; Sprint Quattro Secure MRI SureScan Lead; Sprint Quattro Secure S Lead; Sprint Quattro Secure S MRI SureScan Lead; Sterile Plastic Sleeve; StimLoc; Stretch Coil Extension; Subcutaneous Lead; SynchroMed II Infusion Pump System; SynchroMed Infusion Pump System; SynchroMed™ III; SynchroMed® II Clinician Programmer; Synergy EZ Programmer; T2 Altitude 1.5 Spinal System; T2 STRATOSPHERE™ Expandable Corpectomy System; T2 STRATSOPHERE™ Expandable Corpectomy System; T2 Sceptor Universal Endcleats; T2 TXVBR; TEMPLATE; TOWEL; TRANSLACE™ Spinal Tethering System; TRAY, SURGICAL; TSRH; TSRH Crosslink System; TSRH Expanded Pedicle Screw; TSRH L Rod Connector; TSRH Spinal System; TSRH Spinal System Prebent/precut r; Tissue Approximating Forceps; Titan Anchor; Transvene Lead; Transvene SVC Lead; Tray, Surgical, Instrument; Tunneling Tool; VERTE-STACK Spinal System; VERTE-STACK(TM)SPINAL SYSTEM; VERTEBROPLASTY; VERTEX® Reconstruction System; Vantage Plates; Vanta™ with AdaptiveStim™ Implantable Neurostimulator; Vectris SureScan Lead; Verify Controller; Verify Evaluation System; Verify External Neurostimulator; Versa DR IPG; Verte-Span Lift VB; Verte-Stack Capstone L; Verte-Stack Clydesdale; Verte-Stack Cornerstone Sm End Caps; Verte-Stack Crescent; Verte-Stack Modified Cornerstone; Verte-Stack Perimeter Peek; Verte-Stack Perimeter XS; Verte-Stack Telamon Ti; Vertex Lateral Connectors; Vertex Reconstruction System; Virtuoso II DR/VR ICD; Visia AF MRI S VR SureScan; Visia AF MRI VR SureScan; Visia AF VR; Viva; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D; WRENCH; Wave D- Spinal System; Wave O Spinal System; Wire Caddy; Wire Nest; Wireless Recharger; X-STOP® Interspinous Spacer Titanium; ZEVO Anterior Cervical Plate System; ZPlate II; Zephir Anterior Cervical Plate; Zephir Anterior Cervical Plate System; instrument tray; myPTM Personal Therapy Manager; myStim Programmer; spinal system",1978-02-15,219,2026-02-12,21,3,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003120897%22&limit=1
"Becton, Dickinson & Co.",1119779,1119779,7 Loveton Cir.,Sparks,MD,21152,United States,Becton Dickinson and Company,9922032,Complaint file establishment; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,101,GIO; GMP; GMQ; GNA; GNB; GOW; GOX; GOY; GQG; GRL; GRM; GRP; GSH; GSQ; GTN; GTY; GTZ; ICL; IDC; JJH; JJQ; JJX; JQP; JQW; JQX; JSC; JSD; JSF; JSG; JSH; JSI; JSJ; JSO; JTA; JTC; JTL; JTN; JTO; JTQ; JTS; JTT; JTY; JTZ; JWY; JXB; KET; KEW; KGZ; KJK; KJO; KZB; KZI; KZJ; LDZ; LEE; LIB; LIO; LJG; LON; LQL; LQM; LRG; LSL; LTT; LTW; LXG; MAQ; MDB; MJA; MJK; MJM; MKQ; MKZ; MLA; MNM; MVU; MZC; NJR; NNI; NQX; NSU; OOI; OUG; OUY; OZN; PCH; PCI; POC; PPM; PQA; PSZ; QBN; QEP; QJR; QMN; QOF; QQV; QQX; QQY; QVF; SEP,"Tube, Collection, Capillary Blood; Antisera, Control For Nontreponemal Tests; Antigens, Nontreponemal, All; Antisera, All Types, Escherichia Coli; Antisera, All Types, Shigella Spp.; Antisera, Agglutinating, B. Parapertussis; Antigen, B. Pertussis; Antisera, Agglutinating, B. Pertussis, All; Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus; Antigens, All Groups, Salmonella Spp.; Antisera, All Groups, Salmonella Spp.; Antisera, All Types, H. Influenza; Antisera, All Types, Listeria Monocytogenes; Antiserum, Vibrio Cholerae, All Varieties; Antisera, Fluorescent, All Types, Staphylococcus Spp.; Antigens, All Groups, Streptococcus Spp.; Antisera, All Groups, Streptococcus Spp.; Carbol Fuchsin; Acridine Orange; Clinical Sample Concentrator; Colorimeter, Photometer, Spectrophotometer For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Calculator/Data Processing Module, For Clinical Use; Station, Pipetting And Diluting, For Clinical Use; Nephelometer, For Clinical Use; Culture Media, General Nutrient Broth; Culture Media, Selective Broth; Culture Media, Single Biochemical Test; Culture Media, Non-Selective And Non-Differential; Culture Media, Non-Selective And Differential; Culture Media, Selective And Differential; Culture Media, Selective And Non-Differential; Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar; Monitor, Microbial Growth; Device, Microtiter Diluting/Dispensing; Plasma, Coagulase, Human, Horse And Rabbit; Susceptibility Test Discs, Antimicrobial; Discs, Strips And Reagents, Microorganism Differentiation; Bath, Incubators/Water, All; Stains, Microbiologic; Susceptibility Test Powders, Antimicrobial; Culture Media, For Isolation Of Pathogenic Neisseria; Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth; Manual Antimicrobial Susceptibility Test Systems; Kit, Identification, Yeast; Filters, Cell Collection, Tissue Processing; Slides, Microscope; Accessories, Catheter; Auramine O; Brilliant Green; Automated Colony Counter; Culture Media, Enriched; Device, Gas Generating; Fixative, Alcohol Containing; Stains, Dye Solution; Device, General Purpose, Microbiology, Diagnostic; Device, Specimen Collection; Quality Control Slides; System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Gram Positive Identification Panel; Gram Negative Identification Panel; Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems; Dna-Reagents, Neisseria; Panels, Test, Susceptibility, Antimicrobial; Susceptibility Test Cards, Antimicrobial; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Kit, Dna Detection, Human Papillomavirus; System, Blood Culturing; Susceptibility Test Powders, Antimycobacterial; Dna Probe, Trichomonas Vaginalis; Dna Probe, Gardnerella Vaginalis; Processor, Cervical Cytology Slide, Automated; Dna Probe, Nucleic Acid Amplification, Chlamydia; Dna Probe, Yeast; Reader, Cervical Cytology Slide, Automated; Reagents, Specific, Analyte; System, Detection, Bacterial, For Platelet Transfusion Products; Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test; Container, Specimen, Non-Sterile; System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen; Instrumentation For Clinical Multiplex Test Systems; Real Time Nucleic Acid Amplification System; Medical Device Data System; Trichomonas Vaginalis Nucleic Acid Amplification Test System; C. Difficile Toxin Gene Amplification Assay; Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System; Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System; System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen; General Purpose Reagent; Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System; Devices Detecting Influenza A, B, And C Virus Antigens; Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates; Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections; Reagents, 2019-Novel Coronavirus Nucleic Acid; Covid-19 Multi-Analyte Antigen Device; Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents; Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry; Respiratory Specimen Nucleic Acid Sars-Cov-2 Test; Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms; Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings; Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay",1; 2; 3; N,"241115 - BD Francisella tularensis Antigen; 241116 - BD Francisella tularensis Antisera; 333947 - BD CD117 PerCP-Cy5.5; 333948 - BD CD14 APC-Cy7; 333949 - BD CD33 PE-Cy7; 335804 - BD CD2 PE-Cy7; 335805 - BD CD8 PE-Cy7; 335806 - BD CD16 (B73.1) PE-Cy7; 335807 - BD CD25 PE-Cy7; 335808 - BD CD38 PE-Cy7; 335809 - BD CD56 PE-Cy7; 335811 - BD CD20 PE-Cy7; 335812 - BD CD20 APC-Cy7; 335813 - BD Anti-HLA-DR PE-Cy7; 335814 - BD Anti-HLA-DR APC-Cy7; 335815 - BD CD79B FITC; 335816 - BD CD79B PE; 335817 - BD CD79B APC; 338432 - BD CD13 PE-Cy7; 338433 - BD CD16 (3G8) PerCP-Cy5.5; 339196 - BD IgG1 AmCyan; 339197 - BD CD3 AmCyan; 339198 - BD CD4 AmCyan; 339199 - BD CD8 AmCyan; 339201 - BD CD19 AmCyan; 339203 - BD CD45 AmCyan; 339205 - BD Anti-HLA-DR PerCP-Cy5.5; 339206 - BD CD117 PE-Cy7; 340650 - BD Anti-Bcl-2 FITC; 340651 - BD Anti-Bcl-2 PE; 340653 - BD CD79A APC; 340654 - BD CD79A PE; 340655 - BD Anti-MPO FITC; 340656 - BD CD7 (M-T701) PE; 340658 - BD CD5 APC; 340659 - BD CD8 APC; 340660 - BD CD14 PerCP; 340661 - BD CD3 APC; 340662 - BD CD3 PE; 340663 - BD CD3 PerCP; 340664 - BD CD45 FITC; 340665 - BD CD45 PerCP; 340666 - BD CD34 (8G12) PerCP; 340667 - BD CD34 (8G12) APC; 340668 - BD CD34 (8G12) FITC; 340669 - BD CD34 (8G12) PE; 340670 - BD CD4 PE; 340671 - BD CD4 PerCP; 340672 - BD CD4 APC; 340673 - BD CD20 FITC; 340675 - BD CD20 PerCP; 340676 - BD CD38 PE; 340677 - BD CD38 APC; 340678 - BD CD33 FITC; 340679 - BD CD33 PE; 340680 - BD CD33 APC; 340682 - BD CD14 FITC; 340683 - BD CD14 PE; 340684 - BD CD14 APC; 340685 - BD CD56 PE; 340686 - BD CD13 PE; 340688 - BD Anti-HLA-DR FITC; 340689 - BD Anti-HLA-DR PE; 340690 - BD Anti-HLA-DR PerCP; 340691 - BD Anti-HLA-DR APC; 340692 - BD CD8 (SK1) FITC; 340693 - BD CD8 (SK1) PerCP; 340694 - BD CD25 FITC; 340696 - BD CD5 FITC; 340697 - BD CD5 PE; 340698 - BD CD10 (W8E7) FITC; 340699 - BD CD7 (4H9) FITC; 340700 - BD CD2 FITC; 340701 - BD CD2 PE; 340703 - BD CD15 FITC; 340704 - BD CD16 (NKP15) FITC; 340705 - BD CD16 (B73.1) PE; 340706 - BD CD57 FITC; 340707 - BD CD22 FITC; 340708 - BD CD22 PE; 340712 - BD CD11B PE; 340713 - BD CD11C PE; 340714 - BD CD11C APC; 340715 - BD CD61 FITC; 340716 - BD CD61 PerCP; 340717 - BD CD71 FITC; 340719 - BD CD19 (SJ25C1) FITC; 340720 - BD CD19 (SJ25C1) PE; 340721 - BD CD19 (SJ25C1) PerCP; 340722 - BD CD19 (SJ25C1) APC; 340723 - BD CD56 (NCAM16.2) FITC; 340724 - BD CD56 (NCAM16.2) PE; 340738 - BD CD7 (M-T701) FITC; 340754 - BD Mouse IgG1 APC; 340755 - BD Mouse IgG1 FITC; 340756 - BD Mouse IgG2a Control PE; 340757 - BD Mouse IgG2a APC; 340760 - BD Mouse IgG1 Platelet Control PE; 340761 - BD Mouse IgG1 PE; 340762 - BD Mouse IgG1 PerCP; 340764 - BD Mouse IgG2a FITC; 340765 - BD Mouse IgG2a PerCP; 340766 - BD Mouse IgG2a PE; 340850 - BD CD15 Purified; 340851 - BD CD3 Purified; 340853 - BD CD4 Purified; 340854 - BD CD4 Biotin; 340855 - BD CD8 (SK1) Purified; 340857 - BD Anti-HLA-DR Purified; 340858 - BD Anti-HLA-DR Biotin; 340861 - BD CD57 Biotin; 340864 - BD CD19 (4G7) FITC; 340865 - BD CD19 (4G7) PerCP; 340866 - BD CD45 Purified; 340867 - BD CD117 PE; 340869 - BD CD7 Purified; 340870 - BD CD5 Purified; 340871 - BD CD5 Biotin; 340874 - BD CD11A FITC; 340879 - BD Anti-Her-2/Neu PE; 340880 - BD Anti-Her-2/Neu FITC; 340882 - BD Anti-TCR-1 Alpha/Beta Purified; 340883 - BD Anti-TCR-1 Alpha/Beta FITC; 340884 - BD Anti-TCR-1 Gamma/Delta Purified; 340886 - BD Anti-TCR-1 Gamma/Delta FITC; 340887 - BD Anti-TCR-1 Gamma/Delta PE; 340918 - BD FMC7 FITC; 340920 - BD CD10 (HI10A) PE; 340922 - BD CD10 (HI10A) APC; 340924 - BD CD10 (HI10A) FITC; 340926 - BD CD38 FITC; 340928 - BD CD41A FITC; 340930 - BD CD41A PerCP-Cy5.5; 340932 - BD CD22 APC; 340934 - BD CD23 APC; 340936 - BD CD11B APC; 340938 - BD CD25 APC; 340940 - BD CD20 APC; 340942 - BD CD45 APC; 340944 - BD CD103 FITC; 340946 - BD CD235ab [GA-R2(HIR20] PE; 340948 - BD CD3 PerCP-Cy5.5; 340950 - BD CD19 (SJ25C1) PerCP-Cy5.5; 340952 - BD CD45 PerCP-Cy5.5; 340954 - BD CD20 PerCP-Cy5.5; 340997 - BD CD103 PE; 341008 - BD CD23 PE; 341010 - BD CD25 PE; 341023 - BD CD2 APC; 341026 - BD CD56 APC; 341029 - BD CD71 APC; 341031 - BD CD55 PE; 341049 - BD CD8 PerCP-Cy5.5; 341097 - BD CD138 PerCP-Cy5.5; 341098 - BD Anti-Kappa APC; 341099 - BD CD5 PerCP-Cy5.5; 341100 - BD CD3 APC-Cy7; 341101 - BD CD3 PE-Cy7; 341102 - BD CD10 (HI10A) PE-Cy7; 341103 - BD CD19 PE-Cy7; 341105 - BD CD4 APC-Cy7; 341106 - BD CD117 APC; 341632 - BD Mpo PE; 341633 - BD CD79A PerCP-Cy5.5; 341634 - BD CD30 FITC; 341635 - BD CD30 PE; 341636 - BD CD9 FITC; 341637 - BD CD9 PE; 341638 - BD CD9 APC; 341639 - BD CD9 PerCP-Cy5.5; 341640 - BD CD33 PerCP-Cy5.5; 341641 - BD CD1A PE; 341653 - BD CD4 PerCP-Cy5.5; 344636 - BD Zap70 (1E7.2) PE; 344934 - BD Zap70 (1E7.2) FITC; 346581 - BD CD20 PE; 346586 - BD Anti-Lambda FITC; 346587 - BD Anti-Kappa PE; 347205 - BD CD138 FITC; 347206 - BD CD138 RPE; 347207 - BD CD138 APC; 347208 - BD Anti-TdT FITC; 347209 - BD Anti-TdT PE; 347210 - BD Anti-TdT APC; 347211 - BD Anti-Epcam PE; 347212 - BD Mouse IgG1 PerCP-Cy5.5; 347213 - BD CD34 PerCP-Cy5.5; 348798 - BD Mouse IgG1 PE-Cy7; 348799 - BD CD4 PE-Cy7; 348800 - BD CD5 PE-Cy7; 348801 - BD CD34 PE-Cy7; 348802 - BD Mouse IgG1 APC-Cy7; 348803 - BD CD8 APC-Cy7; 348804 - BD CD19 APC-Cy7; 348805 - BD CD45 APC-Cy7; 641402 - BD Anti-HLA-DR APC-H7; 641405 - BD CD20 APC-H7; 641406 - BD CD3 APC-H7; 641407 - BD CD4 APC-H7; 641408 - BD CD45 APC-H7; 641409 - BD CD8 APC-H7; 641410 - BD IgG1 APC-H7; 642277 - BD IgG1 V450; 642283 - BD CD20 V450; 642284 - BD CD45 V450; 642285 - BD Anti-HLA-DR V450; 642921 - BD CD7 V450; 642922 - BD CD15 V450; 642924 - BD Anti-Lambda PE; 643077 - BD CD14 APC-H7; 643078 - BD CD19 APC-H7; 643774 - BD Anti-Kappa FITC; 644138 - BD Anti-Kappa F(Ab')2 FITC; 644139 - BD Anti-Lambda F(Ab')2 FITC; 644386 - BD CD64 PE; 644486 - BD CD2 V450; 644488 - BD CD5 V450; 644490 - BD CD16 (3G8) V450; 644492 - BD CD19 V450; 644494 - BD FMC7 V450; 646852 - BD CD38 V450; 647450 - BD CD45 V500-C; 647452 - BD IgG1 V500-C; 647454 - BD CD3 V500-C; 647456 - BD CD4 V500-C; 647458 - BD CD8 V500-C; 647460 - BD CD14 V500-C; 647464 - BD CD20 V500-C; 649452 - BD CD45RO PE-Cy7; 649453 - BD CD123 PE; 649454 - BD CD58 PE; 649455 - BD CD26 PE; 649456 - BD CD26 FITC; 649457 - BD CD45RA PE-Cy7; 649458 - BD CD45RA FITC; 649459 - BD CD45RO PE; 649460 - BD CD45RO APC; 650660 - BD CD138 V500-C; 651850 - BD CD4 V450; 652356 - BD Horizon™ CD3 V450 (SK7); 652359 - BD CD11c PE-Cy™7; 653312 - BD CD7 APC; 653314 - BD CD38 APC-H7; 654663 - BD CD69 APC; 654664 - BD CD27 FITC; 654665 - BD CD27 PE; 654666 - BD CD62L PE; 654975 - BD CD69 PE; 654976 - BD CD62P PE; 655019 - BD CD27 APC; 655111 - BD CD8 V450; 655112 - BD CD11c V450; 655114 - BD CD14 V450; 655116 - BD Horizon™ CD56 V450 B159; 655154 - BD CD24 FITC; 655157 - BD CD27 PE-Cy7; 655158 - BD CD43 FITC; 655160 - BD CD45RO FITC; 655426 - BD CD10 (HI10A) APC-H7; 655428 - BD CD200 APC; 655429 - BD CD27 PerCP-Cy5.5; 655430 - BD CD43 APC-H7; 655431 - BD CD71 APC-H7 M-A712; 655432 - BD CD79b PerCP-Cy5.5 SN8; 655433 - BD CD9 APC-H7; 655434 - BD TCR GAMMA / DELTA - 1 PE-Cy7; 655435 - BD B2-Microglobulin PerCP-Cy™ 5.5; 655437 - BD CD13 APC; 655734 - BD CD28 PERCP-Cy5.5; 655735 - BD CD200 PE-Cy7; 655933 - BD IFN GAMMA APC; 656050 - BD CD38 PerCP-Cy5.5; 656145 - BD CD11c PerCP-Cy5.5 (B-ly6); 656147 - BD CD16 FITC CLB-Fc-gran/1 5D2; 656149 - BD CD23 FITC EBVCS-5; 656150 - BD CD24 APC-H7 (ML5); 656152 - BD CD36 FITC CLB-IVC7; 656153 - BD CD49d APC-H7 (9F10); 656154 - BD CD81 APC-H7; 656157 - BD Anti-Lamda APC-H7; 656159 - BD IREM2 APC; 656311 - BD CD22 PerCP-Cy5.5 (S-HCL-1); 657699 - BD CD13 APC-R700; 657701 - BD CD64 APC-R700; 657703 - BD CD79b APC-R700; 657707 - BD TCR g/d-1 APC-R700; 657709 - BD IgG1 APC-R700; 657721 - BD Mouse IgG1 BV605; 657869 - BD CD200 APC-R700; 657887 - BD CD56 APC-R700; 658168 - BD CD9 V450 (M-L13); 658170 - BD CD21 V450 (B-Ly4); 658172 - BD CD123 APC (9F5); 658287 - BD Anti-Kappa V450 (TB28-2; 658367 - BD CD10 PE (MEM-78); 659110 - BD Horizon™ CD3 APC-R700 (SK7); 659111 - BD Horizon™ CD10 APC-R700 (HI10a); 659112 - BD Horizon™ CD19 APC-R700 (SJ25C1); 659113 - BD Horizon™ CD33 APC-R700 (P67-6); 659114 - BD Horizon™ CD34 APC-R700 (8G12); 659115 - BD Horizon™ CD7 APC-R700 (M-T701); 659116 - BD Horizon™ CD23 APC-R700 (EBVCS-5); 659117 - BD Horizon™ CD25 APC-R700 (2A3); 659118 - BD Horizon™ CD38 APC-R700 (HB7); 659448 - BD CD3(SK7)BV421; 659449 - BD CD10(HI10a) BV421; 659450 - BD CD14 (MPhiP9) BV421; 659451 - BD CD20 (L27) BV421; 659452 - BD CD56 (NCAM16.2) BV421; 659453 - BD Mouse IgG1 (X40) BV421; 659454 - BD CD4 SK3 BV510; 659455 - BD CD19 SJ25C1 BV510; 659457 - BD CD56 NCAM16.2 BV510; 659458 - BD Anti-HLA-DR L243 BV510; 659459 - BD Mouse IgG1 X40 BV510; 659476 - BD CD4 (SK3) BV421; 659477 - BD CD19 (SJ25C1) BV421; 659478 - BD CD38 (HB7) BV421; 659479 - BD CD5 (L17F12) BV421; 659482 - BD CD45 2D1 BV510; 659611_BD Horizon™ Brilliant Stain Buffer; 663188 - BD CD4 (SK3) BV605; 663189 - BD CD38 (HB7) BV605; 663190 - BD CD200 (MRC OX-104) BV605; 663191 - BD CD11b (D12) BV605; 663192 - BD Anti- Kappa (TB28-2) BV605; 663193 - BD Anti-Lambda (1-155-2) APC; 663194 - BD CD10 (HI10a) PerCP-Cy5.5; 663195 - BD CD14 (MPhiP9) PE-Cy7; 663196 - BD CD158a (HP-3E4) PE; 663541 - BD CD23 (EBVCS-5)PE-Cy7; 663788 - BD CD7 (M-T701) BV421; 663789 - BD Anti-HLA-DR (G46-6) BV421; 663796 - BD CD1a (SK9) BV605; 663797 - BD CD7 (M-T701) BV605; 663798 - BD CD8 (SK1) BV605; 663799 - BD CD11c (B-Ly6) BV605; 663800 - BD CD13 (L138) BV605; 663801 - BD CD24 (ML5) BV605; 663802 - BD CD45 (HI30) BV605; 663803 - BD CD117 (104D2) BV605; 663804 - BD Anti-Lambda(1-155-2) BV605; 663979 - BD CD22 (HIB22) BV421; 663980 - BD CD33 (P67.6) BV421; 663981 - BD CD 34 (8G12) BV421; 663982 - BD CD 117 (104D2) BV421; 663983 - BD CD 123 (9F5) BV421; 663984 - BD CD138 (MI15) BV421; 663985 - BD CD5 (L17F12) BV605; 663986 - BD CD10 (HI10a) BV605; 663987 - BD CD15 (W6D3) BV605; 663988 - BD CD 16 (3G8) BV605; 663989 - BD CD 19 (SJ25C1) BV605; 663990 - BD CD56 (NCAM 16.2) BV605; 663991 - BD CD64 (10.1) BV605; 663992 - BD CD5 (L17F12) APC-R700; 663994 - BD CD123 (9F5) APC-R700; 663995 - BD CD 138 (MI15) APC-R700; 663996 - BD CD64 (10.1) PerCP-Cy™ 5.5; 664519 - BD CD4 (SK3) BV711; 664520 - BD CD10 (HI10a) BV711; 664521 - BD CD13 (L138) BV711; 664522 - BD CD14 (MPhiP9) BV711; 664523 - BD CD38 (HB7) BV711; 664524 - BD CD56 (NCAM16.2) BV711; 664525 - BD CD123 (9F5) BV711; 664526 - BD Mouse IgG1 (X40) BV711; 664527 - BD CD3 (SK7) BV786; 664528 - BD CD4 (SK3) BV786; 664529 - BD CD5 (L17F12) BV786; 664530 - BD CD8 (SK1) BV786; 664531 - BD CD16 (3G8) BV786; 664532 - BD CD19 (SJ25C1) BV786; 664533 - BD CD20 (L27) BV786; 664534 - BD CD23 (EBVCS-5) BV786; 664535 - BD CD45 (HI30) BV786; 664536 - BD Anti-HLA-DR (G46-6) BV786; 664537 - BD Mouse IgG1 (X40) BV786; 664538 - BD CD22 (S-HCL-1) PE-Cy7; 665116 - BD CD42b (HIP1) PE; 665117 - BD CD152 (BNI3) PE; 665118 - BD CD183 (1C6/CXCR3) PE-Cy7; 665119 - BD CD185 (RF8B2) APC; 665120 - BD CD197 (2-L1-A) APC-R700; 665121 - BD CD223 (T47-530) PerCP-Cy5.5; 665123 - BD CD274 (MIH1) PE-Cy7; 665124 - BD CD279 (MIH4) PE-Cy7; 665125 - BD FoxP3 (236A/E7) PE; 665126 - BD FoxP3 (236A/E7) PerCP-Cy5.5; 665127 - BD Ki-67 (B56) FITC; 665128 - BD CD30 (Ber-H8) BV421; 665129 - BD CD194 (1G1) BV421; 665130 - BD CD196 (11A9) BV421; 665131 - BD CD279 (MIH4) BV421; 665132 - BD CD5 (L17F12) BV510; 665133 - BD CD40 (5C3) BV605; 665134 - BD CD81 (JS-81) BV605; 665135 - BD CD294 (BM16) BV605; 665136 - BD CD366 (7D3) BV605; 665416 - BD CD27 (O323) BV510; 666644 - BD® CD24 (ML5) PE; 666645 - BD® Anti-Human IgD (IA6-2) PerCP-Cy5.5; 666646 - BD® CD13 (WM15) PerCP-Cy5.5; 666648 - BD® CD26 (M-A261) APC; 666649 - BD® CD28 (L293) APC-H7; 666650 - BD Horizon™ CD45RA (HI100) BV510; 666651 - BD Horizon™ CD45RA (HI100) BV605; 666652 - BD Horizon™ CD27 (M-T271) BV421; 666654 - BD Horizon™ CD26 (L272) BV421; 666655 - BD Horizon™ CD25 (2A3) BV421; 666657 - BD Horizon™ Anti-TCR ?? (11F2) BV421; 666658 - BD Horizon™ CD103 (BER-ACT8) BV605; 666660 - BD Horizon™ CD64 (MD22) BV605; 666661 - BD Horizon™ Anti-Human IgM (G20-127) BV605; 666662 - BD Horizon™ CD34 (563) BV605; 666663 - BD Horizon™CD44 (L178) BV605; 666664 - BD Horizon™CD235a (GA-R2/HIR2) BV605; 666665 - BD Horizon™ CD66c (B6.2/CD66) BV786; 666666 - BD Horizon™ CD86 (2331/FUN-1) BV786; 667242 - BD® Anti TCR-C?1 (JOVI.1) PE; 667243 - BD® Anti TCR-C?1 (JOVI.1) APC-R700; 667245 - BD® Anti TCR-C?2 (SAM.2) APC; 671816 - BD Horizon™ CD19 (SJ25C1) RB613; 671817 - BD Horizon™ CD10 (HI10a) RB780; 671818 - BD Horizon™ CD10 (HI10a) R718; 671819 - BD Horizon™ CD107a (H4A3) V450; 671820 - BD Horizon™ CD138 (MI15) R718; 671821 - BD Horizon™ CD14 (M?P9) RB613; 671823 - BD Horizon™ CD16 (3G8) R718; 671824 - BD Horizon™ CD16 (3G8) RB613; 671825 - BD Horizon™ CD19 (SJ25C1) R718; 671826 - BD Horizon™ CD19 (SJ25C1) RB705; 671827 - BD Horizon™ CD38 (HB-7) R718; 671828 - BD Horizon™ CD4 (SK3) R718; 671831 - BD Horizon™ CD4 (SK3) RB780; 671832 - BD Horizon™ CD7 (M-T701) RB613; 671833 - BD Horizon™ CD8 (SK1) R718; 671834 - BD Horizon™ CD3 (SK7) BV510; 671835 - BD® CD81 (JS-81) FITC; 671836 - BD Horizon™ Mouse IgG1 (X40) R718; 671837 - BD Horizon™ Anti-TCR C?b2 (SAM.2.rMAb) RB780; 671838 - BD Horizon™ CD3 (SK7) R718; 671839 - BD Horizon™ CD3 (SK7) RB613; BBL™ CHROMagar™ Orientation; BD Affirm™ VPIII Ambient Temperature Transport System; BD Affirm™ VPIII Microbial Identification Test; BD Affirm™ VPIII Sample Collection Sets; BD Affirm™ VPIII Sample Collection Swabs; BD Affirm™VPIII Microbial Identification Test; BD Alcohol Blend Rinse; BD BACTEC™ 9050; BD BACTEC™ 9120; BD BACTEC™ 9120, Remanufactured; BD BACTEC™ 9240; BD BACTEC™ 9240, Remanufactured; BD BACTEC™ Digital Thermometer; BD BACTEC™ FOS™ Culture Supplement Kit; BD BACTEC™ FX Bottom; BD BACTEC™ FX Top; BD BACTEC™ FX40 Instrument; BD BACTEC™ FXI 480/960 Culture System Software; BD BACTEC™ FXI Culture System Analyzer Module; BD BACTEC™ FXI Culture System Workflow Module; BD BACTEC™ Lytic/10 Anaerobic/F Culture Vials; BD BACTEC™ MGIT™ 320; BD BACTEC™ MGIT™ 960; BD BACTEC™ MGIT™ 960 Calibration Vial; BD BACTEC™ MGIT™ 960 INH 0.4 Kit; BD BACTEC™ MGIT™ 960 IR Kit; BD BACTEC™ MGIT™ 960 Instrument, Refurbished; BD BACTEC™ MGIT™ 960 PZA Kit; BD BACTEC™ MGIT™ 960 PZA Medium; BD BACTEC™ MGIT™ 960 SIRE Kit; BD BACTEC™ MGIT™ 960 STR 4 Kit; BD BACTEC™ MGIT™ 960 Supplement Kit; BD BACTEC™ MGIT™ II 320; BD BACTEC™ MGIT™ II 960; BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes; BD BACTEC™ Myco/F Lytic Culture Vials; BD BACTEC™ Peds Plus™/F Culture Vials; BD BACTEC™ Platelet Aerobic/F Culture Vials; BD BACTEC™ Platelet Anaerobic/F Culture Vials; BD BACTEC™ Plus Aerobic/F Culture Vials; BD BACTEC™ Plus Anaerobic/F Culture Vials; BD BACTEC™ Standard Anaerobic/F Culture Vials; BD BACTEC™ Standard/10 Aerobic/F Culture Vials; BD BACTEC™ Subculturing/Aerobic Venting Unit; BD BBL™ 10% Potassium Hydroxide Reagent Droppers; BD BBL™ AFB Slide; BD BBL™ Acridine Orange Reagent Droppers; BD BBL™ Acridine Orange Stain; BD BBL™ Agar, Grade A; BD BBL™ BCYE Agar; BD BBL™ BCYE Agar Base; BD BBL™ BCYE Selective Agar with PAC; BD BBL™ BiGGY Agar; BD BBL™ Bile Esculin Agar; BD BBL™ Bile Esculin Agar Slants; BD BBL™ Blank Paper Discs, 6mm diameter; BD BBL™ Blood Agar Base Infusion Agar; BD BBL™ Blood Agar Slants; BD BBL™ Bovine Albumin (Fraction V); BD BBL™ Brain Heart Infusion; BD BBL™ Brain Heart Infusion Agar; BD BBL™ Brain Heart Infusion Agar Slant; BD BBL™ Brain Heart Infusion Broth, Modified; BD BBL™ Brain Heart Infusion with 10% Sheep Blood Agar with Chloramphenicol and Gentamicin Slants; BD BBL™ Brain Heart Infusion with 6.5% Sodium Chloride; BD BBL™ Brucella Agar; BD BBL™ Brucella Agar with 5% Sheep Blood, Hemin and Vitamin K1; BD BBL™ Brucella Broth; BD BBL™ CDC Anaerobe 5% Sheep Blood Agar; BD BBL™ CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV); BD BBL™ CHROMAgar™ Orientation and BBL™ Trypticase™ Soy Agar w/5% Sheep Blood (TSA II)-I Plate™; BD BBL™ CHROMAgar™ Salmonella; BD BBL™ CHROMagar™ Candida; BD BBL™ CHROMagar™ MRSA II; BD BBL™ CHROMagar™ MRSA II / CHROMagar™ SA; BD BBL™ CHROMagar™ O157; BD BBL™ CHROMagar™ Staph aureus; BD BBL™ CLED Agar; BD BBL™ CO2 Indicators; BD BBL™ CTA Medium; BD BBL™ CTA Medium™; BD BBL™ Calcofluor White Reagent Droppers; BD BBL™ Campy CVA Agar; BD BBL™ Cary-Blair Transport Medium; BD BBL™ Casman Agar Base; BD BBL™ Catalase Reagent Droppers; BD BBL™ Cefinase™; BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™); BD BBL™ Chocolate II Agar Slants (GC II Agar with Hemoglobin and IsoVitaleX™); BD BBL™ Chopped Meat Carbohydrate Broth, PR II; BD BBL™ Chopped Meat Glucose Broth, Pre-reduced II; BD BBL™ Coagulase Plasma, Rabbit; BD BBL™ Coagulase Plasma, Rabbit with EDTA; BD BBL™ Columbia Agar Base; BD BBL™ Columbia Agar with 5% Sheep Blood; BD BBL™ Columbia CNA Agar; BD BBL™ Columbia CNA Agar with 5% Sheep Blood; BD BBL™ Columbia CNA Agar with 5% Sheep Blood and BD BBL MacConkey II Agar BD I Plate™; BD BBL™ Cooked Meat Medium; BD BBL™ Cooked Meat Medium with Glucose, Hemin and Vitamin K1; BD BBL™ Corn Meal Agar; BD BBL™ DMACA Indole Reagent Droppers; BD BBL™ Dermatophyte Test Medium Base; BD BBL™ Dermatophyte Test Medium, Modified with Chloramphenicol; BD BBL™ Desoxycholate Reagent Droppers; BD BBL™ Dobell and O’Connor Iodine Stain Droppers; BD BBL™ Dry Anaerobic Indicator Strips; BD BBL™ DrySlide™ Indole; BD BBL™ DrySlide™ Oxidase; BD BBL™ DrySlide™ PYR Kit; BD BBL™ Dryslide™ Nitrocefin; BD BBL™ Egg Yolk Tellurite Enrichment; BD BBL™ Enriched Thioglycollate Medium; BD BBL™ Enterococcosel™ Agar; BD BBL™ Enterococcosel™ Broth; BD BBL™ Eosin Methylene Blue Agar, Levine; BD BBL™ Eosin Methylene Blue Agar, Modified; BD BBL™ FTA Hemagglutination Buffer; BD BBL™ Ferric Chloride Reagent Droppers; BD BBL™ Fluid Thioglycollate Medium; BD BBL™ Fluid Thioglycollate Medium, Enriched; BD BBL™ GN Broth; BD BBL™ Gram Basic Fuchsin; BD BBL™ Gram Crystal Violet; BD BBL™ Gram Decolorizer; BD BBL™ Gram Iodine (Stabilized); BD BBL™ Gram Safranin; BD BBL™ Gram Slide; BD BBL™ Gram Stain Kit; BD BBL™ Group A Selective Strep Agar w/5% Sheep Blood (ssA™); BD BBL™ Hektoen Enteric Agar; BD BBL™ Hemoglobin Solution 2%; BD BBL™ Hemoglobin, Bovine, Freeze-Dried; BD BBL™ India Ink Reagent Droppers; BD BBL™ Indole Nitrite Medium; BD BBL™ Indole Reagent Droppers; BD BBL™ Inhibitory Mold Agar; BD BBL™ Inhibitory Mold Agar Deep Fill; BD BBL™ Inhibitory Mold Agar Slants (with Chloramphenicol); BD BBL™ IsoVitaleX™ Enrichment; BD BBL™ Kligler Iron Agar; BD BBL™ Kligler Iron Agar Slants; BD BBL™ LBS Agar; BD BBL™ Lactophenol Cotton Blue Stain Droppers; BD BBL™ Levine EMB Agar; BD BBL™ Lim Broth; BD BBL™ Litmus Milk; BD BBL™ Lowenstein-Jensen Medium Slants; BD BBL™ Lowenstein-Jensen Medium, Gruft, Slants; BD BBL™ Lysine Iron Agar Slants; BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes; BD BBL™ MGIT™ OADC Enrichment; BD BBL™ MGIT™ PANTA™ Antibiotic Mixture; BD BBL™ MR-VP Broth; BD BBL™ MacConkey Agar; BD BBL™ MacConkey Agar without Crystal Violet; BD BBL™ MacConkey II Agar; BD BBL™ MacConkey II Agar with Sorbitol; BD BBL™ Mannitol Salt Agar; BD BBL™ Methylene Blue Loeffler Stain Droppers; BD BBL™ Middlebrook 7H9 Broth with Glycerol; BD BBL™ Middlebrook ADC Enrichment; BD BBL™ Middlebrook OADC Enrichment; BD BBL™ Middlebrook and Cohn 7H10 Agar Slants; BD BBL™ Modified Thayer-Martin (MTM II) Agar; BD BBL™ Moeller Decarboxylase Broth Base; BD BBL™ Motility Test Medium; BD BBL™ Mueller Hinton Agar with 5% Sheep Blood; BD BBL™ Mueller Hinton Broth; BD BBL™ Mueller Hinton II Agar; BD BBL™ Mueller Hinton II Broth, Cation-Adjusted; BD BBL™ MycoPrep™ Kit; BD BBL™ Mycobactosel™ L-J Medium Slants; BD BBL™ Mycophil™ Agar with Low pH; BD BBL™ Mycoplasma Agar Base; BD BBL™ Mycoplasma Broth Base; BD BBL™ Mycosel™ Agar; BD BBL™ Mycosel™ Agar Slants; BD BBL™ Ninhydrin Reagent Droppers; BD BBL™ Nitrate A Reagent Droppers; BD BBL™ Nitrate B Reagent Droppers; BD BBL™ Nutrient Agar Slants; BD BBL™ Nutrient Broth; BD BBL™ OF Medium with Dextrose; BD BBL™ OF Medium with Lactose; BD BBL™ OF Medium with Xylose; BD BBL™ Oxidase Reagent Droppers; BD BBL™ PYR Reagent Droppers; BD BBL™ Phenol Red Broth Base; BD BBL™ Phenol Red Broth with Dextrose and Durham Tube; BD BBL™ Phenol Red Broth with Inulin and Durham Tube; BD BBL™ Phenol Red Broth with Raffinose and Durham Tube; BD BBL™ Phenol Red Dextrose Broth; BD BBL™ Phenol Red Lactose Broth; BD BBL™ Phenol Red Mannitol Broth; BD BBL™ Phenylethyl Alcohol Agar; BD BBL™ Phenylethyl Alcohol Agar with 5% Sheep Blood; BD BBL™ Phosphate Buffer, pH 7.2; BD BBL™ Phytone™ Yeast Extract Agar; BD BBL™ Pseudosel™ Agar (Cetrimide Agar); BD BBL™ Rapid Urea Broth; BD BBL™ SIM Medium; BD BBL™ Sabouraud Brain Heart Infusion Agar Slants; BD BBL™ Sabouraud Brain Heart Infusion Agar with Chloramphenicol and Gentamicin Slants; BD BBL™ Sabouraud Dextrose Agar (Deep Fill); BD BBL™ Sabouraud Dextrose Agar Deeps; BD BBL™ Sabouraud Dextrose Agar Slants; BD BBL™ Sabouraud Dextrose Agar with Chloramphenicol Slants; BD BBL™ Sabouraud Dextrose Agar with Chloramphenicol and Cycloheximide Slants; BD BBL™ Sabouraud Dextrose Agar, Emmons (Deep Fill); BD BBL™ Sabouraud Liquid Broth, Modified (Antibiotic Medium #13); BD BBL™ Saline, Normal; BD BBL™ Salmonella Shigella Agar; BD BBL™ Schaedler Agar; BD BBL™ Schaedler Broth with Vitamin K1; BD BBL™ Select Agar; BD BBL™ Selective 7H11 Agar Slants; BD BBL™ Selenite-F Broth; BD BBL™ Sensi-Disc™ 12-Place Self-Tamping Dispenser; BD BBL™ Sensi-Disc™ 6-Place Self-Tamping Dispenser; BD BBL™ Sensi-Disc™ 8-Place Self-Tamping Dispenser; BD BBL™ Sensi-Disc™ Amikacin 30 ?g; BD BBL™ Sensi-Disc™ Amoxicillin/Clavulanic Acid 20/10 ?g; BD BBL™ Sensi-Disc™ Ampicillin 10 ?g; BD BBL™ Sensi-Disc™ Ampicillin/Sulbactam 10/10 µg; BD BBL™ Sensi-Disc™ Azithromycin 15 ?g; BD BBL™ Sensi-Disc™ Aztreonam 30 µg; BD BBL™ Sensi-Disc™ Bacitracin 10 units; BD BBL™ Sensi-Disc™ Bacitracin 2 units; BD BBL™ Sensi-Disc™ Cefaclor 30 ?g; BD BBL™ Sensi-Disc™ Cefazolin 30 ?g; BD BBL™ Sensi-Disc™ Cefepime 30 ?g; BD BBL™ Sensi-Disc™ Cefiderocol 30 ?g; BD BBL™ Sensi-Disc™ Cefixime 5 ?g; BD BBL™ Sensi-Disc™ Cefmetazole 30 ?g; BD BBL™ Sensi-Disc™ Cefoperazone 75 ?g; BD BBL™ Sensi-Disc™ Cefotaxime 30 ?g; BD BBL™ Sensi-Disc™ Cefotaxime/Clavulanic Acid 30/10 ?g; BD BBL™ Sensi-Disc™ Cefoxitin 30 ?g; BD BBL™ Sensi-Disc™ Cefpodoxime 10 ?g; BD BBL™ Sensi-Disc™ Ceftaroline 30 ?g; BD BBL™ Sensi-Disc™ Ceftazidime 30 ?g; BD BBL™ Sensi-Disc™ Ceftazidime/Avibactam 30/20 ?g; BD BBL™ Sensi-Disc™ Ceftazidime/Clavulanic Acid 30/10 ?g; BD BBL™ Sensi-Disc™ Ceftriaxone 30 ?g; BD BBL™ Sensi-Disc™ Cefuroxime 30 ?g; BD BBL™ Sensi-Disc™ Cephalothin 30 ?g; BD BBL™ Sensi-Disc™ Chloramphenicol 30 ?g; BD BBL™ Sensi-Disc™ Ciprofloxacin 5 ?g; BD BBL™ Sensi-Disc™ Clarithromycin 15 ?g; BD BBL™ Sensi-Disc™ Clindamycin 2 ?g; BD BBL™ Sensi-Disc™ Colistin 10 ?g; BD BBL™ Sensi-Disc™ Doripenem 10 ?g; BD BBL™ Sensi-Disc™ Doxycycline 30 ?g; BD BBL™ Sensi-Disc™ Ertapenem 10 ?g; BD BBL™ Sensi-Disc™ Erythromycin 15 ?g; BD BBL™ Sensi-Disc™ Fosfomycin 200 ?g; BD BBL™ Sensi-Disc™ Gentamicin 10 ?g; BD BBL™ Sensi-Disc™ Gentamicin 120 ?g; BD BBL™ Sensi-Disc™ Imipenem 10 ?g; BD BBL™ Sensi-Disc™ Kanamycin 30 ?g; BD BBL™ Sensi-Disc™ Levofloxacin 5 ?g; BD BBL™ Sensi-Disc™ Linezolid 30 ?g; BD BBL™ Sensi-Disc™ Meropenem 10 ?g; BD BBL™ Sensi-Disc™ Metronidazole 80 µg; BD BBL™ Sensi-Disc™ Minocycline 30 ?g; BD BBL™ Sensi-Disc™ Moxifloxacin 5 ?g; BD BBL™ Sensi-Disc™ Nalidixic Acid 30 ?g; BD BBL™ Sensi-Disc™ Neomycin 30 ?g; BD BBL™ Sensi-Disc™ Netilmicin 30 µg; BD BBL™ Sensi-Disc™ Nitrofurantoin 100 ?g; BD BBL™ Sensi-Disc™ Nitrofurantoin 300 ?g; BD BBL™ Sensi-Disc™ Norfloxacin 10 ?g; BD BBL™ Sensi-Disc™ Novobiocin 30 µg; BD BBL™ Sensi-Disc™ Novobiocin 5 µg; BD BBL™ Sensi-Disc™ Ofloxacin 5 ?g; BD BBL™ Sensi-Disc™ Oxacillin 1 ?g; BD BBL™ Sensi-Disc™ Oxytetracycline 30 µg; BD BBL™ Sensi-Disc™ Penicillin 10 units; BD BBL™ Sensi-Disc™ Piperacillin 100 ?g; BD BBL™ Sensi-Disc™ Piperacillin/Tazobactam 100/10 ?g; BD BBL™ Sensi-Disc™ Polymyxin B 300 units; BD BBL™ Sensi-Disc™ Rifampin 5 ?g; BD BBL™ Sensi-Disc™ Single Disc Dispenser; BD BBL™ Sensi-Disc™ Streptomycin 10 ?g; BD BBL™ Sensi-Disc™ Streptomycin 300 ?g; BD BBL™ Sensi-Disc™ Tetracycline 30 ?g; BD BBL™ Sensi-Disc™ Ticarcillin 75 ?g; BD BBL™ Sensi-Disc™ Ticarcillin/Clavulanic Acid 75/10 ?g; BD BBL™ Sensi-Disc™ Tigecycline 15 µg; BD BBL™ Sensi-Disc™ Tobramycin 10 ?g; BD BBL™ Sensi-Disc™ Trimethoprim 5 µg; BD BBL™ Sensi-Disc™ Trimethoprim/Sulfamethoxazole 1.25/23.75 µg; BD BBL™ Sensi-Disc™ Vancomycin 30 ?g; BD BBL™ Sensi-Disc™ Vancomycin 5 ?g; BD BBL™ Seven H11 Agar Base; BD BBL™ Seven H11 Agar Slants; BD BBL™ Simmons Citrate Agar; BD BBL™ Simmons Citrate Agar Slants; BD BBL™ Spirolate Broth; BD BBL™ Staphyloslide™ Latex Test Kit; BD BBL™ Streptocard™ Acid Extraction Reagent; BD BBL™ Streptocard™ Acid Latex Test Kit; BD BBL™ Streptocard™ Acid Positive Control; BD BBL™ Streptocard™ Acid Test Latex A; BD BBL™ Streptocard™ Acid Test Latex B; BD BBL™ Streptocard™ Acid Test Latex C; BD BBL™ Streptocard™ Acid Test Latex D; BD BBL™ Streptocard™ Acid Test Latex F; BD BBL™ Streptocard™ Acid Test Latex G; BD BBL™ Streptocard™ Enzyme Extraction; BD BBL™ Streptocard™ Enzyme Latex Test Kit; BD BBL™ Streptocard™ Enzyme Positive Control; BD BBL™ Streptocard™ Enzyme Test Latex A; BD BBL™ Streptocard™ Enzyme Test Latex B; BD BBL™ Streptocard™ Enzyme Test Latex D; BD BBL™ Streptocard™ Test Cards; BD BBL™ TAXO™ Blank Paper Discs; BD BBL™ TB Auramine M; BD BBL™ TB Auramine-Rhodamine T; BD BBL™ TB Brilliant Green K; BD BBL™ TB Carbolfuchsin KF; BD BBL™ TB Carbolfuchsin ZN; BD BBL™ TB Decolorizer; BD BBL™ TB Decolorizer TM; BD BBL™ TB Fluorescent Stain Kit M; BD BBL™ TB Fluorescent Stain Kit T; BD BBL™ TB Methylene Blue; BD BBL™ TB Potassium Permanganate; BD BBL™ TB Stain Kit K; BD BBL™ TB Stain Kit ZN; BD BBL™ TCBS Agar; BD BBL™ TSI Agar Slants; BD BBL™ TSN Agar; BD BBL™ Taxo™ A; BD BBL™ Taxo™ Anaerobe Differentiation Discs Set; BD BBL™ Taxo™ Hippurate; BD BBL™ Taxo™ Kanamycin 1 mg; BD BBL™ Taxo™ Novobiocin; BD BBL™ Taxo™ ONPG; BD BBL™ Taxo™ P; BD BBL™ Taxo™ SPS; BD BBL™ Taxo™ TB Niacin Test Strips; BD BBL™ Taxo™ V; BD BBL™ Taxo™ VX; BD BBL™ Taxo™ X; BD BBL™ Thioglycollate Medium with Calcium Carbonate Marble Chip; BD BBL™ Thioglycollate Medium without Indicator; BD BBL™ Thioglycollate Medium without Indicator - 135C; BD BBL™ Thioglycollate Medium, Brewer Modified; BD BBL™ Todd Hewitt Broth; BD BBL™ Todd Hewitt Broth with Gentamicin and Nalidixic Acid; BD BBL™ Transport Medium; BD BBL™ Trichosel™ Broth, Modified; BD BBL™ Trichosel™ Broth, Modified, with 5% Horse Serum; BD BBL™ Trypticase™ Soy Agar; BD BBL™ Trypticase™ Soy Agar (Blood Agar Base), Deeps; BD BBL™ Trypticase™ Soy Agar (Soybean-Casein Digest Agar); BD BBL™ Trypticase™ Soy Agar Slants; BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II); BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood (TSA II) // Levine EMB Agar; BD BBL™ Trypticase™ Soy Agar with 5% Sheep Blood and MacConkey II Agar I Plate™; BD BBL™ Trypticase™ Soy Agar, Modified (TSA II); BD BBL™ Trypticase™ Soy Broth; BD BBL™ Trypticase™ Soy Broth with 20% Glycerol; BD BBL™ Trypticase™ Soy Broth with 6.5% Sodium Chloride; BD BBL™ Trypticase™ Soy Broth, Sterile; BD BBL™ Urea Agar Base; BD BBL™ Urea Agar Slants; BD BBL™ Urease Test Broth; BD BBL™ V-C-N Inhibitor; BD BBL™ V-C-N-T Inhibitor; BD BBL™ Venting Unit; BD BBL™ Vitamin K1 - Hemin Solution; BD BBL™ Voges-Proskauer A Reagent Droppers; BD BBL™ Voges-Proskauer B Reagent Droppers; BD BBL™ XLD Agar; BD Bio-Bag™ Type C; BD CO2 Gas Generators; BD COR MX™ Instrument; BD COR PX™ Instrument; BD COR™ GX Instrument; BD COR™ PX Instrument; BD CTGCTV2; BD Calibrated Disposable Inoculating Loops, Blue; BD Calibrated Disposable Inoculating Loops, Green; BD Control set for the BD Onclarity™ HPV Assay; BD Copan FLOQSwabs for HPV Self Collection; BD CytoRich™ Blue Preservative; BD CytoRich™ Clear Collection Vial; BD CytoRich™ Clear Preservative; BD CytoRich™ Red Preservative; BD Cytology Stain Kit; BD Density Reagent; BD Detergent Solution Concentrate; BD Difco™ Agar; BD Difco™ Agar, Granulated; BD Difco™ Agar, Noble; BD Difco™ Agar, Technical; BD Difco™ Anaerobic Agar; BD Difco™ Antimicrobic Vial A; BD Difco™ Antimicrobic Vial K; BD Difco™ Antimicrobic Vial P; BD Difco™ Asparagine; BD Difco™ Azide Blood Agar Base; BD Difco™ Beef Heart; BD Difco™ Bile Salts No. 3; BD Difco™ Bordet Gengou Agar Base; BD Difco™ Bordetella parapertussis Antiserum; BD Difco™ Bordetella pertussis Antigen; BD Difco™ Bordetella pertussis Antiserum; BD Difco™ Brain Heart Infusion; BD Difco™ Brain Heart Infusion Agar; BD Difco™ Brain Heart Infusion, Porcine; BD Difco™ Brewer Anaerobic Agar; BD Difco™ Brilliant Green Agar; BD Difco™ CHROMagar™ Salmonella; BD Difco™ Candida BCG Agar Base; BD Difco™ Cetrimide Agar Base; BD Difco™ Charcoal Agar; BD Difco™ Columbia Agar Base II; BD Difco™ Columbia Blood Agar Base; BD Difco™ Columbia Blood Agar Base EH; BD Difco™ Columbia Broth; BD Difco™ Cooked Meat Medium; BD Difco™ Cystine Tryptic Agar; BD Difco™ D-Galactose; BD Difco™ D-Mannitol; BD Difco™ D-Sorbitol; BD Difco™ DNase Test Agar; BD Difco™ Decarboxylase Medium Base; BD Difco™ Desoxycholate Agar; BD Difco™ Desoxycholate Lactose Agar; BD Difco™ Dextrose; BD Difco™ Dubos Broth Base; BD Difco™ EY Tellurite Enrichment; BD Difco™ Egg Yolk Enrichment 50%; BD Difco™ Escherichia coli H Antiserum H7; BD Difco™ Escherichia coli O Antiserum O157; BD Difco™ Eugon Agar; BD Difco™ Eugon Broth; BD Difco™ FA Buffer, Dried; BD Difco™ Fluid Thioglycollate Medium; BD Difco™ Fluid Thioglycollate Medium with Beef Extract; BD Difco™ Fraser Broth Supplement; BD Difco™ GC Medium Base; BD Difco™ GN Broth, Hajna; BD Difco™ Gelatin; BD Difco™ Glycerol; BD Difco™ Haemophilus influenzae Antiserum Poly Contains Types a, b, c, d, e, f; BD Difco™ Haemophilus influenzae Antiserum Type a; BD Difco™ Haemophilus influenzae Antiserum Type b; BD Difco™ Haemophilus influenzae Antiserum Type c",1977-12-29,236,2026-05-28,3,117,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221119779%22&limit=1
Arvato Usa LLC,3021008900,3021008900,3303 E Holmes Rd,Memphis,TN,38118,United States,Arvato USA LLC,10082727,Repackager or relabeler,55,FDF; FZP; GAT; GEI; GXI; HAW; HRS; HRY; HSB; HSD; HSX; HTN; HTY; HWC; JAB; JDG; JDI; JDJ; JDO; JDQ; JDS; JDW; JOL; JWH; KRO; KRQ; KRR; KTT; KWI; KWL; KWS; KWY; KWZ; LPH; LWJ; LXT; LZN; LZO; LZY; MBF; MBH; MBI; MBL; MBV; MEH; MRA; NBH; NDG; NEU; NPJ; NXT; OLO; OOG; OSN; PHX,"Colonoscope And Accessories, Flexible/Rigid; Clip, Implantable; Suture, Nonabsorbable, Synthetic, Polyethylene; Electrosurgical, Cutting & Coagulation & Accessories; Probe, Radiofrequency Lesion; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Washer, Bolt Nut; Pin, Fixation, Smooth; Screw, Fixation, Bone; System, X-Ray, Fluoroscopic, Non-Image-Intensified; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Nail, Fixation, Bone; Pin, Fixation, Threaded; Catheter And Tip, Suction; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented; Accessories, Arthroscopic; Washer, Bolt, Nut, Non-Spinal, Metallic; Marker, Radiographic, Implantable; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing; Orthopedic Stereotaxic Instrument; Knee Arthroplasty Implantation System; Software For Diagnosis/Treatment; Shoulder Prosthesis, Reverse Configuration",1; 2; 3,Smith and Nephew,2021-09-23,228,2021-03-25,3,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223021008900%22&limit=1
Aesculap AG,9610612,3002806315,Am Aesculap Platz,"TUTTLINGEN, DONAU Baden-Wurttemberg",,D-78532,Germany,Aesculap AG,8010193,Complaint file establishment; Contract manufacturer; Exporter to the US; Manufacturer; Repackager or relabeler; Specification developer,411,BTA; BWN; CCW; DSS; DWH; DWI; DWS; DXC; DXT; DZC; DZM; DZN; EAX; EBR; ECN; ECP; EEF; EFK; EFL; EGN; EHY; EIC; EIF; EIG; EIK; EIR; EIS; EIX; EIY; EJB; EJE; EJG; EJY; EJZ; EKB; EKC; EKD; EKF; EKG; EKI; EKJ; EKK; EKP; EKR; EMD; EMF; EMG; EMH; EMI; EMJ; EMK; EML; EMM; EMN; EMO; EMP; EMQ; EMR; EPY; EQH; ERA; ETF; EWC; EXX; EZM; FAX; FBQ; FBX; FDR; FEC; FEM; FER; FET; FFD; FFN; FFO; FFQ; FFR; FFY; FGM; FGN; FGY; FHA; FHI; FHL; FHN; FHO; FHQ; FLE; FMA; FQO; FRG; FSE; FSM; FSO; FSP; FSR; FSS; FTX; FTY; FWC; FWF; FWZ; FXR; FZO; FZP; FZQ; FZS; FZT; FZW; FZX; FZY; FZZ; GAA; GAB; GAC; GAD; GAF; GAH; GAI; GAJ; GAZ; GBX; GBY; GCJ; GCX; GCY; GDF; GDG; GDH; GDI; GDJ; GDL; GDM; GDN; GDO; GDR; GDX; GDY; GDZ; GEA; GEF; GEG; GEI; GEJ; GEN; GEO; GES; GET; GEY; GFA; GFC; GFD; GFF; GFI; GFJ; GWG; GWI; GWX; GWY; GWZ; GXJ; GXN; GXQ; GXR; GYK; GZT; GZX; HAB; HAD; HAE; HAO; HAW; HBB; HBC; HBD; HBE; HBM; HBO; HBQ; HBT; HCA; HCD; HCF; HCH; HCI; HCY; HDA; HDF; HDJ; HDK; HDL; HDM; HDQ; HER; HET; HFB; HFW; HGC; HGE; HGI; HGN; HHF; HHM; HIF; HJH; HKF; HLM; HNC; HNF; HNI; HNM; HNR; HNW; HOE; HOI; HPP; HRQ; HRR; HRS; HRT; HRW; HRX; HRY; HSO; HTC; HTD; HTE; HTF; HTJ; HTO; HTP; HTQ; HTR; HTS; HTT; HTW; HTX; HTZ; HWB; HWC; HWD; HWE; HWI; HWJ; HWK; HWM; HWN; HWP; HWQ; HWT; HWW; HWX; HXB; HXC; HXD; HXE; HXG; HXK; HXL; HXN; HXO; HXP; HXS; HXW; HXX; HXY; HXZ; HYA; IKD; IRQ; IZI; JDI; JDQ; JEP; JEX; JEY; JOJ; JWH; JXG; JYA; JYE; JYG; JYH; JYJ; JYK; JYL; JYO; JYP; JYQ; JYR; JYT; JYY; JZD; JZY; KAC; KAD; KAE; KAG; KAI; KAK; KAL; KAM; KAP; KAR; KAS; KAT; KAW; KAY; KBA; KBB; KBC; KBD; KBE; KBG; KBH; KBJ; KBL; KBM; KBN; KBQ; KBR; KBT; KBZ; KCA; KCF; KCH; KCJ; KCL; KCP; KCT; KDG; KDP; KFK; KGS; KGZ; KIK; KKX; KNA; KNF; KNS; KOA; KOH; KQM; KQW; KRO; KTE; KTF; KTG; KTT; KTZ; KWP; KWQ; KWY; KXF; KXG; KYT; KYW; KYZ; KZD; KZF; LDE; LFL; LGG; LGH; LKF; LMB; LMD; LPH; LRC; LRP; LRW; LRY; LWF; LWJ; LWK; LXH; LXK; LXZ; LYS; LYV; LZO; MAI; MAV; MAX; MBH; MDM; MEH; MJO; MMO; MNH; MNI; MOQ; MPN; MQP; MQV; MWS; NBH; NKB; NKG; NQW; OCW; ODP; OLO; OQG; OQH; OQI; OVD; OVE; PLR; PUI,"Pump, Portable, Aspiration (Manual Or Powered); Table And Attachments, Operating-Room; Laryngoscope, Rigid; Clip, Vascular; Blade, Saw, Surgical, Cardiovascular; Saw, Electrically Powered; Instruments, Surgical, Cardiovascular; Clamp, Vascular; Injector And Syringe, Angiographic; Wire, Orthodontic; Needle, Dental; Instruments, Dental Hand; Mirror, Mouth; Unit, Suction Operatory; Clamp, Wire, Orthodontic; Instrument, Ligature Tucking, Orthodontic; Clamp, Rubber Dam; Forceps, Articulation Paper; Forceps, Dressing, Dental; Scissors, Surgical Tissue, Dental; Tray, Impression, Preformed; Syringe, Periodontic, Endodontic, Irrigating; Accessories, Retractor, Dental; Retractor, All Types; Carver, Wax, Dental; Scissors, Collar And Crown; Remover, Crown; Probe, Periodontic; Instrument, Filling, Plastic, Dental; Handle, Instrument, Dental; Frame, Rubber Dam; Forceps, Rubber Dam Clamp; Pliers, Operative; Knife, Margin Finishing, Operative; Explorer, Operative; Excavator, Dental, Operative; Instrument, Cutting, Operative; Instrument, Contouring, Matrix, Operative; Condenser, Amalgam And Foil, Operative; Carrier, Amalgam, Operative; Burnisher, Operative; Spreader, Pulp Canal Filling Material, Endodontic; Reamer, Pulp Canal, Endodontic; Plugger, Root Canal, Endodontic; Hemostat, Surgical; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Forceps, Rongeur, Surgical; File, Bone, Surgical; Elevator, Surgical, Dental; Curette, Surgical, Dental; Chisel, Bone, Surgical; Chisel, Osteotome, Surgical; Scaler, Periodontic; Knife, Periodontic; Marker, Periodontic; Hoe, Periodontic; File, Periodontic; Speculum, Ent; Source, Carrier, Fiberoptic Light; Otoscope; Unit, Examining/Treatment, Ent; Chamber, Acoustic (For Audiometric Testing); Probe, Rectal, Non-Powered; Dilator, Esophageal (Metal Olive) Gastro-Urology; Bougie, Urological; Trocar, Gastro-Urology; Sound, Urethral, Metal Or Plastic; Sphyncteroscope; Obturator, For Endoscope; Accessories, Photographic, For Endoscope (Exclude Light Sources); Anoscope And Accessories; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Evacuator, Bladder, Manually Operated; Clamp, Non-Electrical; Retractor, Self-Retaining; Speculum, Rectal; Device, Locking, For Intestinal Clamp; Adaptor, Bulbs, Miscellaneous, For Endoscope; Probe And Director, Gastro-Urology; Retractor, Non-Self-Retaining; Cannula, Injection; Clamp, Penile; Ring, Laparotomy; Scoop; Ligator, Hemorrhoidal; Pneumoperitoneum Needle; Holder, Needle, Gastroenterologic; Sterilizer, Steam; Depressor, Tongue, Non-Surgical; Table, Operating-Room, Ac-Powered; Wrap, Sterilization; Table, Operating-Room, Manual; Tray, Surgical, Instrument; Microscope, Surgical, General & Plastic Surgery; Loupe, Diagnostic/Surgical; Light, Headband, Surgical; Light, Surgical, Floor Standing; Mirror, General & Plastic Surgery; Tape, Measuring, Rulers And Calipers; Camera, Television, Surgical, With Audio; Camera, Television, Endoscopic, Without Audio; Operating Room Accessories Table Tray; Holder, Camera, Surgical; Chisel, Surgical, Manual; Clip, Implantable; Clip, Removable (Skin); Curette, Surgical, General Use; Cutter, Surgical; Expander, Surgical, Skin Graft; Guide, Surgical, Instrument; Hammer, Surgical; Marker, Skin; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Spatula, Surgical, General & Plastic Surgery; Stylet, Surgical, General & Plastic Surgery; Stripper, Vein, Reusable; Stripper, Vein, Disposable; Tubing, Noninvasive; Catheter, Irrigation; Catheter, Eustachian, General & Plastic Surgery; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Needle, Suturing, Reusable; Needle, Aspiration And Injection, Reusable; Knife, Amputation; Applier, Surgical, Clip; Saw, Manual And Accessories; Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Applier, Staple, Surgical,; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Forceps, General & Plastic Surgery; File, Surgical, General & Plastic Surgery; Blade, Scalpel; Motor, Surgical Instrument, Pneumatic Powered; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Driver, Surgical, Pin; Dermatome; Bur, Surgical, General & Plastic Surgery; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Endoscope, Neurological; Discriminator, Two-Point; Fork, Tuning; Pinwheel; Percussor; Punch, Skull; Plate, Cranioplasty, Preformed, Non-Alterable; Dura Substitute; Cover, Burr Hole; Instrument, Shunt System Implantation; Retractor, Self-Retaining, For Neurosurgery; Instrument, Microsurgical; Saw, Powered, And Accessories; Rongeur, Powered; Rongeur, Manual; Instrument, Surgical, Non-Powered; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Motor, Drill, Electric; Handpiece (Brace), Drill; Drills, Burrs, Trephines & Accessories (Simple, Powered); Headrest, Neurosurgical; Clip, Scalp; Instrument, Clip Removal; Applier, Hemostatic Clip; Catheter, Ventricular; Cannula, Ventricular; Instrument, Ligature Passing And Knot Tying; Clip, Aneurysm; Applier, Aneurysm Clip; Curette, Uterine; Forceps, Obstetrical; Speculum, Vaginal, Metal; Scissors, Umbilical; Scissors, Episiotomy; Retractor, Vaginal; Packer, Uterine; Dilator, Cervical, Fixed Size; Pelvimeter, External; Laparoscope, Gynecologic (And Accessories); Forceps, Biopsy, Gynecological; Clamp, Umbilical; Clamp, Uterine; Amniotome; Electrocautery, Gynecologic (And Accessories); Stethoscope, Fetal; Remover, Intrauterine Device, Contraceptive, Hook-Type; Sound, Uterine; Insufflator, Laparoscopic; Loupe, Binocular, Low Power; Mirror, Headband, Ophthalmic; Instrument, Measuring, Lens, Ac-Powered; Specula, Ophthalmic; Scissors, Ophthalmic; Retractor, Ophthalmic; Needle, Ophthalmic Suturing; Forceps, Ophthalmic; Dilator, Lachrymal; Caliper, Ophthalmic; Spectacle, Magnifying; Headlamp, Operating, Battery-Operated; Hemostat; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Stripper, Surgical; Dynamometer, Nonpowered; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Saw; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Reamer; File; Broach; Rasp; Knife, Orthopedic; Burr, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Corkscrew; Awl; Trephine; Osteotome; Instrument, Compression; Punch, Femoral Neck; Passer; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Fork; Tamp; Holder, Needle; Orthopedic; Mallet; Applier, Cerclage; Pusher, Socket; Instrument, Bending Or Contouring; Twister, Wire; Bender; Screwdriver; Brace, Drill; Cutter, Wire; Forceps, Wire Holding; Cable, Electrode; Unit, Heating, Powered; System, X-Ray, Angiographic; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Cerclage, Fixation; Retainer, Matrix; Plier, Orthodontic; Plate, Bone; Indicator, Physical/Chemical Sterilization Process; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Shunt, Central Nervous System And Components; Scissors, Wire Cutting, Ent, Sterile; Chisel, Middle-Ear; Curette, Ear; Excavator, Ear; Gauge, Measuring; Holder, Ear Speculum; Hook, Microsurgical Ear; Knife, Ear; Knife, Myringotomy; Loop, Wire; Nipper, Malleus; Pick, Microsurgical Ear; Rasp, Ear; Snare, Ear; Knife, Laryngeal; Tube, Laryngectomy; Elevator, Ent; Forceps, Ent; Holder, Speculum, Ent; Mirror, Ent; Probe, Ent; Retractor, Ent; Cannula, Sinus; Curette, Nasal; Irrigator, Sinus; Knife, Nasal; Perforator, Antrum; Punch, Antrum; Punch, Nasal; Rasp, Nasal; Rongeur, Nasal; Saw, Nasal; Scissors, Nasal; Snare, Nasal; Trocar, Sinus; Adenotome; Curette, Adenoid; Depressor, Metal Tongue, Surgical; Dissector, Tonsil; Gag, Mouth; Knife, Tonsil; Needle, Tonsil Suturing; Punch, Tonsil; Snare, Tonsil; Tonsillectome; Dilator, Esophageal, Ent; Hook, Tracheal; Applicator, Ent; Blower, Powder, Ent; Syringe, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Chisel (Osteotome); Regulator, Vacuum; Saw, Pneumatically Powered; Retention Device, Suture; Accessories, Catheter; Hook, Bone; Drape, Surgical, Antimicrobial; Instrument, Manual, Specialized Obstetric-Gynecologic; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Surgical Instruments, G-U, Manual (And Accessories); Instrument, Manual, General Obstetric-Gynecologic; Camera, Surgical And Accessories; Goniometer, Nonpowered; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Trocar, Ent; Punch, Ent; Knife, Ent; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Applicator, Absorbent Tipped, Non-Sterile; Applicator, Absorbent Tipped, Sterile; Light, Examination, Medical, Battery Powered; Container, Liquid Medication, Graduated; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Device, Medical Examination, Ac Powered; Stethoscope, Manual; Instrument, Ultrasonic Surgical; Instrument, Cast Application/Removal, Manual; Instrument, Cast Removal, Ac-Powered; Cannula, Manipulator/Injector, Uterine; Device, Digital Image Storage, Radiological; System, Digital Image Communications, Radiological; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Instrument, Ent Manual Surgical; Tray, Surgical; Scissors, General, Surgical; Punch, Surgical; Dilator, Nasal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Razor, Surgical; Orthopedic Manual Surgical Instrument; Scrapper, Skin Specimen; Guard, Instrument; Bone Mill; Label Or Tag, Sterile; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Fastener, Fixation, Biodegradable, Soft Tissue; Syringe, Balloon Inflation; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Instrument, Manual, Surgical, General Use; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Intervertebral Disc; Tray, Surgical, Ent; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Battery, Replacement, Rechargeable; Tissue Adhesive For The Topical Approximation Of Skin; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; Stabilizer, Heart; Accessories, Arthroscopic; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Orthosis, Spine, Plate, Laminoplasty, Metal; Endoscopic Tissue Approximation Device; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Spinal Vertebral Body Replacement Device - Cervical; Drape, Surgical, Exempt",1; 2; 3; U,ACCESSORIES AND MANUAL SAW; ADENOID CURETTE; ADENOTOME; AESCULAP; AFT SYSTEM TROCAR; AMPUTATION KNIFE; ANTRUM PERFORATOR; ANTRUM PUNCH; AURAL MAGNIFIER; Acculan; ActivL; Aesculap; BINOCULAR LOUPE; BIOPSY FORCEPS; BONE CHISEL; BONE FILE; BONE SCREW TAP; BONE TAP; CERCLAGE INSTRUMENT; CERVICAL DILATOR; CLIP REMOVAL INSTRUMENT; COMPRESSION INSTRUMENT; CONTAINER SYSTEM; CORKSCREW; COTTON APPLICATOR; COTTON APPLICATORS; CUTTING INSTRUMENT; Craniofix Peek; DENTAL; DENTAL DRESSING FORCEPS; DENTAL INSTRUMENT HANDLE; DIAGNOSTIC SET (ENT); DIAGNOSTIC SET (OTOSCOPE); DRILL BRACE; Dental; EAR CURETTE; EAR EXCAVATOR; EAR KNIFE; EAR SNARE; EAR SPECULUM HOLDER; ENDOFREEZE; ENT APPLICATOR; ENT ELEVATOR; ENT ESOPHAGEAL DILATOR; ENT FORCEPS; ENT MIRROR; ENT PROBE; ENT RETRACTOR; ENT SPECULUM; ENT SYRINGE; ENT TUNING FORK; EPISIOTOMY SCISSORS; EUSTACHIA CATHETER; FEMORAL NECK PUNCH; FILE; FIXED SIZE; FOR I.V. BAGS (MULTIPLE BRANDS); FORK; GAUZE; HANDPIECE DRILL; HEMOSTATIC CLIP APPLIER; INFUSOR; INSTRUMENT SURGICAL GUIDE; KNOT TYING INSTRUMENT *V*; LARYNGEAL KNIFE; LIGATURE CARRIER; LIGATURE PASSING; LIGATURE PASSING AND; MALLEUS NIPPER; MANUAL SAW AND ACCESSORIES; MEASURING DEVICES; METAL TONGUE DEPRESSOR ENT; MIASPAS TL; MICROSURGICAL EAR PICK; MIDDLE-EAR CHISEL; MINOP; MOUTH GAG; MULIPLE; MYRINGOTOMY KNIFE; NASAL KNIFE; NASAL PUNCH; NASAL RASP; NASAL SAW; NASAL SCISSORS; NASAL SNARE; NON-POWERED SURGICAL INSTRUMENT; ONE-PIECE SCALPEL; OPERATIVE EXCAVATOR; OPERATIVE PLIERS; OPHTHALMIC FORCEPS; OPHTHALMIC RETRACTOR; OPHTHALMIC SPECULA; OPTHALMIC CALIPER; ORTHODONTIC PLIER; ORTHODONTIC WIRE; ORTHODONTIC WIRE CLAMP; ORTHOPEDIC BENDER; ORTHOPEDIC BONE SCREW STARTER; ORTHOPEDIC BURR; ORTHOPEDIC CLAMP; ORTHOPEDIC CORKSCREW; ORTHOPEDIC COUNTERSINK; ORTHOPEDIC CURETTE; ORTHOPEDIC DEPTH GAUGE; ORTHOPEDIC DRILL; ORTHOPEDIC EXTRACTOR; ORTHOPEDIC FORCEPS; ORTHOPEDIC FORK; ORTHOPEDIC KNIFE; ORTHOPEDIC MALLET; ORTHOPEDIC PROBE; ORTHOPEDIC RASP; ORTHOPEDIC REAMER; ORTHOPEDIC RONGEUR; ORTHOPEDIC SCISSORS; ORTHOPEDIC SCREWDRIVER; ORTHOPEDIC SURGICAL FILE; ORTHOPEDIC SURGICAL PLIERS; ORTHOPEDIC SURGICAL SAW; ORTHOPEDIC SURGICAL STRIPPER; ORTHOPEDIC TREPHINE; ORTHOPEDIC WIRE CUTTER; ORTHOPEDIC WIRE HOLDING FORCEPS; ORTHOPEDIC WIRE TAMP; ORTHOPEDIC WIRE TWISTER; ORTHOPEDIC WRENCH; OSTEOTOME; OTOSCOPE; PELVIMETER; PENILE CLAMP; PERIODONTIC KNIFE; PERIODONTIC MARKER; PERIODONTIC PROBE; PERIODONTIC SCALER; PLATE BENDER; PNEUMATIC SAW; POWDER BLOWER; PRESSURE; PROSTHESIS TEMPLATE; RECTAL SPECULUM; RETENTION; REUSABLE ASPIRATION; REUSABLE VEIN STRIPPER; RONGEUR FORCEPS; RUBBER DAM CLAMP FORCEPS; SAW PASSER; SELF-RETAINING RETRACTOR; SINUS CANNULA; SINUS IRRIGATOR; SINUS TROCAR; SKULL PUNCH; STERILE DISPENSER SET; SURGICAL CAMERA; SURGICAL CANNULA; SURGICAL CLAMP; SURGICAL CLIP APPLIER; SURGICAL CURETTE; SURGICAL DENTAL ELEVATOR; SURGICAL ELEVATOR; SURGICAL HOOK; SURGICAL INSTRUMENT TRAY; SURGICAL KNIFE; SURGICAL LOOP; SURGICAL RASP; SURGICAL SAW; SURGICAL SAW BLADE; SURGICAL SPATULA; SUSI; SUTURE; SUTURING INSTRUMENT SET; TONSIL DISSECTOR; TONSIL KNIFE; TONSIL PUNCH; TONSIL SNARE; TONSIL SUTURING NEEDLE; TONSILLECTOME; TOOTH FORCEP; TRACHEAL HOOK; TREPHINE; TUNING FORK; UMBILICAL SCISSORS *V*; UROLOGICAL BOUGIE; UTERINE CLAMP; UTERINE CURETTE; UTERINE DILATORS-COMPLETE SET; UTERINE DILATORS-COMPLETE SETS; UTERINE PACKER; UTERINE PROBE; VAGINAL RETRACTOR; VEIN STRIPPER; WIRE CUTTER; WIRE CUTTING SCISSORS ENT; WIRE TWISTER; aesculap,1977-11-07,229,2023-06-29,1,1,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229610612%22&limit=1
Abbott Laboratories,3005333358,3005333358,Conway Park 675 North Field Drive,Lake Forest,IL,60045,United States,ABBOTT LABORATORIES,1415939,Complaint file establishment,192,CDD; CDO; CDP; CDQ; CDT; CDZ; CEC; CEK; CEM; CEO; CEP; CEW; CFJ; CFP; CFR; CFT; CGJ; CGN; CGS; CGX; CGZ; CHH; CHI; CHP; CIG; CIT; CIX; CJE; CJW; CJY; CKA; CKB; CZP; CZW; DAD; DBF; DBI; DCK; DDG; DDR; DEM; DER; DEW; DFC; DFT; DGC; DHA; DHR; DHX; DIF; DIO; DIP; DIS; DJG; DJR; DKB; DKC; DKJ; DKZ; DLJ; DLZ; DMT; DNN; EQJ; ERL; GGJ; GGK; GGM; GIF; GJH; GJL; GKZ; GLQ; GTQ; JCB; JCC; JCN; JFJ; JFR; JFT; JFY; JGJ; JGQ; JGS; JHX; JIF; JIQ; JIS; JIT; JIX; JIY; JJE; JJS; JJT; JJX; JJY; JKC; JKD; JLS; JLW; JPK; JPZ; JQF; JQP; JRS; JXM; JXN; JZG; JZJ; JZO; KEW; KHP; KHQ; KHS; KLI; KLQ; KLS; KLT; KNK; KPA; KRX; KRY; KRZ; KSA; KWL; KWY; KXT; LAF; LBR; LBS; LBZ; LCD; LCM; LCP; LCR; LDJ; LDP; LDZ; LEG; LEH; LFH; LFX; LFZ; LGC; LGD; LGR; LGS; LIP; LKL; LOK; LOL; LOM; LPS; LTJ; LTK; LZO; MEH; MJX; MJY; MKW; MLM; MMI; MOI; MQM; MRG; MTF; MTG; MXJ; MYF; MZA; MZF; MZO; NBC; NDW; NDY; NHX; NIG; NQD; NRP; OHQ; OIU; ONX; OSX; PDJ; PMT; PPM; PRI; PTF; QAT; QCH; QKO; SEI,"Radioassay, Vitamin B12; Acid, Uric, Uricase (U.V.); Radioimmunoassay, Total Triiodothyronine; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Radioimmunoassay, Immunoreactive Insulin; Hexokinase, Glucose; Radioimmunoassay, Prolactin (Lactogen); Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Radioimmunoassay, Estradiol; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Bromcresol Purple Dye-Binding, Albumin; Azo Dye, Calcium; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Acid Phosphatase, Naphthyl Phosphate; Iga, Antigen, Antiserum, Control; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Alpha-1-Lipoprotein, Antigen, Antiserum, Control; Igg, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; Igm, Antigen, Antiserum, Control; Ige, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Drug Mixture Control Materials; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Alcohol Control Materials; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet; Calibrators, Ethyl Alcohol; Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Fluid, Diluting, White-Cell; Products, Red-Cell Lysing Products; Control, Hemoglobin; Diluent, Blood Cell; Stain, Reticulocyte; Romanowsky Stains; Counter, Differential Cell; Mixture, Control, White-Cell And Red-Cell Indices; Antistreptolysin - Titer/Streptolysin O Reagent; Detergent; Ph Buffer; Control, Cell Counter, Normal And Abnormal; Catalytic Methods, Amylase; Indirect Copper Assay, Ceruloplasmin; Fluorometric, Cortisol; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Turbidimetric, Total Protein; Electrode, Ion Specific, Sodium; Fluorometric Method, Cpk Or Isoenzymes; Enzymatic Method, Ammonia; Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.); Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Controls For Blood-Gases, (Assayed And Unassayed); Enzyme Controls (Assayed And Unassayed); Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate); Radioimmunoassay, C-Peptides Of Proinsulin; Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Mixture, Hematology Quality Control; Colorimetric Method, Gamma-Glutamyl Transpeptidase; Bathophenanthroline, Iron Binding Capacity; Calculator/Data Processing Module, For Clinical Use; Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis); Enzyme Immunoassay, Benzodiazepine; Enzyme Immunoassay, Propoxyphene; System, Test, Beta-2-Microglobulin Immunological; Prealbumin, Antigen, Antiserum, Control; System, Test, Thyroid Autoantibody; Slides, Microscope; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzymatic, Carbon-Dioxide; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Radioimmunoassay, Amikacin; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Slide Stainer, Automated; Calibrator For Cell Indices; Calibrator For Platelet Counting; Calibrator For Hemoglobin And Hematocrit Measurement; Calibrator For Red-Cell And White-Cell Counting; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Enzyme Immunoassay, Digoxin; Gas Chromatography, Methamphetamine; Ldl & Vldl Precipitation, Hdl; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Quinidine; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Assay, Glycosylated Hemoglobin; Fluorescent Immunoassay, Tobramycin; Enzyme Immunoassay, Cannabinoids; Colorimetry, Acetaminophen; Fixative, Alcohol Containing; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; U.V. Spectrometry, Tricyclic Antidepressant Drugs; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus; Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total); Fluorescence Polarization Immunoassay, Theophylline; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control; Kit, Test, Alpha-Fetoprotein For Neural Tube Defects; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Urinary Homocystine (Nonquantitative) Test System; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Kit, Serological, Positive Control; Kit, Serological, Negative Control; Cyclosporine; Enzyme Immunoassay, Tracrolimus; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; Bilirubin (Total And Unbound) In The Neonate Test System; System, Test, Vitamin D; Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2; Test, Equipment, Automated Bloodborne Pathogen; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Test, Natriuretic Peptide; Assay, Porphyrin, Spectrophotometry, Lithium; Test, Cystatin C; Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp); System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Sirolimus Test System; Multi-Analyte Controls Unassayed; Test, Epithelial Ovarian Tumor Associated Antigen (He4); Ovarian Adnexal Mass Assessment Score Test System; Galectin-3 In Vitro Diagnostic Assay; Hemoglobin A1c Test System; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; General Purpose Reagent; Procalcitonin Assay; Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission; Brain Trauma Assessment Test; Assayed Quality Control Material For Clinical Microbiology Assays; Reagent, Coronavirus Serological; Qualitative And Quantitative Hepatitis B Virus Antibody Assays",1; 2; 3; N; U,"20X SSC, 500g; ACE Calibrator (LN 06U8201); ACE Calibrator (LN 06U8601); ACE Control (LN 06U8210); ACE Control (LN 06U8610); ACID PHOSPHATASE (ACP) (LN 9D87-21); ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42); ACTIVATED ASPARTATE AMINOTRANSFERASE (LN 8L91-21, 8L91-41); ALANINE AMINOTRANSFERASE (ALT) (LN 7D56-21, 7D56-22); ALBUMIN BCG (ALBG) (LN 7D53-23, 7D53-24); ALBUMIN BCP (LN 7D54-21); ALINITY HQ ANALYZER (09P68-01); ALINITY HS SLIDE MAKER STAINER MODULE (09P69-01); ALKALINE PHOSPHATASE (LN 7D55-21, 7D55-22, 7D55-31, 7D55-32); AMP Check E GPR; AMP/6-AM Oral Fluid Calibrator Level 1; AMP/6-AM Oral Fluid Calibrator Level 2; AMP/6-AM Oral Fluid Calibrator Level 3; AMP/6-AM Oral Fluid Calibrator Level 4; AMP/6-AM Oral Fluid Control Set; AMYLASE (LN 7D58-21 and 7D58-22); APOLIPOPROTEIN A1 (ApoA) (LN 9D92-21, 9D92-22); APOLIPOPROTEIN B (APOB) (LN 9D93-21, 9D93-22); ARCHITECT 25-OH Vitamin D Calibrators (LN 5P02-02); ARCHITECT 25-OH Vitamin D Controls (LN 5P02-12); ARCHITECT 25-OH Vitamin D Reagent Kit (LN 5P02-25, 5P02-30, 5P02-35); ARCHITECT 2nd Generation Testosterone Calibrators (LN 2P13-01); ARCHITECT 2nd Generation Testosterone Controls (LN 2P13-10); ARCHITECT 2nd Generation Testosterone Reagent Kit (LN 2P13-27); ARCHITECT AFP Calibrators (LN 3P36-01); ARCHITECT AFP Controls (LN 3P36-10); ARCHITECT AFP Reagent Kit (LN 3P36-25, 3P36-35); ARCHITECT ANTI HCV CALIBRATOR (LN 1L79-01); ARCHITECT ANTI-HCV CONTROLS (LN 1L79-10); ARCHITECT ANTI-HCV REAGENT KIT (LN 1L79-25, 1L79-35); ARCHITECT AUSAB Calibrators (LN 1L82-02, 1L82-03); ARCHITECT AUSAB Controls (LN 1L82-12, 1L82-13); ARCHITECT AUSAB Reagent Kit (LN 1L82-25, 1L82-35, 1L82-26, 1L82-27, 1L82-36, 1L82-37); ARCHITECT AUSAB Reagent Kit (LN 1L82-28, 1L82-38); ARCHITECT AUSAB Specimen Diluent (LN 1L82-40); ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (LN 3P24-01); ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (LN 3P24-02); ARCHITECT Active-B12 (Holotranscobalamin) Controls (LN 3P24-10); ARCHITECT Active-B12 (Holotranscobalamin) Controls (LN 3P24-11); ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit (LN 3P24-25); ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit (LN 3P24-28, 3P24-38); ARCHITECT Anti-CCP Calibrators (LN 1P65-01); ARCHITECT Anti-CCP Controls (LN 1P65-10); ARCHITECT Anti-CCP Reagent Kit (LN 1P65-25); ARCHITECT Anti-TPO Calibrators (LN 2K47-01); ARCHITECT Anti-TPO Controls (LN 2K47-10); ARCHITECT Anti-TPO Reagent Kit (LN 2K47-27); ARCHITECT Anti-Tg Calibrators (LN 2K46-01); ARCHITECT Anti-Tg Controls (LN 2K46-10); ARCHITECT Anti-Tg Reagent Kit (LN 2K46-20, 2K46-25); ARCHITECT B12 Calibrators (LN 7K61-02); ARCHITECT B12 Controls (LN 7K61-12); ARCHITECT B12 Reagent Kit (LN 7K61-27, 7K61-37); ARCHITECT BNP Calibrators - LN 8K28-02, 8K28-03, 8K28-04; ARCHITECT BNP Controls - LN 8K28-11, 8K28-12, 8K28-13; ARCHITECT BNP Reagent Kit - LN 8K28-27 8K28-35 8K28-28 8K28-36; ARCHITECT BRAHMS PCT Calibrators (LN 6P22-01); ARCHITECT BRAHMS PCT Controls (LN 6P22-10); ARCHITECT BRAHMS PCT Reagent Kit (LN 6P22-27, 6P22-37); ARCHITECT C-Peptide Reagent Kit (LN 3L53-27); ARCHITECT CA125 II Calibrators - LN 02K4502; ARCHITECT CA125 II Controls - LN 02K4511; ARCHITECT CA125 II Reagent Kit - LN 02K4524 02K4529 and 02K4539; ARCHITECT CA15-3 Calibrators - LN 02K4402; ARCHITECT CA15-3 Controls - LN 02K4411; ARCHITECT CA15-3 Reagent Kit - LN 02K4421 02K4427 02K4437; ARCHITECT CA19-9XR Calibrators - LN 02K9103; ARCHITECT CA19-9XR Controls - LN 02K9112; ARCHITECT CA19-9XR Reagent Kit - LN 02K9133; ARCHITECT CEA Calibrators (LN 7K68-02); ARCHITECT CEA Controls (LN 7K68-12); ARCHITECT CEA Reagent Kit (LN 7K68-27, 7K68-32, 7K68-35); ARCHITECT CORE Calibrators (LN 6L22-01); ARCHITECT CORE Controls (LN 6L22-10); ARCHITECT CORE Reagent Kit (LN 6L22-25); ARCHITECT CORE-M CALIBRATORS (LN 6L23-01); ARCHITECT CORE-M CONTROLS (LN 6L23-10); ARCHITECT CORE-M REAGENT KIT (LN 6L23-25); ARCHITECT Cortisol Calibrators (LN 8D15-02); ARCHITECT Cortisol Reagent Kit (LN 8D15-25, 8D15-35); ARCHITECT Cyclosporine Calibrators - LN 01L7501; ARCHITECT Cyclosporine Reagent Kit - LN 01L7525; ARCHITECT Cyclosporine Whole Blood Precipitation Reagent Kit - LN 01L7555; ARCHITECT DHEA-S Calibrators (LN 8K27-02); ARCHITECT DHEA-S Controls (LN 8K27-11); ARCHITECT DHEA-S Reagent Kit (LN 8K27-27); ARCHITECT ESTRADIOL CALIBRATORS (LN 7K72-01); ARCHITECT ESTRADIOL CONTROLS (LN 7K72-10); ARCHITECT Estradiol Manual Diluent (LN 7K72-50); ARCHITECT Estradiol Reagent Kit (LN 7K72-25, 7K72-35); ARCHITECT FERRITIN Controls (LN 7K59-10); ARCHITECT FERRITIN Reagent Kit (LN 7K59-25, 7K59-35); ARCHITECT FSH CALBRATORS (LN 7K75-01); ARCHITECT FSH CONTROLS (LN 7K75-10); ARCHITECT FSH Reagent Kit (LN 7K75-25, 7K75-35); ARCHITECT Folate Calibrators (LN 1P74-02); ARCHITECT Folate Controls (LN 1P74-12); ARCHITECT Folate Manual Diluent (LN 1P74-50); ARCHITECT Folate Reagent Kit (LN 1P74-27, 1P74-37); ARCHITECT Free PSA Calibrators (LN 6C07-01); ARCHITECT Free PSA Controls (LN 6C07-10); ARCHITECT Free PSA Reagent Kit (LN 6C07-27); ARCHITECT Free T3 Calibrators (LN 7K63-01); ARCHITECT Free T3 Calibrators (LN 7K63-02); ARCHITECT Free T3 Controls (LN 7K63-10, 7K63-12); ARCHITECT Free T3 Reagent Kit (LN 7K63-25, 7K63-35, 7K63-27, 7K63-32, 7K63-37); ARCHITECT Free T4 Calibrators (LN 7K65-02); ARCHITECT Free T4 Controls (LN 7K65-10); ARCHITECT Free T4 Reagent Kit (LN 7K65-27, 7K65-32, 7K65-35); ARCHITECT Free T4 Reagent Kit (LN 7K65-29, 7K65-34, 7K65-39); ARCHITECT Galectin-3 Calibrators - LN 05P0301; ARCHITECT Galectin-3 Controls - LN 05P0310; ARCHITECT Galectin-3 Reagent Kit - LN 05P0327; ARCHITECT Glucose2 (LN 04T0120, 04T0130); ARCHITECT HAVAB-G Calibrator (LN 6L27-01); ARCHITECT HAVAB-G Controls (LN 6L27-10); ARCHITECT HAVAB-G Reagent Kit (LN 6L27-25); ARCHITECT HAVAB-M Calibrator (LN 6L21-01); ARCHITECT HAVAB-M Controls (LN 6L21-10); ARCHITECT HAVAB-M Reagent Kit (LN 6L21-25); ARCHITECT HBsAg Next Confirmatory Manual Diluent (LN 4P77-42); ARCHITECT HBsAg Next Confirmatory Reagent Kit (LN 4P77-27); ARCHITECT HBsAg Next Qualitative Calibrators (LN 4P76-02); ARCHITECT HBsAg Next Qualitative Controls (LN 4P76-12); ARCHITECT HBsAg Next Qualitative Reagent Kit (LN 4P76-27, 4P76-37, 4P76-32); ARCHITECT HBsAg Qualitative Calibrators (LN 4P53-01); ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent (LN 4P54-40); ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit (LN 4P54-25); ARCHITECT HBsAg Qualitative Controls (LN 4P53-10); ARCHITECT HBsAg Qualitative Reagent Kit (LN 4P53-25, 4P53-35); ARCHITECT HE4 Calibrators - LN 02P5401; ARCHITECT HE4 Controls - LN 02P5410; ARCHITECT HE4 Reagent Kit - LN 02P5427; ARCHITECT HIV Ag/Ab Combo Calibrator (LN 2P36-01); ARCHITECT HIV Ag/Ab Combo Controls (LN 2P36-10); ARCHITECT HIV Ag/Ab Combo Reagent Kit (LN 2P36-25, 2P36-35); ARCHITECT Homocysteine Calibrators (LN 1L71-01); ARCHITECT Homocysteine Controls (LN 1L71-10); ARCHITECT Homocysteine Reagent Kit (LN 1L71-27); ARCHITECT Insulin Calibrators (LN 08K4103); ARCHITECT Insulin Controls (LN 08K4112); ARCHITECT Insulin Reagent Kit (LN 8K41-28); ARCHITECT LH Calibrators (LN 2P40-01); ARCHITECT LH Reagent Kit (LN 2P40-25, 2P40-35); ARCHITECT PROGESTERONE CALIBRATORS (LN 7K77-01); ARCHITECT PROGESTERONE CONTROLS (LN 7K77-10); ARCHITECT PROLACTIN CALIBRATORS (LN 7K76-01); ARCHITECT PROLACTIN CONTROLS (LN 7K76-10); ARCHITECT Phenobarbital Calibrators (LN 1P33-01); ARCHITECT Phenobarbital Reagent Kit (LN 1P33-25); ARCHITECT Progesterone Manual Diluent (LN 7K77-50); ARCHITECT Progesterone Reagent Kit (LN 7K77-25, 7K77-35); ARCHITECT Prolactin Reagent Kit (LN 7K76-25, 7K76-35); ARCHITECT ROMA (LN 6P30-21); ARCHITECT SHBG Calibrators (LN 8K26-02); ARCHITECT SHBG Controls (LN 8K26-11); ARCHITECT SHBG Reagent Kit (LN 8K26-27); ARCHITECT STAT CK-MB Controls - LN 02K4210; ARCHITECT STAT CK-MB Reagent Kit (LN 2K42-25, 2K42-35); ARCHITECT STAT High Sensitivity Troponin-I Calibrators (LN 2R98-01); ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10); ARCHITECT STAT High Sensitivity Troponin-I Reagent Kit (LN 2R98-25, 2R98-35); ARCHITECT STAT Myoglobin Calibrators (LN 2K43-01); ARCHITECT STAT Myoglobin Controls - LN 02K4310; ARCHITECT STAT Myoglobin Reagent Kit (LN 2K43-20, 2K43-25); ARCHITECT STAT Troponin-I Calibrators - LN 02K4101; ARCHITECT STAT Troponin-I Controls - LN 02K4110; ARCHITECT STAT Troponin-I Reagent Kit - LN 02K4127 and 02K4137; ARCHITECT Sirolimus Calibrators (LN 1L76-01); ARCHITECT Sirolimus Reagent Kit (LN 1L76-25); ARCHITECT Sirolimus Whole Blood Precipitation Reagent (LN 1L76-55); ARCHITECT Syphilis TP Calibrator (LN 8D06-04); ARCHITECT Syphilis TP Controls (LN 8D06-13); ARCHITECT Syphilis TP Reagent Kit (LN 8D06-31, 8D06-41); ARCHITECT System; ARCHITECT System Accessories; ARCHITECT T-Uptake Calibrators - LN 02K4801; ARCHITECT T-Uptake Controls - LN 02K4810; ARCHITECT T-Uptake Reagent Kit (LN 02K4820 and 02K4825); ARCHITECT TOTAL B-HCG Calibrators (LN 7K78-01); ARCHITECT TOTAL B-HCG Controls (LN 7K78-10); ARCHITECT TOTAL B-HCG Reagent Kit (LN 7K78-25, 7K78-30, 7K78-35); ARCHITECT TSH Calibrators (LN 7K62-01); ARCHITECT TSH Controls (LN 7K62-10); ARCHITECT TSH Reagent Kit (LN 7K62-25, 7K62-30, 7K62-35); ARCHITECT Tacrolimus Calibrators (LN 01L7701); ARCHITECT Tacrolimus Reagent Kit (LN 01L7725); ARCHITECT Tacrolimus Whole Blood Precipitation Reagent (LN 01L7755); ARCHITECT Total PSA Calibrators (LN 6C06-01); ARCHITECT Total PSA Controls (LN 6C06-10); ARCHITECT Total PSA Reagent Kit (LN 6C06-27, 6C06-35); ARCHITECT Total T3 Calibrators (LN 7K64-01); ARCHITECT Total T3 Calibrators (LN 7K64-02); ARCHITECT Total T3 Manual Diluent (7K64-50); ARCHITECT Total T3 Reagent Kit (LN 7K64-25, 7K64-35, 7K64-27, 7K64-32, 7K64-37); ARCHITECT Total T4 Calibrators (LN 7K66-01); ARCHITECT Total T4 Calibrators (LN 7K66-02); ARCHITECT Total T4 Controls (LN 7K66-10, 7K66-12); ARCHITECT Total T4 Reagent Kit (LN 7K66-25, 7K66-30, 7K66-35, 7K66-27, 7K66-32, 7K66-37); ARCHITECT Transplant Pretreatment Tubes (LN 01P0602); ARCHITECT Transplant Pretreatment Tubes (LN 1P06-02); ARCHITECT Transplant Pretreatment Tubes - LN 01P0602; ARCHITECT iCarbamazepine Calibrator A Multi-Pack (LN 1P36-50); ARCHITECT iCarbamazepine Calibrators (LN 1P36-01); ARCHITECT iCarbamazepine Reagent Kit (LN 1P36-27); ARCHITECT iGentamicin (LN 1P31-27); ARCHITECT iGentamicin Calibrators (LN 1P31-01); ARCHITECT iGentamicin Reagent Kit (LN 1P31-25); ARCHITECT iPTH Calibrators (LN 8K25-04); ARCHITECT iPTH Controls (LN 8K25-13); ARCHITECT iPTH Reagent Kit (LN 8K25-29); ARCHITECT iPhenytoin Calibrators (LN 1P34-01); ARCHITECT iPhenytoin Reagent Kit (LN 1P34-25); ARCHITECT iValproic Calibrators (LN 1P35-01); ARCHITECT iValproic Reagent Kit (LN 1P35-25); ARCHITECT iVancomycin Reagent Kit (LN 1P30-28, 1P30-24); ARCHITECt STAT CK-MB Calibrators (LN 2K42-01); ARCHTIECT FERRITIN Calibrators (LN 7K59-01); ASPARTATE AMINO TRANSFERASE (AST) (LN 7D81-21); Abbott Bisulfite Modification Kit; Abbott Proteinase K; Abbott mSample Preparation System Bulk mLysis DNA Buffer; Accelerator APS; Acetaminophen (Alinity c, LN 07P5420); Acetaminophen (LN 03R7420); Acetaminophen Calibrator (Alinity c, LN 07P5401); Acetaminophen Calibrator (LN 03R7401); Acetaminophen Calibrator - LN 02K9901; Activated Alanine Aminotransferase (A-ALT) (Alinity c, LN 08P1824); Activated Alanine Aminotransferase (ARCHITECT, LN 08L9224, 08L9244); Activated Aspartate Aminotransferase (A-AST) (Alinity c, LN 08P2324); Activated Aspartate Aminotransferase (ARCHITECT, LN 08L9124, 08L9144); Activated Aspartate Aminotransferase (LN 8L91-22, 8L91-42); AdviseDx SARS-CoV-2 IgG II (ARCHITECT, LN 6S60-20, 6S60-30); AdviseDx SARS-CoV-2 IgG II (Alinity i, LN 06S6120, 06S6130); AdviseDx SARS-CoV-2 IgG II Calibrator Kit (ARCHITECT, LN 6S60-01); AdviseDx SARS-CoV-2 IgG II Calibrator Kit (Alinity i, LN 06S6101); AdviseDx SARS-CoV-2 IgG II Control Kit (ARCHITECT, LN 6S60-10); AdviseDx SARS-CoV-2 IgG II Control Kit (Alinity i, LN 06S6110); AdviseDx SARS-CoV-2 IgM Calibrator Kit (ARCHITECT, LN 06R8701); AdviseDx SARS-CoV-2 IgM Calibrator Kit (Alinity i, LN 06R9101); AdviseDx SARS-CoV-2 IgM Control Kit (ARCHITECT, LN 06R8710); AdviseDx SARS-CoV-2 IgM Control Kit (Alinity i, LN 06R9110); AdviseDx SARS-CoV-2 IgM Reagent Kit (ARCHITECT, LN 06R8720, 06R8730); AdviseDx SARS-CoV-2 IgM Reagent Kit (Alinity i, LN 06R9120, 06R9130); Alanine Aminotransferase2 (ARCHITECT; LN 04S8820, 04S8830); Alanine Aminotransferase2 (Alinity c; LN 04T8420, 04T8430); Albumin BCG2 (ARCHITECT, LN 04T3420 and 04T3430); Albumin BCG2 (Alinity c, LN 04U3020 and 04U3030); Albumin BCP2 (ARCHITECT, LN 04U4520 and 04U4530); Albumin BCP2 (Alinity c, LN 04T8220 and 04T8230); Alcohol Diluent GPR 60 mL; Alere NT-proBNP for Alinity i Calibrators (LN 04S7902); Alere NT-proBNP for Alinity i Controls (LN 04S7911); Aliniity c Immunoglobulin G Reagent Kit (LN 09P6220); Alinity Alkaline Phosphatase2 (LN 04T8320, 04T8330); Alinity c A-1-AGP Reagent Kit (LN 01R0821); Alinity c A1-Antitrypsin Reagent Kit (LN 01R0721); Alinity c ASO Calibrator (LN 01R0602); Alinity c ASO Control I (LN 04S0912); Alinity c ASO Control II (LN 04S0913); Alinity c ASO Reagent Kit (LN 01R0621); Alinity c Activated Alanine Aminotransferase Reagent Kit (LN 08P1820); Alinity c Activated Apartate Aminotransferase Reagent Kit (LN 08P2320); Alinity c Alanine Aminotransferase Reagent Kit (LN 07P9820); Alinity c Albumin BCG Reagent Kit (LN 08P0220); Alinity c Albumin BCP Reagent Kit (LN 08P0320); Alinity c Alkaline Phosphatase Reagent Kit (LN 08P2020, 08P2030); Alinity c Amikacin Reagent Kit - LN 09P4420; Alinity c Ammonia Controls (LN 08P2210); Alinity c Ammonia Ultra Reagent Kit (LN 08P2220); Alinity c Amphetamine/Methamphetamine Reagent Kit (LN 09P4520); Alinity c Amylase Reagent Kit (LN 07P5820); Alinity c Apolipoprotein A1 Reagent Kit (LN 09P4620); Alinity c Apolipoprotein B Reagent Kit (LN 09P4720); Alinity c Aspartate Aminotransferase Reagent Kit (LN 08P1720); Alinity c B2-Microglobulin Calibrator (LN 01R0902); Alinity c B2-Microglobulin Reagent Kit (LN 01R0921); Alinity c Barbiturates Reagent Kit (LN 09P5120); Alinity c Benzodiazepines Qual Calibrator Kit (LN 09P5201); Alinity c Benzodiazepines Reagent Kit (LN 09P5220); Alinity c Benzodiazepines Semiquant Calibrator Kit (LN 09P5202); Alinity c Bilirubin Calibrator Kit (LN 08P6101); Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (07P5605); Alinity c CRP Vario HS Control Kit (LN 07P5612); Alinity c CRP Vario High Sensitivity Calibrator Kit (07P5604); Alinity c CRP Vario Reagent Kit (LN 07P5621); Alinity c CRP Vario Reagent Kit (LN 07P5624); Alinity c CRP Vario Wide Range Calibrator Kit (LN 07P5603); Alinity c Calcium Reagent Kit (LN 07P5720, 07P5730); Alinity c Cannabinoids Control 1 Kit (LN 09P5410); Alinity c Cannabinoids Control 2 Kit (LN 09P5411); Alinity c Cannabinoids Qual Calibrator Kit (LN 09P5401); Alinity c Cannabinoids Reagent Kit (LN 09P5420); Alinity c Cannabinoids Semiquant 100 Calibrator Kit (LN 09P5402); Alinity c Cannabinoids Semiquant 200 Calibrator Kit (LN 09P5403); Alinity c Carbamazepine Reagent Kit (LN 08P5820); Alinity c Carbon Dioxide Calibrator Kit (LN 08P7201); Alinity c Carbon Dioxide Reagent Kit (LN 07P7220, 07P7230); Alinity c Ceruloplasmin Reagent Kit (LN 09P9320); Alinity c Cholesterol Reagent Kit (LN 07P7620); Alinity c Clinical Chemistry Calibrator Kit (LN 08P6503); Alinity c Cocaine Reagent Kit (LN 09P5520); Alinity c Complement C3 Reagent Kit (LN 09P5620); Alinity c Complement C4 Reagent Kit (LN 09P5720); Alinity c Creatine Kinase Reagent Kit (LN 08P4220); Alinity c Creatinine (Enzymatic) Reagent Kit (LN 08P0120, 08P0130); Alinity c Creatinine Reagent Kit (LN 07P9920, 07P9930); Alinity c DOA MC I Controls (LN 08P6310, 08P6318); Alinity c DOA MC II Controls (LN 08P6311); Alinity c DOA MC III Controls (LN 08P6312); Alinity c DOA MC Negative Calibrator Kit (LN 08P6305, 08P6306); Alinity c DOA MC Qual Calibrator 2 Kit (LN 08P6302); Alinity c DOA MC Qual Low Calibrator 1 Kit (LN 08P6301); Alinity c DOA MC Semiquant Calibrator Kit (LN 08P6303); Alinity c Digoxin Reagent Kit - LN 08P3720; Alinity c Direct Bilirubin Reagent Kit (LN 07P9720); Alinity c Direct LDL Reagent Kit - LN 07P7120; Alinity c Ecstasy Qual Calibrator Kit (LN 09P5801); Alinity c Ecstasy Reagent Kit (LN 09P5820); Alinity c Ecstasy Semiquant Calibrator Kit (LN 09P5802); Alinity c Ethanol Calibrator Kit (LN 08P4101); Alinity c Ethanol Control Kit (LN 08P4110); Alinity c Ethanol Reagent Kit - LN 08P4120 and 08P4130; Alinity c Ferritin/Myoglobin/IgE Control Kit (LN 04R4612); Alinity c Gamma-Glutamyl Transferase Reagent Kit (LN 07P7320, 07P7330); Alinity c Gentamicin Reagent Kit - LN 08P5520; Alinity c Glucose Reagent Kit (LN 07P5520, 07P5530); Alinity c Glucose2 (LN 04T9720, 04T9730); Alinity c Haptoglobin Reagent Kit (LN 09P5920); Alinity c Hemoglobin A1c Calibrators (LN 08P4301); Alinity c Hemoglobin A1c Controls (LN 08P4310); Alinity c Hemoglobin A1c Reagent Kit (LN 08P4320, 08P4321); Alinity c ICT Sample Diluent (LN 07P5320); Alinity c ICT Serum Calibrator Kit (LN 08P6901); Alinity c ICT Urine Calibrator Kit (LN 08P7001); Alinity c IgE Calibrators (LN 01R1302); Alinity c IgE Reagent Kit (LN 01R1321); Alinity c Immunoglobulin A Reagent Kit (LN 09P6120); Alinity c Immunoglobulin M Reagent Kit (LN 09P6320); Alinity c Iron Calibrator Kit (LN 04U7501); Alinity c Iron Reagent Kit (LN 08P3920); Alinity c Lactate Dehydrogenase Reagent Kit (LN 07P7420, 07P7430); Alinity c Lactic Acid Reagent Kit (LN 08P2120, 08P2121); Alinity c Lipid Multiconstituent Calibrator Kit (LN 09P1403); Alinity c Lithium Reagent Kit (LN 08P5320); Alinity c Lp(a) Calibrators (LN 01R1401); Alinity c Lp(a) Control Kit (LN 01R1410); Alinity c Lp(a) Reagent Kit (LN 01R1421); Alinity c Magnesium Reagent Kit (LN 08P1920, 08P1930); Alinity c Methadone Reagent Kit (LN 09P6420); Alinity c Microalbumin Calibrators - LN 08P0401; Alinity c Microalbumin Controls - LN 08P0410; Alinity c Microalbumin Reagent Kit - LN 08P0420; Alinity c Multiconstituent Calibrator Kit (LN 08P6001); Alinity c Opiates Qual Calibrator Kit ( LN 09P6501); Alinity c Opiates Reagent Kit (LN 09P6520); Alinity c Opiates Semiquant Calibrator Kit (LN 09P6502); Alinity c Phencyclidine Reagent Kit - LN 09P6620; Alinity c Phenobarbital Reagent Kit - LN 09P8520; Alinity c Phenytoin Reagent Kit - LN 08P5420; Alinity c Phosphorus Reagent Kit (LN 08P4020, 08P4030); Alinity c Plasmaproteins Cal 3x Kit (LN 08P6601); Alinity c Prealbumin Calibrator Kit (LN 04S0101); Alinity c Prealbumin Reagent Kit (LN 09P8620); Alinity c Processing Module (LN 03R6701); Alinity c Propoxyphene Reagent Kit (LN 09P8720); Alinity c Proteins Calibrators (LN 08P6702); Alinity c Proteins Control Kit (LN 08P6712); Alinity c Rheumatoid Factor Calibrator Kit (LN 04S0002); Alinity c Rheumatoid Factor Reagent Kit (LN 04R9921); Alinity c Salicylate Calibrator Kit (LN 08P5901); Alinity c Salicylate Reagent Kit - LN 08P5920; Alinity c Serum Benzodiazepines Reagent Kit (LN 09P5320); Alinity c Specific Proteins Multiconstituent Calibrator Kit (LN 08P6201); Alinity c System; Alinity c System Accessories; Alinity c TDM Multiconstituent Calibrator Kit (LN 08P7403, 08P7404); Alinity c Theophylline Reagent Kit - LN 09P8920; Alinity c Tobramycin Calibrators (LN 09P9001); Alinity c Tobramycin Reagent Kit - LN 09P9020; Alinity c Total Bilirubin Reagent Kit (LN 04V5121, 04V5131); Alinity c Total Protein Reagent Kit (LN 07P5220); Alinity c Tox Controls (LN 08P6810); Alinity c Tox Qual Calibrators (LN 08P6802); Alinity c Tox Semiquant Calibrators (LN 08P6801); Alinity c Transferrin Reagent Kit (LN 08P3820); Alinity c Tricyclic Antidepressants Reagent Kit (LN 09P9122); Alinity c Triglyceride Reagent Kit - LN 07P7720; Alinity c UIBC Calibrator Kit (LN 08P4401); Alinity c UIBC Reagent Kit (LN 08P4420); Alinity c Ultra HDL Reagent Kit (LN 07P7520, 07P7530); Alinity c Urea Nitrogen Reagent Kit (LN 08P1620, 08P1630); Alinity c Uric Acid Reagent Kit (LN 08P5620, 08P5630); Alinity c Urine/CSF Protein Calibrator Kit (LN 08P7101); Alinity c Urine/CSF Protein Reagent Kit (LN 07P5920, 07P5930); Alinity c Valproic Acid Reagent Kit - LN 09P9220; Alinity c Vancomycin Reagent Kit - LN 08P5220; Alinity c-series Reagent Cartridge, Black (Large) (LN 04S1760); Alinity ci-series System Control Module (LN 03R7001); Alinity h-series AutoClean Solution (LN 01R5104); Alinity h-series Control 29P (LNs 04U7206, 04U7212, 06V87-06, 06V87-12); Alinity h-series Diluent (LN 04R2601); Alinity h-series Glass Slides (LN 09P8420); Alinity h-series HGB Reagent (LN 07P8104); Alinity h-series HemCal (LN 04U7302, 06V86-02); Alinity h-series May-Grunwald-Giemsa Stain (LN 08P8101); Alinity h-series Phosphate Buffer (LN 07P8301); Alinity h-series Retic Reagent (LN 07P8004); Alinity h-series Slide Label Cartridge (LN 09P8201); Alinity h-series Smear Fix (LN 08P7901); Alinity h-series Smear Tape Cartridge (LN 09P8301); Alinity h-series WBC Reagent (LN 07P7904); Alinity h-series Water Purification System (LN 09P7101); Alinity h-series Wright-Giemsa Stain (LN 08P8001); Alinity hq (LN 09P68-02); Alinity hq Processing Module (LN 09P6801); Alinity hs (09P69-02); Alinity hs Processing Module (LN 09P6901); Alinity i 25-OH Vitamin D Calibrators (LN 08P4501); Alinity i 25-OH Vitamin D Controls (LN 08P4512); Alinity i 25-OH Vitamin D Reagent Kit (08P4522, 08P4532); Alinity i 2nd Generation Testosterone Calibrators (LN 07P6801); Alinity i 2nd Generation Testosterone Controls (LN 07P6810); Alinity i 2nd Generation Testosterone Reagent Kit (LN 07P6821, 07P6831); Alinity i AFP Calibrators (LN 07P9001); Alinity i AFP Controls (LN 07P9010); Alinity i AFP Reagent Kit (LN 07P9020, 07P9030); Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2601); Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2602); Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610); Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2611); Alinity i Active-B12 (Holotranscobalamin) Reagent Kit (LN 09P2620); Alinity i Active-B12 (Holotranscobalamin) Reagent Kit (LN 09P2625, 09P2635); Alinity i Anti-CCP Calibrators (LN 09P2701); Alinity i Anti-CCP Controls (LN 09P2710); Alinity i Anti-CCP Reagent Kit (LN 09P2720); Alinity i Anti-HBc Calibrator (LN 07P8401); Alinity i Anti-HBc Controls (LN 07P8410); Alinity i Anti-HBc IgM Calibrators (LN 07P8602); Alinity i Anti-HBc IgM Controls (LN 07P8612); Alinity i Anti-HBc IgM Reagent Kit (LN 07P8621); Alinity i Anti-HBc Reagent Kit (LN 07P8421, 07P8431); Alinity i Anti-HBs Calibrators (LN 07P8801); Alinity i Anti-HBs Controls (LN 07P8810); Alinity i Anti-HBs Reagent Kit (LN 07P8851, 07P8856); Alinity i Anti-HBs Reagent Kit (LN 07P8852, 07P8857); Alinity i Anti-HBs Specimen Diluent (LN 07P8841); Alinity i Anti-HCV Calibrator (LN 08P0501); Alinity i Anti-HCV Controls (LN 08P0510); Alinity i Anti-HCV Reagent Kit (LN 08P0521); Alinity i Anti-TPO Calibrators (LN 09P3501); Alinity i Anti-TPO Controls (LN 09P3510); Alinity i Anti-TPO Reagent Kit (LN 09P3521); Alinity i Anti-Tg Calibrators (LN 09P3401); Alinity i Anti-Tg Controls (LN 09P3410); Alinity i Anti-Tg Reagent Kit (LN 09P3420); Alinity i B12 Calibrators (LN 07P6702); Alinity i B12 Controls (LN 07P6712); Alinity i B12 Reagent Kit (LN 07P6721, 07P6731); Alinity i BRAHMS PCT Calibrators (LN 01R1801); Alinity i BRAHMS PCT Controls (LN 01R1810); Alinity i BRAHMS PCT Reagent Kit (LN 01R1821); Alinity i C-Peptide Calibrators (LN 09P3601); Alinity i C-Peptide Controls (LN 09P3610); Alinity i C-Peptide Reagent Kit (LN 09P3620); Alinity i CA 125 II Calibrators (LN 08P4901); Alinity i CA 125 II Controls (LN 08P4910); Alinity i CA 125 II Reagent Kit - LN 08P4920 and 08P4930; Alinity i CA 15-3 Calibrators (LN 08P5101); Alinity i CA 15-3 Controls (LN 08P5110); Alinity i CA 15-3 Reagent Kit - LN 08P5120 and 08P5130; Alinity i CA 19-9XR Calibrators (LN 08P3201); Alinity i CA 19-9XR Controls (LN 08P3210); Alinity i CA 19-9XR Reagent Kit - LN 08P3221; Alinity i CEA Calibrators (LN 07P6201); Alinity i CEA Controls (LN 07P6210); Alinity i CEA Reagent Kit (LN 07P6220, 07P6230); Alinity i CMV IgG Calibrators (LN 07P4202); Alinity i CMV IgG Controls (LN 07P4212); Alinity i CMV IgG Reagent Kit (LN 07P4224, 07P4233); Alinity i Cortisol Calibrators (LN 08P3301); Alinity i Cortisol Reagent Kit (LN 08P3320, 08P3330); Alinity i DHEA-S Calibrators (LN 09P3701); Alinity i DHEA-S Controls (LN 09P3710); Alinity i DHEA-S Reagent Kit (LN 09P3720); Alinity i Estradiol Calibrators (LN 07P5001); Alinity i Estradiol Controls (LN 07P5010); Alinity i Estradiol Manual Diluent Kit (LN 07P5040); Alinity i Estradiol Reagent Kit (LN 07P5020, 07P5030); Alinity i FSH Calibrators (LN 07P4901); Alinity i FSH Controls (LN 07P4910); Alinity i FSH Reagent Kit (LN 07P4920, 07P4930); Alinity i Ferritin Calibrators (LN 07P6501); Alinity i Ferritin Controls (LN 07P6510); Alinity i Ferritin Reagent Kit (LN 07P6520, 07P6530); Alinity i Folate Calibrators (LN 08P1402); Alinity i Folate Controls (LN 08P1412); Alinity i Folate Manual Diluent (08P1460); Alinity i Folate Reagent Kit (LN 08P1421, 08P1431); Alinity i Free PSA Calibrators (LN 07P9301); Alinity i Free PSA Controls (LN 07P9310); Alinity i Free PSA Reagent Kit (LN 07P9321, 07P9331); Alinity i Free T3 Calibrators (LN 07P6901); Alinity i Free T3 Controls (LN 07P6910); Alinity i Free T3 Reagent Kit (LN 07P6920, 07P6930); Alinity i Free T4 Calibrators (LN 07P7001); Alinity i Free T4 Controls (LN 7P7010); Alinity i Free T4 Reagent Kit (LN 07P7020, 07P7030); Alinity i HAVAb IgG Calibrator (LN 08P2701); Alinity i HAVAb IgG Controls (LN 08P2710); Alinity i HAVAb IgG Reagent Kit (LN 08P2721); Alinity i HAVAb IgM Calibrator (LN 08P2801); Alinity i HAVAb IgM Controls (LN 08P2810); Alinity i HAVAb IgM Reagent Kit (LN 08P2821, 08P2831); Alinity i HBsAg Next Confirmatory Manual Diluent (LN 01R6542); Alinity i HBsAg Next Confirmatory Reagent Kit (LN 01R6521); Alinity i HBsAg Next Qualitative Calibrators (LN 01R6402); Alinity i HBsAg Next Qualitative Controls (LN 01R6412); Alinity i HBsAg Next Qualitative Reagent Kit (LN 01R6421, 01R6431); Alinity i HBsAg Qualitative II Calibrators (LN 08P1002); Alinity i HBsAg Qualitative II Confirmatory Manual Diluent (LN 08P1141); Alinity i HBsAg Qualitative II Confirmatory Reagent Kit (LN 08P1121); Alinity i HBsAg Qualitative II Controls (LN 08P1012); Alinity i HBsAg Qualitative II Reagent Kit (LN 08P1021, 08P1031); Alinity i HE4 Calibrators (LN 08P5001); Alinity i HE4 Controls (LN 08P5010); Alinity i HE4 Reagent Kit - LN 08P5021; Alinity i HIV Ag/Ab Combo Calibrator (LN 08P0702); Alinity i HIV Ag/Ab Combo Controls (LN 08P0712); Alinity i HIV Ag/Ab Combo Reagent Kit (LN 08P0721, 08P0731); Alinity i HSV-1 IgG Calibrator (LN 04W2002); Alinity i HSV-1 IgG Controls (LN 04W2012); Alinity i HSV-1 IgG Reagent Kit (LN 04W2027); Alinity i HSV-2 IgG Calibrator (LN 04W2102); Alinity i HSV-2 IgG Controls (LN 04W2112); Alinity i HSV-2 IgG Reagent Kit (LN 04W2127, 04W2137); Alinity i Homocysteine Calibrators (LN 09P2801); Alinity i Homocysteine Controls (LN 09P2810); Alinity i Homocysteine Reagent Kit (LN 09P2820); Alinity i Insulin Calibrators (LN 04T7501); Alinity i Insulin Controls (LN 04T7510); Alinity i Insulin Reagent Kit (LN 04T7520); Alinity i Intact PTH Calibrators (LN 08P3102); Alinity i Intact PTH Controls (LN 08P3111); Alinity i Intact PTH Reagent Kit (LN 08P3121); Alinity i LH Calibrators (LN 07P9101); Alinity i LH Reagent Kit (LN 07P9120, 07P9130); Alinity i Progesterone Calibrators (LN 08P3601); Alinity i Progesterone Controls (LN 08P3610); Alinity i Progesterone Manual Diluent Kit (LN 08P3640); Alinity i Progesterone Reagent Kit (LN 08P3620, 08P3630); Alinity i Prolactin Calibrators (LN 07P6601); Alinity i Prolactin Controls (LN 07P6610); Alinity i Prolactin Reagent Kit (LN 07P6620, 07P6630); Alinity i ROMA (LN 03R7521); Alinity i Refurbished Processing Module (LN 03R65-84); Alinity i Rubella IgG Calibrators (LN 04W02-01); Alinity i Rubella IgG Controls (LN 04W02-10); Alinity i Rubella IgG Reagent Kit (LN 04W02-22); Alinity i SHBG Calibrators (LN 09P3801); Alinity i SHBG Controls (LN 09P3810); Alinity i SHBG Reagent Kit (LN 09P3820); Alinity i STAT CK-MB Calibrators (LN 04V3801); Alinity i STAT CK-MB Controls (LN 04V3810); Alinity i STAT CK-MB Reagent Kit (LN 04V3821, 04V3831); Alinity i STAT High Sensitivity Troponin-I (LN 04Z2125, 04Z2135); Alinity i STAT High Sensitivity Troponin-I Calibrators (LN 04Z2101); Alinity i STAT High Sensitivity Troponin-I Controls (LN 04Z2110); Alinity i STAT High Sensitivity Troponin-I Reagent Kit (LN 04Z2125, 04Z2135); Alinity i STAT Myoglobin Calibrators (LN 04V3701); Alinity i STAT Myoglobin Controls (LN 04V3710); Alinity i STAT Myoglobin Reagent Kit (LN 04V3720, 04V3730); Alinity i Sirolimus Calibrators (LN 09P4101); Alinity i Sirolimus Reagent Kit (LN 09P4120); Alinity i Sirolimus Whole Blood Precipitation Reagent (LN 09P4140); Alinity i Syphilis TP Calibrator (LN 07P6001); Alinity i Syphilis TP Controls (LN 07P6010); Alinity i Syphilis TP Reagent Kit (LN 07P6021, 07P6031); Alinity i System; Alinity i System Accessories; Alinity i T-Uptake Calibrators (LN 08P1201); Alinity i T-Uptake Controls (LN 08P1210); Alinity i T-Uptake Reagent Kit (LN 08P1220); Alinity i TSH Calibrators (LN 07P4801); Alinity i TSH Controls (LN 07P4810); Alinity i TSH Reagent Kit (LN 07P4820, 07P4830); Alinity i Tacrolimus Calibrators (LN 09P4201); Alinity i Tacrolimus Reagent Kit (LN 09P4220); Alinity i Tacrolimus Whole Blood Precipitation Reagent (LN 09P4240); Alinity i Total B-HCG Controls (LN 07P5110); Alinity i Total B-hCG Calibrators (LN 07P5101); Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131); Alinity i Total PSA Calibrators (LN 07P9201); Alinity i Total PSA Controls (LN 07P9210); Alinity i Total PSA Reagent Kit (LN 07P9221, 07P9231); Alinity i Total T3 Calibrators (LN 07P9401); Alinity i Total T3 Manual Diluent (LN 07P9440)",1977-12-13,218,2026-09-23,9,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223005333358%22&limit=1
Titanlinks Logistics LLC,3044819802,3044819802,73 Omega Dr Suite 280,Newark,DE,19713,United States,TitanLinks Logistics LLC,10095876,Repackager or relabeler,128,DYH; DYN; DYT; DZA; DZM; DZN; DZP; EAX; EBC; EBD; EBF; EBG; EBH; EBI; EBL; EBZ; ECB; ECQ; EEF; EFB; EFH; EFL; EFN; EFT; EFW; EGD; EGZ; EHJ; EHK; EHL; EHM; EHY; EHZ; EIB; EIC; EID; EIF; EIG; EIH; EIY; EJB; EJH; EJJ; EJK; EJL; EJQ; EJR; EKB; EKH; EKI; EKK; EKM; EKN; EKR; EKS; EKT; ELA; ELC; ELL; ELM; ELR; ELW; ELZ; EMA; EMF; EMG; EMJ; EMN; EMR; FMW; FRG; FSM; FXP; FXX; GAM; GAP; GAR; GAT; GAW; GAZ; GDZ; GES; HRR; HTC; HTD; HTF; IME; IWZ; JEP; JES; JEX; JOJ; KCP; KCQ; KHR; KIF; KLE; KME; KMT; KQM; KTZ; KXF; KXG; KXR; KYW; KYX; LBH; LFD; LYU; LZA; LZC; MAU; MDM; MUH; MVL; MZW; NAB; NEW; NRD; NRU; NSB; OEA; OPJ; PEM; PME; PUI; QDO; QSY,"Adhesive, Bracket And Tooth Conditioner, Resin; Mouthpiece, Saliva Ejector; Maintainer, Space Preformed, Orthodontic; Drill, Dental, Intraoral; Needle, Dental; Instruments, Dental Hand; Instrument, Diamond, Dental; Mirror, Mouth; Sealant, Pit And Fissure, And Conditioner; Coating, Filling Material, Resin; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Material, Impression Tray, Resin; Resin, Denture, Relining, Repairing, Rebasing; Pin, Retentive And Splinting, And Accessory Instruments; Activator, Ultraviolet, For Polymerization; Unit, Syringe, Air And/Or Water; Aligner, Bracket, Orthodontic; Clamp, Rubber Dam; Handpiece, Air-Powered, Dental; Paper, Articulation; Forceps, Dressing, Dental; Cotton, Roll; Cleanser, Denture, Over The Counter; Toothbrush, Manual; Wax, Dental, Intraoral; Holder, Film, X-Ray; Disk, Abrasive; Cup, Prophylaxis; Point, Abrasive; Strip, Polishing Agent; Tray, Impression, Preformed; Evacuator, Oral Cavity; Syringe, Irrigating (Dental); Syringe, Periodontic, Endodontic, Irrigating; Syringe, Restorative And Impression Material; Accessories, Retractor, Dental; Retractor, All Types; Powder, Porcelain; Instrument, Filling, Plastic, Dental; Handle, Instrument, Dental; Alloy, Metal, Base; Alloy, Amalgam; Liner, Cavity, Calcium Hydroxide; Bur, Dental; Wheel, Polishing Agent; Agent, Polishing, Abrasive, Oral Cavity; Explorer, Operative; Carver, Dental Amalgam, Operative; Carrier, Amalgam, Operative; Spreader, Pulp Canal Filling Material, Endodontic; Gutta-Percha; Point, Paper, Endodontic; Plugger, Root Canal, Endodontic; File, Pulp Canal, Endodontic; Curette, Endodontic; Instrument, Hand, Calculus Removal; Scaler, Ultrasonic; Teeth, Porcelain; Denture, Plastic, Teeth; Post, Root Canal; Material, Impression; Crown, Preformed; Cement, Dental; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Elevator, Surgical, Dental; Scaler, Periodontic; File, Periodontic; Cover, Mattress (Medical Purposes); Wrap, Sterilization; Tray, Surgical, Instrument; Cover, Shoe, Operating-Room; Mask, Surgical; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tubing, Noninvasive; Handle, Scalpel; Blade, Scalpel; Scissors, Orthopedic, Surgical; Pliers, Surgical; Forceps; Curette; Pack, Hot Or Cold, Reusable; Film, Radiographic; Retainer, Matrix; Floss, Dental; Plier, Orthodontic; Indicator, Physical/Chemical Sterilization Process; Syringe, Ent; Tube Impression And Matrix; Absorber, Saliva, Paper; Resin, Root Canal Filling; Agent, Tooth Bonding, Resin; Bedding, Disposable, Medical; Tray, Fluoride, Disposable; Camera, Surgical And Accessories; Caliper; Applicator, Absorbent Tipped, Non-Sterile; Applicator, Absorbent Tipped, Sterile; Applicator, Resin; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Varnish, Cavity; Saliva, Artificial; Accessory, Surgical Apparel; Polymer Patient Examination Glove; Medical Glove, Specialty; Eraser, Dental Stain; Instrument, Manual, Surgical, General Use; System, X-Ray, Extraoral Source, Digital; Cord, Retraction; Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief; Gauze / Sponge,Nonresorbable For External Use; Suture, Surgical, Absorbable, Polydioxanone; Unit, Operative Dental, Accessories; Chair, Dental, Without Operative Unit; Patient Personal Hygiene Kit; Non-Surgical Gown; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Dental Barriers And Sleeves; External Cleaning Solution; Drape, Surgical, Exempt; Fentanyl And Other Opioid  Protection Glove; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; U,"AH Plus; Adhesive; Adhesive, Bracket; Air polish; Amalgam; Applicator; Applicator, Absorbent Tipped, Non-Sterile; Articulating Paper Forceps; BLADE, SCALPEL; Barrier Film; Bond; Bonding; Brush Applicator; C&B; CARVER, DENTAL AMALGAM, OPERATIVE; CURETTE; Caliper; Carrier Amalgam; Cement Dental; Coating; Coe; Core; Cotton Roll; Cover; Covers; Crown; Crown & Bridge; Curette; DISPENSER, LIQUID MEDICATION; Dappen Dish; Dental Accessory; Dental Cemenr; Dental Cement; Dental Drill; Dental Filling; Dental Impression; Dental Instrument; Dental Needle; Dental amalgam; Dental barriers and sleeves; Dental cement; Dental impression; Dental instrument; Denture res; Detnal cement; Diamond Burs; Disposable Face Shield; Disposable Prophy Angle; Disposable Utility Syringe; Dressing Gauze; Dry; Elevator; Endo Drill; Endo File; Endo Reamer; Fiber Post; Evacuator Tips; Examination Set; Explorer; Express; FORCEPS; Face Mask; File; Files; Filling material; Finishing & Polishing; Fuji Lining; FujiCem; Gauze; Glove; Graduated Paper Medicine Cup; Gutta; Hand instrument; Handpiece; INSTRUMENT, HAND, CALCULUS REMOVAL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE; INSTRUMENTS, DENTAL HAND; Imoression MAterial; Impression; Impression Material; Impression Trays; Impression material; Impression tray; Indicator, physical/chemical sterilization process; Instrument; Irrigating; Knife Surgical; Kooliner; LED Accessory; LED accessory; Liner; Luxatemp; Mask; Masks; Material impression; Material, Impression; Material, tooth shade, resin; Matrix Bands; Maxcem; Mixing Pad; Mixing Tips; Mixing tips; Mouth Mirrors; NX3; Needle Dental; Nitrile Glove; Non-surgical gown; Occlufast; OptiBond; PAPER, ARTICULATION; Pack; Patient personal hygiene kit; Perio; Pit & FIssure; Pit & Fissure; Plastic bag; Plier; Pliers; Points; Polishing; Porcelain; Positioning Arm; Pouch; Protemp; Relining; RelyX; Retainer; Retraction Cord; Retraction cord; Scissors; Sealant; Sealent; Set-up Tray; Shade Guide; Shade resin; Sterilization; Sterilization Wrap; Structur; Suture; Sutures; Syringe; TRAY, FLUORIDE, DISPOSABLE; TUBING, NONINVASIVE; Temp C&b; Temp crown; Tips; Tooh Shade Reisn; Tooth Bond; Tooth Bonding; Tooth Shade; Tooth bond; Tooth bonding; Tooth shade; Toothbrush; TransBond; Tray Cover; Ultrasonic Cleaning; Ultrasonic Inserts; Universal Flow; Varnish; WHEEL, POLISHING AGENT; Wax; XRay; Z350; accessories; barrier Film; cement dental; coating; cord retraction; crown & Bridge; dental; dental accessory; dental bond; dental cement; dental impression; dental liner; dental lubricant; dental scaler; dental spray; dental varnish; dental xray; endo spreader; handle; indicator; plugger; porcelain; retraction; retractor; sealent; shade; shade resin; tooth bond; tooth bonding; tooth resin; tooth shade; varnish",2026-05-18,227,2025-08-27,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223044819802%22&limit=1
Arrow Internacional de Chihuahua S.A. de C.V.,9680794,3003737899,"Ave. Washington 3701, Interior Circuito Industrial Alta Tecnologia Edificios 2, 4, 36 and 40, Colonia Panamericana",Chihuahua,,CP 31200,Mexico,Arrow International LLC (subsidiary of Teleflex Incorporated,2518433,Contract manufacturer; Exporter to the US; Manufacturer; Repackager or relabeler,113,BSO; BSP; CAZ; DQO; DQX; DQY; DRB; DRF; DRX; DSP; DTL; DXE; DYB; DYG; FCG; FGE; FMF; FMG; FMI; FOZ; FPA; FPB; FRG; FRL; FXX; FYA; FYF; FYH; FZT; GAA; GAB; GAL; GAM; GAP; GAQ; GAR; GAT; GAW; GAX; GBW; GBX; GBZ; GCC; GDT; GDX; GDZ; GEA; GEN; GES; GIM; HRQ; HTD; HXD; ITX; IYO; JDC; JKA; JOL; KDD; KDQ; KGO; KGX; KGZ; KKX; KMK; KNW; KXF; KYX; KYZ; LFJ; LJS; LJT; LKB; LRS; LRW; LWK; LXG; LYU; LZA; MDM; MEG; MPB; MSD; MZY; NAB; NAD; NEC; NFK; NGT; NIE; OBJ; OES; OEZ; OFB; OFC; OFK; OFL; OGE; OWL; PAD; PEZ; PND; POR; POZ; PPO; PUI; PWR; PXB; PXK; PYG; QEZ; QSY; SEL,"Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Anesthesia Conduction Kit; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Stylet, Catheter; Catheter, Electrode Recording, Or Probe, Electrode Recording; Electrode, Electrocardiograph; System, Balloon, Intra-Aortic And Control; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Catheter, Embolectomy; Introducer, Catheter; Catheter, Flow Directed; Biopsy Needle; Stents, Drains And Dilators For The Biliary Ducts; Syringe, Piston; Stopcock, I.V. Set; Needle, Hypodermic, Single Lumen; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Filter, Infusion Line; Wrap, Sterilization; Fiber, Medical, Absorbent; Mask, Surgical; Gown, Surgical; Cap, Surgical; Splint, Extremity, Noninflatable, External, Sterile; Cutter, Surgical; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tourniquet, Nonpneumatic; Catheter, Peritoneal; Catheter, Irrigation; Catheter, Cholangiography; Dilator, Catheter; Staple, Removable (Skin); Scalpel, One-Piece; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Forceps, General & Plastic Surgery; Blade, Scalpel; Tubes, Vacuum Sample, With Anticoagulant; Hemostat; Forceps; Clamp; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; Prosthesis, Elbow, Constrained, Cemented; Tubes, Vials, Systems, Serum Separators, Blood Collection; Catheter And Tip, Suction; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Surgeon'S Gloves; Tape And Bandage, Adhesive; Accessories, Catheter; Drape, Surgical, Antimicrobial; Device, Intravascular Catheter Securement; Instrument, Biopsy; Applicator, Absorbent Tipped, Non-Sterile; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Catheter, Subclavian; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Pad, Alcohol, Device Disinfectant; I.V. Start Kit; Scissors, General, Surgical; Razor, Surgical; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Accessory, Surgical Apparel; Polymer Patient Examination Glove; Instrument, Manual, Surgical, General Use; Syringe, Antistick; Catheter, Hemodialysis, Non-Implanted; Catheter, Hemodialysis, Implanted; Graft, Vascular, Stainless Steel Tunneler; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Occlusive; Bandage, Liquid, Skin Protectant; Kit, Repair, Catheter, Hemodialysis; Saline, Vascular Access Flush; Catheter, Hemodialysis, Triple Lumen, Non-Implanted; Catheter, Ultrasound, Intravascular; Cardiac Catheterization Kit; Cardiovascular Procedure Kit; Catheter Guide Wire Kit; Catheter Introducer Kit; Percutaneous Atrial Catheter Kit; Percutaneous Sheath Introducer Kit; Epidural Anesthesia Kit; Peripheral Catheter Insertion Kit; Chest Drainage Kit; Central Venous Catheter Dressing Change Kit; Midline Catheter; Parenteral Administration Kit; Biopsy Needle Kit; Multi-Lumen Hemodialysis Catheterization Kit; Drape, Surgical, Exempt; Catheter Repair Kit; Percutaneous Introducer Kit; Vascular Access Port Kit; Suction Catheter Kit; Aspiration Thrombectomy Catheter; Hemostatic Wound Dressing Without Thrombin Or Other Biologics; Securement Wound Dressing For Reduction Of Infection",1; 2; U,"'- Arrow PICC Powered by Arrow VPS Stylet; .9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe; 0.9% SODIUM CHLORIDE FLISH SYRINGE; 14 Fr 2-L Hemodialysis Catheters; 2 LUMEN/PSI KIT; 2- Lumen PICC Products w/ Blue Flex; 2-L MAC KIT; 2-Lumen Central Venous Access (MAC); 2L MAC KIT; 3-WAY STOPCOCK; 3M BRAND EAR LOOP FACE MASK, 2000F; 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS; 3M™ Tegaderm™ +Pad Film Dressing with Non-Adherent Pad – Sterile; 6 ML SPECIMEN VIAL WITH CAP; ACCESS KIT; ACCESS TRAY; ACCESSORY KIT; AGB MAC KIT; AGB+ Multi-Lumen CVC Kit; AGB+ Quad Lumen CVC Kit; AGB+ Two-Lumen CVC Kit; AGBA PI JACC KIT; AGBA PI MIDLINE; AGBA PI PICC KIT; AGBA PICC; AGBA PICC KIT; AGBA PICC NaviCurve; AGBA PICC/DELTA; AHDC AGB CURVED KIT; AHDC AGB KIT; AHDC AGB U-BEND KIT; AHDC KIT; AM PICC; AM PICC SET; AM/AT PI MIDLINE; AM/AT PICC; ANGIOCATH & INSYTE AUTOGUARD CATHETERS; ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS; APLICARE ALCOHOL PREP PAD; APLICARE THREE ALCOHOL SWABSTICKS; ARROW INTRA-AORTIC BALL; ARROW PERITONEAL LAVAGE KIT; ARROW Radial Artery Catheterization Set with Integral Needle Protection; ARROW THORACENTESIS KIT; ARROW(R) VPS(R) ACCESS KIT; ARROWg+ard 2-L Access (MAC); ARROWg+ard Blue Plus Multi-Lumen CVC Extreme Kit; ARROWg+ard Blue Plus Multi-Lumen CVC Kit; ARROWg+ard Blue Plus Multi-Lumen CVC Set; ARROWg+ard Blue Plus Multi-Lumen CVC Super Kit; ARROWg+ard Blue Plus Quad-Lumen CVC; ARROWg+ard Blue Plus Quad-Lumen CVC Set; ARROWg+ard Blue Plus Quad-Lumen CVC Super Kit; ARROWg+ard Blue Plus Two-Lumen CVC; ARROWg+ard Blue Plus Two-Lumen CVC Kit; ARROWg+ard Blue Plus Two-Lumen CVC Set; ARROWg+ard Blue Plus Two-Lumen CVC Super Kit; ARROWg+ard CVCs; ARROWg+ard Evolution Antimicrobial Pressure Injectable PICC; ARROWg+ard Hemodialysis Catheters; ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter; ARROW® FlexBlock Continuous Peripheral Nerve Block Kits; ARROW® FlexBlock Continuous Peripheral Nerve Block Sets; ARROW® OnControl® Bone Lesion Biopsy System; Abdominal Paracentesis Kit; Ag+ & Ag+BP Pressure Injectable CVC; Ag+ Blue Plus ML CVCs; Ag+ Quad Lumen CVCs; Ag+ Super ArrowFlex PSIs; Anesthesia Conduct Kit; Antecubital Central Venous Catheterization Kit with Heparin-Coated Catheter; Arrow ""No Leak"" Sheath Adapter with Side Port; Arrow Access Tray; Arrow Berman Catheter, Arrow Berman Angiographic Catheter, Wedge Pressure Catheters and Reverse Berman Catheters; Arrow Catheter Clamp for 5, 6, 7 and 8 Fr. Catheters; Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter; Arrow Central Venous Catheterization Kit; Arrow Continuous Nerve Block Needle; Arrow Continuous Peripheral Nerve Block Kit; Arrow Echogenic Introducer Needle; Arrow Endurance Extended Dwell Peripheral Catherer System; Arrow Endurance Extended Dwell Peripheral Catheter System; Arrow Epidural Anesthesia Kit; Arrow Epidural Catheterization Kit; Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter; Arrow Epidural Catheterization Kit with TheraCath®; Arrow Epidural Catheterization Kit with TheraCath® Catheter; Arrow Epidural Catheterization Kit/Set with FlexTip Plus® Catheter; Arrow Epidural Catheterization Set with FlexTip Plus® Closed Tip Multi-Port Catheter; Arrow Epidural Needle; Arrow Epidural Needle Kit; Arrow FlexBlock Continous Peripheral Nerve Block Kits; Arrow Jugular Puncture Kit; Arrow Large Bore Multi-lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter; Arrow MAC(TM) Two-Lumen Central Venous Access Kit; Arrow MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Nerve Block Prep Tray; Arrow Non-Absorbable Silk Suture; Arrow PICC; Arrow PSI; Arrow Peripherally Inserted Central Catheter; Arrow Peritoneal Lavage Catheterization Kit; Arrow Prep Tray; Arrow Pressure Injectable Central Venous Catheterization Kit; Arrow Pressure Injectable Midline; Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Quickflash Arterial Catheterization Device; Arrow Radial Artery; Arrow Raulerson Syringe; Arrow Seldinger Arterial Catheterization Device; Arrow Select Kits; Arrow SharpsAwayII¿ Locking Disposal Cup; Arrow Simplicity Micro-Introducer Set; Arrow Single Shot Epidural Anesthesia Kit; Arrow SnapLock¿ Clamp Fastener (Bulk Non-Sterile); Arrow Stiffening Stylet; Arrow StimuCath® Continuous Nerve Block Set; Arrow Stimulator Adapter Cable; Arrow TheraCath® Epidural Catheter; Arrow Thoracentesis Kit; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis Set; Arrow Twin-Cath(R) 20/22 Multiple-Lumen Peripheral Catheter; Arrow UserGard(R) Needle-Free Injection Hub; Arrow VPS; Arrow VPS G4; Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS; Arrow(TM) Endurance(TM) Extended Dwell Peripheral Catheter System; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis Set; Arrow-Clark™ VectorFlow™ Antegrade Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Replacement Hub Set; Arrow-Johans ECG Adapter; Arrow-Johans¿ ECG Adapter for Right Atrial Electrocardiography; ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC); Arrowg+ard Blue Advance ™ PICC Kit; Arrowg+ard Blue Advance™ JACC; Arrowg+ard Blue Advance™ Midline; Arrowg+ard Blue Advance™ PICC; Arrowg+ard Blue Advance™ PICC pre-loaded with ARROW® VPS® Stylet; Arrowg+ard Blue Advance™ PICC pre-loaded with Arrow® TipTracker™ Stylet; Arrowg+ard Blue Advance™ PICC pre-loaded with Arrow® VPS Precision™ Stylet; Arrowg+ard Blue Advance™ PICC with 130 cm Hydrophilic-Coated Nitinol Guidewire; Arrowg+ard Blue Advance™ PICC with 80 cm Hydrophilic-Coated Nitinol Guidewire; Arrow™ OnControl™ Powered Bone Access System; Arrow™Temporary Pacing Catheters and Kits; Arrow® 10 mL Luer-Slip Loss of Resistance Syringe; Arrow® 5 mL Luer-Slip Loss of Resistance Syringe; Arrow® Access Tray; Arrow® Arterial Catheterization Set; Arrow® Berman Catheter Kit; Arrow® Continuous Epidural Needle; Arrow® Continuous Nerve Block Kit; Arrow® Continuous Nerve Block Set; Arrow® Emergency Infusion Device - EID¿; Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter; Arrow® Epidural Needle; Arrow® MultiPolar Electrode Catheter; Arrow® MultiPolar Electrode Catheter; Arrow® MultiPolar Mapping/Pacing Catheter; Arrow® MultiPolar Mapping/Pacing Catheter; Arrow® Nitinol Wire; Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath; Arrow® Sheath Adapter with Cath-Gard® Catheter Contamination Shield; Arrow® SnapLock™ Catheter/Syringe Adapter; Arrow® Thermodilution Catheter Kit; Arrow® Thermodilution Catheters; Arrow® TransRadial Arterial Access Device; Arrow® TransRadial Artery Access Kit; Arrow® Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set; Arrow® Wedge Pressure Catheter Kit; Art./Venous Cath Set; Arterial Access Tray; Arterial Cath Kit; Arterial Catheter; Arterial Catheter Kit; Arterial Catheterization Kit; Arterial Line Kit; AutoCAT®2 Intra-Aortic Balloon Pump (IABP); AutoCAT®2 Series; AutoCAT®2WAVE Intra-Aortic Balloon Pump (IABP); BD Angiocath IV Catheter, BD Insyte IV Catheter; BD ECLIPSE HYPODERMIC NEEDLE; BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY; BD Eclipse Hypodermic Needle; BD Piston Syringes; BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE; BLOOD COLLECTION TUBE, LAVENDER; Balloon Thermodilution Catheter; Bandage, Liquid, Skin Protectant; Becton Dickinson Syringe; Blade Cutter; CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC; CG+ Arrow PICC Powered by Arrow VPS Stylet; CG+ PICC; CG+ PICC SET; CVC KIT; CVC Kit; CVC SET; CVC/PSI KIT; Cannon Hemodialysis Catheter; Cannon II Plus; Cannon II Plus Replacement Hub Set; Cannon II Plus; Edge; CathGuard; Catheter Clamp with Fastener; Catheter Dilator; Catheter Hemodialysis; Clamp; Continuous Epidural Anesthesia Kits; DALE BENDABLE ARMBOARD; DRAPE; Drape; Drape surgical; Drape, Surgical; Drape, surgical; Dressing commercial; EF-05510N: FILTER COMPONENT NRFit GVS; EMERGENCY INFUSION DEVICE; EXT. LINE SLIDE CLAMP; EZ-IO Single-Use Procedure Trays; Echogenic Introducer Needle; Echogenic Introducer needle; Edge; Elcam Stopcock; Electrode, Electrocardigraph; Embolectomy Catheter; Emergency Infusion Device; Epidural Catheterization Kit; Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature; Extension Tubing; FIBEROPTIX®; Fiber Optic System (FOS); FiberOptix® IAB Catheter,; FiberOptix® Intra-Aortic Balloon Catheter Kit; Filter Needle; FlexTip Plus & Accessories; FlexTip Plus Combined Spinal Epidural Catheterization Kit; FlexTip Plus Epidural Catheter; FlexTip Plus Epidural Catheterization Kit; FlexTip Plus(R) Epidural Catheterization Kit for Lumbar Placement; FlexTip Plus® Combined Spinal Epidural Catheterizaiton Kit; FlexTip Plus® Epidural Catheterization Kit; FlexTip Plus® Epidural Catheterization Kit for Caudal Placement; Foosin Silk Suture; Forceps; GAUZE PADS; GLIDETHRU; GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING; Gertie Marx; Guide Wire - Lake Region; HEIMLICH VALVE COMMERCIAL; HEMODIALYSIS KIT; HEMODIALYSIS SET; HEMOSTAT; Hands-off Thermodilution Catheters; Hemodialysis (Acute) Products; High Flow Fluid Administration Set; Hypodermic Needle and Syringe; Hypodermic single lumen needle; INTERLINK(TM) INJECTION SITE; INTRAVENOUS SET; INTROCAN SAFETY IV CATHETER; INTRODUCER & INJECTION NEEDLES; Infusion Port Thermodilution; Internal Jugular; Internal Jugular Kit; Intra-Aortic Balloon (IAB) Catheter; Intra-Aortic Balloon Catheter, Ultra 8®; Intravascular catheter securement; Introcan@S afetyTMIV Catheter; Introducer Dilator; Introducer, Catheter; KDL SYRINGES AND NEEDLE; LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS; LARGE BORE SPLITTABLE INTRODUCER KIT; LBCVC AGB KIT; LBCVC KIT; LOR Syringe; Large Bore Multi-Lumen CVCs; Liver Biopsy Kit; Loss of Resistance Syringe; M-L CVC w/BlueFlex Tip; MAC KIT; MAC SEMI KIT; MAC SET; MAC TWO LUMEN/PSI KIT; MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD; MIDLINE CATHETER KIT; MIDLINE CATHETERS; MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA; MULTI LUMEN CVC KIT; MULTI-LUMEN/PSI KIT; MULTILUMEN CVC KIT; MULTILUMEN PI CVC KIT; MULTILUMEN/MAC KIT; MULTILUMEN/PSI KIT; Mandrel Guidewire; Mandrel Guidewires; Marked Spring-Wire Guide with Arrow Advancer; Metz Offset Scissors; Micro Introducer Set; Multi-Lumen CVC; Multiple; Multiple General Use; N/A; NEEDLE COMM STRAIGHT; NEW HYDROPHILIC COATING FOR WIRE GUIDES; NITRILE POWDER-FREE EXAMINATION GLOVES; NarrowFlex® Intra-Aortic Balloon (IAB) Catheter; NarrowFlex® Intra-Aortic Balloon (IAB) System; NaviCurve Stylet; Needle; Needle Safety Glide; Needle, Hypodermic, Single Lumen; NextStep Antegrade; NextStep Retrograde; NextStep Retrograde (femoral lengths); NextStep Retrograde Replacement Hub Set; OnControl Bone Access System; OnControl Bone Marrow Biopsy System; Oxygenator, Cardiopulmonary Bypass; PERCUTANEOUS CAVITY DRAI; PERCUTANEOUS SHEATH INTRODUCER; PERITONEAL LAVAGE CATH KIT; PI AGBA PICC KIT; PI CATHETER; PI CG+ PICC SET; PI CVC KIT; PI CVC KIT AGB+; PI CVC SET; PI JACC KIT; PI MIDLINE; PI MULTI LUMEN CVC; PI PICC; PI PICC KIT; PI PICC NaviCurve; PICC; PICC ACCESS TRAY; PICC KIT; PICC SET; PICC v2; PICC with Chlorag+ard Technology; PREP KIT; PREP TRAY; PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS; PSI ACCESS TRAY; PSI KIT; PSI KIT/AGB CVC KIT; PSI SEMI KIT; PSI SET; PSI/CVC KIT; Pediatric 2-L Hemodialysis Catheter; Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter; Percutaneous Cavity DRAI; Percutaneous Cavity Drainage Catheterization Set/Kit; Percutaneous Cavity Drainage Catheterization Set/Kit; Percutaneous Sheath Introducers; Peripherally Inserted Central Catheter; Peripherally Inserted central catheter (PICC) with Blue; Peripherally inserted central catheter (PICC) Product with Blue Flex Tip and integral needle protection; Pneumothorax Kit; Pneumothorax Set; Pneumothorax kit w/Sutures; Praxiject™ 0.9% NaCl; Predicate III Guidewire; Preox LOR Syringe; Pressure Injectable PICC; Pressure Injectable Peripherally Inserted Catheter; Pronto LP Extraction Catheter; Puncture Kit, Disposable Vein; QUAD LUMEN PI CVC KIT; RA Cath Kit; RA Catheter w/Integral Ndl Protect; Radial Artery Catheter; Radiopaque polyurethane multi-lumen indwelling catheter with heparing coating; Raulerson Syringe; Razor commercial; RediGuard IABs; RediGuard® Intra-Aortic Balloon Catheter; RediGuard® Intra-Aortic Balloon System; S-02200-010: FILTER COMM: .2 MICRON FLAT, GVS; S-02200-010N: FILTER COMM: 0.2. MICRON FLAT NRFit, GVS; SCALPEL COMMERCIAL; SLIC; STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES; STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK; SUR Betha Sheet Holder; SURGICAL APPAREL CAP; SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLES; SWG; SharpsAway Needle Disposal Cups; Sheath Adapter; Silk Suture; Single Lumen CVCs; Single Shot Epidural; Single Shot Epidural Anesthesia Kit; SnapLock™ Clamp Fastener; Specimen Container; Spinal Needle; Sponge; Spring Wire Guide; Spring Wire Guide Component; Sprotte; Staple Anchoring Device; StimuCath (19 Ga); StimuCath PNB Catheter; Stopcock; Super Arrow-Flex® Percutaneous Sheath Introducer Set; Super ArrowFlex PSIs; Surgical Apparel Gown; Surgical Gown SMS with PE Layer; Surgical apparel glove; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, non absorbable-silk; Syringe; TERUMO® SURFLO®0 IX. Catheter; TIPTRACKER STYLET ACCESSORY PACK; TOURNIQUET COMMERCIAL; TRANSDUCER COVER; TRAUMA KIT; TRAUMA SET; TROCAR; Tearaway Introducer Sheath, MicroSlide Tearaway Introducer; The INT STOPPER; TipTracker Stylet; Tissue Dilator; Transduction probe; Transseptal Super ArrowFlex PSI; Trauma Kit; TwinCath Intravenous Catheters; Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter; Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter,; ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN; USER-GARD NEEDLESS INJECTION HUB; Ultra 8® Intra-Aortic Balloon (IAB) Catheter; Ultra 8® Intra-Aortic Balloon (IAB) System; UltraCath Continuous Nerve Block Catheter; UltraCath Continuous Nerve Block Kit; UltraFlex® Intra-Aortic Balloon (IAB) Catheter,; UltraFlex® Intra-Aortic Balloon (IAB) System; Ultrasound Gel; VANISHPOINT SYRINGE; VASCUPUNCTURE PICC GUIDEWIRE; VESSEL CATH KIT; VPS RHYTHM; VPS Rhythm DLX Device with TipTracker Technology; Vascular Positioning System¿ (VPS¿) Stylet; VectorFlow Antegrade Chronic Hemodialysis Catheter; VectorFlow Retrograde Chronic Hemodialysis Catheter; VectorFlow Retrograde Replacement Hub Set; Vessel catheterization Kit/Set; Walrus Multi-Lumen Intravenous Infu; Walrus Spring Wire Guides; Walrus embolectomy catheter; You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; You-Bend Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter; cutter surgical; instrument forceps; none; not applicable; tunneling instrument; wrap, sterilization; wrap, sterilzation",1995-02-02,226,2025-03-14,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229680794%22&limit=1
"Medtronic Puerto Rico Operations Co., Humacao",2647346,2647346,"Road 909, KM. 0.4. Barrio Mariana",Humacao,PR,00792,United States,"Medtronic, Inc.",2112641,Manufacturer,45,ERL; EZX; FSZ; FZT; GAD; HBB; HBC; HBE; HRS; HRX; HSZ; HTW; HWC; HWE; HWT; HXC; HXP; HXW; KIH; KWP; KWQ; LRN; LXH; MAX; MJO; MNH; MNI; MQP; MQV; MRW; NBH; NDN; NEK; NKB; NKG; NQP; NQW; ODP; OLO; OSH; OUR; OVD; OVE; PGM; PML,"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Mesh, Surgical, Metal; Light, Surgical, Carrier; Cutter, Surgical; Retractor; Motor, Drill, Pneumatic; Motor, Drill, Electric; Drills, Burrs, Trephines & Accessories (Simple, Powered); Plate, Fixation, Bone; Arthroscope; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Bit, Drill; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Template; Wrench; Instrument, Bending Or Contouring; Bender; Dispenser, Cement; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Wire, Surgical; Orthopedic Manual Surgical Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Posterior Metal/Polymer Spinal System, Fusion; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Growing Rod System; Bone Cement, Posterior Screw Augmentation",1; 2; 3; U,"ACPii Atlantis Cervial Plate; ANTERIOR CERVICAL PLATE SYSTEM; ARTHROSCOPE; ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS"" Anterior Cervical Plate System; ATLANTIS- Anterior Cervical Plate System; Atlantis Translational Plate; Atlantis Vision Anterior Cervical; Atlas Cable; BIT DRILLS; Bone Graft Washer; CAPSTONE CONTROL PTC Spinal System; CAPSTONE CONTROL Spinal System; CAPSTONE PTC SPINAL SYSTEM; CAPSTONE PTC™ SPINAL SYSTEM; CAPSTONE Spinal System; CCD Spine System; CD 4.5 Crosslink Plates; CD 5.5mm Set Screws; CD Cannulated Screw; CD Central Rod; CD Cobalt Chrome; CD HA Coated; CD HORIZON; CD HORIZON ESSENCE; CD HORIZON ESSENTIALS™ Spinal System; CD HORIZON Fenestrated Screw Set; CD HORIZON Growth Rod Conversion Set; CD HORIZON Longitude 2 Instruments and Rods; CD HORIZON Multiaxial screw; CD HORIZON SOLERA SPINAL SYSTEM; CD HORIZON SOLERA Spinal System; CD HORIZON SOLERA""; CD HORIZON SPINAL SYSTEM; CD HORIZON SPIRE(TM) Z Spinal System; CD HORIZON Solera 5.5/6; CD HORIZON Spinal System; CD HORIZON Spinal System SDS Pre-Bent Rods; CD HORIZON Spinal System SOLERA; CD HORIZON Spinal System, CD HORIZON ESSENTIALS"" Spinal System; CD HORIZON(R) Spinal System; CD HORIZONSPINAL SYSTEM; CD HORIZONSpinal System; CD HORIZON™ Spinal System; CD HORIZON® Fenestrated Screw Set; CD HORIZON® SOLERA® Spinal System; CD HORIZON® Spinal System; CD Horizan Eclipse M8 Screws; CD Horizan M8 Screws; CD Horizon 3.2/4.5 Connectors; CD Horizon 3.5 Rods; CD Horizon 6.35 Crosslink Plates; CD Horizon Advanta; CD Horizon Antares Spinal System; CD Horizon Eclipse; CD Horizon Ilio Sacral; CD Horizon Legacy 4.5; CD Horizon Legacy 6.35 Ti; CD Horizon M8 M10 Reduction Hooks; CD Horizon MAS Design Enhancement; CD Horizon Minor Mod; CD Horizon ModuLeX Spinal System - Degen Scoli Phase 2; CD Horizon Set Screws; CD Horizon Solera 5.5/6 Sagittal Adjusting Screws; CD Horizon Solera HA Screws; CD Horizon Spinal System; CD Horizon Spinous Plate; CD Horizon TAH Pedicle Hooks; CD Horizon- Spinal System; CD Horizon-Spinal System/ CD Horizon SOLERA; CD HorizonSpinal System; CD Horizon™ Astute™ Spinal System; CD Horizon™ ModuLeX™ FNS Screw Set; CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System; CD Horizon™ Modular 5.5/6mm Spinal System; CD Horizon™ Spinal System; CD Horizon® Spinal System; CD Ilio Sacral Screws; CD Modified Set Screws; CD Perc Trauma; CD Spire Spikes; CD Staples and Screws; CDH Legacy 5.5; CDH Solera 4.75; CEMENT; CLYDESDALE Spinal System; COLORADO 2 Spinal Sys 6.35 Rods and; COLORADO 2 Spinal System; COLORADO II Spinal System SS; COLORADO II Spinal System Ti; CORNERSTONE PSR Cervical Fusion System; CORNERSTONEPSR Spinal System; CRESCENT™ SPINAL SYSTEM; CRESCENT™ SPINAL SYSTEM TITANIUM; Capstone Control; Capstone Spinal System; Catalyft™ PL Expandable Interbody System; Centerpiece Plate Fixation System; Clydesdale Spinal System; Crescent Spinal System Interbody F; DIVERGENCE Anterior Cervical Fusion System; DIVERGENCE(TM) Anterior Cervical Fusion System; DIVERGENCE-L"" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM; DRILL BIT (ORTHOPEDIC MA; Danek Unit Rod; Drill; Introducer Tool; Dyan-Lok Anterior Posterior Plating; Dyna-Lok Plate and Screw; Dyna-Lok Ti Spinal System; ELEVATE"" Spinal System; ELEVATE™ SPINAL SYSTEM; Galaky Spinal system; General Instrument; General Instruments; INFINITY™ OCT System; INFUSE BONEGRAFT/ LT-CAGE Lumbar TF; KYPHON Cement Delivery System; KyphX Bone Filler Device; Kyphon HV-R Fenestrated Screw Cement; LAMINOPLASTY; Legacy 6.35 SS; MAST QUADRANT™ Retractor System; MASTERGRAFT PUTTY; METRx Endoscope; METRx Microscope; MICRO-FRANCE; MR8 Drill System; MSB PYRAMESH® Implant System; MULTIPLE TWIST; Medtronic Reusable Instrument; Midas Rex Legend Pneumatic System; Midas Rex MR8 ClearView Tools; Multi Axial Screw System; ORION Anterior Cervical; Orfil Spine Fixation system; Orion Anterior Cervical Plate; PASS LP Spinal System; PEEK Prevail Cervical Interbody Dev; PEEK Previal Cervical Interbody Dev; PERIMETER Interbody Fusion Device; PIVOX"" Oblique Lateral Spinal System; PLATE; PRESTIGE LP Cervical Disc System; PYRAMID +4 Anterior Lumbar Plate S; Peek Rod; Premier Anterior Cervical Plate; Pyramesh C; Pyramesh Implant System; Pyramid +4 Anterior Lumbar Plate; RETRACTOR; RIALTO"" SI FUSION SYSTEM; ROD BENDER; RadiaLux™; SOVEREIGN Spinal System; SPINE; Sovereign; Spacekeeper; Spinal System; T2 Sinal System; T2 TXVBR; TEMPLATE; TENOR SPINAL SYSDYNA-LOK PLUS Plate; TSRH; TSRH 3D Connectors; TSRH 3Dx 90 Degree Offset Connector; TSRH CROSSLINK Axial and Offset Pl; TSRH Chromaloy Plus Precut Contoured Rods; TSRH Cobalt Chrome Rods; TSRH Crosslink System; TSRH Expanded Pedicle Screw; TSRH Hook Holder; TSRH Osteogrip; TSRH Sentry Anterior/Posterior Spin; TSRH Silo; TSRH Spinal System; TSRH Spinal System 3D Connectors an; TSRH Spinal System Anterior L Plate; TSRH Spinal System MPA Screws; TSRH Spinal System Prebent/precut r; TSRH Spinal system Crosslink Plates; TSRH TC 3D MPA Screw; TSRH TC Splined Connectors & Screws; Tenor Spinal System; Thoracolumbosacral pedicle screw system; Timesh System; Titanium GDLH Posterior Spinal Syst; Townley Pedicle Screw; Townley Transfacetpedicular Screw; Transverse Oct Spinal Fixation; Transverse Spinal Fixation; UCSS Non-Cannulated; VENTURE™ Anterior Cervical Plate System; VERTEBROPLASTY; VERTEX; VERTEX Reconstruction System; VERTEX SELECT Reconstruction System; VERTEX® Reconstruction System; Vantage Bolts; Vantage Plates; Venture Cervical Plate; Verte-Stack Capstone Peek; Verte-Stack Cornerstone Sm End Caps; Verte-Stack Crescent; Verte-Stack Modified Center Piece; Verte-Stack Modified Cornerstone; Verte-Stack Perimeter Peek; Verte-Stack T-Peek; Verte-Stack XS; Vertex Adjustable Plate; Vertex Cannulated Screw; Vertex Crosslinks; Vertex Keel Plate; Vertex Lateral Connectors; Vertex Max; Vertex OC MAS, Rods, Hooks; Vertex Occipital Components; Vertex Reconstruction Occipital; Vertex Reconstruction System; WRENCH; ZEVO Anterior Cervical Plate System; ZPlate II; Zephir Anterior Cervical Plate; Zephir Anterior Cervical Plate System; mastergraft; spinal system",1992-12-12,224,2026-04-21,2,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222647346%22&limit=1
STRYKER GmbH,8031020,3002807830,Bohnackerweg 1,SELZACH Solothurn,,2545,Switzerland,STRYKER CORP.,1811755,Complaint file establishment; Contract manufacturer; Manufacturer; Specification developer,61,FSM; FTD; FZX; FZY; GAD; GAH; GDX; GFA; HAW; HBE; HRS; HSB; HSD; HTC; HTD; HTE; HTJ; HTN; HTQ; HTT; HTW; HTY; HWB; HWC; HWD; HWE; HWJ; HWQ; HWT; HWW; HWX; HXD; HXI; HXW; HXX; IPG; IQI; JDB; JDQ; JDR; JDW; JEC; JWJ; KQZ; KTT; KTW; KWG; KWI; KWS; KXE; LRN; LRP; LXH; LXT; LYS; NBH; NTG; OJH; OLO; OUR; PHX,"Tray, Surgical, Instrument; Lamp, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Stylet, Surgical, General & Plastic Surgery; Scalpel, One-Piece; Blade, Saw, General & Plastic Surgery, Surgical; Neurological Stereotaxic Instrument; Drills, Burrs, Trephines & Accessories (Simple, Powered); Plate, Fixation, Bone; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Pliers, Surgical; Forceps; Elevator; Gauge, Depth; Washer, Bolt Nut; Broach; Burr, Orthopedic; Bit, Drill; Pin, Fixation, Smooth; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Passer; Template; Countersink; Tap, Bone; Clamp; Passer, Wire, Orthopedic; Bender; Screwdriver; Shoe, Cast; Orthosis, Limb Brace; Prosthesis, Elbow, Semi-Constrained, Cemented; Cerclage, Fixation; Staple, Fixation, Bone; Pin, Fixation, Threaded; Component, Traction, Invasive; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained; Component, Traction, Non-Invasive; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Prosthesis, Finger, Constrained, Metal/Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Wrist, Hemi-, Ulnar; Wire, Surgical; Tray, Surgical; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Bone Mill; Accessories, Arthroscopic; Prosthesis, Ankle, Uncemented, Non-Constrained; Orthopedic Tray; Orthopedic Stereotaxic Instrument; Sacroiliac Joint Fixation; Shoulder Prosthesis, Reverse Configuration",1; 2; 3,"045 IN. (1.143mm) K-WIRE W/LENGTH MARKINGS; 1.2X10mm BONE SCREWSCROSSPINSELFT; 1.2X12mm BONE SCREWSCROSSPINSELFT; 1.2X14mm BONE SCREWSCROSSPINSELFT; 1.2X16mm BONE SCREWSCROSSPINSELFT; 1.2X18mm BONE SCREWSCROSSPINSELFT; 1.2X20mm BONE SCREWSCROSSPINSELFT; 1.2X4mm BONE SCREWSCROSSPINSELFT; 1.2X5mm BONE SCREWSCROSSPINSELFT; 1.2X6mm BONE SCREWSCROSSPINSELFT; 1.2X7mm BONE SCREWSCROSSPINSELFT; 1.2X8mm BONE SCREWSCROSSPINSELFT; 1.2X9mm BONE SCREWSCROSSPINSELFT; 1.3MM X 35.6CM NITINOL GUIDE WIRE; 1.4X3mm EMERG SCREWSCROSSPINSELFT; 1.4X5mm EMERG SCREWSCROSSPINSELFT; 1.4X7mm EMERG SCREWSCROSSPINSELFT; 1.4X9mm EMERG SCREWSCROSSPINSELFT; 1.7 S PROFYLE HAND LOCK 3-D PLATE,2X2+2H; 1.7 S PROFYLE HAND LOCK 3-D PLATE,2X2H; 1.7 S PROFYLE HAND LOCK 3-D PLATE,3X2H; 1.7 S PROFYLE HAND LOCK 3-D PLATE,4X2H; 1.7 S PROFYLE HAND LOCK 3-D REPL PL,4X2H; 1.7 S PROFYLE HAND LOCK L-PLATE,LE,6H; 1.7 S PROFYLE HAND LOCK L-PLATE,RI,6H; 1.7 S PROFYLE HAND LOCK PLATE,STRAI,16H; 1.7 S PROFYLE HAND LOCK PLATE,STRAI,4H; 1.7 S PROFYLE HAND LOCK ROTATION PLATE,5H; 1.7 S PROFYLE HAND LOCK T-PLATE,NAR,10H; 1.7 S PROFYLE HAND LOCK T-PLATE,NAR,6H; 1.7 S PROFYLE HAND LOCK T-PLATE,REG,7H; 1.7 S PROFYLE HAND LOCK T-PLATE,WIDE,8H; 1.7 S PROFYLE HAND LOCK Z-PLATE,NAR,9H; 1.7 S VARIAX HAND LOCK ROTATION PLATE,5H; 1.7X10MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X10mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X11MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X11mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X12MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X12mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X13MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X13mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X14MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X14mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X15MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X15mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X16MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X16mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X18MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X18mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X20MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X20mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X22MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X22mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X24MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X24mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X5MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X5mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X6MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X6mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X7MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X7mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X8MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X8mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X9MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X9mm BONE SCREWSCROSSPINSELFTAPPING; 1.9MM OBTURATOR; 1.9MM SPEEDLOCK PENCIL TIP OBTURATOR; 1.9MM TROCAR; 1.9X10mm EMERG SCREWSCROSSPINSELFT; 1.9X12mm EMERG SCREWSCROSSPINSELFT; 1.9X5mm EMERG SCREWSCROSSPINSELFT; 1.9X8mm EMERG SCREWSCROSSPINSELFT; 1/1 Size silicon mat; 1/2 size silocon mat; 100MM DRAIN CANNULA; 10MM DRAIN CANNULA; 10mm SUBFIX TRIAL; 11.5mm SUBFIX TRIAL; 135 mm Reusable Slat, SE Retr, 10 Pack; 155 mm Reusable Slat, SE Retr, 10 Pack; 175mm Reusable Slat, SE Retr, 10 Pack; 2 mm  ASNIS MICRO CANNULATED SCREW 10/4 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 11/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 12/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 13/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 14/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 15/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 16/7 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 17/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 17/8 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 18/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 18/8 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 19/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 19/9 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 20/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 20/9 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 22/10 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 22/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 24/10 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 24/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 26/12 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 26/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 28/12 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 28/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 30/14 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 30/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 8/4 mm STERILE; 2 mm  ASNIS MICRO WASHER 2mm STERILE; 2 mm  ASNIS MICRO, CANNULATED SCREW, 10/4 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 11/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 12/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 13/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 14/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 15/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 16/7 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 17/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 17/8 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 18/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 18/8 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 19/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 19/9 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 20/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 20/9 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 22/10 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 22/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 24/10 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 24/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 26/12 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 26/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 28/12 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 28/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 30/14 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 30/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 8/4 mm; 2 mm  ASNIS MICRO, WASHER 2mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 16mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 18mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 20mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 22mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 24mm; 2-0 Knot Pusher/Suture Cutter; 2.1MM BLUNT NOSE DOWN ASSY; 2.1MM BLUNT NOSE LEFT ASSY; 2.1MM BLUNT NOSE RIGHT ASSY; 2.1MM BLUNT NOSE STRAIGHT ASSY; 2.1MM BLUNT NOSE UP ASSY; 2.3 L PROFYLE HAND ROTATION PLATE,5H; 2.3 M PROFYLE HAND LOCK 3-D PLATE,2X2+2H; 2.3 M PROFYLE HAND LOCK 3-D PLATE,2X2H; 2.3 M PROFYLE HAND LOCK 3-D PLATE,3X2H; 2.3 M PROFYLE HAND LOCK 3-D PLATE,4X2H; 2.3 M PROFYLE HAND LOCK 3-D REPL PL,4X2H; 2.3 M PROFYLE HAND LOCK L-PLATE,LE,6H; 2.3 M PROFYLE HAND LOCK L-PLATE,RI,6H; 2.3 M PROFYLE HAND LOCK LE MC V PLATE,5H; 2.3 M PROFYLE HAND LOCK PLATE STRAIGHT BAR 4H; 2.3 M PROFYLE HAND LOCK PLATE,STRAI,16H; 2.3 M PROFYLE HAND LOCK PLATE,STRAI,4H; 2.3 M PROFYLE HAND LOCK RI MC V PLATE,5H; 2.3 M PROFYLE HAND LOCK ROTATION PLATE,5H; 2.3 M PROFYLE HAND LOCK T-PLATE,NAR,6H; 2.3 M PROFYLE HAND LOCK T-PLATE,REG,7H; 2.3 M PROFYLE HAND LOCK T-PLATE,WIDE,8H; 2.3 M PROFYLE HAND LOCK Y-PLATE,NAR,7H; 2.3 M PROFYLE HAND LOCK Z-PLATE,NAR,13H; 2.3 M PROFYLE HAND ROTATION PLATE,5H; 2.3 M VARIAX HAND LOCK ROTATION PLATE,5H; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 10mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 12mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 14mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 28mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 30mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 32mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 34mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 36mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 38mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 10mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 12mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 14mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 28mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 30mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 32mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 34mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 36mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 38mm; 2.3MM  OBTURATOR; 2.3MM AUTOCLAVABLE BLUNT TIP OBTURATOR WITH SPEED-LOCK; 2.3MM AUTOCLAVABLE PENCIL TIP OBTURATOR WITH SPEED-LOCK; 2.3MM AUTOCLAVABLE TROCAR FOR 2.9MM CANNULA WITH SPEED-LOCK; 2.3MM TROCAR; 2.3X10MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X10mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X11MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X11mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X12MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X12mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X13mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X13mm LOCKING SCREWSCROSSPINSELFT; 2.3X14MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X14mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X15MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X15mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X16MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X16mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X18MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X18mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X20MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X20mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X22MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X22mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X24MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X24mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X26MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X26mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X6MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X6mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X8MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X8mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X9MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X9mm BONE SCREWSCROSSPINSELFTAPPING; 2.5MM GRASPER ASSY; 2.5MM SCISSORS ASSY; 2.5X10mm EMERG SCREWSCROSSPINSELFT; 2.5X12mm EMERG SCREWSCROSSPINSELFT; 2.5X6mm EMERG SCREWSCROSSPINSELFT; 2.5X8mm EMERG SCREWSCROSSPINSELFT; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 10mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 12mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 14mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 16mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 18mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 20mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 22mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 24mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 26mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 10mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 12mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 14mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 2.7MM BLUNT NOSE STRAIGHT ASSY; 2.7MM BLUNT NOSE UP ASSY; 2.7MM NORROW PUNCH; 2.7MM OBTURATOR; 2.7MM SCOPE BRIDGE; 2.7MM SPEEDLOCK PENCIL TIP OBTURATOR; 2.7MM TROCAR; 2.8MM  TWO ROTATING STOPCOCKS; 2.8MM CANNULA WITH 1 FIXED STOPCOCK; 2.8MM CANNULA WITH 1 ROTATING STOPCOCK; 2.8MM CANNULA WITH 2 ROTATING STOPCOCKS; 2.9MM AUTOCLAVABLE CANNULA, 1 ROTATING STOPCOCK W/SPEEDLOCK; 2.9MM CANNULA WITH 1 ROTATING STOPCOCK; 206-716 w/2 small sculps/pkg; 234-112-100 VersiQuad Halo Retractor; 266-719-000 PKG, WESSINGER ROD (SMALL); 266-720-000 PKG, WISSINGER ROD (LARGE); 266-721-000 PKG. WISSINGER HANDLE, SE3; 3 mm  ASNIS MICRO CANNULATED SCREW 10/4 mm  STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 11/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 12/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 13/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 14/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 14/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 15/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 15/7 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 16/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 16/7 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 17/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 17/8 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 18/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 18/8 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 19/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 19/9 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 20/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 20/9 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 21/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 21/9 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 22/10 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 22/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 23/10 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 23/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 24/10 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 24/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 25/10 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 25/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 26/12 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 26/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 27/12 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 27/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 28/12 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 28/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 29/12 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 29/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 30/14 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 30/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 32/14 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 32/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 34/16 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 34/7 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 36/16 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 36/7 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 38/18 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 38/8 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 40/18 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 40/8 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 8/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 9/4 mm STERILE; 3 mm  ASNIS MICRO WASHER 3mm STERILE; 3 mm  ASNIS MICRO, CANNULATED SCREW, 10/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 11/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 12/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 13/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 14/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 14/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 15/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 15/7 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 16/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 16/7 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 17/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 17/8 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 18/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 18/8 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 19/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 19/9 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 20/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 20/9 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 21/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 21/9 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 22/10 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 22/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 23/10 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 23/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 24/10 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 24/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 25/10 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 25/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 26/12 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 26/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 27/12 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 27/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 28/12 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 28/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 29/12 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 29/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 30/14 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 30/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 32/14 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 32/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 34/16 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 34/7 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 36/16 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 36/7 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 38/18 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 38/8 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 40/18 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 40/8 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 8/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 9/4 mm; 3 mm  ASNIS MICRO, WASHER 3mm; 3-D PLATE LEFT; 3-D PLATE RIGHT; 3.2MM CANNULA WITH 1 FIXED STOPCOCK; 3.2MM CANNULA WITH 1 ROTATING STOPCOCK; 3.2MM CANNULA WITH 2 FIXED STOPCOCKS; 3.2MM SPEEDLOCK PENCIL TIP OBTURATOR; 3.2mmX14mm TWINFIX COMP. SCREW; 3.2mmX16mm TWINFIX COMP. SCREW; 3.2mmX18mm TWINFIX COMP. SCREW; 3.2mmX20mm TWINFIX COMP. SCREW; 3.2mmX21mm TWINFIX COMP. SCREW; 3.2mmX22mm TWINFIX COMP. SCREW; 3.2mmX23mm TWINFIX COMP. SCREW; 3.2mmX24mm TWINFIX COMP. SCREW; 3.2mmX25mm TWINFIX COMP. SCREW; 3.2mmX26mm TWINFIX COMP. SCREW; 3.2mmX27mm TWINFIX COMP. SCREW; 3.2mmX28mm TWINFIX COMP. SCREW; 3.2mmX30mm TWINFIX COMP. SCREW; 3.2mmX32mm TWINFIX COMP. SCREW; 3.2mmX34mm TWINFIX COMP. SCREW; 3.4MM 30 LEFT MENISCAL PUNCH; 3.4MM 30 RIGHT MENISCAL PUNCH; 3.4MM HIP GRASPER; 3.4MM HIP PUNCH - STRAIGHT; 3.4MM LOOSEBODY GRASPER W/ RATCHET; 3.4MM NARROW PUNCH-15° UP; 3.4MM NORROW PUNCH; 3.5MM FORMULA SERIES, SMALL JOINT CUTTER CANNULA; 3.5MM SWITCHING STICK; 3.9mm Omega Drill; 3.9mm Omega Tap; 3.9mm Omega and 4.75mm AlphaVent Awl; 3910-500-582, ICONIX DC Guide for 2.3mm anchor; 3910-500-583, ICONIX DC Obturator for 2.3mm anchor; 3MM DBL SLEEVE 80MM TROC/ASSY; 3mm PREDRILL ASSEMBLY LONG; 3mm PREDRILL ASSEMBLY SHORT; 4.4MM HIP OBTURATOR CANNULATED; 4.4MM HIP TROCAR CANNULATED; 4.6 X 200 MM CANNULA, 1 FIXED STOPCOCK; 4.6 X 200 MM CANNULA, 1 FIXED STOPCOCK, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK; 4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS AT 95°; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS AT 95°, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS AT 95°; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS AT 95°, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS, NO DISTAL HOLES; 4.75mm AlphaVent Punch Tap; 4.75mm AlphaVent Tap; 4.75mm AlphaVent and Omega Awl; 4.75mm AlphaVent and Omega Drill; 4.75mm Omega Tap; 4Fusion; 4MM CANNULA WITH 1 ROTATING STOPCOCK; 4MM CANNULA WITH 2 FIXED STOPCOCKS; 4MM CANNULA WITH 2 ROTATING STOPCOCKS; 4MM CANNULATED SWITCHING STICK; 4MM DBL SLVE 180MM TROC/ASSY; 4MM X 24 SWITCHING STICK; 4MM, 30 HIP ARTHOSCOPE (HIPSCOPE); 4mm DBL SLEEVE 150mm TROC/ASSY; 4mm PREDRILL ASSEMBLY EXTRA SHORT; 4mm PREDRILL ASSEMBLY LONG; 4mm PREDRILL ASSEMBLY SHORT; 4mm TomCat Shaver Blades; 5.5MM CANNULATED SWITCHING STICK; 5.5MM SLOTTED CANNULA; 5.5mm AlphaVent Tap; 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill; 5.8 CANNULA, 2 ROTATING STOPCOCKS FOR 4MM LONG ARTHROSCOPE; 5.8MM CANNULA, 1 FIXED STOPCOCK; 5.8MM CANNULA, 2 FIXED STOPCOCKS; 5.8MM CANNULA, 2 ROTATING STOPCOCKS; 5.8MM HIPSCOPE CANNULA, 2 ROTATING STOPCOCKS; 5MM CANNULA 1 ROT SPEEDLOCK; 5MM CANNULA 2 ROT STCK (SPEEDLOCK); 5mm HellCat Shaver Blades; 5mm PREDRILL ASSEMBLY EXTRA SHORT; 5mm PREDRILL ASSEMBLY LONG; 5mm PREDRILL ASSEMBLY SHORT; 5mm SPANNER WRENCH; 6.5MM CANNULATED SWITCHING STICK; 6.5MM SLOTTED CANNULA; 6.5MM X 75MM CANNULATED OBTURATOR ASSY.; 6.5MM X 90MM CANNULATED OBTURATOR ASSY.; 6.5mm SUBFIX TRIAL; 611 - ANKLE FUSION NAIL; 6mm PREDRILL ASSEMBLY EXTRA SHORT; 6mm PREDRILL ASSEMBLY LONG; 6mm PREDRILL ASSEMBLY SHORT; 7MM SPANNER WRENCH; 7mm SPANNER WRENCH; 8MM X 75MM CANNULATED OBTURATOR ASSY.; 8MM X 90MM CANNULATED OBTURATOR ASSY.; 8mm SUBFIX TRIAL; 90 mm Reusable Slat, SE Retr, 10 Pack; 95 mm Stylet; 9mm SUBFIX TRIAL; A 2 DRILL BRACE W/O CHUCK; A 4 4MM CHUCK; A 5 T-WRENCH; A 51 T WRENCH W/35 EXTENSION; ACL Reconstruction Accessories; ACL Workstation; ADAPT for Gamma 3; ADAPT for Gamma3; ADAPTOR SPEED LOCK SYRINGE; AEQ FRAC LONG SUP IMP ENS; AEQ FRAC SUPPORT DE BRAS; AEQ FRACT GR AXE LIAISON; AEQ FRACT MESUREUR AMOVIB; AEQ FRACT NM FANT TIG; AEQ IMPACTEUR DE PROTHESE; AEQ TIGE FRA LG FANT; AEQ USA FANT CALO; AEQUALIS; AEQUALIS FRACTURE; AEQUALIS RESURFACING HEAD; AEQUALIS REVERSED; AGM 6 6MM CHUCK; ALEUTIAN Interbody Systems Trays; ALL TORNIER FORCEPS INSTRUMENTS; ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS); ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE; ANCHORAGE CP LAPIDUS TEMPLATE; ANCHORAGE CP MTP PIVOTING DRILL GUIDE; ANCHORAGE CP MTP TEMPLATE; ANCHORAGE CP POLYAXIAL DRILL GUIDE; ANCHORAGE CP UTILITY TEMPLATE; ANCHORAGE FIXATION PIN; ANCHORAGE FIXED DRILL GUIDE 2.5MM; ANCHORAGE FIXED DRILL GUIDE 2MM; ANCHORAGE INSTRUMENTS RACK (LEVEL 1); ANCHORAGE INSTRUMENTS RACK (LEVEL 2); ANCHORAGE INSTRUMENTS RACK COVER; ANCHORAGE PLATE BENDER; ANCHORAGE PLATE GRIPPER; ANTEVERSION GUIDE; AO HANDLE - LENGTH 135MM; AO Quick Coupling with Elastosil Handle; AO/JACOBS QUICK RELEASE APEX CHUCK 3mm; AO/JACOBS QUICK RELEASE APEX CHUCK 4mm; AO/JACOBS QUICK RELEASE APEX CHUCK 5mm; AO/JACOBS QUICK RELEASE APEX CHUCK 6mm; APEX; APEX DRILL BRACE - 3/4/5/6mm; APEX DRILL GUIDE HANDLE; APEX TRAY BASE; APEX TRAY LID; APEX TRAY LOWER INSERT; APEX TRAY UPPER INSERT; ASNIS MICRO 2mm LENGTH 9mm; ASNIS MICRO 2mm LENGTH 9mm STERILE; ATP Disc Prep; ATTACHMENTS; AWL; AXSOS ADAPTOR FOR TORQUE TESTER T20; AXSOS ADAPTOR FOR TORQUE TESTER T8/T15; AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK; Accolade II System Instrumentation; Aequalis Flex Revive; Aequalis Fracture; Aequalis Perform+; Aequalis Reversed Fracture; Aequalis Reversed II; Aequalis"" Ascend"" Flex; Aequalis"" Fx2; Aequalis"" Instrument; Aequalis"" PerFORM; Aequalis"" Retractor Shoulder System; Aggressive Max Shaver Blade 3.5mm; Aiming Block, Proximal Tibia; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; All OrthoHelix Orthopedic Manual Surgical Instruments; All Tornier Orthopeadic Manual Surgical Instruments (exempt); Aluminum Lid - Universal; Anato Hip System Instrumentation; Anatomic Express Tray; Anchorage System; Angeld Farabeuf clamp; Apex; Asnis; Asnis III; Asnis III Cannulated Screw System; Asnis PRO Cannulated Screw System; Asnis® III Cannulated Screw System; Asnis® III Cannulated Screw System And Asnis® PRO Cannulated Screw System; Asnis® PRO Cannulated Screw System; AxSOS; AxSOS 3; AxSOS 3 AF System and AxSOS 3 Ti System, Plate; AxSOS 3 Ankle Fusion; AxSOS 3 Ti; AxSOS 3 Ti; Stryker Plating System; BARREL REAMER ASSEMBLY STAND; BENDER; BIOCOMPRESSION WRENCH 15mm TUBE; BIOCOMPRESSION WRENCH 20mm TUBE; BIOCOMPRESSION WRENCH 25mm TUBE; BLUNT TIP OBTURATOR; BLUNT TIP OBTURATOR FOR 2.8MM CANNULA; BLUNT TIP OBTURATOR FOR 2.9MM CANNULA; BLUNT TIP OBTURATOR FOR 3.2 CANNULA; BLUNT TIP OBTURATOR FOR 4MM CANNULA; BLUNT TIP OBTURATOR FOR 4MM LONG ARTHROSCOPE; BONE MILL; BONE SCREW T10 3.5X10mm; BONE SCREW T10 3.5X12mm; BONE SCREW T10 3.5X14mm; BONE SCREW T10 3.5X16mm; BONE SCREW T10 3.5X18mm; BONE SCREW T10 3.5X20mm; BONE SCREW T10 3.5X22mm; BONE SCREW T10 3.5X24mm; BONE SCREW T10 3.5X26mm; BONE SCREW T10 3.5X28mm; BONE SCREW T10 3.5X30mm; BONE SCREW T10 3.5X32mm; BONE SCREW T10 3.5X34mm; BONE SCREW T10 3.5X36mm; BONE SCREW T10 3.5X38mm; BONE SCREW T10 3.5X40mm; BONE SCREW T10 3.5X42mm; BONE SCREW T10 3.5X44mm; BONE SCREW T10 3.5X46mm; BONE SCREW T10 3.5X48mm; BONE SCREW T10 3.5X50mm; BONE SCREW T10 3.5X55mm; BONE SCREW T10 3.5X60mm; BONE SCREW T10 3.5X65mm; BONE SCREW T10 3.5X70mm; BONE SCREW T7 2.3X10 MM; BONE SCREW T7 2.3X12 MM; BONE SCREW T7 2.3X14MM; BONE SCREW T7 2.3X16 MM; BONE SCREW T7 2.3X18 MM; BONE SCREW T7 2.3X20 MM; BONE SCREW T7 2.3X22MM; BONE SCREW T7 2.3X24 MM; BONE SCREW T7 2.3X26 MM; BONE SCREW T7 2.3X28 MM; BONE SCREW T7 2.3X30 MM; BONE SCREW T7 2.3X32 MM; BONE SCREW T7 2.3X34 MM; BONE SCREW T7 2.3X36 MM; BONE SCREW T7 2.3X38 MM; BONE SCREW T7 2.7X10 MM; BONE SCREW T7 2.7X10mm; BONE SCREW T7 2.7X12 MM; BONE SCREW T7 2.7X12mm; BONE SCREW T7 2.7X14 MM; BONE SCREW T7 2.7X14mm; BONE SCREW T7 2.7X16 MM; BONE SCREW T7 2.7X16mm; BONE SCREW T7 2.7X18 MM; BONE SCREW T7 2.7X18mm; BONE SCREW T7 2.7X20 MM; BONE SCREW T7 2.7X20mm; BONE SCREW T7 2.7X22 MM; BONE SCREW T7 2.7X22mm; BONE SCREW T7 2.7X24 MM; BONE SCREW T7 2.7X24mm; BONE SCREW T7 2.7X26 MM; BONE SCREW T7 2.7X26mm; BONE SCREW T7 2.7X28mm; BONE SCREW T7 2.7X30mm; BONE SCREW T7 2.7X32mm; BONE SCREW T7 2.7X34mm; BONE SCREW T7 2.7X36mm; BONE SCREW T7 2.7X38mm; BONE SCREW T7 2.7X40mm; BONE SCREW T7 2.7X45mm; BONE SCREW T7 2.7X50mm; BONE SCREW T7 2.7X8mm; BOS System; BROAD STRAIGHT PLATE LONG; BROAD STRAIGHT PLATE MEDIUM; BROAD STRAIGHT PLATE SHORT; BUR CANNULA 5MM; BURR, ORTHOPEDIC - ForeFoot STP; Bender; Bending Iron; BioZip System; Bioabsorable Wedge Interference Screw System; Biosteon IntraLine System; Biosteon Wedge Interference Screw System; Bixcut, IM Reamer; Blount Staple; Bone Plug Extractor; Bone Screw Washers; BriteField Depth Gauge; Broach and Inserter Handle; CALCANEUS MESH PLATE LARGE; CALCANEUS MESH PLATE MEDIUM; CALCANEUS MESH PLATE, SMALL; CALCANEUS STANDARD PLATE LARGE; CALCANEUS STANDARD PLATE MEDIUM; CALCANEUS STANDARD PLATE SMALL; CANNULA 4MM; CANNULA 4MM W/2 ROTATING STOPCOCKS; CANNULA 6.5 1 FXD STCK (SPEED-LOCK); CANNULA 6.5MM 1 ROT STCK (SPEED-LOCK); CANNULA 6.5MM 2 FXD STCKS (SPEED-LOCK); CANNULA 6.5MM 2 ROT STCKS (SPEED-LOCK); CANNULA PLUG; CANNULA, 2.8MM; CANNULA, 2.8MM  ONE FIXED STOPCOCK; CANNULA, 2.8MM  ONE ROTATING STOPCOCK; CANNULA, 2.8MM  TWO FIXED STOPCOCKS; CANNULA, 3.2MM  ONE FIXED STOPCOCK; CANNULA, 3.2MM  ONE ROTATING STOPCOCK; CANNULA, 3.2MM  TWO FIXED STOPCOCKS; CANNULA, 3.2MM  TWO ROTATING STOPCOCKS; CANNULA, 4MM ONE FIXED STOPCOCK; CANNULA, 4MM SPEEDLOCK TWO FIXED STOPCOCKS; CANNULATED OBTROCAR FOR 4.6 X 200 MM CANNULA; CANNULATED OBTURATOR FOR 4.6 X 200 MM CANNULA; CANNULATED PENCIL TIP OBTURATOR FOR LONG 5.8MM SCOPE SHEATH; CANNULATED TROCAR FOR 4.6 X 200 MM CANNULA; CANYON Retractor Systems Trays; CAPRI Corpectomy Cage System Trays; CASPIAN Spinal System Trays; CAYMAN Plate System Trays; CHESAPEAKE Stabilization System Trays; CLAMP; CMI; CMI Delivery Clamp; CMI Mesuring Cannula; CURSOR; CURVED HIP BLADE, SHARP TIP; CURVED HIP PROBE; CURVED PLATE 4 HOLES; CURVED PLATE 5 HOLES LEFT; CURVED PLATE 5 HOLES RIGHT; CURVED PLATE 6 HOLES; CUTTER & BUR TRAY; CUTTER CANNULA 4.5MM; CUTTER CANNULA W/ HOLE 5MM; CUTTER CANNULA W/HOLE 4.5MM; CUTTER/ BUR CANNULA 5.6MM; CUTTER/BUR CANNULA (W/HOLE) 5.6MM; CUTTING SCREWDRIVER 4.5; CYLINDRICAL BUSH HOLDER; CableFix; CalcLock; CalcLock Extreme; CalcLock manual surgical instruments; Cannulated Countersink with AO Fitting; Cannulated Drill with AO Fitting; Cannulated Drill ø 2,7/3.5mm with AO Fitting; Cannulated Screwdriver with AO Fitting; Cannulated Screwdriver with Elastosil Handle; Cannulated Tap with AO Fitting; Cannulated Wire Bolt- Short; Cannulated Wire Bolt-Medium; Capsule Punch; CapsulePass 45 Up Suture Passer; Cascadia Interbody System; Champion Shoulder Instrumentation; Champion Slingshot; CinchLock; Cobra Suture Passer, Capture; Cobra Suture Passer, Hook; Colored Plugs; Compression Screw System; Compression Staple System; Counterbore Drill; Cross-Screw System; Cut Guide; DENALI Spinal System Trays; DEPTH GAUGE; DEPTH GAUGE (DISTAL RADIUS); DEPTH GAUGE (HAND); DISPOSABLE CEMENT SCULPS; DJD; DJD II STORAGE CASE; DORSAL SMARTLOCK  PLATE STANDARD LEFT; DORSAL SMARTLOCK  PLATE STANDARD RIGHT; DORSAL SMARTLOCK  PLATE WIDE RIGHT; DORSAL SMARTLOCK DR PLATE STANDARD LEFT X LONG; DORSAL SMARTLOCK DR PLATE STANDARD RIGHT X LONG; DORSAL SMARTLOCK DR PLATE WIDE LEFT X LONG; DORSAL SMARTLOCK DR PLATE WIDE RIGHT X LONG; DORSAL SMARTLOCK PLATE WIDE LEFT; DRAIN CANNULA 70MM; DRAIN CNLA 70MM W/ 2ND; DRILL BIT; DRILL GUIDE; DRILL GUIDE BLOCK COMPACT 4 HOLE; DRILL GUIDE BLOCK COMPACT PERI 4 HOLE; DRILL GUIDE BLOCK HII 10 HOLE; DRILL GUIDE BLOCK HII 5 HOLE; DRILL GUIDE BLOCK MONOTUBE 4 HOLE; DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE; DRILL GUIDE LOCK II 2.5; DRILL SLEEVE; DRIVER; SCREW INSERTER; DRLock Extreme; DRLock Extreme, MaxLock Extreme, MaxTorque, CalcLock, Mini MaxLock Extreme; De Palma Staple; Depth Gauge; Depth Gauge (Foot/Elbow/Distal Fib); Direct Measuring Gauge; Double Drill Guide ø 2,0/3,5mm; Drill Bit; Drill Bit ø 2,0 x 150mm; Drill Guide Non Sterile; Drill Sleeve; Dual Edge Shaver Blade 3.5mm; Dual Edge Shaver Blade 4mm; Dual Edge Shaver Blade 5.5mm; Dual-sided Baseplate Centering Guide; Dynamic Joint Distractor II",1977-12-29,224,2026-06-29,1,21,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228031020%22&limit=1
"Gyrus ACMI, Inc.",3011050570,3011050570,9600 Louisiana Ave North,Brooklyn Park,MN,55445,United States,OLYMPUS CORPORATION,9067818,Complaint file establishment; Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,151,BTA; CCW; DQX; DWX; DXJ; ELW; EMX; EOB; EOQ; EPP; EPW; EPY; EQJ; ERL; ETA; ETB; ETC; ETD; ETN; EWA; EWY; EYA; EYB; EZN; EZO; FAD; FAJ; FAS; FBK; FBN; FBO; FCG; FCL; FCR; FCW; FCX; FDA; FDC; FDF; FDI; FDS; FDT; FDX; FEB; FED; FEO; FET; FFK; FFL; FFS; FFY; FGA; FGB; FGE; FGO; FJL; FNS; FSM; FSQ; FST; FZD; FZE; GAA; GAZ; GCJ; GCM; GCT; GDM; GDW; GEI; GEN; GEX; HAW; HDB; HET; HEW; HGI; HHI; HHK; HIG; HIH; HIN; HKF; HQP; HRX; HTD; HTR; HXL; ITX; IYN; IYO; JAB; JAK; JOL; JOS; JXX; JYG; JYJ; JYL; JYM; JYO; JYS; JZF; KAM; KAP; KBB; KBC; KBM; KCN; KCT; KGE; KHJ; KNF; KNH; KNQ; KNS; KNY; KOA; KOB; KOE; KQM; KQT; KTI; LFL; LJE; LQC; LRC; LYA; LYC; MAV; MDM; MIX; MND; MNL; MQW; NAB; NEA; NEZ; NNI; NTN; NWB; NWV; OCU; OCX; OCZ; ODA; ODC; ODG; PKL; PTZ; QNP,"Pump, Portable, Aspiration (Manual Or Powered); Laryngoscope, Rigid; Wire, Guide, Catheter; Stripper, Artery, Intraluminal; Display, Cathode-Ray Tube, Medical; Material, Impression; Balloon, Epistaxis; Nasopharyngoscope (Flexible Or Rigid); Bronchoscope (Flexible Or Rigid); Splint, Nasal; Support, Head, Surgical, Ent; Speculum, Ent; Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Replacement, Ossicular Prosthesis, Total; Prosthesis, Partial Ossicular Replacement; Mold, Middle-Ear; Tube, Tympanostomy; Stimulator, Nerve; Set, Audiometer Calibration; Mediastinoscope, Surgical; Stylet, Ureteral; Catheter, Ureteral, Gastro-Urology; Dilator, Catheter, Ureteral; Urethrotome; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Endoscopic Injection Needle, Gastroenterology-Urology; Choledochoscope And Accessories, Flexible/Rigid; Cystourethroscope; Biopsy Needle; Forceps, Biopsy, Non-Electric; Light Source, Photographic, Fiberoptic; Light Source, Fiberoptic, Routine; Insufflator, Automatic Carbon-Dioxide For Endoscope; Enteroscope And Accessories; Resectoscope, Working Element; Colonoscope And Accessories, Flexible/Rigid; Snare, Flexible; Gastroscope And Accessories, Flexible/Rigid; Duodenoscope And Accessories, Flexible/Rigid; Endoscopic Cytology Brush; Accessories, Cleaning, For Endoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Lithotriptor, Ultrasonic; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Lithotriptor, Electro-Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Image, Illumination, Fiberoptic, For Endoscope ; Adaptor, Bulbs, Miscellaneous, For Endoscope; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Stents, Drains And Dilators For The Biliary Ducts; Dislodger, Stone, Flexible; Resectoscope; Ring Cutter; Tray, Surgical, Instrument; Light, Surgical, Instrument; Light, Surgical, Fiberoptic; Prosthesis, Ear, Internal; Prosthesis, Nose, Internal; Needle, Aspiration And Injection, Disposable; Tubing, Noninvasive; Laparoscope, General & Plastic Surgery; Endoscope, Rigid; Light Source, Endoscope, Xenon Arc; Needle, Aspiration And Injection, Reusable; Staple, Implantable; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Powered Laser Surgical Instrument; Neurological Stereotaxic Instrument; Extractor, Vacuum, Fetal; Laparoscope, Gynecologic (And Accessories); Culdoscope (And Accessories); Electrocautery, Gynecologic (And Accessories); System, Abortion, Vacuum; Curette, Suction, Endometrial (And Accessories); Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Coagulator-Cutter, Endoscopic, Bipolar (And Accessories); Mirror, Headband, Ophthalmic; Unit, Cautery, Thermal, Battery-Powered; Arthroscope; Forceps; Rasp; Mallet; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Fluoroscopic, Non-Image-Intensified; System, X-Ray, Tomography, Computed; Catheter And Tip, Suction; Electrode, Electrosurgical; Forceps, Wire Closure, Ent, Sterile; Curette, Ear; Gauge, Measuring; Hook, Microsurgical Ear; Inserter, Myringotomy Tube; Knife, Ear; Perforator, Ear-Lobe; Tube, Ear Suction; Cannula, Sinus; Curette, Nasal; Rongeur, Nasal; Saw, Nasal; Dissector, Tonsil; Ear Wick; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Forceps, Biopsy, Electric; Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material); Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Laparoscopic Contraceptive Tubal Occlusion Device; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Accessories, Catheter, G-U; Surgical Instruments, G-U, Manual (And Accessories); Catheter, Suprapubic (And Accessories); Dilator, Urethral; Camera, Surgical And Accessories; Evacuator, Gastro-Urology; Bronchoscope Accessory; Instrument, Ultrasonic Surgical; Catheter, Nephrostomy; Lithotriptor, Biliary Mechanical; Instrument, Ent Manual Surgical; Splint, Intranasal Septal; Bone Grafting Material, Synthetic; Syringe, Balloon Inflation; Instrument, Manual, Surgical, General Use; System, Vocal Cord Medialization; Ligator, Esophageal; Accessories, Cleaning Brushes, For Endoscope; Transilluminator, Fiber Optic; Gauze / Sponge,Nonresorbable For External Use; Cement, Ear, Nose And Throat; System, Imaging, Gastrointestinal, Wireless, Capsule; Container, Specimen, Non-Sterile; Led Light Source; Endoscope, Accessories, Narrow Band Spectrum; Laparoscopic Accessories, Gynecologic; Endoscopic Storage Cover; Endoscopic Irrigation/Suction System; Endoscopic Grasping/Cutting Instrument, Non-Powered; Endoscopic Central Control Unit; Endoscope Channel Accessory; Endoscopic Ultrasound System, Gastroenterology-Urology; Hemostatic Metal Clip For The Gi Tract; Colposcope (And Colpomicroscope), Exempt; Gastrointesinal Lesion Software Detection System",1; 2; 3; U,"006902-902; 188; 2-3/4 Needle Electrode; 20714 (HYSTEROSCOPE); 21G EBUS Needle; 568618; 70140095; 70890728; 70890729; 70890730; 70890731; 70890732; 70890733; 70890734; 70890735; 70890737; 70890738; 70890739; 70890740; 70890741; 70890742; 70890743; 70890750; 70890751; 70890752; 70890753; 70890754; 70890755; 70890756; 70890757; A5961, A5976, A05951A, A05961A,WA05970A, WA05971A , WA05972A, WA05973A, WA05974A, WA05990A, WA05994A, WA05995A; ACMI Light Guide Adapters; AF Nasal Splint; AIL-220 Light Source; ALV-1; ASV1012; AUR-735; Accessory Kit; Adapter for Bovie Specialist Unit; Adenoid forceps; Adj. Micron Ti TORP; Amplatz; Applebaum Incudo-stapedial; Applebaum Incus Replacement; Armstrong Bevelled Grommet; Armstrong Grommet; Arrigg II Piston; Arthroscopes, CLV-S20 light source; Articulated arm and accessories; Aspiration needle; Attic Defect; Austin Modified TORP; Austin Tympanoplasty; Autoclavable Scope; Autoclavable scope; B-V231P-A; BC-V600P-3010; BICAP; BIPOLAR COAGULATING FORCEPS; BLU Epistaxis Pack; BLU Glide Nasal Pack; BLU Nasal Pack; BW-400B; BW-400L; BW-400V; BW-403B; BW-411B; BW-412T; Bantam Sm Chuck Handle Assy; Barnhill Adenoid; Baron Suction Tube; Bellucci Mic Scissors; Bentson; Berger Bobbin Vent Tube; BiCAP Hemorrhoid System; BiCOAG; BiCOAG Hemostasis Probe; Bilap L-Hook; Biopsy Port Seals; Biopsy forceps; Bipolar Nasal cautery; Bivalve Splint Std; Black Oval Top; Blu Ear Wick; Bojrab Dissector; Bone rongeur; Boucheron Ear Speculum; Bovie Accessories; Bovie generator; Buck Ear Currette; Burr; CF-H170I; CF-H170L; CH-S190-08-LB; CH-S190-XZ-Q; CH-S700-XZ-EA; CLL-S700; CLV-190; CV-1500; CV-170; CW-4; CW-5; CYB-2, CYB-3; CYF-5; CYF-VH; CYF-VHA; Cartilage crusher; Causse Piston; Celeris; Centered PORP/TORP; Chest support; ChitoZolve; Classic Stapes Pros. Tit.; Classic Stapes Prosthesis; Clip applier; Cogent 1; Cold Knives; Collar Button, Pacific; Cord; Cottle Septum Speculum; Cotton applicator; Custom McGee Suction Tube; Cutting Forceps; CyberWand; D-201-10704; D-201-11804; D-201-12704; D-201-15004; DE Drill; DTAD; Delacruz measuring; Dermabrader; Diamond Burrs; Diego; Diego Blades; Diego Elite; Diego Otology Tube Set; Diego PK Console; Diego Powered Dissector; Diego Powered Dissectors; Diego Spine; Diego Starlink Handpiece; Diego Trigger Console; Diego Tube Set; Diego Universal Adaptor; Diego Viper; Diego instrument sterilization tray; Disposable Bipolar Cord; Dissector; Dissector Forceps; Dolphin Collection Set; Dolphin II Transducer Tubing; Dornhoffer Footplates; Dornhoffer Ti PORP; Double J II; Double J Stent; Double Pigtail; Double Spoon Biopsy Forceps; Dressing forceps; Dual Lumen Catheter; E-Z Glider; E-Z Grip Guidewire Torque Device; E8213; E8218; EAWE-N; EBC02; EBC05; EBF01; EBF02; EIWE; ENDO-ST Tray; EU-ME1; EU-ME3; EZDilate; EZDilate 3-Stage Balloon Dilation Catheter; Ear curette; Ear forceps; Ear forceps, inserter for ventilation tubes; Ear hook; Ear loop; Electrode Blade; Elite 2 System; Endocapsule; Endoscopic cord; Endoscopic instrument sterilization trays; Everest Adapter cord; Everest Macro Bipolar Forceps; Everest Micro Bipolar Forceps; Extend Blade Electrode; FB-210K; FB-210U; FB-211K; FB-212U; FB-214U; FB-215U; FB-220K; FB-220U; FB-221D; FB-221K; FB-222U; FB-224U; FB-225U; FB-230K; FB-230U; FB-231D; FB-231K; FB-232U; FB-234U; FB-235U; FB-240K; FB-240U; FB-241D; FB-241K; FB-242U; FB-244U; FB-245U; FB-456D; FG-52D; FG-54D; FG-V421PR; FG-V422PR; FG-V431P; FG-V432P; FGT-1 Tray; Falope Ring Band; Falope Ring Band Applicator Kits; Ferguson-Frazier Suction tube; Fergusson Suction; Fiber Optic Light Cable; Fixed Wire; Flex Grasper; Fluoroplastic Piston; Fluoroplastic/Titanium Bobbin; Foam head rest; Footswitch; Frazier Suction Tube; Frontal Ostium Forceps; Fulgurating Electrode; G400 Workstation; GEN. SURGERY FORCEPS; GF-UC140P-AL5; GF-UCT180; GIF-1TH190; GIF-H170; GIF-XP170N; GW Lock; GY5-PCH; GYNE-BR; Gauge pin; Gelfoam pressure forceps; Goldenberg Cap; Goldenberg Incus Prosth.; Goldenberg Incus Stapes; Grasping Forceps; Grasping forceps; Grote Canal Wall; Grote Incus Prothesis; Grote Incus Stapes; Gruber Ear Speculum; Guide Locking Pin; Gyrus PK Footswitch; Gyrus Plasma V; Gyrus Urology Kit; HALO; HF-cables (reusable); HX-201LR-135; HX-201LR-135L; HX-201UR-135; HX-201UR-135L; HX-202LR; HX-202UR; Hajek Sphenoid; Hand peforator; Hartmann Ear Speculum; Hartmann Tuning Fork; Head band; High Speed Drill; Holmgren Speculum; Holster; Hook; Hook Scissors; Hot Knives; House Wire Closure Forceps; Hybrid Guidewire; Iglesias; Inserter, for T-Tubes; InstaClear; Introducer; IrriFlow; Irrigating Blade; Irrigation Bag Spike Assy; Irrigation Tubing; J PlasmaKnife; Jahn Hydroxlvent; Jahn Tube Hydroxlapatite; Joseph Skin Hook; Kartush Hydroxlapatite Disks; Kartush Incus Stapes; Kartush Incus Strut; Killian Septum Speculum; Knife; Knot pusher; LTF-S190-5; Laryngeal forceps; Light carrier; Light clip; Lippy Mod Bucket Handle Titanium; Loop; Loops; Lowsley; Lubri-Flex; Lubri-Flex Stents; MAJ-1119; MAJ-1177; MAJ-1193; MAJ-1215; MAJ-1339; MAJ-1381; MAJ-1453; MAJ-1720; MAJ-1827; MAJ-1828; MAJ-1832; MAJ-1834; MAJ-1862; MAJ-1869; MAJ-1888; MAJ-1917; MAJ-2051; MAJ-207; MAJ-2088; MAJ-2363; MAJ-2412; MAJ-2432; MAJ-2467; MAJ-2511; MAJ-2512; MAJ-528; MAJ-686; MAJ-811; MAJ-843; MAJ-860; MAJ-901; MAJ-902; MH-999E; MNA-110 ENC DP; MNA-110 ENC DVI; MNA-110 ENC HDSDI; MNA-120 DEC DVI AUDIO; MNA-120 ENC DP AUDIO; MNA-120 ENC DVI AUDIO; MNA-120 ENC HDSDI AUDIO; MNA-240 Ouad Decoder; MNT-120 H.264; MOLly Forceps; MR-6A; MR-6LA; MRA-GT Tray; Macro Bipolar Forceps; Macro Forceps; Mallet; Malony Mod PORP/TORP; Mastoid Round Cutting Burrs; McCarthy Electrode; McGee Wire Closing Forceps; Mediastinoscope; Meyerhoff Incus; Micro Bipolar Forceps; Micro Bright; Micro Forceps; Micro instrument wipe; Micron Bobbin Vent Tubes; Micron II CTR PORP Monlithic All Titanium; Micron II CTR TORP Monolithic All Titanium; Micron II OCTR All Titanium TORP; Micron II OCTR PORP Monolithic All Titanium; Micron Spoon Bobbin; Model 1010; Model 1120; Model 1200; Model 2220; Model 2420; Modified T-Tube Silicone; Monopolar Cable; Monopolar single-use HF cable; Moriyama Univ. Cutt. Fcps; Multi-Flex; NA-201SX-4021; NA-201SX-4022; NA-U401SX-4021; NA-U401SX-4022; Nasal forceps; Needle; Needle Nose Dissector; Needle Sleeve Bending Tool; Needle holder; Neiman Sil RB Nasal Splint; Nephro EZDilate Balloon Catheter; Neutral electrode cable; OCS5-DCAD2; OCS5-ETVM; OCS5-HA; OCS5-LG; OCS5-SR; OCS5-STD; OCS5-TVAD1; OCS5-TYS; OCSG-ZB; OEV321UH; OLYMPUS STERILIZATION TRAYS; OPI; OPTHALMIC CAUTERY, FINE TIP, STERILE; OSC5-BA; OSC5-STB; OTRP Trial; OTV-S200; OTV-S500; OTV-S700; OTV-S7H-NA-12E; Occular Occluder; Off-Centered PORP/TORP; Olympus KeyMed Instrument Tray; Open Forceps; Otomimix Otologic cement; Otoview Cupped Forceps; Otoview scope; PBD-1030-0707; PBD-1030-0709; PBD-1030-0712; PBD-1030-0715; PBD-1030-1007; PBD-1030-1009; PBD-1030-1012; PBD-1030-1015; PK Button; PK Cord; PK Diego Blades; PK J-Hook; PK Lap Loop; PK Needle; PK Spatula; PK generator; PK-CF0533; PKS BiLL; PKS Cutting Forceps; PKS Dissectors; PKS L-Hook; PKS Needle; PKS Omni; PKS Plasmaspatula; PKS Seal Open Forceps; PLASMA SECT UROLOGY; POWERSEAL; POWERSEAL 2; PS-0021EJDA; Paparella 2000; Paparella Ultrasil; Paparella-Type Vent Tubes; Peforator; Perc Antegrade ureteral stent; Pharyngeal forceps; Pick; Plasma Cise; Plasma Cut; Plasma J Hook; Plasmasord; Plasti-Pore Septal Button; Pleatman Sac and accessories; Politzer Ear Speculum; Polyp snare; Pope Beveled Grommet; Porous Hydroxlapatite granules; Porous Hydroxylapatite; Powered Suction Pump; Powered laser surgical instrument (TFL-AFSWL); Probe Needle for Nerve Stimulator; Protective Sheath; Punch forceps; Quadra Coil; RC-2 Reusable Cable; RC-20 Reusable Cable; RND; RP Osteotome; Rains Frontal Sinus Stent; Rasp; Raspatory; Renal Dilator; Return Electrodes; Reusable Active Cord; Reut-Bob Vent Tube; Reut-Bob Vent Tubes; Reuter Bobbin, Pacific; Richards; Richards BH Pros Flpl; Richards Bucket Handle Titanium; Richards Sinuscope; Richards T-Tubes; Ritter-Halle Frontal Sinus Dilator; Roller Electrode; Rosette Packing; Russell-Davis Tongue Bld; SB-0520FC; SB-0535FC; SB-0545FC; SD-210U-15; SIF-Q180; SOPI; SPIN Thoracic Navigation System; ST-CR; SURGICAL CAUTERY, FINE TIP; SURGICAL CAUTERY, LOOP TIP STERILE; Saw; Schuring Ossicle Columella; Scissors; Scoring instrument; SecurCatch; Seda Wire Closing Forceps; Septal Needle; Septum Needle; Septum forceps; Shah Aural dressing; Shea Cap; Shea Lg Hd Malleus; Shea PORP; Shea Plat Cup Piston; Shea Pls TORP Pros; Shea TORP; Sheehy Collar Button; Sheehy Flap Knife; Sheehy Modified TORP/PORP Pros; Sheehy TORP; Sheehy Weapon; Sheehy-Type Collar Button; Shepard Grommet; Shepard Grommet Tube; Shepard Grommet Vent Tube; ShockPulse; Silicone Septal Button; Silicone Single J; Sinuscope; Slim Line Nasal Pack; SlimLine; Slimline; Smart 360 Pistons; Smart Dela Cruz Pistons; Smart Malleous Pistons; Smart Stapes Pistons; Sof-Curl; Spanner Strut; Spare rod, vertical, for nasal snare; Speculum and accessories; Spetal Splint Std; Spoon-Bobbin Vent Tube; Spoon-Bobbin Vent Tubes; Stabilized Cutting Loops; Stapes Cutting Burrs; Stent/GW Combo; Stimulator Probe Pod; Straight Vent Tube; Suction Irrigation Sheath; Suction tupe; SuperLoop; SuperPulse generator; SuperSect; Sur-Catch Baskets; Sur-Lock; SurLock Flatwire; SurLock Graspers; SurLock Grasping Forceps; Swab forceps; Synergry Drill system; TB-0009OF; TB-0009OFX; TB-0520FCS; TB-0535FCS; TB-0545FCS; TB-0920OE; TB2-0520FC; TB2-0525FC; TB2-0535FC; TB2-0545FC; TD-410; TD-SB400; TD-TB400; TEL-GT Tray; TFL-AFC-NS, TFL-AFS150-NS, TFL-AFS200-NS, TFL-AFS365-NS, TFL-AFS550-NS, TFL-AFS940-NS; TFL-AFSW; TFL-CPLU; TFL-CSLU; TFL-FBX150BS; TFL-FBX150R; TFL-FBX150S; TFL-FBX200BS; TFL-FBX200R; TFL-FBX200S; TFL-FBX365R; TFL-FBX365S; TFL-FBX550R; TFL-FBX550S; TFL-FBX940R; TFL-FBX940S; TFL-PLS; TFL-SLS; TJF-Q170V; Teleschi Suct; Telescope; Telescope - autoclavable; Thumb forceps; Thunderbeat; Ti Bucket Handle; Tilt-Top TORP Pros-Pls; Tip cleaner; Tonsil dissector and retractor; Tonsil forceps; Tonsil needle; Towel forceps; Tracheal hook; Trapeze Ribbon Loop; Tray; Turbinate forceps; Turbo 7000; Turner Drain Tube; UCR; URO EZDilate; USG-410; Ultasil Richards T Tube; UltraCatch; UltraTrack; Ultrasil Paparella; Ultrasil Sheehy-Type Collar Button; Ultrasil Shepared Grommet; Univ Ext Nasal Splint; Ureteral Catheter; Uro Guide; Uropass Ureteral Access Sheaths; VASECTOMY CAUTERY,ELONGATED TIP HT; VC-10; VH-3200; VISTA; Vacuum-powered body fluid suction apparatus; Vaportrode; Various sterilization trays; Varipass Variable Access Sheath; Verhoven Suction Tube; Versapoint; Viper Drill; Viper Mastoid Burrs; ViziShot 2 FLEX; Vocom; Vokovic I-S Joint replacement plastipore; WA91301W; WA91302W; WA91303W; WA91307C; WA91307W; WA94020A HF cable ""EndoTherapy"", monopolar; WOLF ADAPTER CORD; Wehrs II Incus Stapes; Wehrs Incus Protheses; Wide Line Nasal Pack; Williams Microclips; Woodes Incudo Stapeidial joint; Woods Incus Stapes; X-Catch; Zimmer Diego Spine; adapter; universal",1995-01-20,222,2026-07-01,1,6,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011050570%22&limit=1
Olympus Medical Systems Corp.,8010047,3002807795,2951 Ishikawa-Cho,HACHIOJI-SHI Tokyo,,192-8507,Japan,OLYMPUS CORPORATION,9067818,Exporter to the US; Specification developer,74,BTG; EOB; EOQ; EPT; EQH; EQL; FAJ; FAS; FBK; FBN; FBO; FCG; FCL; FCX; FDA; FDF; FDI; FDS; FDT; FDX; FEB; FED; FEM; FET; FFL; FFY; FGB; FGE; FGX; GAA; GCJ; GCM; GCT; GCW; GEI; HET; HIF; HIH; ITX; IYN; IYO; IZI; KGE; KNS; KQM; KTI; LFL; LQC; LQR; MND; MNK; MNL; NEZ; NFI; NTN; NWB; NWW; OCX; OCY; OCZ; ODA; ODC; ODD; ODG; OSV; OWN; PCV; PGU; PKL; PSV; PTS; QEC; QGE; QNP,"Brush, Biopsy, Bronchoscope (Non-Rigid); Nasopharyngoscope (Flexible Or Rigid); Bronchoscope (Flexible Or Rigid); Microscope, Surgical; Source, Carrier, Fiberoptic Light; Laryngostroboscope; Cystoscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Endoscopic Injection Needle, Gastroenterology-Urology; Choledochoscope And Accessories, Flexible/Rigid; Cystourethroscope; Biopsy Needle; Forceps, Biopsy, Non-Electric; Insufflator, Automatic Carbon-Dioxide For Endoscope; Enteroscope And Accessories; Colonoscope And Accessories, Flexible/Rigid; Snare, Flexible; Gastroscope And Accessories, Flexible/Rigid; Duodenoscope And Accessories, Flexible/Rigid; Endoscopic Cytology Brush; Accessories, Cleaning, For Endoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Accessories, Photographic, For Endoscope (Exclude Light Sources); Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Dislodger, Stone, Basket, Ureteral, Metal; Adaptor, Bulbs, Miscellaneous, For Endoscope; Ureteroscope And Accessories, Flexible/Rigid; Stents, Drains And Dilators For The Biliary Ducts; Snare, Non-Electrical; Needle, Aspiration And Injection, Disposable; Laparoscope, General & Plastic Surgery; Endoscope, Rigid; Light Source, Endoscope, Xenon Arc; Transformer, Endoscope; Electrosurgical, Cutting & Coagulation & Accessories; Laparoscope, Gynecologic (And Accessories); Insufflator, Laparoscopic; Hysteroscope (And Accessories); Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; Forceps, Biopsy, Electric; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Camera, Surgical And Accessories; Bronchoscope Accessory; Instrument, Ultrasonic Surgical; Lithotriptor, Biliary Mechanical; Dislodger, Stone, Biliary; Ligator, Esophageal; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; System, Imaging, Gastrointestinal, Wireless, Capsule; Device, Hardcopy, Images, Ophthalmic; Led Light Source; Endoscope, Accessories, Narrow Band Spectrum; Hysteroscope Accessories; Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Grasping/Cutting Instrument, Non-Powered; Endoscopic Central Control Unit; Endoscope Channel Accessory; Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula; Endoscopic Ultrasound System, Gastroenterology-Urology; Insufflator, Endoscopic Vessel Harvesting; Confocal Optical Imaging; Endoscopic Leak Tester; Spatial Imaging For Display Of Endoscope Position; Hemostatic Metal Clip For The Gi Tract; Ultrasound Bronchoscope; Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt; Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree; Biliary Stent, Drain, And Dilator Accessories; Gastrointesinal Lesion Software Detection System",1; 2; U,"ALT-Pro; B-V233P-A; B-V233P-B; B-V243Q-A; B-V243Q-B; B-V433P-A; B-V433P-B; B-V443Q-A; B-V443Q-B; B5-2C; B5-2Q; B7-2LA; B7-2Q; BC-202D-1210; BC-202D-2010; BC-202D-3010; BC-202D-5010; BC-203D-2006; BC-205D-2010; BC-V600P-3010; BD-210N-0420; BD-210N-0440; BD-210N-0620; BD-210N-0640; BD-210N-0830; BD-VC431Q-1240-20; BD-VC431Q-1240-25; BD-VC431Q-1240-30; BD-VC431Q-1840-20; BD-VC431Q-1840-25; BD-VC431Q-1840-30; BF-1TH1100; BF-1TH190; BF-H1100; BF-H190; BF-P190; BF-UC190F; BF-UCP190F; BF-XP190; BF-XT190; BML-610A; BML-V232QR-26; BML-V232QR-30; BML-V237QR-30; BML-V242QR-30; BML-V437QR-30; BML-V442QR-30; BW-400B; BW-400L; BW-400V; BW-403B; BW-411B; BW-412T; CC-220DR; CF-EZ1500DI; CF-EZ1500DL; CF-H170I; CF-H170L; CF-H190I; CF-H190L; CF-HQ1100DI; CF-HQ1100DL; CF-HQ190I; CF-HQ190L; CH-S190-08-LB; CH-S190-XZ-Q; CH-S200-08-LB; CH-S200-XZ-EA; CH-S200-XZ-EB; CH-S400-XZ-EA; CH-S400-XZ-EB; CH-S700-08-LB; CH-S700-XZ-EA; CLL-S700; CLV-190; CLV-S190; CV-1500; CV-190; CYB-2, CYB-3; CYF-5; CYF-VH; CYF-VHA; CYF-VHR; D-201-10704; D-201-11304; D-201-11802; D-201-11804; D-201-12704; D-201-13404; D-201-14304; D-201-15004; ENF-GP2; ENF-V3; ENF-V4; ENF-VH; ENF-VH2; ENF-VT3; ENF-XP; EU-ME1; EU-ME3; FB-210K; FB-210U; FB-211D; FB-211K; FB-212U; FB-214U; FB-215U; FB-220K; FB-220U; FB-221D; FB-221K; FB-222U; FB-224U; FB-225U; FB-230K; FB-230U; FB-231D; FB-231K; FB-232U; FB-234U; FB-235U; FB-240K; FB-240U; FB-241D; FB-241K; FB-242U; FB-244U; FB-245U; FB-433D; FB-456D; FD-210U; FD-230U; FD-231C; FD-410LR; FD-411UR; FD-412LR; FG-214P; FG-220P; FG-226C; FG-232L; FG-244NR; FG-253SX; FG-460YR; FG-52D; FG-54D; FG-600U; FG-804L; FG-V421PR; FG-V422PR; FG-V431P; FG-V432P; FG-V451P; FS-200L; FS-410L; FS-410U; GF-UC140P-AL5; GF-UCT180; GF-UE160-AL5; GF-UE190; GIF-1100; GIF-1TH190; GIF-2T1500; GIF-EZ1500; GIF-H170; GIF-XP170N; GIF-XP190N; HX-201LR-135; HX-201LR-135L; HX-201UR-135; HX-201UR-135L; HX-202LR; HX-202UR; HX-400U-30; HX-610-090; HX-610-090L; HX-610-090S; HX-610-135; HX-610-135L; HX-610-135S; HX-610-135XS; HX-810LR; HX-810UR; Hysteroscope accessories; K-401; K-402; KD-610L; KD-611L; KD-612L; KD-612U; KD-620UR; KD-625LR; KD-625UR; KD-640L; KD-645L; KD-650L; KD-650U; KD-655L; KD-655U; KD-V411M-0320; KD-V411M-0330; KD-V411M-0720; KD-V411M-0725; KD-V411M-0730; KD-V431M-0720; KD-V431M-0730; KD-V441M; KD-V451M; KD-V611M-07201A; KD-V611M-07201S; KD-V611M-07202A; KD-V611M-07202S; KD-V611M-07251A; KD-V611M-07251S; KD-V611M-07252A; KD-V611M-07252S; KD-V611M-07301A; KD-V611M-07301S; KD-V611M-07302A; KD-V611M-07302S; KD-V631M-07201A; KD-V631M-07201S; KD-V631M-07202A; KD-V631M-07202S; KD-V631M-07301S; KD-V631M-07302A; KD-V631M-07302S; KD-VC411Q-0320; KD-VC411Q-0330; KD-VC411Q-0720; KD-VC411Q-0730; KD-VC412Q-0215; KD-VC431Q-0720; KD-VC431Q-0730; KD-VC433Q-0720; KD-VC433Q-0730; KD-VC611Q-07201A; KD-VC611Q-07201S; KD-VC611Q-07203A; KD-VC611Q-07203S; KD-VC611Q-07301A; KD-VC611Q-07301S; KD-VC611Q-07303A; KD-VC611Q-07303S; KD-VC631Q-07201A; KD-VC631Q-07201S; KD-VC631Q-07203A; KD-VC631Q-07203S; KD-VC631Q-07301A; KD-VC631Q-07301S; KD-VC631Q-07303A; KD-VC631Q-07303S; LTF-190-10-3D; LTF-S190-10; LTF-S190-5; Light Source; Light carrier, fiber optic; MA-238; MA-392; MA-474; MA-651; MAF-DM2; MAF-GM2; MAF-TM2; MAJ-1024; MAJ-1025; MAJ-1026; MAJ-1077; MAJ-1080; MAJ-1084; MAJ-1085; MAJ-1119; MAJ-1193; MAJ-1205; MAJ-1214; MAJ-1218; MAJ-1339; MAJ-1352; MAJ-1379; MAJ-1391; MAJ-1413; MAJ-1414; MAJ-1430; MAJ-1443; MAJ-1444; MAJ-1453; MAJ-1462; MAJ-1464; MAJ-1466; MAJ-1498; MAJ-1503; MAJ-1504; MAJ-1505; MAJ-1508; MAJ-1511; MAJ-1512; MAJ-1513; MAJ-1514; MAJ-1515; MAJ-1516; MAJ-1517; MAJ-1534; MAJ-1538; MAJ-1545; MAJ-1546; MAJ-1555; MAJ-1584; MAJ-1586; MAJ-1632; MAJ-1711; MAJ-1720; MAJ-1726; MAJ-1727; MAJ-1741; MAJ-1742; MAJ-1764; MAJ-1805; MAJ-1817; MAJ-1818; MAJ-1819; MAJ-1820; MAJ-1821; MAJ-1836; MAJ-1837; MAJ-1838; MAJ-1859; MAJ-1860; MAJ-1868; MAJ-1869; MAJ-1870; MAJ-1871; MAJ-1872; MAJ-1873; MAJ-1875; MAJ-1876; MAJ-1878; MAJ-1879; MAJ-1881; MAJ-1888; MAJ-1890; MAJ-1898; MAJ-1899; MAJ-1904; MAJ-1907; MAJ-1912; MAJ-1919; MAJ-1921; MAJ-1927; MAJ-1933; MAJ-1934; MAJ-1937; MAJ-1938; MAJ-1939; MAJ-1941; MAJ-1942; MAJ-1945; MAJ-1948; MAJ-1951; MAJ-1956; MAJ-1957; MAJ-1959; MAJ-1962; MAJ-1969; MAJ-1970; MAJ-1971; MAJ-1981; MAJ-1985; MAJ-1995; MAJ-2009; MAJ-2011; MAJ-2020; MAJ-2052; MAJ-2053; MAJ-207; MAJ-209; MAJ-2092; MAJ-210; MAJ-2114; MAJ-2115; MAJ-2116; MAJ-2117; MAJ-2118; MAJ-2119; MAJ-2124; MAJ-2131; MAJ-2138; MAJ-2144; MAJ-215; MAJ-222; MAJ-2251; MAJ-2268; MAJ-2295; MAJ-2301; MAJ-2303; MAJ-2304; MAJ-2305; MAJ-2307; MAJ-2308; MAJ-2315; MAJ-2316; MAJ-2330; MAJ-2358; MAJ-2363; MAJ-2381; MAJ-2382; MAJ-2383; MAJ-2412; MAJ-2431; MAJ-2432; MAJ-2437; MAJ-2467; MAJ-249; MAJ-2502; MAJ-2511; MAJ-2512; MAJ-2547; MAJ-2548; MAJ-2549; MAJ-2550; MAJ-2551; MAJ-350; MAJ-419; MAJ-438; MAJ-590; MAJ-591; MAJ-604; MAJ-629; MAJ-669; MAJ-679; MAJ-840; MAJ-853; MAJ-854; MAJ-855; MAJ-860; MAJ-864; MAJ-865; MAJ-879; MAJ-900; MAJ-901; MAJ-902; MAJ-905; MAJ-920; MAJ-941; MAJ-960; MB-142; MB-155; MB-156; MB-358; MD-227; MD-252; MD-493; MH-155; MH-244; MH-438; MH-443; MH-553; MH-856; MH-907; MH-944; MH-946; MH-948; MH-968; MH-969; MH-974; MH-984; MH-985; MH-995; MH-999E; MU-1; NA-201SX-4021; NA-201SX-4022; NA-401D-1321; NA-401D-1521; NA-411D-1321; NA-411D-1521; NA-601D-1519; NA-U200H-8019; NA-U200H-8019S; NA-U200H-8022; NA-U200H-8022S; NA-U200H-8025; NA-U201H-8019; NA-U201H-8022; NA-U201H-8025; NA-U210H-8019; NA-U210H-8022; NA-U210H-8025; NA-U401SX-4021; NA-U401SX-4022; NA-U401SX-4025N; NM-221C-0427; NM-400L-0421; NM-400L-0423; NM-400L-0425; NM-400L-0523; NM-400L-0525; NM-400L-0621; NM-400L-0623; NM-400L-0625; NM-400U-0323; NM-400U-0423; NM-400U-0425; NM-400U-0523; NM-400U-0525; NM-400U-0623; NM-400U-0625; NM-400Y-0423; NM-401L-0423; NM-401L-0425; NM-401L-0523; NM-401L-0525; NM-401L-0623; NM-401L-0625; NM-610L-0421; NM-610L-0423; NM-610L-0425; NM-610L-0426; NM-610L-0521; NM-610L-0523; NM-610L-0525; NM-610L-0621; NM-610L-0623; NM-610L-0625; NM-610U-0323; NM-610U-0326; NM-610U-0423; NM-610U-0425; NM-610U-0426; NM-610U-0523; NM-610U-0525; NM-610U-0623; NM-610U-0625; NM-610U-1826; OBCU; OER-Elite; OER-MINI; OEV-271H; OEV-271MUH; OEV-321MUH; OEV-431MUH; OEV321UH; OME-L200; OME-V200; OTV-S190; OTV-S200; OTV-S500; OTV-S700; OTV-S7H-NA-12E; PBD-1030-0707; PBD-1030-0709; PBD-1030-0712; PBD-1030-0715; PBD-1030-1007; PBD-1030-1009; PBD-1030-1012; PBD-1030-1015; PBD-230-0702; PBD-230-0704; PBD-230-0706; PBD-230-0708; PBD-234-0706; PBD-234-0708; PBD-234-0710; PBD-234-0712; PBD-234-1006; PBD-234-1008; PCF-H190I; PCF-H190L; PCF-H190TI; PCF-H190TL; PCF-HQ190I; PCF-HQ190L; PCF-PH190I; PCF-PH190L; PR-V223Q; PR-V414Q; PR-V416Q; PR-V418Q; PR-V420Q; PR-V427Q; PR-V434Q; PR-V435Q; PR-V614M; SB-0520FC; SB-0535FC; SB-0545FC; SD-210U-10; SD-210U-15; SD-210U-25; SD-221U-25; SD-230U-20; SD-240U-10; SD-240U-15; SIF-Q180; ST-SB1; Sur-Lock; TB-0009OF; TB-0009OFX; TB-0520FCS; TB-0535FCS; TB-0545FCS; TB-0920OE; TB2-0520FC; TB2-0525FC; TB2-0535FC; TB2-0545FC; TC-C3; TC-C4; TC-E300; TC-E400; TC-E410; TC-L; TD-410; TD-SB400; TD-TB400; TJF-Q170V; TJF-Q190V; Telescope ""IR""; Telescope ""ULTRA""; Throat microphone; UCES-4; UCR; UHI-4; UM-3R; UM-3R-3; UM-G20-29R; UM-G20-29R-3; UM-S20-17S; UM-S20-20R; UM-S20-20R-3; UPD-3; URF-P7; URF-P7R; URF-V3; URF-V3R; USG-400; USG-410; VirtuoSaph Plus Endoscopic Vein Harvesting System (VSP550EX); Visera Elite II Endoeye 3D; WM-DP3; WM-NP3",1995-01-20,217,2026-09-10,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228010047%22&limit=1
Zapalign LLC,3043226252,3043226252,2281 Griffin Rd,Fort Lauderdale,FL,33312,United States,Zapalign LLC,10095225,Manufacturer for export; Repackager or relabeler,174,BSF; BSJ; BSP; BSR; BSS; BSY; BTG; BTK; BTO; BTR; BTT; BWF; BYD; BYE; BZG; CAE; CAZ; CCK; CCQ; CCX; DOF; DPS; DQD; DRX; DWJ; DWL; DXN; DXO; DXQ; DZN; EAX; EBC; EBF; EBG; EBI; EBZ; EFB; EGS; EGZ; EHJ; EHL; EIA; EIE; EIG; EJG; EJK; EJQ; ELC; ELR; ELW; ELZ; EMA; EMB; EMG; EMJ; EMN; EMS; EOQ; ERA; ETD; EXE; EYQ; FCM; FDS; FHN; FHQ; FLL; FMF; FMH; FMI; FMK; FMP; FOZ; FPA; FPB; FPD; FQM; FRC; FRG; FRO; FSM; FXX; FYA; FYD; FZS; GAA; GAL; GAM; GAP; GAQ; GAT; GAW; GCJ; GCY; GDX; GEA; GEI; GEN; GES; GFA; GFF; GIO; GKR; GNX; GXB; GXY; HHI; HHK; HIB; HIH; HRX; ILI; IPT; IQK; ITX; JKA; JOH; JOJ; JOS; JOW; JTW; JYR; KBN; KCT; KDI; KGO; KGX; KKX; KLE; KMF; KMK; KMW; KNT; KOC; KQO; KYW; KYX; LBH; LHI; LJC; LJH; LKF; LRW; LRY; LSL; LWK; LYR; LYU; LZA; MDA; MEG; MKJ; MLA; MLN; MMK; MNK; MNL; MPN; MQM; MUH; MVL; NAB; NAC; NAD; NAE; NBH; NDP; NEW; NKC; NOC; NTK; ODG; OEA; ONB,"Absorber, Carbon-Dioxide; Mask, Gas, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Tube, Nasogastric; Catheters, Suction, Tracheobronchial; Brush, Biopsy, Bronchoscope (Non-Rigid); Strap, Head, Gas Mask; Tube, Tracheostomy (W/Wo Connector); Tube, Tracheal (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Spirometer, Therapeutic (Incentive); Condenser, Heat And Moisture (Artificial Nose); Attachment, Breathing, Positive End Expiratory Pressure; Spirometer, Diagnostic; Airway, Oropharyngeal, Anesthesiology; Anesthesia Conduction Kit; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Support, Patient Position; Lead, Atomic Absorption; Electrocardiograph; Stethoscope, Electronic; Electrode, Electrocardiograph; System, Thermal Regulating; Stocking, Medical Support (To Prevent Pooling Of Blood In Legs); System, Measurement, Blood-Pressure, Non-Invasive; Transducer, Pressure, Catheter Tip; Blood Pressure Cuff; Instruments, Dental Hand; Mirror, Mouth; Sealant, Pit And Fissure, And Conditioner; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Resin, Denture, Relining, Repairing, Rebasing; Activator, Ultraviolet, For Polymerization; Handpiece, Air-Powered, Dental; Handpiece, Contra- And Right-Angle Attachment, Dental; Holder, Film, X-Ray; Disk, Abrasive; Point, Abrasive; Unit, Operative Dental; Dam, Rubber; Retractor, All Types; Forceps, Rubber Dam Clamp; Liner, Cavity, Calcium Hydroxide; Wheel, Polishing Agent; Scaler, Ultrasonic; Post, Root Canal; Material, Impression; Crown, Preformed; Cement, Dental; Zinc Oxide Eugenol; Forceps, Tooth Extractor, Surgical; Elevator, Surgical, Dental; Scaler, Periodontic; Curette, Periodontic; Bronchoscope (Flexible Or Rigid); Otoscope; Tube, Tympanostomy; Protector, Ostomy; Garment, Protective, For Incontinence; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Gastroscope And Accessories, Flexible/Rigid; Ligator, Hemorrhoidal; Holder, Needle, Gastroenterologic; Continuous Measurement Thermometer; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Protector, Skin Pressure; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Filter, Infusion Line; Tube, Feeding; Bandage, Elastic; Indicator, Biological Sterilization Process; Wrap, Sterilization; Dressing, Wound, Drug; Tray, Surgical, Instrument; Mask, Surgical; Gown, Surgical; Apparatus, Exhaust, Surgical; Curette, Surgical, General Use; Needle, Aspiration And Injection, Disposable; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Scalpel, One-Piece; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Blade, Scalpel; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Tube, Collection, Capillary Blood; System, Hemoglobin, Automated; Antigens, Cf (Including Cf Control), Influenza Virus A, B, C; Esthesiometer; Electrode, Cutaneous; System, Abortion, Vacuum; Curette, Suction, Endometrial (And Accessories); Speculum, Vaginal, Nonmetal; Hysteroscope (And Accessories); Arthroscope; Sling, Arm; Orthosis, Thoracic; Orthosis, Cervical; Transducer, Ultrasonic, Diagnostic; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tube Tracheostomy And Tube Cuff; Indicator, Physical/Chemical Sterilization Process; Electrode, Electrosurgical; Sleeve, Limb, Compressible; System, Transport, Aerobic; Nipper, Malleus; Gag, Mouth; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Surgeon'S Gloves; Tape And Bandage, Adhesive; Drape, Surgical, Antimicrobial; Agent, Tooth Bonding, Resin; Bandage, Liquid; Device, Intravascular Catheter Securement; Handpiece, Rotary Bone Cutting; Tubes, Gastrointestinal (And Accessories); Accessories, Blood Circuit, Hemodialysis; Automated Urinalysis System; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Varnish, Cavity; Set, I.V. Fluid Transfer; Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group); System, Irrigation, Urological; Cannula, Manipulator/Injector, Uterine; Scissors, General, Surgical; Punch, Surgical; Dna-Reagents, Neisseria; Razor, Surgical; Helicobacter Pylori; Accessory, Surgical Apparel; Polymer Patient Examination Glove; Elastomer, Silicone, For Scar Management; Syringe, Antistick; Automated External Defibrillators (Non-Wearable); Dna Probe, Yeast; Electrode, Electrocardiograph, Multi-Function; Container, Sharps; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Tissue Adhesive For The Topical Approximation Of Skin; Bilirubin (Total And Unbound) In The Neonate Test System; System, X-Ray, Extraoral Source, Digital; Cord, Retraction; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Accessories, Arthroscopic; Accessories, Implant, Dental, Endosseous; Suture, Surgical, Absorbable, Polydioxanone; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Splint, Extremity, Non-Inflatable, External, Non-Sterile; Light Transmission Caries Detector; Endoscopic Ultrasound System, Gastroenterology-Urology; Non-Surgical Gown; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System",1; 2; 3; U,"ABSORBER, CARBON-DIOXIDE; ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION; AGENT, TOOTH BONDING, RESIN; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE; Attachment, breathing, positive end expiratory pressure; BUR, SURGICAL, GENERAL & PLASTIC SURGERY; Bandage, liquid; CATHETERS, SUCTION, TRACHEOBRONCHIAL; CEMENT, DENTAL; Cannula, manipulator/injector, uterine; Dressing, Wound, Drug; EBF - Material, tooth shade, resin KLE - AGENT, TOOTH BONDING, RESIN; Elastomer, silicone, for scar management; Electrode, electrocardiograph, multi-function; HANDPIECE, ROTARY BONE CUTTING; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE); Handpiece, air-powered, dental; Handpiece, contra- and right-angle attachment, dental; MASK, GAS, ANESTHETIC; MATERIAL, IMPRESSION; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER); Polymer patient examination glove; Protector, ostomy; RESIN, DENTURE, RELINING, REPAIRING, REBASING; SPIROMETER, DIAGNOSTIC DPS - Electrocardiograph; STRAP, HEAD, GAS MASK; STYLET, TRACHEAL TUBE; Set, administration, intravascular; Stocking, medical support (to prevent pooling of blood in legs); Suture, absorbable, synthetic, polyglycolic acid; TUBE, NASOGASTRIC; Tissue adhesive for the topical approximation of skin; Tray, catheterization, sterile urethral, with or without catheter (kit); Tube tracheostomy and tube cuff; Tube, tracheal (w/wo connector); Tube, tracheostomy (w/wo connector); Tubes, gastrointestinal (and accessories); Unit, operative dental; ZINC OXIDE EUGENOL",2026-02-08,213,2026-03-11,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223043226252%22&limit=1
"DePuy Mitek, Inc.",1221934,1221934,325 Paramount Dr,Raynham,MA,02767,United States,"DEPUY MITEK, A JOHNSON & JOHNSON COMPANY",1221934,Specification developer,82,EOB; FCW; FDC; FEM; FOX; FSM; FST; FSX; FTL; FWF; FZO; FZT; FZX; FZY; GAB; GAD; GAM; GAS; GAT; GCJ; GDX; GEA; GEF; GEG; GEI; GEN; GFG; GFJ; HCF; HNX; HRX; HSD; HSN; HTJ; HTN; HTO; HTQ; HTR; HTS; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWE; HWJ; HWK; HWM; HWR; HWT; HWX; HXB; HXC; HXD; HXG; HXX; JCY; JDB; JDC; JDR; JDW; JEB; KCT; KDD; KIJ; KQW; KWS; KWT; KYJ; LJH; LXH; MAI; MBF; MBI; NBH; NEW; NOV; PAO; PHX; PKC,"Nasopharyngoscope (Flexible Or Rigid); Light Source, Fiberoptic, Routine; Resectoscope, Working Element; Accessories, Photographic, For Endoscope (Exclude Light Sources); Stand, Infusion; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Light, Surgical, Connector; Mesh, Surgical, Polymeric; Camera, Television, Endoscopic, Without Audio; Chisel, Surgical, Manual; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Suturing, Disposable; Retractor; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Scalpel, One-Piece; Cannula, Surgical, General & Plastic Surgery; Applier, Staple, Surgical,; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Bit, Surgical; Mallet, Surgical, General & Plastic Surgery; Instrument, Ligature Passing And Knot Tying; Depressor, Orbital; Arthroscope; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Knife, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Driver, Prosthesis; Template; Tap, Bone; Probe; Wrench; Clamp; Tamp; Screwdriver; Catheter, Infusion; Prosthesis, Elbow, Semi-Constrained, Cemented; Prosthesis, Elbow, Constrained, Cemented; Staple, Fixation, Bone; Pin, Fixation, Threaded; Table, Surgical With Orthopedic Accessories, Manual; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment; Goniometer, Nonpowered; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Finger, Constrained, Polymer; System, Irrigation, Urological; Orthopedic Manual Surgical Instrument; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Fastener, Fixation, Nondegradable, Soft Tissue; Accessories, Arthroscopic; Suture, Surgical, Absorbable, Polydioxanone; Anchor, Suture, Bone Fixation, Metallic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained",1; 2,"2.3mm Side Effect Electrode; ACCLAIM; ACL GRAFT KNIVES; ADHOC CLAW; ADVANTAGE FIXATION SCREW SYSTEM; AGILITY; ARTHROSCOPE; ARTHROSCOPE (MULTIPLE BRANDS); Abs. Micro QA+; Absolute Absorbable; Anchor; Arthroscopic Equipment Cart; Arthroscopic Instruments; BIODHOC; BIOROC EZ SUTURE BONE FASTENER; BOLT; BONE(MULTIPLE BRANDS); Bio-Intrafix Screw/Sheath; BioFastin RC Anchor; Biocryl Interference Screws; Biocryl Rapide Interference Screw; Bioknotless Plus; Bioknotless Rapide; Bristow Latarjet; CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TIS; CANNULATED CROSS PIN SCREW SYSTEM; Camera Control System with Light Source and Light Guides; Camera Control Unit and Camera Head; Clearfix Meniscal Screw; Coupler; Cuff Link; CuffTack; DELTA CTA Shoulder System; DELTA XTEND; DELTA XTEND Reverse Shoulder System; DEPTH GUAGE; DYNACORD Suture; DYNATAPE Suture; DePuy Mitek Instrument; Drill bit; ELECTROSURGICAL SYSTEM; EYED NEEDLE; Electrode, Foot Pedal, Pump, Remote Control; FASTIN RC ANCHOR; FIXATION; FMS ARTHROSCOPY WORKING CANNULA; FMS Cannula; FMS Interface Cable Duo/Solo; FMS PROBE; FMS VUE II Fluid Management and Tissue Debridement System; FMS VUE system; FMS VUE™; Fastin Anchor; Fastin RC; Femoral Intrafix System; Fluid delivery tubing; GII; GII QA+ w #2 Orthocord; GLOBAL ADVANTAGE; GLOBAL AP; GLOBAL APG; GLOBAL APG+; GLOBAL CAP; GLOBAL ENABLE; GLOBAL FX; GLOBAL ICON; GLOBAL SHOULDER; GLOBAL STEPTECH; GLOBAL UNITE; GLOBAL UNITE Platform Shoulder System Short Stem; GRAFT KNIVES; GRYPHON Anchors with DYNACORD Suture; GRYPHON X Anchor; GRYPHON™ Flex Knotless Biocomposite Anchor; GRYPHON™ Flex Knotless PEEK Anchor; Global Shoulder; Global Unite Platform Shoulder System; Gryphon; Gryphon Anchor w/ProKnot; Gryphon Anchor w/ProKnot Technology; Gryphon Anchors; Gryphon P BR; Gryphon T BR; Gryphon T and P BR Anchors; HD Arthroscope; HEALIX ADVANCE Anchor with DYNACORD Suture; HEALIX ADVANCE Anchor with PERMATAPE Suture; HEALIX ADVANCE Knotless Anchors; HEALIX ADVANCE PEEK ANCHOR; HEALIX ADVANCE PEEK Anchor with DYNATAPE Suture; HEALIX ADVANCE SP BIOCOMPOSITE Anchor; HEALIX ADVANCE SP PEEK Anchor; HEALIX ADVANCE Self-Punching Anchors; HEALIX TI™ 3 SUTURE ANCHOR with DYNACORD™; HEALIX TI™ ANCHOR with DYNACORD™; HEALIX TI™ ANCHOR with DYNACORD™ AND NEEDLES; HEALIX TRANSTEND Anchor; HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture; Healix Advance; Healix Advance Anchors with Dyna+Tape Sutures; Healix Advance Anchors with Permacord Suture; Healix Advance Knotless; Healix Advance Knotless BR Anchor; Healix Advance Knotless PEEK Anchor; Healix BR Anchor, Healix PEEK Anchor, Healix Transtend and more.; Healix Knotless PEEK Anchor; Healix PEEK; Healix Ti; Healix Ti anchor with Permacord suture; Healix TransTend Anchors; IDEAL Suture Shuttle, Suture Grasper, Knot Manipulator, Suture Leader Caddy; INHANCE Shoulder System; INSERTER; INTRAFIX Advance; IRRIGATION; Intrafix PEEK Tapered Screw; Intrafix Tibial Sheath; KNOT PUSHER; Laparoscopes; Latarjet; Light Adaptor; Light Guide; LinX HT; Lupine Loop Plus Anchor; Lupine Loop Rapide; MENISCAL DART REPAIR SYSTEM; MICRO QUICKANCHOR; MITEK DRILL; MITEK DRILL GUIDE; MITEK INSERTERS; MITEK KDI; MITEK STERILIZATION TRAY; MULTIPLE ANCHORS; MULTIPLE CANNULAE; MULTIPLE GUIDES; MULTIPLE SUTURE GRASPER; MULTIPLE WASHER; Micro QA+; MicroFix QA+; Milagro Advance Interference Screw; Milagro Advance PEEK; Milagro Interference Screw; Milagro Interference Screws; Milagro/Milagro Advance Screw; Mini Anchor; Mini QA+; Mini Quick Anchor Plus; MiniROC; Minilok QA+; Mitek MILAGRO ADVANCE Screw; Mitek QuickAnchor; NEUFLEX; NUT; OMNICUT Resection Blade; ORBITAL; ORTHOCORD SUTURE; OVS1 Video System; Omnispan Meniscal Repair System; Orthocord; Orthocord - Blue; P50; PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM; PERIOSTEAL ELEVATOR; PERMATAPE; PUREVUE; Panalok; Panalok Loop; Panalok RC Dual Suture; Permaloop Suture; Permatape Suture; Quickanchor; RC; RC/GII; RIDIDFIX; RIGIDFIX BTB Cross Pin Kit; RIGIDFIX Curve; RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM; ROC; ROC EZ; RapidLoc; RigidFix Biocryl; RigidFix Biocryl Cross Pin Kit; RigidFix PLA; RigidLoop; RigidLoop Adjustable Cortical Fixation System; Rigidloop Cortical Fixation System XL Implant; Rigidloop Disposable Kit; Rigidloop Titanium Button; S90 Electrode with Handcontrols; SCREW; SINUSCOPE; STERILIZATION TRAY; STRICKLAND; SUTURE; SUTURE CUTTER; Screw; Shoulder instruments; Single and Double Arm Meniscal Needles; SlingShot; Spiralok; Super Anchor; Super Anchor - Orthocord; TALON ANCHOR SNAP-PAK; TIBIAL FIXATION FASTENER; TIGHT-N Tendon Docking Anchor; TROCARS, SHEATHS, OBTURATORS; Truespan; Tube Set, Shaver Blades, Cutter, Cutter Shaver, Burr, Hand Control Interface, Foot Pedal, Tube Set.; Tubing; UROLOGICAL(MULTIPLE); VAPR 2.3mm End Effect Electrode; VAPR 2.3mm Wedge Electrode; VAPR ARCTIC Suction Electrode; VAPR Electrode w/Integrated Handpiece; VAPR II Generator & TC Electrode; VAPR P50 Electrode; VAPR P50 Electrode with Handcontrols; VAPR S50 Electrode; VAPR S90 Electrode; VAPR S90 Electrode with Handcontrols; VAPR VUE Radiofrequency System; Vapr ""T"" Electrode; Vapr Vue Generator, Vapr 3 Electrosurgical; Versalok Pre-packed W/Orthocord; duo+ and solo",1992-07-22,212,2026-02-26,0,26,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221221934%22&limit=1
Canon Inc.,9614698,3002808382,"1385, Shimoishigami",OTAWARA-SHI Tochigi,,324-8550,Japan,CANON INC.,8030410,Contract manufacturer; Manufacturer,22,CEM; CFR; CGZ; DHA; ITX; IYL; IYN; IYO; IZI; JAA; JAK; JGS; JJE; KPS; LLZ; LNH; MOS; MQB; OWB; QCD; QHJ; QIH,"Electrode, Ion Specific, Potassium; Hexokinase, Glucose; Electrode, Ion-Specific, Chloride; System, Test, Human Chorionic Gonadotropin; Transducer, Ultrasonic, Diagnostic; Collimator, Dermatological, Therapeutic X-Ray; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Tomography, Computed; Electrode, Ion Specific, Sodium; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; System, Tomography, Computed, Emission; System, Image Processing, Radiological; System, Nuclear Magnetic Resonance Imaging; Coil, Magnetic Resonance, Specialty; Solid State X-Ray Imager (Flat Panel/Digital Imager); Interventional Fluoroscopic X-Ray System; Continuous Glucose Monitor, Implanted, Adjunctive Use; Sensor, Glucose, Implanted, Non-Adjunctive Use; Automated Radiological Image Processing Software",1; 2; 3,"APLIO A550, APLIO A450, AND APLIO A, DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V6.5; APLIO A550, APLIO A450, APLIO A, DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V5.1; APLIO I900/I800/I700 DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V7 (TUS-AI900, TUS-AI800, TUS-AI700); AQUILION LIGHTNING (TSX-035A/2, V7); AQUILION LIGHTNING (TSX-036A/7) V10.2 WITH AICE-I; AQUILION ONE (TSX-301C); AQUILION ONE (TSX-305A/3) V8.3 WITH FIRST 2.1; AQUILION ONE (TSX-306A/3) V10 WITH SPECTRAL IMAGING SYSTEM; AQUILION ONE (TSX-306A/3) V10.12 WITH SPECTRAL IMAGING SYSTEM, VITREA SOFTWARE PACKAGE, VSTP-001A; AQUILION ONE (TSX-306A/3) V10.4 WITH SPECTRAL IMAGING SYSTEM; AQUILION ONE (TSX-308A/3) V1.5; AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM; AQUILION ONE VISION, V4.90 (TSX-301C); AQUILION PRECISION (TSX-304A/4) V10.10 WITH AICE; AQUILION PRIME (TSX-302); AQUILION PRIME SP (TSX-303B8) V10.2 WITH AICE-I; AQUILION SERVE (TSX-307A/1) V1.3; Adaptive Motion Correction (AMC) and 4D Airways Analysis; Alinity C Processing Module (03R67-01); Alinity c Processing Module (03R67-01); Alphenix INFX-8000C/B v8; Alphenix INFX-8000F/B v8; Alphenix INFX-8000H/B v8; Alphenix INFX-8000V/B v8; Alphenix, INFX-8000C/B, INFX-8000C/S v9.2; Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5; Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging; Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension); Alphenix, INFX-8000V/S v9.1; Angio Workstation (Alphenix Workstation), V9.3; Aplio 500/400/300 (v3); Aplio 500/400/300 Diagnostic Ultrasound System, v5; Aplio 500/400/300 Diagnostic Ultrasound System, v6; Aplio 500/400/300 v4 Diagnostic Ultrasound System; Aplio 550a/450a/a Diagnostic Ultrasound System Models CUS-AA550/AA450/AA000; Aplio A500/A400/A300; Aplio A500/A400/A300 (V2.1); Aplio A550 (CUS-AA550) Aplio A450A (CUS-AA450) v2.8 Diagnostic Ultrasound System; Aplio Artida V2 SSH-880CV; Aplio Artida V3 SSH-880CV; Aplio Artida v3.2 SSH-880CV; Aplio MX v1 SSA-780A; Aplio XG v4 SSA-790A; Aplio beyond and Aplio me Software V2 Diagnostic Ultrasound System; Aplio flex (CUS-AFL00) and Aplio go (CUS-AGG00) Software V2 Diagnostic Ultrasound System; Aplio i900 (TUS-AI900), Aplio i800 (TUS-AI800) and Aplio i700 (TUS-AI700) Software V8.1 Diagnostic Ultrasound System; Aplio i900, Aplio i800 and Aplio i700 Software V9; Aplio i900/i800/i700 (TUS-AI900, TUS-AI800, TUS-AI700) Diagnostic Ultrasound System v6.5; Aplio i900/i800/i700 (TUS-AI900, TUS-AI800, TUS-AI700) Diagnostic Ultrasound System, Software V5.1; Aplio i900/i800/i700 (TUS-AI900, TUS-AI800, TUS-AI700)Diagnostic Ultrasound System, Software V7; Aplio i900/i800/i700 (TUS-AI900/AI800/AI700); Aplio i900/i800/i700 Diagnostic Ultrasound System v2.1; Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5; Aplio i900/i800/i700/i600 (TUS-AI900, TUS-AI800, TUS-AI700, TUS-AI600) Diagnostic Ultrasound System v2.4; Aplio i900/i800/i700/i600 (TUS-AI900, TUS-AI800, TUS-AI700, TUS-AI600) Diagnostic Ultrasound System v3.1; Aplio i900/i800/i700/i600 (TUS-AI900, TUS-AI800, TUS-AI700, TUS-AI600) Diagnostic Ultrasound System v4; Aplio v5.5 SSA-770A; Aquilion CXL TSX-101A/Q; Aquilion Exceed LB (TSX-202A/3) v10.6 with AiCE-1; Aquilion Exceed LB (TSX-202A/3) v10.9 with AiCE-i; Aquilion LB TSX-201A/3 v6; Aquilion LB Triton TSX-201A/2 v4.91; Aquilion Lightning TSX-035A/4 and/5 v7; Aquilion Lightning TSX-036A/1 v8.4; Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System; Aquilion ONE (TSX-308A/TSX-306A) V2; Aquilion ONE Vision with FIRST 2 (CCRS-001B) V7.4; Aquilion One (TSX-305A/6) v8.9 with AiCe; Aquilion One (TSX-306A/3) v10; Aquilion One Genesis TSX-305A/3 v7.3; Aquilion One Self Propelled Scan Base Kit for IVR-CT (TSX-301C); Aquilion One TSX-301A CT w/4.7ER Software; Aquilion One Vision TSX-301C/1 and TSX-301C/2 v6; Aquilion One Vision TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v8; Aquilion One Vision TSX-301C/3, C/4, C5 V6; Aquilion One Vision with First 1 (CCRS-001A) TSX-301C/6,/7,/8 v7.1; Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE; Aquilion Precision TSX-304A/2 v8.6 with First 3; Aquilion Premium (TSX-301B); Aquilion Prime CT TSX-302A/2; Aquilion Prime SP TSX-303B/1, v8.4; Aquilion Prime Self Propelled Scan Base Kit for IVR CT CGBA-032A TSX-303A; Aquilion Prime TSX-303A/2 & TSX-303A/6 v50; Aquilion Prime TSX-303A/A, /B and F, v6; Aquilion RXL (TSX-101A/R); Aquilion Self Propelled Scan Base Kit for IVR-CT CGBA-034A; Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i; Aquilion Serve SP (TSX-307B) V2; Aquilion Serve SP (TSX-307B/1) V1.3; Architect c16000 Processing Module (03L77-01); Architect c4000 Processing Module (02P24-01); Architect c4000 Processing Module (02P24-40); Architect c8000 Processing Module (01G06-11); CARTESION PRIME (PCD-1000A/3) V10.15; CARTESION PRIME, PCD-1000A, V10.7; CELESTEION, PCA-9000A/3; CELESTEION, PCA-9000A/3, V6.5; CT SCANNER TSX-501R/1 V11.1; Cartesion Prime (PCD-1000A/3) V10.21; Cartesion Prime PCD-1000A; Cartesion Prime PCD-1000A/3 v10.8 with PET-AiCE; Celestion PCA-9000A/2; DUAL ENERGY SYSTEM PACKAGE; EC9-4; VF7-3; C5-2 (TMSC Contract Manufacturer for Siemens); Eversense Continuous Glucose Monitoring System; Eversense E3 Continuous Glucose Monitoring System; Excelart Vantage Atlas, MRT 1503/S5 & S3; Famio SSA-530A; ICT Module (09D28-04); INFX-8000C v6.20; INFX-8000V (Infinix Vfi & Infinix Cfi) v5.30; INFX-8000V Wireless FootSwitch XBFS-880WS; INFX-8000V v6.20; INFX-8000V v6.35; INFX-8000V with 3DRM; INFX-8000V, INFINIX-CFI AND INFINIX VFI; INFX-8000v v6.40; Infinix 8000C with Spot Fluoro; Infinix V with 56 Inch Monitor; Infinix-CSi and Infinix DPi, INFX-8000F; Infinix-i INFX-8000H; Infinix-i, INFX-8000V, V7; JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X; Just Vision SSA320A/SSA-325A; Kalare X-Ray System (DREX-KL80); Kalare with FPD (DREX-KL80); MJAH-137A Atlas Speeder Coil; MJAH-167A Octave Speeder Head Coil; MJAJ-192A 4ch Flex Speeder Coil; MJAJ-197A 4ch Flex Speeder Coil; MJAS-167A Octave Speeder Spine Coil; MJQJ-167A; MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM; MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI); Nemio Diagnostic Ultrasound System; Nemio XG SSA-580; PET-512MC Multiplane Transesophageal Transducer; Radrex-I DRAD-3000E v4; Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP; TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER; TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING; Titan 1.5T with HSR; Titan 3T MRT-3010/A5 (MRA); USWP-100A/4D Viewer; Ultimax 1 FPD DREX-U180; Ultimax-I DREX-UI80 v1.60; Ultimax-i DREX-UI80 v1.60 (with TFP-1417W Wireless Detector); UltraExtend FX; UltraExtend NX CUW-U001S Ultrasound Image Analysis Program; UltraExtend, USWS-900A; UltraExtend, USWS-900A, v2.1 and 3.1; VANTAGE ELAN 1.5T, MRT-2020, V6; VANTAGE GALAN 3T, MRT-3020, V6 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR; VANTAGE GALAN 3T, MRT-3020, V7 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR; VANTAGE ORIAN 1.5T, MRT-1550, V6; VANTAGE ORIAN 1.5T, MRT-1550, V6 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR; VANTAGE ORIAN 1.5T, MRT-1550, V7 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR; VITREA SOFTWARE PACKAGE, VSTP-001A; VITREA SOFTWARE PACKAGE, VSTP-002A V2; Vantage Elan 1.5T v4; Vantage Elan MRT-2020; Vantage Fortian / Orian 1.5T, MRT-1550, V10 with AiCE Reconstruction Processing Unit for MR; Vantage Fortian / Orian 1.5T, MRT-1550, V9 with AiCE; Vantage Fortian 1.5T, MRT-1550, v8 with AiCE Reconstruction Processing Unit for MR; Vantage Fortian/Orian 1.5 T, MRT-1550, V8 with AiCE Reconstruction Processing Unit for MR; Vantage Fortian/Orian 1.5T, MRT-1550, V8 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T MRT-3020 V6; Vantage Galan 3T MRT-3020 v4; Vantage Galan 3T MRT-3020 v4.6; Vantage Galan 3T MRT-3020 v6 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T MRT-3020 v7 SP0050* with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T MRT-3020/A7 v5; Vantage Galan 3T MRT-3020/A9 v5; Vantage Galan 3T, MRT-3020, V10 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T, MRT-3020, V8 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T, MRT-3020, V9 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T,MRT-3020, V10 with AiCE Reconstruction Processing Unit for MR; Vantage Orian 1.5T MRT-1550 v4.5; Vantage Orian 1.5T MRT-1550 v6; Vantage Orian 1.5T MRT-1550 v6 with AiCE Reconstruction Processing Unit for MR; Vantage Orian 1.5T MRT-1550 v7 with AiCE Reconstruction Processing Unit for MR; Vantage Titan; Vantage Titan 1.5 MRT-1510 v3.1; Vantage Titan 1.5T MRT-1510 v3.6; Vantage Titan 3T MRT-3010 v2.5; Vantage Titan 3T MRT-3010 v3.5; Vantage Titan 3T MRT-3010/A5; Vantage Titan 3T MRT-3010/A7 M-Power GX; Vantage Titan MRT-1504/U4; Vantage Titan MRT-1504/U5; Vantage Titan MRT-1510 v4 M Power GX; Vantage Titan MRT-3010/A5; Vantage Titan MRT-3010/A5 v2.30; Viamo c100 TUS-VC-100 Diagnostic Ultrasound System; Viamo v2 SSA-640A; Viamo v4 SSA-640; Vitrea Software Package, VSTP-002A; Vitrea Software Toshiba Package VSTP-001A; XARIO 100 DIAGNOSTIC ULTRASOUND SYSTEM, V5; XIDF -AWS801 v7 Angio Workstation; XIDF-AWS801 v4.51 Angio Workstation; XIDF-AWS801 v5.31 Angio Workstation; XIDF-AWS801 v6.10 Angio Workstation; XIDF-AWS801 v6.20 Angio Workstation; XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5; XIDF-AWS801A Angio Workstation Alphenix Worksation v8; Xario 100 TUS-X100 and X100S v3; Xario 100 v1 TUS-X100 & TUSX-100S; Xario 200 (TUS-X200, TUS-X200S) Diagnostic Ultrasound System v 6; Xario 200 TUS-X200 and TUS-X200S v5; Xario 200 TUS-X200 and X200S v3; Xario 200 TUS-X200/X200S v1; Xario 200G (CUS-X200G) and Xario 100G (CUS-X100G) v1.1 Diagnostic Ultrasound System; Xario XG SSA-680",2023-07-12,211,2026-05-20,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229614698%22&limit=1
Canon Inc.,3012761544,3012761544,"30-2 Shimomaruko, 3-Chome --",OHTA-KU Tokyo,,146-8501,Japan,CANON INC.,8030410,Specification developer,16,ITX; IYL; IYN; IYO; IZI; JAA; JAK; KPS; LLZ; LNH; MOS; MQB; OWB; QCD; QHJ; QIH,"Transducer, Ultrasonic, Diagnostic; Collimator, Dermatological, Therapeutic X-Ray; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Tomography, Computed; System, Tomography, Computed, Emission; System, Image Processing, Radiological; System, Nuclear Magnetic Resonance Imaging; Coil, Magnetic Resonance, Specialty; Solid State X-Ray Imager (Flat Panel/Digital Imager); Interventional Fluoroscopic X-Ray System; Continuous Glucose Monitor, Implanted, Adjunctive Use; Sensor, Glucose, Implanted, Non-Adjunctive Use; Automated Radiological Image Processing Software",2; 3,"APLIO A550, APLIO A450, AND APLIO A, DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V6.5; APLIO A550, APLIO A450, APLIO A, DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V5.1; APLIO I900/I800/I700 DIAGNOSTIC ULTRASOUND SYSTEM, SOFTWARE V7 (TUS-AI900, TUS-AI800, TUS-AI700); AQUILION LIGHTNING (TSX-035A/2, V7); AQUILION LIGHTNING (TSX-036A/7) V10.2 WITH AICE-I; AQUILION ONE (TSX-301C); AQUILION ONE (TSX-305A/3) V8.3 WITH FIRST 2.1; AQUILION ONE (TSX-306A/3) V10 WITH SPECTRAL IMAGING SYSTEM; AQUILION ONE (TSX-306A/3) V10.12 WITH SPECTRAL IMAGING SYSTEM, VITREA SOFTWARE PACKAGE, VSTP-001A; AQUILION ONE (TSX-306A/3) V10.4 WITH SPECTRAL IMAGING SYSTEM; AQUILION ONE (TSX-308A/3) V1.5; AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM; AQUILION ONE VISION, V4.90 (TSX-301C); AQUILION PRECISION (TSX-304A/4) V10.10 WITH AICE; AQUILION PRIME (TSX-302); AQUILION PRIME SP (TSX-303B8) V10.2 WITH AICE-I; AQUILION SERVE (TSX-307A/1) V1.3; Adaptive Motion Correction (AMC) and 4D Airways Analysis; Alphenix INFX-8000C/B v8; Alphenix INFX-8000F/B v8; Alphenix INFX-8000H/B v8; Alphenix INFX-8000V/B v8; Alphenix, INFX-8000C/B, INFX-8000C/S v9.2; Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5; Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging; Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension); Alphenix, INFX-8000V/S v9.1; Angio Workstation (Alphenix Workstation), V9.3; Aplio 500/400/300 (v3); Aplio 500/400/300 Diagnostic Ultrasound System, v5; Aplio 500/400/300 Diagnostic Ultrasound System, v6; Aplio 500/400/300 v4 Diagnostic Ultrasound System; Aplio 550a/450a/a Diagnostic Ultrasound System Models CUS-AA550/AA450/AA000; Aplio A500/A400/A300; Aplio A500/A400/A300 (V2.1); Aplio A550 (CUS-AA550) Aplio A450A (CUS-AA450) v2.8 Diagnostic Ultrasound System; Aplio Artida V2 SSH-880CV; Aplio Artida V3 SSH-880CV; Aplio Artida v3.2 SSH-880CV; Aplio MX v1 SSA-780A; Aplio XG v4 SSA-790A; Aplio beyond and Aplio me Software V2 Diagnostic Ultrasound System; Aplio flex (CUS-AFL00) and Aplio go (CUS-AGG00) Software V2 Diagnostic Ultrasound System; Aplio i900 (TUS-AI900), Aplio i800 (TUS-AI800) and Aplio i700 (TUS-AI700) Software V8.1 Diagnostic Ultrasound System; Aplio i900, Aplio i800 and Aplio i700 Software V9; Aplio i900/i800/i700 (TUS-AI900, TUS-AI800, TUS-AI700) Diagnostic Ultrasound System v6.5; Aplio i900/i800/i700 (TUS-AI900, TUS-AI800, TUS-AI700) Diagnostic Ultrasound System, Software V5.1; Aplio i900/i800/i700 (TUS-AI900, TUS-AI800, TUS-AI700)Diagnostic Ultrasound System, Software V7; Aplio i900/i800/i700 (TUS-AI900/AI800/AI700); Aplio i900/i800/i700 Diagnostic Ultrasound System v2.1; Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5; Aplio i900/i800/i700/i600 (TUS-AI900, TUS-AI800, TUS-AI700, TUS-AI600) Diagnostic Ultrasound System v2.4; Aplio i900/i800/i700/i600 (TUS-AI900, TUS-AI800, TUS-AI700, TUS-AI600) Diagnostic Ultrasound System v3.1; Aplio i900/i800/i700/i600 (TUS-AI900, TUS-AI800, TUS-AI700, TUS-AI600) Diagnostic Ultrasound System v4; Aplio v5.5 SSA-770A; Aquilion CXL TSX-101A/Q; Aquilion Exceed LB (TSX-202A/3) v10.6 with AiCE-1; Aquilion Exceed LB (TSX-202A/3) v10.9 with AiCE-i; Aquilion LB TSX-201A/3 v6; Aquilion LB Triton TSX-201A/2 v4.91; Aquilion Lightning TSX-035A/4 and/5 v7; Aquilion Lightning TSX-036A/1 v8.4; Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System; Aquilion ONE (TSX-308A/TSX-306A) V2; Aquilion ONE Vision with FIRST 2 (CCRS-001B) V7.4; Aquilion One (TSX-305A/6) v8.9 with AiCe; Aquilion One (TSX-306A/3) v10; Aquilion One Genesis TSX-305A/3 v7.3; Aquilion One Self Propelled Scan Base Kit for IVR-CT (TSX-301C); Aquilion One TSX-301A CT w/4.7ER Software; Aquilion One Vision TSX-301C/1 and TSX-301C/2 v6; Aquilion One Vision TSX-301C/1, /2, /3, /4, /5, /6, /7, /8, v8; Aquilion One Vision TSX-301C/3, C/4, C5 V6; Aquilion One Vision with First 1 (CCRS-001A) TSX-301C/6,/7,/8 v7.1; Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE; Aquilion Precision TSX-304A/2 v8.6 with First 3; Aquilion Premium (TSX-301B); Aquilion Prime CT TSX-302A/2; Aquilion Prime SP TSX-303B/1, v8.4; Aquilion Prime Self Propelled Scan Base Kit for IVR CT CGBA-032A TSX-303A; Aquilion Prime TSX-303A/2 & TSX-303A/6 v50; Aquilion Prime TSX-303A/A, /B and F, v6; Aquilion RXL (TSX-101A/R); Aquilion Self Propelled Scan Base Kit for IVR-CT CGBA-034A; Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i; Aquilion Serve SP (TSX-307B) V2; Aquilion Serve SP (TSX-307B/1) V1.3; CARTESION PRIME (PCD-1000A/3) V10.15; CARTESION PRIME, PCD-1000A, V10.7; CELESTEION, PCA-9000A/3; CELESTEION, PCA-9000A/3, V6.5; CT SCANNER TSX-501R/1 V11.1; Cartesion Prime (PCD-1000A/3) V10.21; Cartesion Prime PCD-1000A; Cartesion Prime PCD-1000A/3 v10.8 with PET-AiCE; Celestion PCA-9000A/2; DUAL ENERGY SYSTEM PACKAGE; Eversense Continuous Glucose Monitoring System; Eversense E3 Continuous Glucose Monitoring System; Excelart Vantage Atlas, MRT 1503/S5 & S3; Famio SSA-530A; INFX-8000C v6.20; INFX-8000V (Infinix Vfi & Infinix Cfi) v5.30; INFX-8000V Wireless FootSwitch XBFS-880WS; INFX-8000V v6.20; INFX-8000V v6.35; INFX-8000V with 3DRM; INFX-8000V, INFINIX-CFI AND INFINIX VFI; INFX-8000v v6.40; Infinix 8000C with Spot Fluoro; Infinix V with 56 Inch Monitor; Infinix-CSi and Infinix DPi, INFX-8000F; Infinix-i INFX-8000H; Infinix-i, INFX-8000V, V7; JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X; Just Vision SSA320A/SSA-325A; Kalare X-Ray System (DREX-KL80); Kalare with FPD (DREX-KL80); MJAH-137A Atlas Speeder Coil; MJAH-167A Octave Speeder Head Coil; MJAJ-192A 4ch Flex Speeder Coil; MJAJ-197A 4ch Flex Speeder Coil; MJAS-167A Octave Speeder Spine Coil; MJQJ-167A; MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM; MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI); Nemio Diagnostic Ultrasound System; Nemio XG SSA-580; PET-512MC Multiplane Transesophageal Transducer; Radrex-I DRAD-3000E v4; Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6 with Calculated DAP; TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER; TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING; Titan 1.5T with HSR; Titan 3T MRT-3010/A5 (MRA); USWP-100A/4D Viewer; Ultimax 1 FPD DREX-U180; Ultimax-I DREX-UI80 v1.60; Ultimax-i DREX-UI80 v1.60 (with TFP-1417W Wireless Detector); UltraExtend FX; UltraExtend NX CUW-U001S Ultrasound Image Analysis Program; UltraExtend, USWS-900A; UltraExtend, USWS-900A, v2.1 and 3.1; VANTAGE ELAN 1.5T, MRT-2020, V6; VANTAGE GALAN 3T, MRT-3020, V6 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR; VANTAGE GALAN 3T, MRT-3020, V7 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR; VANTAGE ORIAN 1.5T, MRT-1550, V6; VANTAGE ORIAN 1.5T, MRT-1550, V6 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR; VANTAGE ORIAN 1.5T, MRT-1550, V7 WITH AICE RECONSTRUCTION PROCESSING UNIT FOR MR; VITREA SOFTWARE PACKAGE, VSTP-001A; VITREA SOFTWARE PACKAGE, VSTP-002A V2; Vantage Elan 1.5T v4; Vantage Elan MRT-2020; Vantage Fortian / Orian 1.5T, MRT-1550, V10 with AiCE Reconstruction Processing Unit for MR; Vantage Fortian / Orian 1.5T, MRT-1550, V9 with AiCE; Vantage Fortian 1.5T, MRT-1550, v8 with AiCE Reconstruction Processing Unit for MR; Vantage Fortian/Orian 1.5 T, MRT-1550, V8 with AiCE Reconstruction Processing Unit for MR; Vantage Fortian/Orian 1.5T, MRT-1550, V8 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T MRT-3020 V6; Vantage Galan 3T MRT-3020 v4; Vantage Galan 3T MRT-3020 v4.6; Vantage Galan 3T MRT-3020 v6 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T MRT-3020 v7 SP0050* with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T MRT-3020/A7 v5; Vantage Galan 3T MRT-3020/A9 v5; Vantage Galan 3T, MRT-3020, V10 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T, MRT-3020, V8 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T, MRT-3020, V9 with AiCE Reconstruction Processing Unit for MR; Vantage Galan 3T,MRT-3020, V10 with AiCE Reconstruction Processing Unit for MR; Vantage Orian 1.5T MRT-1550 v4.5; Vantage Orian 1.5T MRT-1550 v6; Vantage Orian 1.5T MRT-1550 v6 with AiCE Reconstruction Processing Unit for MR; Vantage Orian 1.5T MRT-1550 v7 with AiCE Reconstruction Processing Unit for MR; Vantage Titan; Vantage Titan 1.5 MRT-1510 v3.1; Vantage Titan 1.5T MRT-1510 v3.6; Vantage Titan 3T MRT-3010 v2.5; Vantage Titan 3T MRT-3010 v3.5; Vantage Titan 3T MRT-3010/A5; Vantage Titan 3T MRT-3010/A7 M-Power GX; Vantage Titan MRT-1504/U4; Vantage Titan MRT-1504/U5; Vantage Titan MRT-1510 v4 M Power GX; Vantage Titan MRT-3010/A5; Vantage Titan MRT-3010/A5 v2.30; Viamo c100 TUS-VC-100 Diagnostic Ultrasound System; Viamo v2 SSA-640A; Viamo v4 SSA-640; Vitrea Software Package, VSTP-002A; Vitrea Software Toshiba Package VSTP-001A; XARIO 100 DIAGNOSTIC ULTRASOUND SYSTEM, V5; XIDF -AWS801 v7 Angio Workstation; XIDF-AWS801 v4.51 Angio Workstation; XIDF-AWS801 v5.31 Angio Workstation; XIDF-AWS801 v6.10 Angio Workstation; XIDF-AWS801 v6.20 Angio Workstation; XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5; XIDF-AWS801A Angio Workstation Alphenix Worksation v8; Xario 100 TUS-X100 and X100S v3; Xario 100 v1 TUS-X100 & TUSX-100S; Xario 200 (TUS-X200, TUS-X200S) Diagnostic Ultrasound System v 6; Xario 200 TUS-X200 and TUS-X200S v5; Xario 200 TUS-X200 and X200S v3; Xario 200 TUS-X200/X200S v1; Xario 200G (CUS-X200G) and Xario 100G (CUS-X100G) v1.1 Diagnostic Ultrasound System; Xario XG SSA-680",2023-07-12,211,2026-05-20,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012761544%22&limit=1
"Coopersurgical, Inc.",1216677,1216677,95 Corporate Drive,Trumbull,CT,06611,United States,"COOPERSURGICAL, INC.",9002384,Complaint file establishment; Contract manufacturer; Manufacturer; Repackager or relabeler; Specification developer,98,BSY; BZC; BZD; CBH; DPW; DRC; DXN; EME; FAJ; FAX; FCZ; FEN; FER; FFP; FHO; FHQ; FLL; FSM; FZS; GAB; GAD; GAH; GCJ; GCX; GDW; GDX; GEH; GEI; GEN; GEX; HCY; HDB; HDK; HDL; HDQ; HDR; HDW; HEE; HEK; HEP; HES; HET; HEW; HEX; HFB; HFC; HFE; HFF; HGE; HGI; HHK; HHM; HHT; HHW; HIB; HIG; HIH; HQA; HTD; IMD; ITX; IYO; JAF; JAY; JOL; JOP; KDC; KGX; KGY; KNA; KNG; KOA; KOH; KYZ; LKF; LRW; MAA; MDM; MFD; MJG; MPO; MQE; MQF; MQG; MQH; MQK; MQL; NNK; OCX; ODC; OQY; PCF; PFJ; POV; PUB; PUC; PWB; QQS,"Catheters, Suction, Tracheobronchial; Calculator, Pulmonary Function Data; Ventilator, Non-Continuous (Respirator); Device, Fixation, Tracheal Tube; Flowmeter, Blood, Cardiovascular; Trocar; System, Measurement, Blood-Pressure, Non-Invasive; Punch, Biopsy, Surgical; Cystoscope And Accessories, Flexible/Rigid; Bougie, Urological; Tube, Smoke Removal, Endoscopic; Device, Cystometric, Hydraulic; Anoscope And Accessories; Dilator, Rectal; Pneumoperitoneum Needle; Holder, Needle, Gastroenterologic; Continuous Measurement Thermometer; Tray, Surgical, Instrument; Curette, Surgical, General Use; Needle, Suturing, Disposable; Retractor; Stylet, Surgical, General & Plastic Surgery; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Staple, Implantable; Scalpel, One-Piece; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Powered Laser Surgical Instrument; Curette, Uterine; Extractor, Vacuum, Fetal; Scissors, Episiotomy; Retractor, Vaginal; Dilator, Cervical, Fixed Size; Cap, Cervical; Diaphragm, Contraceptive (And Accessories); Set, Anesthesia, Paracervical; Monitor, Heart Sound, Fetal, Ultrasonic; Monitor, Blood-Flow, Ultrasonic; Insufflator, Carbon-Dioxide, Uterotubal (And Accessories); Laparoscope, Gynecologic (And Accessories); Culdoscope (And Accessories); Colposcope (And Colpomicroscope); Forceps, Biopsy, Gynecological; Aspirator, Endocervical; Brush, Endometrial; Aspirator, Endometrial; Amniotome; Electrocautery, Gynecologic (And Accessories); Curette, Suction, Endometrial (And Accessories); Sound, Uterine; Spatula, Cervical, Cytological; Pessary, Vaginal; Speculum, Vaginal, Nonmetal; Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Unit, Cryotherapy, Ophthalmic; Forceps; Pack, Hot Or Cold, Disposable; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; Monitor, Ultrasonic, Nonfetal; Support, Breathing Tube; Catheter And Tip, Suction; Transducer, Ultrasonic; Instrument, Surgical, Disposable; Tape And Bandage, Adhesive; Bag, Intestine; Instrument, Manual, Specialized Obstetric-Gynecologic; Monitor, Ultrasonic, Fetal; Surgical Instruments, G-U, Manual (And Accessories); Instrument, Manual, General Obstetric-Gynecologic; Syringe, Irrigating (Non Dental); Cannula, Manipulator/Injector, Uterine; Scissors, General, Surgical; Monitor, Fetal Doppler Ultrasound; Instrument, Manual, Surgical, General Use; Cannula, Intrauterine Insemination; Device, Percutaneous, Biopsy; Infant Heel Warmer (Chemical Heat Pack); Needle, Assisted Reproduction; Catheter, Assisted Reproduction; Accessory, Assisted Reproduction; Microtools, Assisted Reproduction (Pipettes); Labware, Assisted Reproduction; Media, Reproductive; Container, Specimen Mailer And Storage, Non-Sterile; Endoscopic Irrigation/Suction System; Endoscope Channel Accessory; Intrauterine Tamponade Balloon; Sampler, Endocervical; Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor; Semen Analysis Device; Accessory, Assisted Reproduction, Exempt; Microtools, Assisted Reproduction (Pipettes), Exempt; Fetal Head Elevator; Stapler, Skin",1; 2,"10100060A, 10105060A, 10100500A; 10100060D, 10105060D, 10100500D; 10100060F, 10105060F, 10100500F; 10100060M, 10105060M, 10100500M; 10264010A, 10984010A; 10264010D, 10984010D; 10264010F, 10984010F; 10300060, 10301010, 10305060, 10310060, 10311010, 10315060; 10300060A, 10301010A, 10305060A, 10310060A, 10311010A, 10315060A; 10300060D, 10301010D, 10305060D, 10310060D, 10311010D, 10315060D; 10300060F, 10301010F, 10305060F, 10310060F, 10311010F, 10315060F; 10300060M, 10301010M, 10305060M, 10310060M, 10311010M, 10315060M; 10520010, 11520010; 10520010A, 11520010A; 10520010D, 11520010D; 10520010F, 11520010F; 10520010M, 11520010M; 10532010F; 10542010; 10542010A; 10542010D; 10542010F; 10542010M; 10620010; 10620010A; 10620010D; 10620010F; 10620010M; 10670010A; 10670010D; 10670010F; 10670010M; 10690060A, 10691010A, 10695060A, 10700060A, 10701010A, 10702010A, 10705060A; 10690060D, 10691010D, 10695060D, 10700060D, 10701010D, 10702010D, 10705060D; 10690060F, 10691010F, 10695060F, 10700060F, 10701010F, 10702010F, 10705060F; 10690060M, 10691010M, 10695060M, 10700060M, 10701010M, 10702010M, 10705060M; 10840125, 10845060; 10840125A, 10845060A; 10840125D, 10845060D; 10840125F, 10845060F; 10840125M, 10845060M; 10890001A, 10905000A; 10890001D, 10905000D; 10890001F, 10905000F; 10890001M, 10905000M; 10944000A; 10944000D; 10944000F; 12040003A, 12062003A; 12040003D, 12062003D; 12040003M, 12062003M; 1205; 12050003; 12050003A; 12050003D; 12050003F; 12050003M; 12284001 and 12295002 Medicult Vitrification Cooling and Warming; 12284001A, 12295002A; 12284001D, 12295002D; 12284001F, 12295002F; 12284001M, 12295002M; 15115001A; 15115001D; 15115001F; 15115001X; 15135001A; 15135001D; 15135001M; 15840125A; 15840125D; 15840125F; 16125000A; 16125000D; 16125000F; 16125000M; 17G Wallace Dual Lumen; 26153EAU-10 - 1.2mm GYN SEAL w Luer Lock; 27550ZAG-10 - 1.6 mm URO SEAL wLuer Lock; 38 Special GPS Dish; 38Special GPS Dish; 4-Welll GPS Dish; 4Well GPS Dish; 6066 - Potocky Needle®; 6080 Smoke Evacuator Sys/Access.; 67010010, 67010060; 67010010A, 67010060A; 67010010D, 67010060D; 67010010F, 67010060F; 67010010M, 67010060M; 67020010, 67020060; 67020010A, 67020060A; 67020010D, 67020060D; 67020010F, 67020060F; 67020010M, 67020060M; 7033 Uni-Sem Intrauterine Catheter; 77010003; 77010003A; 77010003D; 77010003F; 77010003M, 77020003M; 77020003; 77020003A; 77020003D; 77020003F; 82214010; 82214010A; 82214010D; 82214010M; 82329 - Sani-Spec® Disposable Specula - Small; 82330 - Sani-Spec® Disposable Specula - Medium; 82331 - Sani-Spec® Disposable Specula - Large; 82340 - Sani-Spec® Disposable Speculum - Small; 82341 - Sani-Spec® Disposable Speculum - Medium; 82420 - Sani-Scope® Disposable Anoscope; 83010010A, 83010060A, 83020010A, 83020060A; 83010010D, 83010060D, 83020010D, 83020060D; 83010010F, 83010060F, 83020010F, 83020060F; 83010010M, 83010060M, 83020010M, 83020060M; 83030010A, 83030060A, 83040010A, 83040060A; 83030010D, 83030060D, 83040010D, 83040060D; 83030010F, 83030060F, 83040010F, 83040060F; 83030010M, 83030060M, 83040010M, 83040060M; 83050010, 83050060, 83060010, 83060060; 83050010A, 83050060A, 83060010A, 83060060A; 83050010D, 83050060D, 83060010D, 83060060D; 83050010F, 83050060F, 83060010F, 83060060F; 83050010M, 83050060M, 83060010M, 83060060M; 8309 - Galenica Vaginal Specula - Small; 8310 - Galenica Vaginal Specula - Medium; 83100060, 83100125, 83110060, 83110125; 83100060A, 83100125A, 83110060A, 83110125A; 83100060F, 83100125F, 83110060F, 83110125F; 83100060M, 83100125M, 83110060M, 83110125M; 8311 - Galenica Vaginal Specula - Large; 84000060A, 84002060A, 84004125A, 84010060A, 84021210A, 84022010A, 84022060A, 84050060A, 84051010A, 84055060A; 84000060D, 84002060D, 84004125D, 84010060D, 84021210D, 84022010D, 84022060D, 84050060D, 84051010D, 84055060D; 84000060F, 84002060F, 84004125F, 84010060F, 84021210F, 84022010F, 84022060F, 84050060F, 84051010F, 84055060F; 84000060M, 84002060M, 84004125M, 84010060M, 84021210M, 84022010M, 84022060M, 84050060M, 84051010M, 84055060M; 8615 - Galenica Vaginal Specula - Small; 8616 - Galenica Medium Vaginal Speculum; 8617 - Galenica Vaginal Specula - Large; 920009 - Wallach® Endocervical Block Kit; ABBI; AIC18 Wallace Intra-uterine Insemination Catheters; ALLY II UPS™ (Uterine Positioning System); ALLY II UPS™ (Uterine Positioning System) Loaner; AMNIOTOME; ART-8035, ART-8035A, ART-8035D; Acidified Medium w/HEPES; Acidified Tyrodes Solution; Advincula Delineator Flexible Soft Cup; Advincular Delineator; Ally UPS; Apple - Fischer Cone Biopsy Excisor; Apple Hunt Organizer; Apple Mobius Retractor for Mini Laparatomy; Apple OB/Mobius Elastic Retractor; Apple Pneumo-Matic Insufflation Needle; Apple's Vaginal Probe for Laparoscopy [900-590]; Apple-Hunt Secondary Cannula; Artifical Insemination Catheter (Wallace); Aspirating (multi); Aspirette Endocervical Needle; Assisted hatching micropipettes; Biopsy Medium; Biovac Smoke Evacuator; BlastFreeze; BlastGen; BlastThaw; Bronchitrac, Bronchitrac ""L"" Set; C Safe; C010013 - 1.2 mm GYN SEAL wLuer Lock; C010014 - 1.6 mm URO SEAL wLuer Lock; C020001 - OfficeSPEC Medium, Non-Sterile; C020100-1 - ER SPEC Small, Non-Sterile; C020110-1 - ER SPEC Medium, Non-Sterile; C020120-1 - ER SPEC Large, Non-Sterile; C020130-1 - ER SPEC XSMALL, Non-Sterile; C020140-1 - ER SPEC XLARGE, Non-Sterile; C020300 - ER-Spec Small, Sterile; C020310 - ER-Spec Medium, Sterile; C020320 - ER-Spec Large, Sterile; C020500 - HER SPEC Small, Non-Sterile; C020510 - HER SPEC Medium, Non-Sterile; C020520 - HER SPEC Large, Non-Sterile; C020600 - HER-Spec Small, Sterile; C020610 - HER-Spec Medium, Sterile; C020620 - HER-Spec Large, Sterile; C060100 - AnoSPEC 90 x 18mm; C060110 - AnoSPEC 96 x 23mm; C060120 - AnoSPEC 103 x 18mm; C100110 - ONETRAC; C100140 - ONETRAC; C100150 - ONETRAC; C100165 - ONETRAC; C100170 - ONETRAC; C100180 - ONETRAC; C100190 - ONETRAC; C100210 - ONETRAC LX; C100220 - ONETRAC LX; C100230 - ONETRAC LX; C100240 - ONETRAC LX; C100250 - ONETRAC LX; C100260 - ONETRAC LX; C100270 - ONETRAC LXD; C100280 - ONETRAC LX; C100290 - ONETRAC LX; C110200 - ONETRAC LXS Yankauer; C110210 - ONETRAC LXS Yankauer; C110220 - ONETRAC LXS Yankauer; C110310 - ONETRAC LXS Frazier; C110320 - ONETRAC LXS Frazier; CC/Brush [Papette]; CCB Density Gradient; CE-2000 Ophthalmic Cryosurgery Sys.; COMFIT Endotracheal Tube Holder; CS-76 / CryoCare1 [Frigi.]; CSI's Guardian Vaginal Retractor; Carter-Thomason[CT] CloseSureSys.; Cervex-Brush; Coda; Cryo Tips; Cryo Tips.; Custom IVF Workstation; Cytobrush Plus / Plus GT; DISPOSA-DERM; DISPOSABLE AMNIOTOME; DP-CAB01 - Doppler Extension Cable; DP-M350 - Doppler Monitor; DP-M350-CHG1 - Doppler Battery Charger; DP-MCV01 - Doppler Monitor Cable-Verifier; DP-SDP001 - Doppler Probe; DP-SDP002 - Doppler Long Cuff Probe; Delineator Adapter Drape; Denuding pipettes; Dil-Os; Dilator Cervical OS Finder; Dopplers,Multi., Fetal & Blood Flow; ER Peak & Embryo Biopsy Kits; EZ-Tip Singles, EZ-Tip vial of 20, EZ-Grip; Embryo Corral Dish; Embryo Culture and Transfer; Embryo Freezing pack 10264010; Embryo Freezing pack 10264010M; Embryo GPS Dish; Embryo Replacement Catheter (Wallace); Embryo Thawing Pack 10984010; Embryo Thawing Pack 10984010M; EmbryoGen 12040003; EmbryoGen/BlastGen 12062003; Endocell [Endometrial Sampler]; Endocervical Block Needle; Endosee; Endosee Advance; Endosee Cannula / Hand Tower; Esophageal Balloon Cath.[Ackrad]; Euro-Med Hooks & Tenaculum; Euro-Med Skin Punch; Euromed Curette, Biopsy &; Euromed Forceps (multi.); Euromed Sound & Dilator (multi); FERTILIZATION MEDIA; FP-010 - Fetal Pillow; Flushing Medium w/o Heparin; Flushing medium; Forceps, Biopsy (multi.); Fortuna Workstations; Frigi. Cryo Surg Model 5900; Frigitronics CM 73 Cryo System,; Fundus Sound; G03014 - Doppler Long Cuff Probe; G21363 - Doppler Probe; G21364 - Doppler Extension Cable; GLOBAL; Global Collect GCOL-100, GCOL-500; Global Collect GCOL-100M, GCOL-500M; Global Fertilization; Global Total LGGT-030, LGGT-060, LGGT-100; Global Total LGGT-030M, LGGT-060M, LGGT-100M; Global Total for Fertilization LGTF-020, LGTF-050, LGTF-100; Global Total for Fertilization LGTF-020M, LGTF-050M, LGTF-100M; Global Total w/HEPES LGTH-050, LGTH-100, LGTH-250; Global Total w/HEPES LGTH-050M, LGTH-100M, LGTH-250M; Global w/HEPES LGGH-050, LGGH-050, LGGH-250, LGGH-500; Global w/HEPES LGGH-050M, LGGH-050M, LGGH-250M, LGGH-500M; Global w/Hepes; H/S Catheter Set 61-3005 & 61-3007.; H/S Catheter [61-30## & 61-50##]; H/S Elliptosphere Catheter[61-4005]; H/S Elliptosphere Procedure Tray; H/S [Elliptosphere] Catheter; H/Stylet, 61-0020; HBA; HS Catheter Trays; HTF Media; HTF w/Hepes; HUI Mini-Flex[HarrisUterineInject.]; HUMI/HUI UterineManipulator/Inject.; Holder, Needle (Multi. REDA); Holding micropipette; Human Serum Albumin; Hyaluronidase 80 U/ml; Hysterosalpingogram Tray; ICSI Cumulase; ICSI Cumulase 1612; ICSI Cumulase 16125000; ICSI injection micropipettes; INCA [Infant Nasal Cannulae Assy]; INFLAT-O-BALL; INFUSET AND IRRIJET STERILE SETS; INSORB SEQUENTIAL FORCEPS; INSORB Subcuticular Skin Stapler; INSORB Subcuticular Stapler- REF 2030; IRRIJET; Incubators; Infant Heel Warmer / WarmGel Infant Heel Warmer; Inseminator; Inserter, DMI, Multiple; Inserter, Inguinal Reservoir; Instant Warm Gel Pack; Instruments, Disposable (multi.); Integration Unit [use w/SmokeEvac.]; Intrauterine Insemination Catheter; Invitro Maturation Media [IVM]; Irrri-Flo Irrigation Delivery System; J-CRB-184000 - Cervical Ripening Balloon; J-CRBS-184000 - Cervical Ripening Balloon with Stylet; J-Needle; J-SOS-100500 - Bakri Tamponade Balloon Catheter; J-SOSR-100500 - Cook Bakri Postpartum Balloon w rapid install components; K-SYSTEMS WORK STATIONS, TYPE, L-13W, L-13E, L-13ES, L-13ET, L-13EM; K-SYSTEMS WORK STATIONS, TYPE, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E, L; K-Systems Workstations; KC-SIZER; KOH Colpotomizer System; Kevor-Curette; Knot Pusher; Kronner Manipujector; LEEP Electrodes; LEEP Electrosurgery System &; LEEP Procedure Kit; LGFR-100, LGFR-500; LGFR-100M, LGFR-500M; LGGG-020, LGGG-050, LGGG-100, LGGF-020, LGGF-050, LGGF-100; LGGG-020M, LGGG-050M, LGGG-100M, LGGF-020M, LGGF-050M, LGGF-100M; LGPS-020, LGPS-050, LGPS-100, LGPS-125, LGPS-250, LGPS-605; LGPS-020M, LGPS-050M, LGPS-605M; LL 100 N2O Cryosurgical System &; LM-900 System / Probes; Laparoscopic Smoke Evacuation Sys.; Lapsac - J-LS-050201; Lapsac - J-LS-060401; Lapsac - J-LS-080500; Lapsac - J-LS-081000; Leisegang Colposcopes; Life Global Total for Fertilization; LifeGlobal Global HP; LifeGlobal Total; LifeGlobal Total w/HEPES; LifeGlobal® Global® Total® LP; LifeGlobal® Global® Total® LP for Fertilization; LifeGlobal® Global® Total® LP w/Hepes; LifeGlobal® Global® Total® for Fertilization w/HSA; LifeGlobal® Global® Total® w/HEPES w/HSA; LifeGlobal® Global® Total® w/HSA; Lifeguard Oil, LGUA-100/LGUA-100M, LGUA-250/LGUA-250M, LGUA-500/LGUA-500M; Liquid Paraffin; Liquid Paraffin 1010; Liquid Paraffin 10100060; Liquid Paraffin 10100500; Liquid Paraffin 10105060; LiteOil, LGOL-100/LGOL-100M, LGOL-250/LGOL-250M, LGOL-500/LGOL-500m; Lone Star Retractors and Stays; Lumax TS Pro System; METRA PS Procedure Kit; MGPS-010, UGPS-010, EGPS-010, EMBC-010, 4GPS-010, MI38-010, SP38-010; MGPS-010M ?Drop GPS® Dish; MGPS-010M, UGPS-010M, EGPS-010M, EMBC-010M, 4GPS-010M, MI38-010M, SP38-010M; MULTIPLE BIOPSY DEVICES; MXPER00  - Ring Folding Pessary #0: 1-3/4""; MXPER01  - Ring Folding Pessary #1: 2""; MXPER02  - Ring Folding Pessary #2: 2-14""; MXPER03  - Ring Folding Pessary #3: 2-1/2""; MXPER04  - Ring Folding Pessary #4: 2-3/4""; MXPER05  - Ring Folding Pessary #5: 3""; MXPER06  - Ring Folding Pessary #6: 3-1/4""; MXPER07  - Ring Folding Pessary #7: 3-1/2""; MXPER08  - Ring Folding Pessary #8: 3-3/4; MXPER09  - Ring Folding Pessary #9: 4; MXPER10  - Ring Folding Pessary #10: 4-1/4; MXPERK00  - Ring Pessary with Knob/Folding # 0: 1-3/4""; MXPERK01  - Ring Pessary with Knob/Folding  # 1: 2""; MXPERK02  - Ring Pessary with Knob/Folding  # 2: 2-1/4""; MXPERK03  - Ring Pessary with Knob/Folding  # 3: 2-1/2""; MXPERK04  - Ring Pessary with Knob/Folding  # 4:  2-3/4""; MXPERK05  - Ring Pessary with Knob/Folding g # 5:  3""; MXPERK06  - Ring Pessary with Knob/Folding  # 6:  3-1/4""; MXPERK07  - Ring Pessary with Knob/Folding  # 7:  3-1/2""; MXPERK08  - Ring Pessary with Knob/Folding  # 8:  3-3/4""; MXPERK09  - Ring Pessary with Knob/Folding  # 9:  4; MXPERK10  - Ring Pessary with Knob/Folding  # 10: 4-1/4; MXPGE1-1/2  - Gellhorn Flexible Pessary 1-1/2""; MXPGE1-3/4  - Gellhorn Flexible Pessary 1-3/4""; MXPGE2-1/2  - Gellhorn Flexible Pessary 2-1/2""; MXPGE2-1/4  - Gellhorn Flexible Pessary 2-1/4""; MXPGE2-3/4  - Gellhorn Flexible Pessary 2-3/4""; MXPGE2-  - Gellhorn Flexible Pessary 2""; MXPGE3-1/2  - Gellhorn Flexible Pessary 3-1/2""; MXPGE3-1/4  - Gellhorn Flexible Pessary 3 1/4""; MXPGE3-3/4  - Gellhorn Flexible Pessary 3 3/4""; MXPGE3-  - Gellhorn Flexible Pessary 3""; MXPGSS1-1/2  - Gellhorn Short Stem Flexible Pessary 1-1/2""; MXPGSS1-3/4  - Gellhorn Short Stem Flexible Pessary 1-3/4""; MXPGSS2-1/2  - Gellhorn Short Stem Flexible Pessary 2-1/2""; MXPGSS2-1/4  - Gellhorn Short Stem Flexible Pessary 2-1/4""; MXPGSS2-3/4  - Gellhorn Short Stem Flexible Pessary 2-3/4""; MXPGSS2-  - Gellhorn Short Stem Flexible Pessary 2""; MXPGSS3-1/2  - Gellhorn Short Stem Flexible Pessary 3-1/2""; MXPGSS3-1/4  - Gellhorn Short Stem Flexible Pessary 3-1/4""; MXPGSS3-3/4  - Gellhorn Short Stem Flexible Pessary3-3/4""; MXPGSS3-  - Gellhorn Short Stem Flexible Pessary 3""; MXPRS00  - Ring Folding Pessary with Support #0: 1-3/4""; MXPRS01  - Ring Folding Pessary with Support #1: 2""; MXPRS02  - Ring Folding Pessary with Support #2: 2-14""; MXPRS03  - Ring Folding Pessary with Support #3: 2-1/2""; MXPRS04  - Ring Folding Pessary with Support #4: 2-3/4""; MXPRS05  - Ring Folding Pessary with Support #5: 3""; MXPRS06  - Ring Folding Pessary with Support #6: 3-1/4""; MXPRS07  - Ring Folding Pessary with Support #7: 3-1/2""; MXPRS08  - Ring Folding Pessary with Support #8: 3-3/4; MXPRS09  - Ring Folding Pessary with Support #9: 4; MXPRS10  - Ring Folding Pessary with Support #10: 4-1/4""; MXPRSK00  - Knob/Folding Ring Pessary with Support #0: 1-3/4""; MXPRSK01  - Knob/Folding Ring Pessary with Support #1: 2""; MXPRSK02  - Knob/Folding Ring Pessary with Support #2: 2-1/4""; MXPRSK03  - Knob/Folding Ring Pessary with Support #3: 2-1/2""; MXPRSK04  - Knob/Folding Ring Pessary with Support #4:  2-3/4""; MXPRSK05  - Knob/Folding Ring Pessary with Support #5:  3""; MXPRSK06  - Knob/Folding Ring Pessary with Support #6:  3-1/4""; MXPRSK07  - Knob/Folding Ring Pessary with Support #7:  3-1/2""; MXPRSK08  - Knob/Folding Ring Pessary with Support #8:  3-3/4; MXPRSK09  - Knob/Folding Ring Pessary with Support #9:  4; MXPRSK10  - Knob/Folding Ring Pessary with Support #10: 4-1/4; MXPSH1-1/2  - Folding Shaatz Pessary 1-1/2""; MXPSH1-3/4  - Folding Shaatz Pessary 1-3/4""; MXPSH2-1/2  - Folding Shaatz Pessary 2-1/2""; MXPSH2-1/4  - Folding Shaatz Pessary 2-1/4""; MXPSH2-3/4  - Folding Shaatz Pessary 2-3/4""; MXPSH2-  - Folding Shaatz Pessary 2""; MXPSH3-1/2  - Folding Shaatz Pessary 3-1/2""; MXPSH3-1/4  - Folding Shaatz Pessary 3-1/4""; MXPSH3-3/4  - Folding Shaatz Pessary 3-3/4""; MXPSH3-  - Folding Shaatz Pessary 3""; Marlow Balloon Cannulae, Family of; Mars Workstations; MediCult IVM System; Media Culture System; Medicult Vitrification Cooling and Warming; MicroDrop GPS Dish; Milex Silicone Pessaries; Milex Wide-Seal Diaphragm; Mini GPS Dish; MitySoft Extractor Cup Systems; MityVac ""M"" Style Vacuum Cup; MityVac OB Vacuum Cup(s), Multi.; MityVac Super M-Style Cup, dispos.; MityVac w/Universal Vacuum Release; Miya Hook; Mystic Disposable Pump; N-DOSURE; NEO-FIT AND COMFIT END; NEO-PREP SKIN BARRIER; NU-TIP SCISSORS; Nu-Tip Laparoscopic Instruments;; OPTIK1-00; OPTIK1-01; OPTIK1-02; OPTIK1-03; OPTIK2-03; OPTIK2-03-002; OPTIK2-04; OPTIK2-04-002; OPTIK2-05; OPTIK2-05-002; OPTIK2-11; ORIGIO; ORIGIO - PIPETTES; ORIGIO Gradient 100; ORIGIO Gradient 100 84000060; ORIGIO Gradient 100 84002060; ORIGIO Gradient 100 84004125; ORIGIO Gradient 40; ORIGIO Gradient 40/80; ORIGIO Gradient 40/80 84021210; ORIGIO Gradient 40/80 84022010; ORIGIO Gradient 40/80 84022060; ORIGIO Gradient 80; ORIGIO Gradient 90; ORIGIO Gradient 90 84010060; ORIGIO Handling Medium; ORIGIO Handling Medium 8310; ORIGIO Handling Medium 83100060D; ORIGIO Handling Medium 83100125D; ORIGIO Handling Medium 8311; ORIGIO Handling Medium 83110060D; ORIGIO Handling Medium 83110125D; ORIGIO Sequential Blast; ORIGIO Sequential Cleav; ORIGIO Sequential Fert; ORIGIO Sperm Wash 8405; ORIGIO Sperm Wash 84050060; ORIGIO Sperm Wash 84051010; ORIGIO Sperm Wash 84055060; ORIGIO® Gradient™ 90 w/o Gentamicin 84905060 (8490); ORIGIO® Gradient™ 90 w/o Gentamicin 84905060D (8490); Oil for Tissue Culture; Origio Gas Line Filter; PERCUTANEOUS; PGD Media; PICSI Dish; PIPETTES; PLUME AWAY - 4; PVP 10%; PVP 7%; PVP Clinical Grade; PVP Clinical Grade 1090; PVP Clinical Grade 10905000; PVP Medium; PVP Medium 1089; PVP Medium 10890001; Pap-Perfect Multi-Test Tray; Pap-Perfect Plastic Spatula; Pasteur Pipets; Phosphate Buffered Saline (PBS); Pioneer Pump; Pioneer Pumps; Pipelle; Pipet Curet; Polyvinylpyrrolidon (PVP) 10%; Potocky Needle, Disposable Injection Needle; Protein Supplement; PureCeption 100% Isotonic Solution; PureCeption 24-Determination Bi-Layer Kit; PureCeption, Lower & Upper Phase; QA Blastocyst Freeze Kit; QA Blastocyst Medium; QA Cleavage Medium; QA Embryo Freeze Kit; QA Fertilization Medium; QA HTF Medium w/HEPES; QA Medium w/HEPES; QA Protein + Blastocyst Medium; QA Protein + Cleavage Medium; QA Protein + Fert. Medium; QA Serum Protein Substitute; QA Sperm Freeze Kit; QA Thaw Kit; Quantum 2000 ESU; Quinn's Sperm Washing Medium; R G Edwards Cath for EmbryoTransfer; RAPP Laparoscopic Instruments; RECTAL DILATOR; REDA Hysterectomy Scissors (mult.); REDA Z-clamp Forceps (mult.); RUMI II & RUMI Arch II Handles [Mfg]; RUMI II & RUMI Arch II Handles [SD]; RUMI System [Mfg]; SAGE 1-Step; SAGE 1-Step GM-CSF; SAGE Vitrification Kit; SAGE Vitrification Kit & Warming Kit; SAGE Vitrification Warming Kit; SAGE™ Vitrification Warming Kit; SANI-SCOPE Disposable Anoscope; SM400 Select UI Intrauterine Catheter; SM507 The Curve Intrauterine Insemination Catheter; SM610 MiniSpace IUI Intrauterine Insemination Catheter; Scissors; Scissors, Episiotomy & Parametrium [HBH & Zeppelin]; Select & MiniSpace IUI Catheters [SM400 & SM610]; SelectCells Standard [SM200] & Mini [SM203]; SelectMucus; Sequential Cleav 83030010, 83030060, 83040010, 83040060; Sequential Cleav w/o phenol red 8303; Sequential Cleav w/o phenol red 83030010; Sequential Cleav w/o phenol red 83030060; Sequential Cleav with phenol red 8304; Sequential Cleav with phenol red 83040010; Sequential Cleav with phenol red 83040060; Sequential Fert 83010010, 83010060, 83020010, 83020060; Sequential Fert w/o phenol red 8301; Sequential Fert w/o phenol red 83010010; Sequential Fert w/o phenol red 83010060; Sequential Fert with phenol red 8302; Sequential Fert with phenol red 83020010; Sequential Fert with phenol red 83020060; SignipHy Trakpod; Sperm Freezing Medium; Sperm Freezing Medium 1067; Sperm Freezing Medium 10670010; Sperm Preparation Medium; Sperm Select; Sperm Select System; Sperm Wash; SpermSlow; SpermSlow 1094; SpermSlow 10944000; SpermSlow 10944000M; Stripper PGD; Stripper TIps; Stripper Tips; Stylet for Embryo Replacement Catheter; Summit; SupraSperm 100; SupraSperm 90; SynVitro® Flush 15840125; SynVitro® Flush w/o Heparin 15840125; SynVitro® Flush without Heparin 15840125; SynVitro® Hyadase 1511; SynVitro® Hyadase 15115001; SynVitro® Hyadase 1513; TPC Pipettes; TRAKE-fit Tracheostomy Tube Holder; TRAKEFIT TRACHEOSTOMY TUBE HOLDER; TRANSWARMER; TRIA Dopplers; Tampa Catheter [61-2005]; TheCurve; Tis-U-Trap w/Metal Curette; Trial Transfer Catheter (Wallace); ULTRA PLUME AWAY - 6; UNI-SEM (TM); UTM Transfer Medium; Ultimate,Reuse, Plastic Vag.Spec.; Ultrafreeze; Universal GPS Dish; Universal IVF Medium; Uterine Dilators [REDA's]; Uterine Injector w/Spring [ZUI]; Uterobrush; Vaginal-Silicone Dilators; ViaBL(TM) SUPER-FAST VITRIFICATION KIT ART-8023/ART-8023D/ART-8023M; ViaBL™ Super-Fast Blastocyst Warming Kit ART-8035; VitriGuard; Vitrification Kit &; Vitrification Warming Kit; WA 1000 Console; WA-2000 Temperature Indicator; Wallace Dual Lumen 16G; Wallace Embryo Transfer Catheter; Wallace Oocyte Needles; Wallace Oocyte Retrieval Needles; Wallace Pessaries; Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK); Wallach 'Scope' Colposcope; Wallach 'Star' Colposcope; Wallach LL CO2 Cryo System, and; Wallach Loop Electrodes; Washing mHTF w/HEPES & Phenol Red; Water for Tissue Culture (500/1.5L); ZMH0850M - ZyMot Multi Sperm Separation Device; ZMH3000M - ZyMot Multi Sperm Separation Device; ZUMI [Uter.Manip./Inject.w/spring]; [Disposable]; [Reusable]; [SeeClear & Plume-Away]; [Skin Punch]; [UVR]; global Collect; global DMSO Blastocyst Vitrification Warming Kit; global® Blastocyst Fast Freeze Kit; global® Blastocyst Fast Thawing Kit; global® DMSO Blastocyst Vitrification Kit; µDrop GPS Dish",1977-12-09,211,2026-08-19,0,71,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221216677%22&limit=1
"Icu Medical, Inc.",2025816,2025816,951 Calle Amanecer,San Clemente,CA,92673,United States,"ICU MEDICAL, INC.",2025816,Complaint file establishment; Specification developer,92,BSK; BSN; BSO; BSP; BSR; BSY; BTC; BTL; BTM; BTO; BTQ; BTR; BTT; BWC; BWF; BXR; BYD; BYE; BYF; BYG; BYI; BYP; BYX; BZA; BZQ; BZT; BZW; CAE; CAF; CAH; CAI; CAN; CAP; CAT; CAZ; CBH; CBI; CBK; CBL; CBP; CBT; CCK; CCO; CCW; DPT; DPZ; DQA; DQE; DQH; DQO; DRS; DTL; DTW; DWJ; DWS; DXN; DXQ; DYB; DYG; FJK; FLL; FMF; FMG; FMI; FOZ; FPA; FPB; FYH; GBZ; GCE; GCJ; GCY; ION; JAY; JKA; JOH; JYJ; KDQ; KGB; KPE; KRB; LHI; LJT; MEG; MHX; MIA; NEP; NHK; ONB; PEH; PWH; QBP,"Cuff, Tracheal Tube, Inflatable; Filter, Conduction, Anesthetic; Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Bag, Reservoir; Ventilator, Emergency, Powered (Resuscitator); Ventilator, Emergency, Manual (Resuscitator); Tube, Tracheostomy (W/Wo Connector); Airway, Nasopharyngeal; Tube, Tracheal (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Needle, Emergency Airway; Spirometer, Therapeutic (Incentive); Meter, Airway Pressure (Inspiratory Force); Condenser, Heat And Moisture (Artificial Nose); Attachment, Breathing, Positive End Expiratory Pressure; Mask, Oxygen, Low Concentration, Venturi; Mask, Oxygen; Percussor, Powered-Electric; Mouthpiece, Breathing; Tubing, Pressure And Accessories; Connector, Airway (Extension); Monitor, Breathing Frequency; Stethoscope, Esophageal, With Electrical Conductors; Stethoscope, Esophageal; Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Regulator, Pressure, Gas Cylinder; Monitor, Airway Pressure (Includes Gauge And/Or Alarm); Cannula, Nasal, Oxygen; Anesthesia Conduction Kit; Device, Fixation, Tracheal Tube; Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector); Ventilator, Continuous, Facility Use; Absorbent, Carbon-Dioxide; Valve, Non-Rebreathing; Arterial Blood Sampling Kit; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Bed, Rocking, Breathing Assist; Laryngoscope, Rigid; Probe, Blood-Flow, Extravascular; Oximeter, Ear; Oximeter; Catheter, Oximeter, Fiber-Optic; Cardiograph, Apex (Vibrocardiograph); Catheter, Intravascular, Diagnostic; Transducer, Blood-Pressure, Extravascular; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass; System, Thermal Regulating; Instruments, Surgical, Cardiovascular; System, Measurement, Blood-Pressure, Non-Invasive; Blood Pressure Cuff; Introducer, Catheter; Catheter, Flow Directed; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve; Continuous Measurement Thermometer; Syringe, Piston; Stopcock, I.V. Set; Needle, Hypodermic, Single Lumen; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Filter, Infusion Line; Splint, Extremity, Noninflatable, External, Sterile; Catheter, Cholangiography; Adaptor, Catheter; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Exerciser, Non-Measuring; Support, Breathing Tube; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tube Tracheostomy And Tube Cuff; Gauge, Measuring; Bottle, Collection, Vacuum; Mask, Oxygen, Non-Rebreathing; Container, I.V.; Probe, Thermodilution; Set, I.V. Fluid Transfer; Port & Catheter, Implanted, Subcutaneous, Intravascular; Syringe, Antistick; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Needle, Spinal, Short Term; System/Device, Pharmacy Compounding; Resuscitator, Manual, Non Self-Inflating; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Hemodialysis Catheter Luer End Cap; Administrations Sets With Neuraxial Connectors; Cap, Device Disinfectant",1; 2,"ADAPTOR, CATHETER; AIRWAY, NASOPHARYNGEAL; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED; Absorbent, carbon-dioxide; Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass; Additive Hinge Cap; Administrations sets with neuraxial connectors; Anesthesia conduction kit; Arterial blood sampling kit; Attachment, breathing, positive end expiratory pressure; BAG, RESERVOIR; BOTTLE, COLLECTION, VACUUM; Bed, rocking, breathing assist; Blood Banking Extension Sets; Bloof Tubing with Anti Regurgitation; CANNULA, NASAL, OXYGEN; CARDIOGRAPH, APEX (VIBROCARDIOGRAPH); CATHETER, CHOLANGIOGRAPHY; CATHETER, CONDUCTION, ANESTHETIC; CATHETERS, SUCTION, TRACHEOBRONCHIAL; CLAVE Extension Sets; CLAVE Vial Access Spike; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE); Cath Lab Kits; Catheter, Flow Directed; Catheter, intravascular, diagnostic; Catheter, intravascular, therapeutic, short-term less than 30 days; Catheter, oximeter, fiber-optic; ChemoCLAVE Prep System; Circuit, breathing (w connector, adaptor, y piece); Clave Ext Set; Clave Neutral-Displacement Needlefree Connectors; ClearGuard HD Antimicrobial barrier cap; Cogent Hemodynamic Monitoring System; Continuous Measurement Thermometer; Cuff, tracheal tube, inflatable; Device, fixation, tracheal tube; Diana; Diana Compounding Workflow System; EXERCISER, NON-MEASURING; Ext Set; FILTER, CONDUCTION, ANESTHETIC; Filter, bacterial, breathing-circuit; Filter, infusion line; GAUGE, MEASURING; Genie; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE); INSTRUMENTS, SURGICAL, CARDIOVASCULAR; IV Ext Set; Introducer, catheter; LARYNGOSCOPE, RIGID; Laparoscope, general & plastic surgery; MASK, GAS, ANESTHETIC; MASK, OXYGEN; MASK, OXYGEN, LOW CONCENTRATION, VENTURI; MASK, OXYGEN, NON-REBREATHING; METER, AIRWAY PRESSURE (INSPIRATORY FORCE); MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM); MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS); MOUTHPIECE, BREATHING; Monitor and/or control, level sensing, cardiopulmonary bypass; Monitor, breathing frequency; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER); NEEDLE, SPINAL, SHORT TERM; Nebulizer (direct patient interface); Needle, emergency airway; Needle, hypodermic, single lumen; NovaCath; Oximeter; PERCUSSOR, POWERED-ELECTRIC; PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR; PROBE, BLOOD-FLOW, EXTRAVASCULAR; Piggy Lock; Primary IV Set; Regulator, pressure, gas cylinder; Resuscitator, manual, non self-inflating; Rio™ Drug Reconstitution Transfer Device; SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS); SPIROMETER, THERAPEUTIC (INCENTIVE); SPLINT, EXTREMITY, NONINFLATABLE, EXTERNAL, STERILE; STETHOSCOPE, ESOPHAGEAL; STETHOSCOPE, ESOPHAGEAL, WITH ELECTRICAL CONDUCTORS; STYLET, TRACHEAL TUBE; SUPPORT, BREATHING TUBE; SYRINGE, ANTISTICK; Safe Connector; Set, administration, intravascular; SetSource Ext Sets; Stopcock, i.V. Set; SwabTip Male Disinfectant Cap; Syringe, piston; System, measurement, blood-pressure, non-invasive; System, thermal regulating; TEGO; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR); TUBING, PRESSURE AND ACCESSORIES; Transducer, blood-pressure, extravascular; Tube tracheostomy and tube cuff; Tube, tracheal (w/wo connector); Tube, tracheostomy (w/wo connector); Tubes, vials, systems, serum separators, blood collection; Universal Spikes; Universal Vial Access Spike; Valve, non-rebreathing; Ventilator, continuous, facility use; Ventilator, emergency, manual (resuscitator); Ventilator, emergency, powered (resuscitator); Vial Access Spike; Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432",1999-08-04,211,2025-06-05,0,45,4,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222025816%22&limit=1
"Wright Medical Technology, Inc.",3010667733,3010667733,11500 Memphis Arlington Road,Arlington,TN,38002,United States,STRYKER CORP.,1811755,Complaint file establishment; Specification developer,92,EMF; FMF; FNS; FSM; FTY; FZO; FZX; GAC; GAD; GAT; GDF; GDO; GEC; GFA; GFG; GFI; HRR; HRS; HSB; HSD; HSN; HSO; HST; HTC; HTD; HTE; HTJ; HTN; HTO; HTQ; HTR; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWD; HWE; HWJ; HWM; HWN; HWP; HWQ; HWR; HWT; HWW; HWX; HXA; HXB; HXC; HXD; HXE; HXG; HXL; HXN; HXO; HXR; HXW; HXX; HYA; ILH; JDB; JDR; JDW; JEC; KDD; KGS; KIH; KQZ; KTT; KTZ; KWD; KWF; KWH; KWI; KWN; KWO; KWS; KYI; LRP; LXH; MBI; MBP; MDM; MQV; NOX; OJH; OUR; OYK; PBF,"Knife, Surgical; Syringe, Piston; Ring Cutter; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Rasp, Surgical, General & Plastic Surgery; Retractor; Suture, Nonabsorbable, Synthetic, Polyethylene; Guide, Needle, Surgical; Applier, Surgical, Clip; Brush, Scrub, Operating-Room; Blade, Saw, General & Plastic Surgery, Surgical; Bit, Surgical; Osteotome, Manual; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Saw; Apparatus, Traction, Non-Powered; Pliers, Surgical; Forceps; Elevator; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Osteotome; Instrument, Compression; Punch, Femoral Neck; Passer; Driver, Prosthesis; Template; Countersink; Tap, Bone; Prosthesis, Tendon, Passive; Probe; Wrench; Clamp; Fork; Tamp; Mallet; Applier, Cerclage; Pusher, Socket; Spatula, Orthopedic; Bender; Screwdriver; Forceps, Wire Holding; Splint, Hand, And Components; Prosthesis, Elbow, Semi-Constrained, Cemented; Staple, Fixation, Bone; Pin, Fixation, Threaded; Component, Traction, Invasive; Kit, Surgical Instrument, Disposable; Retention Device, Suture; Dispenser, Cement; Component, Traction, Non-Invasive; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Finger, Polymer; Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Wrist, Carpal Lunate; Prosthesis, Wrist, Carpal Scaphoid; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Wrist, Carpal Trapezium; Tray, Surgical; Orthopedic Manual Surgical Instrument; Fastener, Fixation, Nondegradable, Soft Tissue; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Instrument, Manual, Surgical, General Use; Filler, Bone Void, Calcium Compound; Filler, Bone Void, Synthetic Peptide; Orthopedic Tray; Sacroiliac Joint Fixation; Ankle Arthroplasty Implantation System; Orthopaedic Surgical Planning And Instrument Guides",1; 2; 3,"10.5MM FLEXIBLE REAMER; 10MM FLEXIBLE REAMER; 10mm SUBFIX TRIAL; 11.5MM FLEXIBLE REAMER; 11.5mm SUBFIX TRIAL; 11MM FLEXIBLE REAMER; 12MM FLEXIBLE REAMER; 135 mm Reusable Slat, SE Retr, 10 Pack; 155 mm Reusable Slat, SE Retr, 10 Pack; 175mm Reusable Slat, SE Retr, 10 Pack; 206-716 w/2 small sculps/pkg; 234-112-100 VersiQuad Halo Retractor; 3.9mm Omega Drill; 3.9mm Omega Tap; 3.9mm Omega and 4.75mm AlphaVent Awl; 3105-000-305 Pivot Guardian Direct PostFree Support; 3105-000-740 Pivot Guardian Safety Boot Liners, Small; 3105-000-741 Pivot Guardian Safety Boot Liners, Medium; 3105-000-742 Pivot Guardian Safety Boot Liners, Large; 3MM DBL SLEEVE 80MM TROC/ASSY; 3mm PREDRILL ASSEMBLY LONG; 3mm PREDRILL ASSEMBLY SHORT; 4.5MM FLEXIBLE REAMER; 4.75mm AlphaVent Punch Tap; 4.75mm AlphaVent Tap; 4.75mm AlphaVent and Omega Awl; 4.75mm AlphaVent and Omega Drill; 4.75mm Omega Tap; 4MM DBL SLVE 180MM TROC/ASSY; 4mm DBL SLEEVE 150mm TROC/ASSY; 4mm PREDRILL ASSEMBLY EXTRA SHORT; 4mm PREDRILL ASSEMBLY LONG; 4mm PREDRILL ASSEMBLY SHORT; 4mm TomCat Shaver Blades; 5.5MM FLEXIBLE REAMER; 5.5mm AlphaVent Tap; 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill; 5MM FLEXIBLE REAMER; 5mm HellCat Shaver Blades; 5mm PREDRILL ASSEMBLY EXTRA SHORT; 5mm PREDRILL ASSEMBLY LONG; 5mm PREDRILL ASSEMBLY SHORT; 5mm SPANNER WRENCH; 6.5MM FLEXIBLE REAMER; 6.5mm SUBFIX TRIAL; 611 - ANKLE FUSION NAIL; 6MM FLEXIBLE REAMER; 6mm PREDRILL ASSEMBLY EXTRA SHORT; 6mm PREDRILL ASSEMBLY LONG; 6mm PREDRILL ASSEMBLY SHORT; 7.5MM FLEXIBLE REAMER; 7MM FLEXIBLE REAMER; 7MM SPANNER WRENCH; 7mm SPANNER WRENCH; 8.5MM FLEXIBLE REAMER; 8MM FLEXIBLE REAMER; 8mm SUBFIX TRIAL; 9.5MM FLEXIBLE REAMER; 90 mm Reusable Slat, SE Retr, 10 Pack; 9MM FLEXIBLE REAMER; 9mm SUBFIX TRIAL; A 2 DRILL BRACE W/O CHUCK; A 4 4MM CHUCK; A 5 T-WRENCH; A 51 T WRENCH W/35 EXTENSION; ACL Disposable Packs; ACL Reconstruction Accessories; ACL Workstation; ACM CARTRIDGE & TIPs; ADJUSTMENT FORK; AEQ FRAC LONG SUP IMP ENS; AEQ FRAC SUPPORT DE BRAS; AEQ FRACT GR AXE LIAISON; AEQ FRACT MESUREUR AMOVIB; AEQ FRACT NM FANT TIG; AEQ IMPACTEUR DE PROTHESE; AEQ TIGE FRA LG FANT; AEQ USA FANT CALO; AEQUALIS; AEQUALIS FRACTURE; AEQUALIS PRESS-FIT; AEQUALIS RESURFACING HEAD; AEQUALIS REVERSED; AGM 6 6MM CHUCK; ALEUTIAN Interbody Systems Trays; ALIQUOT DELIVERY SYSTEM; ALL TORNIER FORCEPS INSTRUMENTS; ALLOMATRIX; ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS); ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE; ANCHORAGE CP LAPIDUS TEMPLATE; ANCHORAGE CP MTP PIVOTING DRILL GUIDE; ANCHORAGE CP MTP TEMPLATE; ANCHORAGE CP POLYAXIAL DRILL GUIDE; ANCHORAGE CP UTILITY TEMPLATE; ANCHORAGE FIXATION PIN; ANCHORAGE FIXED DRILL GUIDE 2.5MM; ANCHORAGE FIXED DRILL GUIDE 2MM; ANCHORAGE INSTRUMENTS RACK (LEVEL 1); ANCHORAGE INSTRUMENTS RACK (LEVEL 2); ANCHORAGE INSTRUMENTS RACK COVER; ANCHORAGE PLATE BENDER; ANCHORAGE PLATE GRIPPER; ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM; ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM; ANTEVERSION GUIDE; AO HANDLE - LENGTH 135MM; AO Quick Coupling with Elastosil Handle; AO/JACOBS QUICK RELEASE APEX CHUCK 3mm; AO/JACOBS QUICK RELEASE APEX CHUCK 4mm; AO/JACOBS QUICK RELEASE APEX CHUCK 5mm; AO/JACOBS QUICK RELEASE APEX CHUCK 6mm; APEX DRILL BRACE - 3/4/5/6mm; APEX DRILL GUIDE HANDLE; APEX TRAY BASE; APEX TRAY LID; APEX TRAY LOWER INSERT; APEX TRAY UPPER INSERT; ATP Disc Prep; ATTACHMENTS; AWL; AXSOS ADAPTOR FOR TORQUE TESTER T20; AXSOS ADAPTOR FOR TORQUE TESTER T8/T15; AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK; Accolade II System Instrumentation; Aequalis Flex Revive; Aequalis Fracture; Aequalis Perform+; Aequalis Reversed Fracture; Aequalis Reversed II; Aequalis"" Ascend"" Flex; Aequalis"" Fx2; Aequalis"" Instrument; Aequalis"" PerFORM; Aequalis"" Retractor Shoulder System; Aggressive Max Shaver Blade 3.5mm; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; All OrthoHelix Orthopedic Manual Surgical Instruments; All Tornier Instruments, Cutting, Orthopeadic; All Tornier Orthopeadic Manual Surgical Instruments (exempt); Aluminum Lid - Universal; Anato Hip System Instrumentation; Anatomic Express Tray; Angeld Farabeuf clamp; Angled Ruler; Ascend"" Ascend"" Flex; Asnis® III Cannulated Screw System; Asnis® PRO Cannulated Screw System; Augment Bone Graft; AxSOS; AxSOS 3; AxSOS 3 AF System and AxSOS 3 Ti System, Plate; AxSOS 3 Ankle Fusion; AxSOS 3 Ti; BARREL REAMER ASSEMBLY STAND; BENDER; BIOARCH; BIOCOMPRESSION WRENCH 15mm TUBE; BIOCOMPRESSION WRENCH 20mm TUBE; BIOCOMPRESSION WRENCH 25mm TUBE; BIOFOAM; BIOFOAM Bone Wedge; BIT; BOLD Screw; Bender; Bending Iron; BioZip System; Bioabsorable Wedge Interference Screw System; Biosteon IntraLine System; Biosteon Wedge Interference Screw System; Bixcut, IM Reamer; Bone Plug Extractor; Bone Wedge; BrainPath Manipulation Tool; BriteField Depth Gauge; Broach and Inserter Handle; CALIPER; CANCELLO-PURE; CANYON Retractor Systems Trays; CAPRI Corpectomy Cage System Trays; CASPIAN Spinal System Trays; CAYMAN Plate System Trays; CELLPLEX; CHARLOTTE; CHARLOTTE CAROLINA; CHARLOTTE MTP; CHARLOTTE MTP Bone Fusion Plate System; CHARLOTTE MUC Screw; CHESAPEAKE Stabilization System Trays; CHILDS PORTABLE TRAC; CLAMP; CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKI; COMPACTOR/COMPRESSION; COMPRESSOR; CSTS; CURSOR; CURVED MULTI-CUT SCISSORS (4BX); CUTTING SCREWDRIVER 4.5; CYLINDRICAL BUSH HOLDER; CalcLock; CalcLock Extreme; CalcLock manual surgical instruments; Caliper; Cannulated Countersink with AO Fitting; Cannulated Drill with AO Fitting; Cannulated Drill ø 2,7/3.5mm with AO Fitting; Cannulated Screw System; Cannulated Screwdriver with AO Fitting; Cannulated Screwdriver with Elastosil Handle; Cannulated Tap with AO Fitting; CapsulePass 45 Up Suture Passer; Cartiva; Cascadia Interbody System; Cement Pusher; Champion Slingshot; Charlotte Carolina Jones; Charlotte Claw; Charlotte Snap Off Screw; CinchLock; Colored Plugs; Compression Staple System; Counterbore Drill; Cross-Screw System; CrossCheck Plating System; Cut Guide; DARCO; DARCO Locking Bone Plate System; DARCO TwistOff; DART-FIRE; DART-FIRE EDGE Cannulated Screws; DENALI Spinal System Trays; DEPTH GAUGE; DEPTH GAUGE (DISTAL RADIUS); DEPTH GAUGE (HAND); DISPOSABLE CEMENT SCULPS; DJD II STORAGE CASE; DRILL BIT; DRILL GUIDE; DRILL GUIDE (ALL); DRILL GUIDE BLOCK COMPACT 4 HOLE; DRILL GUIDE BLOCK COMPACT PERI 4 HOLE; DRILL GUIDE BLOCK HII 10 HOLE; DRILL GUIDE BLOCK HII 5 HOLE; DRILL GUIDE BLOCK MONOTUBE 4 HOLE; DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE; DRILL GUIDE LOCK II 2.5; DRILL SLEEVE; DRIVER; SCREW INSERTER; DRLock Extreme; DRLock Extreme, MaxLock Extreme, MaxTorque, CalcLock, Mini MaxLock Extreme; DUAL SPEED INJECTION GUN; DUALSPEED CEMENT INJECTION GUN; Depth Gauge; Depth Gauge (Foot/Elbow/Distal Fib); Direct Measuring Gauge; Double Drill Guide ø 2,0/3,5mm; Drill Bit; Drill Bit ø 2,0 x 150mm; Drill Guide Non Sterile; Drill Sleeve; Dual Edge Shaver Blade 3.5mm; Dual Edge Shaver Blade 4mm; Dual Edge Shaver Blade 5.5mm; Dual-sided Baseplate Centering Guide; EASY CLIP ANGLED DRILL GUIDE SIZE 15; ENDO-FUSE; EVEREST Spinal System Trays; EVOLVE; EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND BONE SCREWS; EVOLVE ORTHOLOC; EXTRACTOR; EZ Frame; EasyFuse Dynamic Compression System; EdgeLock; Edgelock manual surgical instruments; Eiberg Retractor, Standard; Eiberg Retractor, Standard, Long; Eikon LT Adapt SE 135 mm, Wide Retractor; Eikon LT Adapt SE 135mm Retractor; Eikon LT Adapt SE 135mm, Teeth Retractor; Eikon LT Adapt SE 155 mm, Wide Retractor; Eikon LT Adapt SE 155 mm,Wide,Teeth Retr; Eikon LT Adapt SE 155mm Retractor; Eikon LT Adapt SE 155mm, Teeth Retractor; Eikon LT Adapt SE 175 mm, Wide Retractor; Eikon LT Adapt SE 175 mm,Wide,Teeth Retr; Eikon LT Adapt SE 175mm Retractor; Eikon LT Adapt SE 175mm, Teeth Retractor; Eikon LT Adapt SE 90 mm, Wide Retractor; Eikon LT Adapt SE 90 mm, Wide Teeth Retr; Eikon LT Adapt SE 90mm Retractor; Eikon LT Adapt SE 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide, Teeth Retractor; Eikon LT Adapt, 135 mm; Eikon LT Adapt, 135 mm, Teeth; Eikon LT Adapt, 135 mm, Wide; Eikon LT Adapt, 135 mm, Wide, Teeth; Eikon LT Adapt, 175 mm; Eikon LT Adapt, 175 mm, Teeth; Eikon LT Adapt, 90 mm; Eikon LT Adapt, 90 mm, Teeth; Eikon LT Adapt, 90 mm, Wide; Eikon LT Adapt, 90 mm, Wide, Teeth; Eikon LT FF 135mm Retractor; Eikon LT FF 135mm, Wide Retractor; Eikon LT FF 175mm Retractor; Eikon LT FF 90mm Retractor; Eikon LT FF 90mm, Wide Retractor; Eikon LT FF Replacement Screw; Eikon LT Fixed Frame Retractor, 135mm Eval; Eikon LT Fixed Frame Retractor, 135mm Wide Eval; Eikon LT Fixed Frame Retractor, 90mm Eval; Eikon LT Fixed Frame Retractor, 90mm Wide Eval; Eikon LT Retractor, 135 mm; Eikon LT Retractor, 135 mm, Narrow; Eikon LT Retractor, 135 mm, Narrow Teeth; Eikon LT Retractor, 135 mm, Sweetheart; Eikon LT Retractor, 135 mm, Teeth; Eikon LT Retractor, 135 mm, Wide; Eikon LT Retractor, 135 mm, Wide, Teeth; Eikon LT Retractor, 175 mm; Eikon LT Retractor, 175 mm, Teeth; Eikon LT Retractor, 40 mm, Extra Narrow; Eikon LT Retractor, 40 mm, Narrow; Eikon LT Retractor, 50 mm; Eikon LT Retractor, 50 mm, Teeth; Eikon LT Retractor, 90 mm; Eikon LT Retractor, 90 mm, Narrow; Eikon LT Retractor, 90 mm, Narrow Teeth; Eikon LT Retractor, 90 mm, Teeth; Eikon LT Retractor, 90 mm, Wide; Eikon LT Retractor, 90 mm, Wide, Teeth; Eikon LT Retractor, A-N, 35 mm & 50 mm; Eikon LT Retractor, Rich, 40mm x 38mm; Eikon LT Retractor, Rich, 60mm x 45mm; Eikon LT Retractor, Rich, 80mm x 60mm; Eikon LT SL Sterilization Tray; Eikon LT Sterilization Tray; Elastosil T-Handle with AO Coupling; Evolve; Exeter Hip System Instrumentation; Express Humeral Stem Extractor; Express Insert; Extractor; Extractor Rod; Extractor for Screws; FEELER; PROBE; FEMORAL CANAL BRUSH, STANDARD; FIXOS 4 MV DEPTH GAUGE; FLEXIBLE DEPTH GUAGE; FLEXIBLE GUIDE PIN; FOREFOOT SET; FUNNEL; Farabeuf clamp; Flex Shoulder System; FlowStasis; FlowStasis - 3 Pack; FlowStasis Single-Pack; FlowStasis Suture Retention Device; Fork; Friction Cement Gun; FuseForce Implant; G-FORCE; G-Force; GAITWAY; GENERAL INSTRUMENTS; GLENOID PLANER; GRAVITY; GUIDE FOR HALF-PINS; Gaitway Implant System; Gauge, Depth; General; General Instruments; General Surgical Bits; Glenoid Retractor; Glenoid pin guide; Gordon Brush; Graft box body; Graft box compression screw; Graft box locking screw; Graft box washer; Graft box wedge; Graft container; Graft extractor; Graft sizer; Gravity; Gravity Peek Suture Anchor; Guide Wire; Guide Wire Pusher; Guide Wire Ruler; Guide Wire Targeter; Guide Wire Targeter - Crown; Guide Wire Targeter - Sleeve; Guide Wire, Threaded; HCS; HII 7mm T-WRENCH / 5+6mm SOCKET; HII COMPACT 5mm WRENCH/3&4mm SOCKET; HII COMPACT GUIDE BLOCK W/AO; HII COMPACT MRI STORAGE CASE BASE; HII COMPACT MRI STORAGE CASE LID; HII COMPACT MRI STORAGE CASE UPPER INSERT; HII COMPACT STORAGE CASE BASE; HII COMPACT STORAGE CASE LID; HII COMPACT STORAGE CASE UPPER INSERT; HII MICRO 2mm PIN DRIVER; HII MICRO DRILL GUIDE ASSEMBLY; HII MICRO NUT DRIVER; HII MICRO STORAGE CASE BASE; HII MICRO STORAGE CASE DRILL BIT HOLDER; HII MICRO STORAGE CASE LID; HII MICRO STORAGE CASE LOWER INSERT; HII MICRO STORAGE CASE UPPER INSERT; HII MRI TRAY BASE; HII MRI TRAY LID; HII MRI TRAY LOWER INSERT; HII TRAY BASE; HII TRAY LID; HII TRAY LOWER INSERT; HII TRAY UPPER INSERT; HLS KNEETEC; HLS NOETOS; HLS NOETOS REVISION; HLS UNI EVOLUTION; HM MINI 4 SPANNER WRENCH; HMENTS; HOFFMANN LRF INFO BOARD; HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT; HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY; HOFFMANN LRF RATCHET WRENCH - HEX 10; HOFFMANN LRF SPANNER WRENCH - 5 mm; HOFFMANN LRF SPANNER WRENCH - 7/10 mm; HOFFMANN LRF TELES. STRUT WRENCH; HOFFMANN LRF THUMBWHEEL - HEX 10; HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS; HOFFMANN LRF UNIVERSAL COMPONENTS INSERT; HOFFMANN LRF UNIVERSAL COMPONENTS TRAY; HOFFMANN LRF WIRE BOLT WRENCH; HOFFMANN LRF WIRE TENS. NOSE - LONG; HOFFMANN LRF WIRE TENS. NOSE - SHORT; HOFFMANN LRF WIRE TENSIONER; HOFFMANN XPRESS SILICON MAT; HOFFMANN XPRESS SILICON THUMBWHEEL; HOFFMANN XPRESS SPANNER WRENCH; HOFFMANN XPRESS STORAGE CASE BASE; HOFFMANN XPRESS STORAGE CASE INSERT; HOFFMANN XPRESS STORAGE CASE LID; HOFFMANN XPRESS TORQUE WRENCH; HOFFMANN3 TRAY FOR STANDARD COMPOMENTS; HOLDING FORCEPS; HOLDING SPANNER 4.5; HOWMEDICA MIX KIT I TM 10PK; HPI; HUNTER TENDON; HUNTER Tendon Implants; HV Screw System; HexStar; Hip Probe , 90; Hip Tissue Liberator 20; Hoffmann 3 Military External Fixator Kit; Hoffmann LRF; Hoffmann LRF System, Insert; Hoffmann LRF System, Instrument; Hoffmann LRF System, Ruler; Hoffmann LRF System, Wire Tensioner; Hoffmann LRF System, Wrench; Holding Sleeve; Humeral Express Tray; Hunter Tendon; HydroSet XT; ICONIX All Suture Anchor System; IDEAL SCREW; IGNITE; IMN Instruments Percutaneous guide wire inserter; IMN Instruments Self-Holding Screwdriver T20; IMN™ Instruments drill; IMPACTOR; INBONE; INBONE EVERLAST; INBONE TAS; INBONE Total Ankle System; INBONE and INFINITY Total Ankle System; INCLINED DRILL GUIDE SCREW EZ18; INCLINED DRILLING GUIDE + SCREW EZ20; INFINITY; INFINITY EVERLAST; INFINITY TOTAL ANKLE SYSTEM; INFINITY Total Ankle System; INSTRUMENT TRAY; INSTRUMENT TRAY BASE 4.5; INSTRUMENT TRAY LID FIXOS; INTERMEDIATE PROSTHESIS HOLDER LEFT; INTERMEDIATE PROSTHESIS HOLDER RIGHT; INTRAMEDULLARY BRUSH STANDARD 14MM OD; INVISION Total Ankle; INVISION Total Ankle Revision System; INVISION Total Ankle System; ISO Pocket; Impactor, Orthopedic Manual Surgical Instrument; Implantable K-Wire; Inbone Total Ankle; Infinity Total Ankle System; Injector Transfer Tube; Insertion Sleeve for Guide Wire; Instrument Guides; Instruments for Coverloc Volar Plat; Inter-Lock System; Intraosseous Fixation System; Intraosseous Fixation system manual surgical instruments; Invuity A-N, 35mm & 50mm Extra Narrow Re; Invuity A-N, 35mm & 50mm Extra Narrow Retractor; Invuity A-N, 35mm & 50mm Narrow Retracto; Invuity A-N, 35mm & 50mm Narrow Retractor; Invuity Breisky 130mm; Invuity Breisky 170mm; Invuity Deaver 25mm Wide Retractor; Invuity Deaver 38mm Wide Retractor; Invuity St. Marks 11 in Retractor; Invuity St. Marks 9 in Retractor; JA FANTOME CALOTTE; Jaw Clamp Large Offset Curved; Jaw Clamp Large offset Straight; Jaw Clamp Std Long; Jaw Clamp Std Short; Jaw Clamp offset Overbite; Jaw Clamp offset Underbite; Jaw Clamp, Curved Offs. Counterclockwise; Jaw Clamp, Overbite Counterclockwise; Jaw Clamp, Std Offset Counterclockwise; Jaw Clamp, Std Short Counterclockwise; Jaw Clamp, Std, Long Counterclockwise; Jaw Clamp, Underbite Counterclockwise,; Jungbluth Clamp, Narrow; Jungbluth Clamp, Wide; K-TEK BASIC CLAMP, EU/UK; K-TEK BASIC CLAMP, US; K-TEK SELECT BLADE CLAMP, EU; K2M General Instruments; KEIM SURGICAL CAST TABLE; KTEK ROUND POST CLAMP, US; KTEK SELECT BLADE CLAMP, US; KW BENDING IRON ICS; Knotilus+ 2.4X11.3mm Drill, Hard Bone; Knotilus+ 2.4x11.3mm Drill; Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip; Knotilus+ 2.4x8.9mm Drill, Hip; Knotilus+ 2.9x12.5mm Drill; Knotilus+ 2.9x12.5mm Drill, Hard Bone; Knotilus+ 2.9x12.5mm Drill, Hard Bone, Hip; Knotilus+ 2.9x12.5mm Drill, Hip; Knotilus+ 2.9x15.5mm Drill; Knotilus+ 2.9x15.5mm Drill, Hard Bone; Knotilus+ Crown Tip Guide; Knotilus+ Crown Tip Guide, Hip; Knotilus+ Fishmouth Tip Guide; Knotilus+ Fork Tip Guide, Hip; Knotilus+ Offset Tip Guide; LATE INJECTION CEMENT GUN; LID FOR INSTRUMENT TRAY; LID FOR PLATE RACK - COMPRESSION PLATES; LID FOR PLATE RACK - GENERIC; LID FOR PLATE RACK - SPECIAL PLATES; LITe BIO Delivery System - Loading Funnel; LITe BIO Delivery System - Loading Tool; LITe BIO Delivery System - Sterilization Tray and Lid; LMH; LOCON-T; Lag Screw Sleeve; Large AO Coupling - Hall Fitting; Latitude EV; M/T TRIAX LNG HANDLE WRENCH BLUE; M/T TRIAX LNG HANDLE WRENCH RED; M/T TRIAX LNG HANDLE WRENCH YELLOW; MALLET; MANUAL DRILL BIT; MANUAL SURGICAL INSTRUMENTS; MDI; MESA Spinal System Trays; MFT; MICA Screw System; MICRONAIL; MIIG; MILITARY EXTERNAL FIXATION CASE; MONOTUBE TRIAX YELLOW CASE; MTP PocketLock; Made-To-Order; Mainstay Zip Anchor System; Mako Instrument Trays; MaxLock; MaxLock Extreme; MaxLock Extreme manual surgical instruments; MaxTorque; MaxTorque, DRLock Extreme; Meniscal Transplant Set; Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini; Metal Hemi Implant; MicroFX™; Mini MaxLock; Mini MaxLock Extreme; Mini MaxLock manual surgical instruments; Mini MaxTorque; Mini Variable; Modular Glenoid Surface Trial; Modular Humeral Head Trial; Modular Humeral Head Trial Post; Multiple Drill Guide; NAPA Access System; NEEDLE GUIDE; NEXFIX; NanoPass; NanoTack; NanoTack Flex; Navigated Spine Instruments Trays; Navigation Instruments Trays; NexFix; OBLONG DRILL GUIDE DIAMETER 2MM; OMEGA PLUS 145 DRILL GUIDE INSERT; OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-NEUTRAL; OMEGA PLUS DRILL GUIDE HANDLE; OMEGA PLUS HEAD; OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm; OMEGA PLUS LAG SCREW ADAPTER; OMEGA PLUS SCREW EXTRACTION BOLT; OMEGA PLUS SUPRACONDYLAR DRILL GUIDE; OMEGA PLUS SUPRACONDYLAR PIN GUIDE; OMEGA PLUS TAP GUIDE 4.5mm; OMEGA PLUS TAP GUIDE 6.5mm; OMEGA PLUS TRIAL PLATE 150; OMEGA+ BARREL REAM ASSY SHORT; OMEGA+ PIN W/THREAD 2.8X230MM; OMEGA+ VAR ANGLE GUID REPL KIT; OMNIFLEX; ORTHOLOC; ORTHOLOC 2 Lapidus with Rotation; ORTHOLOC 3DI Ankle Fusion System; ORTHOLOC 3Di; ORTHOLOC 3Di Ankle Fracture System; ORTHOLOC 3Di Ankle Fusion Plating System; ORTHOLOC 3Di Ankle Plating System; ORTHOLOC 3Di CROSSCHECK; ORTHOLOC 3Di Foot Reconstruction System; ORTHOLOC 3Di Hallux System; ORTHOLOC 3Di Midfoot/Flatfoot System; ORTHOLOC 3Di Small Bones Plating System; ORTHOLOC 3Dsi Locking Screws; ORTHOLOC Bone Screws; ORTHOLOC, ORTHOLOC 3Di; ORTHOMET; ORTHOPEDIC MANUAL; ORTHOPEDIC SCREWDRIVER; ORTHOSET; ORTHOSPHERE; OSTEONICS; OSTEONICS BONE TAP; OSTEONOICS; OSTEOSET; OSTEOTOME; OZARK Cervical Plate System Trays; Opening Guide; Opening Reamer; Opening Sleeve; Orthopaedic Manual Instrumentation; Orthopedic Broach; Orthopro Cannulated Screw System; Osteotome; Overdrill for 4.5mm Screws, AO; PASSER; PATELLAR CUTTER; PEDIATRIC CORTICAL REAMER; PEEK IntraLine Anchor System; PERCUTANEOUS CEMENT GUN; PHALINX; PIN CUTTER / HA PINS; PIP Starter Awl; PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM; PKG., DUAL EDGE SHAVER BLADE - 5.5MM; PLANER; PLATE BENDING IRONS; PRECISION DOWEL BONE GRAFT SYSTEM; PRO Plating System; PRO-DENSE; PRO-DENSE LoVisc; PRO-STIM; PRO-TOE; PROBE; PRODENSE; PRODENSE Bone Graft; PROPHECY INBONE; PROPHECY INVISION Pre-operative Navigation Guides; PROPHECY INVISION Preoperative Navigation Alignment System; PROPHECY Preoperative Navigation Alignment System; PROSTEP; PROSTEP MIS BUNION (TBC); PROSTIM; PROTOE C2 2; PROTRACTOR; PUSHER; PYRENEES Cervical Plate System Trays; Pangea Femur Reconstruction System Bender; Pangea Femur Reconstruction System K-Wire; Pangea Femur Reconstruction System Tray; Pangea Platform; Pangea T-Handle; Pangea Torque Limiting Adapter; Parallel Guide for ø 1,4mm/2mm Wires; Perc. Double Wire Guide; PeriPROTM Femur; Periosteal Elavator, Reverse; Periosteal Elavator, Straight; Perisostela Elvator, Standard; PhaLinx Hammertoe; Phoenix; Plastic Tray; Portal Entry Kit; Posterior TLIF; Pro-Toe Hammertoe Fixation System; Pro-Toe X-Flex; Pro-Toe(R) VO; Prophecy Incompass Surgical Planning System; Prophecy Infinity; Prophecy Preoperative Navigation Alignment System; Prophecy Surgical Planning; Prophecy Surgical Planning System; Q Pedicle Instruments; QUESTUS; Quick Release Driver Hall Fitting; RACK FOR OPEN WEDGE PLATES (LEVEL 2); RACK FOR PLP UTILITY/MTP (LEVEL 2); RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2); RASP; RAVINE Access System Trays; RAYHACK; RED & BLUE INTL M/T CASE; REDUCTION HANDLES B & R CLAMPS; REPLACEMENT COMPONENTS; REPLACEMENT KNOB FOR DRILL BRACE; RESECTION GUIDE; RETRACTOR; REVOLUTION TIPS; RING DRIVER 4.5; RONGEUR; RX-FIX; Rasp; Reduction Instruments Complete Kit; Reduction Tray; Reduction Tray Insert for Jaw Clamps; Reduction Tray Insert for Weber Clamps; Reduction Tray generic Insert; Restoration ADM/MDM Instrumentation; Restoration Modular Instrument Trays; Restoration Modular Trials; Retractor; Reusable Awl; Reusable Slat for Eikon LT Adapt Smoke Evacuation 135 mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 155mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 175mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 90mm Retractor, 10 Pack; Reverse Express Tray; Revolution Cement Gun; SAHARA Stabilization System Trays; SALTO TALARIS; SALTO XT; SALVATION 3Di Plating System; SALVATION BEAM; SALVATION External Fixation; SALVATION External Fixation System; SALVATION Midfoot Nail; SAW BLADE; SCREW CADDY FOR 2 / 2.5 FIXO TRAY; SCREW RACK ANCHORAGE; SCREW RACK WS + CS (2MM+3.5MM); SCREW TRAY 4.5; SCREW-HOLDING FORCEPS FIXOS; SET ANCILLARY IMPLANT SUBTALAR; SET SCREW FOR HUMERUS AIMING BLOCK; SET SCREW FOR TIBIA AIMING BLOCK; SET SCREWDRIVER; SI-BONE; SIDEKICK; SIDEKICK EZ FRAME"" External Fixation System; SILICONE MAT; SMALL RULER FOR MEASUREMNET; SMALL SWIVEL JOINT; SMART TOE 1 INSTRUMENT KIT; SMOOTH BITE SHAVER BLADE - 3.5MM; SORBIE TOTAL ELBOW SYSTEM; SPARE SET SCREW HUMERUS TS AIMING BLOCK; SPARE SHAFT TEMP. PLATE HOLDER; SPIKE SCREW INSERTER FOR 4.5MM SCREWS; SPS BENDING SLEEVE - SLOTTED STEEL; STANDARD BENDING SLEEVE; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM; STERNUM SAW REPLACEMENT GUIDE; STRAIGHT FEMORAL CANAL BRUSH; STRAIGHT MULTI-CUT SCISSORS (4BX); STRYKER AUTOMATIC SCREWDRIVER; STRYKER CEMENT INJECTOR; STRYKER COMBO PUNCH; STRYKER SUTURE SLIDERS; STRYKER TUNNELER  STRYKER Y-NEEDLE 100  STRYKER Y-NEEDLE 200  STRYKER Y-NEEDLE 300  STRYKER Y-NEEDLE 400; STS; SUBFIX INSERTION INSTRUMENT; SURGICAL INSTRUMENT MOTORS AND ACCE; SUTURE BUTTON; SWANSON; Salvation EX FIX; Salvation External Fixation System; Screw Holder; Screw Insertion Sleeve; Screwdriver; Screwdriver Blade, AO, T10; Sidekick; Silicon Mat, Generic Insert; Silicon Mat, Insert for Jaw Clamps; Silicon Mat, Insert for Weber Clamps; Silicone MCP, Starter Awl; SlingShot; Smooth Bite Shaver Blade 3.5mm; Solid Screwdriver with AO Fitting; Spike Disk, Large; Spike Disk, Oval; St. Mark’s 11 in. Retractor; St. Mark’s 9 in. Retractor; Stanmore Face Cutter and Alignment Tool; Sterile Needle; Sterilization Box, Lightweight; Stryker Orthopaedics Awl; Stryker Orthopaedics Cutting Instruments; Stryker Orthopaedics Instrument Trays; Stryker Orthopaedics Prosthesis Driver; Stryker Orthopaedics Screw Forceps; Stryker Orthopaedics Templates; Stryker Orthopaedics Trials; Stryker Orthopaedics chisel; Stryker Trauma Pelvic Set (Matta); Stylet; Surgical Clip/Applier; Surgical Knife; Surgical Tray; Suture Anchor System; Swanson; Swanson Hammertoe Weil Design; Synchfix EVT; Syringe; T-HANDLE PIN INSERTER; T-HANDLE STEM HOLDER; T2 Alpha Femur Retrograde Nailing System, Nail Adapter SPI; T2 Alpha Femur Retrograde Nailing System, Nail Holding Screw SPI; T2 Alpha Femur Retrograde Nailing System, Target Device; T2 Alpha Femur Retrograde Nailing System, Tissue Protection Sleeve; T2 Guide Wire Ball Tip; TAMP; TAP; TC Plating System; TCP; TENSION DEVICE 16MM; THE SPIN SNAP-OFF SCREW; TIE-IN; TIGE FRACTURE N.M; TORNIER - INSTRUMENT; TRAY; TRAY FOR MV SCREWS; TRIAL ANCHORAGE PLP10341; TRIAL ANCHORAGE PLP10342; TRIAL ANCHORAGE PLP10461; TRIAL ANCHORAGE PLP10462; TRIAL ANCHORAGE PLP11341; TRIAL ANCHORAGE PLP11342; TRIAL ANCHORAGE PLP30141; TRIAL ANCHORAGE PLP30142; TRIAL ANCHORAGE PLP30171; TRIAL ANCHORAGE PLP30172; TRIAL ANCHORAGE PLP30201; TRIAL ANCHORAGE PLP30202; TRIAL ANCHORAGE PLP40160; TRIAL ANCHORAGE PLP40220; TRIAL ANCHORAGE PLP40280; TRIAL ANCHORAGE PLP40340; TRIAL ANCHORAGE PLP40400; TRIAL ANCHORAGE PLP40460; Terra Nova, Ravine, Serengeti, VCR, Cricket; Threaded Guide Wire; Tissue Protection Sleeve; Tomcat HC Shaver Blade 4mm; Tornier; Tornier Approach; Tornier Drill bits (all); Tornier Extraction; Tornier Flex Shoulder System; Tornier Humeral Nail; Tornier Perform Anatomic Glenoid; Tornier Perform Humeral System; Tornier Perform Reversed; Tornier Pyrocarbon; Tornier Radial Head System; Tornier Simpliciti Shoulder System; Total Compression Plating System; Tray - Silicon Mat; Tray insert; Triathlon; Triathlon MSI Tray; Triathlon MSI Trials; Triathlon Monogram Instruments; Triathlon System Instrument trays; Trocar; TwinLoop Anchor System; TwinLoop FLEX; Twist Screw Implant; Twist-drill cannulated ø8/L300mm; UNICLIP Staple; UNIVERSAL BENDING SLEEVE; UNIVERSAL PIN-WIRE CASE; UniVise; Universal ACL Instrumentation; Universal Neuro III Accessory Tray; VALOR; VALOR ANKLE FUSION NAIL SYSTEM SCREW; VARIOUS STRYKER MANUA; VARIOUS TWIST DRILLS; VERSITOMIC STERILE FLEXIBLE PIN; Valor Hindfoot Fusion Nail System; VariAX 2, Lid For Sterilizing Container; VariAx 2 Compression Plating System, Plate Insert; VariAx 2 Compression Plating System, Plate Trial; VariAx 2 Foot, Drawer; VariAx 2 Foot, Insert; VariAx 2 Foot, Instrument Kit; VariAx 2 Foot, Labeling Clip; VariAx 2 Foot, Module; VariAx 2 Foot, Module Lid; VariAx 2 Foot, Screw Rack; VariAx 2 Foot, SpeedGuide; VariAx 2 Foot, Tap for 2.7mm screws; VariAx 2 foot, Depth Gauge; VariAx 2, Aiming Block Fixation Pin; VariAx 2, Clip; VariAx 2, Depth Gauge; VariAx 2, Distal Radius Container Half-Size; VariAx 2, Distal Radius Implant Module; VariAx 2, Drill Bit; VariAx 2, Drill Guide; VariAx 2, Drill Guide K-Wire; VariAx 2, Fixed Angle Drill Guide 2.3/2.7mm; VariAx 2, Handle With 2.3mm Drill And K-Wire Guide; VariAx 2, Handle With Drill Guides; VariAx 2, Inlay; VariAx 2, Insert; VariAx 2, Joystick; VariAx 2, K-Wire; VariAx 2, K-Wire with Olive Stop; VariAx 2, Pliers; VariAx 2, Reduction Instrument Insert; VariAx 2, Screw Rack; VariAx 2, Screw Rack Locking Screws; VariAx 2, Screw Rack Non-Locking Screws; VariAx 2, ScrewDriver Blade; VariAx 2, Screwdriver Blade; VariAx 2, SpeedGuide; VariAx 2, Tap For 2.7mm Screws; VariAx Foot, Countersink; VariAx Foot, Holding Sleeve; VariAx Foot, K-Wire; VariAx, Drill; VariAx, Drill Guide; VariAx, Handle; VariAx, Safety Shield; VariAx, Screw Length Marker; VariAx, Screwdriver; VariAx, Tap For Bone Screws; VariAx, Tension Plier; VariAx, Tension Sheath; VariAx, Trial; Variable Angle Fixation; Variax 2, Steinmann Pin; VersiTomic Low Profile Reamer10 mm; VersiTomic Low Profile Reamer10.5 mm; VersiTomic Low Profile Reamer11 mm; VersiTomic Low Profile Reamer12 mm; VersiTomic Low Profile Reamer13 mm; VersiTomic Low Profile Reamer4.5 mm; VersiTomic Low Profile Reamer5 mm; VersiTomic Low Profile Reamer5.5 mm; VersiTomic Low Profile Reamer6 mm; VersiTomic Low Profile Reamer6.5 mm; VersiTomic Low Profile Reamer7 mm; VersiTomic Low Profile Reamer7.5 mm; VersiTomic Low Profile Reamer8 mm; VersiTomic Low Profile Reamer8.5 mm; VersiTomic Low Profile Reamer9 mm; VersiTomic Low Profile Reamer9.5 mm; Versitomic RR; Vikos Allograft System; WIRE AND DRILL GUIDE; WIRE CADDY; WIRE DIRECTOR; WMT ULTRA-FIT MODULAR SHOULDER SYSTEM; Weber Clamp Assmmetrical Left; Weber Clamp Assmmetrical Right; Weber Clamp Contoured; Weber Clamp Narrow; Weber Clamp Std; XIA Rod Template; Xcel Anchor RC System; Xcel Anchor System; Xia Blocker Inserter; YUKON OCT Spinal System Trays; driver, prosthesis; extraction shaft; i-Fuse Hammer Toe Systems; lag screw driver; lag screw reamer; precision pin; precision sleeve; screw depth gauge; screw extractor(percufix); set screw driver; tray base",1978-01-10,209,2026-06-16,1,20,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010667733%22&limit=1
Cardinal Health,1921846,1921846,444 James South Mcdonnell BLVD.,Hazelwood,MO,63042,United States,"Cardinal Health 200, LLC",9028292,Specification developer,164,BSY; BTO; BTX; BYX; BYY; BYZ; CBH; CCX; DRC; DRO; DRX; DSA; DSF; DWF; DWL; DWS; DYB; DYN; DZM; EFQ; EHZ; EIC; ERY; EXJ; EXR; EYQ; EYX; EYY; EYZ; EZD; EZL; FAQ; FCE; FCM; FCN; FEG; FFG; FHQ; FLL; FMA; FMF; FMH; FMI; FMJ; FNY; FOD; FOK; FOS; FOX; FOZ; FPK; FQM; FRG; FRL; FRN; FRO; FRQ; FSD; FSM; FSY; FXP; FXX; FYA; FYC; FYF; FZX; FZZ; GAA; GAB; GAX; GAZ; GBM; GBX; GCD; GCJ; GCX; GCY; GDJ; GDX; GDY; GEA; GEC; GIM; GXY; GZJ; HCC; HED; HFX; HGP; HHK; HMP; HMT; HMW; IKD; ILG; IME; ITG; JKA; JOL; JOW; KCY; KDC; KDH; KDQ; KDT; KGO; KGW; KGX; KGY; KGZ; KME; KMF; KMJ; KNT; KNW; KNX; KNY; KOD; KOX; KPE; KST; KYR; KYW; KYX; KYZ; LJS; LKB; LRJ; LRO; LWH; LWK; LXG; LYU; LZA; LZC; LZH; MDM; MEG; MGQ; MKJ; MLN; MLS; MMK; NAB; NAC; NAD; NAE; NNI; OEA; OFA; OJS; OMP; OPJ; OWL; PIF; PNR; PPB; PPG; PRM; PUI; PWY; QDO; QPC; SDV,"Catheters, Suction, Tracheobronchial; Tube, Tracheostomy (W/Wo Connector); Board, Arm (With Cover), Sterile; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Trap, Sterile Specimen; Device, Fixation, Tracheal Tube; Support, Patient Position; Trocar; Pacemaker, Cardiac, External Transcutaneous (Non-Invasive); Electrode, Electrocardiograph; Cable, Transducer And Electrode, Patient, (Including Connector); Recorder, Paper Chart; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Stocking, Medical Support (To Prevent Pooling Of Blood In Legs); Instruments, Surgical, Cardiovascular; Introducer, Catheter; Mouthpiece, Saliva Ejector; Needle, Dental; Gauze/Sponge, Internal; Evacuator, Oral Cavity; Syringe, Periodontic, Endodontic, Irrigating; Drape, Surgical, Ent; Device, Incontinence, Urosheath Type, Sterile; Urinometer, Mechanical; Garment, Protective, For Incontinence; Drape, Pure Latex Sheet, With Self-Retaining Finger Cot; Drape, Urological, Disposable; System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile; Catheter, Straight; Catheter, Retention Type, Balloon; Bag, Urine Collection, Leg, For External Use, Sterile; Enema Kit; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Urinary Drainage Collection Kit, For Indwelling Catheter; Tube, Double Lumen For Intestinal Decompression And/Or Intubation; Device, Urine Flow Rate Measuring, Non-Electrical, Disposable; Holder, Needle, Gastroenterologic; Continuous Measurement Thermometer; Depressor, Tongue, Non-Surgical; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Manometer, Spinal-Fluid; Basin, Emesis; Device, Occlusion, Umbilical; Pad, Neonatal Eye; Catheter, Umbilical Artery; Stand, Infusion; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Tubing, Fluid Delivery; Bandage, Elastic; Wrap, Sterilization; Fiber, Medical, Absorbent; Pump, Infusion; Dressing, Wound, Drug; Tube, Levine; Binder, Abdominal; Tray, Surgical, Instrument; Light, Surgical, Ceiling Mounted; Cover, Shoe, Operating-Room; Mask, Surgical; Gown, Surgical; Gown, Isolation, Surgical; Cap, Surgical; Guide, Surgical, Instrument; Marker, Skin; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Urethral; Catheter, Irrigation; Connector, Catheter; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Clamp, Surgical, General & Plastic Surgery; Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Cannula, Surgical, General & Plastic Surgery; Brush, Scrub, Operating-Room; Tubes, Vacuum Sample, With Anticoagulant; Electrode, Cutaneous; Stimulator, Nerve, Transcutaneous, For Pain Relief; Device, Biofeedback; Douche Apparatus, Vaginal, Therapeutic; Clamp, Circumcision; Electrode, Circular (Spiral), Scalp And Applicator; Curette, Suction, Endometrial (And Accessories); Pad, Eye; Drape, Patient, Ophthalmic; Drape, Microscope, Ophthalmic; Cable, Electrode; Stocking, Elastic; Pack, Hot Or Cold, Reusable; Bandage, Cast; Tubes, Vials, Systems, Serum Separators, Blood Collection; Catheter And Tip, Suction; Sleeve, Limb, Compressible; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration; Bottle, Collection, Vacuum; Container, Specimen Mailer And Storage, Sterile; Surgeon'S Gloves; Ring (Wound Protector), Drape Retention, Internal; Tape And Bandage, Adhesive; Bag, Intestine; Accessories, Catheter; Bedding, Disposable, Medical; Bandage, Liquid; Lubricant, Patient; Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Collector, Urine, (And Accessories) For Indwelling Catheter; Accessories, Catheter, G-U; Catheter, Urological; Solvent, Adhesive Tape; Container, I.V.; System, Blood Collection, Vacuum-Assisted, Manual; Bag, Ice; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Pad, Alcohol, Device Disinfectant; Disinfectant, Medical Devices; General Surgery Tray; Counter, Sponge, Surgical; Razor, Surgical; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Accessory, Surgical Apparel; Polymer Patient Examination Glove; Medical Glove, Specialty; Pump, Infusion, Enteral; Instrument, Manual, Surgical, General Use; Syringe, Antistick; Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic; Automated External Defibrillators (Non-Wearable); Electrode, Electrocardiograph, Multi-Function; Labor And Delivery Kit; Container, Sharps; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; Container, Specimen, Non-Sterile; Non-Surgical Gown; Cardiovascular Surgical Instruments Tray; Tourniquet Kit; Negative Pressure Wound Therapy Powered Suction Pump; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Peripheral Catheter Insertion Kit; Gastrointestinal Tubes With Enteral Specific Connectors; Enteral Syringes With Enteral Specific Connectors; Foley Catheter Kit (Excludes Hiv Testing); Urinary Drainage Collection Kit; Enteral Administration Kit (Adult & Pediatric); Drape, Surgical, Exempt; Lumbar Puncture Tray (Adult & Pediatric); Fentanyl And Other Opioid  Protection Glove; Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection; Clinical Electronic Thermometer",1; 2; 3; U,CARDINAL HEALTH NITRILE EXAMINATION GLOVES EXTENDED CUFF; Stainless Steel Tongue Cleaner,1977-12-23,207,2026-09-02,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221921846%22&limit=1
"Nuvasive, Inc.",2031966,3002980729,7475 Lusk Blvd,San Diego,CA,92121,United States,"NUVASIVE, INC.",9036345,Complaint file establishment; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,60,BSK; BTR; BXM; ETN; FST; FTL; FTY; GAD; GEI; GWF; HAW; HSB; HST; HTJ; HTW; HWA; HWB; HWJ; HWN; HWR; HWT; HXC; HXL; HXX; IKD; IKN; INK; JAA; JAC; KCT; KWP; KWQ; LLZ; LXH; MAX; MBP; MJO; MNH; MNI; MQP; MQV; MRW; NBH; NKB; NKG; NQW; ODP; OLO; OSH; OVD; OVE; OWB; OWI; PDQ; PEK; PGM; PHM; PLR; PML; QLQ,"Cuff, Tracheal Tube, Inflatable; Tube, Tracheal (W/Wo Connector); Stimulator, Nerve, Ac-Powered; Stimulator, Nerve; Light, Surgical, Fiberoptic; Mesh, Surgical, Polymeric; Tape, Measuring, Rulers And Calipers; Retractor; Electrosurgical, Cutting & Coagulation & Accessories; Stimulator, Electrical, Evoked Response; Neurological Stereotaxic Instrument; Rod, Fixation, Intramedullary And Accessories; Apparatus, Traction, Non-Powered; Gauge, Depth; Bit, Drill; Impactor; Extractor; Awl; Instrument, Compression; Driver, Prosthesis; Template; Wrench; Mallet; Screwdriver; Cable, Electrode; Electromyograph, Diagnostic; Stretcher, Wheeled, Powered; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Film Marking, Radiographic; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; System, Image Processing, Radiological; Orthopedic Manual Surgical Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Accessories, Arthroscopic; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Interventional Fluoroscopic X-Ray System; Bone Fixation Cerclage, Sublaminar; Neurosurgical Nerve Locator; Spinous Process Plate; Growing Rod System; Intervertebral Fusion Device With Bone Graft, Thoracic; Spinal Vertebral Body Replacement Device - Cervical; Bone Cement, Posterior Screw Augmentation; Manual Instruments Designed For Use With Total Disc Replacement Devices",1; 2; 3; U,"ARCHON-R ACP; AffiX Next Gen Spinous Process Plate System; Affix II Spinous Process Plate System; Affix Spinous Process Plate System; Archon-R ACP System; Armada Spinal Fixation system; AttraX Granules; AttraX Putty; Awl; BIT, DRILL; BRIGADE ANTERIOR PLATE SYSTEM; Bendini Cloud Application; Bendini Spinal Rod Bending System; Bipolar Coagulating Forceps; Brigade ALIF Plate; Brigade Hyperlordotic; Brigade XLR STANDALONE SYSTEM; COROENT TITANIUM SYSTEM; COROENT XL STERILE; CoRoent S Interbody System; CoRoent Small & SHL Interbody System; CoRoent Small Contoured Interbody System; CoRoent Small Interbody System; CoRoent Small Interlock; CoRoent Small Interlock II System; CoRoent Small Interlock System; CoRoent Small Ti-C System; CoRoent Thoracolumbar Implants; CoRoent Ti-C System; CoRoent XL-F System; CoRoent Zero-Profile System; CoRoent® Ti-C System; Coalesce™ Lumbar Interbody Fusion System; Cohere Cervical Interbody System; DRIVER, PROSTHESIS; Decade Lateral Plate System; ELECTRODE CABLE OR HARNESS; EXTRACTOR; FormaGraft Collagen Bone Graft Matrix; GAUGE, DEPTH; General Instruments; Gradient Plus System; Halo Anterior Lumbar Plate System; Helix Anterior Cervical Plating System; Helix Mini Anterior Cervical Plating System; Helix Revolution ACP System; Helix-T Anterior Cervical Plating System; IMPACTOR; Instrument, Compression; LessRay® System; Leverage Laminoplasty System; MANUAL SURGICAL INSTRUMENTS; MLX - Medial Lateral Expandable Lumbar Interbody; MLX™-Medial Lateral Expandable Lumbar Interbody System; Mallet; NUVASIVE COROENT EXTENSURE SYSTEM; NUVASIVE COROENT L & XL SYSTEMS; NUVASIVE COROENT SYSTEM; NUVASIVE EMBRACE SYSTEM; NUVASIVE MESH; NUVASIVE NV JJB SYSTEM; NV JJB SYSTEM; NV JJB SYSTEMS; NV JJB System; NV M5 System; NuVaisve® Reline® Cervical System; NuVasive ALIF Buttress Plate System; NuVasive ALIF Interfixated System; NuVasive AP Expandable XLIF System; NuVasive Affix IIS Spinous Process Plate System; NuVasive Affix Spinous Process Plate System; NuVasive AttraX Scaffold; NuVasive Bendini Spinal Rod Bending System; NuVasive CoRoent Single Tab System; NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Interlock System (Allograft); NuVasive CoRoent System; NuVasive CoRoent System (Degenerative Scoliosis); NuVasive CoRoent Thoracolumbar System; NuVasive CoRoent Ti-C System; NuVasive CoRoent® Small Interbody System; NuVasive Cohere ALIF System Intervertebral Body Fusion Device; NuVasive ET TUBE; NuVasive Expandable Lumbar Interbody System; NuVasive GSB Global Spinal Balance System; NuVasive Lateral VBR System; NuVasive Lumbar Interbody Implants; NuVasive MAS PlIF Fixation System; NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2 Interbody System; NuVasive MaXcess Light Guide; NuVasive Modulus ALIF System; NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System; NuVasive Modulus XLIF Interbody System; NuVasive NV EMG Endotracheal Tube; NuVasive NV M5; NuVasive NVJJB System; NuVasive NVM5 System; NuVasive Navigation Instruments; NuVasive Next Generation NVM5 System; NuVasive PCM Cervical Disc; NuVasive PEEK Corpectomy Railed; NuVasive Polyaxial Spinal Screws; NuVasive Precept Spinal System; NuVasive Propel DBM Putty; NuVasive Propel DBM Putty and Gel Plus; NuVasive Pulse System; NuVasive RELINE Cervical System; NuVasive RELINE System; NuVasive Reline System; NuVasive Reline System (Pediatric Indications); NuVasive SpheRx II Spinal System; NuVasive SpheRx Spinal System; NuVasive StruXure Spinal System; NuVasive StruXureFixation System; NuVasive Surgical Mesh; NuVasive TLX Interbody System; NuVasive Thoracolumbar Plates; NuVasive Triad Facet Screw System; NuVasive VersaTie System; NuVasive VuePoint OCT System; NuVasive X-Core Expandable VBR System; NuVasive X-Core® Expandable VBR System, NuVasive X-Core® Mini Cervical Expandable VBR System; NuVasive XLIF Decade Lateral Plate System; NuVasive® 3DP Interfixated ALIF System; NuVasive® ACP System; NuVasive® Anterior Cervical Plate Systems; NuVasive® AttraX Scaffold; NuVasive® AttraX® Putty; NuVasive® BASE Interfixated Titanium System; NuVasive® Brigade® Lateral System; NuVasive® Camber Laminoplasty System; NuVasive® CoRoent® Lumbar Sytem; NuVasive® CoRoent® Small Interbody System; NuVasive® CoRoent® Small Interlock™ System; NuVasive® CoRoent® Small Ti-C System; NuVasive® CoRoent® Thoracolumbar System; NuVasive® Cohere® Thoracolumbar Interbody System; NuVasive® Foundation-LL System; NuVasive® Growth Rod Conversion Set; NuVasive® Interfixated Interbody System; NuVasive® LessRay® with Enhanced Tracking; NuVasive® Lumbar Interbody Implants; NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody  System, NuVasive® AP Expandable XLIF System; NuVasive® MLX® - Medial Lateral Expandable Lumbar Interbody System, NuVasive® AP Expandable XLIF System; NuVasive® MOD-EX XLIF Interbody System; NuVasive® Modulus TLIF Interbody System; NuVasive® Modulus XLIF Interbody System; NuVasive® Modulus-C Interbody System; NuVasive® Modulus® ALIF System; NuVasive® Modulus® XLIF Interbody System; NuVasive® Monolith Corpectomy System; NuVasive® Monolith™ Cervical Corpectomy System; NuVasive® Navigation Instruments; NuVasive® NuvaLineTM Mobile App; NuVasive® NuvaLine®; NuVasive® PEEK Corpectomy System; NuVasive® Precept™ Spinal System; NuVasive® Pulse™ System; NuVasive® RELINE® Fenestrated Screws, High V+ Bone Cement; NuVasive® Reline® 4.5-5 System; NuVasive® Reline® System; NuVasive® Sterilization Trays; NuVasive® TLX Interbody System; NuVasive® Thoracolumbar Interbody Systems; NuVasive® VersaTie System; NuVasive® VersaTie™ System; NuVasive® VuePoint® II OCT System; NuVasive® X-Core® Mini Cervical Expandable VBR System; NuVasive® XLX Interbody System; PIN TRACTION; PreCept Spinal System; Radian Facet Screw System; Retractor; Rod Registration Frame; Screwdriver; Simplify® Cervical Artificial Disc; Simplify® Disc Inserter FP; SpheRx DBR II System; SpheRx PPS Beta System; SpheRx PPS System; SpheRx Spinal System; Stimulation/Dissection Instruments; Supplemental Instrument Trays; System, x-ray, film marking, radiographic; Tape, Measuring, Rulers and Calipers; Template; Traverse 2 Bolt Lateral Plate System; Traverse Lateral Plate System; Vertera Spine Cohere Cervical Interbody Fusion Device; Vertera SpineTM Cohere® Cervical Interbody Fusion Device; Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System; VuePoint OCT System; Wrench; X-Core ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM; XLIF Stimulating Electrode; XLP II Lateral Plate; XLP Lateral Plate; XLP Lateral Plate System",2006-10-17,205,2024-08-02,2,6,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222031966%22&limit=1
"O&M Halyard, Inc.",3014421917,3014421917,1220 Old Alpharetta Rd Ste 320,Alpharetta,GA,30005,United States,"O&M Halyard, Inc.",10057479,Complaint file establishment; Manufacturer; Remanufacturer; Repackager or relabeler; Specification developer,127,BSY; BWN; BWP; BYY; BYZ; CAE; CAF; CAH; CCX; DRX; DSF; DSW; DWJ; DXQ; EFW; EXI; EYJ; EYQ; EZD; EZS; FCM; FME; FMF; FMH; FMI; FMQ; FNL; FNY; FOX; FPD; FQM; FRC; FRG; FRL; FRO; FSM; FXO; FXP; FXX; FYA; FYC; FYF; GAX; GCD; GCX; GCY; GDS; GDY; GEI; HDJ; HFW; HIB; HOY; IKX; ILH; ILI; IMD; IME; INB; INP; IOR; IPM; IPR; IPS; IQI; ISH; ISR; ITC; ITJ; ITX; JCY; JOJ; JOL; JYG; KCT; KDC; KDD; KES; KEW; KGO; KGT; KGX; KKX; KME; KMI; KMJ; KMK; KNT; KNX; KOX; KST; KYR; KYW; KYZ; KZD; LDE; LGM; LHC; LRO; LWG; LWH; LYU; LYY; LYZ; LZA; LZC; MPN; MPO; MSH; NAB; NAC; NAD; NEC; NGT; NNI; NNK; NZD; OCT; OEA; OHY; OPJ; OXZ; PIF; PSH; PUI; QDO; SDV,"Catheters, Suction, Tracheobronchial; Table And Attachments, Operating-Room; Shoe And Shoe Cover, Conductive; Tube, Aspirating, Flexible, Connecting; Trap, Sterile Specimen; Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Filter, Bacterial, Breathing-Circuit; Support, Patient Position; Electrode, Electrocardiograph; Recorder, Paper Chart; Bag, Polymeric Mesh, Pacemaker; System, Thermal Regulating; Blood Pressure Cuff; Toothbrush, Manual; Device, Paste-On For Incontinence, Sterile; Holder, Ureteral Catheter; Garment, Protective, For Incontinence; Catheter, Straight; Appliance, Colostomy, Disposable; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Gown, Examination; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Restraint, Protective; Bed, Ac-Powered Adjustable Hospital; Basin, Emesis; Stand, Infusion; Tube, Feeding; Bandage, Elastic; Indicator, Biological Sterilization Process; Wrap, Sterilization; Fiber, Medical, Absorbent; Dressing, Wound, Drug; Tray, Surgical, Instrument; Suit, Surgical; Cover, Shoe, Operating-Room; Mask, Surgical; Gown, Surgical; Gown, Isolation, Surgical; Cap, Surgical; Tourniquet, Nonpneumatic; Connector, Catheter; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Bag, Stomal; Gauze/Sponge, Internal, X-Ray Detectable; Electrosurgical, Cutting & Coagulation & Accessories; Scissors, Umbilical; Clamp, Umbilical; Speculum, Vaginal, Nonmetal; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Aid, Transfer; Splint, Hand, And Components; Sling, Arm; Pack, Hot Or Cold, Disposable; Pack, Hot Or Cold, Reusable; Attachment, Commode, Wheelchair; Tips And Pads, Cane, Crutch And Walker; Wheelchair, Mechanical; Cover, Limb; Crutch; Cane; Orthosis, Limb Brace; Component, External, Limb, Ankle/Foot; Band Or Belt, Pelvic Support; Stirrup, External Brace Component; Walker, Mechanical; Transducer, Ultrasonic, Diagnostic; Catheter, Infusion; Indicator, Physical/Chemical Sterilization Process; Catheter And Tip, Suction; Curette, Ear; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Coverslips, Microscope Slide; Slides, Microscope; Surgeon'S Gloves; Drape, Adhesive, Aerosol; Tape And Bandage, Adhesive; Drape, Surgical, Antimicrobial; Bedding, Disposable, Medical; Monitor, Bed Patient; Lubricant, Patient; Device, Intravascular Catheter Securement; Tubes, Gastrointestinal (And Accessories); Collector, Urine, (And Accessories) For Indwelling Catheter; Solvent, Adhesive Tape; System, Blood Collection, Vacuum-Assisted, Manual; Bag, Ice; Container, Liquid Medication, Graduated; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Stethoscope, Manual; Chamber, Patient Isolation; Warmer, Irrigation Solution; General Surgery Tray; Surgical Table Cushion; Counter, Sponge, Surgical; Accessory, Surgical Apparel; Latex Patient Examination Glove; Vinyl Patient Examination Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; Tissue Adhesive For The Topical Approximation Of Skin; Infant Heel Warmer (Chemical Heat Pack); Respirator, Surgical; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Bandage, Liquid, Skin Protectant; Saline, Vascular Access Flush; Container, Specimen, Non-Sterile; Container, Specimen Mailer And Storage, Non-Sterile; Stretcher, Patient Restraint; Anti Fog Solution And Accessories, Endoscopy; Non-Surgical Gown; Pill Crusher/Cutter; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Pediatric/Child Facemask; Gastrointestinal Tubes With Enteral Specific Connectors; Percutaneous Replacement Gastrostomy Tube Kit; Drape, Surgical, Exempt; Fentanyl And Other Opioid  Protection Glove; Clinical Electronic Thermometer",1; 2; U,"62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask; AERO BLUE SURGICAL GOWN; AID, TRANSFER; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY; AMSafe(R) Pre-Filled Normal Saline Flush Syringe; ANESTHESIA BREATHING CIRCUIT; ASTM Fluid-Rated Fog-Free Procedure Mask; ASTM Fluid-Rated Procedure Mask; Aero Blue Performance Surgical Gowns; Aero Chrome Breathable Performance Surgical Gown; Aero Chrome Select; Anti-Fog Surgical Mask; BANDAGE, ELASTIC; BASICS* Blue Powder-Free Nitrile Exam Gloves; Back Table Covers; Bandage, liquid, skin protectant; CANE; CATHETER AND TIP, SUCTION; CATHETERS, SUCTION, TRACHEOBRONCHIAL; CONTAINER, SPECIMEN, STERILE; CRUTCH; Counter, sponge, surgical; Cover, Limb; Curaplex® TritonGrip VL™ Nitrile Exam Gloves; DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES; DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES; DISPOSABLE HOT / COLD PACK; DISPOSABLE MEDICAL BEDDING; Disposable Powder Free Nitrile Examination Glove, White Color, Tested for Use with Chemotherapy Drugs, Disposable Powder; Dressing, wound, occlusive; EXAMINATION GLOVE, SPECIALTY; EXAMINATION GOWN; EYE SHIELD; Equipment Covers; Equipment Drapes; Evolution AAMI 4 Surgical Gown; FLEXAPRENE GREEN POWDER-FREE EXAM GLOVES; FLUID CONTROL* Floor Suction Mat; FLUID WARMER; FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798); FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805); FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining; FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining, High Clarity WrapAround Visor; FLUIDSHIELD* 2 Fog-Free Procedure Mask with SO SOFT* Earloops, Blue, WrapAround Visor; FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print; FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print, WrapAround Visor; FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops; FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops, Blue; FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; FLUIDSHIELD* 3 Fog-Free Procedure Mask with So Soft* Lining; FLUIDSHIELD* 3 Fog-Free Surgical Mask with So Soft* Lining; FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask; Fetal Monitor Security Strap with Buttonhole Attachment; Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802); Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116); Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Orange; Foam Patient Positioning; Fusion Black Powder-Free Nitrile Exam Glove; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE; GOWN, DRAPE PACKS; Gauze / sponge,nonresorbable for external use; Gauze/sponge, internal, x-ray detectable; General Surgery Tray; HALYARD BASICS SURGICAL GOWN; HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops; HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor; HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor; HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor; HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining; HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor; HALYARD Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor; HALYARD Fluidshield * 3 Surgical Mask with SO SOFT* Lining; HALYARD Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor; HALYARD GOWN; HALYARD PROCEDURE GOWN; HALYARD ULTRA SURGICAL GOWN; HALYARD* AQUASOFT ZERO* Nitrile Exam Gloves; HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* Absorbent Table Cover; HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* Alginate Dressing; HALYARD* Black Powder-Free Nitrile Exam Gloves; HALYARD* Conforming Skin Barrier Ring; HALYARD* Disposable Underpad; HALYARD* Drawcord Bag, Clear; HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806); HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue, WrapAround Visor; HALYARD* Gelling Fiber (CMC) Dressing; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY*Technology; HALYARD* Level 1 Procedure Mask (48388); HALYARD* Lubricating Deodorant Clear Unscented; HALYARD* Non-Bordered Silicone Foam Dressing; HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* PUREZERO* Black Nitrile Examination Gloves; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* Regional Anesthesia Pain Management Drape; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650); HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STERLING Nitrile Powder-Free Exam Gloves; HALYARD* STERLING SG* Nitrile Powder-Free Exam Gloves; HALYARD* Skin Barrier Arc One Half Circle; HALYARD* Skin Barrier Ostomy Powder; HALYARD* Xeroform Dressing; HALYARD® ONE-STEP® Sterilization Wrap; HALYARD® QUICK CHECK® Sterilization Wrap; HALYARD® SEQUENTIAL Sterilization Wrap; HALYARD® SMART-FOLD® Sterilization Wrap; Halyard Anti-Fog Level 1 Tie Mask and Halyard Anti-Fog Level 3 Tie Mask; Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove; Halyard Gown; Halyard Lavender Nitrile Powder-Free Exam Gloves; Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fenta; Halyard ONE-STEP Sterilization Wrap; Halyard Pink Underguard Nitrile Powder-Free Exam Glove; Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested With Chemotherapy Drugs; Halyard Purple Nitrile Max Powder-Free Exam Gloves; Halyard Purple Nitrile* Powder-Free Exam Gloves; Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fenta; Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves; Halyard STERLING* Powder-Free Nitrile Exam Gloves; Halyard Surgical N95 Respirator Cup Type Regular Size; Halyard Surgical N95 Respirator Cup Type Small Size; INSTRUMENT, SURGICAL, DISPOSABLE; ISOLATION SURGICAL GOWN; Impervious Stockinette; K160709; K823078; Kit, surgical instrument, disposable; Latex Micro Powder-Free Sterile Surgical Gloves; Latex Powder-Free Sterile Surgical Gloves Tested for use with Chemothera; LiquiBand Exceed; MediChoice; Medical adhesive tape and adhesive bandage (Tape and Bandage, Adhesive); NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS; NITRILE POWDER FREE EXAMINATION GLOVES; NON-STERILE DISPOSABLE VAGINAL SPECULUM; Nebulizer (direct patient interface); Needle, hypodermic, single lumen; Neoprene Micro Powder-Free Sterile Surgical Gloves; Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color); Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue); ONE-STEP Sterilization Wrap, QUICK CHECK Sterilization Wrap; OPERATING ROOM SHOE COVER; OPERATING ROOM TABLE AND ATTACHMENTS; Obstetric-gynecologic specialized manual instrument (Clamp, Umbilical); PATIENT EXAMINATION GLOVE, SPECIALTY; PATIENT RESTRAINT; PEDIATRIC / CHILD FACEMASK; PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL; POLYMER PATIENT EXAM GLOVE; POLYMER PATIENT EXAMINATION GLOVE; POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE; POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE; POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE; POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF; POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED; POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED; PUREZERO Ultra Violet Nitrile Exam Glove; PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves; Personal Stirrup Strap with Slip Ring; Polyisoprene Micro Powder-Free Sterile Surgical Gloves; Polyisoprene Powder-Free Sterile Surgical Gloves; Polyisoprene/Neoprene Hybrid Sterile Surgical Glove; Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue); Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs; Probe Cover; Procedure Mask; PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim; PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim; Regard® Latex Powder-Free Sterile Surgical Gloves; Regard® Polyisoprene Powder-Free Sterile Surgical Gloves; SAFESKIN NITRILE EXAM GLOVE; SHOE AND SHOE COVER; SKYBREEZE LDP* Powder-Free Nitrile Exam Gloves; SKYBREEZE* Powder-Free Nitrile Exam Gloves; SMART-FOLD Sterilization Wrap; SPLINT, HAND AND COMPONENTS; STERILE LUBRICATING JELLY; STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED; STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE; STERILIZATION WRAP; STERILIZATION WRAP AND ACCESSORIES; STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves; STETHOSCOPE, MANUAL; SURGICAL CAP; SURGICAL DRAPE; SURGICAL DRAPE HALYARD; SURGICAL GOWN; SURGICAL ISOLATION GOWN; SURGICAL MASK; SURGICAL SUIT; SURGICAL TABLE CUSHION; SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE; SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE; SYRINGE, IRRIGATING (NON DENTAL); Safe Secure Sterilization Pouches And Rolls; Scatter Radiation Drape; SkyBreeze Zero Nitrile Powder-Free Exam Glove; Skybreeze Powder-Free Nitrile Exam Glove; Specimen transport and storage container (Container, Specimen, Non-Sterile); Standard Cone Mask; Sterilization Monitoring Products; Sterilization Pouch Heat Seal-Flat Pack; Sterisystem Dry-Base Instrument Tray; Sterling Nitrile Powder-Free Exam Gloves; Surgical Drape; Surgical Drapes and/or accessories; Surgical Drapes and/or accessories (Stockinette Drapes); Surgical Mask; Surgical Packs; Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs; Syringe, piston; THERMAL REGULATING SYSTEM; TOURNIQUET, NONPNEUMATIC; TRAY, SURGICAL, INSTRUMENT; TRI-LAYER AAMI3 OVER-THE-HEAD ISOLATION GOWN; TUBE, ASPIRATING, FLEXIBLE, CONNECTING; TUBE-CONTROL PLUS with Hydrogel; Tape Strips; Telemetry Unit Pouch; Tips and pads, cane, crutch and walker; Tray, catheterization, sterile urethral, with or without catheter (kit); Tri-Layer AAMI 3 Isolation Gowns; VALUESELECT* Film-Reinforced Surgical Gown with Towels; VALUESELECT* Standard Surgical Gown with Towels; VINYL PATIENT EXAMINATION GLOVE-POWDER FREE; Vinyl patient examination glove; Walker, mechanical; White Powder-Free Nitrile PPE Exam Gloves; YK9000 SERIES MANUAL WHEELCHAIR; container, liquid medication, graduated; sling, arm; solvent, adhesive tape",2018-04-20,207,2026-07-21,0,3,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014421917%22&limit=1
Soher Med Limited,3045857207,3045857207,"Suite C, Level 7, Word Trust Tower, 50 Stanley Sueet",Hong Kong,,999077,Hong Kong,Soher Med Limited,10095823,Exporter to the US,75,DYH; DYT; DZA; DZM; DZN; DZP; EAX; EBC; EBD; EBF; EBG; EBI; EBL; EBZ; ECB; EEF; EFB; EFH; EFW; EGD; EGZ; EHJ; EHK; EHL; EHM; EHY; EIB; EIC; EID; EIH; EIY; EJB; EJJ; EJK; EJL; EJR; EKB; EKJ; EKK; EKM; EKN; EKR; EKS; EKT; ELC; ELL; ELM; ELR; ELW; ELZ; EMA; EMG; EMJ; EMN; EMR; FSM; GAM; GES; IWZ; JEP; JEX; KHR; KIF; KLE; KQM; KXR; LBH; LFD; LYU; MAU; MUH; MVL; MZW; NRD; PME,"Adhesive, Bracket And Tooth Conditioner, Resin; Maintainer, Space Preformed, Orthodontic; Drill, Dental, Intraoral; Needle, Dental; Instruments, Dental Hand; Instrument, Diamond, Dental; Mirror, Mouth; Sealant, Pit And Fissure, And Conditioner; Coating, Filling Material, Resin; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Resin, Denture, Relining, Repairing, Rebasing; Pin, Retentive And Splinting, And Accessory Instruments; Activator, Ultraviolet, For Polymerization; Unit, Syringe, Air And/Or Water; Clamp, Rubber Dam; Handpiece, Air-Powered, Dental; Paper, Articulation; Toothbrush, Manual; Wax, Dental, Intraoral; Holder, Film, X-Ray; Disk, Abrasive; Cup, Prophylaxis; Point, Abrasive; Strip, Polishing Agent; Tray, Impression, Preformed; Syringe, Irrigating (Dental); Syringe, Periodontic, Endodontic, Irrigating; Syringe, Restorative And Impression Material; Powder, Porcelain; Instrument, Filling, Plastic, Dental; Handle, Instrument, Dental; Alloy, Amalgam; Liner, Cavity, Calcium Hydroxide; Bur, Dental; Agent, Polishing, Abrasive, Oral Cavity; Explorer, Operative; Burnisher, Operative; Spreader, Pulp Canal Filling Material, Endodontic; Gutta-Percha; Point, Paper, Endodontic; Plugger, Root Canal, Endodontic; File, Pulp Canal, Endodontic; Curette, Endodontic; Scaler, Ultrasonic; Teeth, Porcelain; Denture, Plastic, Teeth; Post, Root Canal; Material, Impression; Crown, Preformed; Cement, Dental; Forceps, Tooth Extractor, Surgical; Elevator, Surgical, Dental; Scaler, Periodontic; File, Periodontic; Tray, Surgical, Instrument; Suture, Absorbable, Synthetic, Polyglycolic Acid; Blade, Scalpel; Film, Radiographic; Retainer, Matrix; Plier, Orthodontic; Absorber, Saliva, Paper; Resin, Root Canal Filling; Agent, Tooth Bonding, Resin; Camera, Surgical And Accessories; Applicator, Resin; Varnish, Cavity; Saliva, Artificial; Accessory, Surgical Apparel; Eraser, Dental Stain; System, X-Ray, Extraoral Source, Digital; Cord, Retraction; Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief; Unit, Operative Dental, Accessories; External Cleaning Solution",1; 2; U,"AH Plus; Adhesive; Adhesive, Bracket; Air polish; Amalgam; Applicatory Resin; Bond; Bonding; Burnisher; C&B; Calcimol; Clamp; Coe; Composite dispensing; Crown & Bridge; Crowns; Cup; Curette; Dental; Dental Accessory; Dental Blade; Dental Cement; Dental Filling; Dental Filling Material; Dental Impression; Dental Needle; Dental Wax; Dental cement; Dental elevator; Dental instrument; Denture; Denture resin; Dry mouth; Endo; Endo file; Explorer; Express; File; Filling material; Film Holder; Flow; Forecep; Fuji Lining; Gutta percha; Impression; Impression Dental; Impression Material; Impression material; Instrument; Kooliner; LED Accessory; LED accessory; Liner; Luxatemp; MATERIAL, IMPRESSION; Maxcem; Mirror; Mixing Tips; NX3; Occlufast; OptiBond; Paper, Articulation; Perio; Pit & Fissure; Plier; Polishing; Porcelain; Posts; Protemp; Retraction Cord; Sealant; Shade resin; Structur; Suture; Temp Crown; Tips; Tooth Bonding; Tooth Shade; Tooth bond; Tooth bonding; Tooth resin; Tooth shade; Toothbrush; Tray; Unitek; Varnish; Z350; abrasive; absorber; accessories; bonding; bur dental; cord retraction; core; dental; dental accessory; dental bag; dental bond; dental bonding; dental cement; dental composite; dental filling; dental impression; dental instrument; dental lubricant; dental resin; dental retraction; denture; denture resin; endo spreader; impression material; irrigating; paper point; pit & Fissure; retainer; retraction cord; scaler; shade; shade resin; share resin; temp C&B; tooth bond; tooth bonding; tooth shade; varnish; xray accessory",2026-05-05,205,2021-12-09,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223045857207%22&limit=1
"Smith & Nephew, Inc.",3038503932,3038503932,4340 Swinnea Rd,Memphis,TN,38118,United States,"Smith & Nephew, Inc.",1020279,Manufacturer,102,FNS; FQH; FSM; FTY; FZO; FZP; FZX; FZY; GAD; GAT; GDG; GEY; GFA; HAB; HAW; HRS; HRY; HSB; HSD; HST; HSX; HTC; HTD; HTE; HTF; HTJ; HTN; HTO; HTQ; HTR; HTW; HTX; HTY; HWA; HWB; HWC; HWJ; HWK; HWM; HWQ; HWR; HWT; HWX; HXC; HXD; HXG; HXJ; HXL; HXP; HXR; HXS; HXX; HXZ; HYA; IPR; JDG; JDI; JDJ; JDO; JDQ; JDR; JDS; JDW; JDY; JDZ; JOL; JWH; KGS; KIH; KIK; KQW; KRO; KRQ; KRR; KTT; KTZ; KWI; KWL; KWS; KWY; KWZ; LPH; LWJ; LXH; LXT; LZN; LZO; LZY; MAI; MBH; MBI; MBL; MBV; MEH; NAB; NBH; NDG; NEU; NPJ; OLO; OOG; OSN,"Ring Cutter; Lavage, Jet; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Clip, Implantable; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Suture, Nonabsorbable, Synthetic, Polyethylene; Hook, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Saw, Powered, And Accessories; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Impactor; Extractor; Screw, Fixation, Bone; Awl; Trephine; Osteotome; Passer; Driver, Prosthesis; Template; Tap, Bone; Wrench; Clamp; Tamp; Staple Driver; Mallet; Instrument, Bending Or Contouring; Spatula, Orthopedic; Twister, Wire; Screwdriver; Cutter, Wire; Forceps, Wire Holding; Crutch; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Evacuator, Vapor, Cement Monomer; Mixer, Cement, For Clinical Use; Catheter And Tip, Suction; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Retention Device, Suture; Dispenser, Cement; Hook, Bone; Goniometer, Nonpowered; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Gauze / Sponge,Nonresorbable For External Use; Accessories, Arthroscopic; Washer, Bolt, Nut, Non-Spinal, Metallic; Marker, Radiographic, Implantable; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Orthopedic Stereotaxic Instrument; Knee Arthroplasty Implantation System; Software For Diagnosis/Treatment",1; 2,"(6) MINITAPE (BLUE) 39.5; (6) MINITAPE (COBRAID BLUE) 39.5; (6) MINITAPE (COBRAID WHITE) 39.5; 1.2 ENDOBUTTON CL ULTRA PAC; 1.2 RAP-PAC A LATEX FREE; 1.2 RAP-PAC A, 72202796; 1.2 RAP-PAC B LATEX FREE; 1.2 RAP-PAC B, 72202797; 1.2 RAP-PAC C; 1.5 MM TENDON DRILL PIN; 1.5mm Guidewire, 12"", 72202189; 10MM DILATOR; 11 MM GRAFT SIZING TUBE; 11MM DILATOR; 12 MM GRAFT SIZING TUBE; 12MM DILATOR; 13 MM GRAFT SIZING TUBE; 14 MM GRAFT SIZING TUBE; 15 DEGREE CLOSED CURETTE 3 MM; 15 DEGREE OPEN CURETTE 2.5 MM; 15 DEGREE OPEN CURETTE 4 MM; 15 DEGREE OSTEOTOME 3MM; 2 MM FULL RADIUS MINI BLADES, POWER/EP-1, BLUE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2-5 MM OFFSET GUIDE; 2.4 MM FLEXIBLE PASSING PINS, STERILE 5 PER PACKAGE; 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE; 2.4MM X 10 INCH DRILL-TIP GUIDE WIRE; 2.4MM X 11 INCH 28 CM TROCAR-TIP PASSING PIN; 2.6 MM TWIST DRILL BIT FOR 2.3 ANCHOR; 2.7 MM CHISEL GUARD; 2.7 MM DILATOR; 2.9 MM ABRADER MINI BURRS, POWER/EP-1, ORANGE, PACKAGED 6 PER BOX, STERILE; 2.9 MM BARREL ABRADER MINI BURRS, POWER/EP-1, PURPLE, PACKAGED 6 PER BOX, STERILE; 2.9 MM CUTTER MINI BLADES, POWER/EP-1, BEIGE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2.9 MM FULL RADIUS MINI BLADES RED, POWER/EP-1, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 20 DEGREE OSTEOTOME 4MM; 3.5 MM ABRADER MINI BURRS, POWER/EP-1, AQUA, PACKAGED 6 PER BOX, STERILE; 3.5 MM CUTTER STRAIGHT BLADE; 3.5 MM DILATOR; 3.5 MM FULL RADIUS BLADE; 3.5 MM FULL RADIUS CURVED, CONCAVE, 8 CM MINI BLADES, POWER/EP-1, PLUM, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM HEX DRIVER, 2 MM CANNULATION; 3.5 MM INCISOR PLUS, 8 CM MINI BLADES, POWER/EP-1, SAGE GREEN, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM INCISOR STRAIGHT BLADE; 3.5 MM RAZORCUT STRAIGHT BLADE; 3.5 MM RAZORCUT, 8 CM MINI BLADES, POWER/EP-1, PUMPKIN/ORANGE, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 mm Bonecutter Platinum Blade; 3.5MM INCISOR PLUS PLAT BLD; 3.5MM SPADE TIP DRILL FOR USE WITH 4.5 MM ANCHOR HOLE PREPARATION DEVICE FOR HARD BONE; 3.5MM SYNOVATOR PLAT BLD; 30 DEGREE OPEN CURETTE 2.5 MM; 4 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, SAGE GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4 MM ABRADER STRAIGHT BURR; 4 MM ACROMIONIZER STRAIGHT BURR; 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS; 4 MM PORTAL STICK X 12 INCH 30 CM LONG; 4 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, MAROON, PACKAGED 6 PER BOX, STERILE; 4 MM SHOULDER ROD X 12 INCH 30 CM LONG; 4 MM STONECUTTER STRAIGHT BURR; 4.5 FULL RADIUS BONECUTTER BLADES, YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, CURVED, INCISOR CURVED BLADES, POWER/EP-1, LIME GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, FULL RADIUS, CURVE, CURVED BLADES, POWER/EP-1, YELLOW, CURVE LENGHTS 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, SYNOVATOR CURVED BLADES, POWER/EP-1, FOREST GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CUTTER STRAIGHT BLADE; 4.5 MM DILATOR; 4.5 MM FULL RADIUS STRAIGHT BLADE; 4.5 MM HELICUT STRAIGHT BURRS, POWER/EP-1, SLATE, 5000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, VIOLET, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR STRAIGHT BLADE; 4.5 MM LONG CURVED FULL RADIUS CONCAVE SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM LONG FULL RADIUS SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM OBTURATOR, CONICAL TIP; 4.5 MM ORBIT FULL RADIUS CURVED BLADE; 4.5 MM ORBIT INCIISOR PLUS CURVED BLADES, POWER/EP-1, POWER/EP-1, VIOLET, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERIL; 4.5 MM ORBIT INCISOR CURVED BLADE; 4.5 MM ORBIT SYNOVATOR CURVED BLADE; 4.5 MM RAZORCUT STRAIGHT BLADE; 4.5 MM SYNOVATOR STRAIGHT BLADE; 4.5 MM TURBOTRIMMER STRAIGHT BLADE; 4.5 MM TURBOWHISKER STRAIGHT BLADE; 4.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, FOREST GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 mm Incisor Plus Platinum Curved Blade; 4.5 mm Synovator Platinum Curved Blade; 4.5MM FULL RADIUS PLATINUM SERIES; 4.5MM INCISOR PLUS PLATINUM BLADE; 4.5MM SYNOVATOR PLATINUM SERIES; 4MM CANNULATED CAPTURED SCREW 32MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 34MM Stainless Stee; 4MM CANNULATED CAPTURED SCREW 38MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 42MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 44MM Stainless Steel; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 30MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 32MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 34MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 36MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 38MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 40MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 42MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 44MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 46MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 48MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 50MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 30MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 32MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 34MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 36MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 38MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 40MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 42MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 44MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 46MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 48MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 50MM; 4mm PLATINUM FLYER Blade; 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS; 5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, BLUE, LARGE DELRIN HANDLE; 5 MM FLEXIBLE DRILL; 5 MM HALF-ROUND RASP; 5.5 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, BRICK RED, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5 MM ABRADER STRAIGHT BURR; 5.5 MM ACROMIONIZER STRAIGHT BURR; 5.5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, RED, LARGE DELRIN HANDLE; 5.5 MM FULL RADIUS STRAIGHT BLADE; 5.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, TEAL, PACKAGED 6 PER BOX, STERILE; 5.5 MM INCISOR STRAIGHT BLADE; 5.5 MM OBTURATOR, CONICAL TIP, FOR CANNULAS WITH FLUID SEALS; 5.5 MM RAZORCUT STRAIGHT BLADE; 5.5 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, OLIVE, PACKAGED 6 PER BOX, STERILE; 5.5 MM STONECUTTER STRAIGHT BURR; 5.5 MM SYNOVATOR STRAIGHT BLADE; 5.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, MELON YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5MM FULL RADIUS PLATINUM SERIES; 5.5MM INCISOR PLUS PLATINUM SERIES; 5.5MM SYNOVATOR PLATINUM SERIES; 6 MM GRAFT SIZING TUBE; 6 MM OFFSET ENDOFEMORAL AIMER; 6.5 MM CHISEL GUARD; 6.5 MM DILATOR; 6.5MM DILATOR; 6MM DILATOR; 7 MM OFFSET ENDOFEMORAL AIMER; 7 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 7.5MM DILATOR; 7MM BICEPTOR TAP; 7MM DILATOR; 7MM ENDOSCOPIC DRILL XL; 7MM TENDON FORK; 8 MM PL TIBIAL AIMER POST; 8 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 8.5 MM DILATOR; 8.5MM DILATOR; 8MM BICEPTOR TAP; 8MM DILATOR; 8MM TENDON FORK; 9 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 9.5MM DILATOR; 90 DEGREE CURETTE, ANTERIOR LESION; 9MM DILATOR; 9MM TENDON FORK; A-Tech ACL Sterilization Tray; A-Tech Controlled Flexion Guidewire; A-Tech Femoral Locator Handle; AC Powered Instrument Motor; ACCORD; ACCORD CABLE SYSTEM; ACCU-PASS STR SHTL BIG C STERILE BOX 1; ACCU-PASS SUTURE SHUTTLE 70 DEGREE; ACCU-PASS SUTURE SHUTTLE J-HOOK STERIL; ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE; ACCUPASS STR SHUTL MONOFIL -SEE72201361; ACCURIS; ACHIEVE CAS; ACL Bullet; ACL Closed Curette; ACL Disposables Guidewire Kit; ACL Disposables Kit; ACL Open Curette; ACL Tunnel Rasp; ACUFEX DIRECTOR ACL ELBOW AIMER; ACUFEX DIRECTOR ACL TIP AIMER; ACUFEX DIRECTOR ANGLED BULLET; ACUFEX DIRECTOR DRILL GUIDE. REQUIRES 1 AIMER AND 1 BULLET NOT INCLUDED; ACUFEX DIRECTOR PCL FEMORAL AIMER; ACUFEX DIRECTOR PCL SAFETY STOP; ACUFEX EXTRA ARTICULAR RECONSTRUCTION FEMORAL GUIDE; ACUFEX EXTRA ARTICULAR RECONSTRUCTION OFFSET GUIDE; ACUFEX Extra-Articular Reconstruction Fibular Guide; ACUFEX Extra-Articular Reconstruction Long Bullet; ACUFEX Extra-Articular Reconstruction Short Bullet; ACUFEX Extra-Articular Reconstruction System Tray; ACUFEX Extra-Articular Reconstruction Tibial Guide; ACUFEX Extra-Articular Retractor; ACUFEX GRAFTMASTER III PREPARATION BOARD; ACUFEX MTO PUNCH BASKET DUCKBILL UPBITER CURVED RIGHT PRO HANDLE; ACUFEX PINPOINT ADAPTER; ACUFEX PINPOINT BULLET 4 POINT - 6.5; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-6MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 6-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 7-8MM; ACUFEX PINPOINT DBL BNDL BULL SPT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-6MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 7-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-6MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 7-8MM; ACUFEX PINPOINT INSIDE-OUT HANDLE; ACUFEX PINPOINT OUTSIDE-IN AMR ARM LEFT; ACUFEX PINPOINT OUTSIDE-IN AMR ARM RT; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 10MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 6MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 8MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 9MM; ACUFEX PINPOINT SNGL BNDL GD 7MM; ACUFEX PUNCH BASKET CURVED RIGHT PRO HANDLE; ACUFEX PUNCH BASKET LEFT PRO HANDLE; ACUFEX PUNCH BASKET PRO RIGHT PRO HANDLE; ACUFEX PUNCH BASKET STRAIGHT PRO HANDLE; ACUFEX PUNCH BASKET UPBITER PRO HANDLE; ACUFEX PUNCH BASKET UPSWEPT PRO HANDLE; ACUFEX PUNCH OVAL STRAIGHT PRO HANDLE; ACUFEX PUNCH OVAL UPBITER PRO HANDLE; ACUFEX PUNCH SCISSOR STRAIGHT PRO HANDLE; ACUFEX PUNCH SCISSOR UPBITER PRO HANDLE; ACUFEX TUNNEL GAUGE; ACUFEX-PRO 3.4MM CUPPED GRASPR; ACUFEX-PRO NARROWLINE STR; ACUFEX-PRO NARROWLINE UPBITER; ACUFEX-PRO PITBULL GRASPER; ADVANSYS; ADVANSYS DLP; ADVANSYS MLP; ADVANSYS TTC; AHTB UNIVERSAL HIP DISTRACTOR; AHTB WELL LEG HOLDER; AIMER ENDOFEMORAL 3MM OFFSET (BLUE); AIMER ENDOFEMORAL 4MM OFFSET (PURPLE); AIMER ENDOFEMORAL 5MM OFFSET (RED); AIMER TIBIAL PCL; AMBI; ANKLE ARTHROSCOPY ACCESSORY 2 UNITS; ANTHOLOGY; ANTHOLOGY HIP SYSTEM; ARO Osteotomy Guide Assembly; ARO Spacer Plate; ARTHRO-PIERCE STRAIGHT; ARTHROGARDE 4.5MM HIP CANNULA; ARTHROGARDE 5.5MM HIP CANNULA; ARTHROGARDE 5MM HIP CANNULA; ARTHROGARDE SLOTTLED CANNULA HIP; ARTHROPIERCE; ARTHROPIERCE 35 DEGREE UP; ARTHROPIERCE 45 DEG RIGHT; ARTHROPIERCE 45 DEGREE LEFT; ARTHROPIERCE INSTRUMENT CURVED LEFT; ARTHROPIERCE INSTRUMENT CURVED RIGHT; ARTHROPIERCE UTRATAPE; ARTHROPIERCE XL STRAIGHT; ARTHROSCOPIC LATARJET/BONE BLOCK LID; ARTHROSCOPIC LATARJET/BONE BLOCK TRAY; ARTHROSCOPIC NEEDLE STERILE; ASSEMBLY ENDOBUTTON INDICATOR; AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY 9.5 INCH LENGTH X 3 INCH WIDTH X 1.25 INCH HEIGHT; AWL STRAIGHT 3.8MM DISPOSABLE; AWL, INSERTION SITE MARKING, 45 DEGREES; Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361; Accu-pass suture shuttle 45 degree up, 7210425; Accu-pass suture shuttle 70 degree, Upbend, 72200419; Accu-pass suture shuttle J-hook; Accu-pass suture shuttle left 45 degree, 7210423; Accu-pass suture shuttle right 45 degree; Accu-pass suture shuttle, Big Curve; Accu-pass suture shuttle, crescent, 7210427; Accu-pass suture shuttle, straight, 7210426; Acufex Access Cart; Adaptor; Anatomic ACL Tray; Ankle Distractor; Ankle Distractor Strap; Arthroscopic needle, 72202825; Ascension; Austin Moore; Awl; Awl straight 3.8mm, 72202986; Awl tapered 3.8mm; Awl, tap, driver, dilator; B-BOP; BANKART RASP; BHR; BI-GRIP PIN PULLER; BICEPTOR 7 MM X 15 MM PK SCREW; BICEPTOR 7 MM X 25 MM PK SCREW; BICEPTOR 8 MM X 15 MM PK SCREW; BICEPTOR 8 MM X 25 MM PK SCREW; BICEPTOR 9 MM X 15 MM PK SCREW; BICEPTOR 9 MM X 25 MM PK SCREW; BICEPTOR DRIVER; BIO-FIT; BIOLOX; BIORAPTOR INLINE DRILL GUIDE - OFFSET FISHMOUTH TIP 2.9 MM; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, CROWN TIP; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP; BIORAPTOR KNOTLESS INLINE OBTURATOR, BLUNT; BIORAPTOR TWIST DRILL, 2.9 MM INLINE; BIOSURE DRIVER; BIOSURE EASY TAP 10MM; BIOSURE EASY TAP 6MM; BIOSURE EASY TAP 7MM; BIOSURE EASY TAP 8MM; BIOSURE EASY TAP 9MM; BIOSURE RATCHET DRIVER; BIOSURE SYNC Inserter; BIOSURE TAP 10MM; BIOSURE TAP 6MM; BIOSURE TAP 7MM; BIOSURE TAP 8MM; BIOSURE TAP 9MM; BLADE 3.5 CURVED CONCAVE FULL RADIUS; BLADE 3.5MM ELITE FULL RADIUS; BLADE 4 ELITE ABRADER 6/BX; BLADE 5.5 FULL RADIUS ELITE DISPOSABLE; BLADE,4.5 BONECUTTER,FR,180MM LG,DSP; BLT ASSY. 4 POINT DIRECTOR; BLUNT NOSE JR. PUNCH; BOARD, PATIENT TRANSFER; BONE GRASPER; BONE TUNNEL PLUG; BONE TUNNEL PLUG NON-CANNULATED, LARGE 10-11 MM 3 PER PACKAGE; BONE TUNNEL PLUG NON-CANNULATED, SMALL 7-8 MM 3 PER PACKAGE; BONE TUNNEL PLUG XL 11-12 MM 3 PER PACKAGE; BUCK; BURR 4MM ABRADER 180MML DISPOSABLE (3; BURR 5.5MM ABRADER 180MML DISPOSABLE; Beath pin 2.4mm, 72202815; Beluga Retro; Bilok Instrument Sterilization Tray; Bilok ST Graft Expander; Biosure 1.2mm x 18"", 72201201; Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile; Blade, Sheath, Burr, Abrader, Incisor, Synovator, Acromionizer, Tubowhisker, Bonecutter, Acromioblaster, Notchblaster; Blunt Nose Junior; Bone Hook; Bone Tap; Brun; CALF STRAP EQUIPMENT RPLT AHTB; CALIBRATED DEPTH GAGE; CANN 5.5 WO/HOLES LTX FREE ORANGE; CANN DIAG RTTBL DBL VLV 4.5 ASCOPE; CANN DV ROT HF STORZ INT 6MM; CANN H.F. DGNST 6MM RTBL SGL VLV; CANN M.F. DGNST 6MM HIP DBL VLV; CANNU-FLEX 1.5 MM X 305 MM 62 INCH X 12 INCH GUIDE WIRE; CANNU-FLEX GDE WIRES 45X12; CANNU-FLEX SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM 6 PER PACKAGE; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 12 INCH 30 CM, BLUNT TIP, STERILE; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE; CANNULA; CANNULA 2.9MM LONG WINDOW ASSEMBLY; CANNULA 2.9MM SHORT WINDOW; CANNULA 5.5MM OPER. W/STOPCOCK; CANNULA 5.5MM W/FINGER POST; CANNULA 6MM FMS 4MM AS W/O STOPCK; CANNULA 6MM FMS4MM ASCOPE W/STPCK; CANNULA CLEARTRAC 4.5 X 72MM THREADED; CANNULA CLEARTRAC SMOOTH 7 X 72MM; CANNULA CLEARTRAC THREADED 8.5 X 45MM; CANNULA CLEARTRAC THREADED 8.5 X 90MM; CANNULA ECTR; CANNULA FINGER POSTED 4.5MM; CANNULA FINGER POSTED 5.5MM; CANNULA FMS 2.7 LONG ASCOPE; CANNULA FMS SHORT 2.7 AS 3.8; CANNULA FOR 3.6 OPERATIVE SET; CANNULA INTEL NON-SCOPE 3MM; CANNULA MED FLOW ROT DBL VLV 5MM; CANNULA OPERATIVE 4.5MM NO DISATLHOLES; CANNULA OPERATIVE 5.5MM FINGERPOST; CANNULA OPERATIVE 5.5MM NO DISTAL HOLE; CANNULA OPERATIVE 5MM NO DIS HOLES; CANNULA SMOOTH FLEX 5.5 X 55MM; CANNULA SMOOTH FLEX 6.5 X 72MM; CANNULA SMOOTH FLEX 8 X 72MM; CANNULA THREADED DISP 8.5 X 72MM; CANNULA THREADED FLEX 5.5 X 45MM; CANNULA THREADED FLEX 6.5 X 72MM; CANNULA THREADED FLEX 8 X 90MM; CANNULATED OBTURATOR W/DELRIN 4.5MM; CANNULATED OBTURATOR W/DELRIN 5.5MM; CANNULATED OTBURATOR 8MM; CANNULATED SCREW; CANNULATED SCREWS; CANNULATED SCREWS CHS COMPRESSION HIP SCREW CONQUEST FN D-RAD PLATING SYSTEM EVOS PLATING SYSTEM; CAP-FIX Blade, Curved; CAP-FIX Blade, Curved, with Handle; CAP-FIX Blade, Curved, with Hip Pac; CAP-FIX Blade, Straight; CAP-FIX Blade, Straight, with Handle; CAP-FIX Blade, Straight, with Hip Pac; CARRIAGE REPLACEMENT KIT; CART PROCEDURE W. ISOL. TRANSFORMER; CART TRANSPORT SPIDER; CERAMIC FEMORAL HEAD; CHISEL GUARD; CHONDRAL PICK, LARGE, 20 DEGREE; CHONDRAL PICK, LARGE, 40 DEGREE; CHONDRAL PICK, SMALL, 20 DEGREE; CHONDRAL PICK, SMALL, 40 DEGREE; CHONDRAL PICK, SMALL, 90 DEGREE; CHS COMPRESSION HIP SCREW; CIRCLE SUTURE MENISCAL MENDER II; CLANCY 10 MM FLEXIBLE DRILL; CLANCY 10.5 MM FLEXIBLE DRILL; CLANCY 11 MM FLEXIBLE DRILL; CLANCY 12 MM FLEXIBLE DRILL; CLANCY 7.5 MM FLEXIBLE DRILL; CLANCY 9 MM FLEXIBLE DRILL; CLANCY 9.5 MM FLEXIBLE DRILL; CLANCY CURVED FEMORAL GUIDE, 42 DEGREE; CLEAR TRAC COMPLETE HIP CANNULA 7X110; CLEAR TRAC COMPLETE HIP CANNULA 8.5X110; CLEAR-TRAC CMPL. CANN. HIP OBT.8.5X110; CLEAR-TRAC CMPL.CANN. HIP OBT.7X110; CLEAR-TRAC DISPOSABLE STOPCOCK; CLEAR-TRAC MTO 5.5 MM X 72 MM REUSABLE OBTURATOR 4.3 MM CANNULATION; CLEAR-TRAC SCR CANN 8MM LTX FREE; CLEAR-TRAC THREADED CANNULA WITH OBTURATOR 5 MM X 76 MM, LATEX FREE, BOX OF 10; CLEARTRAC SCOPE/SHAVER CANNULA SMOOTH; COFIELD; COFIELD SHOULDER SYSTEM; COMPASS; COMPASS HINGE; CONQUEST FN; CONTOUR; CORACOID DRILLING GUIDE; CORACOID DRILLING OFFSETGUIDE 10MM; CPCS; CROSSTRAC HIP GUIDE; CROSSTRAC HIP GUIDE BULLET; CURETTE CURVED 90 DEG; CURETTE OPEN 6MM 15 DEG; CURVED BLUNT DISSECTOR; CURVED ELEVATOR; CURVED INCISOR PLUS ELITE BL 4.5MM; CURVED LONG INCISOR PLUS ELITE BLADE; CURVED PROBE 3MM; Calipers; Cannuflex 9"" Blunt Guidewire, 72202807; Cannula 5.5mm; Cannula Driver; Cannula set 4.5mm; Cannula set 5.5mm; Cannula set 7mm; Cannula, Obturator, Punch, Scissor, Suture cutter, Aimer, Gore smoother, Trephine adaptor, Guide, Knife; Cannula; post same as DOV, no holes; Cannulated Screw; Cannulated Switching Stick; Cement Tube with Suction Bypass; Chisel; Chondral Pick; Chondral Pick Sterilization Tray; Clamp; Clear-Trac Screw Cannula 7mm; Clear-Trac Screw Cannula 9mm; Clear-Trac Threaded Cannula 8mm x 76mm; Clear-Trac Threaded Cannula Kit 5mm ID, 76mm LG; Clear-Trac Threaded Cannula Kit, 8mm I.D., 76mm LG; Clear-Trac cannula Stopcock; Clear-Trac scope/shaver cannula; Clear-Trac scope/shaver cannula w/rib; Clearcut Suture Cutter; Closed Tendon Harvester; Cobb; Crochet Hook; Crosstrac Flexible Passing Pin 13.50 x 2.4mm; Cuff Elevator; D-RAD; D-RAD PLATING SYSTEM; DART SUTURE PASSER; DELTA; DENYER RAIL CLAMP (LATERL DSTRCTR SYS); DENYER SUPINE RAIL CLAMPS 2; DETACHABLE OBTURATOR HANDLE ECTRA 2; DEUCE; DIA. 15MM CANNULA COVER; DIA. 15MM CANNULA TROCAR; DIA. 15MM CANNULA TUBE; DIAGNOSTIC CANNULAS 2.9MM; DILATOR; DILATOR 11-12MM BIOSURE SYNC; DILATOR 7-8MM BIOSURE SYNC; DILATOR 9-10MM BIOSURE SYNC; DIRECTOR PCL ELEVATOR WITH WIRE CATCHER; DISPOSABLE BL 4.5 ORBIT FR ELITE; DISPOSABLE BL 4.5MM CURVED FR ELITE (6); DISPOSABLE KNIFE; DISPOSABLE KNIFE HOOK STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE HOOK STRAIGHT 3 MM BOX OF 5, 10600; DISPOSABLE KNIFE ROSSETTE STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE SERRATED BANANA STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE SHARP TIP STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE V SHAPED; DISPOSABLE KNIFE V SHAPED, 10660; DISPOSABLE MIXING BOWL; DISSECTOR BLUNT CURVED ECTR; DISTRACTOR WARUPA DOUBLE 1.1MM&1.6MM; DOUBLE POSTERIOR GLENOID DRILL GUIDE; DPR SYSTEM; DRILL 2.6 MM BIORAPTOR 2.3 SUT ANC; DRILL 4.5MM FOR 5.5MM ANCHOR SL-PLUS; DRILL 4.5MM SPADE TIP; DRILL 4MM FOR 4.5MM ANCHOR SL-PLUS; DRILL 5.5MM SPADE TIP; DRILL FIXATION POSTERIOR STERILE BX OF 1; DRILL FLUTED 3MM WITH DEPTH STOP; DRILL GUIDE AC JOINT LEFT; DRILL GUIDE OFFSET; DRILL GUIDE PHALANGEAL EXTRA ARTICULAR; DRILL GUIDE PHALANGEAL LONG OFFSET; DRILL GUIDE PHALANGEAL SHORT OFFSET; DRILL GUIDE SLOTTED SPIKE TIP 2.3MM; DRILL SURETAC IXC 8MM; DRIVER CANNULATED SCREW; DRIVER PIP MIDDLE PHALANX; DRIVER PIP PROXIMAL PHALANX; DRIVER PIP PROXIMAL PHALANX 10 DEGREE; DUCKBILL PUNCH BASKET UPBITER 1.5MM LOOP HANDLE; DUCKBILL PUNCH BASKET UPBITER CURVED LEFT 1.5 MM LOOP HANDLE; DUCKBILL PUNCH BASKET UPBITER CURVED RIGHT 1.5 MM LOOP HANDLE; DUCKLING PUNCH BASKET CURVED LEFT LOOP HANDLE; DUCKLING PUNCH BASKET CURVED RIGHT LOOP HANDLE; DUCKLING PUNCH BASKET ELEVATOR LOOP HANDLE; DUCKLING PUNCH BASKET STRAIGHT LOOP HANDLE; DUCKLING PUNCH BASKET UPBITER LOOP HANDLE; DUCKLING PUNCH BASKET UPSWEPT LOOP HANDLE; DYONICS 2 MM FULL RADIUS BLADES, 7 CM LENGTH, BLUE, PACKAGED 6 PER BOX, STERILE; DYONICS 2 MM TURBOWHISKER BLADES, 7 CM LENGTH, YELLOW, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM ABRADER BURRS, 7 CM LENGTH, ORANGE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM BARREL BURRS, 7 CM LENGTH, PURPLE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM CUTTER BLADES, 7 CM LENGTH, BEIGE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM FULL RADIUS BLADES, 7 CM LENGTH, RED, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM INCISOR PLUS ELITE BLADES, 7 CM LENGTH, PEACH, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM TURBOWHISKER BLADES, 7 CM LENGTH, GREEN, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM ABRADER BURRS, 7 CM LENGTH, AQUA, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM FULL RADIUS BLADES, 7 CM LENGTH, PLUM, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM INCISOR PLUS ELITE BLADES, 7 CM LENGTH, SAGE GREEN, PACKAGED 6 PER BOX, STERILE; DYONICS 3.5 MM RAZORCUT BLADES, 7 CM LENGTH, PUMPKIN ORANGE, PACKAGED 6 PER BOX, STERILE; DYONICS 4MM ELITE ACROMIOBLASTER BURR; DYONICS 4MM ELITE ACROMIONIZER BURR(6); DYONICS 4MM ELITE NOTCHBLSTR ABRD BURR; DYONICS 4MM ELITE STONECUTTER BURR; DYONICS 5.5 FULL RADIUS BONECUTTER BLADES, ORANGE, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; DYONICS 5.5MM ELITE ABRADER BURR; DYONICS 5.5MM ELITE ACROMIOBLASTER BURR; DYONICS 5.5MM ELITE ACROMIONIZER BURR; DYONICS 5.5MM ELITE NOTCHBLSTR ABRD BURR; DYONICS 5.5MM ELITE STONECUTTER BURR; DYONICS KEYLESS SAGITTAL SW SML BT HNDPC; DYONICS MINI-MOTOR DRIVE, SUCTION LEVER, 10 FT 3 M CORD; DYONICS POWER CABLE ASSEMBLY; DYONICS POWERMINI SMALL JOINT HANDPIECE WITH BLADE MULTI-POSITIONING, NO HAND CONTROLS, SUCTION LEVER, 10 FT 3 M CORD.; DYONICS SAGITTAL SAW W/KEY SML BAT HNDPC; DYOVAC KIT CLEANING BRUSHES FOR 5.2 MM SUCTION PUNCH, 10 PER BOX; DYOVAC SUCTION PUNCH 3.4MM STRAIGHT; DYOVAC SUCTION PUNCH 5.2MM STRAIGHT; Depth Gage; Depth Probe; Digital Goniometer; Disposable Knee Instruments; Doane; Drill Bit; Drill Tip Passing Pin; Drill for Q-FIX with Needles; Driver; ECHELON; ECHELON HIP SYSTEM; ECTRA HAND HOLDER/STERILIZATION TRAY WITH COVER; ELEVATOR COTTLE; ELEVATOR CURVED TEARDROP; ELITE MTO SHOULDER ELEVATOR BLUNT DOWN; ELITE MTO SHOULDER ELEVATOR BLUNT UP; ELITE MTO SHOULDER ELEVATOR DOWN; ELITE MTO SHOULDER ELEVATOR UP; ELITE PREMIUM ALLIGATOR GRASPER; ELITE PREMIUM COMBINATION GRASPER; ELITE PREMIUM CROCHET HOOK; ELITE PREMIUM KNOT MANIPULATOR; EMPERION; ENDER; ENDOBUTTON DEPTH PROBE; ENDOBUTTON HOLDER SCALE EXTENDER; ENDOBUTTON, 4 MM X 12 MM; ENDOFEMORAL AIMER, NO OFFSET; ENDOSCOPIC FEMORAL AIM ARM 3MM OFFSET; ENDOSCOPIC FEMORAL AIM ARM 4MM OFFSET; ENDOSCOPIC FEMORAL GUIDE HANDLE; ENGAGE; EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH; EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS); EVOS; EVOS PLATING SYSTEMS; EVac Bending Tool; Elevator Rasp; Endobutton Pin Passing 2.4mm Trocar; Endobutton, sterile, non-sterile; Extractor; Extremities Guide, Universal; FAST-FIX 360 CURVED KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS; FAST-FIX 360 STRAIGHT KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS; FEMORAL AIMER; FEMORAL CANAL SUCTION ABSORBER; FERKEL 15 DEGREE ANTERIOR LESION CURETTE, 2.5 MM; FERKEL 15 DEGREE OPEN CURETTE, 2.5 MM; FERKEL 15 DEGREE OPEN CURETTE, 4 MM; FERKEL 30 DEGREE OPEN CURETTE, 2.5 MM; FERKEL MICROFRACTURE PICK 40 DEGREE; FERKEL MICROFRACTURE PICK 65 DEGREE; FERKEL MICROFRACTURE PICK 90 DEGREE; FIRSTPASS MINI Suture Passer; FIXATION CERCLAGE; FIXATION STAPLE; FLEXIBLE DRILL; FLUID MAN EXT DIAG CANN W/INFLOW & VALVE; FLUID SEAL ADAPTOR; FLUSH SUTURE CUTTER; FLUSH SUTURE CUTTER XL; FOOTPRINT ULR 4.5 PK SUT SL; FOOTPRINT ULR 5.5 PK SUT SL; FOOTPRINT Ultra PK Suture Anchor 4.5mm SL; FOOTPRINT Ultra PK Suture Anchor 5.5mm SL; FOREFOOT; FULL RADIUS BONECUTTER 4.5MM PLATINUM; FULL RADIUS BONECUTTER 5.5MM PLATINUM; Femoral Aimer; Femoral Locator; FirstPass Mini Suture Passer Left Curved; FirstPass Mini Suture Passer Right Curved; FirstPass Needle and Suture Capture; Fixation post drill, 72202879; Forefoot II; GD WIRE NITINOL 1.2 X 45CM; GENESIS; GENESIS II; GENESIS II KNEE SYSTEM; GENESIS II OXINIUM; GENESIS II POROUS PLUS; GENESIS KNEE SYSTEM; GLENOID DRILL GUIDE LONG BULLET; GLENOID DRILL GUIDE SHORT BULLET; GRAFT SIZING BLOCK; GRAFT SIZING TUBE - 5.5MM; GRAFT SIZING TUBE - 5MM; GRAFT SIZING TUBE - 9.5MM; GRAFT SIZING TUBE -10.5MM; GRAFT SIZING TUBE -11.5MM; GRAFT SIZING TUBE -12.5MM; GRAFT SIZING TUBE -13.5MM; GRAFTMASTER ENDOBUTTON HOLDER; GRAFTMASTER II CUTTING STRIP; GRAFTMASTER II GRAFT PREP BRD.; GRAFTMASTER II SYSTEN TRAY; GRAFTMASTER III BTB HOLDER; GRAFTMASTER III CUTTING STRIP; GRAFTMASTER III SLIDING BASE 2; GRAFTMASTER III TENSIONING POST; GRAFTMASTER III TISSUE GRASPER 2; GRASPER ALLIGATOR MAX EXTENDED; GRASPER CUPPED 3.4MM EXTENDED 2.25; GRASPER EXTENDED 2.25; GRSPR ALGTR MAX; GRSPR ALGTR STR 2.7MM; GRSPR ALGTR UPBTR; GRSPR ATRMTC CANLTD TNSNR TIS; GRSPR ATRMTC TNSNR TIS; GRSPR CUPD 2.7MM; GRSPR CUPD 3.4MM; GRSPR FRCP LOOSEBODY PTBLL; GRSPR JT SM; GUHL NON-INVASIVE ANKLE DISTRACTOR STERILIZATION TRAY; GUIDE 2.3MM INLINE DRILL CROWN TIP; GUIDE 2.3MM INLINE DRILL F MOUTH TIP; GUIDE 2.3MM INLINE DRILL SPIKE TIP; GUIDE METATARSAL OSTEOTOMY; GUIDE WIRE 1.2MM X 9 BOX OF 5 STERILE; GUIDE WIRE 1.2MM X18 BX OF 5 STER.; GUIDE WIRE ALIGNER 45 MVECT; GUIDE WIRE ALIGNER 62 MVECT; GUIDE WIRE BEATH PIN 2.4 MM STERILE; GUIDE WIRE PCL 2.4MM X10; GUIDE WR 1.2MM X 12 BOX OF 5 STERILE; GUIDE, 4MM INLINE DRILL BIORAPTOR, HIP; GUIDEWIRE CANNFLEX 9 BLUNT TIP; Gelpi; Glenoid Holder; Graft Assist, Board; Graft Bar Drill; Graft Bar Holder; Graft Board Hook; Graft sizing tube; PCL two-tunnel template; Tensioning device; Graft preparation block; Graft, Base Lock; Graft, Suture Clamp; Graft, Tissue Clamp; Graftologer Tray; Grasper, Irrigation extender w valve, Trocar, Hook probe, Chisel guard, Tap, Cuff stitch, Dilator; Guide; Guide wire 2mm, 15"", 7207222; Guide-TRAC; Guidewire 1.5mm x 229mm; Guidewire 2.4mm Drill Tip, guide wire, 12"", 7207221; Guidewire Aimer; Guidewire, Nitinol 1.2mm x 45cm; HALF CANNULA - SHORT; HALF CANNULA OBTURATOR - SHORT; HALLU-FIX; HALLU-LOCK; HALLU-REAM; HAMMER; HAMMER SLAP DILATOR SYSTEM; HANDLE MODULAR; HARMONY; HEALICOIL Knotless Drill, 4.75mm, 72205308; HEAVY HOOK PROBE W/ HANDLE 3MM; HEIDELBERG; HEWSON; HEX-FIX; HIGH FLOW IRRIGATION EXTENDER, SINGLE-VALVE, ROTATABLE; HIGH VISIBILITY SHEATH 4 MM ABRADER BURR; HIGH VISIBILITY SHEATH 4 MM BARREL BURR; HIGH VISIBILITY SHEATH 4 MM FLAT TOP BURR; HIGH VISIBILITY SHEATH 5.5 MM ABRADER BURR; HIGH VISIBILITY SHEATH 5.5 MM BARREL BURR; HIGH VISIBILITY SHEATH 5.5 MM FLAT TOP BURR; HIP Tray; HOOK KNIFE SHOULDER; HUDSON DRILL; HUMERAL STAPLE; HYSTEROSCOPE SET STERILIZATION TRAY. INCLUDES SILICONE MAT, COVER, 12 POSTS, 12 TIE-DOWNS, POST REMOVAL TOO; HYSTEROSCOPE SET STERILIZATION TRAY. INCLUDES SILICONE MAT, COVER, 12 POSTS, 12 TIE-DOWNS, POST REMOVAL TOOL; Half Pin; Hammerhead Rotary Punch; Hammerhead Rotary Scissor; Handheld Instrument Sterilization Tray, Small; Hibbs; Hip Pac; Hohmann; Hoke; Hook; I.CO.S.; I.CO.S. XL; ILIZAROV; ILIZAROV External Fixator; IMHS; INCISOR PLUS ELITE BL 4.5MM DSPL DYO PW; INCISOR PLUS ELITE BLADE 3.5MM DSPL DYO; INCISOR PLUS ELITE BLADE 5.5MM DSPL 6BX; INCISOR PLUS ELITE LONG 4.5MM; INFUSION ADAPTER W/STOPCOCK; INFUSION ADAPTOR; INLINE DRILL BIT 2.7 MM, SUITABLE FOR USE WITH BIORAPTOR 2.9 MM ANCHORS FOR SOFT BONE; INLINE DRILL BIT 2.9 MM, SUITABLE FOR USE WITH KINSA ANCHOR AND BIORAPTOR 2.9 MM ANCHORS; INLINE DRILL GUIDE - SPIKED TIP; INLINE OBTURATOR - BLUNT TIP; INLINE OBTURATOR - TROCAR TIP; INTELIJET FLUID SEALS, PACKAGE OF 25; INTERFIT; INTERTAN; INTRAMEDULLARY HIP SCREW SYSTEM; INVIS; IPP-ON; IRR EXT ROT J-LOCK W/O VALVE; IRR EXT ROT J-LOCK W/VALVE; IRR. EXTR HIGH FLOW D.V. FLD; IRR. EXTR HIGH FLOW DOUBLE VALVE; IRRIGATION EXTENDER , SINGLE-VALVE, FIXED; ISO-PAC LTX FREE; Image Guided Surgical Instruments for Hip Applications; Impactor; Insert Trials; Inserter Tip; Integra; Intermediate; Intramedullary Nailing System; J-SNAP QUICK RELEASE IRRIGATION EXTENDERS, DOUBLE VALVE; J-SNAP QUICK RELEASE IRRIGATION EXTENDERS, SINGLE VALVE; JET-VAC; JET-X; JET-X Fixator; JET-X HALF PIN; JOURNEY; JOURNEY KNEE SYSTEM; Jaws Great White Grasper; Jaws Retro Junior Grasper; Jaws Retro Toothed Grasper; Jaws Tigar Shark Grasper; Journey II Mid-Level Tibial Inserts; K-WIRE; K-wire; KFN; KIRSCHNER; KIRSCHNER WIRE; KIT 5.5mm FP SUT ANC SL ACH TENDON RE; KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR; KIT AHTB RETRFIT HARDWARE WELL LEG HOLDR; KIT BICEPTOR DISPOSABLES 7MM X 25MM; KIT BICEPTOR DISPOSABLES 8MM X 25MM; KIT BICEPTOR DISPOSABLES 9MM X 25MM; KIT BLADE RETENTION SCREW FOR 3.4 MM SUCTION PUNCH, 12 PER BOX; KIT BLADE RETENTION SCREW FOR 5.2 MM SUCTION PUNCH, 12 PER BOX; KIT CLEANING BRUSHES FOR 3.4 MM SUCTION PUNCH, 10 PER BOX; KIT, 4.5mm FP SUT AN CSL, ACH TENDON RE; KNEE FUSION NAIL; KNEE HOLDER; KNIFE NON-SERRATED BANANA RE-USABLE; KNIFE RASP; KNIFE SERRATED BANANA 5MM STRAIGHT; KNOT PUSHER XL; Knee Fusion Nail; LABELS FOR RING MODULE; LARGE INSERTER DSP; LARGE QWIX; LARGE TENDON STRIPPER, CLOSED, 7.4 MM I.D. X 13.5 INCH WORKING LENGTH; LEGION; LEGION INSERTS WITH JRNY LOCK; LEGION KNEE SYSTEM; LEGION Porous CR Narrow Femoral Components; LINEAR INSTRUMENTS 15-UNIT STERILIZATION TRAY; LOCKING WRENCH; LOOP TIP GUIDEWIRE; LOW PROFILE SUTURE GRASPER HORIZ; Lane; Large Goniometer; Large Sterilization Tray; Ligament Tunnel Drill; Lobster Claw Suture Retriever; Long Probe; MANUAL INSTRUMENT TRAY; MATRIX; MAVERICK External Fixation System; MAVERICK MINI; MAXI; MDF; MENISCAL ROOT REPAIR PACK W/ULTRABRAID; MENISCAL ROOT REPAIR PACK WITH ULTRABRAID; MENISCAL ROOT REPAIR PACK WITH ULTRATAPE; MENISCAL ROOT REPAIR PACK WITH ULTRATAPE SUTURE; META-NAIL; MIA; MICRO VECTOR GUIDE; MICRO VECTOR K-WIRE GUIDE FOR .125 INCH K-WIRE; MICROFRACTURE PICK ASSIST; MICROFRACTURE PICK HIP 30 DEGREE; MICROFRACTURE PICK HIP 60 DEGREE; MICROFRACTURE PICK XL 90 DEG HIP; MICROFRACTURE PICK, HIP, 45 DEGREE; MICROFRACTURE STRAIGHT 40 DEGREE PICK; MICROFRACTURE STRAIGHT 65 DEGREE PICK; MICROGRASPER STRAIGHT; MICROGRASPER UPBITER; MICROPUNCH STRAIGHT; MINI-OPEN ARTHRO ASSIST LATARJET BB LID; MINI-OPEN ARTHRO ASSIST LATARJET BB TRAY; MIS HIP STEM; MODULAR T-HANDLE",1978-02-22,205,2022-09-29,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223038503932%22&limit=1
"Globus Medical, Inc.",3004142400,3004142400,2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER,Audubon,PA,19403,United States,"GLOBUS MEDICAL, INC.",9056090,Manufacturer; Manufacturer for export,86,CAC; FMF; GAD; GCJ; GEY; GFF; GKT; HAW; HRS; HRX; HSB; HSX; HTJ; HTN; HTO; HTQ; HTW; HWA; HWB; HWC; HWE; HWR; HWT; HXC; HXX; ITQ; JDG; JDI; JDO; JDQ; JDS; JDZ; JEB; JQC; JWH; KTT; KTZ; KWI; KWL; KWP; KWQ; KWY; LPH; LWJ; LXH; LXT; LYC; LYS; LZO; MAX; MAY; MBH; MBI; MBL; MJO; MNH; MNI; MQP; MQV; MRW; NDN; NKB; NKG; NQO; NQP; NQW; ODP; OIY; OLO; OQG; OQH; OQI; ORG; OSH; OUR; OVD; OVE; OWI; PEK; PGM; PHM; PLR; PML; QHP; QKL; SBF,"Apparatus, Autotransfusion; Syringe, Piston; Retractor; Laparoscope, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Bur, Surgical, General & Plastic Surgery; Separator, Automated, Blood Cell, Diagnostic; Neurological Stereotaxic Instrument; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Bit, Drill; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Driver, Prosthesis; Template; Wrench; Screwdriver; Joint, Knee, External Brace; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Nail, Fixation, Bone; Mixer, Cement, For Clinical Use; Table, Surgical With Orthopedic Accessories, Manual; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Bone Grafting Material, Synthetic; Bone Mill; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Cement, Bone, Vertebroplasty; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Prosthesis, Spinous Process Spacer/Plate; Posterior Metal/Polymer Spinal System, Fusion; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Cervical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Stereotaxic Instrument; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Platelet And Plasma Separator For Bone Graft Handling; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Bone Fixation Cerclage, Sublaminar; Spinous Process Plate; Growing Rod System; Intervertebral Fusion Device With Bone Graft, Thoracic; Spinal Vertebral Body Replacement Device - Cervical; Bone Cement, Posterior Screw Augmentation; Vertebral Body Tethering System; Lipoaspirate Washing System For Aesthetic Body Contouring; Orthopedic Augmented Reality",1; 2; 3; N; U,"ACTIFY 3D; ACTIFY Uni; ADIRA; AERIAL; AFFIRM VCF; ALTERA; ALVUE; ANTHEM; ARBOR; ASSURE; ASSURE ANTERIOR CERVICAL PLATE SYST; AUTOBAHN; BEACON ML CONNECTORS; BEACON STABILIZATION SYSTEM; BEACON Stabilization System; BIOLOX DELTA; BIT, DRILL; Bone Cement; CALIBER; CALIBER TPS Spacers; CANOPY Laminoplasty Fixation System; CAPTIVATE; CITADEL ANTERIO; CITADEL ANTERIOR LUMBAR PLATE SYSTEM; COALITION; COALITION AGX; COALITION MIS; COALITION SPACER; COALITION TPS Spacers; COALITION® Spacer; COLONIAL; COLOSSEUM; CONFIRM; CORBEL; CORRIDOR; CORRIDOR FIXATION SYSTEM; COSINE; CREO; CREO Stabilization System; CROSSWAY; Caliber Additional Implants; Calipers For Clinical Use; Capitol - Ellipse Additional; CoCr Rods; DUAL TAPER WEDGE; Depth Gauge For Clinical Use; DuraPro; ELLIPSE; ELLIPSE Additional Implants; ELLIPSE OCCIPITO-CERVICO-THORACIC S; ELSA; EXCELSIUS GPS; ExcelsiusFlex; ExcelsiusGPS; ExcelsiusGPS™ Instruments; ExcelsiusXR; FORTIFY; FORTIFY Corpectomy Spacer; FORTIFY I-R TPS Corpectomy Spacer; FORTIFY-R TPS Corpectomy Spacer; FORTIFY¿ I and FORTIFY¿ I-R Corpectomy Spacers; FORTRESS; FORTRESS-Plus; GATEWAY THORACOLUMBAR PLATE SYSTEM; GENflex2; Globus Medical Manual Surgical Instruments; H-LINK Integrated Rod; HAVEN; HEDRON; HILINE; Harvest; Harvest Adiprep; Harvest Graft Delivery; Harvest PRP; Harvest SmartCell; Harvest SmartJet; Harvest SmartPrep; Harvest SmartPrep2; Harvest SmartPrep2 BMAC; INDEPENDENCE; INDEPENDENCE MIS; INDEPENDENCE SPACER; INDEPENDENCE TPS Spacers; INTERCONTINENTAL; InstaFill; InterContinental Plate-Spacer; JOINT, KNEE, EXTERNAL BRACE; KINEX; LATIS Spacers; MAGNIFY Spacers; MARVEL; MICROFUSE BONE VOID FILLER POSTEREO; MONUMENT; MicroFuse Bone Void Filler; MicroFuse Putty & MIS; MicroFuse with Barium Sulfate; Modulus; NIKO Corpectomy Spacer; NIKO TPS Corpectomy Spacer; Navigation Instruments; ONVOY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; PATRIOT; PATRIOT SPACERS: COLONIAL ACDF SPAC; PATRIOT Spacers; PATRIOT TPS Spacers; PATRIOT TransContinenetal Lateral; PLYMOUTH¿ Thoracolumbar Plate System; PRECICE; PROCLASS; PROFORM; PROGENY; PROTEX CT; PROTEX CT CERVICOTHORACIC SPINAL SY; PROTEX CT CERVICOTHORACIC SPINAL SYSTEM; PROTEX STABILIZATION SYSTEM; PROTRACT; PROVEN Gen-Flex; PROVIDENCE ANTERIOR CERVICAL PLATE; PROVIDENT; PROVIDENT II; Patriot Signature Additional; Proven Gen-Flex; QUARTEX; REFLECT; RELIEVE LAMINOPLASTY FIXATION SYSTE; RESONATE; RETAIN RADIOLUCENT SPACER; REVEL; REVERE; REVERE 4.5 Stabilization System; REVERE 6.35 STABILIZATION SYSTEM; REVERE Additional Implants; REVERE CROSSTOP; REVERE STABILIZATION SYSTEM; REVERE Sacral Plates; REVERE UNIPLANAR SCREWS; REVLOK; REVLOK Fenestrated; REVOLVE Additional Implants; REVOLVE STABILIZATION SYSTEM; RIB LINK; RISE¿ Spacer; Retractor; SABLE; SCRIPT; SECURE®-C Cervical Artificial Disc; SHIELD VCF; SI-LOK; SIGNIFY; SILC; SP-Fix; STRETTO; SUSTAIN; SUSTAIN R TPS Spacers; SUSTAIN RADIOLUCENT SPACER; SUSTAIN-IR; SUSTAIN® and SUSTAIN® Radiolucent (SUSTAIN® R) Spacers; SmartPrep; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL; TEM; TENSOR; TRANSCONTINENTAL; TRANSITION STABILIZATION SYSTEM; TRIVANCE; TRUSS THORACOLUMBAR PLATE SYSTEM; Template For Clinical Use; TransContinental M; UNIFY; UNIFY¿ Dynamic Anterior Cervical Plate System; VERZA; VICTORY; VIP ANTERIOR CERVICAL PLATE SYSTEM; XPAND CORPECTOMY SPACER; XPAND RADIOLUCENT CORPECTOMY; XPand-R TPS Corpectomy Spacer; XTEND; ZYFUSE",2003-08-19,202,2026-10-23,1,15,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004142400%22&limit=1
Merit Medical Canada Ltd.,3012536737,3012536737,"1 Valleywood Drive, units 4&5",Markham Ontario,,L3R 5L9,Canada,"Merit Medical Systems, Inc.",1721504,Exporter to the US,128,BWN; BZN; CCX; DQF; DQO; DQX; DQY; DRA; DRC; DRE; DRS; DSK; DSY; DTE; DTL; DWM; DWO; DWS; DWZ; DXC; DXE; DXG; DXN; DXT; DYB; ESW; EXF; FAD; FAJ; FCG; FCY; FDY; FED; FGE; FJS; FKO; FKX; FMF; FMG; FPA; FPK; FQM; FZX; GAA; GAH; GAX; GBW; GBX; GCB; GCC; GDF; GEA; GEH; GEI; GES; GXI; HCG; HRX; HTW; HXG; JAQ; JCT; JDZ; JKA; JOL; JRL; KCY; KDC; KDD; KDQ; KGS; KGX; KGZ; KIH; KME; KMK; KNQ; KNS; KNW; KRA; KRB; KRD; KTI; KYZ; KZD; LDF; LJS; LOD; LXH; LYV; MAV; MDM; MHW; MMX; MSD; NDN; NEU; NOY; NWU; OAR; OCX; OCY; ODE; ODY; OEQ; OEX; OEZ; OJA; OJV; OMT; OWL; OYI; PEV; PFV; PNG; PPD; PTL; PTM; PUR; PXI; PXU; PYB; PYC; QBP; QEY; QEZ; QJH; QSY,"Table And Attachments, Operating-Room; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Support, Patient Position; Actuator, Syringe, Injector Type; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Transducer, Blood-Pressure, Extravascular; Computer, Blood-Pressure; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Pulse-Generator, Pacemaker, External; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Apparatus, Suction, Patient Care; Needle, Biopsy, Cardiovascular; Instruments, Surgical, Cardiovascular; Device, Biopsy, Endomyocardial; Clamp, Vascular; Catheter, Embolectomy; Computer, Diagnostic, Pre-Programmed, Single-Function; System, Measurement, Blood-Pressure, Non-Invasive; Injector And Syringe, Angiographic; Introducer, Catheter; Prosthesis, Esophageal; Bag, Bile Collecting; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Biopsy Needle; Bulb, Inflation, For Endoscope; Device, Measuring, For Panendoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Stents, Drains And Dilators For The Biliary Ducts; Catheter, Peritoneal, Long-Term Indwelling; Catheter, Peritoneal Dialysis, Single Use; System, Peritoneal, Automatic Delivery; Syringe, Piston; Stopcock, I.V. Set; Set, Administration, Intravascular; Tubing, Fluid Delivery; Bandage, Elastic; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Stylet, Surgical, General & Plastic Surgery; Tourniquet, Nonpneumatic; Catheter, Peritoneal; Catheter, Irrigation; Needle, Catheter; Dilator, Catheter; Guide, Needle, Surgical; Cannula, Surgical, General & Plastic Surgery; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Scalpel; Probe, Radiofrequency Lesion; Device, Neurovascular Embolization; Arthroscope; Bit, Drill; Tamp; System, Applicator, Radionuclide, Remote-Controlled; Prosthesis, Tracheal, Expandable; Mixer, Cement, For Clinical Use; Tubes, Vials, Systems, Serum Separators, Blood Collection; Catheter And Tip, Suction; Unit, Filter, Membrane; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Dispenser, Cement; Bedding, Disposable, Medical; Device, Intravascular Catheter Securement; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Instrument, Biopsy; Catheter, Continuous Flush; Probe, Thermodilution; Device, Vascular, For Promoting Embolization; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Electrode, Pacemaker, Temporary; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Bone Cement; Orthopedic Manual Surgical Instrument; Label Or Tag, Sterile; Syringe, Balloon Inflation; Instrument, Manual, Surgical, General Use; Dressing, Compression; Device, Percutaneous Retrieval; Catheter, Hemodialysis, Implanted; Cement, Bone, Vertebroplasty; Marker, Radiographic, Implantable; Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia; Endoscope Introducer Kit; Injector, Vertebroplasty (Does Not Contain Cement); Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd); Tunneled Catheter Remover; Angiography/Angioplasty Kit; Cardiovascular Catheter Sheath Introducer Kit; Cardiovascular Procedure Kit; Intravenous Extension Tubing Set; Single Use Instrument Tray; Absorbable Lung Biopsy Plug; Peripheral Catheter Insertion Kit; Non-Bronchoscopic Bronchoalveolar Lavage Catheter; Dialysis Administration Kit; System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Universal Drainage Tray; Wire, Guide, Catheter, Exempt; Syringe, Balloon Inflation, Exempt; Vacuum Syringe; Thoracentesis Tray; Fluid Drainage Tray; Minor Surgical Procedures Tray; Paracentesis Tray; Cap, Device Disinfectant; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter; Reverse Central Venous Recanalization System; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; 3; U,"1 mL syringe(Polypropylene); 10Fore Hemostasis Valve; 10Fore Hemostasis Valve Kit; 5.5 F Worley Advanced LVI Lateral Vein Introducer; AEROmini Tracheobronchial Stent System; ARC Catheter; ASAP Aspiration Catheter; ASAP Catheter; ASAPLP Aspiration Catheter; ASAPLP Embolectomy Catheter; Access-9; AccessPLUS; Achieve; Activation Element, ERx bone cement; Acutiy Universal Cutter; Adjustable Biopsy Port Seal BPS-A; Advance Angiographic Needle; Aero DV Tracheobronchial Stent System; Aero Tracheo Stent and Delivery System; Aerosizer; Alimaxx E; Arcadia Balloon Catheter; Arcadia Balloon Catheter Kit; Aspira Peritoneal Drainage System; Aspira Pleural Drainage System; BIG60; BIG60 ALPHA Inflation Devie; BRC-BAL-INT-FL/A; BackStop Plus Closed Waste Basin; Bath Probe; Bedford™ Guided Hard Bone Biopsy System; BioFlo Duramax; BioSentry Tract Sealant System; Blue Diamond Inflation Syringe; BowTie Guide Wire Insertion Device; Brochoalveloar Lavage (BAL) Custom Convenience Kit; Bulldog Lead Extender; C2 Cryoballoon Ablation System; C2 Cryoballoon Endogrip; CT Transfer Set; CardiaGuide Fixed Curve Braided Transseptal Sheath; Cardiac Output Kit; Catheter Connection Cable; Catheter Connection Cables and Cardia Computer; Cen-Step Centesis Catheter; Centros Long-Term Hemodialysis Catheter; CentrosFLO Long-Term Hemodialysis Catheter; Check Valve; ClariVein IC Infusion Catheter; Coil Expander; Concierge Guiding Catheter; Connecta PE Lines; Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI); Coronary Control Syringe; Corvocet Biopsy System; Corvocet Coaxial Introducer; Critiflo; Critiflo Dome; Critikit Plus In-Line Room/ Ice Injectate; Cuff Implantor; Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; DTX Disposable Temperature Probe; DTX Plus Disposable Pressure Transducer; DTX/DTX Plus Kit and Accessories; Dark Blue Cap for Male Luers; Dash 9F Hydrophilic Sheath Introducer; DiamondTOUCH Inflation Device and Fluid Dispensing Syringe; DiamondTOUCH Syringe; Disposable In Line Sensor Housing; DoublePlay Hemostasis Valve; Drainage Tubing; DriPAD Super Absorbent Pad; DualCap; DualCap Duo; DualCap IV Pole Strips; DualCap Solo; DuraFlow 2 Hemodialysis Catheter; Duramax; EN Snare Endovascular Snare System; ER2 Saturate Mixing System; Elation Fixed Wire Balloon; Elation Pulmonary Balloon; Elation Pulmonary Balloon 4mm; Elation Wireguided Balloon; Elation5 Fixed Wire Balloon; Elation5 Wireguided Balloon; Embedding Tool; EmboGold Microspheres; Emboshpere PRO; Embosphere Microspheres; EndoMAXX; EsophyX Z+ Device; EvenMore Chronic Hemodialysis Catheter; Excite Contrast Injection Line; ExxTended Catheter; FLO30; FLO40XR; FLO50; Faller Trocar; FastBreak Connector; Finale Radial Compression System; Flex-Neck Catheter; Flex-Neck Extender/Repair Kit; Flex-Neck Infant Catheter; FlowGuard; Fluid Dispensing Syringe; Fountain 4F Catheter & Occluding GW; Fountain Catheter/Occluding Guide Wire; Fountain Infusion Catheter w/ Occluding Guide Wire; Fountain Infusion System; Fountain ValveTip Infusion Catheter; Futura Safety Scalpel; Go2Wire Guide Wire; Guidewire Introducer; Guidewire with Palladium Tip; H20 Guidewire; H20 Torque Device; HeRO Graft; HeartLight Deflectable Sheath; HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al.; HeartSpan Steerable Introducer Sheath; HeartSpan Steerable Sheath Introducer; Hemostasis Valve Adapter; Honor hemostasis valve; Huntington Guided, Perforating Bone Biospy System with Drill; Hydraulic Assembly; Hydraulic-Master Syringe Assembly; Hydrophilic Guidewire; Hydrophilic Prelude SNAP Splittable Sheath Introducer; Impress Angiographic Catheter; Impress UAC Catheter; Impress and Impress Legato Hydrophilic Angiographic Catheter; Impress with Legato Hydrophilic Coating; InQwire; InQwire Amplatz Super Stiff Guide Wire; InQwire Diagnostic (Support) Non-Vascular Guide Wire; InQwire Guidewire-Prelude Introducer; InQwire Guidewires; Injectate Sensor Cable; Insufflation Set; Integral Injectate Temperature Probe; Intellisystem Inflation Device; Introducer Needle WithTrocar Stylet; K01 Kit (MSS); K01 Syringe Kit (1mL & 20mL COP); K01 Syringe Kit (1mL Polypropylene); K02 Syringe Kit (multiple K01); K02 Syringe Kit (multiple K01)); K02-00873A, K02-01105A, K02-01481A; K04 - Tubing Kit; K05 Inflation Kit; K05T - Inflation Kit; K06 Syringe Kit (single CSS); K07 Syringe Kit (multiple K06); K08 Fluid Management Kit; K09 Manifold Kit; K09T - Manifold Kit; K10 Waste Management Kit; K10T - Waste Management Kit; K11 Pressure Monitoring Kit; K12 Procedure Kit; K12T - Procedure Kit; K13 Label Kit; K14 Dialysis Kit; K15 Sheath Introducer Kit; K16 Microcatheter Kit; K17 Interventional Kit; K17T - Interventional Kit; K18 Sheath Introducer Kit (Ease); K19 Combination Packs; K20 Endoscopic Kit; K20T - Endoscopic Kit; K21 Sheath Introducer Kit (IDeal); K22C Vein Tray; K23C Vein Accessory Kit; KYPHON KyphoFlex Balloon Catheter; KYPHON KyphoFlex Balloon Catheter Kit; Kensington Guide Wire Bone Biopsy System; Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411); Lead Clippers; Low Profile Companion Sheath; MAK-NV Non-Vascular; MAP Torque Device & Introducer; MBA; MYSHELL Hemostatic Valve; Madison Mini™ Bone Biopsy System; Madison™ Perforating Bone Biopsy System with Drill; Maestro Microcatheter; Majestik Angiographic Needle; Master Syringe Assembly; Maxxwire; Medallion Syringe; Merit 1mL Syringe (COP); Merit 20 mL Syringe (COP); Merit Administration Set; Merit Centros Long-Term Hemodialysis Catehter; Merit CentrosFLO Long-Term Hemodialysis Catheter; Merit Convenience Kits; Merit Disposal Depot; Merit Drainage Depot; Merit HeRO Graft; Merit High Pressure Tubing; Merit Hydrophilic Guide Wire; Merit InQwire® Amplatz Super Stiff Guide Wire; Merit MAK (Mini Access Kit); Merit Manifold; Merit Marquis Flow Switch; Merit Marquis Stopcock; Merit PAK; Merit Pressure Monitoring Tubing; Merit Pursue Microcatheter; Merit S-MAK (Stiffened Mini Access Kit); Merit Safety Needle; Merit Syringe; Merit Triboglide Syringe; Meritrans Disposable Transducer; MetaSTAR RF Generator; Micro Ace Advanced Micro Access System; Micro Ace Gold Advanced Micro Access System; Micro Plug Set; Mighty Wire; MiniStop Filter Closed Waste Basin; MiniStop Plus Closed Waste Basin; Miser Contrast Management System; Monarch Compak Inflation Syringe; Monarch Syringe Fluid Dispense System; MultiPlex II Controller; Needle's Eye Snare Retrieval Set; NeoVasc; Non-vascular tissue dilators; Novatome Endomyocardial Biopsy Forceps; One Snare Endovascular Snare System ONE1501; One-Step Centesis Catheter; One-Tie Compression Coil; One-Vac Evacuated Drainage Bottle; OneSnare Endovascular Snare System; Osseoflex Access Kit; Osseoflex CD-H Hydraulic Cement Delivery System; Osseoflex SB Steerable Balloon (10Ga); Osseoflex SB Steerable Balloon (8ga); Osseoflex SB Straight Balloon (10ga); Osseoflex SB Straight Balloon (8ga); Osseoflex SN; Osseoflex SN Needle; Osseoflex SN+ Needle; Osseoflex Straight Hand Drill; Osseon Bone Filler Device (BFD); Ostial Pro Stent Positioning System; OuTake Catheter Extractor; PAL (Pen and Labels) Family; Passage Hemostasis Valve; Perchik Button Assembly; Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M); Performa Diagnostic Intravascular Catheter; Pericardiocentesis Catheter Kit; Peritoneal Dialysis Catheter Connector; Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211); PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing; Pin Vise Polymer; PinVise Torque Device; Pink Achieve; Pinvise Torque Device; PowerCURVE Navigating Osteotome; Prelude Choice Hemostasis Valve Adapter; Prelude IDeal Hydrophilic Sheath Introducer; Prelude Plastic Jacketed Guide Wire; Prelude Prestige Splittable Sheath Introducer; Prelude SNAP 165 Valved Splittable Sheath Introducer; Prelude SNAP Splittable Sheath Introducer; Prelude Sheath Half Size (ACT); Prelude Sheath Introducer; Prelude Short Sheath Introducer; Prelude Wave Hydrophilic Sheath Introducer; PreludeEASE Hydrophilic Sheath Introducer, 4F-6F; PreludeEASE Hydrophilic Sheath Introducer, 7F; PreludeSYNC DISTAL Radial Compression Device; PreludeSYNC EVO Radial Compression Device; PreludeSYNC EZ Radial Compression Device; Pressure Infusor Bags (PIB); Pressure Tubing; Preston Bone Filler; Preston™ Hard Bone Access Needle with Drill; Preston™ Hard Bone Introducer; Preston™ Long Drill; Preston™ Transpedicular Drill; Preston™ Transpedicular Introducer; ProGuide Long Term Hemodialysis Catheter; Purge Assist; QuadraSphere Microspheres; QuadraSphere Q2 Microspheres; Quick Silver; RADstat Radial Artery Compression Device; ROSE; RTT14038MB; RXP (Rapid Exchange Flushing Syringe); Rad Board; Rad Board 2 Reusable Arm Board; Rad Board Xtra; Rad Rest; Rad Trac; ReSolve Biliary Locking Drainage Catheter; ReSolve ConvertX Biliary Stent System; ReSolve ConvertX Nephroureteral Stent System; ReSolve Dilators; ReSolve Locking Drainage Catheter; ReSolve Non-Locking Drainage Catheter; Repositional Chest Tube; Resilience Fully Covered Esophageal Stent System; Revolution Catheter Securement Dev.; Roadster Guide Sheath; Rotating Adaptor; S-MAK; S-MAK XL; SAVI Applicator Kit; SAVI Prep Device; SAVI Spacer; SCOUT Bx Delivery System; SCOUT Console and Accessory Cart; SCOUT MD Console; SCOUT MD Delivery System; SCOUT MD Guides; SCOUT MD Single-Use Handpieces; SCOUT MD Single-use Handpieces; SCOUT Reflector and Delivery Systems; SCOUT Single-Use Handpiece, SCOUT Surgical Guides; SCOUT Surgical Console and SCOUT Check Console; SPINR High-Performance Guidewire Catheter; STAR Tumor Ablation Kit and Accessories; STAR Tumor Ablation Kit with PowerCURVE; STATSEAL; SafT Needle Direct Blood Transfer; SafeGuard Focus Compression Device; SafeGuard Focus Compression Device (Adhesive Free); SafeGuard Focus Cool Device; SafeGuard Focus Cool Device (Adhesive Free); SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al.; SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al.; SafeSheath Sealing Adapter; Safedraw Blood Sampling System; Safeguard Pressure Assisted Device (12cm); Safeguard Pressure Assisted Dressing (24cm); Safeguard Radial Compression Device; Safety Paracentesis Tray (SPPT); SeaDragon Torque Device; ShortStop Advantage Temporary Sharps Holder; ShortStop Grandstand Temporary Sharps Holder; ShortStop Temporary Sharps Holder; Sidecar External Working Channel (FG-1011); Siege Vascular Plug; Slip-Not; Smart Tip Control Syringe; Sof-Grip Hemostat; Softouch Diag. Intra Cath. w/Vessel; Solo Pace Control; Solo Pace Fusion System (SOLOFUSE1); Spectraject Control Syringe; Spectranetics; SpineSTAR Ablation Instruments; Squirt Fluid Delivery System; StabiliT Bone Cement and Saturate Mixing System; StabiliT Cement Delivery Syringe; StabiliT ER2 Bone Cement and Saturate Mixing System; StabiliT Introducer and Delivery Instruments; StabiliT MX Fracture Kits; StabiliT MX Fracture Kits with PowerCURVE; StabiliT VP Fracture Kits; StabiliT VP Vertebrosplasty Kit; StayFix Fixation Device; Sterilized Convenience Kits; Stopcock One Port Manifold; Straightline Osteotome, VerteCOR Midline Osteotome; Stylette (rod obturator); SureCross Support Catheter; Surfacer Inside-Out Access Catheter System; SwiftNINJA Microcatheter; SwiftNINJA Steerable Microcatheter; TRAM; TRAM-P; Temno ACT; Temno Elite Biopsy Systems; Temno Evolution; Temno Original; Thoracentesis Tray (TAPS); Torpedo Gelatin Foam; Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al.; TruCut 14Ga; TruCut 18Ga; True Form Reshapable Guide Wire; Tubing, Fluid Delivery; Universal Coaxial Needles; VACLOK Syringe; VacLok AT Syringe; Valve Adapter; Ventrax Delivery System; VertecoR Bone Drill, 3; Vessel Dilator; Vessel Sizing Catheter (VSC); ViaVerte RF Generator; ViaVerte Steerable RF Ablation Kit; WOUNDSEAL; Westbrook™ Bone Biopsy System; Worley; Wrapsody Cell-Impermeable Endoprosthesis; X-Change Cement Dispensing Syringe; basixCompak Analog Inflation Syringe; basixSKY Inflation Device; basixTOUCH; basixTOUCH40 Inflation Syringe",1992-07-14,197,2026-02-13,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012536737%22&limit=1
Merit Medical UK Limited,3015309643,3015309643,"Unit 27, Suttons Business Park Sutton Park Avenue",Earley Reading,,RG6 1AW,United Kingdom,"Merit Medical Systems, Inc.",1721504,Exporter to the US; Remanufacturer,129,BWN; BZN; CCX; DQF; DQO; DQX; DQY; DRA; DRB; DRC; DRE; DRS; DSK; DSY; DTE; DTL; DWM; DWO; DWS; DWZ; DXC; DXE; DXG; DXN; DXT; DYB; ESW; EXF; FAD; FAJ; FCG; FCY; FDY; FED; FGE; FJS; FKO; FKX; FMF; FMG; FPA; FPK; FQM; FZX; GAA; GAH; GAX; GBW; GBX; GCB; GCC; GDF; GEA; GEH; GEI; GES; GXI; HCG; HRX; HTW; HXG; JAQ; JCT; JDZ; JKA; JOL; JRL; KCY; KDC; KDD; KDQ; KGS; KGX; KGZ; KIH; KME; KMK; KNQ; KNS; KNW; KRA; KRB; KRD; KTI; KYZ; KZD; LDF; LJS; LOD; LXH; LYV; MAV; MDM; MHW; MMX; MSD; NDN; NEU; NOY; NWU; OAR; OCX; OCY; ODE; ODY; OEQ; OEX; OEZ; OJA; OJV; OMT; OWL; OYI; PEV; PFV; PNG; PPD; PTL; PTM; PUR; PXI; PXU; PYB; PYC; QBP; QEY; QEZ; QJH; QSY,"Table And Attachments, Operating-Room; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Support, Patient Position; Actuator, Syringe, Injector Type; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Stylet, Catheter; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Transducer, Blood-Pressure, Extravascular; Computer, Blood-Pressure; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Pulse-Generator, Pacemaker, External; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Apparatus, Suction, Patient Care; Needle, Biopsy, Cardiovascular; Instruments, Surgical, Cardiovascular; Device, Biopsy, Endomyocardial; Clamp, Vascular; Catheter, Embolectomy; Computer, Diagnostic, Pre-Programmed, Single-Function; System, Measurement, Blood-Pressure, Non-Invasive; Injector And Syringe, Angiographic; Introducer, Catheter; Prosthesis, Esophageal; Bag, Bile Collecting; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Biopsy Needle; Bulb, Inflation, For Endoscope; Device, Measuring, For Panendoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Stents, Drains And Dilators For The Biliary Ducts; Catheter, Peritoneal, Long-Term Indwelling; Catheter, Peritoneal Dialysis, Single Use; System, Peritoneal, Automatic Delivery; Syringe, Piston; Stopcock, I.V. Set; Set, Administration, Intravascular; Tubing, Fluid Delivery; Bandage, Elastic; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Stylet, Surgical, General & Plastic Surgery; Tourniquet, Nonpneumatic; Catheter, Peritoneal; Catheter, Irrigation; Needle, Catheter; Dilator, Catheter; Guide, Needle, Surgical; Cannula, Surgical, General & Plastic Surgery; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Scalpel; Probe, Radiofrequency Lesion; Device, Neurovascular Embolization; Arthroscope; Bit, Drill; Tamp; System, Applicator, Radionuclide, Remote-Controlled; Prosthesis, Tracheal, Expandable; Mixer, Cement, For Clinical Use; Tubes, Vials, Systems, Serum Separators, Blood Collection; Catheter And Tip, Suction; Unit, Filter, Membrane; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Dispenser, Cement; Bedding, Disposable, Medical; Device, Intravascular Catheter Securement; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Instrument, Biopsy; Catheter, Continuous Flush; Probe, Thermodilution; Device, Vascular, For Promoting Embolization; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Electrode, Pacemaker, Temporary; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Bone Cement; Orthopedic Manual Surgical Instrument; Label Or Tag, Sterile; Syringe, Balloon Inflation; Instrument, Manual, Surgical, General Use; Dressing, Compression; Device, Percutaneous Retrieval; Catheter, Hemodialysis, Implanted; Cement, Bone, Vertebroplasty; Marker, Radiographic, Implantable; Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia; Endoscope Introducer Kit; Injector, Vertebroplasty (Does Not Contain Cement); Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd); Tunneled Catheter Remover; Angiography/Angioplasty Kit; Cardiovascular Catheter Sheath Introducer Kit; Cardiovascular Procedure Kit; Intravenous Extension Tubing Set; Single Use Instrument Tray; Absorbable Lung Biopsy Plug; Peripheral Catheter Insertion Kit; Non-Bronchoscopic Bronchoalveolar Lavage Catheter; Dialysis Administration Kit; System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Universal Drainage Tray; Wire, Guide, Catheter, Exempt; Syringe, Balloon Inflation, Exempt; Vacuum Syringe; Thoracentesis Tray; Fluid Drainage Tray; Minor Surgical Procedures Tray; Paracentesis Tray; Cap, Device Disinfectant; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter; Reverse Central Venous Recanalization System; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; 3; U,"1 mL syringe(Polypropylene); 10Fore Hemostasis Valve; 10Fore Hemostasis Valve Kit; 5.5 F Worley Advanced LVI Lateral Vein Introducer; AEROmini Tracheobronchial Stent System; ARC Catheter; ASAP Aspiration Catheter; ASAP Catheter; ASAPLP Aspiration Catheter; ASAPLP Embolectomy Catheter; Access-9; AccessPLUS; Achieve; Activation Element, ERx bone cement; Acutiy Universal Cutter; Adjustable Biopsy Port Seal BPS-A; Advance Angiographic Needle; Aero DV Tracheobronchial Stent System; Aero Tracheo Stent and Delivery System; Aerosizer; Alimaxx E; Arcadia Balloon Catheter; Arcadia Balloon Catheter Kit; Aspira Peritoneal Drainage System; Aspira Pleural Drainage System; BIG60; BIG60 ALPHA Inflation Devie; BRC-BAL-INT-FL/A; BackStop Plus Closed Waste Basin; Bath Probe; Bedford™ Guided Hard Bone Biopsy System; BioFlo Duramax; BioSentry Tract Sealant System; Blue Diamond Inflation Syringe; BowTie Guide Wire Insertion Device; Brochoalveloar Lavage (BAL) Custom Convenience Kit; Bulldog Lead Extender; C2 Cryoballoon Ablation System; C2 Cryoballoon Endogrip; CT Transfer Set; CardiaGuide Fixed Curve Braided Transseptal Sheath; Cardiac Output Kit; Catheter Connection Cable; Catheter Connection Cables and Cardia Computer; Cen-Step Centesis Catheter; Centros Long-Term Hemodialysis Catheter; CentrosFLO Long-Term Hemodialysis Catheter; Check Valve; ClariVein IC Infusion Catheter; Coil Expander; Concierge Guiding Catheter; Connecta PE Lines; Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI); Coronary Control Syringe; Corvocet Biopsy System; Corvocet Coaxial Introducer; Critiflo; Critiflo Dome; Critikit Plus In-Line Room/ Ice Injectate; Cuff Implantor; Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; DTX Disposable Temperature Probe; DTX Plus Disposable Pressure Transducer; DTX/DTX Plus Kit and Accessories; Dark Blue Cap for Male Luers; Dash 9F Hydrophilic Sheath Introducer; DiamondTOUCH Inflation Device and Fluid Dispensing Syringe; DiamondTOUCH Syringe; Disposable In Line Sensor Housing; DoublePlay Hemostasis Valve; Drainage Tubing; DriPAD Super Absorbent Pad; DualCap; DualCap Duo; DualCap IV Pole Strips; DualCap Solo; DuraFlow 2 Hemodialysis Catheter; Duramax; EN Snare Endovascular Snare System; ER2 Saturate Mixing System; Elation Fixed Wire Balloon; Elation Pulmonary Balloon; Elation Pulmonary Balloon 4mm; Elation Wireguided Balloon; Elation5 Fixed Wire Balloon; Elation5 Wireguided Balloon; Embedding Tool; EmboGold Microspheres; Emboshpere PRO; Embosphere Microspheres; EndoMAXX; EsophyX Z+ Device; EvenMore Chronic Hemodialysis Catheter; Excite Contrast Injection Line; ExxTended Catheter; FLO30; FLO40XR; FLO50; Faller Trocar; FastBreak Connector; Finale Radial Compression System; Flex-Neck Catheter; Flex-Neck Extender/Repair Kit; Flex-Neck Infant Catheter; FlowGuard; Fluid Dispensing Syringe; Fountain 4F Catheter & Occluding GW; Fountain Catheter/Occluding Guide Wire; Fountain Infusion Catheter w/ Occluding Guide Wire; Fountain Infusion System; Fountain ValveTip Infusion Catheter; Futura Safety Scalpel; Go2Wire Guide Wire; Guidewire Introducer; Guidewire with Palladium Tip; H20 Guidewire; H20 Torque Device; HeRO Graft; HeartLight Deflectable Sheath; HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al.; HeartSpan Steerable Introducer Sheath; HeartSpan Steerable Sheath Introducer; Hemostasis Valve Adapter; Honor hemostasis valve; Huntington Guided, Perforating Bone Biospy System with Drill; Hydraulic Assembly; Hydraulic-Master Syringe Assembly; Hydrophilic Guidewire; Hydrophilic Prelude SNAP Splittable Sheath Introducer; Impress Angiographic Catheter; Impress UAC Catheter; Impress and Impress Legato Hydrophilic Angiographic Catheter; Impress with Legato Hydrophilic Coating; InQwire; InQwire Amplatz Super Stiff Guide Wire; InQwire Diagnostic (Support) Non-Vascular Guide Wire; InQwire Guidewire-Prelude Introducer; InQwire Guidewires; Injectate Sensor Cable; Insufflation Set; Integral Injectate Temperature Probe; Intellisystem Inflation Device; Introducer Needle WithTrocar Stylet; K01 Kit (MSS); K01 Syringe Kit (1mL & 20mL COP); K01 Syringe Kit (1mL Polypropylene); K02 Syringe Kit (multiple K01); K02 Syringe Kit (multiple K01)); K02-00873A, K02-01105A, K02-01481A; K04 - Tubing Kit; K05 Inflation Kit; K05T - Inflation Kit; K06 Syringe Kit (single CSS); K07 Syringe Kit (multiple K06); K08 Fluid Management Kit; K09 Manifold Kit; K09T - Manifold Kit; K10 Waste Management Kit; K10T - Waste Management Kit; K11 Pressure Monitoring Kit; K12 Procedure Kit; K12T - Procedure Kit; K13 Label Kit; K14 Dialysis Kit; K15 Sheath Introducer Kit; K16 Microcatheter Kit; K17 Interventional Kit; K17T - Interventional Kit; K18 Sheath Introducer Kit (Ease); K19 Combination Packs; K20 Endoscopic Kit; K20T - Endoscopic Kit; K21 Sheath Introducer Kit (IDeal); K22C Vein Tray; K23C Vein Accessory Kit; KYPHON KyphoFlex Balloon Catheter; KYPHON KyphoFlex Balloon Catheter Kit; Kensington Guide Wire Bone Biopsy System; Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411); Lead Clippers; Liberator Beacon Tip Locking Stylet; Low Profile Companion Sheath; MAK-NV Non-Vascular; MAP Torque Device & Introducer; MBA; MYSHELL Hemostatic Valve; Madison Mini™ Bone Biopsy System; Madison™ Perforating Bone Biopsy System with Drill; Maestro Microcatheter; Majestik Angiographic Needle; Master Syringe Assembly; Maxxwire; Medallion Syringe; Merit 1mL Syringe (COP); Merit 20 mL Syringe (COP); Merit Administration Set; Merit Centros Long-Term Hemodialysis Catehter; Merit CentrosFLO Long-Term Hemodialysis Catheter; Merit Convenience Kits; Merit Disposal Depot; Merit Drainage Depot; Merit HeRO Graft; Merit High Pressure Tubing; Merit Hydrophilic Guide Wire; Merit InQwire® Amplatz Super Stiff Guide Wire; Merit MAK (Mini Access Kit); Merit Manifold; Merit Marquis Flow Switch; Merit Marquis Stopcock; Merit PAK; Merit Pressure Monitoring Tubing; Merit Pursue Microcatheter; Merit S-MAK (Stiffened Mini Access Kit); Merit Safety Needle; Merit Syringe; Merit Triboglide Syringe; Meritrans Disposable Transducer; MetaSTAR RF Generator; Micro Ace Advanced Micro Access System; Micro Ace Gold Advanced Micro Access System; Micro Plug Set; Mighty Wire; MiniStop Filter Closed Waste Basin; MiniStop Plus Closed Waste Basin; Miser Contrast Management System; Monarch Compak Inflation Syringe; Monarch Syringe Fluid Dispense System; MultiPlex II Controller; Needle's Eye Snare Retrieval Set; NeoVasc; Non-vascular tissue dilators; Novatome Endomyocardial Biopsy Forceps; One Snare Endovascular Snare System ONE1501; One-Step Centesis Catheter; One-Tie Compression Coil; One-Vac Evacuated Drainage Bottle; OneSnare Endovascular Snare System; Osseoflex Access Kit; Osseoflex CD-H Hydraulic Cement Delivery System; Osseoflex SB Steerable Balloon (10Ga); Osseoflex SB Steerable Balloon (8ga); Osseoflex SB Straight Balloon (10ga); Osseoflex SB Straight Balloon (8ga); Osseoflex SN; Osseoflex SN Needle; Osseoflex SN+ Needle; Osseoflex Straight Hand Drill; Osseon Bone Filler Device (BFD); Ostial Pro Stent Positioning System; OuTake Catheter Extractor; PAL (Pen and Labels) Family; Passage Hemostasis Valve; Perchik Button Assembly; Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M); Performa Diagnostic Intravascular Catheter; Pericardiocentesis Catheter Kit; Peritoneal Dialysis Catheter Connector; Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211); PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing; Pin Vise Polymer; PinVise Torque Device; Pink Achieve; Pinvise Torque Device; PowerCURVE Navigating Osteotome; Prelude Choice Hemostasis Valve Adapter; Prelude IDeal Hydrophilic Sheath Introducer; Prelude Plastic Jacketed Guide Wire; Prelude Prestige Splittable Sheath Introducer; Prelude SNAP 165 Valved Splittable Sheath Introducer; Prelude SNAP Splittable Sheath Introducer; Prelude Sheath Half Size (ACT); Prelude Sheath Introducer; Prelude Short Sheath Introducer; Prelude Wave Hydrophilic Sheath Introducer; PreludeEASE Hydrophilic Sheath Introducer, 4F-6F; PreludeEASE Hydrophilic Sheath Introducer, 7F; PreludeSYNC DISTAL Radial Compression Device; PreludeSYNC EVO Radial Compression Device; PreludeSYNC EZ Radial Compression Device; Pressure Infusor Bags (PIB); Pressure Tubing; Preston Bone Filler; Preston™ Hard Bone Access Needle with Drill; Preston™ Hard Bone Introducer; Preston™ Long Drill; Preston™ Transpedicular Drill; Preston™ Transpedicular Introducer; ProGuide Long Term Hemodialysis Catheter; Purge Assist; QuadraSphere Microspheres; QuadraSphere Q2 Microspheres; Quick Silver; RADstat Radial Artery Compression Device; ROSE; RTT14038MB; RXP (Rapid Exchange Flushing Syringe); Rad Board; Rad Board 2 Reusable Arm Board; Rad Board Xtra; Rad Rest; Rad Trac; ReSolve Biliary Locking Drainage Catheter; ReSolve ConvertX Biliary Stent System; ReSolve ConvertX Nephroureteral Stent System; ReSolve Dilators; ReSolve Locking Drainage Catheter; ReSolve Non-Locking Drainage Catheter; Repositional Chest Tube; Resilience Fully Covered Esophageal Stent System; Revolution Catheter Securement Dev.; Roadster Guide Sheath; Rotating Adaptor; S-MAK; S-MAK XL; SAVI Applicator Kit; SAVI Prep Device; SAVI Spacer; SCOUT Bx Delivery System; SCOUT Console and Accessory Cart; SCOUT MD Console; SCOUT MD Delivery System; SCOUT MD Guides; SCOUT MD Single-Use Handpieces; SCOUT MD Single-use Handpieces; SCOUT Reflector and Delivery Systems; SCOUT Single-Use Handpiece, SCOUT Surgical Guides; SCOUT Surgical Console and SCOUT Check Console; SPINR High-Performance Guidewire Catheter; STAR Tumor Ablation Kit and Accessories; STAR Tumor Ablation Kit with PowerCURVE; STATSEAL; SafT Needle Direct Blood Transfer; SafeGuard Focus Compression Device; SafeGuard Focus Compression Device (Adhesive Free); SafeGuard Focus Cool Device; SafeGuard Focus Cool Device (Adhesive Free); SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al.; SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al.; SafeSheath Sealing Adapter; Safedraw Blood Sampling System; Safeguard Pressure Assisted Device (12cm); Safeguard Pressure Assisted Dressing (24cm); Safeguard Radial Compression Device; Safety Paracentesis Tray (SPPT); SeaDragon Torque Device; ShortStop Advantage Temporary Sharps Holder; ShortStop Grandstand Temporary Sharps Holder; ShortStop Temporary Sharps Holder; Sidecar External Working Channel (FG-1011); Siege Vascular Plug; Slip-Not; Smart Tip Control Syringe; Sof-Grip Hemostat; Softouch Diag. Intra Cath. w/Vessel; Solo Pace Control; Solo Pace Fusion System (SOLOFUSE1); Spectraject Control Syringe; Spectranetics; SpineSTAR Ablation Instruments; Squirt Fluid Delivery System; StabiliT Bone Cement and Saturate Mixing System; StabiliT Cement Delivery Syringe; StabiliT ER2 Bone Cement and Saturate Mixing System; StabiliT Introducer and Delivery Instruments; StabiliT MX Fracture Kits; StabiliT MX Fracture Kits with PowerCURVE; StabiliT VP Fracture Kits; StabiliT VP Vertebrosplasty Kit; StayFix Fixation Device; Sterilized Convenience Kits; Stopcock One Port Manifold; Straightline Osteotome, VerteCOR Midline Osteotome; Stylet Wire; Stylette (rod obturator); SureCross Support Catheter; Surfacer Inside-Out Access Catheter System; SwiftNINJA Microcatheter; SwiftNINJA Steerable Microcatheter; TRAM; TRAM-P; Temno ACT; Temno Elite Biopsy Systems; Temno Evolution; Temno Original; Thoracentesis Tray (TAPS); Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al.; TruCut 14Ga; TruCut 18Ga; True Form Reshapable Guide Wire; Tubing, Fluid Delivery; Universal Coaxial Needles; VACLOK Syringe; VacLok AT Syringe; Valve Adapter; Ventrax Delivery System; VertecoR Bone Drill, 3; Vessel Dilator; Vessel Sizing Catheter (VSC); ViaVerte RF Generator; ViaVerte Steerable RF Ablation Kit; WOUNDSEAL; Westbrook™ Bone Biopsy System; Worley; Wrapsody Cell-Impermeable Endoprosthesis; X-Change Cement Dispensing Syringe; basixCompak Analog Inflation Syringe; basixSKY Inflation Device; basixTOUCH; basixTOUCH40 Inflation Syringe",1992-07-14,197,2026-02-13,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015309643%22&limit=1
Medtronic Distribution Center,3009380063,3009380063,5300 Airways Blvd,Memphis,TN,38116,United States,"Medtronic, Inc.",2112641,Manufacturer; Repackager or relabeler,110,CAC; DQX; DQY; DSI; DTB; DTL; DWE; DWF; DXY; EZW; FER; FHO; FSZ; FTL; FYD; FZP; FZT; FZX; GAD; GAG; GAL; GAM; GAT; GCI; GCJ; GDH; GDO; GDT; GDW; GEI; GEX; HBE; HCG; HDA; HET; HTD; HTJ; HTO; HTW; HWB; HWE; HWJ; HWM; HWN; HXB; HXC; HXW; HXX; KFM; KIH; KRA; KRD; KRG; KWP; KWQ; LFL; LGW; LWP; LWS; LXH; MAX; MBX; MFE; MFR; MHY; MIH; MNH; MNI; MPN; MQP; MRU; MXD; NBH; NHL; NIK; NIQ; NKB; NKE; NKG; NPT; NRY; NVN; NVY; NVZ; OCT; OCW; OJX; OLM; OLO; ONU; OSH; OSR; OTD; OUR; OUT; OVD; OVE; OWI; OXC; PJS; PNJ; POL; QAN; QEW; QJP; QON; QRB; QZI; SGS; SGU,"Apparatus, Autotransfusion; Wire, Guide, Catheter; Catheter, Percutaneous; Detector And Alarm, Arrhythmia; Permanent Pacemaker Electrode; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Tubing, Pump, Cardiopulmonary Bypass; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Implantable Pacemaker Pulse-Generator; Stimulator, Electrical, Implantable, For Incontinence; Anoscope And Accessories; Pneumoperitoneum Needle; Light, Surgical, Carrier; Mesh, Surgical, Polymeric; Apparatus, Exhaust, Surgical; Clip, Implantable; Cutter, Surgical; Guide, Surgical, Instrument; Retractor; Stapler, Surgical; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyethylene; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Removable (Skin); Staple, Implantable; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Drills, Burrs, Trephines & Accessories (Simple, Powered); Device, Neurovascular Embolization; Forceps, Obstetrical; Laparoscope, Gynecologic (And Accessories); Forceps; Gauge, Depth; Reamer; Bit, Drill; Extractor; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Osteotome; Instrument, Compression; Probe; Wrench; Bender; Screwdriver; Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type; Dispenser, Cement; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Programmer, Pacemaker; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Instrument, Ultrasonic Surgical; Stimulator, Spinal-Cord, Totally Implanted For Pain Relief; Implantable Pulse Generator, Pacemaker (Non-Crt); Implantable Cardioverter Defibrillator (Non-Crt); Orthopedic Manual Surgical Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Stimulator, Thalamic, Epilepsy, Implanted; Agent, Injectable, Embolic; Stimulator, Brain, Implanted, For Behavior Modification; Stimulator, Electrical, Implanted, For Parkinsonian Tremor; System, Endovascular Graft, Aortic Aneurysm Treatment; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Tissue Adhesive For The Topical Approximation Of Skin; Spinal Vertebral Body Replacement Device; Implanted Subcortical Electrical Stimulator (Motor Disorders); Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection); Accessories, Arthroscopic; Stimulator, Electrical, Implanted, For Parkinsonian Symptoms; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D); Coronary Drug-Eluting Stent; Thoracolumbosacral Pedicle Screw System; Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P); Posterior Cervical Screw System; Aortic Valve, Prosthesis, Percutaneously Delivered; Catheter, Thrombus Retriever; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes; Permanent Defibrillator Electrodes; Pulse Generator, Permanent, Implantable; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Tissue Approximation Device; Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode; Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd); Orthopedic Stereotaxic Instrument; Drug-Eluting Peripheral Transluminal Angioplasty Catheter; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Pacemaker/Icd/Crt Non-Implanted Components; Endovascular Suturing System; Sacroiliac Joint Fixation; Intracranial Aneurysm Flow Diverter; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Bone Fixation Cerclage, Sublaminar; Mesh, Surgical, Absorbable, Staple Line Reinforcement; Stimulator, Electrical, Implanted, For Essential Tremor; Leadless Pacemaker; Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment; Stent, Iliac Vein; Peripheral Mechanical Thrombectomy With Aspiration; Catheter, Percutaneous, Neurovasculature; Implanted Electrical Device Intended For Treatment Of Fecal Incontinence; Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation; Deep Brain Stimulation For The Treatment Of Dystonia; Neurovascular Liquid Embolic Agent",1; 2; 3; U; f,", MOTORS; ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology; AURORA EV-ICD™ MRI SURESCAN™ SW041; AUTOSUTURE ENDOSCOPIC CLAMP; Abre™ Venous Self-expanding Stent System; AbsorbaTack; Absorbatack; Access Review Therapy Controller; Access Therapy Controller; Ace Header Emulator; Activa Dystonia Therapy; Activa PC Neurostimulator; Activa Parkinsons Control Therapy; Activa RC Neurostimulator; Activa SC Neurostimulator; Activa Tremor Control Therapy; Adapta; Adapta L; Adapta S; Adapter; Adapter Cable; Adapters; Adaptor Extender Kit; Adaptor Kit; Adhesive; Advisa DR; Advisa DR MRI SureScan; Advisa SR MRI SureScan; Amplia MRI CRT-D SureScan; Amplia MRI Quad CRT-D SureScan; Analyzer Adapter; Analyzer Cable; Apollo Onyx Delivery Micro Catheter; Appose Skin Staplers; ArthroPort; Attain; Attain Ability Lead; Attain Ability MRI SureScan Lead; Attain Ability Plus Lead; Attain Ability Plus MRI SureScan Lead; Attain Ability Straight Lead; Attain Ability Straight MRI SureScan Lead; Attain Bipolar OTW Lead; Attain OTW; Attain Performa Lead; Attain Performa MRI SureScan Lead; Attain Performa S Lead; Attain Performa S MRI SureScan Lead; Attain Performa Straight Lead; Attain Performa Straight MRI SureScan Lead; Attain Stability Quad MRI SureScan Lead; Attain StarFix; Attesta DR MRI; Attesta L DR MRI; Attesta S DR MRI; Attesta SR MRI; Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator; Autolog Autotransfusion; Avigo¿ Hydrophilic Guidewire; Axium Detachable Coil System; Axium Prime Detachable Coil System (FitzRoy); Azure S DR MRI; Azure S SR MRI; Azure XT DR MRI; Azure XT SR MRI; BIOPUMP (VARIOUS MODELS); BIT DRILLS; Bio-Medicus; Bio-Medicus Cannula; Blunt Tip Trocars; Bluntport; Brava; Brava Quadripolar CRT-D; CD HORIZON SOLERA Spinal System; CD HORIZON Spinal System; CD HORIZON® Fenestrated Screw Set; CD Horizon™ ModuLeX™ FNS Screw Set; CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ LigaMAS Head Assm; CD Horizon™ ModuLeX™ Spinal System; CD Horizon™ Spinal System; Cannula; CapSure Epicardial Pacing lead; CapSure Lead; CapSure SP Novus; CapSure Sense; CapSure Sense MRI SureScan Leads; CapSure Unipolar Lead; CapSure VDD-2 Lead; CapSure Z Novus; CapSureFix Lead; CapSureFix MRI SureScan Lead; CapSureFix Novus Leads; CapSureFix Novus MRI SureScan Leads; Capsure SP Novus; CardioSight Reader; CareLink Encore Programmer; CareLink Encore Programmer RF Head; CareLink Express Mobile System - Android; CareLink Express Mobile System - iOS; CareLink Express Monitor; CareLink Network Software; CareLink Programmer RF Head; CareLink SmartSync Azure Astra Application; CareLink SmartSync Base 24970A; CareLink SmartSync Common Application iOS; CareLink SmartSync PSA Application; CareLink SmartSync Patient Connector 24967; CareLink SmartSync Percepta, Solera, Serena Application; CareLink SmartSync Power Cord 249705; CareLink SmartSync Power Supply 249701; CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025; CareLink Wireless Network Adapter Card; Carpentier Bi-Caval Femoral Cannula; Catalyft™ LS Expandable Interbody System; Claria MRI CRT-D; Claria MRI Quad CRT-D; Clearify; Clearview Intracoronary Shunt; Coated Electrodes; Cobalt DR MRI Surescan; Cobalt HF CRT-D MRI SureScan; Cobalt HF Quad CRT-D MRI SureScan; Cobalt VR MRI Surescan; Cobalt XT DR MRI Surescan; Cobalt XT HF CRT-D MRI SureScan; Cobalt XT HF Quad CRT-D MRI SureScan; Cobalt XT VR MRI Surescan; Compia MRI CRT-D SureScan; Compia MRI Quad CRT-D SureScan; Concerto Detachable Coil System; Concerto ICD; Concerto II CRT-D; ConcordeMultifire Premium skin stapler; Consulta CRT-P; Consulta DF4 ICD; Consulta ICD; CoreValve Evolut PRO System; CoreValve Evolut PRO+ System; CoreValve Evolut R System; Covidien; Crome DR MRI Surescan; Crome HF CRT-D MRI SureScan; Crome HF Quad CRT-D MRI SureScan; Crome VR MRI Surescan; DBS Extension Kit; DBS Therapy for Dystonia; DF-1 Port Pin Plug; DLP Air Aspirating Needle; DLP Aortic Root Cannula; DLP Cannula; DLP Pericardial Sump; DLP Pressure Monitoring Catheter; DLP Silicone RCSP Cannula; DRILL BIT (ORTHOPEDIC MA; DRILL GUIDES; DRILLS; Dextile™ Anatomical Mesh; Divider One-step Sealing, Nano-coated (LF1930T); Doubletime Trocar; Drill; Introducer Tool; E3770-36, Valleylab™ Laparoscopic Straight Spatula Electrode, Solid, 36cm; E3770-36C, CleanCoat™ Laparoscopic Straight Spatula Electrode Coated, 36cm; E3771-36, Valleylab™ Laparoscopic Curved Spatula Electrode, Solid, 36cm; E3771-36C, CleanCoat™ Laparoscopic Curved Spatula Electrode, Coated, 36cm; E3771-45, Valleylab™ Laparoscopic Curved Spatula Electrode, Solid, 45cm; E3771-45C, CleanCoat™ Laparoscopic Curved Spatula Electrode, Coated, 45cm; E3772-36, Valleylab™ Laparoscopic Wire J-Hook Electrode, Solid, 36cm; E3772-36C, CleanCoat™ Laparoscopic Wire J-Hook Electrode, Coated, 36cm; E3773-36, Valleylab™ Laparoscopic Wire L-Hook Electrode, Solid, 36cm; E3773-36C, CleanCoat™ Laparoscopic Wire L-Hook Electrode Coated, 36cm; E3773-45, Valleylab™ Laparoscopic Wire L-Hook Electrode, Solid, 45cm; E3773-45C, CleanCoat™ Laparoscopic Wire L-Hook Electrode , Coated, 45cm; E3774-36, Valleylab™ Laparoscopic Flat L-Hook Electrode, Solid, 36cm; E3774-36C, CleanCoat™ Laparoscopic Flat L-Hook Electrode, Coated, 36cm; E3774-45, Valleylab™ Laparoscopic Flat L-Hook Electrode, Solid, 45cm; E3774-45C, CleanCoat™ Laparoscopic Flat L-Hook Electrode, Coated, 45cm; ECG Cable; ECG Output Adapter; ECG Port Plug; EEA OrVil; EEA Surgical Stapler; EEA TAID; ENDO CATCH; ENDO CLOSE; ENDO GIA ROTICULATOR Staplers; ENDO MINI-SHEARS; ENDO PADDLE RETRACT; ENDO SHEARS; ENDO STITCH; ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT; ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD); ENDOSKELETON(R) TL INTERBODY FUSION DEVICE; EOPA; EOPA 3D; EZ Anchor; Echelon Micro Catheter; Edge Blade Electrode, (3” (, 7.62 cm), E1450G and E1450GNSB; Edge Blade Electrode, (4"", (10.16 cm), E1450-NSB; Edge Blade Electrode, (6.5"" (, 16.51 cm), E1450-6 and E1450-6NSB; Edge Coated Blade Extended Electrode, ( 4"" , (10.16 cm), E1450-4; Edge Hex-locking Blade Electrode, (2.5” (, 6.35 cm), E1450X and E1450XNSB; Edge Insulated Blade Electrode, (2.75"", (7 cm), E1455; Edge Insulated Blade Electrode, (4"", (10.16 cm), E1455-4 and E1455-4NSB; Edge Insulated Blade Electrode, (6.5"", (16.51 cm), E1455-6 and E1455-6NSB; Edge Insulated Blade Electrode, Safety Sleeve (2.75"", (7 cm), E1455NSB; Edge Insulated Blade Electrode, Safety Sleeve, (2.75"" (, 7 cm), E1455B; Edge Insulated Blade Electrode, Safety Sleeve, (2.75"", (7 cm), E1455BNSB; Edge Insulated Blade Electrode, Safety Sleeve, (4"" (, 10.16 cm), E1455B4; Edge Insulated Blade Electrode, Safety Sleeve, (4"", (10.16 cm), E1455B-4NSB; Edge Insulated Needle Electrode, (2.8"", (7.2 cm), E1465; Edge Insulated Needle Electrode, (2.8"", (7.2 cm), E1465NSB; Edge Insulated Needle Electrode, 6.5"" (16.51 cm), E1465-6; Edge Insulated Needle Electrode, Safety Sleeve, (2.8"", (7.2 cm), E1465B and E1465BNSB; Edge Insulated Needle Electrode, Safety Sleeve, (4"", (10.16 cm), E1465B-4; Edge Needle Electrode, (2.8"" (, 7.2 cm), E1452; Edge Needle Electrode, (2.8"", (7.2 cm), E1452NSB; Edge Needle Electrode, (6.5"" (, 16.51 cm), E1452-6; Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDBNSB; Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HGNSB; Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450H; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HDBNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HGNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HNSB; Edge™ Button Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2450HS; Edge™ Pencil Blade Electrode, Holster, E2250H; Edge™ Pencil Blade Electrode, Holster, E2250HNSB; Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350H; Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350HDB; Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HS; Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HSNSB; Electrodes; EnTrust ICD; End Cap; Endo Clip III; Endo GIA Pancreas Indication; Endoskeleton TCS Interbody Fusion Device; Endurant II AUI Stent Graft System; Endurant II Stent Graft System; Endurant IIs Stent Graft System; Endurant Stent Graft System; Epicardial Patch Lead; Epsila EV™ MRI SureScan™ extravascular lead; Epsila EV™ Sternal Tunneling Tool; Epsila EV™ Transverse Tunneling Tool; Evera; Evera MRI S DR SureScan; Evera MRI S VR; Evera MRI XT DR SureScan; Evera MRI XT VR SureScan; Evera S DR; Evera S VR; Evera XT DR; Evera XT VR; Evolut FX+ System; Expandable Cage; FORCEPS (MANUAL INSTRU; Force TriVerse; GEM; GEM VR; GUIDE WIRES (PINS); General Instrument; General Instruments; Guide Pin; Introducer Tool; Gundry RSCP; Heli-FX EndoAnchor System; Heli-FX Thoracic EndoAnchor System; IB3D™ PL Spinal System; INFINITY™ Occipitocervical Upper Thoracic System; IS-1 Port Pin Plug Kit; Impulse II Lead; In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter; In.Pact Admiral Paclitaxel-Coated PTA Balloon Catheter; InCheck Patient Assistant; Inceptiv™ Implantable Neurostimulator; Inceptiv™ LT Implantable Neurostimulator; Injex BiWing Anchor; Injex Bumpy Anchor; Instant Detacher; Instrument Command Library (ICL)Device Command Library (DCL); Insync; Integrated Diagnostics Data Calculation Module Model 5242; Intellis™ Pro Implantable Neurostimulator; Intellis™ with AdaptiveStim™ Implantable Neurostimulator; InterStim II Neurostimulator; InterStim II Sacral Nerve Stim; InterStim Micro™ Implantable Neurostimulator; InterStim Neurostimulator; InterStim Sacral Nerve Stimulation; InterStim Therapy System; InterStim iCon Patient Programmer; InterStim iCon Programmer; InterStim™ SureScan™ MRI leads; InterStim™ X Implantable Neurostimulator; Intercept™; Intrinsic ICD; Itrel 4 Neurostimulation System; Itrel 4 Neurostimulator; Itrel EZ Programmer; KYPHON Cement Delivery System; KyphX Bone Filler Device; LAA Selection Guide; LIGASURE MARYLAND; LINQ II Insertable Cardiac Monitor; LINQ Tool Kit; Laparoscope; Laparoscopic Handswitch/Electrodes; Lead Analyzer; Lead Patch; Lead anchoring Sleeve; Liberant™ Thrombectomy System; LigaSure Maryland Jaw Thoracic Sealer; LigaSure™ Blunt Tip Open Sealer/Divider Nano-coated, LF1823; LigaSure™ Blunt Tip, Laparoscopic Sealer/Divider Nano-coated, LF1837 and LF1844; LigaSure™ Exact Dissector Nano-coated, LF2019; LigaSure™ Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Nano-coated, LF1937 and LF1944; LigaSure™ Maryland Jaw Open Sealer/Divider One-step Sealing, Nano-coated, LF1923; LigaSure™ Retractable L-Hook Laparoscopic Sealer/Divider, LF5637 and LF5644; MAST QUADRANT™ Retractor System; MC2 Multistage; MICRO JEWEL; MICRO JEWEL II; MICRO-FRANCE; MONITOR TEMPERATURE; MRI SureScan™; MSB PYRAMESH® Implant System; MULTIPLE (DEPTH GAUGES); MULTIPLE (DRIVER-EXTRACTORS); MULTIPLE (ORTHOPEDIC OSTEOTOMES); MULTIPLE (ORTHOPEDIC REAMERS); MULTIPLE FORCEPS; MULTIPLE TWIST; Marathon Micro Catheter; Marathon™ Flow Directed Catheter; Marquis DR ICD; Marquis VR ICD; Maximo DR ICD; Maximo II CRT-D; Maximo II DR; Maximo II VR; Maximo VR ICD; McKesson Skin Staplers 35 REGULAR; McKesson Skin Staplers 35 WIDE; Medtronic CareLink Monitor; Medtronic CareLink Programmer; Medtronic CoreValve System; Medtronic Evolut FX System; Medtronic Longevity; Medtronic Reusable Instrument; Micra AV TPS; Micra AV2 TPS; Micra TPS; Micra Transcatheter Pacemaker System; Micra VR2 TPS; Micro-Needle Electrodes, E16XX; MyCareLink Patient Monitor; Myocardial Pacing Lead; N'Vision Programmer; N'Vision Software Application Card; Navien Intracranial Support Catheter; Navigated CD HORIZON SOLERA Screwdrivers and Taps; OmniaSecure™; One Step; Onyx AVM; Onyx Frontier Zotarolimus-Eluting Coronary Stent System; Onyx Liquid Embolic System; OptiMumm Smoke Prefilter Reducer Adapter, E3660; OptiMumm Smoke Prefilter Reducer Adapter, E3665; OptiMumm Smoke Prefilter, E3630; OptiMumm Smoke Reducer Fitting, E3655; OptiMumm Smoke Sponge Guard Tubing, E3635; OptiMumm Smoke Tubing, E3645; OptiMumm ULPA Filter, E3625; Orion Micro Catheter; PASS LP Spinal System; PCD; PDB; PROBE (ORTHOPEDIC MANU; Parietex™ Hydrophilic 2-Dimensional Mesh; Patient Cable; Patient Magnet; Pencils; Percepta CRT-P MRI SureScan; Percepta Quad CRT-P MRI SureScan; Percept™ PC BrainSense™; Percept™ RC Rechargeable Neurostimulator with BrainSense™ Technology; Pipeline Flex Embolization Device; Pipeline Flex Embolization Device with Shield Technology; Pipeline Flex with Shield Technology; Pipeline Vantage™ Embolization Device with Shield Technology™; Pisces-Quad Compact Lead; Pisces-Quad Plus Lead; Polyhesive Patient Return Electrode; Polysorb; PrimeAdvanced Neurostimulator; PrimeAdvanced SureScan MRI Neurostimulator; Primo MRI DR SureScan; Primo MRI VR SureScan; ProGrip™ Laparoscopic Self-Fixating Mesh; ProGrip™ Self-Gripping Polyester Mesh; ProStream Sidehole Infusion Wire; Prodigy IPG; Program Interface Cable; Protack; Protecta CRT-D; Protecta DR; Protecta VR; Protecta XT CRT-D; Protecta XT DR; Protecta XT VR; PulseSelect Pulsed Field Ablation (PFA) Loop Catheter; PulseSelect™ Pulsed Field Ablation (PFA); RCSP; RETRACTOR; REVEAL LINQ; RIALTO"" SI FUSION SYSTEM; RadiaLux™; RapidVac Laparoscopic Tubing, SEA3720; RapidVac Tubing with Sponge Guard, SEA3715; RapidVac Tubing, SEA3705; RapidVac Tubing, SEA3710; RapidVac Wand, Laser Resistant, SEA3725; Rebar Micro Catheter; Reclaim Deep Brain Stimulation; Relia IPG; ReliaCatch; Reliant Stent Graft Balloon Catheter; Resolute Onyx Zotarolimus-Eluting Coronary Stent System; RestoreAdvanced Neurostimulator; RestoreAdvanced SureScan MRI Neurostimulator; RestorePrime Neurostimulator; RestoreSensor Neurostimulator; RestoreSensor SureScan MRI Neurostimulator; RestoreUltra Neurostimulator; RestoreUltra SureScan MRI Neurostimulator; Resume II Lead; Resume TL Lead; Reveal DX ICM; Reveal LINQ; Reveal LINQ™ Insertion Tools; Reveal Patient Assistant; Reveal XT ICM; Reveal XT Patient Assistant; Revo MRI SureScan; Riptide™ Large Bore Aspiration Tubing; Robotic Graft Delivery Instruments; SCREWDRIVER; SELECT; SELECTSECURE; SFS Stapler; SILS; SILS Articulating Hand Instruments; STAT Tack; SURGICAL DRIVE SYSTEM; SURGINEEDLE; SURGIPORT; SURGIWAND; Secura DR; Secura VR; Select 3D; SelectSecure MRI SureScan; SenSight™; Sensia DR IPG; Sensia IPG; Serena CRT-P MRI SureScan; Serena Quad CRT-P MRI SureScan; Service Kit; Signature; Signet; Signia Stapler; Sizing Sleeve; Solara CRT-P MRI SureScan; Solara Quad CRT-P MRI SureScan; Solitaire Platinum Revascularization Device; Solitaire X Revascularization Device; Solitaire™ Platinum Revascularization Device; Sonicision 26cm dissector (SCD26); Sonicision 28 cm dissector (SCD48); Sonicision™ Battery Charger, CBCA; Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 13 cm, SCDA13; Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 26 cm, SCDA26; Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 39 cm, SCDA39; Sonicision™ Curved Jaw Cordless Ultrasonic Dissector 5 mm – 48 cm, SCDA48; Sonicision™ Reusable Battery Insertion Guide, SCBIGA; Sonicision™ Reusable Battery Pack, SCBA; Sonicision™ Reusable Generator, SCGAA; Soveriegn Spinal System; Spacekeeper; Specify Lead; Specify SureScan MRI Lead; Sphera DR MRI; Sphera L DR MRI; Sphera SR MRI; Sprint Quattro Lead; Sprint Quattro MRI SureScan Lead; Sprint Quattro Secure Lead; Sprint Quattro Secure MRI SureScan Lead; Sprint Quattro Secure S Lead; Sprint Quattro Secure S MRI SureScan Lead; Sterile Plastic Sleeve; StimLoc; Straight Tip Radiance Illumination System; Stretch Coil Extension; Subcutaneous Lead; Suction Coagulators; SureFix; SurgiTie; Surgiclip""; Symmetrix™ L Spinal System; Syncra CRT-P; Synergy EZ Programmer; Tacker System; Talent Occluder with Occluder Delivery System; Tissue Approximating Forceps; Titan Anchor; Topical Tissue Adhesive; Transvene Lead; Transvene SVC Lead; Tri-Staple™ 2 Intelligent Cartridges; Tri-staple 2 Reinforced Reload; Tunneling Tool; Upsizing Sleeve; V-Loc; V-Loc Reloads; VERSAPORT; VERSASEAL; Valiant Thoracic Stent Graft System; Valleylab Ball Electrode; Valleylab Ball Electrode, 5 mm, E1550; Valleylab Ball Electrode, 6.5"" (16.51 cm), E1551-6NSB; Valleylab Ball Electrode, Reusable, 3.2 mm, E1000; Valleylab Ball Electrode, Reusable, 5.6 mm, E1002; Valleylab Blade Electrode; Valleylab Fine -Needle Electrode, Reusable, 2.6"" (6.6 cm),E1003; Valleylab Hex-locking Blade Electrode, 2.4"" (6.2 cm),E1551XNSB; Valleylab Needle Electrode; Valleylab Needle Electrode, 2.8"" (7.2 cm), E1552; Valleylab Needle Electrode, 2.8"" (7.2 cm), E1552NSB; Valleylab Smoke Evacuation Pencil, Sterile, CVPLP2000; Valleylab Straight Extension; Valleylab Straight Extension, 13 cm, E1502; Valleylab Straight Extension, 34.3 cm, E1504; Valleylab Tungsten Loop Electrode, Reusable, 9.5 mm,E1005; Valleylab™ Active Adapter, E0005-3C; Valleylab™ Angled Micro-Needle Electrode, 45 degree, 1 cm from tip, 3 cm, E1653; Valleylab™ Angled Micro-Needle Electrode, 45 degree, 3 mm from tip, 3 cm, E1652; Valleylab™ Button Switch Pencil Holster, E2516H, E2516HGNSB, and E2516HNSB; Valleylab™ Button Switch Pencil Needle Electrode, Holster, E2516HDA; Valleylab™ Button Switch Pencil, E2516, E2516GNSB, and E2516NSB; Valleylab™ Insulated Micro-Needle Electrode, 9 cm, E1654B; Valleylab™ Monopolar Adapter , E0502-1; Valleylab™ Monopolar Cord 10' (3 m), E0503; Valleylab™ Non-REM Polyhesive™ Patient Return Electrode, E7506; Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7508; Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, E7507; Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, E7507DB; Valleylab™ REM™ Patient Return Electrode Adapter, E0600; Valleylab™ Rocker Switch Pencil Holster, E2515H, E2515HDB, E2515HDBNSB, E2515HGNSB, and E2515HNSB; Valleylab™ Rocker Switch Pencil Needle Electrode, Holster, E2515HDA and E2515HDANSB; Valleylab™ Rocker Switch Pencil, E2515, E2515NSB, and E2515GNSB; Valleylab™ Straight Micro-Needle Electrode, 2 cm, E1650; Valleylab™ Straight Micro-Needle Electrode, 3 cm, E1651; Valleylab™ Universal Monopolar Adapter, E0017; Valleylab™ monopolar cord; Vanta™ with AdaptiveStim™ Implantable Neurostimulator; Vectris SureScan Lead; Verify Controller; Verify Evaluation System; Verify External Neurostimulator; Versa DR IPG; VersaOne™ Bladed and Bladeless Trocars; VersaOne™ Bladeless and Optical 15mm; Versaport Bladeless; Versaport Bladeless Optical Trocar; Versaport RPF; Versaport V2 Bladeless Optical Trocar; Versastep; Versastep V2; Virtuoso II DR/VR ICD; Visia AF MRI S VR SureScan; Visia AF MRI VR SureScan; Visia AF VR; Visiport; Vitatron Crystalline Lead; Vitatron Excellence PS+ Lead; Viva; Viva CRT-P; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D; WRENCH; Wave O Spinal System; myStim Programmer; spinal system; stylet kit",1992-12-12,164,2026-07-14,33,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009380063%22&limit=1
Merit Medical Australia Pty Ltd.,3033589330,3033589330,53 Canterbury Road,Braiside Victoria,,3195,Australia,"Merit Medical Systems, Inc.",1721504,Exporter to the US,129,BWN; BZN; CCX; DQF; DQO; DQX; DQY; DRA; DRB; DRC; DRE; DRS; DSK; DSY; DTE; DTL; DWM; DWO; DWS; DWZ; DXC; DXE; DXG; DXN; DXT; DYB; ESW; EXF; FAD; FAJ; FCG; FCY; FDY; FED; FGE; FJS; FKO; FKX; FMF; FMG; FPA; FPK; FQM; FZX; GAA; GAH; GAX; GBW; GBX; GCB; GCC; GDF; GEA; GEH; GEI; GES; GXI; HCG; HRX; HTW; HXG; JAQ; JCT; JDZ; JKA; JOL; JRL; KCY; KDC; KDD; KDQ; KGS; KGX; KGZ; KIH; KME; KMK; KNQ; KNS; KNW; KRA; KRB; KRD; KTI; KYZ; KZD; LDF; LJS; LOD; LXH; LYV; MAV; MDM; MHW; MMX; MSD; NDN; NEU; NOY; NWU; OAR; OCX; OCY; ODE; ODY; OEQ; OEX; OEZ; OJA; OJV; OMT; OWL; OYI; PEV; PFV; PNG; PPD; PTL; PTM; PUR; PXI; PXU; PYB; PYC; QBP; QEY; QEZ; QJH; QSY,"Table And Attachments, Operating-Room; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Support, Patient Position; Actuator, Syringe, Injector Type; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Stylet, Catheter; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Transducer, Blood-Pressure, Extravascular; Computer, Blood-Pressure; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Pulse-Generator, Pacemaker, External; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Apparatus, Suction, Patient Care; Needle, Biopsy, Cardiovascular; Instruments, Surgical, Cardiovascular; Device, Biopsy, Endomyocardial; Clamp, Vascular; Catheter, Embolectomy; Computer, Diagnostic, Pre-Programmed, Single-Function; System, Measurement, Blood-Pressure, Non-Invasive; Injector And Syringe, Angiographic; Introducer, Catheter; Prosthesis, Esophageal; Bag, Bile Collecting; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Biopsy Needle; Bulb, Inflation, For Endoscope; Device, Measuring, For Panendoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Stents, Drains And Dilators For The Biliary Ducts; Catheter, Peritoneal, Long-Term Indwelling; Catheter, Peritoneal Dialysis, Single Use; System, Peritoneal, Automatic Delivery; Syringe, Piston; Stopcock, I.V. Set; Set, Administration, Intravascular; Tubing, Fluid Delivery; Bandage, Elastic; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Stylet, Surgical, General & Plastic Surgery; Tourniquet, Nonpneumatic; Catheter, Peritoneal; Catheter, Irrigation; Needle, Catheter; Dilator, Catheter; Guide, Needle, Surgical; Cannula, Surgical, General & Plastic Surgery; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Scalpel; Probe, Radiofrequency Lesion; Device, Neurovascular Embolization; Arthroscope; Bit, Drill; Tamp; System, Applicator, Radionuclide, Remote-Controlled; Prosthesis, Tracheal, Expandable; Mixer, Cement, For Clinical Use; Tubes, Vials, Systems, Serum Separators, Blood Collection; Catheter And Tip, Suction; Unit, Filter, Membrane; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Dispenser, Cement; Bedding, Disposable, Medical; Device, Intravascular Catheter Securement; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Instrument, Biopsy; Catheter, Continuous Flush; Probe, Thermodilution; Device, Vascular, For Promoting Embolization; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Electrode, Pacemaker, Temporary; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Bone Cement; Orthopedic Manual Surgical Instrument; Label Or Tag, Sterile; Syringe, Balloon Inflation; Instrument, Manual, Surgical, General Use; Dressing, Compression; Device, Percutaneous Retrieval; Catheter, Hemodialysis, Implanted; Cement, Bone, Vertebroplasty; Marker, Radiographic, Implantable; Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia; Endoscope Introducer Kit; Injector, Vertebroplasty (Does Not Contain Cement); Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd); Tunneled Catheter Remover; Angiography/Angioplasty Kit; Cardiovascular Catheter Sheath Introducer Kit; Cardiovascular Procedure Kit; Intravenous Extension Tubing Set; Single Use Instrument Tray; Absorbable Lung Biopsy Plug; Peripheral Catheter Insertion Kit; Non-Bronchoscopic Bronchoalveolar Lavage Catheter; Dialysis Administration Kit; System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Universal Drainage Tray; Wire, Guide, Catheter, Exempt; Syringe, Balloon Inflation, Exempt; Vacuum Syringe; Thoracentesis Tray; Fluid Drainage Tray; Minor Surgical Procedures Tray; Paracentesis Tray; Cap, Device Disinfectant; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter; Reverse Central Venous Recanalization System; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; 3; U,"1 mL syringe(Polypropylene); 10Fore Hemostasis Valve; 10Fore Hemostasis Valve Kit; 5.5 F Worley Advanced LVI Lateral Vein Introducer; AEROmini Tracheobronchial Stent System; ARC Catheter; ASAP Aspiration Catheter; ASAP Catheter; ASAPLP Aspiration Catheter; ASAPLP Embolectomy Catheter; Access-9; AccessPLUS; Achieve; Activation Element, ERx bone cement; Acutiy Universal Cutter; Adjustable Biopsy Port Seal BPS-A; Advance Angiographic Needle; Aero DV Tracheobronchial Stent System; Aero Tracheo Stent and Delivery System; Aerosizer; Alimaxx E; Arcadia Balloon Catheter; Arcadia Balloon Catheter Kit; Aspira Peritoneal Drainage System; Aspira Pleural Drainage System; BIG60; BIG60 ALPHA Inflation Devie; BRC-BAL-INT-FL/A; BackStop Plus Closed Waste Basin; Bath Probe; Bedford™ Guided Hard Bone Biopsy System; BioFlo Duramax; BioSentry Tract Sealant System; Blue Diamond Inflation Syringe; BowTie Guide Wire Insertion Device; Brochoalveloar Lavage (BAL) Custom Convenience Kit; Bulldog Lead Extender; C2 Cryoballoon Ablation System; C2 Cryoballoon Endogrip; CT Transfer Set; CardiaGuide Fixed Curve Braided Transseptal Sheath; Cardiac Output Kit; Catheter Connection Cable; Catheter Connection Cables and Cardia Computer; Cen-Step Centesis Catheter; Centros Long-Term Hemodialysis Catheter; CentrosFLO Long-Term Hemodialysis Catheter; Check Valve; ClariVein IC Infusion Catheter; Coil Expander; Concierge Guiding Catheter; Connecta PE Lines; Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI); Coronary Control Syringe; Corvocet Biopsy System; Corvocet Coaxial Introducer; Critiflo; Critiflo Dome; Critikit Plus In-Line Room/ Ice Injectate; Cuff Implantor; Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; DTX Disposable Temperature Probe; DTX Plus Disposable Pressure Transducer; DTX/DTX Plus Kit and Accessories; Dark Blue Cap for Male Luers; Dash 9F Hydrophilic Sheath Introducer; DiamondTOUCH Inflation Device and Fluid Dispensing Syringe; DiamondTOUCH Syringe; Disposable In Line Sensor Housing; DoublePlay Hemostasis Valve; Drainage Tubing; DriPAD Super Absorbent Pad; DualCap; DualCap Duo; DualCap IV Pole Strips; DualCap Solo; DuraFlow 2 Hemodialysis Catheter; Duramax; EN Snare Endovascular Snare System; ER2 Saturate Mixing System; Elation Fixed Wire Balloon; Elation Pulmonary Balloon; Elation Pulmonary Balloon 4mm; Elation Wireguided Balloon; Elation5 Fixed Wire Balloon; Elation5 Wireguided Balloon; Embedding Tool; EmboGold Microspheres; Emboshpere PRO; Embosphere Microspheres; EndoMAXX; EsophyX Z+ Device; EvenMore Chronic Hemodialysis Catheter; Excite Contrast Injection Line; ExxTended Catheter; FLO30; FLO40XR; FLO50; Faller Trocar; FastBreak Connector; Finale Radial Compression System; Flex-Neck Catheter; Flex-Neck Extender/Repair Kit; Flex-Neck Infant Catheter; FlowGuard; Fluid Dispensing Syringe; Fountain 4F Catheter & Occluding GW; Fountain Catheter/Occluding Guide Wire; Fountain Infusion Catheter w/ Occluding Guide Wire; Fountain Infusion System; Fountain ValveTip Infusion Catheter; Futura Safety Scalpel; Go2Wire Guide Wire; Guidewire with Palladium Tip; H20 Guidewire; H20 Torque Device; HeRO Graft; HeartLight Deflectable Sheath; HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al.; HeartSpan Steerable Introducer Sheath; HeartSpan Steerable Sheath Introducer; Hemostasis Valve Adapter; Honor hemostasis valve; Huntington Guided, Perforating Bone Biospy System with Drill; Hydraulic Assembly; Hydraulic-Master Syringe Assembly; Hydrophilic Guidewire; Hydrophilic Prelude SNAP Splittable Sheath Introducer; Impress Angiographic Catheter; Impress UAC Catheter; Impress and Impress Legato Hydrophilic Angiographic Catheter; Impress with Legato Hydrophilic Coating; InQwire; InQwire Amplatz Super Stiff Guide Wire; InQwire Diagnostic (Support) Non-Vascular Guide Wire; InQwire Guidewires; Injectate Sensor Cable; Insufflation Set; Integral Injectate Temperature Probe; Intellisystem Inflation Device; Introducer Needle WithTrocar Stylet; K01 Kit (MSS); K01 Syringe Kit (1mL & 20mL COP); K01 Syringe Kit (1mL Polypropylene); K02 Syringe Kit (multiple K01); K02 Syringe Kit (multiple K01)); K02-00873A, K02-01105A, K02-01481A; K04 - Tubing Kit; K05 Inflation Kit; K05T - Inflation Kit; K06 Syringe Kit (single CSS); K07 Syringe Kit (multiple K06); K08 Fluid Management Kit; K09 Manifold Kit; K09T - Manifold Kit; K10 Waste Management Kit; K10T - Waste Management Kit; K11 Pressure Monitoring Kit; K12 Procedure Kit; K12T - Procedure Kit; K13 Label Kit; K14 Dialysis Kit; K15 Sheath Introducer Kit; K16 Microcatheter Kit; K17 Interventional Kit; K17T - Interventional Kit; K18 Sheath Introducer Kit (Ease); K19 Combination Packs; K20 Endoscopic Kit; K20T - Endoscopic Kit; K21 Sheath Introducer Kit (IDeal); K22C Vein Tray; K23C Vein Accessory Kit; KYPHON KyphoFlex Balloon Catheter; KYPHON KyphoFlex Balloon Catheter Kit; Kensington Guide Wire Bone Biopsy System; Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411); Lead Clippers; Liberator Beacon Tip Locking Stylet; Low Profile Companion Sheath; MAK-NV Non-Vascular; MBA; MYSHELL Hemostatic Valve; Madison Mini™ Bone Biopsy System; Madison™ Perforating Bone Biopsy System with Drill; Maestro Microcatheter; Majestik Angiographic Needle; Master Syringe Assembly; Maxxwire; Medallion Syringe; Merit 1mL Syringe (COP); Merit 20 mL Syringe (COP); Merit Administration Set; Merit Centros Long-Term Hemodialysis Catehter; Merit CentrosFLO Long-Term Hemodialysis Catheter; Merit Convenience Kits; Merit Disposal Depot; Merit Drainage Depot; Merit HeRO Graft; Merit High Pressure Tubing; Merit Hydrophilic Guide Wire; Merit InQwire® Amplatz Super Stiff Guide Wire; Merit MAK (Mini Access Kit); Merit Manifold; Merit Marquis Flow Switch; Merit Marquis Stopcock; Merit PAK; Merit Pressure Monitoring Tubing; Merit Pursue Microcatheter; Merit S-MAK (Stiffened Mini Access Kit); Merit Safety Needle; Merit Syringe; Merit Triboglide Syringe; Meritrans Disposable Transducer; MetaSTAR RF Generator; Micro Ace Advanced Micro Access System; Micro Ace Gold Advanced Micro Access System; Micro Plug Set; Mighty Wire; MiniStop Filter Closed Waste Basin; MiniStop Plus Closed Waste Basin; Miser Contrast Management System; Monarch Compak Inflation Syringe; Monarch Syringe Fluid Dispense System; MultiPlex II Controller; Needle's Eye Snare Retrieval Set; NeoVasc; Non-vascular tissue dilators; Novatome Endomyocardial Biopsy Forceps; One Snare Endovascular Snare System ONE1501; One-Step Centesis Catheter; One-Tie Compression Coil; One-Vac Evacuated Drainage Bottle; OneSnare Endovascular Snare System; Osseoflex Access Kit; Osseoflex CD-H Hydraulic Cement Delivery System; Osseoflex SB Steerable Balloon (10Ga); Osseoflex SB Steerable Balloon (8ga); Osseoflex SB Straight Balloon (10ga); Osseoflex SB Straight Balloon (8ga); Osseoflex SN; Osseoflex SN Needle; Osseoflex SN+ Needle; Osseoflex Straight Hand Drill; Osseon Bone Filler Device (BFD); Ostial Pro Stent Positioning System; OuTake Catheter Extractor; PAL (Pen and Labels) Family; Passage Hemostasis Valve; Perchik Button Assembly; Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M); Performa Diagnostic Intravascular Catheter; Pericardiocentesis Catheter Kit; Peritoneal Dialysis Catheter Connector; Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211); PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing; Pin Vise Polymer; PinVise Torque Device; Pink Achieve; Pinvise Torque Device; PowerCURVE Navigating Osteotome; Prelude Choice Hemostasis Valve Adapter; Prelude IDeal Hydrophilic Sheath Introducer; Prelude Plastic Jacketed Guide Wire; Prelude Prestige Splittable Sheath Introducer; Prelude SNAP 165 Valved Splittable Sheath Introducer; Prelude SNAP Splittable Sheath Introducer; Prelude Sheath Half Size (ACT); Prelude Sheath Introducer; Prelude Short Sheath Introducer; Prelude Wave Hydrophilic Sheath Introducer; PreludeEASE Hydrophilic Sheath Introducer, 4F-6F; PreludeEASE Hydrophilic Sheath Introducer, 7F; PreludeSYNC DISTAL Radial Compression Device; PreludeSYNC EVO Radial Compression Device; PreludeSYNC EZ Radial Compression Device; Pressure Infusor Bags (PIB); Pressure Tubing; Preston Bone Filler; Preston™ Hard Bone Access Needle with Drill; Preston™ Hard Bone Introducer; Preston™ Long Drill; Preston™ Transpedicular Drill; Preston™ Transpedicular Introducer; ProGuide Long Term Hemodialysis Catheter; Purge Assist; QuadraSphere Microspheres; QuadraSphere Q2 Microspheres; Quick Silver; RADstat Radial Artery Compression Device; ROSE; RTT14038MB; RXP (Rapid Exchange Flushing Syringe); Rad Board; Rad Board 2 Reusable Arm Board; Rad Board Xtra; Rad Rest; Rad Trac; ReSolve Biliary Locking Drainage Catheter; ReSolve ConvertX Biliary Stent System; ReSolve ConvertX Nephroureteral Stent System; ReSolve Dilators; ReSolve Locking Drainage Catheter; ReSolve Non-Locking Drainage Catheter; Repositional Chest Tube; Resilience Fully Covered Esophageal Stent System; Revolution Catheter Securement Dev.; Roadster Guide Sheath; Rotating Adaptor; S-MAK; S-MAK XL; SAVI Applicator Kit; SAVI Prep Device; SAVI Spacer; SCOUT Bx Delivery System; SCOUT Console and Accessory Cart; SCOUT MD Console; SCOUT MD Delivery System; SCOUT MD Guides; SCOUT MD Single-Use Handpieces; SCOUT MD Single-use Handpieces; SCOUT Reflector and Delivery Systems; SCOUT Single-Use Handpiece, SCOUT Surgical Guides; SCOUT Surgical Console and SCOUT Check Console; SPINR High-Performance Guidewire Catheter; STAR Tumor Ablation Kit and Accessories; STAR Tumor Ablation Kit with PowerCURVE; STATSEAL; SafT Needle Direct Blood Transfer; SafeGuard Focus Compression Device; SafeGuard Focus Compression Device (Adhesive Free); SafeGuard Focus Cool Device; SafeGuard Focus Cool Device (Adhesive Free); SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al.; SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al.; SafeSheath Sealing Adapter; Safedraw Blood Sampling System; Safeguard Pressure Assisted Device (12cm); Safeguard Pressure Assisted Dressing (24cm); Safeguard Radial Compression Device; Safety Paracentesis Tray (SPPT); SeaDragon Torque Device; ShortStop Advantage Temporary Sharps Holder; ShortStop Grandstand Temporary Sharps Holder; ShortStop Temporary Sharps Holder; Sidecar External Working Channel (FG-1011); Siege Vascular Plug; Slip-Not; Smart Tip Control Syringe; Sof-Grip Hemostat; Softouch Diag. Intra Cath. w/Vessel; Solo Pace Control; Solo Pace Fusion System (SOLOFUSE1); Spectraject Control Syringe; Spectranetics; SpineSTAR Ablation Instruments; Squirt Fluid Delivery System; StabiliT Bone Cement and Saturate Mixing System; StabiliT Cement Delivery Syringe; StabiliT ER2 Bone Cement and Saturate Mixing System; StabiliT Introducer and Delivery Instruments; StabiliT MX Fracture Kits; StabiliT MX Fracture Kits with PowerCURVE; StabiliT VP Fracture Kits; StabiliT VP Vertebrosplasty Kit; StayFix Fixation Device; Sterilized Convenience Kits; Stopcock One Port Manifold; Straightline Osteotome, VerteCOR Midline Osteotome; Stylet Wire; Stylette (rod obturator); SureCross Support Catheter; Surfacer Inside-Out Access Catheter System; SwiftNINJA Microcatheter; SwiftNINJA Steerable Microcatheter; TRAM; TRAM-P; Temno ACT; Temno Elite Biopsy Systems; Temno Evolution; Temno Original; Thoracentesis Tray (TAPS); Torpedo Gelatin Foam; Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al.; TruCut 14Ga; TruCut 18Ga; True Form Reshapable Guide Wire; Tubing, Fluid Delivery; Universal Coaxial Needles; VACLOK Syringe; VacLok AT Syringe; Valve Adapter; Ventrax Delivery System; VertecoR Bone Drill, 3; Vessel Dilator; Vessel Sizing Catheter (VSC); ViaVerte RF Generator; ViaVerte Steerable RF Ablation Kit; WOUNDSEAL; Westbrook™ Bone Biopsy System; Worley; Wrapsody Cell-Impermeable Endoprosthesis; X-Change Cement Dispensing Syringe; basixCompak Analog Inflation Syringe; basixSKY Inflation Device; basixTOUCH; basixTOUCH40 Inflation Syringe",1992-07-14,196,2026-02-13,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223033589330%22&limit=1
Jersey Dental Supplies,3012187973,3012187973,1095 Towbin Ave,Lakewood,NJ,08701,United States,Jersey Dental Supplies,10050503,Repackager or relabeler; Reprocessor,52,BYG; DYH; DZE; DZN; DZS; EBC; EBD; EBF; EBG; EBH; EBI; EBZ; EFB; EHD; EHJ; EHL; EID; EIG; EIH; EJJ; EJK; EJR; EKQ; ELC; ELR; ELW; ELY; ELZ; EMA; EMB; FOZ; FPA; FXX; IWZ; JEP; JES; JKA; KGX; KIF; KJJ; KLE; KMF; KOQ; KXR; LBH; LMF; LRJ; MUH; MVL; MZW; NHA; OIV,"Mask, Oxygen; Adhesive, Bracket And Tooth Conditioner, Resin; Implant, Endosseous, Root-Form; Instruments, Dental Hand; Capsule, Dental, Amalgam; Sealant, Pit And Fissure, And Conditioner; Coating, Filling Material, Resin; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Material, Impression Tray, Resin; Resin, Denture, Relining, Repairing, Rebasing; Activator, Ultraviolet, For Polymerization; Handpiece, Air-Powered, Dental; Unit, X-Ray, Extraoral With Timer; Disk, Abrasive; Point, Abrasive; Syringe, Restorative And Impression Material; Retractor, All Types; Powder, Porcelain; Alloy, Amalgam; Liner, Cavity, Calcium Hydroxide; Agent, Polishing, Abrasive, Oral Cavity; Preparer, Root Canal Endodontic; Scaler, Ultrasonic; Post, Root Canal; Material, Impression; Mercury; Crown, Preformed; Cement, Dental; Zinc Oxide Eugenol; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Mask, Surgical; Film, Radiographic; Retainer, Matrix; Floss, Dental; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tape And Bandage, Adhesive; Resin, Root Canal Filling; Cleanser, Root Canal; Agent, Tooth Bonding, Resin; Bandage, Liquid; Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&); Applicator, Resin; Varnish, Cavity; Agent, Absorbable Hemostatic, Collagen Based; Disinfectant, Medical Devices; System, X-Ray, Extraoral Source, Digital; Cord, Retraction; Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief; Abutment, Implant, Dental, Endosseous; Dental Amalgam",1; 2; 3; U,"3 Dynamic TiBase; 3M CLINPRO SEALANT; 3M DENT II SYSTEM; 3M DENT SYSTEM; 3M LVR SYSTEM; 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95; 3M Protemp Cement Temporary Dental Cement; 3M RESIN CEMENT; 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE; 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM; ACRYPOINT; BROWNIE; BURBUTLER ALL CERAMIC ABRASIVE KIT; BURBUTLER CADMASTER KIT; CERAMASTER; CERAMISTE; CERAMISTE SOFT;; ADHESE UNIVERSAL; ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN; ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (40-100&); ADPER PROMPT, ADPER PROMPT L-POP; AFFINIS; HydroXtreme; Jet Bite; President Jet light / regular body; President Plus; President Plus Jet; AGENT, TOOTH BONDING, RESIN; AH PLUS ROOT CANAL SEALER; AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL; AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL; AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL; Admira Fusion X-Base; Adseal; Apexit Root Canal Sealer; Aquasil Ultra + Smart Wetting Impression Material; Automix; BEAUTIFIL FLOW PLUS; BEAUTIFIL II; BEAUTISEALANT; BIFIX QM; BLUEPHASE STYLE; BeautiBond; Black Mini Brush Tips; Inspiral Brush Tips; Opal Red Tips; Opal Seal Tips; CALIBRA CEMENT; CAULK DYCAL LIGHT CURED; CEMENT, DENTAL; CERASMART; CHARISMA -- MODIFIED; CLEARFIL PHOTO BOND; CLEARFIL SE BOND; CLEARFIL TRI-S BOND PLUS; COE COMFORT; COE PAK AUTO MIX, REGULAR OR HARD SET; COE SOFT; COMPOSITE 168 RESTORATIVE SYSTEM; COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE; COSP2; CROWN, PREFORMED; DENTAL COMPOSITE RESTORATIVE; DENTSPLY CAVITRON SPS SCALER SYSTEM; DEXIS SENSOR; DIMENSION PENTA H, DIMENSION PENTA H QUICK; DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE; DMC COMPOSITE 2; DSI Dental Implant System; DSI Impression Tray Cleaner Powder; Dispersalloy Capsules; Dyract Flow Restorative; EDTA 18% Solution; ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING; ENAMEL AND PORCELAIN ETCH PRODUCT LINE; ENAMIC; EQUIA; EXTRUDE; Emiluma; ULTRADENT LC BLOCK-OUT RESIN; FILM, RADIOGRAPHIC; FILTEK BULK FILL FLOWABLE RESTORATIVE; FILTEK BULK FILL POSTERIOR RESTROATIVE; FLEXTIME; FLOWABLE COMPOSITE; FUJI DUET; FUJI I; FUJI II LC CAPSULE; FUJI IX GP; FUJI VII CAPSULE; FUTURABOND DC/SINGLE DOSE; FUTURABOND M+; G-BOND; G-Premio BOND; G-aenial; GC FUJI IX GP EXTRA; GC FUJI LINING LC PASTE PAK; GC FUJI ORTHO BAND PASTE REFILL; GC FUJICEM; GC MI PASTE PLUS; GC PATTERN RESIN; GC RELINE; GC XLC-100 CAPSULE; GLASIONOMER BASE CEMENT; GLUMA COMFORT BOND; GLUMA DESENSITIZER/GLUMA 3 PRIMER; Gradia Plus; GrandioSO x-tra; HELIOBOND; HELIOMOLAR(R) DENTAL RESTORATIVE; HELIOSEAL; HERCULITE ULTRA; HERCULITE XR & XRV; HYDROGUM 5; IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF; IMPREGUM F; IMPREGUM F ADHESIVE; IMPREGUM GARANT L DUOSOFT; IMPREGUM PENTA; IMPRESSION COMPOUND; IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL; INTEGRITY; IPS E.MAX CAD/IPS E.MAX ZIRCAD; IPS EMPRESS; IPS EMPRESS 2; IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE; Impregum Soft; Impregum Soft Quick Step; KAVO SPRAY; KERR VPS IMPRESSION MATERIAL; KETAC-CEM MAXICAP; KOOLINER II; Ketac Fil Plus Aplicap; LCR; LUXATEMP AUTOMIX; MATERIAL, TOOTH SHADE, RESIN; METAMORPHOSIS; METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING; METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING; MI PASTE; MIRACLE MIX POWDER/LIQUID; MONOBOND PLUS; MULTILINK AUTOMIX; Material, Impression; NEOCOLLOID, ORTHOPRINT; NEW STETIC DENTAL AMALGAM ALLOY; NEXCOMP AND META ETCHANT; NEXUS 3; NEXUS RMGI; NOMAD PRO X-RAY SYSTEM; NUPRO PROPHY PASTE; OPALDAM; OPTIBOND ALL-IN-ONE; OPTRAGATE; One Coat 7 Universal; One Coat 7 Universal, One Coat 7, One Coat 7 Activator; PERMLASTIC 2; POINT 4 MODIFIED; POSITION PENTA, POSITION PENTA QUICK; POST, ROOT CANAL; PREMISE FLOWABLE MODIFIED; PREPARER, ROOT CANAL ENDODONTIC; PRESIDENT TRAY; PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM; Palodent; Penta Elastomer; Protemp Plus; Temp XN28; RELY X CERAMIC PRIMER; RELYX RMGIP; RESIN, DENTURE, RELINING, REPAIRING, REBASING; REVOLUTION FORMULA 2; Regisil; Reprosil; Tray Adhesive; Riva Silver; Root Canal Filling Resin; SCOTCHBOND MULTI-PURPOSE- ADHESIVE; SILANE PRIMER; STRUCTUR 2; SUGLUE-10; SURGIFLO Hemostatic Matrix; SURGIFOAM Absorbable Gelatin Powder; SURGIFOAM Absorbable Gelatin Sponge; SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL; Sealapex Tubes, Sealapex Bulk Package, Sealapex Xpress Dual-Barrel Syringes; TELIO CS INLAY & TELIO CS ONLAY; TEMP BOND NE; TEMP-BOND NE 2; TEMPBOND CLEAR WITH TRICLOSAN; TEMPBOND CLEAR-2; TEMPORARY DENTAL CEMENT; TETRIC EVOCERAM BULK FILL; TETRIC FLOW; TORPICALGIN; TYTIN; Take 1 Advanced; Tooth Shade Resin Material; Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress; ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE; ULTRACAL XS; ULTRADENT PORCELAIN ETCH; UNICEM HM; UNIFAST LC; UltraPak; UltraPak Kit; UltraSeal XT hydro; VALO Cordless; VALO Cordless Accessory(Battery Charger,Rechargeable Batteries,Light Shield,Bracket Holder,Charging Unit; VINYL POLYSILOXANE IMPRESSION MATERIAL; VOCO PROFLUORID VARNISH; Variolink Esthetic; Varnish, Cavity; Venus Diamond Flow; ViscoStat Clear; ZETAPLUS SOFT; ZINC OXIDE EUGENOL",2016-07-21,195,2026-04-10,1,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012187973%22&limit=1
Depuy Orthopaedics,3004464325,3004464325,50 Scotland BLVD.,Bridgewater,MA,02324,United States,"DePuy Synthes, Inc.",1818910,Manufacturer; Manufacturer for export; Repackager or relabeler,154,BTA; BZN; DZI; DZJ; DZL; ERL; ETN; EZX; FCW; FDG; FMF; FQH; FQP; FSM; FSQ; FTL; FTM; FTY; FZO; FZT; FZX; FZY; GAA; GAB; GAC; GAD; GBX; GCJ; GDG; GDI; GDX; GDZ; GEA; GEF; GEG; GEI; GEY; GFA; GFC; GFF; GFG; GFI; GFJ; GWO; GXP; GXQ; GXR; GXZ; GZT; HAW; HAX; HBB; HBE; HBW; HCF; HDB; HRS; HRX; HSB; HST; HSZ; HTC; HTD; HTE; HTF; HTJ; HTN; HTO; HTQ; HTR; HTS; HTT; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWE; HWJ; HWK; HWM; HWN; HWR; HWT; HWW; HWX; HXB; HXC; HXD; HXG; HXL; HXP; HXQ; HXW; HXX; HXZ; HYA; IPM; JDQ; JDR; JDS; JDW; JEB; JEC; JEY; JOL; JTQ; KCT; KDD; KIH; KIK; KQM; KTT; KTW; KTZ; KWI; KWP; KWQ; LOD; LRN; LRW; LRY; LXH; LXT; LYC; LYS; MAX; MDM; MNH; MNI; MOQ; MQN; MQP; MQV; NBH; NDN; NJL; NKB; NKG; ODP; OIS; OLO; OSH; OSN; OWY; OXB; OXE; OXH; PAJ; PDQ; PGM; PKC,"Pump, Portable, Aspiration (Manual Or Powered); Cart, Emergency, Cardiopulmonary (Excluding Equipment); Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Screw, Fixation, Intraosseous; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Stimulator, Nerve; Mesh, Surgical, Metal; Light Source, Fiberoptic, Routine; Retractor, Fiberoptic; Syringe, Piston; Lavage, Jet; Lamp, Operating-Room; Tray, Surgical, Instrument; Light, Surgical, Instrument; Mesh, Surgical, Polymeric; Mesh, Surgical; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Catheter, Irrigation; Laparoscope, General & Plastic Surgery; Hook, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Scalpel, One-Piece; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Applier, Staple, Surgical,; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Driver, Surgical, Pin; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Plate, Cranioplasty, Preformed, Alterable; Methyl Methacrylate For Cranioplasty; Dura Substitute; Cover, Burr Hole; Electrode, Needle; Retractor, Self-Retaining, For Neurosurgery; Neurological Stereotaxic Instrument; Tong, Skull For Traction; Motor, Drill, Pneumatic; Drills, Burrs, Trephines & Accessories (Simple, Powered); Fastener, Plate, Cranioplasty; Instrument, Ligature Passing And Knot Tying; Extractor, Vacuum, Fetal; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Apparatus, Traction, Non-Powered; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Knife, Orthopedic; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Instrument, Compression; Driver, Prosthesis; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Tamp; Mallet; Instrument, Bending Or Contouring; Crimper, Pin; Bender; Screwdriver; Cutter, Wire; Forceps, Wire Holding; Cover, Limb; Cerclage, Fixation; Staple, Fixation, Bone; Nail, Fixation, Bone; Pin, Fixation, Threaded; Table, Surgical With Orthopedic Accessories, Manual; Component, Traction, Invasive; Plate, Bone; Catheter And Tip, Suction; Bath, Incubators/Water, All; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Dispenser, Cement; Hook, Bone; Camera, Surgical And Accessories; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Caliper; Prosthesis, Elbow, Hemi-, Radial, Polymer; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Bone Cement; Wire, Surgical; Scissors, General, Surgical; Punch, Surgical; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Bone Grafting Material, Synthetic; Bone Mill; Intervertebral Fusion Device With Bone Graft, Lumbar; Instrument, Manual, Surgical, General Use; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Battery, Replacement, Rechargeable; External Mandibular Fixator And/Or Distractor; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Intervertebral Fusion Device With Bone Graft, Cervical; Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Software For Diagnosis/Treatment; Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction; Mesh, Surgical, Collagen, Staple Line Reinforcement; Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery; Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed; Neurosurgical Nerve Locator; Growing Rod System; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained",1; 2; 3,"3.5mm Locking Attachment Plates; 6.5mm Midfoot Fusion Bolt; ACE MARKIII ASSEMBLY; ADJUSTABLE LARGE FIXATOR SYSTEM; ARICULATED TENSION DEVICE SYNTHES TEN; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 3; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 4; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 5; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 6; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 7; ATTUNE REVISION ASSEMBLY FEMORAL SHIM SIZE 8; ATTUNE REVISION BOSS AND STEM ADAPTOR TRIAL EXTRACTOR; ATTUNE REVISION FEMORAL IM ADAPTOR; ATTUNE REVISION FEMORAL STRAIGHT STEM WRENCH; ATTUNE REVISION RP BASE TRIAL SIZE 10; ATTUNE REVISION RP BASE TRIAL SIZE 2; ATTUNE REVISION RP BASE TRIAL SIZE 3; ATTUNE REVISION RP BASE TRIAL SIZE 4; ATTUNE REVISION RP BASE TRIAL SIZE 5; ATTUNE REVISION RP BASE TRIAL SIZE 6; ATTUNE REVISION RP BASE TRIAL SIZE 7; ATTUNE REVISION RP BASE TRIAL SIZE 8; ATTUNE REVISION RP BASE TRIAL SIZE 9; ATTUNE REVISION RP CONICAL REAMER; ATTUNE REVISION RP INSERT TRIAL SIZE 3 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 3 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 4 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 5 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 6 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 7 8MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 10MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 12MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 14MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 16MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 18MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 20MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 22MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 24MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 26MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 6MM; ATTUNE REVISION RP INSERT TRIAL SIZE 8 8MM; ATTUNE REVISION RP STEM ADAPTOR TRIAL; ATTUNE REVISION SOLID RP INSERTS SIZE 3-4 CASE; ATTUNE REVISION SOLID RP INSERTS SIZE 5-6 CASE; ATTUNE REVISION SOLID RP INSERTS SIZE 7-8 CASE; ATTUNE REVISION TIBIAL BASE TRIAL EXTRACTOR; ATTUNE REVISION TIBIAL BROACH 29MM; ATTUNE REVISION TIBIAL BROACH 37MM; ATTUNE REVISION TIBIAL BROACH 45MM; ATTUNE REVISION TIBIAL BROACH 53MM; ATTUNE REVISION TIBIAL BROACH 61MM; ATTUNE REVISION TIBIAL BROACH 69MM; ATTUNE REVISION TIBIAL BROACH CADDY; ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - ATTUNE SLEEVE WEDGE; ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - BASE ATTACHMENT; ATTUNE REVISION TIBIAL SLEEVE SEPARATOR - DRIVER; ATTUNE REVISION TIBIAL SLEEVE TRIAL 29MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 37MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 45MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 53MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 61MM; ATTUNE REVISION TIBIAL SLEEVE TRIAL 69MM; ATTUNE Revision CRS Rotating Platform Insert Size 3 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 3 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 4 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 5 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 6 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 7 8 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 10 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 12 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 14 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 16 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 18 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 20 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 22 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 24 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 26 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 6 mm; ATTUNE Revision CRS Rotating Platform Insert Size 8 8 mm; ATTUNE Revision Tibial Base Rotating Platform Size 10 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 2 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 3 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 4 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 5 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 6 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 7 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 8 Cemented; ATTUNE Revision Tibial Base Rotating Platform Size 9 Cemented; ATTUNE Revision Tibial Sleeve 29 mm Cemented; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 29 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 37 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 45 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 53 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 61 mm; ATTUNE Revision Tibial Sleeve Porocoat Fully Coated 69 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 29 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 37 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 45 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 53 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 61 mm; ATTUNE Revision Tibial Sleeve Porocoat Partially Coated 69 mm; ATTUNE® Revision Knee System; Accessories/Attachmnts to AC Powered Motors for Joint Recon; Akros Fibulink Syndesmosis Repair Kit; Akros Fibulink™ Syndesmosis Repair Kit; Attune; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL; Bengal; Bone Marrow Aspiration (BMA) Syringe; Bone Punch, Tibial Punch, Femoral Punch, Acetabular Punch; Burr, Orthopedic; CATHETER AND TIP; CELLECT; CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP; CLAMPFIX; CONCORDE Clear MIS Discectomy Device; COUNTERSINK (MULTIPLE BRANDS); Caliper Instruments (Joint Recon); Charnley; ChronOS BMA; Clamp for Joint Recon; Concorde; Concorde Bullet; Concorde Curve Spinal System; Concorde Inline Spinal System; Control Cable; DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS); DOC Ventral Cervical Stabilization System; DePuy Synthes 2mm Quick Insertion Screws; DePuy Synthes 3.5 mm Intrapelvic Acetabular System; DePuy Synthes 4 Mm And 4.5 Mm Cortex Screws, DePuy Synthes 2.4 Mm Cannulated Screws, DePuy Synthes 3.5 Mm And 4 Mm C; DePuy Synthes Femoral Recon Nail System; DePuy Synthes MatrixSTERNUM Fixation System; DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System; Dental Bone Cutting Instruments; Depuy Synthes Retrograde Femoral Nail Advanced System and DePuy Synthes Locking Screws for Medullary Nails, 5 mm; Devex; E-Z X System; EXPEDIUM; Expedium; Expedium Spine System; Guide, Surgical, Instrument; HAMMERLOCK 2; Hammertoe Continuous Compression Implant; Impactor Instruments (Joint Recon); Instrument Retractors; Introduction/drainage catheter and accessories; Isola; Joing Recon Forceps, Wire Holding; Joint Ortho Tamp Instrument; Joint Recon Awl instruments; Joint Recon Bone Hook Instrument; Joint Recon Curettes; Joint Recon Cutting Instrument; Joint Recon Hammers; Joint Recon Mallet instruments; Joint Recon Surgical instrument motors and accessories/attachments; Joint Recon instrument -chisel, surgical, manual; Joint Reconstruction wire cutters; Kaneda Sr; LCS, New Jersey Total Knee; LOW PROFILE HALO VEST ASSEMBLY; Lere; MATRIXRIB FIXATION SYSTEM; MAXILLARY DISTRACTOR; MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY); Maxframe; Mitek ARTHROSCOPIC SURGERY INSTRUMENT; Mitek CANNULA; Mitek ELEVATOR; Mitek EYED NEEDLE; Mitek GRAFT KNIVES; Mitek INSERTERS; Mitek KNIFE; Mitek KNOT PUSHER; Mitek PROBE; Mitek SUTURE CUTTER; Monarch Spine System; Mountaineer; NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY; NeuralMAS; Norian Drillable; ORTHOPAEDIC TRACTION ACCESSORY; Ocelot Stackable Cage System; Orthomesh; Orthopaedic DRILL; Orthopaedic EXTRACTOR; Orthopaedic GUIDE; Orthopaedic REAMER; Orthopaedic TAP; Orthopedic manual surgical instrument; PINNACLE Dual Mobility; PULSE Cervical Cage System Implants; Pinnacle; Pipeline Access System; Porous Polyethylene Implants; Proxima; Pulse Anterior Cervical Plate System Implants; Pulse Lumbar Cage Implants; Pulse Lumbar Screw Implants; Punch, Surgical; RAM; RASP; Radial Head; Radial Head Prosthesis; Rapid Resorb. Cranial Clamp; Rasp for Joint Recon; Rhythmlink International Monopolar Stimulating Instrument; Rhythmlink International Subdermal Needle Electrodes; Rongeur for Joint Recon; SMALL FRAGMENT DYNAMIC COMPRESSION; SMALL STATURE USS; SYNAPSE SYSTEM; SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM; SYNEX II; SYNFRAME; SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY; SYNTHES (USA) 2.4/2.7 MM LOCKING FO; SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP; SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM; SYNTHES (USA) CLAVICLE HOOK PLATES; SYNTHES (USA) COMPACT AIR DRIVE II; SYNTHES (USA) EXTERNAL FIXATION COM; SYNTHES (USA) EXTERNAL MULTI VECTOR; SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP); SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM; SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM; SYNTHES (USA) REAMER IRRIGATOR AS; SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM; SYNTHES (USA) RIA SYSTEM; SYNTHES (USA) SMALL ADJUSTABLE CLAM; SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM; SYNTHES (USA) TIBIAL NAIL SYSTEM EX; SYNTHES (USA) [SYNTHES] MINI EXTERN; SYNTHES 1.5MM/2MM ORTHOGNATHIC MA; SYNTHES AIR PEN DRIVE (APD) SYSTEM; SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS); SYNTHES ANTERIOR CERVICAL LOCKING P; SYNTHES ANTERIOR CSLP SYSTEM; SYNTHES ANTERIOR TENSION BAND (ATB); SYNTHES CERVICAL VERTABRAE PLATES; SYNTHES CERVIFIX SYSTEM; SYNTHES CERVIFIX/ AXON; SYNTHES DUAL-OPENING USS; SYNTHES EXTERNAL FIXATION DEVICES; SYNTHES LARGE COMBINATION CLAMP AND; SYNTHES LARGE FRAGMENT DYNAMIC COMP; SYNTHES LCP PROXIMAL HUMERUS PLATES; SYNTHES MANDIBLE EXTERNAL FIXATOR; SYNTHES MATRIX MIS RODS; SYNTHES MEDIUM EXTERNAL FIXATION SY; SYNTHES MINI EXTERNAL FIXATOR; SYNTHES MODULAR FOOT SYSTEM; SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM; SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SY; SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM; SYNTHES SIMPLE SMALL EXTERNAL FIXAT; SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM; SYNTHES SPINE OCCIPITAL-CERVICAL PL; SYNTHES SPINE UNIVERSAL SPINAL HOOK; SYNTHES STERILE DRILL BITS; SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM; SYNTHES SYNMESH; SYNTHES SYNMESH SPACER SYSTEM; SYNTHES TOMOFIX OSTEOTOMY SYSTEM; SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL; SYNTHES USS (10MM SIDE OPENING SCREWS; SYNTHES USS, CLICK`X, USS VAS, DUAL; SYNTHES VECTRA SYSTEM; SYNTHES VECTRA-ONE SYSTEM; SYNTHES VECTRA-T SYSTEM; Screwdrivers for Joint Recon; Sentio MMG; Sentio MMG Gen2; Shoulder Replacement Device; Skyline Anterior Cervical Plate System; Spine Bale; Spine Crown; Spine Halo; Spine Mesh; Spine Monoaxial Screw; Spine Polyaxial Screw; Spine Port; Spine Ti; Spine Washer; Spotlight; Staple; Strickland; Summit; Suprapatellar; Surgical Scissors; Symphony; Synapse Occipital-Cervical-Thoracic (OCT) System; SyntheCel; Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System; Synthes 90 Degree Screwdriver; Synthes Clampfix System; Synthes Cortex Screws; Synthes Distraction Osteogenesis Sy; Synthes Distraction Osteogenesis System; Synthes Hybrid External Fixator; Synthes Large Ex Fix MR Conditional; Synthes Matrix System; Synthes Navigable Pedicle Preparation Instruments; Synthes SyntheCel Dura Replacement Devices; TELIGEN; TORQUE LIMITING ATTACHMENT; TRAUMACEM™ V+ Injectable Bone Cement; TRAUMAFIX (TM) EXTERNAL FIXATOR; TRUMATCH Personalized Solutions; Tandem Connector; Titanium Screws; Trephine; USS Iliosacral and Polyaxial System; USS-LINE EXTENSION; Uniplate; VAPR; VARIOUS TYPES OF HAMMERS; VIPER PRIME™; Viper; Viper Prime; Viper System; WATER BATH TRAY; WILLIAMS GAUGES; Wire Cable (joints); battery; bender; bit; blade; bone filler; broach, wire cutter, prosthesis driver, extractor, file, femoral neck punch, reamer, screwdriver, tamp wrench, etc.; bur; chisel, instrument guide, hammer, mallet, osteotome, rasp, retractor, saw, calipers; compression instrument for Joint Recon; dissector, surgical, general & plastic surgery; drill kit; expedium; filler; guides; instrument; instrument tray, instrument case; measuring; monarch; mountaineer; orthopaedic knife; osteotome, manual; power; retractor; scissors; screw; spine instrument; surgical instrument motor; tape, measuring, rulers and calipers for Joint Recon; templates; traction; various broach instruments; various cement dispensers; various general plier instruments; various osteotome general instruments; various prosthesis drivers; viper; wrenches for Joint Recon",1977-12-22,194,2026-03-02,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004464325%22&limit=1
Merit Medical Nederland BV,3006950086,3006950086,Amerikalaan 42,Maastricht Airport Limburg,,6199 AE,Netherlands,"Merit Medical Systems, Inc.",1721504,Exporter to the US,129,BWN; BZN; CCX; DQF; DQO; DQX; DQY; DRA; DRB; DRC; DRE; DRS; DSK; DSY; DTE; DTL; DWM; DWO; DWS; DWZ; DXC; DXE; DXG; DXN; DXT; DYB; ESW; EXF; FAD; FAJ; FCG; FCY; FDY; FED; FGE; FJS; FKO; FKX; FMF; FMG; FPA; FPK; FQM; FZX; GAA; GAH; GAX; GBW; GBX; GCB; GCC; GDF; GEA; GEH; GEI; GES; GXI; HCG; HRX; HTW; HXG; JAQ; JCT; JDZ; JKA; JOL; JRL; KCY; KDC; KDD; KDQ; KGS; KGX; KGZ; KIH; KME; KMK; KNQ; KNS; KNW; KRA; KRB; KRD; KTI; KYZ; KZD; LDF; LJS; LOD; LXH; LYV; MAV; MDM; MHW; MMX; MSD; NAJ; NDN; NEU; NWU; OAR; OCX; OCY; ODE; ODY; OEQ; OEX; OEZ; OJA; OJV; OMT; OWL; OYI; PEV; PFV; PNG; PPD; PTL; PTM; PUR; PXI; PXU; PYB; PYC; QBP; QEY; QEZ; QJH; QSY,"Table And Attachments, Operating-Room; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Support, Patient Position; Actuator, Syringe, Injector Type; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Stylet, Catheter; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Transducer, Blood-Pressure, Extravascular; Computer, Blood-Pressure; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Pulse-Generator, Pacemaker, External; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Apparatus, Suction, Patient Care; Needle, Biopsy, Cardiovascular; Instruments, Surgical, Cardiovascular; Device, Biopsy, Endomyocardial; Clamp, Vascular; Catheter, Embolectomy; Computer, Diagnostic, Pre-Programmed, Single-Function; System, Measurement, Blood-Pressure, Non-Invasive; Injector And Syringe, Angiographic; Introducer, Catheter; Prosthesis, Esophageal; Bag, Bile Collecting; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Biopsy Needle; Bulb, Inflation, For Endoscope; Device, Measuring, For Panendoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Stents, Drains And Dilators For The Biliary Ducts; Catheter, Peritoneal, Long-Term Indwelling; Catheter, Peritoneal Dialysis, Single Use; System, Peritoneal, Automatic Delivery; Syringe, Piston; Stopcock, I.V. Set; Set, Administration, Intravascular; Tubing, Fluid Delivery; Bandage, Elastic; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Stylet, Surgical, General & Plastic Surgery; Tourniquet, Nonpneumatic; Catheter, Peritoneal; Catheter, Irrigation; Needle, Catheter; Dilator, Catheter; Guide, Needle, Surgical; Cannula, Surgical, General & Plastic Surgery; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Scalpel; Probe, Radiofrequency Lesion; Device, Neurovascular Embolization; Arthroscope; Bit, Drill; Tamp; System, Applicator, Radionuclide, Remote-Controlled; Prosthesis, Tracheal, Expandable; Mixer, Cement, For Clinical Use; Tubes, Vials, Systems, Serum Separators, Blood Collection; Catheter And Tip, Suction; Unit, Filter, Membrane; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Dispenser, Cement; Bedding, Disposable, Medical; Device, Intravascular Catheter Securement; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Instrument, Biopsy; Catheter, Continuous Flush; Probe, Thermodilution; Device, Vascular, For Promoting Embolization; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Electrode, Pacemaker, Temporary; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Bone Cement; Orthopedic Manual Surgical Instrument; Label Or Tag, Sterile; Syringe, Balloon Inflation; Instrument, Manual, Surgical, General Use; Dressing, Compression; Device, Percutaneous Retrieval; Catheter, Hemodialysis, Implanted; Agents, Embolic, For Treatment Of Uterine Fibroids; Cement, Bone, Vertebroplasty; Marker, Radiographic, Implantable; Endoscope Introducer Kit; Injector, Vertebroplasty (Does Not Contain Cement); Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd); Tunneled Catheter Remover; Angiography/Angioplasty Kit; Cardiovascular Catheter Sheath Introducer Kit; Cardiovascular Procedure Kit; Intravenous Extension Tubing Set; Single Use Instrument Tray; Absorbable Lung Biopsy Plug; Peripheral Catheter Insertion Kit; Non-Bronchoscopic Bronchoalveolar Lavage Catheter; Dialysis Administration Kit; System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Universal Drainage Tray; Wire, Guide, Catheter, Exempt; Syringe, Balloon Inflation, Exempt; Vacuum Syringe; Thoracentesis Tray; Fluid Drainage Tray; Minor Surgical Procedures Tray; Paracentesis Tray; Cap, Device Disinfectant; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter; Reverse Central Venous Recanalization System; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; 3; U,"1 mL syringe(Polypropylene); 10Fore Hemostasis Valve; 10Fore Hemostasis Valve Kit; 5.5 F Worley Advanced LVI Lateral Vein Introducer; AEROmini Tracheobronchial Stent System; ARC Catheter; ASAP Aspiration Catheter; ASAP Catheter; ASAPLP Aspiration Catheter; ASAPLP Embolectomy Catheter; Access-9; AccessPLUS; Achieve; Activation Element, ERx bone cement; Acutiy Universal Cutter; Adjustable Biopsy Port Seal BPS-A; Advance Angiographic Needle; Aero DV Tracheobronchial Stent System; Aero Tracheo Stent and Delivery System; Aerosizer; Alimaxx E; Arcadia Balloon Catheter; Arcadia Balloon Catheter Kit; Aspira Peritoneal Drainage System; Aspira Pleural Drainage System; BIG60; BIG60 ALPHA Inflation Devie; BRC-BAL-INT-FL/A; BackStop Plus Closed Waste Basin; Bath Probe; Bearing nsPVA Embolization Particles; Bedford™ Guided Hard Bone Biopsy System; BioFlo Duramax; BioSentry Tract Sealant System; Blue Diamond Inflation Syringe; BowTie Guide Wire Insertion Device; Brochoalveloar Lavage (BAL) Custom Convenience Kit; Bulldog Lead Extender; C2 Cryoballoon Ablation System; C2 Cryoballoon Endogrip; CT Transfer Set; CardiaGuide Fixed Curve Braided Transseptal Sheath; Cardiac Output Kit; Catheter Connection Cable; Catheter Connection Cables and Cardia Computer; Cen-Step Centesis Catheter; Centros Long-Term Hemodialysis Catheter; CentrosFLO Long-Term Hemodialysis Catheter; Check Valve; ClariVein IC Infusion Catheter; Coil Expander; Concierge Guiding Catheter; Connecta PE Lines; Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI); Coronary Control Syringe; Corvocet Biopsy System; Corvocet Coaxial Introducer; Critiflo; Critiflo Dome; Critikit Plus In-Line Room/ Ice Injectate; Cuff Implantor; Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; DTX Disposable Temperature Probe; DTX Plus Disposable Pressure Transducer; DTX/DTX Plus Kit and Accessories; Dark Blue Cap for Male Luers; Dash 9F Hydrophilic Sheath Introducer; DiamondTOUCH Inflation Device and Fluid Dispensing Syringe; DiamondTOUCH Syringe; Disposable In Line Sensor Housing; DoublePlay Hemostasis Valve; Drainage Tubing; DriPAD Super Absorbent Pad; DualCap; DualCap Duo; DualCap IV Pole Strips; DualCap Solo; DuraFlow 2 Hemodialysis Catheter; Duramax; EN Snare Endovascular Snare System; ER2 Saturate Mixing System; Elation Fixed Wire Balloon; Elation Pulmonary Balloon; Elation Pulmonary Balloon 4mm; Elation Wireguided Balloon; Elation5 Fixed Wire Balloon; Elation5 Wireguided Balloon; Embedding Tool; EmboCube Gelatin Embolization; EmboGold Microspheres; EndoMAXX; EsophyX Z+ Device; EvenMore Chronic Hemodialysis Catheter; Excite Contrast Injection Line; ExxTended Catheter; FLO30; FLO40XR; FLO50; Faller Trocar; FastBreak Connector; Finale Radial Compression System; Flex-Neck Catheter; Flex-Neck Extender/Repair Kit; Flex-Neck Infant Catheter; FlowGuard; Fluid Dispensing Syringe; Fountain 4F Catheter & Occluding GW; Fountain Catheter/Occluding Guide Wire; Fountain Infusion Catheter w/ Occluding Guide Wire; Fountain Infusion System; Fountain ValveTip Infusion Catheter; Futura Safety Scalpel; Go2Wire Guide Wire; Guidewire Introducer; Guidewire with Palladium Tip; H20 Guidewire; H20 Torque Device; HeRO Graft; HeartLight Deflectable Sheath; HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al.; HeartSpan Steerable Introducer Sheath; HeartSpan Steerable Sheath Introducer; Hemostasis Valve Adapter; Honor hemostasis valve; Huntington Guided, Perforating Bone Biospy System with Drill; Hydraulic Assembly; Hydraulic-Master Syringe Assembly; Hydrophilic Guidewire; Hydrophilic Prelude SNAP Splittable Sheath Introducer; Impress Angiographic Catheter; Impress UAC Catheter; Impress and Impress Legato Hydrophilic Angiographic Catheter; Impress with Legato Hydrophilic Coating; InQwire; InQwire Diagnostic (Support) Non-Vascular Guide Wire; InQwire Guidewire-Prelude Introducer; InQwire Guidewires; Injectate Sensor Cable; Insufflation Set; Integral Injectate Temperature Probe; Intellisystem Inflation Device; Introducer Needle WithTrocar Stylet; K01 Kit (MSS); K01 Syringe Kit (1mL & 20mL COP); K01 Syringe Kit (1mL Polypropylene); K02 Syringe Kit (multiple K01); K02 Syringe Kit (multiple K01)); K02-00873A, K02-01105A, K02-01481A; K04 - Tubing Kit; K05 Inflation Kit; K05T - Inflation Kit; K06 Syringe Kit (single CSS); K07 Syringe Kit (multiple K06); K08 Fluid Management Kit; K09 Manifold Kit; K09T - Manifold Kit; K10 Waste Management Kit; K10T - Waste Management Kit; K11 Pressure Monitoring Kit; K12 Procedure Kit; K12T - Procedure Kit; K13 Label Kit; K14 Dialysis Kit; K15 Sheath Introducer Kit; K16 Microcatheter Kit; K17 Interventional Kit; K17T - Interventional Kit; K18 Sheath Introducer Kit (Ease); K19 Combination Packs; K20 Endoscopic Kit; K20T - Endoscopic Kit; K21 Sheath Introducer Kit (IDeal); K22C Vein Tray; K23C Vein Accessory Kit; KYPHON KyphoFlex Balloon Catheter; KYPHON KyphoFlex Balloon Catheter Kit; Kensington Guide Wire Bone Biopsy System; Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411); Lead Clippers; Liberator Beacon Tip Locking Stylet; Low Profile Companion Sheath; MAK-NV Non-Vascular; MAP Torque Device & Introducer; MBA; MYSHELL Hemostatic Valve; Madison Mini™ Bone Biopsy System; Madison™ Perforating Bone Biopsy System with Drill; Maestro Microcatheter; Majestik Angiographic Needle; Master Syringe Assembly; Maxxwire; Medallion Syringe; Merit 1mL Syringe (COP); Merit 20 mL Syringe (COP); Merit Administration Set; Merit Centros Long-Term Hemodialysis Catehter; Merit CentrosFLO Long-Term Hemodialysis Catheter; Merit Convenience Kits; Merit Disposal Depot; Merit Drainage Depot; Merit HeRO Graft; Merit High Pressure Tubing; Merit Hydrophilic Guide Wire; Merit MAK (Mini Access Kit); Merit Manifold; Merit Marquis Flow Switch; Merit Marquis Stopcock; Merit PAK; Merit Pressure Monitoring Tubing; Merit Pursue Microcatheter; Merit S-MAK (Stiffened Mini Access Kit); Merit Safety Needle; Merit Syringe; Merit Triboglide Syringe; Meritrans Disposable Transducer; MetaSTAR RF Generator; Micro Ace Advanced Micro Access System; Micro Ace Gold Advanced Micro Access System; Micro Plug Set; Mighty Wire; MiniStop Filter Closed Waste Basin; MiniStop Plus Closed Waste Basin; Miser Contrast Management System; Monarch Compak Inflation Syringe; Monarch Syringe Fluid Dispense System; MultiPlex II Controller; Needle's Eye Snare Retrieval Set; NeoVasc; Non-vascular tissue dilators; Novatome Endomyocardial Biopsy Forceps; One Snare Endovascular Snare System ONE1501; One-Step Centesis Catheter; One-Tie Compression Coil; One-Vac Evacuated Drainage Bottle; OneSnare Endovascular Snare System; Osseoflex Access Kit; Osseoflex CD-H Hydraulic Cement Delivery System; Osseoflex SB Steerable Balloon (10Ga); Osseoflex SB Steerable Balloon (8ga); Osseoflex SB Straight Balloon (8ga); Osseoflex SN; Osseoflex SN Needle; Osseoflex SN+ Needle; Osseoflex Straight Hand Drill; Osseon Bone Filler Device (BFD); Ostial Pro Stent Positioning System; OuTake Catheter Extractor; PAL (Pen and Labels) Family; Passage Hemostasis Valve; Perchik Button Assembly; Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M); Performa Diagnostic Intravascular Catheter; Pericardiocentesis Catheter Kit; Peritoneal Dialysis Catheter Connector; Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211); PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing; Pin Vise Polymer; PinVise Torque Device; Pink Achieve; Pinvise Torque Device; PowerCURVE Navigating Osteotome; Prelude Choice Hemostasis Valve Adapter; Prelude IDeal Hydrophilic Sheath Introducer; Prelude Plastic Jacketed Guide Wire; Prelude Prestige Splittable Sheath Introducer; Prelude SNAP 165 Valved Splittable Sheath Introducer; Prelude SNAP Splittable Sheath Introducer; Prelude Sheath Half Size (ACT); Prelude Sheath Introducer; Prelude Short Sheath Introducer; Prelude Wave Hydrophilic Sheath Introducer; PreludeEASE Hydrophilic Sheath Introducer, 4F-6F; PreludeEASE Hydrophilic Sheath Introducer, 7F; PreludeSYNC DISTAL Radial Compression Device; PreludeSYNC EVO Radial Compression Device; PreludeSYNC EZ Radial Compression Device; Pressure Infusor Bags (PIB); Pressure Tubing; Preston Bone Filler; Preston™ Hard Bone Access Needle with Drill; Preston™ Hard Bone Introducer; Preston™ Long Drill; Preston™ Transpedicular Drill; Preston™ Transpedicular Introducer; ProGuide Long Term Hemodialysis Catheter; Purge Assist; Quick Silver; RADstat Radial Artery Compression Device; ROSE; RTT14038MB; RXP (Rapid Exchange Flushing Syringe); Rad Board; Rad Board 2 Reusable Arm Board; Rad Board Xtra; Rad Rest; Rad Trac; ReSolve Biliary Locking Drainage Catheter; ReSolve ConvertX Biliary Stent System; ReSolve ConvertX Nephroureteral Stent System; ReSolve Dilators; ReSolve Locking Drainage Catheter; ReSolve Non-Locking Drainage Catheter; Repositional Chest Tube; Resilience Fully Covered Esophageal Stent System; Revolution Catheter Securement Dev.; Roadster Guide Sheath; Rotating Adaptor; S-MAK; S-MAK XL; SAVI Applicator Kit; SAVI Prep Device; SAVI Spacer; SCOUT Bx Delivery System; SCOUT Console and Accessory Cart; SCOUT MD Console; SCOUT MD Delivery System; SCOUT MD Guides; SCOUT MD Single-Use Handpieces; SCOUT MD Single-use Handpieces; SCOUT Reflector and Delivery Systems; SCOUT Single-Use Handpiece, SCOUT Surgical Guides; SCOUT Surgical Console and SCOUT Check Console; SPINR High-Performance Guidewire Catheter; STAR Tumor Ablation Kit and Accessories; STAR Tumor Ablation Kit with PowerCURVE; STATSEAL; SafT Needle Direct Blood Transfer; SafeGuard Focus Compression Device; SafeGuard Focus Compression Device (Adhesive Free); SafeGuard Focus Cool Device; SafeGuard Focus Cool Device (Adhesive Free); SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al.; SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al.; SafeSheath Sealing Adapter; Safedraw Blood Sampling System; Safeguard Pressure Assisted Device (12cm); Safeguard Pressure Assisted Dressing (24cm); Safeguard Radial Compression Device; Safety Paracentesis Tray (SPPT); SeaDragon Torque Device; ShortStop Advantage Temporary Sharps Holder; ShortStop Grandstand Temporary Sharps Holder; ShortStop Temporary Sharps Holder; Sidecar External Working Channel (FG-1011); Siege Vascular Plug; Slip-Not; Smart Tip Control Syringe; Sof-Grip Hemostat; Softouch Diag. Intra Cath. w/Vessel; Solo Pace Control; Solo Pace Fusion System (SOLOFUSE1); Spectraject Control Syringe; Spectranetics; SpineSTAR Ablation Instruments; Squirt Fluid Delivery System; StabiliT Bone Cement and Saturate Mixing System; StabiliT Cement Delivery Syringe; StabiliT ER2 Bone Cement and Saturate Mixing System; StabiliT Introducer and Delivery Instruments; StabiliT MX Fracture Kits; StabiliT MX Fracture Kits with PowerCURVE; StabiliT VP Fracture Kits; StabiliT VP Vertebrosplasty Kit; StayFix Fixation Device; Sterilized Convenience Kits; Stopcock One Port Manifold; Straightline Osteotome, VerteCOR Midline Osteotome; Stylet Wire; Stylette (rod obturator); SureCross Support Catheter; Surfacer Inside-Out Access Catheter System; SwiftNINJA Microcatheter; SwiftNINJA Steerable Microcatheter; TRAM; TRAM-P; Temno ACT; Temno Elite Biopsy Systems; Temno Evolution; Temno Original; Thoracentesis Tray (TAPS); Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al.; TruCut 14Ga; TruCut 18Ga; True Form Reshapable Guide Wire; Tubing, Fluid Delivery; Universal Coaxial Needles; VACLOK Syringe; VacLok AT Syringe; Valve Adapter; Ventrax Delivery System; VertecoR Bone Drill, 3; Vessel Dilator; Vessel Sizing Catheter (VSC); ViaVerte RF Generator; ViaVerte Steerable RF Ablation Kit; WOUNDSEAL; Westbrook™ Bone Biopsy System; Worley; Wrapsody Cell-Impermeable Endoprosthesis; X-Change Cement Dispensing Syringe; basixCompak Analog Inflation Syringe; basixSKY Inflation Device; basixTOUCH; basixTOUCH40 Inflation Syringe",1992-07-14,194,2026-02-13,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006950086%22&limit=1
Medtronic Mexico S. de R.L. de CV,9617601,3002534070,Av. Paseo Cucapah 10510 El Lago,Tijuana Baja California,,C.P. 22210,Mexico,"Medtronic, Inc.",2112641,Manufacturer,59,BYS; CAC; DPT; DQO; DQY; DRA; DRF; DRY; DTF; DTI; DTL; DTM; DTN; DTP; DTR; DTS; DTZ; DWA; DWE; DWF; DWS; FLL; FMH; GAA; GCY; GWM; HAM; HCA; HCG; HRX; HTD; HXG; JOD; JXG; KFM; KIH; KPE; KRA; KRD; KRH; LIT; LOX; LPB; LWR; LXH; MDM; MIH; MJG; NDN; NPT; NPV; NTE; OAE; PCB; QHW; QJP; QJZ; QNR; QWF,"Oxygenator, Long Term Support Greater Than 6 Hours; Apparatus, Autotransfusion; Probe, Blood-Flow, Extravascular; Catheter, Intravascular, Diagnostic; Catheter, Percutaneous; Catheter, Steerable; Catheter, Electrode Recording, Or Probe, Electrode Recording; Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass; Tools, Pacemaker Service; Sizer, Heart-Valve, Prosthesis; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Filter, Blood, Cardiopulmonary Bypass, Arterial Line; Reservoir, Blood, Cardiopulmonary Bypass; Defoamer, Cardiopulmonary Bypass; Heat-Exchanger, Cardiopulmonary Bypass; Sucker, Cardiotomy Return, Cardiopulmonary Bypass; Oxygenator, Cardiopulmonary Bypass; Control, Pump Speed, Cardiopulmonary Bypass; Tubing, Pump, Cardiopulmonary Bypass; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Instruments, Surgical, Cardiovascular; Continuous Measurement Thermometer; Container, Specimen, Sterile; Needle, Aspiration And Injection, Disposable; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Device, Monitoring, Intracranial Pressure; Apparatus, Electrosurgical; Catheter, Ventricular; Device, Neurovascular Embolization; Arthroscope; Forceps; Tamp; Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass; Shunt, Central Nervous System And Components; Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type; Dispenser, Cement; Container, I.V.; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Ring, Annuloplasty; Catheter, Angioplasty, Peripheral, Transluminal; Catheters, Transluminal Coronary Angioplasty, Percutaneous; Cardiac Ablation Percutaneous Catheter; Heart-Valve, Non-Allograft Tissue; Orthopedic Manual Surgical Instrument; Instrument, Manual, Surgical, General Use; System, Endovascular Graft, Aortic Aneurysm Treatment; Device, Percutaneous, Biopsy; Cement, Bone, Vertebroplasty; Aortic Valve, Prosthesis, Percutaneously Delivered; Pulmonary Valve Prosthesis Percutaneously Delivered; Temporary Carotid Catheter For Embolic Capture; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation; External Cerebrospinal Fluid (Csf) Diversion; Single Lumen Ecmo Cannula; Catheter, Percutaneous, Neurovasculature; Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure; Blood Pump For Ecmo, Long-Term (> 6 Hours) Use; Tubing, Long Term Support Greater Than 6 Hours",1; 2; 3; f,"6F Launcher Guiding Catheter; 6F Sherpa NX Balanced7F Sherpa NX Balanced; 6F Taiga; AORTIC CUFF; ATRIAL LIFT SYSTEM; AUTOLOG; Accessory Port ATS Medical Thoracic Port System; Achieve; Actuators; Adapter; Adapters; Adaptors; Adjustable Slitter; Admiral Xtreme; Admiral Xtreme PTA Balloon Catheter; Admiral Xtreme PTA Balloon Dilatation Catheter; Admiral Xtreme PTA Balloon Dilatation Catheter (Long Balloon); Affinity; Affinity CP Adapter; Affinity CP Centrifugal Blood Pump; Affinity CP Centrifugal Blood Pump w/ Carmeda Bioactive Surf; Affinity CP Centrifugal Bloop Pump w/ Balance Biosurface; Affinity CP Centrifugal Pump; Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface; Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface; Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface; Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface; Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva™BioActive Surface and Cardiotomy/ Venous Reservoi; Affinity Fusion Recirculation Line; Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface; Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface; Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface and Cardiotomy/Venous Reservo; Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface; Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir; Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir; Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface; Affinity NT™ Oxygenator; Affinity NT™ Oxygenator with Cortiva™ BioActive Surface; Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface; Affinity Pixie Arterial Filter with Balance Biosurface; Affinity Pixie CVR; Affinity Pixie Oxygenator with Balance Biosurface; Affinity Pixie Oxygenator with Cortiva BioActive Surface; Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity Temperature Probe; Affinity™ CP Centrifugal Blood Pump; Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface; Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber; Affinity® Pediatric Arterial Filter; Amphirion Deep 014"" OTW PTA Balloon Catheter; Amphirion Deep 014"" OTW PTA Balloon Catheter (Balloon Extension); Amphirion Deep 014"" OTW PTA Balloon Catheter (Long Balloon); Amphirion Deep 014"" OTW PTA Balloon Catheter (Shaft Extension); Amphirion Deep 014” OTW PTA Balloon Catheter; Amphirion Deep PTA Catheter; Arctic Front Advance ProTM; Arctic Front Advance cardiac cryoablation catheter; Aspiration Needles; Attain Prevail 6228 CTH; Autolog; Autolog Autotransfusion; Avalus™ Sizers; Avalus™ bioprosthesis; Axium Detachable Coil System; Axium Prime Detachable Coil System; Axium Prime Detachable Coil System (FitzRoy); Axium™ Detachable Coil; Axium™ Prime Detachable Coil; BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM; BECKER EXTERNAL DRAINAGE/MONITOR SYSTEM LUMBAR CATHETER; BIO-PUMP; BIOPUMP (VARIOUS MODELS); Becker External Drainage and Monitoring System; Bio-Medicus; Bio-Medicus Cannula; Bio-Medicus Life Support Catheter and Introducer; Bio-Medicus"" Adult Cannula Kit; Bio-MedicusTM Insertion Kit; Bio-Pump BP50; Bio-probe; Biotherm; CD HORIZON® Fenestrated Screw Set; CG Future Band; CG Future Ring; CG Future Sizers; CSF-VENTRICULAR CATHETER, STANDARD; CV-SH Cannulae, Fem Arterial 1-Piece, Bio-Medicus; CV-SH Cannulae, Femoral Venous 1-Piece, BioMedicus; Cannula; Cannulae; Cannulae, Femoral Venous 1-Piece, BioMedicus; Cannulae, Femoral, Insertion Kits; Carpentier Bi-Caval Femoral Cannula; Cement, Bone; Coaxial; Coaxial Cable; Concerto Detachable Coil System; Connectors; Container; Contour 3D sizers; CoreValve Evolut PRO System; CoreValve Evolut PRO+ System; CoreValve Evolut R System; Cryoconsole; DLP Air Aspirating Needle; DLP Aortic Root Cannula; DLP Cannula; DLP Pericardial Sump; DLP Phrenic Nerve Pad; DLP Pressure Monitoring Catheter; DLP Rapid Prime Set, 14; DLP Silicone RCSP Cannula; DLP Single Stage Venous Cannula; DLP Suction Tube; DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr; DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr.; DLP Tourniquet Set, Pediatric; DUET; DUET EDMS; DUET External Drainage And Monitoring System; Distal Perfusion Kit; Duet EDMS; Duet External Drainage and Monitoring System (EDMS); Duran Ancore Band; Duran Ancore Ring; Duran Ancore Sizers; ECG Cable; ECMO; EL Reservoir; EOPA; EXTRA LG BLADE SET TOOL; Emergency Hand Crank; Endurant II AUI Stent Graft System; Endurant II Stent Graft System; Endurant IIs Stent Graft System; Endurant Stent Graft System; Ensemble; Euphora Rapid Exchange (RX) Balloon Dilatation Catheter; Euphora Rapid Exchange Balloon Dilatation Catheter; Evolut FX+ System; Exacta External Drainage and Monitoring System (EDMS); Exacta™; External Motor; FILTER,O2,BI-DIRECTIONAL,CAP- DUST,3/16IN,GREEN,VENT,ST; FORCEPS (MANUAL INSTRU; Freestyle Obturators; Freezor MAX Surgical cryoablation catheter; Freezor MAX cardiac cryoablation catheter; Freezor Xtra Surgical cardiac cryoablation catheter; Freezor Xtra cardiac cryoablation catheter; Freezor cardiac cryoablation catheter; General Instrument; Hancock II Aortic and Mitral Obturators; Hancock II ULTRA Supra-X Aortic Sizers; Harmony Transcatheter Pulmonary Valve System; INTERCOSTAL RETRACTOR SYSTEM; INTRACRANIAL PRESSURING MONITORING SYSTEM; Implant Tool Kit; Inflate FX Fracture Management Inflatable Bone Tamp; Instant Detacher; Intersept; Intersept Filtered Cardiotomy Reservoir; KYPHON Cement Delivery System; KYPHON ELEMENT"" Inflatable Bone Tamp; KyphX 11 Gauge Bone Access Needle; KyphX Bone Biopsy Device; KyphX Bone Filler Device; KyphX Handle; Introducer; Kyphon Exact Inflatable Bone Tamp; Kyphon Express II Inflatable Bone Tamp; Kyphon Express Inflatable Bone Tamp; Kyphon Inflation Syringe; Kyphon Xpander II Inflatable Bone Tamp; Kyphopak First Fracture Tray; LARGE BLADE SET TOOL; Launcher Guide Catheter; Launcher Guide Catheters; Lead Accessory Kit; MC2 Multistage; MC2Two-Stage Venous Cannula; MC2XThree-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula; MC2™ Two-Stage Venous Cannula; MEDIUM BLADE SET TOOL; MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT; MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM; MEDTRONIC PS MEDICAL EXACTA DRAINAGE SYSTEM POLE CLAMP; MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING VENTRICULAR CATHETER; MICRO-FRANCE Manual Surgical Instr; MITRAL COLLAR AND TIE; MONITOR TEMPERATURE; MULTIPLE FORCEPS; MULTIPLE Manual Surgical Instruments; MYOtherm; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and MYOtherm XP Cardioplegia Delivery System Uncoated; MYOtherm XP with Cortiva BioActive Surface, Non-Sterile; MYOtherm XP with Cortiva BioActive Surface, Sterile; MYOtherm XP™ Cardioplegia Delivery System with Cortiva™ BioActive Surface; Marksman Catheter; Medtronic CoreValve System; Medtronic DUET External Drainage And Monitoring System; Medtronic Evolut FX System; Medtronic External Drainage and Monitoring System (EDMS); Medtronic External Drive Motor; Minimax; Mo.Ma Ultra Proximal Cerebral Protection Device; Mosaic Aortic and Mitral Obturators; Mosaic Neo; Mosaic Ultra Supra-X Aortic Sizers; Mounting Rail; Myotherm; NC Euphora Rapid Exchange (RX) Balloon Dilatation Catheter; NC Euphora"" Rapid Exchange Balloon Dilatation Catheter; NC Sprinter RX; NC Stormer Over-the-Wire; Nitron CryoConsole; Nitron Remote; ORO-TRACHEAL INJECTOR NEEDLE; OVAL MC2Two-Stage Venous Cannula; Open Pivot sizers; PASS LP Spinal System; PS MEDICAL BIOGLIDE CSF; PS MEDICAL CSF-FLOW CONTROL VALVE; PS MEDICAL CSF-LUMBOPERITONEAL SHU; Pacemaker Repair Kit; Pacific Plus PTA Catheter; Pacific Xtreme PTA Balloon Dilatation Catheter; Phenom Catheters; Pixie Oxygenation and CVR Combo, Balance coated; Pixie Oxygenation and CVR Combo, Carmeda coated; Pixie Oxygenator, Balance coated; Pixie Oxygenator, Carmeda coated; Posterior Annuloplasty Band; Preset Needles; Profile 3D Annuloplasty Ring; Profile 3D Ring Sizers; Pulmonary Valve; Quickflow DPS; RCSP; RETRACTOR RACK TOOL; Ring, Annuloplasty - Contour 3D Ring; Rist 071 Radial Access Guide Catheter; Rist 079 Radial Access Guide Catheter; Rist Radial Access Selective Catheter; Rist™ 071 Radial Access Guide Catheter; Rist™ 079 Radial Access Guide Catheter; Rotation Tool Kit; SELECT; SMALL BLADE SET TOOL; STERILIZATION TRAY TOOL; SUTURE BELT; Select 3D; Sherpa NX Balanced Guide Catheter; Signature; Simplici-T; SimuPlus, SimuForm; Simulus Adjustable Annuloplasty Band; Simulus Adjustable Annuloplasty Ring; Simulus Flexible Annuloplasty Band; Simulus Flexible Annuloplasty Ring; Simulus Semi-Rigid Annuloplasty Band; Simulus Semi-Rigid Annuloplasty Ring; Simulus Sizers; Sprinter Legend 1.25 OTW; Sprinter Legend 1.25 RX; Sprinter Legend RX; Sprinter Legend Rapid Exchange Balloon Dilatation Catheter; Sprinter Over-the-Wire; Talent Occluder with Occluder Delivery System; Thin Wall Two-Stage Venous Cannula; Tissue Approximating Forceps; Torclip; Tri-Ad Adams Annuloplasty Ring; TriAd sizers; Tubing Pack; Tubing, Connectors, and Accessories; Uncoated MYOtherm XP Cardioplegia Delivery Systems, Non-Sterile; Uncoated MYOtherm XP Cardioplegia Delivery Systems, Sterile; Universal II Slitter; Universal Mounting Rail; Vacuum Relief Valve; Valiant Thoracic Stent Graft System; Vent Catheter; Visualase; VitalFlow™ Set with Balance™ Biosurface; XOMED; pinch on tool",1992-07-30,184,2026-08-14,9,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229617601%22&limit=1
Tribe Medical Group,3010400367,3010400367,595 Industrial Road,London Ontario,,N5V 1V2,Canada,Tribe Medical Group,10082587,Exporter to the US,75,DXJ; EBW; FEI; FMF; FMP; FRO; FSM; FST; FTM; FWB; FYD; GAP; GAS; GAT; GCJ; GDZ; GEI; GFA; GFF; HIF; HRS; HRX; HSB; HSD; HST; HSX; HTC; HTJ; HTN; HTO; HTW; HTX; HTY; HWC; HWE; HWT; HXJ; HXX; ITX; IYN; IYO; IZI; JDQ; JDR; JQC; JQO; JWH; KGS; KQM; KRR; KWD; KWS; KYZ; LMD; LXH; LXI; LZB; MAI; MBI; MDM; MNU; MQV; NAC; NBH; ORG; OSV; OWY; OXB; OXE; OXH; PHX; PKC; PLF; QHQ; QPB,"Display, Cathode-Ray Tube, Medical; Controller, Foot, Handpiece And Cord; Instrument, Special Lens, For Endoscope; Syringe, Piston; Protector, Skin Pressure; Dressing, Wound, Drug; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Mesh, Surgical; Camera, Television, Surgical, Without Audio; Apparatus, Exhaust, Surgical; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Handle, Scalpel; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Insufflator, Laparoscopic; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Pliers, Surgical; Gauge, Depth; Washer, Bolt Nut; Reamer; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Template; Staple Driver; Screwdriver; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; Cerclage, Fixation; Staple, Fixation, Bone; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Balance, Analytical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Retention Device, Suture; Camera, Surgical And Accessories; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Syringe, Irrigating (Non Dental); System, Digital Image Communications, Radiological; Orthopedic Manual Surgical Instrument; Guide, Drill, Ligament; Finger Cot; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Staple, Absorbable; Filler, Bone Void, Calcium Compound; Dressing, Wound, Hydrophilic; Accessories, Arthroscopic; Platelet And Plasma Separator For Bone Graft Handling; Insufflator, Endoscopic Vessel Harvesting; Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction; Mesh, Surgical, Collagen, Staple Line Reinforcement; Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Bone Wedge; Total Shoulder Arthroplasty System; System, Suction, Lipoplasty For Removal",1; 2; U,"ARTHROSCOPY PUMP; Apparatus, Traction, Non-Powered; Arthrex Ankle Fusion Plating System; Arthrex FastThread Interference Screw; Arthrex Fracture Plates and Screws; Arthrex RetroFusion Screw Smooth or Threaded Metallic Bone Fixation Fastener; Arthrex Univers CA Heads; Arthroscope; Arthroscopes; Balance, Analytical; Bio-Button; Bit, Drill; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; CAMERA, SURGICAL AND ACCESSORIES; Camera, Surgical And Accessories; Camera, Television, Surgical, Without Audio; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; DISPLAY, CATHODE-RAY TUBE, MEDICAL; DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL #'S SB 313 PB, SB 313 PBH; DOUBLE SYRINGE (ACP) SYSTEM; Dressing, wound, hydrophilic; Dual Wave Pump; ENDOSCOPY; Electrosurgical, cutting & coagulation & accessories; FASTAK SUTURE ANCHOR; FILLER, BONE VOID, CALCIUM COMPOUND; Fastener, Fixation, nondegradable, soft tissue; Fastener, fixation, biodegradable, soft tissue; Fastener, fixation, nondegradable, soft tissue; Finger cot; Fracture Plates & Screws; GAUGE, DEPTH; General Instruments; Guide, drill, ligament; HATRIC; HUMERAL FRACTURE PLATE; Handle, Scalpel; INTERFERENCE SCREW; Instrument, Special Lens, For Endoscope; Instrument, manual, surgical, general use; Insufflator, laparoscopic; LIGHT, SURGICAL, FIBEROPTIC; Laparoscope, general & plastic surgery; Laproscopes; Mesh, surgical; ORTHOPEDIC MANUAL INSTRUMENTS; Orthopedic manual surgical instrument; PIN, FIXATION, SMOOTH; PLIERS, SURGICAL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED; PROSTHESIS, TOE, HEMI-, PHALANGEAL; Plate, fixation, bone; Platelet and plasma separator for bone graft handling; Protector, Skin Pressure; Reamer; Rongeur; SHAVER SYSTEM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE; Screw, fixation, bone; Sheath; Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis; Shoulder joint metal/ polymer semi-constrained cemented prosthesis; Single/multiple component metallic bone fixation appliances and accessories; Smooth or threaded metallic bone fixation fastner; Staple, fixation, bone; Syringe, Irrigating; Syringe, piston; System, Digital Image Communications, Radiological; System, imaging, ultrasonic; TEMPLATE; Tray, Surgical, Instrument; VARIOUS INSTRUMENTS; WASHER, BOLT NUT; Wrist Drill Guide; orthopedic manual instrument; single contact layer; single/ multiple component metallic bone fixation appliances and accessories; smooth or threaded metallic bone fixation fastener",2021-08-19,193,2024-01-18,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010400367%22&limit=1
"Intuitive Surgical, Inc.",3015612252,3015612252,3410 Central Expressway --,Santa Clara,CA,95051,United States,"Intuitive Surgical, Inc.",9028901,Complaint file establishment; Manufacturer for export,29,EOQ; EQH; ERY; FCW; FDE; FDS; FET; FFY; FOX; GAG; GCI; GCJ; GDW; GEH; GEI; HIF; IZI; KCT; KKX; LFL; LKF; LLZ; MNL; NAY; NTN; NVE; OWN; PUI; QIH,"Bronchoscope (Flexible Or Rigid); Source, Carrier, Fiberoptic Light; Drape, Surgical, Ent; Light Source, Fiberoptic, Routine; Laparoscopy Kit; Gastroscope And Accessories, Flexible/Rigid; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Adaptor, Bulbs, Miscellaneous, For Endoscope; Stand, Infusion; Stapler, Surgical; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Staple, Implantable; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Insufflator, Laparoscopic; System, X-Ray, Angiographic; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Drape, Surgical, Antimicrobial; Instrument, Ultrasonic Surgical; Cannula, Manipulator/Injector, Uterine; System, Image Processing, Radiological; Accessories, Cleaning Brushes, For Endoscope; System, Surgical, Computer Controlled Instrument; Led Light Source; Washer, Cleaner, Automated, Endoscope; Confocal Optical Imaging; Drape, Surgical, Exempt; Automated Radiological Image Processing Software",1; 2; U,"10-12mm+Stapler Cannula Seal; 12 Mm & Stapler Bladeless Obturator; 12 mm Assist Cannula; 12 mm Blunt Obturator, da Vinci S, Si; 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si; 12 mm Endoscope Cannula Mount, Balloon Port; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si; 12 mm Endoscope Cannula Mount, COV; 12 mm Endoscope Cannula Mount, COV, da Vinci; 12 mm Endoscope Cannula Mount, ETH, da Vinci; 12 mm Endoscope Cannula Mount, ETH/TAUT, da Vinci S, Si; 12 mm Endoscope, 0°; 12 mm Endoscope, 30°; 12 mm Instrument Cannula, da Vinci S, Si; 12mm IS4000 Endoscopes and Accessories; 3D Camera, Wide Angle, NTSC; 3D Camera, Wide Angle, PAL; 3D Model Viewer; 3DHD Camera Head and Cable; 3DHD Camera Head and Cable (Ikegami HD); 3DHD Camera Head and Cable (Panasonic HD); 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000); 5 mm Blunt Obturator, da Vinci S, Si; 5 mm Flared Cannula, da Vinci S, Si; 5 mm Sharp Obturator, da Vinci S, Si; 5 mm to 8 mm Cannula Seal; 8 mm Assist Cannula; 8 mm Bladeless Obturator (Optical); 8 mm Bladeless Obturator (Optical), Long; 8 mm Blunt Obturator, Long, da Vinci S, Si; 8 mm Blunt Obturator, da Vinci S, Si; 8 mm Cannula Seal, da Vinci, da Vinci S, Si; 8 mm Cannula with Outlet, Long, da Vinci S, Si; 8 mm Cannula with Outlet, da Vinci S, Si; 8 mm Harmonic ACE Curved Shears; 8 mm Instrument Cannula, Long, da Vinci S, Si; 8 mm Instrument Cannula, da Vinci S, Si; 8 mm Sharp Obturator, Long, da Vinci S, Si; 8 mm Sharp Obturator, da Vinci S, Si; 8 mm SureForm 30 Curved-Tip Stapler; 8 mm SureForm 30 Reload, Blue; 8 mm SureForm 30 Reload, Gray; 8 mm SureForm 30 Reload, White; 8 mm SureForm 30 Stapler; 8 mm SureForm 30 System; 8 mm Trocar, Long; 8 mm Trocar, Standard; 8 mm to 5 mm Cannula Reducer, da Vinci; 8 mm to 5 mm Cannula Reducer, da Vinci S, Si; 8.5 mm Endoscope, 0°; 8.5 mm Endoscope, 30°; 8.5-13 mm Cannula Seal; 8.5mm Endoscope, 0°; 8.5mm Endoscope, 30°; 8mm 0 degree endoscope; 8mm 30 degree endoscope; 8mm Atrial Retractor Short Right, Xi; 8mm Black Diamond Micro Forceps, Xi; 8mm Blunt Obturator Long, Xi; 8mm Blunt Obturator, Xi; 8mm Cadiere Forceps; 8mm Cannula Long, Xi; 8mm Cannula Standard, Xi; 8mm Cardiac Probe Grasper, Xi; 8mm Cobra Grasper; 8mm Cobra Graspers; 8mm Curved Bipolar Dissector; 8mm Debakey Forceps; 8mm Dual Blade Retractor, Xi; 8mm Endoscope, 0°, Gen5; 8mm Endoscope, 30°, Gen5; 8mm Fenestrated Bipolar Forceps; 8mm Fenstrated Bipolar Forceps, Xi; 8mm Flared Cannula, Xi; 8mm Force Bipolar; 8mm Hex Cannula, Long; 8mm Hex Cannula, Standard; 8mm Instrument Introducer, Xi; 8mm Large Hem-O-Lok Clip Applier, Xi; 8mm Large Needle Driver; 8mm Large Needle Driver, Xi; 8mm Large SutureCut Needle Driver; 8mm Large Suturecut Needle Driver, Xi; 8mm Long Bipolar Grasper; 8mm Long Tip Forceps; 8mm Long Tip Forceps, Xi; 8mm Maryland Bipolar Forceps; 8mm Maryland Bipolar Forceps, Xi; 8mm Medium Large Hem-O-Lok Clip Applier; 8mm Medium-Large Clip Applier, Xi; 8mm Mega SutureCut Needle Driver; 8mm Mega SutureCut Needle Driver, Xi; 8mm Micro Bipolar Forceps; 8mm Micro Bipolar Forceps, Xi; 8mm Monopolar Curved Scissors; 8mm Monopolar Curved Scissors, Xi; 8mm Permanent Monopolar Cautery Hook, Xi; 8mm Permanent Monopolar Cautery Spatula, Xi; 8mm Potts Scissors, Xi; 8mm ProGrasp Forceps; 8mm ProGrasp Forceps, Xi; 8mm Resano Forceps, Xi; 8mm Round Tip Scissor; 8mm Small Clip Applier, Xi; 8mm Small Grasping Retractor, Xi; 8mm Snap-Fit Instrument, Xi; 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm Reloads; 8mm SureForm Stapler; 8mm Tenaculum Forceps, Xi; 8mm Tip-Up Fenstrated Grasper, Xi; ARM 4 PROXIMAL DRAPE, IS4200; ASSY,CABLE,CORE TO DOCO; ASSY,CABLE,DOCO TO ILLUMINATOR; ASSY,PSCART,IS3000,3-ARM; ASSY,PSCART,IS3000,4-ARM; ASSY,SSC,IS3000; ASSY,VSS VISION SYSTEM W/AVP,VS3000; AUTOMATED REPROCESSING CONNECTOR SET,8MM ENDOSCOPE,IS4000; Accessory Base Starter Kit; Accessory Base Starter Kit, Multi-Specialty, ETH; Alignment Target, 8.6mm Endoscope; Assembly, Cannula Mount, Dual Jaw COV, ECM, da Vinci S, Si; Assembly, PSCart, IS2000, 4-Arm, G1.1; Assembly, Patient Side Cart; Assembly, Surgeon Side Console; Assembly, Surgeon Side System, IS2000; Assembly, VSC, VS2000 Panasonic HD, Domestic; Assembly, Vision System; Assembly, Vision System w/TS, NTSC, VS2000 HD, Domestic; Atrial Retractor , 8mm, da Vinci; Atrial Retractor Short Right; Atrial Retractor Short Right , 8mm, da Vinci S, Si; Automated Reprocessing Connector Set, 8mm Endoscope, Xi; BRACKET(SET),DOCO/ILLUMINATOR RESTRAINING,IS3000; Bath Probe; Bifurcated Light Guide; Bipolar Cautery Cord; Bipolar Cautery Cord, da Vinci SP; Bipolar Energy Activation Cable, CONMED; Bipolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Bipolar Energy Activation Cable, ERBE; Bipolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Gyrus ACMI; Bipolar Energy Activation Cable, Gyrus ACMI, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Valleylab; Bipolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; Black Diamond Micro Forceps , 8mm, da Vinci S, Si; Blade Protector, Snap-fit, da Vinci, da Vinci S, Si; Blue System Cable, Type A to Type B, 7m; Blue System Cable, Type B, 7m; Blue System Cable, da Vinci Si; Bowel Grasper , 5mm, da Vinci; Bowel Grasper , 5mm, da Vinci S, Si; CABLE KIT,BLUE FIBERCONNECT,20M; CABLE,PMED,COVIDIEN FORCE TRIAD; CAMERA ARM DRAPE,IS3000; CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100; CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2; CAMERA STARTER KIT,PANASONIC,HD; CIM extended height adjustable arm; CIM extended pivot arm; CIM height adjustable arm; CIM pivot arm; CO2 Tank Gas Accessory, CGA 940; CO2 Tank Gas Accessory, DIN 477; CO2 Tank Gas Accessory, ISO 407; CO2 Tank Gas Accessory, ISO 5145; COLUMN DRAPE, IS4000; Cadiere Forceps , 8mm, da Vinci S, Si; Cadiere Forceps, da Vinci SP; Camera Arm Sterile Adapter; Camera Head Cable; Camera Head Sterile Adapter; Camera Head Video Cable, Ikegami® HD; Camera Head Video Cable, Panasonic® HD; Camera Head Video Cable, Sumitomo® SD; Camera Sheath, da Vinci SP; Camera Starter Kit; Camera Starter Kit, NTSC Wide Angle, Type 2; Camera Starter Kit, PAL High Mag, Type 2; Camera Starter Kit, PAL Wide Angle, Type 2; Camera Starter Kit, Panasonic HD; Cannula 5 mm Regular, da Vinci S, Si; Cannula Holder, Twist¿Lock, da Vinci; Cannula Seal, 8mm; Cannula, 8.5mm Endoscope; Cannula, Circular, 25 mm x 100 mm, da Vinci SP; Cardiac Probe Grasper; Cardiac Probe Grasper , 8mm, da Vinci; Cardiac Probe Grasper , 8mm, da Vinci S, Si; Catheter Continuity Cable; Catheter Continuity Stand; Catheter Guide; Cautery Hook Tip, 5 mm, da Vinci, da Vinci S, Si; Cautery Hook Tip, da Vinci SP; Cautery Spatula Tip, 5mm, da Vinci, da Vinci S, Si; Cautery Spatula Tip, da Vinci SP; Cleaning and Disinfection Tray, Catheter and Vision Probe, IF1000; Cleaning and Sterilization Kit; Cleaning and Sterilization Kit, English; Cleaning and Sterilization Kit, da Vinci SP; Cobra Grasper , 8mm, da Vinci S, Si; Controller; Curved Bipolar Dissector , 8mm, da Vinci S, Si; Curved Scissors , 5mm, da Vinci; Curved Scissors , 5mm, da Vinci S, Si; Curved Scissors , 8mm, da Vinci S, Si; Curved Stapler 30; DEVICE,ENERGY,ERBE VIO 300D; DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR; DUCT,LEFT,ILLUMINATOR,FIREFLY100; DUCT,RIGHT,ILLUMINATOR,FIREFLY100; Da Vinci 5 Console - Model: C5000; Da Vinci 5 Robot - Model: R5000; Da Vinci 5 Tower - Model: T5000; Da Vinci E-200 Electrosurgical Generator; Da Vinci E-200 Generator; Da Vinci E200 Generator; Da Vinci Force Feedback Cadiere Forceps; Da Vinci Force Feedback Fenestrated Bipolar Forceps; Da Vinci Force Feedback Large Needle Driver; Da Vinci Force Feedback Maryland Bipolar Forceps; Da Vinci Force Feedback Mega SutureCut Needle Driver; Da Vinci Force Feedback ProGrasp Forceps; Da Vinci Handheld Camera; Da Vinci Monopolar and Bipolar Adapters; Da Vinci SP Vision Cart; Da Vinci X/Xi 8mm Endoscope Plus, 0 degree; Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees; Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree; DeBakey Forceps , 5mm, da Vinci; DeBakey Forceps , 5mm, da Vinci S, Si; DeBakey Forceps , 8mm, da Vinci S, Si; Double Fenestrated Grasper , 8mm, da Vinci S, Si; Double Receptacle System Cable Extension Kit; Dual Blade Retractor , 8mm, da Vinci; Dual Blade Retractor , 8mm, da Vinci S, Si; E-100; EndoPass Endoscopic Delivery Instruments; EndoWrist 5mm Thoracic Grasper; EndoWrist Accessories, da Vinci Xi; EndoWrist Cardiac Probe Grasper; EndoWrist Endoscopic Instruments; EndoWrist Instruments, da Vinci S/Si; EndoWrist Instruments, da Vinci Xi; EndoWrist Introducer Instrument; EndoWrist One Suction/Irrigator; EndoWrist One Suction/Irrigator, 8mm, da Vinci Si; EndoWrist One Vessel Sealer , 8mm, da Vinci Si; EndoWrist One Vessel Sealer, 8mm, da Vinci Si; EndoWrist PK Dissecting Forceps; EndoWrist Permanent Cautery Instruments; EndoWrist SP Camera, 0 degree, da Vinci SP; EndoWrist Stabilizer; EndoWrist Stapler 30 Instrument; EndoWrist Stapler 30 Reloads; EndoWrist Stapler 30 System; EndoWrist Stapler 45; EndoWrist Stapler 45 Reload, Blue; EndoWrist Stapler 45 Reload, Green; EndoWrist Stapler 45 System; EndoWrist Stapler Cable; EndoWrist Stapler Cannula Blunt Obturator, da Vinci S, Si; EndoWrist Stapler Cannula Kit; EndoWrist Stapler Cannula Reducer, da Vinci S, Si; EndoWrist Stapler Cannula Seal; EndoWrist Stapler Cannula, da Vinci S, Si; EndoWrist Stapler Motor Pack; EndoWrist Stapler Release Kit; EndoWrist Stapler Sheath; EndoWrist Stapler System Starter Kit - 45 mm; EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm; EndoWrist Suction Irrigator; EndoWrist Vessel Sealer; EndoWrist Vessel Sealer Extend; EndoWrist resuable Accessories, da Vinci S/Si; EndoWristStapler 30 and Stapler 30Reloads; EndoWristStapler 45 and Stapler 45 Reloads; EndoWrist® Stapler 45; EndoWrist® Stapler 45 Curved-Tip; Endopass Delivery Instrument; Endoscope Sterilization Tray; Endoscope, 0 degrees, Xi; Endoscope, 30 degrees, Xi; Endoscopes, da Vinci S/Si; Endoscopes, da Vinci Xi; Endoscopic Instruments; Endowrist Bipolar Instruments; Endowrist Instruments; Endowrist Permanent Cautery Instrum; Endowrist Stapler Cannula; Endowrist Stapler Obturator; Endowrsit Stapler Reducer; Energy Activation Adapter, Ethicon GEN11, da Vinci Si; Energy Activation Cable, CONMED, da Vinci Si; Energy Activation Cable, ERBE, da Vinci Si; Energy Activation Cable, Ethicon; Energy Activation Cable, Ethicon, da Vinci Si; Energy Activation Cable, Gyrus, da Vinci Si; Energy Activation Cable, Valleylab, da Vinci Si; EnergyShield Monopolar Cautery Cord, da Vinci SP; EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP; Fenestrated Bipolar Forceps , 8mm, da Vinci S, Si; Fenestrated Bipolar Forceps, 5mm, da Vinci Si; Fenestrated Bipolar Forceps, da Vinci SP; Fiber Cable Cleaning Kit; Fine Tissue Forceps , 8mm, da Vinci; Flexision"" Biopsy Needle 19G; Flexision"" Biopsy Needle 21G; Flexision"" Biopsy Needle 23G; Flexision™ Biopsy Needle 19G; Flexision™ Biopsy Needle 21G; Flexision™ Biopsy Needle 23G; Fluorescence Imaging Camera Head and Cable Kit; Fluorescence Imaging Illuminator; Fluorescence Imaging Kit; Force Bipolar; Gage Pin, Xi; Grasping Retractor , 8mm, da Vinci S, Si; Green System Cable, da Vinci Si; Handheld Camera Light Guide; Handheld Camera Light Guide Adapter; Handheld Camera Sterilization Tray; Harmonic ACE; Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic ACE Curved Shears, 5mm, da Vinci S/Si; Harmonic ACE Curved Shears, 8mm, da Vinci S/Si; Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Ace Curved Shears; Harmonic Ace Curved Shears , 5mm, da Vinci; Harmonic Ace Curved Shears , 5mm, da Vinci S, Si; Harmonic Ace Curved Shears , 8mm, da Vinci S, Si; Harmonic Curved Shears; Harmonic Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Curved Shears Instrument; Harmonic Curved Shears, 5mm, da Vinci; Harmonic Curved Shears, 5mm, da Vinci S, Si; Harmonic Curved Shears, 8mm, da Vinci; Harmonic Curved Shears, 8mm, da Vinci S, Si; ICB, Instrument Control Box; IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000; ILLUMINATOR,Y1865; INSTRUMENT ARM DRAPE IS2000; INSTRUMENT ARM DRAPE, IS4000; INTUITIVE SURGICAL STEREO ENDOSCOPE; IRIS System 1; IRISeg; IRK,ENGLISH,IS4000; IRK,OUS,IS3000; IRK,OUS,IS4000; IRK,OUS,W/O VS,IS3000; IRK,OUS,W/O VS,IS4000; IS Endoscopic Control System; IS Endoscopic Instruments; IS Endowrist Bipolar Instrument; IS da Vinci Surgical System; IS3000 Stapler 45 Accessories; IS3000 Stapler 45 Instrument; IS4000 ACCESSORY STARTER KIT; IS4000 EndoWrist Stapler 30; IS4000 Long Bipolar Forceps; IS4000 Small Clip Applier  IS4000 Long Bipolar Forceps; IS4000 Stapler 45 Accessories; IS4000 Stapler 45 Instrument; IS4000 da Vinci EndoWrist Instruments; IS4200 ACCESSORY STARTER KIT; Illuminator Lamp Module, Model Y1866; Instrument Arm Drape, da Vinci SP; Instrument Release Kit, Xi; Instrument Sheath, da Vinci SP; Instrument Tray, da Vinci, da Vinci S, Si; Instrument/Accessory Steriliz Tray; Introducer 5Fr , 5mm, da Vinci S, Si; Intuitive Endoluminal Gastrointestinal System (IG1000); Intuitive Surgical EndoWrist Stabilizer; Intuitive Surgical Vessel Sealer Extend; Intuitive Surgical da Vinci S Surgical System, Model IS2000 with Connect OnSite and Wireless Connectivity Option; Intuitive Surgical da Vinci Surgical System; Intuitive Surgical da Vinci®,da Vinci S®, and da Vinci Si® Surgical Systems and EndoWrist Instruments and Accessories; Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System; Ion Endoluminal System (IF1000); Ion Reprocessing Consumable Kit; Ion reprocessing accessory kit; Ion"" Fully Articulating Catheter; Ion"" Peripheral Vision Probe; Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000); Ion™ Endoluminal System, Model IF1000; Ion™ Fully Articulating Catheter; Ion™ Peripheral Vision Probe; KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F; Laparoscope 10mm, 0, NIR; Laparoscope 10mm, 30, NIR; Laparoscope 5mm, 0; Laparoscope 5mm, 30; Large Clip Applier , 8mm, da Vinci S, Si; Large Needle Driver , 8mm, da Vinci S, Si; Large SutureCut Needle Driver , 8mm, da Vinci S, Si; Leak Test Adapter; Light Guide Cable Adapter; Light Guide Cable Adapter, da Vinci, da Vinci S; Long Tip Forceps , 8mm, da Vinci S, Si; MARS 1; MCS Tip, da Vinci SP; MP Instrument Reprocessing Connector, 1 Device; MP Instrument Reprocessing Connector, 2 Device; MP Instrument Reprocessing Tray; Maryland Bipolar Forceps , 8mm, da Vinci S, Si; Maryland Bipolar Forceps, da Vinci SP; Maryland Dissector , 5mm, da Vinci; Maryland Dissector , 5mm, da Vinci S, Si; Medium-Large Clip Applier , 8mm, da Vinci S, Si; Medium-Large Clip Applier, da Vinci SP; Mega Needle Driver , 8mm, da Vinci S, Si; Mega SutureCut Needle Driver , 8mm, da Vinci; Mega SutureCut Needle Driver , 8mm, da Vinci S, Si; Micro Bipolar Forceps , 8mm, da Vinci; Micro Bipolar Forceps, 8mm, da Vinci S, Si; Monopolar Cautery , 5mm, da Vinci; Monopolar Cautery , 5mm, da Vinci S, Si; Monopolar Cautery Cord; Monopolar Cautery Instrument, da Vinci SP; Monopolar Curved Scissors , 8mm, da Vinci; Monopolar Curved Scissors , 8mm, da Vinci S, Si; Monopolar Curved Scissors, 8mm, da Vinci S, Si; Monopolar Curved Scissors, da Vinci SP; Monopolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Monopolar Energy Activation Cable, ERBE; Monopolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; NIR Handheld Camera; NIR Handheld Camera Control Unit (CCU); NIR Handheld Camera Light Guide; NIR Handheld Camera Light Guide Adapter; NIR Handheld Camera Light Source; NIR Handheld Camera System Starter Kit; NIR Handheld Camera Tray; Needle Driver , 5mm, da Vinci; Needle Driver , 5mm, da Vinci S, Si; Needle Driver, da Vinci SP; Obturator, Circular, 25 mm x 100 mm, da Vinci SP; Option, Connect, da Vinci Si; PANASONIC CAMERA HEAD,HDTV,SCHOELLY; PK Dissecting Forceps; PK Dissecting Forceps , 8mm, da Vinci S, Si; PK® Instrument Cord, G400 Generator, da Vinci, da Vinci S, Si; PK® Instrument Cord, PK/SP Generator, da Vinci, da Vinci S, Si; PROBE HOLDER SYSTEM; Pericardial Dissector , 8mm, da Vinci; Permanent Cautery Hook , 8mm, da Vinci S, Si; Permanent Cautery Spatula , 8mm, da Vinci S, Si; PlanPoint"" Software; PlanPoint™ Software; Planning Laptop; Potts Scissors , 8mm, da Vinci S, Si; Power Cord, 3.7 Meter, 115V, US, C13 > Hospital Grade; PreCise Bipolar Forceps , 8mm, da Vinci; PreCise Bipolar Forceps , 8mm, da Vinci S, Si; Procedure Tray, da Vinci, da Vinci S, Si; Prograsp Forceps , 8mm, da Vinci S, Si; Red System Cable, da Vinci® S¿, da Vinci S; Reprocessing Cover; Resano Forceps , 8mm, da Vinci; Resano Forceps , 8mm, da Vinci S, Si; Roll stands and charts; Round Tip Scissors , 5mm, da Vinci; Round Tip Scissors , 5mm, da Vinci S, Si; Round Tip Scissors , 8mm, da Vinci S, Si; Round Tooth Retractor, da Vinci SP; SP Access Port Kit, Large Incision (2.7 cm-7 cm); SP Access Port Kit, Small Incision (2.7 cm-4 cm); SP Cadiere Forceps; SP Cadiere Forceps, Extended Range; SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP; SP Cleaning and Sterilization Kit, da Vinci SP; SP Endoscope Reprocessing Tray; SP Endoscope, 0°; SP Fenestrated Bipolar Forceps; SP Force Bipolar; SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments); SP Force Bipolar, Extended Range; SP Instrument Reprocessing Tray; SP Maryland Bipolar Forceps; SP Maryland Bipolar Forceps, Extended Range; SP Medium Large Clip Applier; SP Monopolar Cautery Instrument; SP Monopolar Curved Scissors; SP Monopolar Curved Scissors Extended Range; SP Needle Driver; SP Needle Driver Extended Range; SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP; SP Reprocessing Connector, 1 device; SP Reprocessing Connector, 2 devices; SP Round Tooth Retractor Extended Range; SRK,ENGLISH,IS4000; SRK,OUS,IS4000; STARTER KIT,FF100 VISION; STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM; STARTER KIT,IS3000,HD ENDOSCOPE,12MM; STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM; Schertel Grasper , 5mm, da Vinci; Schertel Grasper , 5mm, da Vinci S, Si; Single Instrument Tray, da Vinci, da Vinci S, Si; Single Receptacle System Cable Extension Kit; Single-Site 10 mm Accessory Cannula, da Vinci Si; Single-Site 10 mm Blunt Obturator, da Vinci Si; Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si; Single-Site Bipolar Maryland, 5mm, da Vinci Si; Single-Site Fundus Grasper , 5mm, da Vinci Si; Single-Site Maryland Dissector , 5mm, da Vinci Si; Single-Site Monopolar Cautery , 5mm, da Vinci Si; Single-Site Port for 8.5 mm Endoscope, da Vinci Si; Single-Site Starter Kit US, Cholecystectomy, 20 Cases; Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si; Small Clip Applier , 8mm, da Vinci S, Si; Small Grasping Retractor , 8mm, da Vinci S, Si; Snap-Fit Scalpel Instrument , 8mm, da Vinci; Snap-Fit Scalpel Instrument , 8mm, da Vinci S, Si; Snap-fit Blue Blade, da Vinci, da Vinci S, Si; Snap-fit Paddle Blade, da Vinci, da Vinci S, Si; Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5; Stapler 45 Reload, Blue; Stapler 45 Reload, Green; Stapler 45 Reload, White; Stapler Cannula; Stapler Cannula Blunt Obturator; Stapler Cannula Blunt Obturator, Long; Stapler Cannula, Long; Stapler Release Kit; Stapler Sheath; Stapler-8mm Cannula Reducer; Streme App; SureForm 45 Curved Tip, SureForm 45 Gray Reload; SureForm 45 System; SureForm 45, SureForm 45 Reloads; SureForm 60; SureForm 60 Reloads; SureForm 60 System; Swivel Connector; SynchroSeal; System Cart; Teleflex Obturators; Tenaculum Forceps , 8mm, da Vinci S, Si; Thoracic Grasper , 5mm, da Vinci S, Si; Thoracic Grasper , 8mm, da Vinci; Thoracic Grasper , 8mm, da Vinci S, Si; Tip Cover Accessory; Tip Cover Accessory, da Vinci, da Vinci S, Si; UPGRADE,CO2 TANK INTERFACE,CGA940,US; Universal Seal; Universal Seal (5-12 mm); Universal Seal (5-12mm); VIO DV 2,INTEGRATED ELECTRO SURGICAL UNIT; VIO-ICB Mounting Bracket; Valve Hook , 8mm, da Vinci; Valve Hook , 8mm, da Vinci S, Si; Video Review (also referred to as “Replay”); Vision Probe Adapter and Suction Adapter; Vision Probe Bag; VisionBoom¿ Extension Cable; X; Xi; da Vinci 5 Force Feedback Cadiere Forceps; da Vinci 5 Force Feedback Fenestrated Bipolar Forceps; da Vinci 5 Force Feedback Large Needle Driver; da Vinci 5 Force Feedback Maryland Bipolar Forceps; da Vinci 5 Force Feedback Mega SutureCut Needle Driver; da Vinci 5 Force Feedback ProGrasp Forceps; da Vinci 5 Handheld Camera Head; da Vinci 5 Handheld Camera Laparoscope, 0°; da Vinci 5 Handheld Camera Laparoscope, 30°; da Vinci 5 Handheld Camera Tray; da Vinci E-200 Electrosurgical Generator; da Vinci Firefly Imaging System; da Vinci Fluorescence Imaging Vision System; da Vinci Force Feedback Cadiere Forceps; da Vinci Force Feedback Fenestrated Bipolar Forceps; da Vinci Force Feedback Large Needle Driver; da Vinci Force Feedback Maryland Bipolar Forceps; da Vinci Force Feedback Mega SutureCut Needle Driver; da Vinci Force Feedback ProGrasp Forceps; da Vinci Instrument Reprocessing Tray; da Vinci Insufflator; da Vinci Insufflator Tube Set with Smoke Evacuation; da Vinci S Surgical System; da Vinci SP Advanced Access Port Kit; da Vinci SP Firefly Imaging System; da Vinci SP SureForm™ 45 Curved-Tip Stapler; da Vinci SP SureForm™ 45 Stapler; da Vinci SP Surgical System; da Vinci SP Surgical System (SP1098); da Vinci SP Surgical System, Patient Cart; da Vinci SP Surgical System, Surgeon Console; da Vinci SP Surgical System, Vision Cart; da Vinci SP® Instruments and Accessories; da Vinci SP® Surgical System, Model SP1098; da Vinci Si; da Vinci Single-Site Accessories; da Vinci Single-Site Instrument and Accessories; da Vinci Single-Site Instruments; da Vinci Single-Site Instruments and Accessories; da Vinci Single-Site Port; da Vinci SonicPro Cleaning System; da Vinci Surgi=cal System, S (HD); da Vinci Surgical System (IS5000); da Vinci Surgical System, Model IS5000; da Vinci Surgical System, S; da Vinci Surgical System, Si; da Vinci X; da Vinci X Surgical System; da Vinci X Surgical System (IS4200); da Vinci Xi; da Vinci Xi 12 mm and Stapler Hasson Cone; da Vinci Xi 12-8 mm Reducer; da Vinci Xi 8 mm Hasson Cone; da Vinci Xi Surgical System (IS4000); da Vinci Xi Surgical System with Table Motion; da Vinci Xi Surgical System, Patient Cart; da Vinci Xi Surgical System, Surgeon Console; da Vinci Xi Surgical System, Vision Cart; da Vinci® 8 mm Cannula Gage Pin, da Vinci, da Vinci S, Si; da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200; iESU; surgical drapes",1998-01-06,190,2026-10-14,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015612252%22&limit=1
"Merit Medical Systems, Inc.",1721504,1721504,1600 West Merit Pkwy.,South Jordan,UT,84095,United States,"Merit Medical Systems, Inc.",1721504,Complaint file establishment; Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,122,BWN; BZN; CCX; DQO; DQX; DQY; DRA; DRB; DRC; DRE; DRS; DSY; DTE; DTL; DWM; DWO; DWS; DWZ; DXC; DXE; DXT; DYB; ESW; EXF; FAD; FAJ; FCG; FCY; FDY; FED; FGE; FJS; FKO; FKX; FMF; FPA; FPK; FQM; FZX; GAA; GAH; GAX; GBW; GBX; GCB; GCC; GDF; GEA; GEH; GEI; GES; GXI; HRX; HTW; HXG; JAQ; JCT; JDZ; JOL; JRL; KCY; KDC; KDD; KDQ; KGS; KGX; KGZ; KIH; KME; KMK; KNQ; KNS; KNW; KRA; KRD; KTI; KYZ; KZD; LDF; LJS; LOD; LXH; LYV; MAV; MDM; MHW; MMX; MSD; NAJ; NDN; NEU; NRY; NWU; OAD; OAR; OCX; OCY; ODE; ODY; OEQ; OEX; OEZ; OJA; OJV; OMT; OWL; PEV; PFV; PNG; PPD; PTL; PTM; PUR; PXI; PXU; PYB; PYC; QBP; QEY; QEZ; QJH; QSY,"Table And Attachments, Operating-Room; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Support, Patient Position; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Stylet, Catheter; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Transducer, Blood-Pressure, Extravascular; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Pulse-Generator, Pacemaker, External; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Apparatus, Suction, Patient Care; Needle, Biopsy, Cardiovascular; Instruments, Surgical, Cardiovascular; Device, Biopsy, Endomyocardial; Clamp, Vascular; Catheter, Embolectomy; Injector And Syringe, Angiographic; Introducer, Catheter; Prosthesis, Esophageal; Bag, Bile Collecting; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Biopsy Needle; Bulb, Inflation, For Endoscope; Device, Measuring, For Panendoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Stents, Drains And Dilators For The Biliary Ducts; Catheter, Peritoneal, Long-Term Indwelling; Catheter, Peritoneal Dialysis, Single Use; System, Peritoneal, Automatic Delivery; Syringe, Piston; Set, Administration, Intravascular; Tubing, Fluid Delivery; Bandage, Elastic; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Stylet, Surgical, General & Plastic Surgery; Tourniquet, Nonpneumatic; Catheter, Peritoneal; Catheter, Irrigation; Needle, Catheter; Dilator, Catheter; Guide, Needle, Surgical; Cannula, Surgical, General & Plastic Surgery; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Scalpel; Probe, Radiofrequency Lesion; Arthroscope; Bit, Drill; Tamp; System, Applicator, Radionuclide, Remote-Controlled; Prosthesis, Tracheal, Expandable; Mixer, Cement, For Clinical Use; Catheter And Tip, Suction; Unit, Filter, Membrane; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Dispenser, Cement; Bedding, Disposable, Medical; Device, Intravascular Catheter Securement; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Instrument, Biopsy; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Electrode, Pacemaker, Temporary; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Bone Cement; Orthopedic Manual Surgical Instrument; Label Or Tag, Sterile; Syringe, Balloon Inflation; Instrument, Manual, Surgical, General Use; Dressing, Compression; Device, Percutaneous Retrieval; Catheter, Hemodialysis, Implanted; Agents, Embolic, For Treatment Of Uterine Fibroids; Cement, Bone, Vertebroplasty; Marker, Radiographic, Implantable; Catheter, Thrombus Retriever; Endoscope Introducer Kit; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter; Injector, Vertebroplasty (Does Not Contain Cement); Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd); Tunneled Catheter Remover; Angiography/Angioplasty Kit; Cardiovascular Catheter Sheath Introducer Kit; Cardiovascular Procedure Kit; Intravenous Extension Tubing Set; Single Use Instrument Tray; Absorbable Lung Biopsy Plug; Peripheral Catheter Insertion Kit; Dialysis Administration Kit; System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Universal Drainage Tray; Wire, Guide, Catheter, Exempt; Syringe, Balloon Inflation, Exempt; Vacuum Syringe; Thoracentesis Tray; Fluid Drainage Tray; Minor Surgical Procedures Tray; Paracentesis Tray; Cap, Device Disinfectant; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter; Reverse Central Venous Recanalization System; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; 3; U,"1 mL syringe(Polypropylene); 10Fore Hemostasis Valve; 10Fore Hemostasis Valve Kit; 5.5 F Worley Advanced LVI Lateral Vein Introducer; AEROmini Tracheobronchial Stent System; ARC Catheter; ASAP Aspiration Catheter; ASAP CATHETER; ASAP Catheter; ASAPLP Aspiration Catheter; ASAPLP Embolectomy Catheter; Access-9; AccessPLUS; Achieve; Activation Element, ERx bone cement; Acutiy Universal Cutter; Adjustable Biopsy Port Seal BPS-A; Advance Angiographic Needle; Aero DV Tracheobronchial Stent System; Aero Tracheo Stent and Delivery System; Aerosizer; Alimaxx E; Arcadia Balloon Catheter; Arcadia Balloon Catheter Kit; Aspira Peritoneal Drainage System; Aspira Pleural Drainage System; BIG60; BIG60 ALPHA Inflation Devie; BRC-BAL-INT-FL/A; BackStop Plus Closed Waste Basin; Bearing nsPVA Embolization Particles; Bedford™ Guided Hard Bone Biopsy System; BioFlo Duramax; BioSentry Tract Sealant System; Blue Diamond Inflation Syringe; BowTie Guide Wire Insertion Device; Bulldog Lead Extender; Byrd Dilator Sheath Set; C2 Cryoballoon Ablation System; C2 Cryoballoon Endogrip; CT Transfer Set; CardiaGuide Fixed Curve Braided Transseptal Sheath; Cardiac Output Kit; Cen-Step Centesis Catheter; Centros Long-Term Hemodialysis Catheter; CentrosFLO Long-Term Hemodialysis Catheter; Cerenovus Aspiration Tubing set; Check Valve; ClariVein IC Infusion Catheter; ClariVein OC; Coil Expander; Concierge Guiding Catheter; Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI); Cool Point Irrigation Pump; Coronary Control Syringe; Corvocet Biopsy System; Corvocet Coaxial Introducer; Cuff Implantor; Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; Dark Blue Cap for Male Luers; Dash 9F Hydrophilic Sheath Introducer; DiamondTOUCH Inflation Device and Fluid Dispensing Syringe; DiamondTOUCH Syringe; DoublePlay Hemostasis Valve; Drainage Tubing; DriPAD Super Absorbent Pad; DualCap; DualCap Duo; DualCap IV Pole Strips; DualCap Solo; DuraFlow 2 Hemodialysis Catheter; Duramax; EN Snare Endovascular Snare System; ER2 Saturate Mixing System; Elation Fixed Wire Balloon; Elation Pulmonary Balloon; Elation Pulmonary Balloon 4mm; Elation Wireguided Balloon; Elation5 Fixed Wire Balloon; Elation5 Wireguided Balloon; Embedding Tool; EndoMAXX; EsophyX Z+ Device; EvenMore Chronic Hemodialysis Catheter; Evolution RL & Evolution Shortie RL; Excite Contrast Injection Line; ExxTended Catheter; FLO30; FLO40XR; FLO50; Faller Trocar; FastBreak Connector; Finale Radial Compression System; Flex-Neck Catheter; Flex-Neck Extender/Repair Kit; Flex-Neck Infant Catheter; FlexTract Deflectable-Rotational Dilator Sheath Set; FlowGuard; Fluid Dispensing Syringe; Fountain 4F Catheter & Occluding GW; Fountain Catheter/Occluding Guide Wire; Fountain Infusion Catheter w/ Occluding Guide Wire; Fountain Infusion System; Fountain ValveTip Infusion Catheter; Futura Safety Scalpel; Go2Wire Guide Wire; Guidewire Introducer; Guidewire with Palladium Tip; H20 Guidewire; H20 Torque Device; HeRO Graft; HeartLight Deflectable Sheath; HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al.; HeartSpan Steerable Introducer Sheath; HeartSpan Steerable Sheath Introducer; Hemostasis Valve Adapter; Honor hemostasis valve; Huntington Guided, Perforating Bone Biospy System with Drill; Hydraulic Assembly; Hydraulic-Master Syringe Assembly; Hydrophilic Guidewire; Hydrophilic Prelude SNAP Splittable Sheath Introducer; Impress Angiographic Catheter; Impress UAC Catheter; Impress and Impress Legato Hydrophilic Angiographic Catheter; Impress with Legato Hydrophilic Coating; InQwire; InQwire Amplatz Super Stiff Guide Wire; InQwire Diagnostic (Support) Non-Vascular Guide Wire; InQwire Guidewire-Prelude Introducer; InQwire Guidewires; InQwire Super Stiff Guide Wire; Insufflation Set; Intellisystem Inflation Device; Introducer Needle WithTrocar Stylet; K01 Kit (MSS); K01 Syringe Kit (1mL & 20mL COP); K01 Syringe Kit (1mL Polypropylene); K02 Syringe Kit (multiple K01); K02 Syringe Kit (multiple K01)); K02-00873A, K02-01105A, K02-01481A; K04 - Tubing Kit; K05 Inflation Kit; K05T - Inflation Kit; K06 Syringe Kit (single CSS); K07 Syringe Kit (multiple K06); K08 Fluid Management Kit; K09 Manifold Kit; K09T - Manifold Kit; K10 Waste Management Kit; K10T - Waste Management Kit; K11 Pressure Monitoring Kit; K12 Procedure Kit; K12T - Procedure Kit; K13 Label Kit; K14 Dialysis Kit; K15 Sheath Introducer Kit; K16 Microcatheter Kit; K17 Interventional Kit; K17T - Interventional Kit; K18 Sheath Introducer Kit (Ease); K19 Combination Packs; K20 Endoscopic Kit; K20T - Endoscopic Kit; K21 Sheath Introducer Kit (IDeal); K22C Vein Tray; K23C Vein Accessory Kit; KYPHON KyphoFlex Balloon Catheter; KYPHON KyphoFlex Balloon Catheter Kit; Kensington Guide Wire Bone Biopsy System; Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411); Lead Clippers; Liberator Beacon Tip Locking Stylet; Low Profile Companion Sheath; MAK-NV Non-Vascular; MAP Torque Device & Introducer; MBA; MYSHELL Hemostatic Valve; Madison Mini™ Bone Biopsy System; Madison™ Perforating Bone Biopsy System with Drill; Maestro Microcatheter; Majestik Angiographic Needle; Master Syringe Assembly; Maxxwire; Medallion Syringe; Merit 1mL Syringe (COP); Merit 20 mL Syringe (COP); Merit Administration Set; Merit Centros Long-Term Hemodialysis Catehter; Merit CentrosFLO Long-Term Hemodialysis Catheter; Merit Convenience Kits; Merit Disposal Depot; Merit Drainage Depot; Merit HeRO Graft; Merit High Pressure Tubing; Merit Hydrophilic Guide Wire; Merit InQwire® Amplatz Super Stiff Guide Wire; Merit MAK (Mini Access Kit); Merit Manifold; Merit Marquis Flow Switch; Merit Marquis Stopcock; Merit PAK; Merit Pressure Monitoring Tubing; Merit Pursue Microcatheter; Merit S-MAK (Stiffened Mini Access Kit); Merit Safety Needle; Merit Syringe; Merit Triboglide Syringe; Meritrans Disposable Transducer; MetaSTAR RF Generator; Micro Ace Advanced Micro Access System; Micro Ace Gold Advanced Micro Access System; Mighty Wire; MiniStop Filter Closed Waste Basin; MiniStop Plus Closed Waste Basin; Miser Contrast Management System; Monarch Compak Inflation Syringe; Monarch Syringe Fluid Dispense System; MultiPlex II Controller; Needle's Eye Snare Retrieval Set; NeoVasc; Non-vascular tissue dilators; Novatome Endomyocardial Biopsy Forceps; One Snare Endovascular Snare System ONE1501; One-Step Centesis Catheter; One-Tie Compression Coil; One-Vac Evacuated Drainage Bottle; OneMark Breast Localization Marker; OneMark DIS Console & Probe Activities: Manufacturer; OneMark DIS Probe 01; OneMark Detection Imaging System; OneMark Detector Console; OneSnare Endovascular Snare System; Osseoflex Access Kit; Osseoflex CD-H Hydraulic Cement Delivery System; Osseoflex SB Steerable Balloon (10Ga); Osseoflex SB Steerable Balloon (8ga); Osseoflex SB Straight Balloon (10ga); Osseoflex SB Straight Balloon (8ga); Osseoflex SN; Osseoflex SN Needle; Osseoflex SN+ Needle; Osseoflex Straight Hand Drill; Osseon Bone Filler Device (BFD); Ostial Pro Stent Positioning System; OuTake Catheter Extractor; PAL (Pen and Labels) Family; Passage Hemostasis Valve; Perchik Button Assembly; Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M); Performa Diagnostic Intravascular Catheter; Pericardiocentesis Catheter Kit; Peritoneal Dialysis Catheter Connector; Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211); PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing; Pin Vise Polymer; PinVise Torque Device; Pink Achieve; Pinvise Torque Device; PowerCURVE Navigating Osteotome; Prelude Choice Hemostasis Valve Adapter; Prelude IDeal Hydrophilic Sheath Introducer; Prelude Plastic Jacketed Guide Wire; Prelude Prestige Splittable Sheath Introducer; Prelude SNAP 165 Valved Splittable Sheath Introducer; Prelude SNAP Splittable Sheath Introducer; Prelude Sheath Half Size (ACT); Prelude Sheath Introducer; Prelude Short Sheath Introducer; Prelude Wave Hydrophilic Sheath Introducer; PreludeEASE Hydrophilic Sheath Introducer, 4F-6F; PreludeEASE Hydrophilic Sheath Introducer, 7F; PreludeSYNC DISTAL Radial Compression Device; PreludeSYNC EVO Radial Compression Device; PreludeSYNC EZ Radial Compression Device; Pressure Infusor Bags (PIB); Preston Bone Filler; Preston™ Hard Bone Access Needle with Drill; Preston™ Hard Bone Introducer; Preston™ Long Drill; Preston™ Transpedicular Drill; Preston™ Transpedicular Introducer; ProGuide Long Term Hemodialysis Catheter; Purge Assist; Quick Silver; RADstat Radial Artery Compression Device; RTT14038MB; RXP (Rapid Exchange Flushing Syringe); Rad Board; Rad Board 2 Reusable Arm Board; Rad Board Xtra; Rad Rest; Rad Trac; ReSolve Biliary Locking Drainage Catheter; ReSolve ConvertX Biliary Stent System; ReSolve ConvertX Nephroureteral Stent System; ReSolve Dilators; ReSolve Locking Drainage Catheter; ReSolve Non-Locking Drainage Catheter; Repositional Chest Tube; Resilience Fully Covered Esophageal Stent System; Revolution Catheter Securement Dev.; Roadster Guide Sheath; Rotating Adaptor; S-MAK XL; SAVI Applicator Kit; SAVI Prep Device; SAVI Spacer; SCOUT Bx Delivery System; SCOUT Console and Accessory Cart; SCOUT MD Console; SCOUT MD Delivery System; SCOUT MD Guides; SCOUT MD Single-Use Handpieces; SCOUT MD Single-use Handpieces; SCOUT Reflector and Delivery Systems; SCOUT Single-Use Handpiece, SCOUT Surgical Guides; SCOUT Surgical Console and SCOUT Check Console; SPINR High-Performance Guidewire Catheter; STAR Tumor Ablation Kit and Accessories; STAR Tumor Ablation Kit with PowerCURVE; STATSEAL; SafeGuard Focus Compression Device; SafeGuard Focus Compression Device (Adhesive Free); SafeGuard Focus Cool Device; SafeGuard Focus Cool Device (Adhesive Free); SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al.; SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al.; SafeSheath Sealing Adapter; Safeguard Pressure Assisted Device (12cm); Safeguard Pressure Assisted Dressing (24cm); Safeguard Radial Compression Device; Safety Paracentesis Tray (SPPT); SeaDragon Torque Device; ShortStop Advantage Temporary Sharps Holder; ShortStop Grandstand Temporary Sharps Holder; ShortStop Temporary Sharps Holder; Sidecar External Working Channel (FG-1011); Siege Vascular Plug; Slip-Not; Smart Tip Control Syringe; Sof-Grip Hemostat; Softouch Diag. Intra Cath. w/Vessel; Solo Pace Control; Solo Pace Fusion System (SOLOFUSE1); Spectranetics; SpineSTAR Ablation Instruments; Splashwire Hydrophilic Guide Wire; Splashwire Hydrophilic guide wire; Squirt Fluid Delivery System; StabiliT Bone Cement and Saturate Mixing System; StabiliT Cement Delivery Syringe; StabiliT ER2 Bone Cement and Saturate Mixing System; StabiliT Introducer and Delivery Instruments; StabiliT MX Fracture Kits; StabiliT MX Fracture Kits with PowerCURVE; StabiliT VP Fracture Kits; StabiliT VP Vertebrosplasty Kit; StayFix Fixation Device; SteadySheath & Shortie; Sterilized Convenience Kits; Stopcock One Port Manifold; Straightline Osteotome, VerteCOR Midline Osteotome; Stylet Wire; Stylette (rod obturator); SureCross Support Catheter; Surfacer Inside-Out Access Catheter System; SwiftNINJA Microcatheter; SwiftNINJA Steerable Microcatheter; TRAM; TRAM-P; Temno ACT; Temno Elite Biopsy Systems; Temno Evolution; Temno Original; Thoracentesis Tray (TAPS); Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al.; TruCut 14Ga; TruCut 18Ga; True Form Reshapable Guide Wire; Universal Coaxial Needles; VACLOK Syringe; VacLok AT Syringe; Valve Adapter; Ventrax Delivery System; VertecoR Bone Drill, 3; Vessel Sizing Catheter (VSC); ViaVerte RF Generator; ViaVerte Steerable RF Ablation Kit; WOUNDSEAL; Westbrook™ Bone Biopsy System; Worley; Wrapsody Cell-Impermeable Endoprosthesis; X-Change Cement Dispensing Syringe; basixCompak Analog Inflation Syringe; basixSKY Inflation Device; basixTOUCH; basixTOUCH40 Inflation Syringe",1992-07-14,188,2026-07-27,1,89,2,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221721504%22&limit=1
Worldwide Supplies Limited,3014579161,3014579161,"50 Bonham Strand NO.5, 17/F Bonham Trade Centre",Hong Kong,,none,Hong Kong,Worldwide Supplies Limited,10057941,Exporter to the US,201,BSF; BSP; BSR; BSZ; BTM; BTO; BTX; BWF; BYD; BYH; BZA; BZG; BZQ; CAD; CAE; CAI; CCK; CCW; DPS; DPZ; DQA; DQD; DQK; DQX; DQY; DRO; DRT; DRX; DSA; DSK; DWS; DXH; DXN; DXQ; EBD; EBF; EFT; EGN; EGS; EHL; EHY; EIX; EJG; EJY; EKB; ELW; EMA; EMG; EMJ; EMN; EMS; ERA; EWO; EXB; EXE; EXH; EYB; EYQ; EYZ; EZD; EZL; EZP; EZR; FAM; FCG; FCM; FCY; FEG; FER; FFL; FGE; FHN; FHQ; FKK; FLL; FMF; FMH; FMI; FMK; FMP; FNY; FON; FOZ; FPA; FQM; FRC; FRI; FRO; FSA; FSM; FSR; FTY; FYD; GAA; GAL; GAM; GAP; GAQ; GAR; GAT; GAW; GBO; GBX; GBZ; GCD; GCJ; GCW; GCX; GDF; GEA; GEI; GEJ; GWQ; GXB; GXY; HBF; HFW; HGE; HIB; HIF; HJN; HKM; HLJ; HLS; HMF; HNY; HRX; IFP; IKD; IKY; IME; ITG; ITQ; JEQ; JKA; JKS; JOH; JOL; JOW; JTW; KAI; KDC; KDI; KGO; KGX; KKX; KMF; KMK; KNS; KNT; KOD; KOE; KPE; KTI; KYZ; KZF; LDD; LDE; LHC; LHI; LJE; LJH; LJT; LKB; LKF; LMF; LQR; LWK; LYU; LZA; LZC; LZH; MAV; MEG; MGQ; MHW; MHX; MKJ; MMK; MWI; NAB; NAC; NAD; NBY; NEC; NEP; NEU; NEW; NOI; OCT; OCY; OCZ; ODG; OPJ; PNG; PSZ; PUI; PUK; QAU; QDO; SDV,"Absorber, Carbon-Dioxide; Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Gas-Machine, Anesthesia; Ventilator, Emergency, Manual (Resuscitator); Tube, Tracheostomy (W/Wo Connector); Board, Arm (With Cover), Sterile; Spirometer, Therapeutic (Incentive); Condenser, Heat And Moisture (Artificial Nose); Drain, Tee (Water Trap); Connector, Airway (Extension); Spirometer, Diagnostic; Monitor, Breathing Frequency; Vaporizer, Anesthesia, Non-Heated; Airway, Oropharyngeal, Anesthesiology; Circuit, Breathing (W Connector, Adaptor, Y Piece); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Laryngoscope, Rigid; Electrocardiograph; Oximeter, Ear; Oximeter; Stethoscope, Electronic; Computer, Diagnostic, Programmable; Wire, Guide, Catheter; Catheter, Percutaneous; Pacemaker, Cardiac, External Transcutaneous (Non-Invasive); Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Electrode, Electrocardiograph; Cable, Transducer And Electrode, Patient, (Including Connector); Computer, Blood-Pressure; Instruments, Surgical, Cardiovascular; Transmitters And Receivers, Electrocardiograph, Telephone; System, Measurement, Blood-Pressure, Non-Invasive; Blood Pressure Cuff; Coating, Filling Material, Resin; Material, Tooth Shade, Resin; Cleanser, Denture, Over The Counter; Scissors, Surgical Tissue, Dental; Handpiece, Contra- And Right-Angle Attachment, Dental; Point, Abrasive; Tray, Impression, Preformed; Probe, Periodontic; Forceps, Rubber Dam Clamp; Pliers, Operative; Explorer, Operative; Material, Impression; Cement, Dental; Forceps, Tooth Extractor, Surgical; Elevator, Surgical, Dental; Scaler, Periodontic; Curette, Periodontic; Otoscope; Audiometer; Collector, Ostomy; Protector, Ostomy; Bag, Urinary, Ileostomy; Catheter, Ureteral, Gastro-Urology; Garment, Protective, For Incontinence; System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile; Catheter, Straight; Catheter, Retention Type, Balloon; Rod, Colostomy; Cement, Stomal Appliance, Ostomy; Sigmoidoscope And Accessories, Flexible/Rigid; Biopsy Needle; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Bulb, Inflation, For Endoscope; Tube, Double Lumen For Intestinal Decompression And/Or Intubation; Anoscope And Accessories; Dislodger, Stone, Basket, Ureteral, Metal; Stents, Drains And Dilators For The Biliary Ducts; Ligator, Hemorrhoidal; Holder, Needle, Gastroenterologic; Clamp, Line; Continuous Measurement Thermometer; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Protector, Skin Pressure; Basin, Emesis; Bag, Drainage, With Adhesive, Ostomy; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Bandage, Elastic; Indicator, Biological Sterilization Process; Scale, Stand-On, Patient; Dressing, Wound, Drug; Lift, Patient, Non-Ac-Powered; Tray, Surgical, Instrument; Light, Headband, Surgical; Tape, Measuring, Rulers And Calipers; Apparatus, Exhaust, Surgical; Needle, Aspiration And Injection, Disposable; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Irrigation; Catheter, Cholangiography; Connector, Catheter; Laparoscope, General & Plastic Surgery; Transformer, Endoscope; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Guide, Needle, Surgical; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Full-Montage Standard Electroencephalograph; Esthesiometer; Electrode, Cutaneous; Drills, Burrs, Trephines & Accessories (Compound, Powered); Clamp, Umbilical; Amniotome; Speculum, Vaginal, Nonmetal; Insufflator, Laparoscopic; Transilluminator, Battery-Powered; Retinoscope, Battery-Powered; Ophthalmoscope, Battery-Powered; Exophthalmometer; Stand, Instrument, Ac-Powered, Ophthalmic; Cystotome; Arthroscope; Formalin, Neutral Buffered; Cable, Electrode; Mattress, Flotation Therapy, Non-Powered; Pack, Hot Or Cold, Reusable; Bandage, Cast; Joint, Knee, External Brace; Toothbrush, Powered; Tubes, Vials, Systems, Serum Separators, Blood Collection; Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide; Tube Tracheostomy And Tube Cuff; Catheter And Tip, Suction; Sleeve, Limb, Compressible; System, Transport, Aerobic; Mirror, Ent; Instrument, Surgical, Disposable; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Surgeon'S Gloves; Tape And Bandage, Adhesive; Drape, Surgical, Antimicrobial; Bandage, Liquid; Device, Intravascular Catheter Securement; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Catheter, Urological; Dilator, Urethral; Container, I.V.; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Device, Medical Examination, Ac Powered; Dc-Defibrillator, Low-Energy, (Including Paddles); Stethoscope, Manual; Warmer, Irrigation Solution; Set, I.V. Fluid Transfer; Catheter, Nephrostomy; System, Irrigation, Urological; Port & Catheter, Implanted, Subcutaneous, Intravascular; Pad, Alcohol, Device Disinfectant; Cannula, Manipulator/Injector, Uterine; Agent, Absorbable Hemostatic, Collagen Based; Dislodger, Stone, Biliary; Razor, Surgical; Accessory, Surgical Apparel; Polymer Patient Examination Glove; Medical Glove, Specialty; Pump, Infusion, Enteral; Syringe, Balloon Inflation; Syringe, Antistick; Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic; Dressing, Compression; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Automated External Defibrillators (Non-Wearable); Container, Sharps; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene; Bandage, Liquid, Skin Protectant; System/Device, Pharmacy Compounding; Marker, Radiographic, Implantable; Suture, Surgical, Absorbable, Polydioxanone; Stand, Instrument, Ophthalmic, Battery Powered; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Grasping/Cutting Instrument, Non-Powered; Endoscopic Ultrasound System, Gastroenterology-Urology; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Devices Detecting Influenza A, B, And C Virus Antigens; Drape, Surgical, Exempt; Administration Set Securement Device; Hemostatic Device For Endoscopic Gastrointestinal Use; Fentanyl And Other Opioid  Protection Glove; Clinical Electronic Thermometer",1; 2; 3; U,,2018-06-14,188,2026-01-26,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014579161%22&limit=1
"Wright Medical Technology, Inc.",1043534,1043534,11576 Memphis-Arlington Rd,Arlington,TN,38002,United States,STRYKER CORP.,1811755,Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler,94,EMF; EMX; FMF; FNS; FSM; FTY; FZO; FZX; GAC; GAD; GAT; GDF; GDO; GEC; GFA; GFG; GFI; HRR; HRS; HSB; HSD; HSN; HSO; HST; HTC; HTD; HTE; HTJ; HTN; HTO; HTQ; HTR; HTW; HTX; HTY; HTZ; HWA; HWB; HWC; HWD; HWE; HWJ; HWM; HWP; HWQ; HWR; HWT; HWW; HWX; HXA; HXB; HXC; HXD; HXE; HXG; HXL; HXN; HXO; HXR; HXW; HXX; HYA; ILH; JDB; JDR; JDW; JEC; KDD; KGS; KQZ; KTT; KTZ; KWD; KWF; KWH; KWI; KWN; KWO; KWS; KYI; LRP; LXH; LYA; MBI; MBP; MDM; MQV; NOX; OJH; OUR; OYK; PBF; PHX; QHE,"Knife, Surgical; Balloon, Epistaxis; Syringe, Piston; Ring Cutter; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Rasp, Surgical, General & Plastic Surgery; Retractor; Suture, Nonabsorbable, Synthetic, Polyethylene; Guide, Needle, Surgical; Applier, Surgical, Clip; Brush, Scrub, Operating-Room; Blade, Saw, General & Plastic Surgery, Surgical; Bit, Surgical; Osteotome, Manual; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Saw; Apparatus, Traction, Non-Powered; Pliers, Surgical; Forceps; Elevator; Gauge, Depth; Washer, Bolt Nut; Reamer; Broach; Rasp; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Osteotome; Punch, Femoral Neck; Passer; Driver, Prosthesis; Template; Countersink; Tap, Bone; Prosthesis, Tendon, Passive; Probe; Wrench; Clamp; Fork; Tamp; Mallet; Applier, Cerclage; Pusher, Socket; Spatula, Orthopedic; Bender; Screwdriver; Forceps, Wire Holding; Splint, Hand, And Components; Prosthesis, Elbow, Semi-Constrained, Cemented; Staple, Fixation, Bone; Pin, Fixation, Threaded; Component, Traction, Invasive; Kit, Surgical Instrument, Disposable; Retention Device, Suture; Component, Traction, Non-Invasive; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Finger, Polymer; Prosthesis, Toe, Constrained, Polymer; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Wrist, Carpal Lunate; Prosthesis, Wrist, Carpal Scaphoid; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Wrist, Carpal Trapezium; Tray, Surgical; Orthopedic Manual Surgical Instrument; Splint, Intranasal Septal; Fastener, Fixation, Nondegradable, Soft Tissue; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Instrument, Manual, Surgical, General Use; Filler, Bone Void, Calcium Compound; Filler, Bone Void, Synthetic Peptide; Orthopedic Tray; Sacroiliac Joint Fixation; Ankle Arthroplasty Implantation System; Orthopaedic Surgical Planning And Instrument Guides; Shoulder Prosthesis, Reverse Configuration; Shoulder Arthroplasty Implantation System",1; 2; 3,"10.5MM FLEXIBLE REAMER; 10MM FLEXIBLE REAMER; 10mm SUBFIX TRIAL; 11.5MM FLEXIBLE REAMER; 11.5mm SUBFIX TRIAL; 11MM FLEXIBLE REAMER; 12MM FLEXIBLE REAMER; 135 mm Reusable Slat, SE Retr, 10 Pack; 155 mm Reusable Slat, SE Retr, 10 Pack; 175mm Reusable Slat, SE Retr, 10 Pack; 206-716 w/2 small sculps/pkg; 234-112-100 VersiQuad Halo Retractor; 3.9mm Omega Drill; 3.9mm Omega Tap; 3.9mm Omega and 4.75mm AlphaVent Awl; 3105-000-305 Pivot Guardian Direct PostFree Support; 3105-000-740 Pivot Guardian Safety Boot Liners, Small; 3105-000-741 Pivot Guardian Safety Boot Liners, Medium; 3105-000-742 Pivot Guardian Safety Boot Liners, Large; 3MM DBL SLEEVE 80MM TROC/ASSY; 3mm PREDRILL ASSEMBLY LONG; 3mm PREDRILL ASSEMBLY SHORT; 4.5MM FLEXIBLE REAMER; 4.75mm AlphaVent Punch Tap; 4.75mm AlphaVent Tap; 4.75mm AlphaVent and Omega Awl; 4.75mm AlphaVent and Omega Drill; 4.75mm Omega Tap; 4MM DBL SLVE 180MM TROC/ASSY; 4mm DBL SLEEVE 150mm TROC/ASSY; 4mm PREDRILL ASSEMBLY EXTRA SHORT; 4mm PREDRILL ASSEMBLY LONG; 4mm PREDRILL ASSEMBLY SHORT; 4mm TomCat Shaver Blades; 5.5MM FLEXIBLE REAMER; 5.5mm AlphaVent Tap; 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill; 5MM FLEXIBLE REAMER; 5mm HellCat Shaver Blades; 5mm PREDRILL ASSEMBLY EXTRA SHORT; 5mm PREDRILL ASSEMBLY LONG; 5mm PREDRILL ASSEMBLY SHORT; 5mm SPANNER WRENCH; 6.5MM FLEXIBLE REAMER; 6.5mm SUBFIX TRIAL; 611 - ANKLE FUSION NAIL; 6MM FLEXIBLE REAMER; 6mm PREDRILL ASSEMBLY EXTRA SHORT; 6mm PREDRILL ASSEMBLY LONG; 6mm PREDRILL ASSEMBLY SHORT; 7.5MM FLEXIBLE REAMER; 7MM FLEXIBLE REAMER; 7MM SPANNER WRENCH; 7mm SPANNER WRENCH; 8.5MM FLEXIBLE REAMER; 8MM FLEXIBLE REAMER; 8mm SUBFIX TRIAL; 9.5MM FLEXIBLE REAMER; 90 mm Reusable Slat, SE Retr, 10 Pack; 9MM FLEXIBLE REAMER; 9mm SUBFIX TRIAL; A 2 DRILL BRACE W/O CHUCK; A 4 4MM CHUCK; A 5 T-WRENCH; A 51 T WRENCH W/35 EXTENSION; ACL Disposable Packs; ACL Reconstruction Accessories; ACL Workstation; ADJUSTMENT FORK; AEQ FRAC LONG SUP IMP ENS; AEQ FRAC SUPPORT DE BRAS; AEQ FRACT GR AXE LIAISON; AEQ FRACT MESUREUR AMOVIB; AEQ FRACT NM FANT TIG; AEQ IMPACTEUR DE PROTHESE; AEQ TIGE FRA LG FANT; AEQ USA FANT CALO; AEQUALIS; AEQUALIS FRACTURE; AEQUALIS PERFORM REVERSED; AEQUALIS PerFORM Reversed & AEQUALIS PerFORM+ Reversed; AEQUALIS RESURFACING HEAD; AEQUALIS REVERSED; AGM 6 6MM CHUCK; ALEUTIAN Interbody Systems Trays; ALL TORNIER FORCEPS INSTRUMENTS; ALLOMATRIX; ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS); ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE; ANCHORAGE CP LAPIDUS TEMPLATE; ANCHORAGE CP MTP PIVOTING DRILL GUIDE; ANCHORAGE CP MTP TEMPLATE; ANCHORAGE CP POLYAXIAL DRILL GUIDE; ANCHORAGE CP UTILITY TEMPLATE; ANCHORAGE FIXATION PIN; ANCHORAGE FIXED DRILL GUIDE 2.5MM; ANCHORAGE FIXED DRILL GUIDE 2MM; ANCHORAGE INSTRUMENTS RACK (LEVEL 1); ANCHORAGE INSTRUMENTS RACK (LEVEL 2); ANCHORAGE INSTRUMENTS RACK COVER; ANCHORAGE PLATE BENDER; ANCHORAGE PLATE GRIPPER; ANTEVERSION GUIDE; AO HANDLE - LENGTH 135MM; AO Quick Coupling with Elastosil Handle; AO/JACOBS QUICK RELEASE APEX CHUCK 3mm; AO/JACOBS QUICK RELEASE APEX CHUCK 4mm; AO/JACOBS QUICK RELEASE APEX CHUCK 5mm; AO/JACOBS QUICK RELEASE APEX CHUCK 6mm; APEX DRILL BRACE - 3/4/5/6mm; APEX DRILL GUIDE HANDLE; APEX TRAY BASE; APEX TRAY LID; APEX TRAY LOWER INSERT; APEX TRAY UPPER INSERT; ATP Disc Prep; ATTACHMENTS; AUGMATRIX; AWL; AXSOS ADAPTOR FOR TORQUE TESTER T20; AXSOS ADAPTOR FOR TORQUE TESTER T8/T15; AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK; Accolade II System Instrumentation; Aequalis Flex Revive; Aequalis Fracture; Aequalis Perform+; Aequalis Reversed Fracture; Aequalis Reversed II; Aequalis"" Ascend"" Flex; Aequalis"" Fx2; Aequalis"" Instrument; Aequalis"" PerFORM; Aequalis"" Retractor Shoulder System; Aggressive Max Shaver Blade 3.5mm; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; All OrthoHelix Orthopedic Manual Surgical Instruments; All Tornier Instruments, Cutting, Orthopeadic; All Tornier Orthopeadic Manual Surgical Instruments (exempt); Aluminum Lid - Universal; Anato Hip System Instrumentation; Anatomic Express Tray; Angeld Farabeuf clamp; Angled Ruler; Asnis® III Cannulated Screw System; Asnis® PRO Cannulated Screw System; Augment Bone Graft; AxSOS; AxSOS 3; AxSOS 3 AF System and AxSOS 3 Ti System, Plate; AxSOS 3 Ankle Fusion; AxSOS 3 Ti; BARREL REAMER ASSEMBLY STAND; BENDER; BIOARCH; BIOCOMPRESSION WRENCH 15mm TUBE; BIOCOMPRESSION WRENCH 20mm TUBE; BIOCOMPRESSION WRENCH 25mm TUBE; BIOFOAM; BIOFOAM Bone Wedge; BIT; Bender; Bending Iron; BioZip System; Bioabsorable Wedge Interference Screw System; Biosteon IntraLine System; Biosteon Wedge Interference Screw System; Bixcut, IM Reamer; Blueprint™ Patient Specific Instrumentation; Bone Plug Extractor; Bone Wedge; BrainPath Manipulation Tool; BriteField Depth Gauge; Broach and Inserter Handle; CALIPER; CANYON Retractor Systems Trays; CAPRI Corpectomy Cage System Trays; CASPIAN Spinal System Trays; CAYMAN Plate System Trays; CELLPLEX; CHARLOTTE; CHARLOTTE CAROLINA; CHARLOTTE MTP; CHARLOTTE MTP Bone Fusion Plate System; CHARLOTTE MUC Screw; CHESAPEAKE Stabilization System Trays; CHILDS PORTABLE TRAC; CLAMP; CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKI; CSTS; CURSOR; CURVED MULTI-CUT SCISSORS (4BX); CUTTING SCREWDRIVER 4.5; CYLINDRICAL BUSH HOLDER; CalcLock; CalcLock Extreme; CalcLock manual surgical instruments; Caliper; Cannulated Countersink with AO Fitting; Cannulated Drill with AO Fitting; Cannulated Drill ø 2,7/3.5mm with AO Fitting; Cannulated Screw System; Cannulated Screwdriver with AO Fitting; Cannulated Screwdriver with Elastosil Handle; Cannulated Tap with AO Fitting; CapsulePass 45 Up Suture Passer; Cascadia Interbody System; Champion Slingshot; Charlotte Carolina Jones; Charlotte Claw; Charlotte Snap Off Screw; CinchLock; Colored Plugs; Compression Staple System; Counterbore Drill; Cross-Screw System; CrossCheck Plating System; Cut Guide; DARCO; DARCO Locking Bone Plate System; DARCO TwistOff; DART-FIRE; DART-FIRE EDGE Cannulated Screws; DENALI Spinal System Trays; DEPTH GAUGE; DEPTH GAUGE (DISTAL RADIUS); DEPTH GAUGE (HAND); DISPOSABLE CEMENT SCULPS; DJD II STORAGE CASE; DRILL BIT; DRILL GUIDE; DRILL GUIDE (ALL); DRILL GUIDE BLOCK COMPACT 4 HOLE; DRILL GUIDE BLOCK COMPACT PERI 4 HOLE; DRILL GUIDE BLOCK HII 10 HOLE; DRILL GUIDE BLOCK HII 5 HOLE; DRILL GUIDE BLOCK MONOTUBE 4 HOLE; DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE; DRILL GUIDE LOCK II 2.5; DRILL SLEEVE; DRIVER; SCREW INSERTER; DRLock Extreme; DRLock Extreme, MaxLock Extreme, MaxTorque, CalcLock, Mini MaxLock Extreme; Depth Gauge; Depth Gauge (Foot/Elbow/Distal Fib); Direct Measuring Gauge; Double Drill Guide ø 2,0/3,5mm; Drill Bit; Drill Bit ø 2,0 x 150mm; Drill Guide Non Sterile; Drill Sleeve; Dual Edge Shaver Blade 3.5mm; Dual Edge Shaver Blade 4mm; Dual Edge Shaver Blade 5.5mm; Dual-sided Baseplate Centering Guide; EASY CLIP ANGLED DRILL GUIDE SIZE 15; ENDO-FUSE; EVEREST Spinal System Trays; EVOLVE; EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND BONE SCREWS; EVOLVE ORTHOLOC; EXTRACTOR; EZ Frame; EasyFuse Dynamic Compression System; EdgeLock; Edgelock manual surgical instruments; Eiberg Retractor, Standard; Eiberg Retractor, Standard, Long; Eikon LT Adapt SE 135 mm, Wide Retractor; Eikon LT Adapt SE 135mm Retractor; Eikon LT Adapt SE 135mm, Teeth Retractor; Eikon LT Adapt SE 155 mm, Wide Retractor; Eikon LT Adapt SE 155 mm,Wide,Teeth Retr; Eikon LT Adapt SE 155mm Retractor; Eikon LT Adapt SE 155mm, Teeth Retractor; Eikon LT Adapt SE 175 mm, Wide Retractor; Eikon LT Adapt SE 175 mm,Wide,Teeth Retr; Eikon LT Adapt SE 175mm Retractor; Eikon LT Adapt SE 175mm, Teeth Retractor; Eikon LT Adapt SE 90 mm, Wide Retractor; Eikon LT Adapt SE 90 mm, Wide Teeth Retr; Eikon LT Adapt SE 90mm Retractor; Eikon LT Adapt SE 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide, Teeth Retractor; Eikon LT Adapt, 135 mm; Eikon LT Adapt, 135 mm, Teeth; Eikon LT Adapt, 135 mm, Wide; Eikon LT Adapt, 135 mm, Wide, Teeth; Eikon LT Adapt, 175 mm; Eikon LT Adapt, 175 mm, Teeth; Eikon LT Adapt, 90 mm; Eikon LT Adapt, 90 mm, Teeth; Eikon LT Adapt, 90 mm, Wide; Eikon LT Adapt, 90 mm, Wide, Teeth; Eikon LT FF 135mm Retractor; Eikon LT FF 135mm, Wide Retractor; Eikon LT FF 175mm Retractor; Eikon LT FF 90mm Retractor; Eikon LT FF 90mm, Wide Retractor; Eikon LT FF Replacement Screw; Eikon LT Fixed Frame Retractor, 135mm Eval; Eikon LT Fixed Frame Retractor, 135mm Wide Eval; Eikon LT Fixed Frame Retractor, 90mm Eval; Eikon LT Fixed Frame Retractor, 90mm Wide Eval; Eikon LT Retractor, 135 mm; Eikon LT Retractor, 135 mm, Narrow; Eikon LT Retractor, 135 mm, Narrow Teeth; Eikon LT Retractor, 135 mm, Sweetheart; Eikon LT Retractor, 135 mm, Teeth; Eikon LT Retractor, 135 mm, Wide; Eikon LT Retractor, 135 mm, Wide, Teeth; Eikon LT Retractor, 175 mm; Eikon LT Retractor, 175 mm, Teeth; Eikon LT Retractor, 40 mm, Extra Narrow; Eikon LT Retractor, 40 mm, Narrow; Eikon LT Retractor, 50 mm; Eikon LT Retractor, 50 mm, Teeth; Eikon LT Retractor, 90 mm; Eikon LT Retractor, 90 mm, Narrow; Eikon LT Retractor, 90 mm, Narrow Teeth; Eikon LT Retractor, 90 mm, Teeth; Eikon LT Retractor, 90 mm, Wide; Eikon LT Retractor, 90 mm, Wide, Teeth; Eikon LT Retractor, A-N, 35 mm & 50 mm; Eikon LT Retractor, Rich, 40mm x 38mm; Eikon LT Retractor, Rich, 60mm x 45mm; Eikon LT Retractor, Rich, 80mm x 60mm; Eikon LT SL Sterilization Tray; Eikon LT Sterilization Tray; Elastosil T-Handle with AO Coupling; Evolve; Exeter Hip System Instrumentation; Express Humeral Stem Extractor; Express Insert; Extractor; Extractor Rod; Extractor for Screws; FEELER; PROBE; FEMORAL CANAL BRUSH, STANDARD; FIXOS 4 MV DEPTH GAUGE; FLEXIBLE DEPTH GUAGE; FLEXIBLE GUIDE PIN; FOREFOOT SET; FUNNEL; Farabeuf clamp; Flex Shoulder System; FlowStasis; FlowStasis - 3 Pack; FlowStasis Single-Pack; FlowStasis Suture Retention Device; Fork; FuseForce Implant; G-FORCE; G-Force; GAITWAY; GENERAL INSTRUMENTS; GLENOID PLANER; GRAVITY; GUIDE FOR HALF-PINS; Gauge, Depth; General; General Instruments; General Surgical Bits; Glenoid Retractor; Glenoid pin guide; Gordon Brush; Graft box body; Graft box compression screw; Graft box locking screw; Graft box washer; Graft box wedge; Graft container; Graft extractor; Graft sizer; Gravity; Gravity Peek Suture Anchor; Guide Wire; Guide Wire Pusher; Guide Wire Ruler; Guide Wire Targeter; Guide Wire Targeter - Crown; Guide Wire Targeter - Sleeve; Guide Wire, Threaded; HCS; HII 7mm T-WRENCH / 5+6mm SOCKET; HII COMPACT 5mm WRENCH/3&4mm SOCKET; HII COMPACT GUIDE BLOCK W/AO; HII COMPACT MRI STORAGE CASE BASE; HII COMPACT MRI STORAGE CASE LID; HII COMPACT MRI STORAGE CASE UPPER INSERT; HII COMPACT STORAGE CASE BASE; HII COMPACT STORAGE CASE LID; HII COMPACT STORAGE CASE UPPER INSERT; HII MICRO 2mm PIN DRIVER; HII MICRO DRILL GUIDE ASSEMBLY; HII MICRO NUT DRIVER; HII MICRO STORAGE CASE BASE; HII MICRO STORAGE CASE DRILL BIT HOLDER; HII MICRO STORAGE CASE LID; HII MICRO STORAGE CASE LOWER INSERT; HII MICRO STORAGE CASE UPPER INSERT; HII MRI TRAY BASE; HII MRI TRAY LID; HII MRI TRAY LOWER INSERT; HII TRAY BASE; HII TRAY LID; HII TRAY LOWER INSERT; HII TRAY UPPER INSERT; HLS KNEETEC; HLS NOETOS; HLS NOETOS REVISION; HLS UNI EVOLUTION; HM MINI 4 SPANNER WRENCH; HMENTS; HOFFMANN LRF INFO BOARD; HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT; HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY; HOFFMANN LRF RATCHET WRENCH - HEX 10; HOFFMANN LRF SPANNER WRENCH - 5 mm; HOFFMANN LRF SPANNER WRENCH - 7/10 mm; HOFFMANN LRF TELES. STRUT WRENCH; HOFFMANN LRF THUMBWHEEL - HEX 10; HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS; HOFFMANN LRF UNIVERSAL COMPONENTS INSERT; HOFFMANN LRF UNIVERSAL COMPONENTS TRAY; HOFFMANN LRF WIRE BOLT WRENCH; HOFFMANN LRF WIRE TENS. NOSE - LONG; HOFFMANN LRF WIRE TENS. NOSE - SHORT; HOFFMANN LRF WIRE TENSIONER; HOFFMANN XPRESS SILICON MAT; HOFFMANN XPRESS SILICON THUMBWHEEL; HOFFMANN XPRESS SPANNER WRENCH; HOFFMANN XPRESS STORAGE CASE BASE; HOFFMANN XPRESS STORAGE CASE INSERT; HOFFMANN XPRESS STORAGE CASE LID; HOFFMANN XPRESS TORQUE WRENCH; HOFFMANN3 TRAY FOR STANDARD COMPOMENTS; HOLDING FORCEPS; HOLDING SPANNER 4.5; HOWMEDICA MIX KIT I TM 10PK; HUNTER TENDON; HUNTER Tendon Implants; HV Screw System; HexStar; Hip Probe , 90; Hip Tissue Liberator 20; Hoffmann 3 Military External Fixator Kit; Hoffmann LRF; Hoffmann LRF System, Insert; Hoffmann LRF System, Instrument; Hoffmann LRF System, Ruler; Hoffmann LRF System, Wire Tensioner; Hoffmann LRF System, Wrench; Holding Sleeve; Humeral Express Tray; ICONIX All Suture Anchor System; IGNITE; IMN Instruments Percutaneous guide wire inserter; IMN Instruments Self-Holding Screwdriver T20; IMN™ Instruments drill; IMPACTOR; INBONE; INBONE EVERLAST; INBONE TAS; INBONE Total Ankle System; INBONE and INFINITY Total Ankle System; INCLINED DRILL GUIDE SCREW EZ18; INCLINED DRILLING GUIDE + SCREW EZ20; INFINITY; INFINITY EVERLAST; INFINITY TOTAL ANKLE SYSTEM; INFINITY Total Ankle System; INSTRUMENT TRAY; INSTRUMENT TRAY BASE 4.5; INSTRUMENT TRAY LID FIXOS; INTERMEDIATE PROSTHESIS HOLDER LEFT; INTERMEDIATE PROSTHESIS HOLDER RIGHT; INTRAMEDULLARY BRUSH STANDARD 14MM OD; INVISION Total Ankle; INVISION Total Ankle Revision System; INVISION Total Ankle System; ISO Pocket; Impactor, Orthopedic Manual Surgical Instrument; Inbone Total Ankle; Infinity Total Ankle System; Insertion Sleeve for Guide Wire; Instrument Guides; Instruments for Coverloc Volar Plat; Inter-Lock System; Intraosseous Fixation System; Intraosseous Fixation system manual surgical instruments; Invuity A-N, 35mm & 50mm Extra Narrow Re; Invuity A-N, 35mm & 50mm Extra Narrow Retractor; Invuity A-N, 35mm & 50mm Narrow Retracto; Invuity A-N, 35mm & 50mm Narrow Retractor; Invuity Breisky 130mm; Invuity Breisky 170mm; Invuity Deaver 25mm Wide Retractor; Invuity Deaver 38mm Wide Retractor; Invuity St. Marks 11 in Retractor; Invuity St. Marks 9 in Retractor; JA FANTOME CALOTTE; Jaw Clamp Large Offset Curved; Jaw Clamp Large offset Straight; Jaw Clamp Std Long; Jaw Clamp Std Short; Jaw Clamp offset Overbite; Jaw Clamp offset Underbite; Jaw Clamp, Curved Offs. Counterclockwise; Jaw Clamp, Overbite Counterclockwise; Jaw Clamp, Std Offset Counterclockwise; Jaw Clamp, Std Short Counterclockwise; Jaw Clamp, Std, Long Counterclockwise; Jaw Clamp, Underbite Counterclockwise,; Jungbluth Clamp, Narrow; Jungbluth Clamp, Wide; K-TEK BASIC CLAMP, EU/UK; K-TEK BASIC CLAMP, US; K-TEK SELECT BLADE CLAMP, EU; K2M General Instruments; KEIM SURGICAL CAST TABLE; KTEK ROUND POST CLAMP, US; KTEK SELECT BLADE CLAMP, US; KW BENDING IRON ICS; Knotilus+ 2.4X11.3mm Drill, Hard Bone; Knotilus+ 2.4x11.3mm Drill; Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip; Knotilus+ 2.4x8.9mm Drill, Hip; Knotilus+ 2.9x12.5mm Drill; Knotilus+ 2.9x12.5mm Drill, Hard Bone; Knotilus+ 2.9x12.5mm Drill, Hard Bone, Hip; Knotilus+ 2.9x12.5mm Drill, Hip; Knotilus+ 2.9x15.5mm Drill; Knotilus+ 2.9x15.5mm Drill, Hard Bone; Knotilus+ Crown Tip Guide; Knotilus+ Crown Tip Guide, Hip; Knotilus+ Fishmouth Tip Guide; Knotilus+ Fork Tip Guide, Hip; Knotilus+ Offset Tip Guide; LID FOR INSTRUMENT TRAY; LID FOR PLATE RACK - COMPRESSION PLATES; LID FOR PLATE RACK - GENERIC; LID FOR PLATE RACK - SPECIAL PLATES; LITe BIO Delivery System - Loading Funnel; LITe BIO Delivery System - Loading Tool; LITe BIO Delivery System - Sterilization Tray and Lid; LMH; LOCON-T; Lag Screw Sleeve; Large AO Coupling - Hall Fitting; Latitude EV; M/T TRIAX LNG HANDLE WRENCH BLUE; M/T TRIAX LNG HANDLE WRENCH RED; M/T TRIAX LNG HANDLE WRENCH YELLOW; MALLET; MANUAL DRILL BIT; MANUAL SURGICAL INSTRUMENTS; MDI; MESA Spinal System Trays; MFT; MICA Screw System; MICRONAIL; MIIG; MILITARY EXTERNAL FIXATION CASE; MONOTUBE TRIAX YELLOW CASE; MTP PocketLock; Made-To-Order; Mainstay Zip Anchor System; Mako Instrument Trays; MaxLock; MaxLock Extreme; MaxLock Extreme manual surgical instruments; MaxTorque; MaxTorque, DRLock Extreme; Meniscal Transplant Set; Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini; Metal Hemi Implant; MicroFX™; Mini MaxLock; Mini MaxLock Extreme; Mini MaxLock manual surgical instruments; Mini MaxTorque; Mini Variable; Modular Glenoid Surface Trial; Modular Humeral Head Trial; Modular Humeral Head Trial Post; Multiple Drill Guide; NAPA Access System; NEEDLE GUIDE; NanoPass; NanoTack; NanoTack Flex; Navigated Spine Instruments Trays; Navigation Instruments Trays; NexFix; OBLONG DRILL GUIDE DIAMETER 2MM; OMEGA PLUS 145 DRILL GUIDE INSERT; OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-NEUTRAL; OMEGA PLUS DRILL GUIDE HANDLE; OMEGA PLUS HEAD; OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm; OMEGA PLUS LAG SCREW ADAPTER; OMEGA PLUS SCREW EXTRACTION BOLT; OMEGA PLUS SUPRACONDYLAR DRILL GUIDE; OMEGA PLUS SUPRACONDYLAR PIN GUIDE; OMEGA PLUS TAP GUIDE 4.5mm; OMEGA PLUS TAP GUIDE 6.5mm; OMEGA PLUS TRIAL PLATE 150; OMEGA+ BARREL REAM ASSY SHORT; OMEGA+ PIN W/THREAD 2.8X230MM; OMEGA+ VAR ANGLE GUID REPL KIT; OMNIFLEX; ORTHOLOC; ORTHOLOC 2 Lapidus with Rotation; ORTHOLOC 3DI Ankle Fusion System; ORTHOLOC 3Di; ORTHOLOC 3Di Ankle Fracture System; ORTHOLOC 3Di Ankle Fusion Plating System; ORTHOLOC 3Di Ankle Plating System; ORTHOLOC 3Di CROSSCHECK; ORTHOLOC 3Di Foot Reconstruction System; ORTHOLOC 3Di Hallux System; ORTHOLOC 3Di Midfoot/Flatfoot System; ORTHOLOC 3Di Small Bones Plating System; ORTHOLOC 3Dsi Locking Screws; ORTHOLOC Bone Screws; ORTHOLOC, ORTHOLOC 3Di; ORTHOPEDIC MANUAL; ORTHOPEDIC SCREWDRIVER; ORTHOSET; ORTHOSPHERE; OSTEONICS; OSTEONICS BONE TAP; OSTEONOICS; OSTEOSET; OSTEOSET T; OSTEOTOME; OZARK Cervical Plate System Trays; Opening Guide; Opening Reamer; Opening Sleeve; Orthopaedic Manual Instrumentation; Orthopedic Broach; Orthopro Cannulated Screw System; Osteotome; Overdrill for 4.5mm Screws, AO; PASSER; PATELLAR CUTTER; PEDIATRIC CORTICAL REAMER; PEEK IntraLine Anchor System; PHALINX; PIN CUTTER / HA PINS; PIP Starter Awl; PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM; PKG., DUAL EDGE SHAVER BLADE - 5.5MM; PLANER; PLATE BENDING IRONS; PRECISION DOWEL BONE GRAFT SYSTEM; PRO Plating System; PRO-DENSE; PRO-DENSE LoVisc; PRO-STIM; PRO-TOE; PROBE; PRODENSE; PRODENSE Bone Graft; PROPHECY INBONE; PROPHECY INVISION Pre-operative Navigation Guides; PROPHECY INVISION Preoperative Navigation Alignment System; PROPHECY Preoperative Navigation Alignment System; PROSTEP; PROSTEP MIS BUNION (TBC); PROSTIM; PROTOE C2 2; PROTRACTOR; PUSHER; PYRENEES Cervical Plate System Trays; Pangea Femur Reconstruction System Bender; Pangea Femur Reconstruction System K-Wire; Pangea Femur Reconstruction System Tray; Pangea Platform; Pangea T-Handle; Pangea Torque Limiting Adapter; Parallel Guide for ø 1,4mm/2mm Wires; Perc. Double Wire Guide; PeriPROTM Femur; Periosteal Elavator, Reverse; Periosteal Elavator, Straight; Perisostela Elvator, Standard; PhaLinx Hammertoe; Phoenix; Plastic Tray; Portal Entry Kit; Posterior TLIF; Pro-Toe Hammertoe Fixation System; Pro-Toe X-Flex; Pro-Toe(R) VO; Prophecy Incompass Surgical Planning System; Prophecy Infinity; Prophecy Preoperative Navigation Alignment System; Prophecy Surgical Planning; Prophecy Surgical Planning System; Q Pedicle Instruments; Quick Release Driver Hall Fitting; RACK FOR OPEN WEDGE PLATES (LEVEL 2); RACK FOR PLP UTILITY/MTP (LEVEL 2); RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2); RASP; RAVINE Access System Trays; RAYHACK; RED & BLUE INTL M/T CASE; REDUCTION HANDLES B & R CLAMPS; REPLACEMENT COMPONENTS; REPLACEMENT KNOB FOR DRILL BRACE; RESECTION GUIDE; RETRACTOR; RING DRIVER 4.5; RONGEUR; RX-FIX; Rasp; Reduction Instruments Complete Kit; Reduction Tray; Reduction Tray Insert for Jaw Clamps; Reduction Tray Insert for Weber Clamps; Reduction Tray generic Insert; Restoration ADM/MDM Instrumentation; Restoration Modular Instrument Trays; Restoration Modular Trials; Retractor; Reusable Awl; Reusable Slat for Eikon LT Adapt Smoke Evacuation 135 mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 155mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 175mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 90mm Retractor, 10 Pack; Reverse Express Tray; SAHARA Stabilization System Trays; SALTO TALARIS; SALTO XT; SALVATION 3Di Plating System; SALVATION BEAM; SALVATION External Fixation; SALVATION External Fixation System; SALVATION Midfoot Nail; SAW BLADE; SCREW CADDY FOR 2 / 2.5 FIXO TRAY; SCREW RACK ANCHORAGE; SCREW RACK WS + CS (2MM+3.5MM); SCREW TRAY 4.5; SCREW-HOLDING FORCEPS FIXOS; SET ANCILLARY IMPLANT SUBTALAR; SET SCREW FOR HUMERUS AIMING BLOCK; SET SCREW FOR TIBIA AIMING BLOCK; SET SCREWDRIVER; SI-BONE; SIDEKICK; SIDEKICK EZ FRAME"" External Fixation System; SILICONE MAT; SMALL RULER FOR MEASUREMNET; SMALL SWIVEL JOINT; SMART TOE 1 INSTRUMENT KIT; SMOOTH BITE SHAVER BLADE - 3.5MM; SORBIE TOTAL ELBOW SYSTEM; SPARE SET SCREW HUMERUS TS AIMING BLOCK; SPARE SHAFT TEMP. PLATE HOLDER; SPIKE SCREW INSERTER FOR 4.5MM SCREWS; SPS BENDING SLEEVE - SLOTTED STEEL; STANDARD BENDING SLEEVE; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM; STERNUM SAW REPLACEMENT GUIDE; STRAIGHT FEMORAL CANAL BRUSH; STRAIGHT MULTI-CUT SCISSORS (4BX); STRYKER AUTOMATIC SCREWDRIVER; STRYKER COMBO PUNCH; STRYKER SUTURE SLIDERS; STRYKER TUNNELER  STRYKER Y-NEEDLE 100  STRYKER Y-NEEDLE 200  STRYKER Y-NEEDLE 300  STRYKER Y-NEEDLE 400; STS; SUBFIX INSERTION INSTRUMENT; SURGICAL INSTRUMENT MOTORS AND ACCE; SUTURE BUTTON; SWANSON; Salvation EX FIX; Salvation External Fixation System; Screw Holder; Screw Insertion Sleeve; Screwdriver; Screwdriver Blade, AO, T10; Shoulder iD™; Shoulder iD™ Primary Reversed Glenoid; Sidekick; Silicon Mat, Generic Insert; Silicon Mat, Insert for Jaw Clamps; Silicon Mat, Insert for Weber Clamps; Silicone MCP, Starter Awl; SlingShot; Smooth Bite Shaver Blade 3.5mm; Solid Screwdriver with AO Fitting; Spacer Block; Spike Disk, Large; Spike Disk, Oval; St. Mark’s 11 in. Retractor; St. Mark’s 9 in. Retractor; Stanmore Face Cutter and Alignment Tool; Sterile Charlotte Bone Screws; Sterile Charlotte Plates; Sterile Charlotte Staples; Sterile Needle; Sterilization Box, Lightweight; Stryker Orthopaedics Awl; Stryker Orthopaedics Cutting Instruments; Stryker Orthopaedics Instrument Trays; Stryker Orthopaedics Prosthesis Driver; Stryker Orthopaedics Screw Forceps; Stryker Orthopaedics Templates; Stryker Orthopaedics Trials; Stryker Orthopaedics chisel; Stryker Trauma Pelvic Set (Matta); Stylet; Surgical Clip/Applier; Surgical Knife; Surgical Tray; Suture Anchor System; Swanson; Swanson Hammertoe Weil Design; Synchfix EVT; T-HANDLE PIN INSERTER; T-HANDLE STEM HOLDER; T2 Alpha Femur Retrograde Nailing System, Nail Adapter SPI; T2 Alpha Femur Retrograde Nailing System, Nail Holding Screw SPI; T2 Alpha Femur Retrograde Nailing System, Target Device; T2 Alpha Femur Retrograde Nailing System, Tissue Protection Sleeve; T2 Guide Wire Ball Tip; TAMP; TAP; TC Plating System; TCP; TENSION DEVICE 16MM; TIE-IN; TIGE FRACTURE N.M; TORNIER - INSTRUMENT; TRAY; TRAY FOR MV SCREWS; TRIAL ANCHORAGE PLP10341; TRIAL ANCHORAGE PLP10342; TRIAL ANCHORAGE PLP10461; TRIAL ANCHORAGE PLP10462; TRIAL ANCHORAGE PLP11341; TRIAL ANCHORAGE PLP11342; TRIAL ANCHORAGE PLP30141; TRIAL ANCHORAGE PLP30142; TRIAL ANCHORAGE PLP30171; TRIAL ANCHORAGE PLP30172; TRIAL ANCHORAGE PLP30201; TRIAL ANCHORAGE PLP30202; TRIAL ANCHORAGE PLP40160; TRIAL ANCHORAGE PLP40220; TRIAL ANCHORAGE PLP40280; TRIAL ANCHORAGE PLP40340; TRIAL ANCHORAGE PLP40400; TRIAL ANCHORAGE PLP40460; Terra Nova, Ravine, Serengeti, VCR, Cricket; Threaded Guide Wire; Tissue Protection Sleeve; Tomcat HC Shaver Blade 4mm; Tornier; Tornier Approach; Tornier Drill bits (all); Tornier Extraction; Tornier Flex Shoulder System; Tornier Humeral Nail; Tornier Perform Anatomic Glenoid; Tornier Perform Humeral System; Tornier Perform Reversed; Tornier Perform Reversed Glenoid & Tornier Perform Reversed Augmented Glenoid; Tornier Perform™ Patient-Matched Primary Reversed Glenoid; Tornier Perform® Reversed Glenoid Cannulated Glenospheres; Tornier Pyrocarbon; Tornier Radial Head System; Tornier Simpliciti Shoulder System; Total Compression Plating System; Tray - Silicon Mat; Tray insert; Triathlon; Triathlon MSI Tray; Triathlon MSI Trials; Triathlon Monogram Instruments; Triathlon System Instrument trays; Trocar; TwinLoop Anchor System; TwinLoop FLEX; Twist-drill cannulated ø8/L300mm; UNIVERSAL BENDING SLEEVE; UNIVERSAL PIN-WIRE CASE; UniVise; Universal ACL Instrumentation; Universal Neuro III Accessory Tray; VALOR; VALOR ANKLE FUSION NAIL SYSTEM SCREW; VARIOUS STRYKER MANUA; VARIOUS TWIST DRILLS; VERSITOMIC STERILE FLEXIBLE PIN; Valor Hindfoot Fusion Nail System; VariAX 2, Lid For Sterilizing Container; VariAx 2 Compression Plating System, Plate Insert; VariAx 2 Compression Plating System, Plate Trial; VariAx 2 Foot, Drawer; VariAx 2 Foot, Insert; VariAx 2 Foot, Instrument Kit; VariAx 2 Foot, Labeling Clip; VariAx 2 Foot, Module; VariAx 2 Foot, Module Lid; VariAx 2 Foot, Screw Rack; VariAx 2 Foot, SpeedGuide; VariAx 2 Foot, Tap for 2.7mm screws; VariAx 2 foot, Depth Gauge; VariAx 2, Aiming Block Fixation Pin; VariAx 2, Clip; VariAx 2, Depth Gauge; VariAx 2, Distal Radius Container Half-Size; VariAx 2, Distal Radius Implant Module; VariAx 2, Drill Bit; VariAx 2, Drill Guide; VariAx 2, Drill Guide K-Wire; VariAx 2, Fixed Angle Drill Guide 2.3/2.7mm; VariAx 2, Handle With 2.3mm Drill And K-Wire Guide; VariAx 2, Handle With Drill Guides; VariAx 2, Inlay; VariAx 2, Insert; VariAx 2, Joystick; VariAx 2, K-Wire; VariAx 2, K-Wire with Olive Stop; VariAx 2, Pliers; VariAx 2, Reduction Instrument Insert; VariAx 2, Screw Rack; VariAx 2, Screw Rack Locking Screws; VariAx 2, Screw Rack Non-Locking Screws; VariAx 2, ScrewDriver Blade; VariAx 2, Screwdriver Blade; VariAx 2, SpeedGuide; VariAx 2, Tap For 2.7mm Screws; VariAx Foot, Countersink; VariAx Foot, Holding Sleeve; VariAx Foot, K-Wire; VariAx, Drill; VariAx, Drill Guide; VariAx, Handle; VariAx, Safety Shield; VariAx, Screw Length Marker; VariAx, Screwdriver; VariAx, Tap For Bone Screws; VariAx, Tension Plier; VariAx, Tension Sheath; VariAx, Trial; Variable Angle Fixation; Variax 2, Steinmann Pin; VersiTomic Low Profile Reamer10 mm; VersiTomic Low Profile Reamer10.5 mm; VersiTomic Low Profile Reamer11 mm; VersiTomic Low Profile Reamer12 mm; VersiTomic Low Profile Reamer13 mm; VersiTomic Low Profile Reamer4.5 mm; VersiTomic Low Profile Reamer5 mm; VersiTomic Low Profile Reamer5.5 mm; VersiTomic Low Profile Reamer6 mm; VersiTomic Low Profile Reamer6.5 mm; VersiTomic Low Profile Reamer7 mm; VersiTomic Low Profile Reamer7.5 mm; VersiTomic Low Profile Reamer8 mm; VersiTomic Low Profile Reamer8.5 mm; VersiTomic Low Profile Reamer9 mm; VersiTomic Low Profile Reamer9.5 mm; Versitomic RR; Vikos Allograft System; WIRE AND DRILL GUIDE; WIRE CADDY; WIRE DIRECTOR; WMT ULTRA-FIT MODULAR SHOULDER SYSTEM; Weber Clamp Assmmetrical Left; Weber Clamp Assmmetrical Right; Weber Clamp Contoured; Weber Clamp Narrow; Weber Clamp Std; XIA Rod Template; Xcel Anchor RC System; Xcel Anchor System; XeroGel Nasal/Epistaxis Pack; Xia Blocker Inserter; YUKON OCT Spinal System Trays; driver, prosthesis; extraction shaft; i-Fuse Hammer Toe Systems; lag screw driver; lag screw reamer; precision pin; precision sleeve; screw depth gauge; screw extractor(percufix); set screw driver; tray base",1978-01-10,187,2026-06-16,0,29,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221043534%22&limit=1
Bio Analitica Argentina S.A.,3011063460,3011063460,"OSVALDO CRUZ 3201 y AGUSTIN MAGALDI 1765 NAVE 03 DEPOSITO N 04, (Verotin SA)",Ciudad Autonoma de Buenos Aires,,CP 1286,Argentina,"Intuitive Surgical, Inc.",9028901,Exporter to the US,28,EOQ; EQH; ERY; FCW; FDE; FET; FFY; FOX; GAG; GCI; GCJ; GDW; GEH; GEI; HIF; IZI; KCT; KKX; LFL; LKF; LLZ; MNL; NAY; NTN; NVE; OWN; PUI; QIH,"Bronchoscope (Flexible Or Rigid); Source, Carrier, Fiberoptic Light; Drape, Surgical, Ent; Light Source, Fiberoptic, Routine; Laparoscopy Kit; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Adaptor, Bulbs, Miscellaneous, For Endoscope; Stand, Infusion; Stapler, Surgical; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Staple, Implantable; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Insufflator, Laparoscopic; System, X-Ray, Angiographic; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Drape, Surgical, Antimicrobial; Instrument, Ultrasonic Surgical; Cannula, Manipulator/Injector, Uterine; System, Image Processing, Radiological; Accessories, Cleaning Brushes, For Endoscope; System, Surgical, Computer Controlled Instrument; Led Light Source; Washer, Cleaner, Automated, Endoscope; Confocal Optical Imaging; Drape, Surgical, Exempt; Automated Radiological Image Processing Software",1; 2; U,"10-12mm+Stapler Cannula Seal; 12 Mm & Stapler Bladeless Obturator; 12 mm Assist Cannula; 12 mm Blunt Obturator, da Vinci S, Si; 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si; 12 mm Endoscope Cannula Mount, Balloon Port; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si; 12 mm Endoscope Cannula Mount, COV; 12 mm Endoscope Cannula Mount, COV, da Vinci; 12 mm Endoscope Cannula Mount, ETH, da Vinci; 12 mm Endoscope Cannula Mount, ETH/TAUT, da Vinci S, Si; 12 mm Endoscope, 0°; 12 mm Endoscope, 30°; 12 mm Instrument Cannula, da Vinci S, Si; 12mm IS4000 Endoscopes and Accessories; 3D Camera, Wide Angle, NTSC; 3D Camera, Wide Angle, PAL; 3D Model Viewer; 3DHD Camera Head and Cable; 3DHD Camera Head and Cable (Ikegami HD); 3DHD Camera Head and Cable (Panasonic HD); 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000); 5 mm Blunt Obturator, da Vinci S, Si; 5 mm Flared Cannula, da Vinci S, Si; 5 mm Sharp Obturator, da Vinci S, Si; 5 mm to 8 mm Cannula Seal; 8 mm Assist Cannula; 8 mm Bladeless Obturator (Optical); 8 mm Bladeless Obturator (Optical), Long; 8 mm Blunt Obturator, Long, da Vinci S, Si; 8 mm Blunt Obturator, da Vinci S, Si; 8 mm Cannula Seal, da Vinci, da Vinci S, Si; 8 mm Cannula with Outlet, Long, da Vinci S, Si; 8 mm Cannula with Outlet, da Vinci S, Si; 8 mm Harmonic ACE Curved Shears; 8 mm Instrument Cannula, Long, da Vinci S, Si; 8 mm Instrument Cannula, da Vinci S, Si; 8 mm Sharp Obturator, Long, da Vinci S, Si; 8 mm Sharp Obturator, da Vinci S, Si; 8 mm SureForm 30 Curved-Tip Stapler; 8 mm SureForm 30 Reload, Blue; 8 mm SureForm 30 Reload, Gray; 8 mm SureForm 30 Reload, White; 8 mm SureForm 30 Stapler; 8 mm SureForm 30 System; 8 mm Trocar, Long; 8 mm Trocar, Standard; 8 mm to 5 mm Cannula Reducer, da Vinci; 8 mm to 5 mm Cannula Reducer, da Vinci S, Si; 8.5 mm Endoscope, 0°; 8.5 mm Endoscope, 30°; 8.5-13 mm Cannula Seal; 8.5mm Endoscope, 0°; 8.5mm Endoscope, 30°; 8mm 0 degree endoscope; 8mm 30 degree endoscope; 8mm Atrial Retractor Short Right, Xi; 8mm Black Diamond Micro Forceps, Xi; 8mm Blunt Obturator Long, Xi; 8mm Blunt Obturator, Xi; 8mm Cadiere Forceps; 8mm Cannula Long, Xi; 8mm Cannula Standard, Xi; 8mm Cardiac Probe Grasper, Xi; 8mm Cobra Grasper; 8mm Cobra Graspers; 8mm Curved Bipolar Dissector; 8mm Debakey Forceps; 8mm Dual Blade Retractor, Xi; 8mm Endoscope, 0°, Gen5; 8mm Endoscope, 30°, Gen5; 8mm Fenestrated Bipolar Forceps; 8mm Fenstrated Bipolar Forceps, Xi; 8mm Flared Cannula, Xi; 8mm Force Bipolar; 8mm Hex Cannula, Long; 8mm Hex Cannula, Standard; 8mm Instrument Introducer, Xi; 8mm Large Hem-O-Lok Clip Applier, Xi; 8mm Large Needle Driver; 8mm Large Needle Driver, Xi; 8mm Large SutureCut Needle Driver; 8mm Large Suturecut Needle Driver, Xi; 8mm Long Bipolar Grasper; 8mm Long Tip Forceps; 8mm Long Tip Forceps, Xi; 8mm Maryland Bipolar Forceps; 8mm Maryland Bipolar Forceps, Xi; 8mm Medium Large Hem-O-Lok Clip Applier; 8mm Medium-Large Clip Applier, Xi; 8mm Mega SutureCut Needle Driver; 8mm Mega SutureCut Needle Driver, Xi; 8mm Micro Bipolar Forceps; 8mm Micro Bipolar Forceps, Xi; 8mm Monopolar Curved Scissors; 8mm Monopolar Curved Scissors, Xi; 8mm Permanent Monopolar Cautery Hook, Xi; 8mm Permanent Monopolar Cautery Spatula, Xi; 8mm Potts Scissors, Xi; 8mm ProGrasp Forceps; 8mm ProGrasp Forceps, Xi; 8mm Resano Forceps, Xi; 8mm Round Tip Scissor; 8mm Small Clip Applier, Xi; 8mm Small Grasping Retractor, Xi; 8mm Snap-Fit Instrument, Xi; 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm Reloads; 8mm SureForm Stapler; 8mm Tenaculum Forceps, Xi; 8mm Tip-Up Fenstrated Grasper, Xi; ARM 4 PROXIMAL DRAPE, IS4200; ASSY,CABLE,CORE TO DOCO; ASSY,CABLE,DOCO TO ILLUMINATOR; ASSY,PSCART,IS3000,3-ARM; ASSY,PSCART,IS3000,4-ARM; ASSY,SSC,IS3000; ASSY,VSS VISION SYSTEM W/AVP,VS3000; Accessory Base Starter Kit; Accessory Base Starter Kit, Multi-Specialty, ETH; Alignment Target, 8.6mm Endoscope; Assembly, Cannula Mount, Dual Jaw COV, ECM, da Vinci S, Si; Assembly, PSCart, IS2000, 4-Arm, G1.1; Assembly, Patient Side Cart; Assembly, Surgeon Side Console; Assembly, Surgeon Side System, IS2000; Assembly, VSC, VS2000 Panasonic HD, Domestic; Assembly, Vision System; Assembly, Vision System w/TS, NTSC, VS2000 HD, Domestic; Atrial Retractor , 8mm, da Vinci; Atrial Retractor Short Right , 8mm, da Vinci S, Si; BRACKET(SET),DOCO/ILLUMINATOR RESTRAINING,IS3000; Bath Probe; Bifurcated Light Guide; Bipolar Cautery Cord; Bipolar Cautery Cord, da Vinci SP; Bipolar Energy Activation Cable, CONMED; Bipolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Bipolar Energy Activation Cable, ERBE; Bipolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Gyrus ACMI; Bipolar Energy Activation Cable, Gyrus ACMI, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Valleylab; Bipolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; Black Diamond Micro Forceps , 8mm, da Vinci S, Si; Blade Protector, Snap-fit, da Vinci, da Vinci S, Si; Blue System Cable, Type A to Type B, 7m; Blue System Cable, Type B, 7m; Blue System Cable, da Vinci Si; Bowel Grasper , 5mm, da Vinci; Bowel Grasper , 5mm, da Vinci S, Si; CABLE KIT,BLUE FIBERCONNECT,20M; CABLE,PMED,COVIDIEN FORCE TRIAD; CAMERA ARM DRAPE,IS3000; CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100; CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2; CAMERA STARTER KIT,PANASONIC,HD; CIM extended height adjustable arm; CIM extended pivot arm; CIM height adjustable arm; CIM pivot arm; COLUMN DRAPE, IS4000; Cadiere Forceps , 8mm, da Vinci S, Si; Cadiere Forceps, da Vinci SP; Camera Arm Sterile Adapter; Camera Head Cable; Camera Head Sterile Adapter; Camera Head Video Cable, Ikegami® HD; Camera Head Video Cable, Panasonic® HD; Camera Head Video Cable, Sumitomo® SD; Camera Sheath, da Vinci SP; Camera Starter Kit; Camera Starter Kit, NTSC Wide Angle, Type 2; Camera Starter Kit, PAL High Mag, Type 2; Camera Starter Kit, PAL Wide Angle, Type 2; Camera Starter Kit, Panasonic HD; Cannula 5 mm Regular, da Vinci S, Si; Cannula Holder, Twist¿Lock, da Vinci; Cannula Seal, 8mm; Cannula, 8.5mm Endoscope; Cannula, Circular, 25 mm x 100 mm, da Vinci SP; Cardiac Probe Grasper; Cardiac Probe Grasper , 8mm, da Vinci; Cardiac Probe Grasper , 8mm, da Vinci S, Si; Catheter Continuity Cable; Catheter Continuity Stand; Catheter Guide; Cautery Hook Tip, 5 mm, da Vinci, da Vinci S, Si; Cautery Hook Tip, da Vinci SP; Cautery Spatula Tip, 5mm, da Vinci, da Vinci S, Si; Cautery Spatula Tip, da Vinci SP; Cleaning and Sterilization Kit; Cleaning and Sterilization Kit, English; Cleaning and Sterilization Kit, da Vinci SP; Cobra Grasper , 8mm, da Vinci S, Si; Controller; Curved Bipolar Dissector , 8mm, da Vinci S, Si; Curved Scissors , 5mm, da Vinci; Curved Scissors , 5mm, da Vinci S, Si; Curved Scissors , 8mm, da Vinci S, Si; Curved Stapler 30; DEVICE,ENERGY,ERBE VIO 300D; DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR; DUCT,LEFT,ILLUMINATOR,FIREFLY100; DUCT,RIGHT,ILLUMINATOR,FIREFLY100; Da Vinci 5 Console - Model: C5000; Da Vinci 5 Robot - Model: R5000; Da Vinci 5 Tower - Model: T5000; Da Vinci E-200 Electrosurgical Generator; Da Vinci E-200 Generator; Da Vinci E200 Generator; Da Vinci Force Feedback Cadiere Forceps; Da Vinci Force Feedback Fenestrated Bipolar Forceps; Da Vinci Force Feedback Large Needle Driver; Da Vinci Force Feedback Maryland Bipolar Forceps; Da Vinci Force Feedback Mega SutureCut Needle Driver; Da Vinci Force Feedback ProGrasp Forceps; Da Vinci Handheld Camera; Da Vinci Monopolar and Bipolar Adapters; Da Vinci SP Vision Cart; Da Vinci X/Xi 8mm Endoscope Plus, 0 degree; Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees; Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree; DeBakey Forceps , 5mm, da Vinci; DeBakey Forceps , 5mm, da Vinci S, Si; DeBakey Forceps , 8mm, da Vinci S, Si; Double Fenestrated Grasper , 8mm, da Vinci S, Si; Double Receptacle System Cable Extension Kit; Dual Blade Retractor , 8mm, da Vinci; Dual Blade Retractor , 8mm, da Vinci S, Si; E-100; EndoPass Endoscopic Delivery Instruments; EndoWrist 5mm Thoracic Grasper; EndoWrist Accessories, da Vinci Xi; EndoWrist Cardiac Probe Grasper; EndoWrist Endoscopic Instruments; EndoWrist Instruments, da Vinci S/Si; EndoWrist Instruments, da Vinci Xi; EndoWrist Introducer Instrument; EndoWrist One Suction/Irrigator; EndoWrist One Suction/Irrigator, 8mm, da Vinci Si; EndoWrist One Vessel Sealer , 8mm, da Vinci Si; EndoWrist One Vessel Sealer, 8mm, da Vinci Si; EndoWrist PK Dissecting Forceps; EndoWrist Permanent Cautery Instruments; EndoWrist SP Camera, 0 degree, da Vinci SP; EndoWrist Stabilizer; EndoWrist Stapler 30 Instrument; EndoWrist Stapler 30 Reloads; EndoWrist Stapler 30 System; EndoWrist Stapler 45; EndoWrist Stapler 45 Reload, Blue; EndoWrist Stapler 45 Reload, Green; EndoWrist Stapler 45 System; EndoWrist Stapler Cable; EndoWrist Stapler Cannula Blunt Obturator, da Vinci S, Si; EndoWrist Stapler Cannula Kit; EndoWrist Stapler Cannula Reducer, da Vinci S, Si; EndoWrist Stapler Cannula Seal; EndoWrist Stapler Cannula, da Vinci S, Si; EndoWrist Stapler Motor Pack; EndoWrist Stapler Release Kit; EndoWrist Stapler Sheath; EndoWrist Stapler System Starter Kit - 45 mm; EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm; EndoWrist Suction Irrigator; EndoWrist Vessel Sealer; EndoWrist Vessel Sealer Extend; EndoWrist resuable Accessories, da Vinci S/Si; EndoWristStapler 30 and Stapler 30Reloads; EndoWristStapler 45 and Stapler 45 Reloads; EndoWrist® Stapler 45; EndoWrist® Stapler 45 Curved-Tip; Endopass Delivery Instrument; Endoscope Sterilization Tray; Endoscope, 0 degrees, Xi; Endoscope, 30 degrees, Xi; Endoscopes, da Vinci S/Si; Endoscopes, da Vinci Xi; Endoscopic Instruments; Endowrist Bipolar Instruments; Endowrist Instruments; Endowrist Permanent Cautery Instrum; Endowrist Stapler Cannula; Endowrist Stapler Obturator; Endowrsit Stapler Reducer; Energy Activation Adapter, Ethicon GEN11, da Vinci Si; Energy Activation Cable, CONMED, da Vinci Si; Energy Activation Cable, ERBE, da Vinci Si; Energy Activation Cable, Ethicon; Energy Activation Cable, Ethicon, da Vinci Si; Energy Activation Cable, Gyrus, da Vinci Si; Energy Activation Cable, Valleylab, da Vinci Si; EnergyShield Monopolar Cautery Cord, da Vinci SP; EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP; Fenestrated Bipolar Forceps , 8mm, da Vinci S, Si; Fenestrated Bipolar Forceps, 5mm, da Vinci Si; Fenestrated Bipolar Forceps, da Vinci SP; Fiber Cable Cleaning Kit; Fine Tissue Forceps , 8mm, da Vinci; Flexision"" Biopsy Needle 19G; Flexision"" Biopsy Needle 21G; Flexision"" Biopsy Needle 23G; Flexision™ Biopsy Needle 19G; Flexision™ Biopsy Needle 21G; Flexision™ Biopsy Needle 23G; Fluorescence Imaging Camera Head and Cable Kit; Fluorescence Imaging Illuminator; Fluorescence Imaging Kit; Force Bipolar; Gage Pin, Xi; Grasping Retractor , 8mm, da Vinci S, Si; Green System Cable, da Vinci Si; Handheld Camera Light Guide; Handheld Camera Light Guide Adapter; Handheld Camera Sterilization Tray; Harmonic ACE; Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic ACE Curved Shears, 5mm, da Vinci S/Si; Harmonic ACE Curved Shears, 8mm, da Vinci S/Si; Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Ace Curved Shears; Harmonic Ace Curved Shears , 5mm, da Vinci; Harmonic Ace Curved Shears , 5mm, da Vinci S, Si; Harmonic Ace Curved Shears , 8mm, da Vinci S, Si; Harmonic Curved Shears; Harmonic Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Curved Shears Instrument; Harmonic Curved Shears, 5mm, da Vinci; Harmonic Curved Shears, 5mm, da Vinci S, Si; Harmonic Curved Shears, 8mm, da Vinci; Harmonic Curved Shears, 8mm, da Vinci S, Si; ICB, Instrument Control Box; IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000; ILLUMINATOR,Y1865; INSTRUMENT ARM DRAPE IS2000; INSTRUMENT ARM DRAPE, IS4000; INTUITIVE SURGICAL STEREO ENDOSCOPE; IRIS System 1; IRISeg; IRK,ENGLISH,IS4000; IS Endoscopic Control System; IS Endoscopic Instruments; IS Endowrist Bipolar Instrument; IS da Vinci Surgical System; IS3000 Stapler 45 Accessories; IS3000 Stapler 45 Instrument; IS4000 ACCESSORY STARTER KIT; IS4000 EndoWrist Stapler 30; IS4000 Long Bipolar Forceps; IS4000 Small Clip Applier  IS4000 Long Bipolar Forceps; IS4000 Stapler 45 Accessories; IS4000 Stapler 45 Instrument; IS4000 da Vinci EndoWrist Instruments; IS4200 ACCESSORY STARTER KIT; Illuminator Lamp Module, Model Y1866; Instrument Arm Drape, da Vinci SP; Instrument Release Kit, Xi; Instrument Sheath, da Vinci SP; Instrument Tray, da Vinci, da Vinci S, Si; Instrument/Accessory Steriliz Tray; Introducer 5Fr , 5mm, da Vinci S, Si; Intuitive Surgical EndoWrist Stabilizer; Intuitive Surgical Vessel Sealer Extend; Intuitive Surgical da Vinci S Surgical System, Model IS2000 with Connect OnSite and Wireless Connectivity Option; Intuitive Surgical da Vinci Surgical System; Intuitive Surgical da Vinci®,da Vinci S®, and da Vinci Si® Surgical Systems and EndoWrist Instruments and Accessories; Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System; Ion Endoluminal System (IF1000); Ion Reprocessing Consumable Kit; Ion reprocessing accessory kit; Ion"" Fully Articulating Catheter; Ion"" Peripheral Vision Probe; Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000); Ion™ Endoluminal System, Model IF1000; Ion™ Fully Articulating Catheter; Ion™ Peripheral Vision Probe; KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F; Laparoscope 10mm, 0, NIR; Laparoscope 10mm, 30, NIR; Laparoscope 5mm, 0; Laparoscope 5mm, 30; Large Clip Applier , 8mm, da Vinci S, Si; Large Needle Driver , 8mm, da Vinci S, Si; Large SutureCut Needle Driver , 8mm, da Vinci S, Si; Leak Test Adapter; Light Guide Cable Adapter; Light Guide Cable Adapter, da Vinci, da Vinci S; Long Tip Forceps , 8mm, da Vinci S, Si; MARS 1; MCS Tip, da Vinci SP; Maryland Bipolar Forceps , 8mm, da Vinci S, Si; Maryland Bipolar Forceps, da Vinci SP; Maryland Dissector , 5mm, da Vinci; Maryland Dissector , 5mm, da Vinci S, Si; Medium-Large Clip Applier , 8mm, da Vinci S, Si; Medium-Large Clip Applier, da Vinci SP; Mega Needle Driver , 8mm, da Vinci S, Si; Mega SutureCut Needle Driver , 8mm, da Vinci; Mega SutureCut Needle Driver , 8mm, da Vinci S, Si; Micro Bipolar Forceps , 8mm, da Vinci; Micro Bipolar Forceps, 8mm, da Vinci S, Si; Monopolar Cautery , 5mm, da Vinci; Monopolar Cautery , 5mm, da Vinci S, Si; Monopolar Cautery Cord; Monopolar Cautery Instrument, da Vinci SP; Monopolar Curved Scissors , 8mm, da Vinci; Monopolar Curved Scissors , 8mm, da Vinci S, Si; Monopolar Curved Scissors, 8mm, da Vinci S, Si; Monopolar Curved Scissors, da Vinci SP; Monopolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Monopolar Energy Activation Cable, ERBE; Monopolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; NIR Handheld Camera; NIR Handheld Camera Control Unit (CCU); NIR Handheld Camera Light Guide; NIR Handheld Camera Light Guide Adapter; NIR Handheld Camera Light Source; NIR Handheld Camera System Starter Kit; NIR Handheld Camera Tray; Needle Driver , 5mm, da Vinci; Needle Driver , 5mm, da Vinci S, Si; Needle Driver, da Vinci SP; Obturator, Circular, 25 mm x 100 mm, da Vinci SP; Option, Connect, da Vinci Si; PK Dissecting Forceps; PK Dissecting Forceps , 8mm, da Vinci S, Si; PK® Instrument Cord, G400 Generator, da Vinci, da Vinci S, Si; PK® Instrument Cord, PK/SP Generator, da Vinci, da Vinci S, Si; PROBE HOLDER SYSTEM; Pericardial Dissector , 8mm, da Vinci; Permanent Cautery Hook , 8mm, da Vinci S, Si; Permanent Cautery Spatula , 8mm, da Vinci S, Si; PlanPoint"" Software; PlanPoint™ Software; Planning Laptop; Potts Scissors , 8mm, da Vinci S, Si; Power Cord, 3.7 Meter, 115V, US, C13 > Hospital Grade; PreCise Bipolar Forceps , 8mm, da Vinci; PreCise Bipolar Forceps , 8mm, da Vinci S, Si; Procedure Tray, da Vinci, da Vinci S, Si; Prograsp Forceps , 8mm, da Vinci S, Si; Red System Cable, da Vinci® S¿, da Vinci S; Reprocessing Cover; Resano Forceps , 8mm, da Vinci; Resano Forceps , 8mm, da Vinci S, Si; Roll stands and charts; Round Tip Scissors , 5mm, da Vinci; Round Tip Scissors , 5mm, da Vinci S, Si; Round Tip Scissors , 8mm, da Vinci S, Si; Round Tooth Retractor, da Vinci SP; SP Access Port Kit, Large Incision (2.7 cm-7 cm); SP Access Port Kit, Small Incision (2.7 cm-4 cm); SP Cadiere Forceps; SP Cadiere Forceps, Extended Range; SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP; SP Cleaning and Sterilization Kit, da Vinci SP; SP Endoscope, 0°; SP Fenestrated Bipolar Forceps; SP Force Bipolar; SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments); SP Force Bipolar, Extended Range; SP Maryland Bipolar Forceps; SP Maryland Bipolar Forceps, Extended Range; SP Medium Large Clip Applier; SP Monopolar Cautery Instrument; SP Monopolar Curved Scissors; SP Monopolar Curved Scissors Extended Range; SP Needle Driver; SP Needle Driver Extended Range; SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP; SP Round Tooth Retractor Extended Range; SRK,ENGLISH,IS4000; STARTER KIT,FF100 VISION; STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM; STARTER KIT,IS3000,HD ENDOSCOPE,12MM; STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM; Schertel Grasper , 5mm, da Vinci; Schertel Grasper , 5mm, da Vinci S, Si; Single Instrument Tray, da Vinci, da Vinci S, Si; Single Receptacle System Cable Extension Kit; Single-Site 10 mm Accessory Cannula, da Vinci Si; Single-Site 10 mm Blunt Obturator, da Vinci Si; Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si; Single-Site Bipolar Maryland, 5mm, da Vinci Si; Single-Site Fundus Grasper , 5mm, da Vinci Si; Single-Site Maryland Dissector , 5mm, da Vinci Si; Single-Site Monopolar Cautery , 5mm, da Vinci Si; Single-Site Port for 8.5 mm Endoscope, da Vinci Si; Single-Site Starter Kit US, Cholecystectomy, 20 Cases; Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si; Small Clip Applier , 8mm, da Vinci S, Si; Small Grasping Retractor , 8mm, da Vinci S, Si; Snap-Fit Scalpel Instrument , 8mm, da Vinci; Snap-Fit Scalpel Instrument , 8mm, da Vinci S, Si; Snap-fit Blue Blade, da Vinci, da Vinci S, Si; Snap-fit Paddle Blade, da Vinci, da Vinci S, Si; Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5; Stapler 45 Reload, Blue; Stapler 45 Reload, Green; Stapler 45 Reload, White; Stapler Cannula; Stapler Cannula Blunt Obturator; Stapler Cannula Blunt Obturator, Long; Stapler Cannula, Long; Stapler Release Kit; Stapler Sheath; Stapler-8mm Cannula Reducer; Streme App; SureForm 45 Curved Tip, SureForm 45 Gray Reload; SureForm 45 System; SureForm 45, SureForm 45 Reloads; SureForm 60; SureForm 60 Reloads; SureForm 60 System; Swivel Connector; SynchroSeal; System Cart; Teleflex Obturators; Tenaculum Forceps , 8mm, da Vinci S, Si; Thoracic Grasper , 5mm, da Vinci S, Si; Thoracic Grasper , 8mm, da Vinci; Thoracic Grasper , 8mm, da Vinci S, Si; Tip Cover Accessory; Tip Cover Accessory, da Vinci, da Vinci S, Si; UPGRADE,CO2 TANK INTERFACE,CGA940,US; Universal Seal; Universal Seal (5-12 mm); Universal Seal (5-12mm); VIO DV 2,INTEGRATED ELECTRO SURGICAL UNIT; VIO-ICB Mounting Bracket; Valve Hook , 8mm, da Vinci; Valve Hook , 8mm, da Vinci S, Si; Video Review (also referred to as “Replay”); Vision Probe Adapter and Suction Adapter; Vision Probe Bag; VisionBoom¿ Extension Cable; X; Xi; da Vinci 5 Force Feedback Cadiere Forceps; da Vinci 5 Force Feedback Fenestrated Bipolar Forceps; da Vinci 5 Force Feedback Large Needle Driver; da Vinci 5 Force Feedback Maryland Bipolar Forceps; da Vinci 5 Force Feedback Mega SutureCut Needle Driver; da Vinci 5 Force Feedback ProGrasp Forceps; da Vinci E-200 Electrosurgical Generator; da Vinci Firefly Imaging System; da Vinci Fluorescence Imaging Vision System; da Vinci Force Feedback Cadiere Forceps; da Vinci Force Feedback Fenestrated Bipolar Forceps; da Vinci Force Feedback Large Needle Driver; da Vinci Force Feedback Maryland Bipolar Forceps; da Vinci Force Feedback Mega SutureCut Needle Driver; da Vinci Force Feedback ProGrasp Forceps; da Vinci Insufflator; da Vinci Insufflator Tube Set with Smoke Evacuation; da Vinci S Surgical System; da Vinci SP Advanced Access Port Kit; da Vinci SP Firefly Imaging System; da Vinci SP SureForm™ 45 Curved-Tip Stapler; da Vinci SP SureForm™ 45 Stapler; da Vinci SP Surgical System; da Vinci SP Surgical System (SP1098); da Vinci SP Surgical System, Patient Cart; da Vinci SP Surgical System, Surgeon Console; da Vinci SP Surgical System, Vision Cart; da Vinci SP® Instruments and Accessories; da Vinci SP® Surgical System, Model SP1098; da Vinci Si; da Vinci Single-Site Accessories; da Vinci Single-Site Instrument and Accessories; da Vinci Single-Site Instruments; da Vinci Single-Site Instruments and Accessories; da Vinci Single-Site Port; da Vinci SonicPro Cleaning System; da Vinci Surgi=cal System, S (HD); da Vinci Surgical System (IS5000); da Vinci Surgical System, S; da Vinci Surgical System, Si; da Vinci X; da Vinci X Surgical System; da Vinci X Surgical System (IS4200); da Vinci Xi; da Vinci Xi 12 mm and Stapler Hasson Cone; da Vinci Xi 12-8 mm Reducer; da Vinci Xi 8 mm Hasson Cone; da Vinci Xi Surgical System (IS4000); da Vinci Xi Surgical System with Table Motion; da Vinci Xi Surgical System, Patient Cart; da Vinci Xi Surgical System, Surgeon Console; da Vinci Xi Surgical System, Vision Cart; da Vinci® 8 mm Cannula Gage Pin, da Vinci, da Vinci S, Si; da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200; iESU; surgical drapes",1998-01-06,185,2026-07-14,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011063460%22&limit=1
DSV Solutions LTD.,3013868968,3013868968,Units 3/4 Stratus Park Brudenell Drive,Brinklow Milton Keynes,,MK10 0DE,United Kingdom,"Intuitive Surgical, Inc.",9028901,Exporter to the US,28,EOQ; EQH; ERY; FCW; FDE; FET; FFY; FOX; GAG; GCI; GCJ; GDW; GEH; GEI; HIF; IZI; KCT; KKX; LFL; LKF; LLZ; MNL; NAY; NTN; NVE; OWN; PUI; QIH,"Bronchoscope (Flexible Or Rigid); Source, Carrier, Fiberoptic Light; Drape, Surgical, Ent; Light Source, Fiberoptic, Routine; Laparoscopy Kit; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Adaptor, Bulbs, Miscellaneous, For Endoscope; Stand, Infusion; Stapler, Surgical; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Staple, Implantable; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Insufflator, Laparoscopic; System, X-Ray, Angiographic; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Drape, Surgical, Antimicrobial; Instrument, Ultrasonic Surgical; Cannula, Manipulator/Injector, Uterine; System, Image Processing, Radiological; Accessories, Cleaning Brushes, For Endoscope; System, Surgical, Computer Controlled Instrument; Led Light Source; Washer, Cleaner, Automated, Endoscope; Confocal Optical Imaging; Drape, Surgical, Exempt; Automated Radiological Image Processing Software",1; 2; U,"10-12mm+Stapler Cannula Seal; 12 Mm & Stapler Bladeless Obturator; 12 mm Assist Cannula; 12 mm Blunt Obturator, da Vinci S, Si; 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si; 12 mm Endoscope Cannula Mount, Balloon Port; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si; 12 mm Endoscope Cannula Mount, COV; 12 mm Endoscope Cannula Mount, COV, da Vinci; 12 mm Endoscope Cannula Mount, ETH, da Vinci; 12 mm Endoscope Cannula Mount, ETH/TAUT, da Vinci S, Si; 12 mm Endoscope, 0°; 12 mm Endoscope, 30°; 12 mm Instrument Cannula, da Vinci S, Si; 12mm IS4000 Endoscopes and Accessories; 3D Camera, Wide Angle, NTSC; 3D Camera, Wide Angle, PAL; 3D Model Viewer; 3DHD Camera Head and Cable; 3DHD Camera Head and Cable (Ikegami HD); 3DHD Camera Head and Cable (Panasonic HD); 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000); 5 mm Blunt Obturator, da Vinci S, Si; 5 mm Flared Cannula, da Vinci S, Si; 5 mm Sharp Obturator, da Vinci S, Si; 5 mm to 8 mm Cannula Seal; 8 mm Assist Cannula; 8 mm Bladeless Obturator (Optical); 8 mm Bladeless Obturator (Optical), Long; 8 mm Blunt Obturator, Long, da Vinci S, Si; 8 mm Blunt Obturator, da Vinci S, Si; 8 mm Cannula Seal, da Vinci, da Vinci S, Si; 8 mm Cannula with Outlet, Long, da Vinci S, Si; 8 mm Cannula with Outlet, da Vinci S, Si; 8 mm Harmonic ACE Curved Shears; 8 mm Instrument Cannula, Long, da Vinci S, Si; 8 mm Instrument Cannula, da Vinci S, Si; 8 mm Sharp Obturator, Long, da Vinci S, Si; 8 mm Sharp Obturator, da Vinci S, Si; 8 mm SureForm 30 Curved-Tip Stapler; 8 mm SureForm 30 Reload, Blue; 8 mm SureForm 30 Reload, Gray; 8 mm SureForm 30 Reload, White; 8 mm SureForm 30 Stapler; 8 mm SureForm 30 System; 8 mm Trocar, Long; 8 mm Trocar, Standard; 8 mm to 5 mm Cannula Reducer, da Vinci; 8 mm to 5 mm Cannula Reducer, da Vinci S, Si; 8.5 mm Endoscope, 0°; 8.5 mm Endoscope, 30°; 8.5-13 mm Cannula Seal; 8.5mm Endoscope, 0°; 8.5mm Endoscope, 30°; 8mm 0 degree endoscope; 8mm 30 degree endoscope; 8mm Atrial Retractor Short Right, Xi; 8mm Black Diamond Micro Forceps, Xi; 8mm Blunt Obturator Long, Xi; 8mm Blunt Obturator, Xi; 8mm Cadiere Forceps; 8mm Cannula Long, Xi; 8mm Cannula Standard, Xi; 8mm Cardiac Probe Grasper, Xi; 8mm Cobra Grasper; 8mm Cobra Graspers; 8mm Curved Bipolar Dissector; 8mm Debakey Forceps; 8mm Dual Blade Retractor, Xi; 8mm Endoscope, 0°, Gen5; 8mm Endoscope, 30°, Gen5; 8mm Fenestrated Bipolar Forceps; 8mm Fenstrated Bipolar Forceps, Xi; 8mm Flared Cannula, Xi; 8mm Force Bipolar; 8mm Hex Cannula, Long; 8mm Hex Cannula, Standard; 8mm Instrument Introducer, Xi; 8mm Large Hem-O-Lok Clip Applier, Xi; 8mm Large Needle Driver; 8mm Large Needle Driver, Xi; 8mm Large SutureCut Needle Driver; 8mm Large Suturecut Needle Driver, Xi; 8mm Long Bipolar Grasper; 8mm Long Tip Forceps; 8mm Long Tip Forceps, Xi; 8mm Maryland Bipolar Forceps; 8mm Maryland Bipolar Forceps, Xi; 8mm Medium Large Hem-O-Lok Clip Applier; 8mm Medium-Large Clip Applier, Xi; 8mm Mega SutureCut Needle Driver; 8mm Mega SutureCut Needle Driver, Xi; 8mm Micro Bipolar Forceps; 8mm Micro Bipolar Forceps, Xi; 8mm Monopolar Curved Scissors; 8mm Monopolar Curved Scissors, Xi; 8mm Permanent Monopolar Cautery Hook, Xi; 8mm Permanent Monopolar Cautery Spatula, Xi; 8mm Potts Scissors, Xi; 8mm ProGrasp Forceps; 8mm ProGrasp Forceps, Xi; 8mm Resano Forceps, Xi; 8mm Round Tip Scissor; 8mm Small Clip Applier, Xi; 8mm Small Grasping Retractor, Xi; 8mm Snap-Fit Instrument, Xi; 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm Reloads; 8mm SureForm Stapler; 8mm Tenaculum Forceps, Xi; 8mm Tip-Up Fenstrated Grasper, Xi; ARM 4 PROXIMAL DRAPE, IS4200; ASSY,CABLE,CORE TO DOCO; ASSY,CABLE,DOCO TO ILLUMINATOR; ASSY,PSCART,IS3000,3-ARM; ASSY,PSCART,IS3000,4-ARM; ASSY,SSC,IS3000; ASSY,VSS VISION SYSTEM W/AVP,VS3000; Accessory Base Starter Kit; Accessory Base Starter Kit, Multi-Specialty, ETH; Alignment Target, 8.6mm Endoscope; Assembly, Cannula Mount, Dual Jaw COV, ECM, da Vinci S, Si; Assembly, PSCart, IS2000, 4-Arm, G1.1; Assembly, Patient Side Cart; Assembly, Surgeon Side Console; Assembly, Surgeon Side System, IS2000; Assembly, VSC, VS2000 Panasonic HD, Domestic; Assembly, Vision System; Assembly, Vision System w/TS, NTSC, VS2000 HD, Domestic; Atrial Retractor , 8mm, da Vinci; Atrial Retractor Short Right , 8mm, da Vinci S, Si; BRACKET(SET),DOCO/ILLUMINATOR RESTRAINING,IS3000; Bath Probe; Bifurcated Light Guide; Bipolar Cautery Cord; Bipolar Cautery Cord, da Vinci SP; Bipolar Energy Activation Cable, CONMED; Bipolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Bipolar Energy Activation Cable, ERBE; Bipolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Gyrus ACMI; Bipolar Energy Activation Cable, Gyrus ACMI, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Valleylab; Bipolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; Black Diamond Micro Forceps , 8mm, da Vinci S, Si; Blade Protector, Snap-fit, da Vinci, da Vinci S, Si; Blue System Cable, Type A to Type B, 7m; Blue System Cable, Type B, 7m; Blue System Cable, da Vinci Si; Bowel Grasper , 5mm, da Vinci; Bowel Grasper , 5mm, da Vinci S, Si; CABLE KIT,BLUE FIBERCONNECT,20M; CABLE,PMED,COVIDIEN FORCE TRIAD; CAMERA ARM DRAPE,IS3000; CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100; CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2; CAMERA STARTER KIT,PANASONIC,HD; CIM extended height adjustable arm; CIM extended pivot arm; CIM height adjustable arm; CIM pivot arm; COLUMN DRAPE, IS4000; Cadiere Forceps , 8mm, da Vinci S, Si; Cadiere Forceps, da Vinci SP; Camera Arm Sterile Adapter; Camera Head Cable; Camera Head Sterile Adapter; Camera Head Video Cable, Ikegami® HD; Camera Head Video Cable, Panasonic® HD; Camera Head Video Cable, Sumitomo® SD; Camera Sheath, da Vinci SP; Camera Starter Kit; Camera Starter Kit, NTSC Wide Angle, Type 2; Camera Starter Kit, PAL High Mag, Type 2; Camera Starter Kit, PAL Wide Angle, Type 2; Camera Starter Kit, Panasonic HD; Cannula 5 mm Regular, da Vinci S, Si; Cannula Holder, Twist¿Lock, da Vinci; Cannula Seal, 8mm; Cannula, 8.5mm Endoscope; Cannula, Circular, 25 mm x 100 mm, da Vinci SP; Cardiac Probe Grasper; Cardiac Probe Grasper , 8mm, da Vinci; Cardiac Probe Grasper , 8mm, da Vinci S, Si; Catheter Continuity Cable; Catheter Continuity Stand; Catheter Guide; Cautery Hook Tip, 5 mm, da Vinci, da Vinci S, Si; Cautery Hook Tip, da Vinci SP; Cautery Spatula Tip, 5mm, da Vinci, da Vinci S, Si; Cautery Spatula Tip, da Vinci SP; Cleaning and Sterilization Kit; Cleaning and Sterilization Kit, English; Cleaning and Sterilization Kit, da Vinci SP; Cobra Grasper , 8mm, da Vinci S, Si; Controller; Curved Bipolar Dissector , 8mm, da Vinci S, Si; Curved Scissors , 5mm, da Vinci; Curved Scissors , 5mm, da Vinci S, Si; Curved Scissors , 8mm, da Vinci S, Si; Curved Stapler 30; DEVICE,ENERGY,ERBE VIO 300D; DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR; DUCT,LEFT,ILLUMINATOR,FIREFLY100; DUCT,RIGHT,ILLUMINATOR,FIREFLY100; Da Vinci 5 Console - Model: C5000; Da Vinci 5 Robot - Model: R5000; Da Vinci 5 Tower - Model: T5000; Da Vinci E-200 Electrosurgical Generator; Da Vinci E-200 Generator; Da Vinci E200 Generator; Da Vinci Force Feedback Cadiere Forceps; Da Vinci Force Feedback Fenestrated Bipolar Forceps; Da Vinci Force Feedback Large Needle Driver; Da Vinci Force Feedback Maryland Bipolar Forceps; Da Vinci Force Feedback Mega SutureCut Needle Driver; Da Vinci Force Feedback ProGrasp Forceps; Da Vinci Handheld Camera; Da Vinci Monopolar and Bipolar Adapters; Da Vinci SP Vision Cart; Da Vinci X/Xi 8mm Endoscope Plus, 0 degree; Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees; Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree; DeBakey Forceps , 5mm, da Vinci; DeBakey Forceps , 5mm, da Vinci S, Si; DeBakey Forceps , 8mm, da Vinci S, Si; Double Fenestrated Grasper , 8mm, da Vinci S, Si; Double Receptacle System Cable Extension Kit; Dual Blade Retractor , 8mm, da Vinci; Dual Blade Retractor , 8mm, da Vinci S, Si; E-100; EndoPass Endoscopic Delivery Instruments; EndoWrist 5mm Thoracic Grasper; EndoWrist Accessories, da Vinci Xi; EndoWrist Cardiac Probe Grasper; EndoWrist Endoscopic Instruments; EndoWrist Instruments, da Vinci S/Si; EndoWrist Instruments, da Vinci Xi; EndoWrist Introducer Instrument; EndoWrist One Suction/Irrigator; EndoWrist One Suction/Irrigator, 8mm, da Vinci Si; EndoWrist One Vessel Sealer , 8mm, da Vinci Si; EndoWrist One Vessel Sealer, 8mm, da Vinci Si; EndoWrist PK Dissecting Forceps; EndoWrist Permanent Cautery Instruments; EndoWrist SP Camera, 0 degree, da Vinci SP; EndoWrist Stabilizer; EndoWrist Stapler 30 Instrument; EndoWrist Stapler 30 Reloads; EndoWrist Stapler 30 System; EndoWrist Stapler 45; EndoWrist Stapler 45 Reload, Blue; EndoWrist Stapler 45 Reload, Green; EndoWrist Stapler 45 System; EndoWrist Stapler Cable; EndoWrist Stapler Cannula Blunt Obturator, da Vinci S, Si; EndoWrist Stapler Cannula Kit; EndoWrist Stapler Cannula Reducer, da Vinci S, Si; EndoWrist Stapler Cannula Seal; EndoWrist Stapler Cannula, da Vinci S, Si; EndoWrist Stapler Motor Pack; EndoWrist Stapler Release Kit; EndoWrist Stapler Sheath; EndoWrist Stapler System Starter Kit - 45 mm; EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm; EndoWrist Suction Irrigator; EndoWrist Vessel Sealer; EndoWrist Vessel Sealer Extend; EndoWrist resuable Accessories, da Vinci S/Si; EndoWristStapler 30 and Stapler 30Reloads; EndoWristStapler 45 and Stapler 45 Reloads; EndoWrist® Stapler 45; EndoWrist® Stapler 45 Curved-Tip; Endopass Delivery Instrument; Endoscope Sterilization Tray; Endoscope, 0 degrees, Xi; Endoscope, 30 degrees, Xi; Endoscopes, da Vinci S/Si; Endoscopes, da Vinci Xi; Endoscopic Instruments; Endowrist Bipolar Instruments; Endowrist Instruments; Endowrist Permanent Cautery Instrum; Endowrist Stapler Cannula; Endowrist Stapler Obturator; Endowrsit Stapler Reducer; Energy Activation Adapter, Ethicon GEN11, da Vinci Si; Energy Activation Cable, CONMED, da Vinci Si; Energy Activation Cable, ERBE, da Vinci Si; Energy Activation Cable, Ethicon; Energy Activation Cable, Ethicon, da Vinci Si; Energy Activation Cable, Gyrus, da Vinci Si; Energy Activation Cable, Valleylab, da Vinci Si; EnergyShield Monopolar Cautery Cord, da Vinci SP; EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP; Fenestrated Bipolar Forceps , 8mm, da Vinci S, Si; Fenestrated Bipolar Forceps, 5mm, da Vinci Si; Fenestrated Bipolar Forceps, da Vinci SP; Fiber Cable Cleaning Kit; Fine Tissue Forceps , 8mm, da Vinci; Flexision"" Biopsy Needle 19G; Flexision"" Biopsy Needle 21G; Flexision"" Biopsy Needle 23G; Flexision™ Biopsy Needle 19G; Flexision™ Biopsy Needle 21G; Flexision™ Biopsy Needle 23G; Fluorescence Imaging Camera Head and Cable Kit; Fluorescence Imaging Illuminator; Fluorescence Imaging Kit; Force Bipolar; Gage Pin, Xi; Grasping Retractor , 8mm, da Vinci S, Si; Green System Cable, da Vinci Si; Handheld Camera Light Guide; Handheld Camera Light Guide Adapter; Handheld Camera Sterilization Tray; Harmonic ACE; Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic ACE Curved Shears, 5mm, da Vinci S/Si; Harmonic ACE Curved Shears, 8mm, da Vinci S/Si; Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Ace Curved Shears; Harmonic Ace Curved Shears , 5mm, da Vinci; Harmonic Ace Curved Shears , 5mm, da Vinci S, Si; Harmonic Ace Curved Shears , 8mm, da Vinci S, Si; Harmonic Curved Shears; Harmonic Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Curved Shears Instrument; Harmonic Curved Shears, 5mm, da Vinci; Harmonic Curved Shears, 5mm, da Vinci S, Si; Harmonic Curved Shears, 8mm, da Vinci; Harmonic Curved Shears, 8mm, da Vinci S, Si; ICB, Instrument Control Box; IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000; ILLUMINATOR,Y1865; INSTRUMENT ARM DRAPE IS2000; INSTRUMENT ARM DRAPE, IS4000; INTUITIVE SURGICAL STEREO ENDOSCOPE; IRIS System 1; IRISeg; IRK,ENGLISH,IS4000; IS Endoscopic Control System; IS Endoscopic Instruments; IS Endowrist Bipolar Instrument; IS da Vinci Surgical System; IS3000 Stapler 45 Accessories; IS3000 Stapler 45 Instrument; IS4000 ACCESSORY STARTER KIT; IS4000 EndoWrist Stapler 30; IS4000 Long Bipolar Forceps; IS4000 Small Clip Applier  IS4000 Long Bipolar Forceps; IS4000 Stapler 45 Accessories; IS4000 Stapler 45 Instrument; IS4000 da Vinci EndoWrist Instruments; IS4200 ACCESSORY STARTER KIT; Illuminator Lamp Module, Model Y1866; Instrument Arm Drape, da Vinci SP; Instrument Release Kit, Xi; Instrument Sheath, da Vinci SP; Instrument Tray, da Vinci, da Vinci S, Si; Instrument/Accessory Steriliz Tray; Introducer 5Fr , 5mm, da Vinci S, Si; Intuitive Surgical EndoWrist Stabilizer; Intuitive Surgical Vessel Sealer Extend; Intuitive Surgical da Vinci S Surgical System, Model IS2000 with Connect OnSite and Wireless Connectivity Option; Intuitive Surgical da Vinci Surgical System; Intuitive Surgical da Vinci®,da Vinci S®, and da Vinci Si® Surgical Systems and EndoWrist Instruments and Accessories; Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System; Ion Endoluminal System (IF1000); Ion Reprocessing Consumable Kit; Ion reprocessing accessory kit; Ion"" Fully Articulating Catheter; Ion"" Peripheral Vision Probe; Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000); Ion™ Endoluminal System, Model IF1000; Ion™ Fully Articulating Catheter; Ion™ Peripheral Vision Probe; KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F; Laparoscope 10mm, 0, NIR; Laparoscope 10mm, 30, NIR; Laparoscope 5mm, 0; Laparoscope 5mm, 30; Large Clip Applier , 8mm, da Vinci S, Si; Large Needle Driver , 8mm, da Vinci S, Si; Large SutureCut Needle Driver , 8mm, da Vinci S, Si; Leak Test Adapter; Light Guide Cable Adapter; Light Guide Cable Adapter, da Vinci, da Vinci S; Long Tip Forceps , 8mm, da Vinci S, Si; MARS 1; MCS Tip, da Vinci SP; Maryland Bipolar Forceps , 8mm, da Vinci S, Si; Maryland Bipolar Forceps, da Vinci SP; Maryland Dissector , 5mm, da Vinci; Maryland Dissector , 5mm, da Vinci S, Si; Medium-Large Clip Applier , 8mm, da Vinci S, Si; Medium-Large Clip Applier, da Vinci SP; Mega Needle Driver , 8mm, da Vinci S, Si; Mega SutureCut Needle Driver , 8mm, da Vinci; Mega SutureCut Needle Driver , 8mm, da Vinci S, Si; Micro Bipolar Forceps , 8mm, da Vinci; Micro Bipolar Forceps, 8mm, da Vinci S, Si; Monopolar Cautery , 5mm, da Vinci; Monopolar Cautery , 5mm, da Vinci S, Si; Monopolar Cautery Cord; Monopolar Cautery Instrument, da Vinci SP; Monopolar Curved Scissors , 8mm, da Vinci; Monopolar Curved Scissors , 8mm, da Vinci S, Si; Monopolar Curved Scissors, 8mm, da Vinci S, Si; Monopolar Curved Scissors, da Vinci SP; Monopolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Monopolar Energy Activation Cable, ERBE; Monopolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; NIR Handheld Camera; NIR Handheld Camera Control Unit (CCU); NIR Handheld Camera Light Guide; NIR Handheld Camera Light Guide Adapter; NIR Handheld Camera Light Source; NIR Handheld Camera System Starter Kit; NIR Handheld Camera Tray; Needle Driver , 5mm, da Vinci; Needle Driver , 5mm, da Vinci S, Si; Needle Driver, da Vinci SP; Obturator, Circular, 25 mm x 100 mm, da Vinci SP; Option, Connect, da Vinci Si; PK Dissecting Forceps; PK Dissecting Forceps , 8mm, da Vinci S, Si; PK® Instrument Cord, G400 Generator, da Vinci, da Vinci S, Si; PK® Instrument Cord, PK/SP Generator, da Vinci, da Vinci S, Si; PROBE HOLDER SYSTEM; Pericardial Dissector , 8mm, da Vinci; Permanent Cautery Hook , 8mm, da Vinci S, Si; Permanent Cautery Spatula , 8mm, da Vinci S, Si; PlanPoint"" Software; PlanPoint™ Software; Planning Laptop; Potts Scissors , 8mm, da Vinci S, Si; Power Cord, 3.7 Meter, 115V, US, C13 > Hospital Grade; PreCise Bipolar Forceps , 8mm, da Vinci; PreCise Bipolar Forceps , 8mm, da Vinci S, Si; Procedure Tray, da Vinci, da Vinci S, Si; Prograsp Forceps , 8mm, da Vinci S, Si; Red System Cable, da Vinci® S¿, da Vinci S; Reprocessing Cover; Resano Forceps , 8mm, da Vinci; Resano Forceps , 8mm, da Vinci S, Si; Roll stands and charts; Round Tip Scissors , 5mm, da Vinci; Round Tip Scissors , 5mm, da Vinci S, Si; Round Tip Scissors , 8mm, da Vinci S, Si; Round Tooth Retractor, da Vinci SP; SP Access Port Kit, Large Incision (2.7 cm-7 cm); SP Access Port Kit, Small Incision (2.7 cm-4 cm); SP Cadiere Forceps; SP Cadiere Forceps, Extended Range; SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP; SP Cleaning and Sterilization Kit, da Vinci SP; SP Endoscope, 0°; SP Fenestrated Bipolar Forceps; SP Force Bipolar; SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments); SP Force Bipolar, Extended Range; SP Maryland Bipolar Forceps; SP Maryland Bipolar Forceps, Extended Range; SP Medium Large Clip Applier; SP Monopolar Cautery Instrument; SP Monopolar Curved Scissors; SP Monopolar Curved Scissors Extended Range; SP Needle Driver; SP Needle Driver Extended Range; SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP; SP Round Tooth Retractor Extended Range; SRK,ENGLISH,IS4000; STARTER KIT,FF100 VISION; STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM; STARTER KIT,IS3000,HD ENDOSCOPE,12MM; STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM; Schertel Grasper , 5mm, da Vinci; Schertel Grasper , 5mm, da Vinci S, Si; Single Instrument Tray, da Vinci, da Vinci S, Si; Single Receptacle System Cable Extension Kit; Single-Site 10 mm Accessory Cannula, da Vinci Si; Single-Site 10 mm Blunt Obturator, da Vinci Si; Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si; Single-Site Bipolar Maryland, 5mm, da Vinci Si; Single-Site Fundus Grasper , 5mm, da Vinci Si; Single-Site Maryland Dissector , 5mm, da Vinci Si; Single-Site Monopolar Cautery , 5mm, da Vinci Si; Single-Site Port for 8.5 mm Endoscope, da Vinci Si; Single-Site Starter Kit US, Cholecystectomy, 20 Cases; Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si; Small Clip Applier , 8mm, da Vinci S, Si; Small Grasping Retractor , 8mm, da Vinci S, Si; Snap-Fit Scalpel Instrument , 8mm, da Vinci; Snap-Fit Scalpel Instrument , 8mm, da Vinci S, Si; Snap-fit Blue Blade, da Vinci, da Vinci S, Si; Snap-fit Paddle Blade, da Vinci, da Vinci S, Si; Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5; Stapler 45 Reload, Blue; Stapler 45 Reload, Green; Stapler 45 Reload, White; Stapler Cannula; Stapler Cannula Blunt Obturator; Stapler Cannula Blunt Obturator, Long; Stapler Cannula, Long; Stapler Release Kit; Stapler Sheath; Stapler-8mm Cannula Reducer; Streme App; SureForm 45 Curved Tip, SureForm 45 Gray Reload; SureForm 45 System; SureForm 45, SureForm 45 Reloads; SureForm 60; SureForm 60 Reloads; SureForm 60 System; Swivel Connector; SynchroSeal; System Cart; Teleflex Obturators; Tenaculum Forceps , 8mm, da Vinci S, Si; Thoracic Grasper , 5mm, da Vinci S, Si; Thoracic Grasper , 8mm, da Vinci; Thoracic Grasper , 8mm, da Vinci S, Si; Tip Cover Accessory; Tip Cover Accessory, da Vinci, da Vinci S, Si; UPGRADE,CO2 TANK INTERFACE,CGA940,US; Universal Seal; Universal Seal (5-12 mm); Universal Seal (5-12mm); VIO DV 2,INTEGRATED ELECTRO SURGICAL UNIT; VIO-ICB Mounting Bracket; Valve Hook , 8mm, da Vinci; Valve Hook , 8mm, da Vinci S, Si; Video Review (also referred to as “Replay”); Vision Probe Adapter and Suction Adapter; Vision Probe Bag; VisionBoom¿ Extension Cable; X; Xi; da Vinci 5 Force Feedback Cadiere Forceps; da Vinci 5 Force Feedback Fenestrated Bipolar Forceps; da Vinci 5 Force Feedback Large Needle Driver; da Vinci 5 Force Feedback Maryland Bipolar Forceps; da Vinci 5 Force Feedback Mega SutureCut Needle Driver; da Vinci 5 Force Feedback ProGrasp Forceps; da Vinci E-200 Electrosurgical Generator; da Vinci Firefly Imaging System; da Vinci Fluorescence Imaging Vision System; da Vinci Force Feedback Cadiere Forceps; da Vinci Force Feedback Fenestrated Bipolar Forceps; da Vinci Force Feedback Large Needle Driver; da Vinci Force Feedback Maryland Bipolar Forceps; da Vinci Force Feedback Mega SutureCut Needle Driver; da Vinci Force Feedback ProGrasp Forceps; da Vinci Insufflator; da Vinci Insufflator Tube Set with Smoke Evacuation; da Vinci S Surgical System; da Vinci SP Advanced Access Port Kit; da Vinci SP Firefly Imaging System; da Vinci SP SureForm™ 45 Curved-Tip Stapler; da Vinci SP SureForm™ 45 Stapler; da Vinci SP Surgical System; da Vinci SP Surgical System (SP1098); da Vinci SP Surgical System, Patient Cart; da Vinci SP Surgical System, Surgeon Console; da Vinci SP Surgical System, Vision Cart; da Vinci SP® Instruments and Accessories; da Vinci SP® Surgical System, Model SP1098; da Vinci Si; da Vinci Single-Site Accessories; da Vinci Single-Site Instrument and Accessories; da Vinci Single-Site Instruments; da Vinci Single-Site Instruments and Accessories; da Vinci Single-Site Port; da Vinci SonicPro Cleaning System; da Vinci Surgi=cal System, S (HD); da Vinci Surgical System (IS5000); da Vinci Surgical System, S; da Vinci Surgical System, Si; da Vinci X; da Vinci X Surgical System; da Vinci X Surgical System (IS4200); da Vinci Xi; da Vinci Xi 12 mm and Stapler Hasson Cone; da Vinci Xi 12-8 mm Reducer; da Vinci Xi 8 mm Hasson Cone; da Vinci Xi Surgical System (IS4000); da Vinci Xi Surgical System with Table Motion; da Vinci Xi Surgical System, Patient Cart; da Vinci Xi Surgical System, Surgeon Console; da Vinci Xi Surgical System, Vision Cart; da Vinci® 8 mm Cannula Gage Pin, da Vinci, da Vinci S, Si; da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200; iESU; surgical drapes",1998-01-06,185,2026-07-14,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013868968%22&limit=1
Device Technologies Australia,3010885402,3010885402,158 Hollinsworth Road,Marsden Park New South Wales,,2765,Australia,"Intuitive Surgical, Inc.",9028901,Exporter to the US,28,EOQ; EQH; ERY; FCW; FDE; FET; FFY; FOX; GAG; GCI; GCJ; GDW; GEH; GEI; HIF; IZI; KCT; KKX; LFL; LKF; LLZ; MNL; NAY; NTN; NVE; OWN; PUI; QIH,"Bronchoscope (Flexible Or Rigid); Source, Carrier, Fiberoptic Light; Drape, Surgical, Ent; Light Source, Fiberoptic, Routine; Laparoscopy Kit; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Adaptor, Bulbs, Miscellaneous, For Endoscope; Stand, Infusion; Stapler, Surgical; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Staple, Implantable; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Insufflator, Laparoscopic; System, X-Ray, Angiographic; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Drape, Surgical, Antimicrobial; Instrument, Ultrasonic Surgical; Cannula, Manipulator/Injector, Uterine; System, Image Processing, Radiological; Accessories, Cleaning Brushes, For Endoscope; System, Surgical, Computer Controlled Instrument; Led Light Source; Washer, Cleaner, Automated, Endoscope; Confocal Optical Imaging; Drape, Surgical, Exempt; Automated Radiological Image Processing Software",1; 2; U,"10-12mm+Stapler Cannula Seal; 12 Mm & Stapler Bladeless Obturator; 12 mm Assist Cannula; 12 mm Blunt Obturator, da Vinci S, Si; 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si; 12 mm Endoscope Cannula Mount, Balloon Port; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si; 12 mm Endoscope Cannula Mount, COV; 12 mm Endoscope Cannula Mount, COV, da Vinci; 12 mm Endoscope Cannula Mount, ETH, da Vinci; 12 mm Endoscope Cannula Mount, ETH/TAUT, da Vinci S, Si; 12 mm Endoscope, 0°; 12 mm Endoscope, 30°; 12 mm Instrument Cannula, da Vinci S, Si; 12mm IS4000 Endoscopes and Accessories; 3D Camera, Wide Angle, NTSC; 3D Camera, Wide Angle, PAL; 3D Model Viewer; 3DHD Camera Head and Cable; 3DHD Camera Head and Cable (Ikegami HD); 3DHD Camera Head and Cable (Panasonic HD); 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000); 5 mm Blunt Obturator, da Vinci S, Si; 5 mm Flared Cannula, da Vinci S, Si; 5 mm Sharp Obturator, da Vinci S, Si; 5 mm to 8 mm Cannula Seal; 8 mm Assist Cannula; 8 mm Bladeless Obturator (Optical); 8 mm Bladeless Obturator (Optical), Long; 8 mm Blunt Obturator, Long, da Vinci S, Si; 8 mm Blunt Obturator, da Vinci S, Si; 8 mm Cannula Seal, da Vinci, da Vinci S, Si; 8 mm Cannula with Outlet, Long, da Vinci S, Si; 8 mm Cannula with Outlet, da Vinci S, Si; 8 mm Harmonic ACE Curved Shears; 8 mm Instrument Cannula, Long, da Vinci S, Si; 8 mm Instrument Cannula, da Vinci S, Si; 8 mm Sharp Obturator, Long, da Vinci S, Si; 8 mm Sharp Obturator, da Vinci S, Si; 8 mm SureForm 30 Curved-Tip Stapler; 8 mm SureForm 30 Reload, Blue; 8 mm SureForm 30 Reload, Gray; 8 mm SureForm 30 Reload, White; 8 mm SureForm 30 Stapler; 8 mm SureForm 30 System; 8 mm Trocar, Long; 8 mm Trocar, Standard; 8 mm to 5 mm Cannula Reducer, da Vinci; 8 mm to 5 mm Cannula Reducer, da Vinci S, Si; 8.5 mm Endoscope, 0°; 8.5 mm Endoscope, 30°; 8.5-13 mm Cannula Seal; 8.5mm Endoscope, 0°; 8.5mm Endoscope, 30°; 8mm 0 degree endoscope; 8mm 30 degree endoscope; 8mm Atrial Retractor Short Right, Xi; 8mm Black Diamond Micro Forceps, Xi; 8mm Blunt Obturator Long, Xi; 8mm Blunt Obturator, Xi; 8mm Cadiere Forceps; 8mm Cannula Long, Xi; 8mm Cannula Standard, Xi; 8mm Cardiac Probe Grasper, Xi; 8mm Cobra Grasper; 8mm Cobra Graspers; 8mm Curved Bipolar Dissector; 8mm Debakey Forceps; 8mm Dual Blade Retractor, Xi; 8mm Endoscope, 0°, Gen5; 8mm Endoscope, 30°, Gen5; 8mm Fenestrated Bipolar Forceps; 8mm Fenstrated Bipolar Forceps, Xi; 8mm Flared Cannula, Xi; 8mm Force Bipolar; 8mm Hex Cannula, Long; 8mm Hex Cannula, Standard; 8mm Instrument Introducer, Xi; 8mm Large Hem-O-Lok Clip Applier, Xi; 8mm Large Needle Driver; 8mm Large Needle Driver, Xi; 8mm Large SutureCut Needle Driver; 8mm Large Suturecut Needle Driver, Xi; 8mm Long Bipolar Grasper; 8mm Long Tip Forceps; 8mm Long Tip Forceps, Xi; 8mm Maryland Bipolar Forceps; 8mm Maryland Bipolar Forceps, Xi; 8mm Medium Large Hem-O-Lok Clip Applier; 8mm Medium-Large Clip Applier, Xi; 8mm Mega SutureCut Needle Driver; 8mm Mega SutureCut Needle Driver, Xi; 8mm Micro Bipolar Forceps; 8mm Micro Bipolar Forceps, Xi; 8mm Monopolar Curved Scissors; 8mm Monopolar Curved Scissors, Xi; 8mm Permanent Monopolar Cautery Hook, Xi; 8mm Permanent Monopolar Cautery Spatula, Xi; 8mm Potts Scissors, Xi; 8mm ProGrasp Forceps; 8mm ProGrasp Forceps, Xi; 8mm Resano Forceps, Xi; 8mm Round Tip Scissor; 8mm Small Clip Applier, Xi; 8mm Small Grasping Retractor, Xi; 8mm Snap-Fit Instrument, Xi; 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm Reloads; 8mm SureForm Stapler; 8mm Tenaculum Forceps, Xi; 8mm Tip-Up Fenstrated Grasper, Xi; ARM 4 PROXIMAL DRAPE, IS4200; ASSY,CABLE,CORE TO DOCO; ASSY,CABLE,DOCO TO ILLUMINATOR; ASSY,PSCART,IS3000,3-ARM; ASSY,PSCART,IS3000,4-ARM; ASSY,SSC,IS3000; ASSY,VSS VISION SYSTEM W/AVP,VS3000; Accessory Base Starter Kit; Accessory Base Starter Kit, Multi-Specialty, ETH; Alignment Target, 8.6mm Endoscope; Assembly, Cannula Mount, Dual Jaw COV, ECM, da Vinci S, Si; Assembly, PSCart, IS2000, 4-Arm, G1.1; Assembly, Patient Side Cart; Assembly, Surgeon Side Console; Assembly, Surgeon Side System, IS2000; Assembly, VSC, VS2000 Panasonic HD, Domestic; Assembly, Vision System; Assembly, Vision System w/TS, NTSC, VS2000 HD, Domestic; Atrial Retractor , 8mm, da Vinci; Atrial Retractor Short Right , 8mm, da Vinci S, Si; BRACKET(SET),DOCO/ILLUMINATOR RESTRAINING,IS3000; Bath Probe; Bifurcated Light Guide; Bipolar Cautery Cord; Bipolar Cautery Cord, da Vinci SP; Bipolar Energy Activation Cable, CONMED; Bipolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Bipolar Energy Activation Cable, ERBE; Bipolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Gyrus ACMI; Bipolar Energy Activation Cable, Gyrus ACMI, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Valleylab; Bipolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; Black Diamond Micro Forceps , 8mm, da Vinci S, Si; Blade Protector, Snap-fit, da Vinci, da Vinci S, Si; Blue System Cable, Type A to Type B, 7m; Blue System Cable, Type B, 7m; Blue System Cable, da Vinci Si; Bowel Grasper , 5mm, da Vinci; Bowel Grasper , 5mm, da Vinci S, Si; CABLE KIT,BLUE FIBERCONNECT,20M; CABLE,PMED,COVIDIEN FORCE TRIAD; CAMERA ARM DRAPE,IS3000; CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100; CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2; CAMERA STARTER KIT,PANASONIC,HD; CIM extended height adjustable arm; CIM extended pivot arm; CIM height adjustable arm; CIM pivot arm; COLUMN DRAPE, IS4000; Cadiere Forceps , 8mm, da Vinci S, Si; Cadiere Forceps, da Vinci SP; Camera Arm Sterile Adapter; Camera Head Cable; Camera Head Sterile Adapter; Camera Head Video Cable, Ikegami® HD; Camera Head Video Cable, Panasonic® HD; Camera Head Video Cable, Sumitomo® SD; Camera Sheath, da Vinci SP; Camera Starter Kit; Camera Starter Kit, NTSC Wide Angle, Type 2; Camera Starter Kit, PAL High Mag, Type 2; Camera Starter Kit, PAL Wide Angle, Type 2; Camera Starter Kit, Panasonic HD; Cannula 5 mm Regular, da Vinci S, Si; Cannula Holder, Twist¿Lock, da Vinci; Cannula Seal, 8mm; Cannula, 8.5mm Endoscope; Cannula, Circular, 25 mm x 100 mm, da Vinci SP; Cardiac Probe Grasper; Cardiac Probe Grasper , 8mm, da Vinci; Cardiac Probe Grasper , 8mm, da Vinci S, Si; Catheter Continuity Cable; Catheter Continuity Stand; Catheter Guide; Cautery Hook Tip, 5 mm, da Vinci, da Vinci S, Si; Cautery Hook Tip, da Vinci SP; Cautery Spatula Tip, 5mm, da Vinci, da Vinci S, Si; Cautery Spatula Tip, da Vinci SP; Cleaning and Sterilization Kit; Cleaning and Sterilization Kit, English; Cleaning and Sterilization Kit, da Vinci SP; Cobra Grasper , 8mm, da Vinci S, Si; Controller; Curved Bipolar Dissector , 8mm, da Vinci S, Si; Curved Scissors , 5mm, da Vinci; Curved Scissors , 5mm, da Vinci S, Si; Curved Scissors , 8mm, da Vinci S, Si; Curved Stapler 30; DEVICE,ENERGY,ERBE VIO 300D; DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR; DUCT,LEFT,ILLUMINATOR,FIREFLY100; DUCT,RIGHT,ILLUMINATOR,FIREFLY100; Da Vinci 5 Console - Model: C5000; Da Vinci 5 Robot - Model: R5000; Da Vinci 5 Tower - Model: T5000; Da Vinci E-200 Electrosurgical Generator; Da Vinci E-200 Generator; Da Vinci E200 Generator; Da Vinci Force Feedback Cadiere Forceps; Da Vinci Force Feedback Fenestrated Bipolar Forceps; Da Vinci Force Feedback Large Needle Driver; Da Vinci Force Feedback Maryland Bipolar Forceps; Da Vinci Force Feedback Mega SutureCut Needle Driver; Da Vinci Force Feedback ProGrasp Forceps; Da Vinci Handheld Camera; Da Vinci Monopolar and Bipolar Adapters; Da Vinci SP Vision Cart; Da Vinci X/Xi 8mm Endoscope Plus, 0 degree; Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees; Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree; DeBakey Forceps , 5mm, da Vinci; DeBakey Forceps , 5mm, da Vinci S, Si; DeBakey Forceps , 8mm, da Vinci S, Si; Double Fenestrated Grasper , 8mm, da Vinci S, Si; Double Receptacle System Cable Extension Kit; Dual Blade Retractor , 8mm, da Vinci; Dual Blade Retractor , 8mm, da Vinci S, Si; E-100; EndoPass Endoscopic Delivery Instruments; EndoWrist 5mm Thoracic Grasper; EndoWrist Accessories, da Vinci Xi; EndoWrist Cardiac Probe Grasper; EndoWrist Endoscopic Instruments; EndoWrist Instruments, da Vinci S/Si; EndoWrist Instruments, da Vinci Xi; EndoWrist Introducer Instrument; EndoWrist One Suction/Irrigator; EndoWrist One Suction/Irrigator, 8mm, da Vinci Si; EndoWrist One Vessel Sealer , 8mm, da Vinci Si; EndoWrist One Vessel Sealer, 8mm, da Vinci Si; EndoWrist PK Dissecting Forceps; EndoWrist Permanent Cautery Instruments; EndoWrist SP Camera, 0 degree, da Vinci SP; EndoWrist Stabilizer; EndoWrist Stapler 30 Instrument; EndoWrist Stapler 30 Reloads; EndoWrist Stapler 30 System; EndoWrist Stapler 45; EndoWrist Stapler 45 Reload, Blue; EndoWrist Stapler 45 Reload, Green; EndoWrist Stapler 45 System; EndoWrist Stapler Cable; EndoWrist Stapler Cannula Blunt Obturator, da Vinci S, Si; EndoWrist Stapler Cannula Kit; EndoWrist Stapler Cannula Reducer, da Vinci S, Si; EndoWrist Stapler Cannula Seal; EndoWrist Stapler Cannula, da Vinci S, Si; EndoWrist Stapler Motor Pack; EndoWrist Stapler Release Kit; EndoWrist Stapler Sheath; EndoWrist Stapler System Starter Kit - 45 mm; EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm; EndoWrist Suction Irrigator; EndoWrist Vessel Sealer; EndoWrist Vessel Sealer Extend; EndoWrist resuable Accessories, da Vinci S/Si; EndoWristStapler 30 and Stapler 30Reloads; EndoWristStapler 45 and Stapler 45 Reloads; EndoWrist® Stapler 45; EndoWrist® Stapler 45 Curved-Tip; Endopass Delivery Instrument; Endoscope Sterilization Tray; Endoscope, 0 degrees, Xi; Endoscope, 30 degrees, Xi; Endoscopes, da Vinci S/Si; Endoscopes, da Vinci Xi; Endoscopic Instruments; Endowrist Bipolar Instruments; Endowrist Instruments; Endowrist Permanent Cautery Instrum; Endowrist Stapler Cannula; Endowrist Stapler Obturator; Endowrsit Stapler Reducer; Energy Activation Adapter, Ethicon GEN11, da Vinci Si; Energy Activation Cable, CONMED, da Vinci Si; Energy Activation Cable, ERBE, da Vinci Si; Energy Activation Cable, Ethicon; Energy Activation Cable, Ethicon, da Vinci Si; Energy Activation Cable, Gyrus, da Vinci Si; Energy Activation Cable, Valleylab, da Vinci Si; EnergyShield Monopolar Cautery Cord, da Vinci SP; EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP; Fenestrated Bipolar Forceps , 8mm, da Vinci S, Si; Fenestrated Bipolar Forceps, 5mm, da Vinci Si; Fenestrated Bipolar Forceps, da Vinci SP; Fiber Cable Cleaning Kit; Fine Tissue Forceps , 8mm, da Vinci; Flexision"" Biopsy Needle 19G; Flexision"" Biopsy Needle 21G; Flexision"" Biopsy Needle 23G; Flexision™ Biopsy Needle 19G; Flexision™ Biopsy Needle 21G; Flexision™ Biopsy Needle 23G; Fluorescence Imaging Camera Head and Cable Kit; Fluorescence Imaging Illuminator; Fluorescence Imaging Kit; Force Bipolar; Gage Pin, Xi; Grasping Retractor , 8mm, da Vinci S, Si; Green System Cable, da Vinci Si; Handheld Camera Light Guide; Handheld Camera Light Guide Adapter; Handheld Camera Sterilization Tray; Harmonic ACE; Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic ACE Curved Shears, 5mm, da Vinci S/Si; Harmonic ACE Curved Shears, 8mm, da Vinci S/Si; Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Ace Curved Shears; Harmonic Ace Curved Shears , 5mm, da Vinci; Harmonic Ace Curved Shears , 5mm, da Vinci S, Si; Harmonic Ace Curved Shears , 8mm, da Vinci S, Si; Harmonic Curved Shears; Harmonic Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Curved Shears Instrument; Harmonic Curved Shears, 5mm, da Vinci; Harmonic Curved Shears, 5mm, da Vinci S, Si; Harmonic Curved Shears, 8mm, da Vinci; Harmonic Curved Shears, 8mm, da Vinci S, Si; ICB, Instrument Control Box; IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000; ILLUMINATOR,Y1865; INSTRUMENT ARM DRAPE IS2000; INSTRUMENT ARM DRAPE, IS4000; INTUITIVE SURGICAL STEREO ENDOSCOPE; IRIS System 1; IRISeg; IRK,ENGLISH,IS4000; IS Endoscopic Control System; IS Endoscopic Instruments; IS Endowrist Bipolar Instrument; IS da Vinci Surgical System; IS3000 Stapler 45 Accessories; IS3000 Stapler 45 Instrument; IS4000 ACCESSORY STARTER KIT; IS4000 EndoWrist Stapler 30; IS4000 Long Bipolar Forceps; IS4000 Small Clip Applier  IS4000 Long Bipolar Forceps; IS4000 Stapler 45 Accessories; IS4000 Stapler 45 Instrument; IS4000 da Vinci EndoWrist Instruments; IS4200 ACCESSORY STARTER KIT; Illuminator Lamp Module, Model Y1866; Instrument Arm Drape, da Vinci SP; Instrument Release Kit, Xi; Instrument Sheath, da Vinci SP; Instrument Tray, da Vinci, da Vinci S, Si; Instrument/Accessory Steriliz Tray; Introducer 5Fr , 5mm, da Vinci S, Si; Intuitive Surgical EndoWrist Stabilizer; Intuitive Surgical Vessel Sealer Extend; Intuitive Surgical da Vinci S Surgical System, Model IS2000 with Connect OnSite and Wireless Connectivity Option; Intuitive Surgical da Vinci Surgical System; Intuitive Surgical da Vinci®,da Vinci S®, and da Vinci Si® Surgical Systems and EndoWrist Instruments and Accessories; Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System; Ion Endoluminal System (IF1000); Ion Reprocessing Consumable Kit; Ion reprocessing accessory kit; Ion"" Fully Articulating Catheter; Ion"" Peripheral Vision Probe; Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000); Ion™ Endoluminal System, Model IF1000; Ion™ Fully Articulating Catheter; Ion™ Peripheral Vision Probe; KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F; Laparoscope 10mm, 0, NIR; Laparoscope 10mm, 30, NIR; Laparoscope 5mm, 0; Laparoscope 5mm, 30; Large Clip Applier , 8mm, da Vinci S, Si; Large Needle Driver , 8mm, da Vinci S, Si; Large SutureCut Needle Driver , 8mm, da Vinci S, Si; Leak Test Adapter; Light Guide Cable Adapter; Light Guide Cable Adapter, da Vinci, da Vinci S; Long Tip Forceps , 8mm, da Vinci S, Si; MARS 1; MCS Tip, da Vinci SP; Maryland Bipolar Forceps , 8mm, da Vinci S, Si; Maryland Bipolar Forceps, da Vinci SP; Maryland Dissector , 5mm, da Vinci; Maryland Dissector , 5mm, da Vinci S, Si; Medium-Large Clip Applier , 8mm, da Vinci S, Si; Medium-Large Clip Applier, da Vinci SP; Mega Needle Driver , 8mm, da Vinci S, Si; Mega SutureCut Needle Driver , 8mm, da Vinci; Mega SutureCut Needle Driver , 8mm, da Vinci S, Si; Micro Bipolar Forceps , 8mm, da Vinci; Micro Bipolar Forceps, 8mm, da Vinci S, Si; Monopolar Cautery , 5mm, da Vinci; Monopolar Cautery , 5mm, da Vinci S, Si; Monopolar Cautery Cord; Monopolar Cautery Instrument, da Vinci SP; Monopolar Curved Scissors , 8mm, da Vinci; Monopolar Curved Scissors , 8mm, da Vinci S, Si; Monopolar Curved Scissors, 8mm, da Vinci S, Si; Monopolar Curved Scissors, da Vinci SP; Monopolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Monopolar Energy Activation Cable, ERBE; Monopolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; NIR Handheld Camera; NIR Handheld Camera Control Unit (CCU); NIR Handheld Camera Light Guide; NIR Handheld Camera Light Guide Adapter; NIR Handheld Camera Light Source; NIR Handheld Camera System Starter Kit; NIR Handheld Camera Tray; Needle Driver , 5mm, da Vinci; Needle Driver , 5mm, da Vinci S, Si; Needle Driver, da Vinci SP; Obturator, Circular, 25 mm x 100 mm, da Vinci SP; Option, Connect, da Vinci Si; PK Dissecting Forceps; PK Dissecting Forceps , 8mm, da Vinci S, Si; PK® Instrument Cord, G400 Generator, da Vinci, da Vinci S, Si; PK® Instrument Cord, PK/SP Generator, da Vinci, da Vinci S, Si; PROBE HOLDER SYSTEM; Pericardial Dissector , 8mm, da Vinci; Permanent Cautery Hook , 8mm, da Vinci S, Si; Permanent Cautery Spatula , 8mm, da Vinci S, Si; PlanPoint"" Software; PlanPoint™ Software; Planning Laptop; Potts Scissors , 8mm, da Vinci S, Si; Power Cord, 3.7 Meter, 115V, US, C13 > Hospital Grade; PreCise Bipolar Forceps , 8mm, da Vinci; PreCise Bipolar Forceps , 8mm, da Vinci S, Si; Procedure Tray, da Vinci, da Vinci S, Si; Prograsp Forceps , 8mm, da Vinci S, Si; Red System Cable, da Vinci® S¿, da Vinci S; Reprocessing Cover; Resano Forceps , 8mm, da Vinci; Resano Forceps , 8mm, da Vinci S, Si; Roll stands and charts; Round Tip Scissors , 5mm, da Vinci; Round Tip Scissors , 5mm, da Vinci S, Si; Round Tip Scissors , 8mm, da Vinci S, Si; Round Tooth Retractor, da Vinci SP; SP Access Port Kit, Large Incision (2.7 cm-7 cm); SP Access Port Kit, Small Incision (2.7 cm-4 cm); SP Cadiere Forceps; SP Cadiere Forceps, Extended Range; SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP; SP Cleaning and Sterilization Kit, da Vinci SP; SP Endoscope, 0°; SP Fenestrated Bipolar Forceps; SP Force Bipolar; SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments); SP Force Bipolar, Extended Range; SP Maryland Bipolar Forceps; SP Maryland Bipolar Forceps, Extended Range; SP Medium Large Clip Applier; SP Monopolar Cautery Instrument; SP Monopolar Curved Scissors; SP Monopolar Curved Scissors Extended Range; SP Needle Driver; SP Needle Driver Extended Range; SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP; SP Round Tooth Retractor Extended Range; SRK,ENGLISH,IS4000; STARTER KIT,FF100 VISION; STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM; STARTER KIT,IS3000,HD ENDOSCOPE,12MM; STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM; Schertel Grasper , 5mm, da Vinci; Schertel Grasper , 5mm, da Vinci S, Si; Single Instrument Tray, da Vinci, da Vinci S, Si; Single Receptacle System Cable Extension Kit; Single-Site 10 mm Accessory Cannula, da Vinci Si; Single-Site 10 mm Blunt Obturator, da Vinci Si; Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si; Single-Site Bipolar Maryland, 5mm, da Vinci Si; Single-Site Fundus Grasper , 5mm, da Vinci Si; Single-Site Maryland Dissector , 5mm, da Vinci Si; Single-Site Monopolar Cautery , 5mm, da Vinci Si; Single-Site Port for 8.5 mm Endoscope, da Vinci Si; Single-Site Starter Kit US, Cholecystectomy, 20 Cases; Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si; Small Clip Applier , 8mm, da Vinci S, Si; Small Grasping Retractor , 8mm, da Vinci S, Si; Snap-Fit Scalpel Instrument , 8mm, da Vinci; Snap-Fit Scalpel Instrument , 8mm, da Vinci S, Si; Snap-fit Blue Blade, da Vinci, da Vinci S, Si; Snap-fit Paddle Blade, da Vinci, da Vinci S, Si; Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5; Stapler 45 Reload, Blue; Stapler 45 Reload, Green; Stapler 45 Reload, White; Stapler Cannula; Stapler Cannula Blunt Obturator; Stapler Cannula Blunt Obturator, Long; Stapler Cannula, Long; Stapler Release Kit; Stapler Sheath; Stapler-8mm Cannula Reducer; Streme App; SureForm 45 Curved Tip, SureForm 45 Gray Reload; SureForm 45 System; SureForm 45, SureForm 45 Reloads; SureForm 60; SureForm 60 Reloads; SureForm 60 System; Swivel Connector; SynchroSeal; System Cart; Teleflex Obturators; Tenaculum Forceps , 8mm, da Vinci S, Si; Thoracic Grasper , 5mm, da Vinci S, Si; Thoracic Grasper , 8mm, da Vinci; Thoracic Grasper , 8mm, da Vinci S, Si; Tip Cover Accessory; Tip Cover Accessory, da Vinci, da Vinci S, Si; UPGRADE,CO2 TANK INTERFACE,CGA940,US; Universal Seal; Universal Seal (5-12 mm); Universal Seal (5-12mm); VIO DV 2,INTEGRATED ELECTRO SURGICAL UNIT; VIO-ICB Mounting Bracket; Valve Hook , 8mm, da Vinci; Valve Hook , 8mm, da Vinci S, Si; Video Review (also referred to as “Replay”); Vision Probe Adapter and Suction Adapter; Vision Probe Bag; VisionBoom¿ Extension Cable; X; Xi; da Vinci 5 Force Feedback Cadiere Forceps; da Vinci 5 Force Feedback Fenestrated Bipolar Forceps; da Vinci 5 Force Feedback Large Needle Driver; da Vinci 5 Force Feedback Maryland Bipolar Forceps; da Vinci 5 Force Feedback Mega SutureCut Needle Driver; da Vinci 5 Force Feedback ProGrasp Forceps; da Vinci E-200 Electrosurgical Generator; da Vinci Firefly Imaging System; da Vinci Fluorescence Imaging Vision System; da Vinci Force Feedback Cadiere Forceps; da Vinci Force Feedback Fenestrated Bipolar Forceps; da Vinci Force Feedback Large Needle Driver; da Vinci Force Feedback Maryland Bipolar Forceps; da Vinci Force Feedback Mega SutureCut Needle Driver; da Vinci Force Feedback ProGrasp Forceps; da Vinci Insufflator; da Vinci Insufflator Tube Set with Smoke Evacuation; da Vinci S Surgical System; da Vinci SP Advanced Access Port Kit; da Vinci SP Firefly Imaging System; da Vinci SP SureForm™ 45 Curved-Tip Stapler; da Vinci SP SureForm™ 45 Stapler; da Vinci SP Surgical System; da Vinci SP Surgical System (SP1098); da Vinci SP Surgical System, Patient Cart; da Vinci SP Surgical System, Surgeon Console; da Vinci SP Surgical System, Vision Cart; da Vinci SP® Instruments and Accessories; da Vinci SP® Surgical System, Model SP1098; da Vinci Si; da Vinci Single-Site Accessories; da Vinci Single-Site Instrument and Accessories; da Vinci Single-Site Instruments; da Vinci Single-Site Instruments and Accessories; da Vinci Single-Site Port; da Vinci SonicPro Cleaning System; da Vinci Surgi=cal System, S (HD); da Vinci Surgical System (IS5000); da Vinci Surgical System, S; da Vinci Surgical System, Si; da Vinci X; da Vinci X Surgical System; da Vinci X Surgical System (IS4200); da Vinci Xi; da Vinci Xi 12 mm and Stapler Hasson Cone; da Vinci Xi 12-8 mm Reducer; da Vinci Xi 8 mm Hasson Cone; da Vinci Xi Surgical System (IS4000); da Vinci Xi Surgical System with Table Motion; da Vinci Xi Surgical System, Patient Cart; da Vinci Xi Surgical System, Surgeon Console; da Vinci Xi Surgical System, Vision Cart; da Vinci® 8 mm Cannula Gage Pin, da Vinci, da Vinci S, Si; da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200; iESU; surgical drapes",1998-01-06,185,2026-07-14,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010885402%22&limit=1
Arthrex Singapore Pte Ltd.,3014004349,3014004349,21 Biopolis Road Nucleos North Tower Unit 03-08,Singapore Central Singapore,,138567,Singapore,"ARTHREX, INC.",1220287,Exporter to the US,71,BWN; EBW; EMH; FMF; FMP; FRO; FSM; FST; FWB; FWL; FWZ; FZO; FZW; GAB; GAP; GAS; GAT; GCJ; GEI; GFA; GFF; HNW; HRS; HRX; HSB; HSD; HST; HTD; HTJ; HTN; HTO; HTW; HTY; HTZ; HWC; HWE; HWT; HXB; HXD; HXJ; HXL; IZI; JDQ; JDR; JQC; JQO; JYQ; KGS; KNW; KQM; KQZ; KWD; KWS; LLZ; LRY; LXH; LXI; LZB; MAI; MBI; MDM; MNU; MQV; NBH; ORG; OUG; PHX; PKC; PLF; QHE; QHQ,"Table And Attachments, Operating-Room; Controller, Foot, Handpiece And Cord; Forceps, Rongeur, Surgical; Syringe, Piston; Protector, Skin Pressure; Dressing, Wound, Drug; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Camera, Television, Surgical, Without Audio; Camera, Cine, Endoscopic, Without Audio; Operating Room Accessories Table Tray; Chisel, Surgical, Manual; Expander, Surgical, Skin Graft; Needle, Suturing, Disposable; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Dilator, Lachrymal; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Forceps; Gauge, Depth; Washer, Bolt Nut; Reamer; Bit, Drill; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Template; Probe; Clamp; Staple Driver; Mallet; System, X-Ray, Angiographic; Cerclage, Fixation; Staple, Fixation, Bone; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Balance, Analytical; Loop, Wire; Retention Device, Suture; Instrument, Biopsy; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; System, Image Processing, Radiological; Punch, Surgical; Orthopedic Manual Surgical Instrument; Guide, Drill, Ligament; Finger Cot; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Staple, Absorbable; Filler, Bone Void, Calcium Compound; Accessories, Arthroscopic; Platelet And Plasma Separator For Bone Graft Handling; Medical Device Data System; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Bone Wedge; Shoulder Arthroplasty Implantation System; Total Shoulder Arthroplasty System",1; 2; U,"ACL TightRope Double Bundle; ANATOEMIC PROSTHESIS; AR-200 - Clips; ARTHREX ANATOEMIC P; ARTHROERESIS IMPLANT; ARTHROSCOPY LEG HOLDER; ARTHROSCOPY PUMP; Apparatus, Traction, Non-Powered; Arthrex Ankle Fusion Plating System; Arthrex BioComposite SutureTak; Arthrex BioSuture; Arthrex Biocomposite Transfix; Arthrex Distal Extremity Plate System; Arthrex Fracture Plates; Arthrex Fracture Plates and Screws; Arthrex Fracture System; Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi; Arthrex Graft-Anchor; Arthrex Low Profile Screws; Arthrex MicroSuture Anchors; Arthrex PCL TightRope; Arthrex Plates, Screws, and Staples; Arthrex PushLock; Arthrex Pushlock; Arthrex RetroFusion Screw  Smooth or Threaded Metallic Bone Fixation Fastener; Arthrex Suture; Arthrex SwiveLock Anchors; Arthrex Tibial  GraftBolt; Arthrex Tibial GraftBolt; Arthrex Univers Apex; Arthroscope; Arthroscopes; BI-CORTICAL BIO-POST AND WASHER; BIO-ABSORBABLE CORKSCREW; BIO-BUTTON; BIO-COMPRESSION SCREW; BIO-CORKSCREW FT; BIO-PIN; BIO-POST AND WASHER; BIOCOMPOSITE INTERFERENCE SCREW; BIOCOMPOSITE SUTURE ANCHORS; Balance, Analytical; Bio-Composite SutureTak; Biosync; Biosync Bone wedge; CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO; CHONDRAL DART; COMPRESSION STAPLE; CONTINUOUS WAVE III; CORKSCREW ANCHORS; Camera Heads; Camera, Television, Surgical, Without Audio; Chisel, Surgical, Manual; Clamp; Component, Traction, Non-Invasive; DISCOSCOPES, CERVICAL ENDOSCOPES; DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER; DOUBLE SYRINGE (ACP) SYSTEM; Dual Wave Pump; FASTAK SUTURE ANCHOR; FIBERWIRE BUTTON REPAIR KIT; FINGERSHIELD; Fastener, Fixation, nondegradable, soft tissue; FiberTape; FiberWire; Fiberstick; Forceps, Rongeur, Surgical; Fracture Plates & Screws; General Hospital and Personal Use Miscellaneous Devices; Graft Delivery Device with Integrated Stylet; HATRIC; HUMERAL FRACTURE PLATE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT; INTERFERENCE SCREW; INTERFERENCE SCREWS; Instrument, manual, surgical, general use; JumpStart Pin Site Dressing Kit; JumpStart Antibacterial Wound Dressing; JumpStart FlexEFit Wound Dressing; LOW PROFILE PLATE AND SCREW SYSTEM; Laproscopes; Loop, wire; MENISCAL DART, DARTSTICK,; MINI TIGHTROPE; Mallet; Metallic Bone Fixation; Mini TightRope CMC; Nonabsorbable poly(ethylene terephthalate) Surgical Suture; OPES ELECTRODES AND ACCESSORIES; ORTHOPEDIC MANUAL INSTRUMENTS; OSTEOTOMY PLATE; Orthopedic Template; PARS Needle; PUSHLOCK; PowerHeal Antibacterial Wound Dressing; Procellera Composite Antibacterial Wound Dressing; Procellera FlexEFit Antibacterial Wound Dressing; Protector, Skin Pressure; RETROBUTTON; RF device, blade, hook; SHAVER BLADES; SHAVER SYSTEM; SHOULDER HOLDER; Shoulder joint metal/ polymer semi-constrained cemented prosthesis; Single/multiple component metallic bone fixation appliances and accessories; Sutter CURIS RF Generator; Syringe, piston; TAK FAMILY; TENODESIS FAMILY; TRIM-IT FAMILY; Table Attachments, Operating-Room; UNIVERS II; UNIVERS SHOULDER; Univers Revers Shoulder Prosthesis System; VARIOUS BURS; VARIOUS INSTRUMENTS; WASHER; Weight, 2.5 lb (1.1kg); drill bit; elevator, surgical, general & plastic surgery; fixation pin; fixation plate; iBalance; orthopedic manual instrument; smooth or threaded metallic bone fixation fastener",1994-01-27,182,2024-07-25,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014004349%22&limit=1
"Intuitive Surgical, Inc.",3001675293,3001675293,1266 Kifer Road,Sunnyvale,CA,94086,United States,"Intuitive Surgical, Inc.",9028901,Manufacturer; Manufacturer for export; Specification developer,26,EOQ; ERY; FDE; FDS; FET; FFY; FOX; GAG; GCI; GCJ; GDW; GEH; GEI; HIF; IZI; KCT; KKX; LFL; LKF; LLZ; MNL; NAY; NVE; OWN; PUI; QIH,"Bronchoscope (Flexible Or Rigid); Drape, Surgical, Ent; Laparoscopy Kit; Gastroscope And Accessories, Flexible/Rigid; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Adaptor, Bulbs, Miscellaneous, For Endoscope; Stand, Infusion; Stapler, Surgical; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Staple, Implantable; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Insufflator, Laparoscopic; System, X-Ray, Angiographic; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Drape, Surgical, Antimicrobial; Instrument, Ultrasonic Surgical; Cannula, Manipulator/Injector, Uterine; System, Image Processing, Radiological; Accessories, Cleaning Brushes, For Endoscope; System, Surgical, Computer Controlled Instrument; Washer, Cleaner, Automated, Endoscope; Confocal Optical Imaging; Drape, Surgical, Exempt; Automated Radiological Image Processing Software",1; 2; U,"10-12mm+Stapler Cannula Seal; 12 Mm & Stapler Bladeless Obturator; 12 mm Assist Cannula; 12 mm Blunt Obturator, da Vinci S, Si; 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si; 12 mm Endoscope Cannula Mount, Balloon Port; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si; 12 mm Endoscope Cannula Mount, COV; 12 mm Endoscope Cannula Mount, COV, da Vinci; 12 mm Endoscope Cannula Mount, ETH, da Vinci; 12 mm Endoscope Cannula Mount, ETH/TAUT, da Vinci S, Si; 12 mm Endoscope, 0°; 12 mm Endoscope, 30°; 12 mm Instrument Cannula, da Vinci S, Si; 12mm IS4000 Endoscopes and Accessories; 3D Camera, Wide Angle, NTSC; 3D Camera, Wide Angle, PAL; 3D Model Viewer; 3DHD Camera Head and Cable; 3DHD Camera Head and Cable (Ikegami HD); 3DHD Camera Head and Cable (Panasonic HD); 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000); 5 mm Blunt Obturator, da Vinci S, Si; 5 mm Flared Cannula, da Vinci S, Si; 5 mm Sharp Obturator, da Vinci S, Si; 5 mm to 8 mm Cannula Seal; 8 mm Assist Cannula; 8 mm Bladeless Obturator (Optical); 8 mm Bladeless Obturator (Optical), Long; 8 mm Blunt Obturator, Long, da Vinci S, Si; 8 mm Blunt Obturator, da Vinci S, Si; 8 mm Cannula Seal, da Vinci, da Vinci S, Si; 8 mm Cannula with Outlet, Long, da Vinci S, Si; 8 mm Cannula with Outlet, da Vinci S, Si; 8 mm Harmonic ACE Curved Shears; 8 mm Instrument Cannula, Long, da Vinci S, Si; 8 mm Instrument Cannula, da Vinci S, Si; 8 mm Sharp Obturator, Long, da Vinci S, Si; 8 mm Sharp Obturator, da Vinci S, Si; 8 mm SureForm 30 Curved-Tip Stapler; 8 mm SureForm 30 Reload, Blue; 8 mm SureForm 30 Reload, Gray; 8 mm SureForm 30 Reload, White; 8 mm SureForm 30 Stapler; 8 mm SureForm 30 System; 8 mm Trocar, Long; 8 mm Trocar, Standard; 8 mm to 5 mm Cannula Reducer, da Vinci; 8 mm to 5 mm Cannula Reducer, da Vinci S, Si; 8.5 mm Endoscope, 0°; 8.5 mm Endoscope, 30°; 8.5-13 mm Cannula Seal; 8.5mm Endoscope, 0°; 8.5mm Endoscope, 30°; 8mm 0 degree endoscope; 8mm 30 degree endoscope; 8mm Atrial Retractor Short Right, Xi; 8mm Black Diamond Micro Forceps, Xi; 8mm Blunt Obturator Long, Xi; 8mm Blunt Obturator, Xi; 8mm Cadiere Forceps; 8mm Cannula Long, Xi; 8mm Cannula Standard, Xi; 8mm Cardiac Probe Grasper, Xi; 8mm Cobra Grasper; 8mm Cobra Graspers; 8mm Curved Bipolar Dissector; 8mm Debakey Forceps; 8mm Dual Blade Retractor, Xi; 8mm Endoscope, 0°, Gen5; 8mm Endoscope, 30°, Gen5; 8mm Fenestrated Bipolar Forceps; 8mm Fenstrated Bipolar Forceps, Xi; 8mm Flared Cannula, Xi; 8mm Force Bipolar; 8mm Hex Cannula, Long; 8mm Hex Cannula, Standard; 8mm Instrument Introducer, Xi; 8mm Large Hem-O-Lok Clip Applier, Xi; 8mm Large Needle Driver; 8mm Large Needle Driver, Xi; 8mm Large SutureCut Needle Driver; 8mm Large Suturecut Needle Driver, Xi; 8mm Long Bipolar Grasper; 8mm Long Tip Forceps; 8mm Long Tip Forceps, Xi; 8mm Maryland Bipolar Forceps; 8mm Maryland Bipolar Forceps, Xi; 8mm Medium Large Hem-O-Lok Clip Applier; 8mm Medium-Large Clip Applier, Xi; 8mm Mega SutureCut Needle Driver; 8mm Mega SutureCut Needle Driver, Xi; 8mm Micro Bipolar Forceps; 8mm Micro Bipolar Forceps, Xi; 8mm Monopolar Curved Scissors; 8mm Monopolar Curved Scissors, Xi; 8mm Permanent Monopolar Cautery Hook, Xi; 8mm Permanent Monopolar Cautery Spatula, Xi; 8mm Potts Scissors, Xi; 8mm ProGrasp Forceps; 8mm ProGrasp Forceps, Xi; 8mm Resano Forceps, Xi; 8mm Round Tip Scissor; 8mm Small Clip Applier, Xi; 8mm Small Grasping Retractor, Xi; 8mm Snap-Fit Instrument, Xi; 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm Reloads; 8mm SureForm Stapler; 8mm Tenaculum Forceps, Xi; 8mm Tip-Up Fenstrated Grasper, Xi; ARM 4 PROXIMAL DRAPE, IS4200; ASSY,CABLE,CORE TO DOCO; ASSY,CABLE,DOCO TO ILLUMINATOR; ASSY,PSCART,IS3000,3-ARM; ASSY,PSCART,IS3000,4-ARM; ASSY,SSC,IS3000; ASSY,VSS VISION SYSTEM W/AVP,VS3000; AUTOMATED REPROCESSING CONNECTOR SET,8MM ENDOSCOPE,IS4000; Accessory Base Starter Kit; Accessory Base Starter Kit, Multi-Specialty, ETH; Alignment Target, 8.6mm Endoscope; Assembly, Cannula Mount, Dual Jaw COV, ECM, da Vinci S, Si; Assembly, PSCart, IS2000, 4-Arm, G1.1; Assembly, Patient Side Cart; Assembly, Surgeon Side Console; Assembly, Surgeon Side System, IS2000; Assembly, VSC, VS2000 Panasonic HD, Domestic; Assembly, Vision System; Assembly, Vision System w/TS, NTSC, VS2000 HD, Domestic; Atrial Retractor , 8mm, da Vinci; Atrial Retractor Short Right; Atrial Retractor Short Right , 8mm, da Vinci S, Si; Automated Reprocessing Connector Set, 8mm Endoscope, Xi; BRACKET(SET),DOCO/ILLUMINATOR RESTRAINING,IS3000; Bath Probe; Bifurcated Light Guide; Bipolar Cautery Cord; Bipolar Cautery Cord, da Vinci SP; Bipolar Energy Activation Cable, CONMED; Bipolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Bipolar Energy Activation Cable, ERBE; Bipolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Gyrus ACMI; Bipolar Energy Activation Cable, Gyrus ACMI, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Valleylab; Bipolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; Black Diamond Micro Forceps , 8mm, da Vinci S, Si; Blade Protector, Snap-fit, da Vinci, da Vinci S, Si; Blue System Cable, Type A to Type B, 7m; Blue System Cable, Type B, 7m; Blue System Cable, da Vinci Si; Bowel Grasper , 5mm, da Vinci; Bowel Grasper , 5mm, da Vinci S, Si; CABLE KIT,BLUE FIBERCONNECT,20M; CABLE,PMED,COVIDIEN FORCE TRIAD; CAMERA ARM DRAPE,IS3000; CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100; CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2; CAMERA STARTER KIT,PANASONIC,HD; CIM extended height adjustable arm; CIM extended pivot arm; CIM height adjustable arm; CIM pivot arm; CO2 Tank Gas Accessory, CGA 940; CO2 Tank Gas Accessory, DIN 477; CO2 Tank Gas Accessory, ISO 407; CO2 Tank Gas Accessory, ISO 5145; COLUMN DRAPE, IS4000; Cadiere Forceps , 8mm, da Vinci S, Si; Cadiere Forceps, da Vinci SP; Camera Arm Sterile Adapter; Camera Head Cable; Camera Head Sterile Adapter; Camera Head Video Cable, Ikegami® HD; Camera Head Video Cable, Panasonic® HD; Camera Head Video Cable, Sumitomo® SD; Camera Sheath, da Vinci SP; Camera Starter Kit; Camera Starter Kit, NTSC Wide Angle, Type 2; Camera Starter Kit, PAL High Mag, Type 2; Camera Starter Kit, PAL Wide Angle, Type 2; Camera Starter Kit, Panasonic HD; Cannula 5 mm Regular, da Vinci S, Si; Cannula Holder, Twist¿Lock, da Vinci; Cannula Seal, 8mm; Cannula, 8.5mm Endoscope; Cannula, Circular, 25 mm x 100 mm, da Vinci SP; Cardiac Probe Grasper; Cardiac Probe Grasper , 8mm, da Vinci; Cardiac Probe Grasper , 8mm, da Vinci S, Si; Catheter Continuity Cable; Catheter Continuity Stand; Catheter Guide; Cautery Hook Tip, 5 mm, da Vinci, da Vinci S, Si; Cautery Hook Tip, da Vinci SP; Cautery Spatula Tip, 5mm, da Vinci, da Vinci S, Si; Cautery Spatula Tip, da Vinci SP; Cleaning and Disinfection Tray, Catheter and Vision Probe, IF1000; Cleaning and Sterilization Kit; Cleaning and Sterilization Kit, English; Cleaning and Sterilization Kit, da Vinci SP; Cobra Grasper , 8mm, da Vinci S, Si; Controller; Curved Bipolar Dissector , 8mm, da Vinci S, Si; Curved Scissors , 5mm, da Vinci; Curved Scissors , 5mm, da Vinci S, Si; Curved Scissors , 8mm, da Vinci S, Si; Curved Stapler 30; DEVICE,ENERGY,ERBE VIO 300D; DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR; DUCT,LEFT,ILLUMINATOR,FIREFLY100; DUCT,RIGHT,ILLUMINATOR,FIREFLY100; Da Vinci 5 Console - Model: C5000; Da Vinci 5 Robot - Model: R5000; Da Vinci 5 Tower - Model: T5000; Da Vinci E-200 Electrosurgical Generator; Da Vinci E-200 Generator; Da Vinci E200 Generator; Da Vinci Force Feedback Cadiere Forceps; Da Vinci Force Feedback Fenestrated Bipolar Forceps; Da Vinci Force Feedback Large Needle Driver; Da Vinci Force Feedback Maryland Bipolar Forceps; Da Vinci Force Feedback Mega SutureCut Needle Driver; Da Vinci Force Feedback ProGrasp Forceps; Da Vinci Handheld Camera; Da Vinci Monopolar and Bipolar Adapters; Da Vinci SP Vision Cart; Da Vinci X/Xi 8mm Endoscope Plus, 0 degree; Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees; Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree; DeBakey Forceps , 5mm, da Vinci; DeBakey Forceps , 5mm, da Vinci S, Si; DeBakey Forceps , 8mm, da Vinci S, Si; Double Fenestrated Grasper , 8mm, da Vinci S, Si; Double Receptacle System Cable Extension Kit; Dual Blade Retractor , 8mm, da Vinci; Dual Blade Retractor , 8mm, da Vinci S, Si; E-100; EndoPass Endoscopic Delivery Instruments; EndoWrist 5mm Thoracic Grasper; EndoWrist Accessories, da Vinci Xi; EndoWrist Cardiac Probe Grasper; EndoWrist Endoscopic Instruments; EndoWrist Instruments, da Vinci S/Si; EndoWrist Instruments, da Vinci Xi; EndoWrist Introducer Instrument; EndoWrist One Suction/Irrigator; EndoWrist One Suction/Irrigator, 8mm, da Vinci Si; EndoWrist One Vessel Sealer , 8mm, da Vinci Si; EndoWrist One Vessel Sealer, 8mm, da Vinci Si; EndoWrist PK Dissecting Forceps; EndoWrist Permanent Cautery Instruments; EndoWrist SP Camera, 0 degree, da Vinci SP; EndoWrist Stabilizer; EndoWrist Stapler 30 Instrument; EndoWrist Stapler 30 Reloads; EndoWrist Stapler 30 System; EndoWrist Stapler 45; EndoWrist Stapler 45 Reload, Blue; EndoWrist Stapler 45 Reload, Green; EndoWrist Stapler 45 System; EndoWrist Stapler Cable; EndoWrist Stapler Cannula Blunt Obturator, da Vinci S, Si; EndoWrist Stapler Cannula Kit; EndoWrist Stapler Cannula Reducer, da Vinci S, Si; EndoWrist Stapler Cannula Seal; EndoWrist Stapler Cannula, da Vinci S, Si; EndoWrist Stapler Motor Pack; EndoWrist Stapler Release Kit; EndoWrist Stapler Sheath; EndoWrist Stapler System Starter Kit - 45 mm; EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm; EndoWrist Suction Irrigator; EndoWrist Vessel Sealer; EndoWrist Vessel Sealer Extend; EndoWrist resuable Accessories, da Vinci S/Si; EndoWristStapler 30 and Stapler 30Reloads; EndoWristStapler 45 and Stapler 45 Reloads; EndoWrist® Stapler 45; EndoWrist® Stapler 45 Curved-Tip; Endopass Delivery Instrument; Endoscope Sterilization Tray; Endoscope, 0 degrees, Xi; Endoscope, 30 degrees, Xi; Endoscopes, da Vinci S/Si; Endoscopes, da Vinci Xi; Endoscopic Instruments; Endowrist Bipolar Instruments; Endowrist Instruments; Endowrist Permanent Cautery Instrum; Endowrist Stapler Cannula; Endowrist Stapler Obturator; Endowrsit Stapler Reducer; Energy Activation Adapter, Ethicon GEN11, da Vinci Si; Energy Activation Cable, CONMED, da Vinci Si; Energy Activation Cable, ERBE, da Vinci Si; Energy Activation Cable, Ethicon; Energy Activation Cable, Ethicon, da Vinci Si; Energy Activation Cable, Gyrus, da Vinci Si; Energy Activation Cable, Valleylab, da Vinci Si; EnergyShield Monopolar Cautery Cord, da Vinci SP; EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP; Fenestrated Bipolar Forceps , 8mm, da Vinci S, Si; Fenestrated Bipolar Forceps, 5mm, da Vinci Si; Fenestrated Bipolar Forceps, da Vinci SP; Fiber Cable Cleaning Kit; Fine Tissue Forceps , 8mm, da Vinci; Flexision"" Biopsy Needle 19G; Flexision"" Biopsy Needle 21G; Flexision"" Biopsy Needle 23G; Flexision™ Biopsy Needle 19G; Flexision™ Biopsy Needle 21G; Flexision™ Biopsy Needle 23G; Fluorescence Imaging Camera Head and Cable Kit; Fluorescence Imaging Illuminator; Fluorescence Imaging Kit; Force Bipolar; Gage Pin, Xi; Grasping Retractor , 8mm, da Vinci S, Si; Green System Cable, da Vinci Si; Handheld Camera Light Guide; Handheld Camera Light Guide Adapter; Handheld Camera Sterilization Tray; Harmonic ACE; Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic ACE Curved Shears, 5mm, da Vinci S/Si; Harmonic ACE Curved Shears, 8mm, da Vinci S/Si; Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Ace Curved Shears; Harmonic Ace Curved Shears , 5mm, da Vinci; Harmonic Ace Curved Shears , 5mm, da Vinci S, Si; Harmonic Ace Curved Shears , 8mm, da Vinci S, Si; Harmonic Curved Shears; Harmonic Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Curved Shears Instrument; Harmonic Curved Shears, 5mm, da Vinci; Harmonic Curved Shears, 5mm, da Vinci S, Si; Harmonic Curved Shears, 8mm, da Vinci; Harmonic Curved Shears, 8mm, da Vinci S, Si; ICB, Instrument Control Box; IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000; ILLUMINATOR,Y1865; INSTRUMENT ARM DRAPE IS2000; INSTRUMENT ARM DRAPE, IS4000; INTUITIVE SURGICAL STEREO ENDOSCOPE; IRIS System 1; IRISeg; IRK,ENGLISH,IS4000; IRK,OUS,IS3000; IRK,OUS,IS4000; IRK,OUS,W/O VS,IS3000; IRK,OUS,W/O VS,IS4000; IS Endoscopic Control System; IS Endoscopic Instruments; IS Endowrist Bipolar Instrument; IS da Vinci Surgical System; IS3000 Stapler 45 Accessories; IS3000 Stapler 45 Instrument; IS4000 ACCESSORY STARTER KIT; IS4000 EndoWrist Stapler 30; IS4000 Long Bipolar Forceps; IS4000 Small Clip Applier  IS4000 Long Bipolar Forceps; IS4000 Stapler 45 Accessories; IS4000 Stapler 45 Instrument; IS4000 da Vinci EndoWrist Instruments; IS4200 ACCESSORY STARTER KIT; Illuminator Lamp Module, Model Y1866; Instrument Arm Drape, da Vinci SP; Instrument Release Kit, Xi; Instrument Sheath, da Vinci SP; Instrument Tray, da Vinci, da Vinci S, Si; Instrument/Accessory Steriliz Tray; Introducer 5Fr , 5mm, da Vinci S, Si; Intuitive Endoluminal Gastrointestinal System (IG1000); Intuitive Surgical EndoWrist Stabilizer; Intuitive Surgical Vessel Sealer Extend; Intuitive Surgical da Vinci S Surgical System, Model IS2000 with Connect OnSite and Wireless Connectivity Option; Intuitive Surgical da Vinci Surgical System; Intuitive Surgical da Vinci®,da Vinci S®, and da Vinci Si® Surgical Systems and EndoWrist Instruments and Accessories; Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System; Ion Endoluminal System (IF1000); Ion Reprocessing Consumable Kit; Ion reprocessing accessory kit; Ion"" Fully Articulating Catheter; Ion"" Peripheral Vision Probe; Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000); Ion™ Endoluminal System, Model IF1000; Ion™ Fully Articulating Catheter; Ion™ Peripheral Vision Probe; KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F; Large Clip Applier , 8mm, da Vinci S, Si; Large Needle Driver , 8mm, da Vinci S, Si; Large SutureCut Needle Driver , 8mm, da Vinci S, Si; Leak Test Adapter; Light Guide Cable Adapter; Light Guide Cable Adapter, da Vinci, da Vinci S; Long Tip Forceps , 8mm, da Vinci S, Si; MARS 1; MCS Tip, da Vinci SP; MP Instrument Reprocessing Connector, 1 Device; MP Instrument Reprocessing Connector, 2 Device; MP Instrument Reprocessing Tray; Maryland Bipolar Forceps , 8mm, da Vinci S, Si; Maryland Bipolar Forceps, da Vinci SP; Maryland Dissector , 5mm, da Vinci; Maryland Dissector , 5mm, da Vinci S, Si; Medium-Large Clip Applier , 8mm, da Vinci S, Si; Medium-Large Clip Applier, da Vinci SP; Mega Needle Driver , 8mm, da Vinci S, Si; Mega SutureCut Needle Driver , 8mm, da Vinci; Mega SutureCut Needle Driver , 8mm, da Vinci S, Si; Micro Bipolar Forceps , 8mm, da Vinci; Micro Bipolar Forceps, 8mm, da Vinci S, Si; Monopolar Cautery , 5mm, da Vinci; Monopolar Cautery , 5mm, da Vinci S, Si; Monopolar Cautery Cord; Monopolar Cautery Instrument, da Vinci SP; Monopolar Curved Scissors , 8mm, da Vinci; Monopolar Curved Scissors , 8mm, da Vinci S, Si; Monopolar Curved Scissors, 8mm, da Vinci S, Si; Monopolar Curved Scissors, da Vinci SP; Monopolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Monopolar Energy Activation Cable, ERBE; Monopolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; NIR Handheld Camera System Starter Kit; Needle Driver , 5mm, da Vinci; Needle Driver , 5mm, da Vinci S, Si; Needle Driver, da Vinci SP; Obturator, Circular, 25 mm x 100 mm, da Vinci SP; Option, Connect, da Vinci Si; PANASONIC CAMERA HEAD,HDTV,SCHOELLY; PK Dissecting Forceps; PK Dissecting Forceps , 8mm, da Vinci S, Si; PK® Instrument Cord, G400 Generator, da Vinci, da Vinci S, Si; PK® Instrument Cord, PK/SP Generator, da Vinci, da Vinci S, Si; PROBE HOLDER SYSTEM; Pericardial Dissector , 8mm, da Vinci; Permanent Cautery Hook , 8mm, da Vinci S, Si; Permanent Cautery Spatula , 8mm, da Vinci S, Si; PlanPoint"" Software; PlanPoint™ Software; Planning Laptop; Potts Scissors , 8mm, da Vinci S, Si; Power Cord, 3.7 Meter, 115V, US, C13 > Hospital Grade; PreCise Bipolar Forceps , 8mm, da Vinci; PreCise Bipolar Forceps , 8mm, da Vinci S, Si; Procedure Tray, da Vinci, da Vinci S, Si; Prograsp Forceps , 8mm, da Vinci S, Si; Red System Cable, da Vinci® S¿, da Vinci S; Reprocessing Cover; Resano Forceps , 8mm, da Vinci; Resano Forceps , 8mm, da Vinci S, Si; Roll stands and charts; Round Tip Scissors , 5mm, da Vinci; Round Tip Scissors , 5mm, da Vinci S, Si; Round Tip Scissors , 8mm, da Vinci S, Si; Round Tooth Retractor, da Vinci SP; SP Access Port Kit, Large Incision (2.7 cm-7 cm); SP Access Port Kit, Small Incision (2.7 cm-4 cm); SP Cadiere Forceps; SP Cadiere Forceps, Extended Range; SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP; SP Cleaning and Sterilization Kit, da Vinci SP; SP Endoscope Reprocessing Tray; SP Endoscope, 0°; SP Fenestrated Bipolar Forceps; SP Force Bipolar; SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments); SP Force Bipolar, Extended Range; SP Instrument Reprocessing Tray; SP Maryland Bipolar Forceps; SP Maryland Bipolar Forceps, Extended Range; SP Medium Large Clip Applier; SP Monopolar Cautery Instrument; SP Monopolar Curved Scissors; SP Monopolar Curved Scissors Extended Range; SP Needle Driver; SP Needle Driver Extended Range; SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP; SP Reprocessing Connector, 1 device; SP Reprocessing Connector, 2 devices; SP Round Tooth Retractor Extended Range; SRK,ENGLISH,IS4000; SRK,OUS,IS4000; STARTER KIT,FF100 VISION; STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM; STARTER KIT,IS3000,HD ENDOSCOPE,12MM; STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM; Schertel Grasper , 5mm, da Vinci; Schertel Grasper , 5mm, da Vinci S, Si; Single Instrument Tray, da Vinci, da Vinci S, Si; Single Receptacle System Cable Extension Kit; Single-Site 10 mm Accessory Cannula, da Vinci Si; Single-Site 10 mm Blunt Obturator, da Vinci Si; Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si; Single-Site Bipolar Maryland, 5mm, da Vinci Si; Single-Site Fundus Grasper , 5mm, da Vinci Si; Single-Site Maryland Dissector , 5mm, da Vinci Si; Single-Site Monopolar Cautery , 5mm, da Vinci Si; Single-Site Port for 8.5 mm Endoscope, da Vinci Si; Single-Site Starter Kit US, Cholecystectomy, 20 Cases; Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si; Small Clip Applier , 8mm, da Vinci S, Si; Small Grasping Retractor , 8mm, da Vinci S, Si; Snap-Fit Scalpel Instrument , 8mm, da Vinci; Snap-Fit Scalpel Instrument , 8mm, da Vinci S, Si; Snap-fit Blue Blade, da Vinci, da Vinci S, Si; Snap-fit Paddle Blade, da Vinci, da Vinci S, Si; Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5; Stapler 45 Reload, Blue; Stapler 45 Reload, Green; Stapler 45 Reload, White; Stapler Cannula; Stapler Cannula Blunt Obturator; Stapler Cannula Blunt Obturator, Long; Stapler Cannula, Long; Stapler Release Kit; Stapler Sheath; Stapler-8mm Cannula Reducer; Streme App; SureForm 45 Curved Tip, SureForm 45 Gray Reload; SureForm 45 System; SureForm 45, SureForm 45 Reloads; SureForm 60; SureForm 60 Reloads; SureForm 60 System; Swivel Connector; SynchroSeal; System Cart; Teleflex Obturators; Tenaculum Forceps , 8mm, da Vinci S, Si; Thoracic Grasper , 5mm, da Vinci S, Si; Thoracic Grasper , 8mm, da Vinci; Thoracic Grasper , 8mm, da Vinci S, Si; Tip Cover Accessory; Tip Cover Accessory, da Vinci, da Vinci S, Si; UPGRADE,CO2 TANK INTERFACE,CGA940,US; Universal Seal; Universal Seal (5-12 mm); Universal Seal (5-12mm); VIO DV 2,INTEGRATED ELECTRO SURGICAL UNIT; VIO-ICB Mounting Bracket; Valve Hook , 8mm, da Vinci; Valve Hook , 8mm, da Vinci S, Si; Video Review (also referred to as “Replay”); Vision Probe Adapter and Suction Adapter; Vision Probe Bag; VisionBoom¿ Extension Cable; X; Xi; da Vinci 5 Force Feedback Cadiere Forceps; da Vinci 5 Force Feedback Fenestrated Bipolar Forceps; da Vinci 5 Force Feedback Large Needle Driver; da Vinci 5 Force Feedback Maryland Bipolar Forceps; da Vinci 5 Force Feedback Mega SutureCut Needle Driver; da Vinci 5 Force Feedback ProGrasp Forceps; da Vinci 5 Handheld Camera Head; da Vinci 5 Handheld Camera Laparoscope, 0°; da Vinci 5 Handheld Camera Laparoscope, 30°; da Vinci 5 Handheld Camera Tray; da Vinci E-200 Electrosurgical Generator; da Vinci Firefly Imaging System; da Vinci Fluorescence Imaging Vision System; da Vinci Force Feedback Cadiere Forceps; da Vinci Force Feedback Fenestrated Bipolar Forceps; da Vinci Force Feedback Large Needle Driver; da Vinci Force Feedback Maryland Bipolar Forceps; da Vinci Force Feedback Mega SutureCut Needle Driver; da Vinci Force Feedback ProGrasp Forceps; da Vinci Instrument Reprocessing Tray; da Vinci Insufflator; da Vinci Insufflator Tube Set with Smoke Evacuation; da Vinci S Surgical System; da Vinci SP Advanced Access Port Kit; da Vinci SP Firefly Imaging System; da Vinci SP SureForm™ 45 Curved-Tip Stapler; da Vinci SP SureForm™ 45 Stapler; da Vinci SP Surgical System; da Vinci SP Surgical System (SP1098); da Vinci SP Surgical System, Patient Cart; da Vinci SP Surgical System, Surgeon Console; da Vinci SP Surgical System, Vision Cart; da Vinci SP® Instruments and Accessories; da Vinci SP® Surgical System, Model SP1098; da Vinci Si; da Vinci Single-Site Accessories; da Vinci Single-Site Instrument and Accessories; da Vinci Single-Site Instruments; da Vinci Single-Site Instruments and Accessories; da Vinci Single-Site Port; da Vinci SonicPro Cleaning System; da Vinci Surgi=cal System, S (HD); da Vinci Surgical System (IS5000); da Vinci Surgical System, Model IS5000; da Vinci Surgical System, S; da Vinci Surgical System, Si; da Vinci X; da Vinci X Surgical System; da Vinci X Surgical System (IS4200); da Vinci Xi; da Vinci Xi 12 mm and Stapler Hasson Cone; da Vinci Xi 12-8 mm Reducer; da Vinci Xi 8 mm Hasson Cone; da Vinci Xi Surgical System (IS4000); da Vinci Xi Surgical System with Table Motion; da Vinci Xi Surgical System, Patient Cart; da Vinci Xi Surgical System, Surgeon Console; da Vinci Xi Surgical System, Vision Cart; da Vinci® 8 mm Cannula Gage Pin, da Vinci, da Vinci S, Si; da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200; iESU; surgical drapes",1998-01-06,182,2026-10-14,0,122,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223001675293%22&limit=1
Medtronic Perfusion Systems,2184009,1000116158,7611 Northland Dr,Minneapolis,MN,55428,United States,"Medtronic, Inc.",2112641,Manufacturer; Manufacturer for export; Specification developer,46,CAC; DPT; DQY; DRA; DRF; DRY; DTL; DTM; DTN; DTP; DTQ; DTR; DTS; DTW; DTY; DTZ; DWA; DWE; DWF; DWS; DXS; FLL; FMH; FQH; FZX; GAD; GCY; GDJ; GEI; GFT; GGN; GGY; GKN; HAM; JBP; JOD; JOX; JPA; KFM; KPE; KRD; LDF; MWS; OCL; PZX; QHW,"Apparatus, Autotransfusion; Probe, Blood-Flow, Extravascular; Catheter, Percutaneous; Catheter, Steerable; Catheter, Electrode Recording, Or Probe, Electrode Recording; Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Filter, Blood, Cardiopulmonary Bypass, Arterial Line; Reservoir, Blood, Cardiopulmonary Bypass; Defoamer, Cardiopulmonary Bypass; Console, Heart-Lung Machine, Cardiopulmonary Bypass; Heat-Exchanger, Cardiopulmonary Bypass; Sucker, Cardiotomy Return, Cardiopulmonary Bypass; Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass; Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass; Oxygenator, Cardiopulmonary Bypass; Control, Pump Speed, Cardiopulmonary Bypass; Tubing, Pump, Cardiopulmonary Bypass; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Instruments, Surgical, Cardiovascular; Gauge, Pressure, Coronary, Cardiopulmonary Bypass; Continuous Measurement Thermometer; Container, Specimen, Sterile; Lavage, Jet; Guide, Surgical, Instrument; Retractor; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Clamp, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Protamine Sulphate; Plasma, Coagulation Control; Pipette, Diluting; Timer, Clot, Automated; Apparatus, Electrosurgical; Activated Whole Blood Clotting Time; Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass; Analyzer, Heparin, Automated; System, Multipurpose For In Vitro Coagulation Studies; Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type; Container, I.V.; Device, Vascular, For Promoting Embolization; Electrode, Pacemaker, Temporary; Stabilizer, Heart; Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue; Left Atrial Appendage Clip, Implantable; Single Lumen Ecmo Cannula",1; 2,"540; 550M; 560; 68000 CARDIOBLATE; ABLATION PEN 4920501 W/PACING; ABLT PEN 49205YN W/PACE OUS18L; ACT; ACT EASY FILL DEVICE; ANALYZER, HEPARIN, AUTOMATED; AORTIC CUFF; ATRIAL LIFT SYSTEM; AUTOLOG; Accessory Port ATS Medical Thoracic Port System; Actuators; Adapter; Adapters; Adaptors; Adjustable Slitter; Affinity; Affinity Aterial Filter with Balance Biosurface; Affinity CP Adapter; Affinity CP Centrifugal Blood Pump; Affinity CP Centrifugal Blood Pump w/ Carmeda Bioactive Surf; Affinity CP Centrifugal Bloop Pump w/ Balance Biosurface; Affinity CP Centrifugal Pump; Affinity CVR; Affinity Fusion Cadriotomy/Venous Reservoir with Balance Biosurface; Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface; Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface; Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface; Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface; Affinity Fusion Oxygenator with Integrated Arterial Filter and Cortiva™BioActive Surface and Cardiotomy/ Venous Reservoi; Affinity Fusion Recirculation Line; Affinity Fusion™ Oxygenator System; Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Balance™ Biosurface; Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance™ Biosurface; Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface; Affinity Fusion™ Oxygenator with Integrated Arterial Filter and Cortiva™ BioActive Surface and Cardiotomy/Venous Reservo; Affinity Fusion™ Oxygenator with Integrated Arterial Filter with Balance™ Biosurface; Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir; Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir; Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface; Affinity NT™ Oxygenator; Affinity NT™ Oxygenator with Balance Biosurface; Affinity NT™ Oxygenator with Cortiva™ BioActive Surface; Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface; Affinity Pixie Arterial Filter with Balance Biosurface; Affinity Pixie CVR; Affinity Pixie Oxygenator with Balance Biosurface; Affinity Pixie Oxygenator with Cortiva BioActive Surface; Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity Pixie™ Oxygenation System; Affinity Temperature Probe; Affinity™ CP Centrifugal Blood Pump; Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trillium™ Biosurface; Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber; Affinity® Pediatric Arterial Filter; Autolog; Autolog Autotransfusion; BIO-PUMP; BIOPUMP (VARIOUS MODELS); Bio-Console and Handcrank; Bio-Medicus; Bio-Medicus Cannula; Bio-Medicus Life Support Catheter and Introducer; Bio-Medicus"" Adult Cannula Kit; Bio-MedicusTM Insertion Kit; Bio-Pump BP50; Bio-console and Handcrank; Bio-probe; BioTrend; Biotherm; CARDIOBLATE GEMINI; CATHETER, CANNULA &TUBING, VASCULAR, CARDIOPULMONARY BYPASS; CLAMP CRYOFLEX; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY; CLOTtrac; CLOTtrac CWB; CLOTtrac HR Abnormal Control; CLOTtrac HTC; CONSOLE, RR5100052 RECON PCPB; CV-SH Cannulae, Fem Arterial 1-Piece, Bio-Medicus; CV-SH Cannulae, Femoral Venous 1-Piece, BioMedicus; Cannula; Cannulae; Cannulae, Femoral Venous 1-Piece, BioMedicus; Cannulae, Femoral, Insertion Kits; Cardioblate 49313 Surgical Ablation Pen; Cardioblate 49314 XL Surgical Ablation Pen; Cardioblate BP2 Surgical Ablation Device; Cardioblate CryoFlex Surgical Ablation System Probes; Cardioblate Diagnostic Kit; Cardioblate Gemini; Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device; Cardioblate Generator; Cardioblate LP Surgical Ablation Device; Cardioblate MAPS; Cardioblate Surg Abl System; Cardioblate Surgical Abl Generator; Cardioblate Surgical Ablation Pen; Cardioblate XL Surg Abl Pen; Cardioblate™ Gemini™; Cardiopulmonary bypass vascular catheter, cannula, or tubing; Carpentier Bi-Caval Femoral Cannula; ClearView Intracoronary Shunts; Clearview; Connectors; Container; Cryoflex; DLP Air Aspirating Needle; DLP Aortic Root Cannula; DLP Cannula; DLP Coronary Artery Ostial Cannula; DLP PVC RCSP Cannulae Auto-Inflate Cuff 11 in. (27.9 cm) length - Smooth preformed Cuff, Multi-port tip, and integral; DLP PVC RCSP Cannulae Auto-Inflate Cuff 11 in. (27.9 cm) length - Smooth preformed Cuff, multi-port tip, and integral; DLP PVC RCSP Cannulae Auto-Inflate Cuff, 10 in. (25.4 cm) length - Smooth preformed Cuff, short fluted tip, and integ; DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12 in. (30.5 cm) length - Smooth preformed Cuff, short fluted, bullet nosed; DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Ridged preformed Silicone Cuff, short fluted, bull; DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Smooth preformed Cuff, fluted, bullet nosed tip,; DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Smooth preformed Cuff, fluted, bullet nosed tip, a; DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length -Ridged preformed Silicone Cuff, short fluted, bulle; DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8cm) length - Ridged preformed Silicone Cuff, short fluted, bulle; DLP Pericardial Sump; DLP Phrenic Nerve Pad; DLP Pressure Monitoring Catheter; DLP Rapid Prime Set, 14; DLP Retrograde Coronary Sinus Cannula Without Pressure Monitoring Line; DLP Retrograde Coronary Sinus Perfusion Cannulae Without Pressure Monitoring Lumen; DLP Silicone RCSP Cannula; DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) - WW Body/Ridged preformed Cuff- guidewire Stylet/Tru-To; DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length - WW Body/Smooth preformed Cuff - Guidewire Sty; DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length - WW Body/Smooth preformed Cuff - Solid Stylet; DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length- WW Body/Ridged preformed Cuff- Solid Stylet/Tru-; DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length- WW Body/Smooth preformed Cuff -guidewire Stylet/; DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length-WW Body/Smooth preformed Cuff -Solid Stylet/Tru-T; DLP Single Stage Venous Cannula; DLP Suction Tube; DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr; DLP Suction Tube, 6 1/2, Frazier Tip, 6 Fr.; DLP Tourniquet Set, Pediatric; DLP™ Silicone Coronary Artery Ostial Cannulae; DRILL GUIDES; Dispersive Electrode Adapter; Dispersive Electrode Cable; Distal Perfusion Kit; ECMO; EEA TAID; EGM Cable; EL Reservoir; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES; EOPA; EOPA 3D; EOPA 3D Arterial Cannula; EXTRA LG BLADE SET TOOL; Emergency Hand Crank; External Motor; FILTER,O2,BI-DIRECTIONAL,CAP- DUST,3/16IN,GREEN,VENT,ST; FUSION; GUIDE WIRES (PINS); Gauge, Pressure, Coronary, Cardiopulmonary Bypass; Guide Pin; Introducer Tool; Gundry RSCP; HMS Control; Heparin Assay 4 CH; Heparin Assay 6 CH; Hepcon HMS Plus; INTERCOSTAL RETRACTOR SYSTEM; Implant Tool Kit; Intersept; Intersept Filtered Cardiotomy Reservoir; LAA Exclusion System; LAA Selection Guide; LARGE BLADE SET TOOL; LR-ACT; Lead Accessory Kit; MC2 Multistage; MC2Two-Stage Venous Cannula; MC2XThree-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula; MC2™ Two-Stage Venous Cannula; MEDIUM BLADE SET TOOL; MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT; MEDTRONIC BIOMEDICUS BIO-CONSOLE MO; MITRAL COLLAR AND TIE; MONITOR TEMPERATURE; MYOtherm; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface and MYOtherm XP Cardioplegia Delivery System Uncoated; MYOtherm XP with Cortiva BioActive Surface, Non-Sterile; MYOtherm XP with Cortiva BioActive Surface, Sterile; MYOtherm XP™ Cardioplegia Delivery System with Cortiva™ BioActive Surface; Medtronic Bio Console 560 System with Level Sensing System (level Sensor [LS100] and Level Sensing Tape [LST]); Medtronic External Drive Motor; Medtronic Performer CPB System with Level Sensing System (Level Sensor [LS100] and Level Sensing Tape [LST]); Minimax; Mounting Rail; Myocardial Needle Temperature Probe; Myotherm; OVAL MC2Two-Stage Venous Cannula; Octopus; PRESSURE DISPLAY BOX; Performer; Pixie Oxygenation and CVR Combo, Balance coated; Pixie Oxygenation and CVR Combo, Carmeda coated; Pixie Oxygenator, Balance coated; Pixie Oxygenator, Carmeda coated; Quickflow DPS; RACT Cartridge; RCSP; RETRACTOR; RETRACTOR RACK TOOL; Remote Control Foot Switch; Resting Heart; Reusable and Disposable Temperature Probes; Rotation Tool Kit; SELECT; SMALL BLADE SET TOOL; STERILIZATION TRAY TOOL; SUTURE BELT; SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES; Select 3D; Signature; Starfish; Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue; THORATRAK MICS RETRACTOR SYSTEM; TRI-OPTIC MEASUREMENT; Temperature Probe, Affinity Temperature Probe; Thermistor Probe; Thin Wall Two-Stage Venous Cannula; Tubing Pack; Tubing, Connectors, and Accessories; Uncoated MYOtherm XP Cardioplegia Delivery Systems, Non-Sterile; Uncoated MYOtherm XP Cardioplegia Delivery Systems, Sterile; Universal II Slitter; Universal Mounting Rail; Urchin; Vacuum Relief Valve; Vent Catheter; autoLog IQ Autotransfusion System; pinch on tool",1992-12-02,181,2026-01-20,0,55,4,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222184009%22&limit=1
Expeditors International BV,3016832577,3016832577,Conakryweg 1,Amsterdam Noord-Holland,,1047 HS,Netherlands,"Intuitive Surgical, Inc.",9028901,Exporter to the US,28,EOQ; EQH; ERY; FCW; FDE; FET; FFY; FOX; GAG; GCI; GCJ; GDW; GEH; GEI; HIF; IZI; KCT; KKX; LFL; LKF; LLZ; MNL; NAY; NTN; NVE; OWN; PUI; QIH,"Bronchoscope (Flexible Or Rigid); Source, Carrier, Fiberoptic Light; Drape, Surgical, Ent; Light Source, Fiberoptic, Routine; Laparoscopy Kit; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Adaptor, Bulbs, Miscellaneous, For Endoscope; Stand, Infusion; Stapler, Surgical; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Staple, Implantable; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Insufflator, Laparoscopic; System, X-Ray, Angiographic; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Drape, Surgical, Antimicrobial; Instrument, Ultrasonic Surgical; Cannula, Manipulator/Injector, Uterine; System, Image Processing, Radiological; Accessories, Cleaning Brushes, For Endoscope; System, Surgical, Computer Controlled Instrument; Led Light Source; Washer, Cleaner, Automated, Endoscope; Confocal Optical Imaging; Drape, Surgical, Exempt; Automated Radiological Image Processing Software",1; 2; U,"10-12mm+Stapler Cannula Seal; 12 Mm & Stapler Bladeless Obturator; 12 mm Assist Cannula; 12 mm Blunt Obturator, da Vinci S, Si; 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si; 12 mm Endoscope Cannula Mount, Balloon Port; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci; 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si; 12 mm Endoscope Cannula Mount, COV; 12 mm Endoscope Cannula Mount, COV, da Vinci; 12 mm Endoscope Cannula Mount, ETH, da Vinci; 12 mm Endoscope Cannula Mount, ETH/TAUT, da Vinci S, Si; 12 mm Endoscope, 0°; 12 mm Endoscope, 30°; 12 mm Instrument Cannula, da Vinci S, Si; 12mm IS4000 Endoscopes and Accessories; 3D Camera, Wide Angle, NTSC; 3D Camera, Wide Angle, PAL; 3D Model Viewer; 3DHD Camera Head and Cable; 3DHD Camera Head and Cable (Ikegami HD); 3DHD Camera Head and Cable (Panasonic HD); 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000); 5 mm Blunt Obturator, da Vinci S, Si; 5 mm Flared Cannula, da Vinci S, Si; 5 mm Sharp Obturator, da Vinci S, Si; 5 mm to 8 mm Cannula Seal; 8 mm Assist Cannula; 8 mm Bladeless Obturator (Optical); 8 mm Bladeless Obturator (Optical), Long; 8 mm Blunt Obturator, Long, da Vinci S, Si; 8 mm Blunt Obturator, da Vinci S, Si; 8 mm Cannula Seal, da Vinci, da Vinci S, Si; 8 mm Cannula with Outlet, Long, da Vinci S, Si; 8 mm Cannula with Outlet, da Vinci S, Si; 8 mm Harmonic ACE Curved Shears; 8 mm Instrument Cannula, Long, da Vinci S, Si; 8 mm Instrument Cannula, da Vinci S, Si; 8 mm Sharp Obturator, Long, da Vinci S, Si; 8 mm Sharp Obturator, da Vinci S, Si; 8 mm SureForm 30 Curved-Tip Stapler; 8 mm SureForm 30 Reload, Blue; 8 mm SureForm 30 Reload, Gray; 8 mm SureForm 30 Reload, White; 8 mm SureForm 30 Stapler; 8 mm SureForm 30 System; 8 mm Trocar, Long; 8 mm Trocar, Standard; 8 mm to 5 mm Cannula Reducer, da Vinci; 8 mm to 5 mm Cannula Reducer, da Vinci S, Si; 8.5 mm Endoscope, 0°; 8.5 mm Endoscope, 30°; 8.5-13 mm Cannula Seal; 8.5mm Endoscope, 0°; 8.5mm Endoscope, 30°; 8mm Atrial Retractor Short Right, Xi; 8mm Black Diamond Micro Forceps, Xi; 8mm Blunt Obturator Long, Xi; 8mm Blunt Obturator, Xi; 8mm Cadiere Forceps; 8mm Cannula Long, Xi; 8mm Cannula Standard, Xi; 8mm Cardiac Probe Grasper, Xi; 8mm Cobra Grasper; 8mm Cobra Graspers; 8mm Curved Bipolar Dissector; 8mm Debakey Forceps; 8mm Dual Blade Retractor, Xi; 8mm Endoscope, 0°, Gen5; 8mm Endoscope, 30°, Gen5; 8mm Fenestrated Bipolar Forceps; 8mm Fenstrated Bipolar Forceps, Xi; 8mm Flared Cannula, Xi; 8mm Force Bipolar; 8mm Hex Cannula, Long; 8mm Hex Cannula, Standard; 8mm Instrument Introducer, Xi; 8mm Large Hem-O-Lok Clip Applier, Xi; 8mm Large Needle Driver; 8mm Large Needle Driver, Xi; 8mm Large SutureCut Needle Driver; 8mm Large Suturecut Needle Driver, Xi; 8mm Long Bipolar Grasper; 8mm Long Tip Forceps; 8mm Long Tip Forceps, Xi; 8mm Maryland Bipolar Forceps; 8mm Maryland Bipolar Forceps, Xi; 8mm Medium Large Hem-O-Lok Clip Applier; 8mm Medium-Large Clip Applier, Xi; 8mm Mega SutureCut Needle Driver; 8mm Mega SutureCut Needle Driver, Xi; 8mm Micro Bipolar Forceps; 8mm Micro Bipolar Forceps, Xi; 8mm Monopolar Curved Scissors; 8mm Monopolar Curved Scissors, Xi; 8mm Permanent Monopolar Cautery Hook, Xi; 8mm Permanent Monopolar Cautery Spatula, Xi; 8mm Potts Scissors, Xi; 8mm ProGrasp Forceps; 8mm ProGrasp Forceps, Xi; 8mm Resano Forceps, Xi; 8mm Round Tip Scissor; 8mm Small Clip Applier, Xi; 8mm Small Grasping Retractor, Xi; 8mm Snap-Fit Instrument, Xi; 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm Reloads; 8mm SureForm Stapler; 8mm Tenaculum Forceps, Xi; 8mm Tip-Up Fenstrated Grasper, Xi; ARM 4 PROXIMAL DRAPE, IS4200; ASSY,CABLE,CORE TO DOCO; ASSY,CABLE,DOCO TO ILLUMINATOR; ASSY,PSCART,IS3000,3-ARM; ASSY,PSCART,IS3000,4-ARM; ASSY,SSC,IS3000; ASSY,VSS VISION SYSTEM W/AVP,VS3000; Accessory Base Starter Kit; Accessory Base Starter Kit, Multi-Specialty, ETH; Alignment Target, 8.6mm Endoscope; Assembly, Cannula Mount, Dual Jaw COV, ECM, da Vinci S, Si; Assembly, PSCart, IS2000, 4-Arm, G1.1; Assembly, Patient Side Cart; Assembly, Surgeon Side Console; Assembly, Surgeon Side System, IS2000; Assembly, VSC, VS2000 Panasonic HD, Domestic; Assembly, Vision System; Assembly, Vision System w/TS, NTSC, VS2000 HD, Domestic; Atrial Retractor , 8mm, da Vinci; Atrial Retractor Short Right , 8mm, da Vinci S, Si; BRACKET(SET),DOCO/ILLUMINATOR RESTRAINING,IS3000; Bath Probe; Bifurcated Light Guide; Bipolar Cautery Cord; Bipolar Cautery Cord, da Vinci SP; Bipolar Energy Activation Cable, CONMED; Bipolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Bipolar Energy Activation Cable, ERBE; Bipolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Gyrus ACMI; Bipolar Energy Activation Cable, Gyrus ACMI, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Bipolar Energy Activation Cable, Valleylab; Bipolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; Black Diamond Micro Forceps , 8mm, da Vinci S, Si; Blade Protector, Snap-fit, da Vinci, da Vinci S, Si; Blue System Cable, Type A to Type B, 7m; Blue System Cable, Type B, 7m; Blue System Cable, da Vinci Si; Bowel Grasper , 5mm, da Vinci; Bowel Grasper , 5mm, da Vinci S, Si; CABLE KIT,BLUE FIBERCONNECT,20M; CABLE,PMED,COVIDIEN FORCE TRIAD; CAMERA ARM DRAPE,IS3000; CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100; CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2; CAMERA STARTER KIT,PANASONIC,HD; CIM extended height adjustable arm; CIM extended pivot arm; CIM height adjustable arm; CIM pivot arm; COLUMN DRAPE, IS4000; Cadiere Forceps , 8mm, da Vinci S, Si; Cadiere Forceps, da Vinci SP; Camera Arm Sterile Adapter; Camera Head Cable; Camera Head Sterile Adapter; Camera Head Video Cable, Ikegami® HD; Camera Head Video Cable, Panasonic® HD; Camera Head Video Cable, Sumitomo® SD; Camera Sheath, da Vinci SP; Camera Starter Kit; Camera Starter Kit, NTSC Wide Angle, Type 2; Camera Starter Kit, PAL High Mag, Type 2; Camera Starter Kit, PAL Wide Angle, Type 2; Camera Starter Kit, Panasonic HD; Cannula 5 mm Regular, da Vinci S, Si; Cannula Holder, Twist¿Lock, da Vinci; Cannula Seal, 8mm; Cannula, 8.5mm Endoscope; Cannula, Circular, 25 mm x 100 mm, da Vinci SP; Cardiac Probe Grasper; Cardiac Probe Grasper , 8mm, da Vinci; Cardiac Probe Grasper , 8mm, da Vinci S, Si; Catheter Continuity Cable; Catheter Continuity Stand; Catheter Guide; Cautery Hook Tip, 5 mm, da Vinci, da Vinci S, Si; Cautery Hook Tip, da Vinci SP; Cautery Spatula Tip, 5mm, da Vinci, da Vinci S, Si; Cautery Spatula Tip, da Vinci SP; Cleaning and Sterilization Kit; Cleaning and Sterilization Kit, English; Cleaning and Sterilization Kit, da Vinci SP; Cobra Grasper , 8mm, da Vinci S, Si; Controller; Curved Bipolar Dissector , 8mm, da Vinci S, Si; Curved Scissors , 5mm, da Vinci; Curved Scissors , 5mm, da Vinci S, Si; Curved Scissors , 8mm, da Vinci S, Si; Curved Stapler 30; DEVICE,ENERGY,ERBE VIO 300D; DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR; DUCT,LEFT,ILLUMINATOR,FIREFLY100; DUCT,RIGHT,ILLUMINATOR,FIREFLY100; Da Vinci 5 Console - Model: C5000; Da Vinci 5 Robot - Model: R5000; Da Vinci 5 Tower - Model: T5000; Da Vinci E-200 Electrosurgical Generator; Da Vinci E-200 Generator; Da Vinci E200 Generator; Da Vinci Force Feedback Cadiere Forceps; Da Vinci Force Feedback Fenestrated Bipolar Forceps; Da Vinci Force Feedback Large Needle Driver; Da Vinci Force Feedback Maryland Bipolar Forceps; Da Vinci Force Feedback Mega SutureCut Needle Driver; Da Vinci Force Feedback ProGrasp Forceps; Da Vinci Handheld Camera; Da Vinci Monopolar and Bipolar Adapters; Da Vinci SP Vision Cart; Da Vinci X/Xi 8mm Endoscope Plus, 0 degree; Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees; Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree; DeBakey Forceps , 5mm, da Vinci; DeBakey Forceps , 5mm, da Vinci S, Si; DeBakey Forceps , 8mm, da Vinci S, Si; Double Fenestrated Grasper , 8mm, da Vinci S, Si; Double Receptacle System Cable Extension Kit; Dual Blade Retractor , 8mm, da Vinci; Dual Blade Retractor , 8mm, da Vinci S, Si; E-100; EndoPass Endoscopic Delivery Instruments; EndoWrist 5mm Thoracic Grasper; EndoWrist Accessories, da Vinci Xi; EndoWrist Cardiac Probe Grasper; EndoWrist Endoscopic Instruments; EndoWrist Instruments, da Vinci S/Si; EndoWrist Instruments, da Vinci Xi; EndoWrist Introducer Instrument; EndoWrist One Suction/Irrigator; EndoWrist One Suction/Irrigator, 8mm, da Vinci Si; EndoWrist One Vessel Sealer , 8mm, da Vinci Si; EndoWrist One Vessel Sealer, 8mm, da Vinci Si; EndoWrist PK Dissecting Forceps; EndoWrist Permanent Cautery Instruments; EndoWrist SP Camera, 0 degree, da Vinci SP; EndoWrist Stapler 30 Instrument; EndoWrist Stapler 30 Reloads; EndoWrist Stapler 30 System; EndoWrist Stapler 45; EndoWrist Stapler 45 Reload, Blue; EndoWrist Stapler 45 Reload, Green; EndoWrist Stapler 45 System; EndoWrist Stapler Cable; EndoWrist Stapler Cannula Blunt Obturator, da Vinci S, Si; EndoWrist Stapler Cannula Kit; EndoWrist Stapler Cannula Reducer, da Vinci S, Si; EndoWrist Stapler Cannula Seal; EndoWrist Stapler Cannula, da Vinci S, Si; EndoWrist Stapler Motor Pack; EndoWrist Stapler Release Kit; EndoWrist Stapler Sheath; EndoWrist Stapler System Starter Kit - 45 mm; EndoWrist Stapler System Starter Kit without Cannula Kit – 45 mm; EndoWrist Suction Irrigator; EndoWrist Vessel Sealer; EndoWrist Vessel Sealer Extend; EndoWrist resuable Accessories, da Vinci S/Si; EndoWristStapler 30 and Stapler 30Reloads; EndoWristStapler 45 and Stapler 45 Reloads; EndoWrist® Stapler 45; EndoWrist® Stapler 45 Curved-Tip; Endopass Delivery Instrument; Endoscope Sterilization Tray; Endoscope, 0 degrees, Xi; Endoscope, 30 degrees, Xi; Endoscopes, da Vinci S/Si; Endoscopes, da Vinci Xi; Endoscopic Instruments; Endowrist Bipolar Instruments; Endowrist Instruments; Endowrist Permanent Cautery Instrum; Endowrist Stapler Cannula; Endowrist Stapler Obturator; Endowrsit Stapler Reducer; Energy Activation Adapter, Ethicon GEN11, da Vinci Si; Energy Activation Cable, CONMED, da Vinci Si; Energy Activation Cable, ERBE, da Vinci Si; Energy Activation Cable, Ethicon; Energy Activation Cable, Ethicon, da Vinci Si; Energy Activation Cable, Gyrus, da Vinci Si; Energy Activation Cable, Valleylab, da Vinci Si; EnergyShield Monopolar Cautery Cord, da Vinci SP; EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP; Fenestrated Bipolar Forceps , 8mm, da Vinci S, Si; Fenestrated Bipolar Forceps, 5mm, da Vinci Si; Fenestrated Bipolar Forceps, da Vinci SP; Fiber Cable Cleaning Kit; Fine Tissue Forceps , 8mm, da Vinci; Flexision™ Biopsy Needle 19G; Flexision™ Biopsy Needle 21G; Flexision™ Biopsy Needle 23G; Fluorescence Imaging Camera Head and Cable Kit; Fluorescence Imaging Illuminator; Force Bipolar; Gage Pin, Xi; Grasping Retractor , 8mm, da Vinci S, Si; Green System Cable, da Vinci Si; Handheld Camera Light Guide; Handheld Camera Light Guide Adapter; Handheld Camera Sterilization Tray; Harmonic ACE; Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic ACE Curved Shears, 5mm, da Vinci S/Si; Harmonic ACE Curved Shears, 8mm, da Vinci S/Si; Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Ace Curved Shears; Harmonic Ace Curved Shears , 5mm, da Vinci; Harmonic Ace Curved Shears , 5mm, da Vinci S, Si; Harmonic Ace Curved Shears , 8mm, da Vinci S, Si; Harmonic Curved Shears; Harmonic Curved Shears Insert, da Vinci, da Vinci S, Si; Harmonic Curved Shears Instrument; Harmonic Curved Shears, 5mm, da Vinci; Harmonic Curved Shears, 5mm, da Vinci S, Si; Harmonic Curved Shears, 8mm, da Vinci; Harmonic Curved Shears, 8mm, da Vinci S, Si; ICB, Instrument Control Box; IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000; ILLUMINATOR,Y1865; INSTRUMENT ARM DRAPE IS2000; INSTRUMENT ARM DRAPE, IS4000; INTUITIVE SURGICAL STEREO ENDOSCOPE; IRIS System 1; IRISeg; IRK,ENGLISH,IS4000; IS Endoscopic Control System; IS Endoscopic Instruments; IS Endowrist Bipolar Instrument; IS da Vinci Surgical System; IS3000 Stapler 45 Accessories; IS3000 Stapler 45 Instrument; IS4000 ACCESSORY STARTER KIT; IS4000 EndoWrist Stapler 30; IS4000 Long Bipolar Forceps; IS4000 Small Clip Applier  IS4000 Long Bipolar Forceps; IS4000 Stapler 45 Accessories; IS4000 Stapler 45 Instrument; IS4000 da Vinci EndoWrist Instruments; IS4200 ACCESSORY STARTER KIT; Illuminator Lamp Module, Model Y1866; Instrument Arm Drape, da Vinci SP; Instrument Release Kit, Xi; Instrument Sheath, da Vinci SP; Instrument Tray, da Vinci, da Vinci S, Si; Instrument/Accessory Steriliz Tray; Introducer 5Fr , 5mm, da Vinci S, Si; Intuitive Surgical EndoWrist Stabilizer; Intuitive Surgical Vessel Sealer Extend; Intuitive Surgical da Vinci S Surgical System, Model IS2000 with Connect OnSite and Wireless Connectivity Option; Intuitive Surgical da Vinci®,da Vinci S®, and da Vinci Si® Surgical Systems and EndoWrist Instruments and Accessories; Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System; Ion Endoluminal System (IF1000); Ion Reprocessing Consumable Kit; Ion reprocessing accessory kit; Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000); Ion™ Endoluminal System, Model IF1000; Ion™ Fully Articulating Catheter; Ion™ Peripheral Vision Probe; KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F; Laparoscope 10mm, 0, NIR; Laparoscope 10mm, 30, NIR; Laparoscope 5mm, 0; Laparoscope 5mm, 30; Large Clip Applier , 8mm, da Vinci S, Si; Large Needle Driver , 8mm, da Vinci S, Si; Large SutureCut Needle Driver , 8mm, da Vinci S, Si; Leak Test Adapter; Light Guide Cable Adapter; Light Guide Cable Adapter, da Vinci, da Vinci S; Long Tip Forceps , 8mm, da Vinci S, Si; MARS 1; MCS Tip, da Vinci SP; Maryland Bipolar Forceps , 8mm, da Vinci S, Si; Maryland Bipolar Forceps, da Vinci SP; Maryland Dissector , 5mm, da Vinci; Maryland Dissector , 5mm, da Vinci S, Si; Medium-Large Clip Applier , 8mm, da Vinci S, Si; Medium-Large Clip Applier, da Vinci SP; Mega Needle Driver , 8mm, da Vinci S, Si; Mega SutureCut Needle Driver , 8mm, da Vinci; Mega SutureCut Needle Driver , 8mm, da Vinci S, Si; Micro Bipolar Forceps , 8mm, da Vinci; Micro Bipolar Forceps, 8mm, da Vinci S, Si; Monopolar Cautery , 5mm, da Vinci; Monopolar Cautery , 5mm, da Vinci S, Si; Monopolar Cautery Cord; Monopolar Cautery Instrument, da Vinci SP; Monopolar Curved Scissors , 8mm, da Vinci; Monopolar Curved Scissors , 8mm, da Vinci S, Si; Monopolar Curved Scissors, 8mm, da Vinci S, Si; Monopolar Curved Scissors, da Vinci SP; Monopolar Energy Activation Cable, CONMED, da Vinci, da Vinci S; Monopolar Energy Activation Cable, ERBE; Monopolar Energy Activation Cable, ERBE, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S; Monopolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S; NIR Handheld Camera; NIR Handheld Camera Control Unit (CCU); NIR Handheld Camera Light Guide; NIR Handheld Camera Light Guide Adapter; NIR Handheld Camera Light Source; NIR Handheld Camera System Starter Kit; NIR Handheld Camera Tray; Needle Driver , 5mm, da Vinci; Needle Driver , 5mm, da Vinci S, Si; Needle Driver, da Vinci SP; Obturator, Circular, 25 mm x 100 mm, da Vinci SP; Option, Connect, da Vinci Si; PK Dissecting Forceps; PK Dissecting Forceps , 8mm, da Vinci S, Si; PK® Instrument Cord, G400 Generator, da Vinci, da Vinci S, Si; PK® Instrument Cord, PK/SP Generator, da Vinci, da Vinci S, Si; PROBE HOLDER SYSTEM; Pericardial Dissector , 8mm, da Vinci; Permanent Cautery Hook , 8mm, da Vinci S, Si; Permanent Cautery Spatula , 8mm, da Vinci S, Si; PlanPoint™ Software; Planning Laptop; Potts Scissors , 8mm, da Vinci S, Si; Power Cord, 3.7 Meter, 115V, US, C13 > Hospital Grade; PreCise Bipolar Forceps , 8mm, da Vinci; PreCise Bipolar Forceps , 8mm, da Vinci S, Si; Procedure Tray, da Vinci, da Vinci S, Si; Prograsp Forceps , 8mm, da Vinci S, Si; Red System Cable, da Vinci® S¿, da Vinci S; Reprocessing Cover; Resano Forceps , 8mm, da Vinci; Resano Forceps , 8mm, da Vinci S, Si; Roll stands and charts; Round Tip Scissors , 5mm, da Vinci; Round Tip Scissors , 5mm, da Vinci S, Si; Round Tip Scissors , 8mm, da Vinci S, Si; Round Tooth Retractor, da Vinci SP; SP Access Port Kit, Large Incision (2.7 cm-7 cm); SP Access Port Kit, Small Incision (2.7 cm-4 cm); SP Cadiere Forceps; SP Cadiere Forceps, Extended Range; SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP; SP Cleaning and Sterilization Kit, da Vinci SP; SP Endoscope, 0°; SP Fenestrated Bipolar Forceps; SP Force Bipolar; SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments); SP Force Bipolar, Extended Range; SP Maryland Bipolar Forceps; SP Maryland Bipolar Forceps, Extended Range; SP Medium Large Clip Applier; SP Monopolar Cautery Instrument; SP Monopolar Curved Scissors; SP Monopolar Curved Scissors Extended Range; SP Needle Driver; SP Needle Driver Extended Range; SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP; SP Round Tooth Retractor Extended Range; SRK,ENGLISH,IS4000; STARTER KIT,FF100 VISION; STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM; STARTER KIT,IS3000,HD ENDOSCOPE,12MM; STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM; Schertel Grasper , 5mm, da Vinci; Schertel Grasper , 5mm, da Vinci S, Si; Single Instrument Tray, da Vinci, da Vinci S, Si; Single Receptacle System Cable Extension Kit; Single-Site 10 mm Accessory Cannula, da Vinci Si; Single-Site 10 mm Blunt Obturator, da Vinci Si; Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si; Single-Site Bipolar Maryland, 5mm, da Vinci Si; Single-Site Fundus Grasper , 5mm, da Vinci Si; Single-Site Maryland Dissector , 5mm, da Vinci Si; Single-Site Monopolar Cautery , 5mm, da Vinci Si; Single-Site Port for 8.5 mm Endoscope, da Vinci Si; Single-Site Starter Kit US, Cholecystectomy, 20 Cases; Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si; Small Clip Applier , 8mm, da Vinci S, Si; Small Grasping Retractor , 8mm, da Vinci S, Si; Snap-Fit Scalpel Instrument , 8mm, da Vinci; Snap-Fit Scalpel Instrument , 8mm, da Vinci S, Si; Snap-fit Blue Blade, da Vinci, da Vinci S, Si; Snap-fit Paddle Blade, da Vinci, da Vinci S, Si; Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5; Stapler 45 Reload, Blue; Stapler 45 Reload, Green; Stapler 45 Reload, White; Stapler Cannula; Stapler Cannula Blunt Obturator; Stapler Cannula Blunt Obturator, Long; Stapler Cannula, Long; Stapler Release Kit; Stapler Sheath; Stapler-8mm Cannula Reducer; Streme App; SureForm 45 Curved Tip, SureForm 45 Gray Reload; SureForm 45 System; SureForm 45, SureForm 45 Reloads; SureForm 60; SureForm 60 Reloads; SureForm 60 System; Swivel Connector; SynchroSeal; System Cart; Teleflex Obturators; Tenaculum Forceps , 8mm, da Vinci S, Si; Thoracic Grasper , 5mm, da Vinci S, Si; Thoracic Grasper , 8mm, da Vinci; Thoracic Grasper , 8mm, da Vinci S, Si; Tip Cover Accessory; Tip Cover Accessory, da Vinci, da Vinci S, Si; UPGRADE,CO2 TANK INTERFACE,CGA940,US; Universal Seal; Universal Seal (5-12 mm); Universal Seal (5-12mm); VIO DV 2,INTEGRATED ELECTRO SURGICAL UNIT; VIO-ICB Mounting Bracket; Valve Hook , 8mm, da Vinci; Valve Hook , 8mm, da Vinci S, Si; Video Review (also referred to as “Replay”); Vision Probe Adapter and Suction Adapter; Vision Probe Bag; VisionBoom¿ Extension Cable; X; Xi; da Vinci 5 Force Feedback Cadiere Forceps; da Vinci 5 Force Feedback Fenestrated Bipolar Forceps; da Vinci 5 Force Feedback Large Needle Driver; da Vinci 5 Force Feedback Maryland Bipolar Forceps; da Vinci 5 Force Feedback Mega SutureCut Needle Driver; da Vinci 5 Force Feedback ProGrasp Forceps; da Vinci E-200 Electrosurgical Generator; da Vinci Firefly Imaging System; da Vinci Fluorescence Imaging Vision System; da Vinci Force Feedback Cadiere Forceps; da Vinci Force Feedback Fenestrated Bipolar Forceps; da Vinci Force Feedback Large Needle Driver; da Vinci Force Feedback Maryland Bipolar Forceps; da Vinci Force Feedback Mega SutureCut Needle Driver; da Vinci Force Feedback ProGrasp Forceps; da Vinci Insufflator; da Vinci Insufflator Tube Set with Smoke Evacuation; da Vinci SP Advanced Access Port Kit; da Vinci SP Firefly Imaging System; da Vinci SP SureForm™ 45 Curved-Tip Stapler; da Vinci SP SureForm™ 45 Stapler; da Vinci SP Surgical System; da Vinci SP Surgical System (SP1098); da Vinci SP Surgical System, Patient Cart; da Vinci SP Surgical System, Surgeon Console; da Vinci SP Surgical System, Vision Cart; da Vinci SP® Instruments and Accessories; da Vinci SP® Surgical System, Model SP1098; da Vinci Si; da Vinci Single-Site Accessories; da Vinci Single-Site Instrument and Accessories; da Vinci Single-Site Instruments; da Vinci Single-Site Instruments and Accessories; da Vinci Single-Site Port; da Vinci SonicPro Cleaning System; da Vinci Surgi=cal System, S (HD); da Vinci Surgical System (IS5000); da Vinci Surgical System, S; da Vinci Surgical System, Si; da Vinci X; da Vinci X Surgical System; da Vinci X Surgical System (IS4200); da Vinci Xi; da Vinci Xi 12 mm and Stapler Hasson Cone; da Vinci Xi 12-8 mm Reducer; da Vinci Xi 8 mm Hasson Cone; da Vinci Xi Surgical System (IS4000); da Vinci Xi Surgical System with Table Motion; da Vinci Xi Surgical System, Patient Cart; da Vinci Xi Surgical System, Surgeon Console; da Vinci Xi Surgical System, Vision Cart; da Vinci® 8 mm Cannula Gage Pin, da Vinci, da Vinci S, Si; da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200; iESU; surgical drapes",1998-01-06,180,2026-07-14,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223016832577%22&limit=1
Merit Medical Asia Company Limited,3015225571,3015225571,Rm 614 6/F Tsim Sha Tsui Center 66 Mody Road,Tsim Sha Tsui,,0000,Hong Kong,"Merit Medical Systems, Inc.",1721504,Exporter to the US,118,BWN; BZN; CCX; DQO; DQX; DQY; DRA; DRB; DRC; DRE; DRS; DSY; DTE; DTL; DWM; DWO; DWS; DWZ; DXC; DXE; DXT; DYB; ESW; EXF; FAD; FAJ; FCG; FCY; FDY; FED; FGE; FJS; FKO; FKX; FMF; FPA; FPK; FQM; FZX; GAA; GAH; GAX; GBW; GBX; GCB; GCC; GDF; GEA; GEH; GEI; GES; HRX; HTW; HXG; JAQ; JCT; JDZ; JOL; JRL; KCY; KDC; KDD; KDQ; KGS; KGX; KGZ; KIH; KME; KMK; KNQ; KNW; KRA; KRD; KTI; KYZ; KZD; LDF; LJS; LOD; LXH; LYV; MAV; MDM; MHW; MMX; MSD; NDN; NEU; NWU; OAR; OCX; OCY; ODE; ODY; OEQ; OEX; OEZ; OJA; OJV; OMT; OWL; OYI; PEV; PFV; PNG; PPD; PTL; PTM; PUR; PXI; PXU; PYB; PYC; QBP; QEY; QEZ; QJH; QSY,"Table And Attachments, Operating-Room; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Support, Patient Position; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Stylet, Catheter; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Transducer, Blood-Pressure, Extravascular; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Pulse-Generator, Pacemaker, External; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Apparatus, Suction, Patient Care; Needle, Biopsy, Cardiovascular; Instruments, Surgical, Cardiovascular; Device, Biopsy, Endomyocardial; Clamp, Vascular; Catheter, Embolectomy; Injector And Syringe, Angiographic; Introducer, Catheter; Prosthesis, Esophageal; Bag, Bile Collecting; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Biopsy Needle; Bulb, Inflation, For Endoscope; Device, Measuring, For Panendoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Stents, Drains And Dilators For The Biliary Ducts; Catheter, Peritoneal, Long-Term Indwelling; Catheter, Peritoneal Dialysis, Single Use; System, Peritoneal, Automatic Delivery; Syringe, Piston; Set, Administration, Intravascular; Tubing, Fluid Delivery; Bandage, Elastic; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Stylet, Surgical, General & Plastic Surgery; Tourniquet, Nonpneumatic; Catheter, Peritoneal; Catheter, Irrigation; Needle, Catheter; Dilator, Catheter; Guide, Needle, Surgical; Cannula, Surgical, General & Plastic Surgery; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Scalpel; Arthroscope; Bit, Drill; Tamp; System, Applicator, Radionuclide, Remote-Controlled; Prosthesis, Tracheal, Expandable; Mixer, Cement, For Clinical Use; Catheter And Tip, Suction; Unit, Filter, Membrane; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Dispenser, Cement; Bedding, Disposable, Medical; Device, Intravascular Catheter Securement; Dilator, Esophageal; Instrument, Biopsy; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Electrode, Pacemaker, Temporary; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Bone Cement; Orthopedic Manual Surgical Instrument; Label Or Tag, Sterile; Syringe, Balloon Inflation; Instrument, Manual, Surgical, General Use; Dressing, Compression; Device, Percutaneous Retrieval; Catheter, Hemodialysis, Implanted; Cement, Bone, Vertebroplasty; Marker, Radiographic, Implantable; Endoscope Introducer Kit; Injector, Vertebroplasty (Does Not Contain Cement); Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd); Tunneled Catheter Remover; Angiography/Angioplasty Kit; Cardiovascular Catheter Sheath Introducer Kit; Cardiovascular Procedure Kit; Intravenous Extension Tubing Set; Single Use Instrument Tray; Absorbable Lung Biopsy Plug; Peripheral Catheter Insertion Kit; Non-Bronchoscopic Bronchoalveolar Lavage Catheter; Dialysis Administration Kit; System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Universal Drainage Tray; Wire, Guide, Catheter, Exempt; Syringe, Balloon Inflation, Exempt; Vacuum Syringe; Thoracentesis Tray; Fluid Drainage Tray; Minor Surgical Procedures Tray; Paracentesis Tray; Cap, Device Disinfectant; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter; Reverse Central Venous Recanalization System; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; 3; U,"1 mL syringe(Polypropylene); 10Fore Hemostasis Valve; 10Fore Hemostasis Valve Kit; 5.5 F Worley Advanced LVI Lateral Vein Introducer; AEROmini Tracheobronchial Stent System; ARC Catheter; ASAP Aspiration Catheter; ASAP Catheter; ASAPLP Aspiration Catheter; ASAPLP Embolectomy Catheter; Access-9; AccessPLUS; Achieve; Activation Element, ERx bone cement; Acutiy Universal Cutter; Adjustable Biopsy Port Seal BPS-A; Advance Angiographic Needle; Aero DV Tracheobronchial Stent System; Aero Tracheo Stent and Delivery System; Aerosizer; Alimaxx E; Arcadia Balloon Catheter; Arcadia Balloon Catheter Kit; Aspira Peritoneal Drainage System; Aspira Pleural Drainage System; BIG60; BIG60 ALPHA Inflation Devie; BRC-BAL-INT-FL/A; BackStop Plus Closed Waste Basin; Bedford™ Guided Hard Bone Biopsy System; BioFlo Duramax; BioSentry Tract Sealant System; Blue Diamond Inflation Syringe; BowTie Guide Wire Insertion Device; Brochoalveloar Lavage (BAL) Custom Convenience Kit; Bulldog Lead Extender; C2 Cryoballoon Ablation System; C2 Cryoballoon Endogrip; CT Transfer Set; CardiaGuide Fixed Curve Braided Transseptal Sheath; Cardiac Output Kit; Cen-Step Centesis Catheter; Centros Long-Term Hemodialysis Catheter; CentrosFLO Long-Term Hemodialysis Catheter; Check Valve; ClariVein IC Infusion Catheter; Coil Expander; Concierge Guiding Catheter; Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI); Coronary Control Syringe; Corvocet Biopsy System; Corvocet Coaxial Introducer; Cuff Implantor; Curved Inner Femoral Sheath and Curved Introducer Sheath Set - Femoral.; Dark Blue Cap for Male Luers; Dash 9F Hydrophilic Sheath Introducer; DiamondTOUCH Inflation Device and Fluid Dispensing Syringe; DiamondTOUCH Syringe; DoublePlay Hemostasis Valve; Drainage Tubing; DriPAD Super Absorbent Pad; DualCap; DualCap Duo; DualCap IV Pole Strips; DualCap Solo; DuraFlow 2 Hemodialysis Catheter; Duramax; EN Snare Endovascular Snare System; ER2 Saturate Mixing System; Elation Fixed Wire Balloon; Elation Pulmonary Balloon; Elation Pulmonary Balloon 4mm; Elation Wireguided Balloon; Elation5 Fixed Wire Balloon; Elation5 Wireguided Balloon; Embedding Tool; EndoMAXX; EsophyX Z+ Device; EvenMore Chronic Hemodialysis Catheter; Excite Contrast Injection Line; ExxTended Catheter; FLO30; FLO40XR; FLO50; Faller Trocar; FastBreak Connector; Finale Radial Compression System; Flex-Neck Catheter; Flex-Neck Extender/Repair Kit; Flex-Neck Infant Catheter; FlowGuard; Fluid Dispensing Syringe; Fountain 4F Catheter & Occluding GW; Fountain Catheter/Occluding Guide Wire; Fountain Infusion Catheter w/ Occluding Guide Wire; Fountain Infusion System; Fountain ValveTip Infusion Catheter; Futura Safety Scalpel; Go2Wire Guide Wire; Guidewire Introducer; Guidewire with Palladium Tip; H20 Guidewire; H20 Torque Device; HeRO Graft; HeartLight Deflectable Sheath; HeartSpan Fixed Curve Braided Transseptal Sheath, Braided Guiding Introducer, EZ Cross Introducer Kit; et al.; HeartSpan Steerable Introducer Sheath; HeartSpan Steerable Sheath Introducer; Hemostasis Valve Adapter; Honor hemostasis valve; Huntington Guided, Perforating Bone Biospy System with Drill; Hydraulic Assembly; Hydraulic-Master Syringe Assembly; Hydrophilic Guidewire; Hydrophilic Prelude SNAP Splittable Sheath Introducer; Impress Angiographic Catheter; Impress UAC Catheter; Impress and Impress Legato Hydrophilic Angiographic Catheter; Impress with Legato Hydrophilic Coating; InQwire; InQwire Amplatz Super Stiff Guide Wire; InQwire Diagnostic (Support) Non-Vascular Guide Wire; InQwire Guidewire-Prelude Introducer; InQwire Guidewires; Insufflation Set; Intellisystem Inflation Device; Introducer Needle WithTrocar Stylet; K01 Kit (MSS); K01 Syringe Kit (1mL & 20mL COP); K01 Syringe Kit (1mL Polypropylene); K02 Syringe Kit (multiple K01); K02 Syringe Kit (multiple K01)); K02-00873A, K02-01105A, K02-01481A; K04 - Tubing Kit; K05 Inflation Kit; K05T - Inflation Kit; K06 Syringe Kit (single CSS); K07 Syringe Kit (multiple K06); K08 Fluid Management Kit; K09 Manifold Kit; K09T - Manifold Kit; K10 Waste Management Kit; K10T - Waste Management Kit; K11 Pressure Monitoring Kit; K12 Procedure Kit; K12T - Procedure Kit; K13 Label Kit; K14 Dialysis Kit; K15 Sheath Introducer Kit; K16 Microcatheter Kit; K17 Interventional Kit; K17T - Interventional Kit; K18 Sheath Introducer Kit (Ease); K19 Combination Packs; K20 Endoscopic Kit; K20T - Endoscopic Kit; K21 Sheath Introducer Kit (IDeal); K22C Vein Tray; K23C Vein Accessory Kit; KYPHON KyphoFlex Balloon Catheter; KYPHON KyphoFlex Balloon Catheter Kit; Kensington Guide Wire Bone Biopsy System; Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-411); Lead Clippers; Liberator Beacon Tip Locking Stylet; Low Profile Companion Sheath; MAK-NV Non-Vascular; MAP Torque Device & Introducer; MBA; MYSHELL Hemostatic Valve; Madison Mini™ Bone Biopsy System; Madison™ Perforating Bone Biopsy System with Drill; Maestro Microcatheter; Majestik Angiographic Needle; Master Syringe Assembly; Maxxwire; Medallion Syringe; Merit 1mL Syringe (COP); Merit 20 mL Syringe (COP); Merit Administration Set; Merit Centros Long-Term Hemodialysis Catehter; Merit CentrosFLO Long-Term Hemodialysis Catheter; Merit Convenience Kits; Merit Disposal Depot; Merit Drainage Depot; Merit HeRO Graft; Merit High Pressure Tubing; Merit Hydrophilic Guide Wire; Merit InQwire® Amplatz Super Stiff Guide Wire; Merit MAK (Mini Access Kit); Merit Manifold; Merit Marquis Flow Switch; Merit Marquis Stopcock; Merit PAK; Merit Pressure Monitoring Tubing; Merit Pursue Microcatheter; Merit S-MAK (Stiffened Mini Access Kit); Merit Safety Needle; Merit Syringe; Merit Triboglide Syringe; Meritrans Disposable Transducer; MetaSTAR RF Generator; Micro Ace Advanced Micro Access System; Micro Ace Gold Advanced Micro Access System; Micro Plug Set; Mighty Wire; MiniStop Filter Closed Waste Basin; MiniStop Plus Closed Waste Basin; Miser Contrast Management System; Monarch Compak Inflation Syringe; Monarch Syringe Fluid Dispense System; MultiPlex II Controller; Needle's Eye Snare Retrieval Set; NeoVasc; Non-vascular tissue dilators; Novatome Endomyocardial Biopsy Forceps; One Snare Endovascular Snare System ONE1501; One-Step Centesis Catheter; One-Tie Compression Coil; One-Vac Evacuated Drainage Bottle; OneSnare Endovascular Snare System; Osseoflex Access Kit; Osseoflex CD-H Hydraulic Cement Delivery System; Osseoflex SB Steerable Balloon (10Ga); Osseoflex SB Steerable Balloon (8ga); Osseoflex SB Straight Balloon (10ga); Osseoflex SB Straight Balloon (8ga); Osseoflex SN; Osseoflex SN Needle; Osseoflex SN+ Needle; Osseoflex Straight Hand Drill; Osseon Bone Filler Device (BFD); Ostial Pro Stent Positioning System; OuTake Catheter Extractor; PAL (Pen and Labels) Family; Passage Hemostasis Valve; Perchik Button Assembly; Percutaneous Peritoneal Dialysis Catheter Implantation Systems (VP-511, VP-511M); Performa Diagnostic Intravascular Catheter; Pericardiocentesis Catheter Kit; Peritoneal Dialysis Catheter Connector; Peritoneoscopic or Laparoscopic Peritoneal Dialysis Catheter Implantation Systems (VP-210, VP-211); PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing; Pin Vise Polymer; PinVise Torque Device; Pink Achieve; Pinvise Torque Device; PowerCURVE Navigating Osteotome; Prelude Choice Hemostasis Valve Adapter; Prelude IDeal Hydrophilic Sheath Introducer; Prelude Plastic Jacketed Guide Wire; Prelude Prestige Splittable Sheath Introducer; Prelude SNAP 165 Valved Splittable Sheath Introducer; Prelude SNAP Splittable Sheath Introducer; Prelude Sheath Half Size (ACT); Prelude Sheath Introducer; Prelude Short Sheath Introducer; Prelude Wave Hydrophilic Sheath Introducer; PreludeEASE Hydrophilic Sheath Introducer, 4F-6F; PreludeEASE Hydrophilic Sheath Introducer, 7F; PreludeSYNC DISTAL Radial Compression Device; PreludeSYNC EVO Radial Compression Device; PreludeSYNC EZ Radial Compression Device; Pressure Infusor Bags (PIB); Preston Bone Filler; Preston™ Hard Bone Access Needle with Drill; Preston™ Hard Bone Introducer; Preston™ Long Drill; Preston™ Transpedicular Drill; Preston™ Transpedicular Introducer; ProGuide Long Term Hemodialysis Catheter; Purge Assist; RADstat Radial Artery Compression Device; RTT14038MB; RXP (Rapid Exchange Flushing Syringe); Rad Board; Rad Board 2 Reusable Arm Board; Rad Board Xtra; Rad Rest; Rad Trac; ReSolve Biliary Locking Drainage Catheter; ReSolve ConvertX Biliary Stent System; ReSolve ConvertX Nephroureteral Stent System; ReSolve Dilators; ReSolve Locking Drainage Catheter; ReSolve Non-Locking Drainage Catheter; Repositional Chest Tube; Resilience Fully Covered Esophageal Stent System; Revolution Catheter Securement Dev.; Roadster Guide Sheath; Rotating Adaptor; S-MAK; S-MAK XL; SAVI Applicator Kit; SAVI Prep Device; SAVI Spacer; SCOUT Bx Delivery System; SCOUT Console and Accessory Cart; SCOUT MD Console; SCOUT MD Delivery System; SCOUT MD Guides; SCOUT MD Single-Use Handpieces; SCOUT MD Single-use Handpieces; SCOUT Reflector and Delivery Systems; SCOUT Single-Use Handpiece, SCOUT Surgical Guides; SCOUT Surgical Console and SCOUT Check Console; SPINR High-Performance Guidewire Catheter; STAR Tumor Ablation Kit and Accessories; STAR Tumor Ablation Kit with PowerCURVE; STATSEAL; SafeGuard Focus Compression Device; SafeGuard Focus Compression Device (Adhesive Free); SafeGuard Focus Cool Device; SafeGuard Focus Cool Device (Adhesive Free); SafeSafeSheath, ClassicSheath, Input SSV , Split Sheath Introducer Kit With Valve; et al.; SafeSheath CSG Introducer Sheath Kit , Worley Advanced CSG , Worley Advanced LVI Lateral Vein Introducers, et al.; SafeSheath Sealing Adapter; Safeguard Pressure Assisted Device (12cm); Safeguard Pressure Assisted Dressing (24cm); Safeguard Radial Compression Device; Safety Paracentesis Tray (SPPT); SeaDragon Torque Device; ShortStop Advantage Temporary Sharps Holder; ShortStop Grandstand Temporary Sharps Holder; ShortStop Temporary Sharps Holder; Sidecar External Working Channel (FG-1011); Siege Vascular Plug; Slip-Not; Smart Tip Control Syringe; Sof-Grip Hemostat; Softouch Diag. Intra Cath. w/Vessel; Solo Pace Control; Solo Pace Fusion System (SOLOFUSE1); Spectranetics; SpineSTAR Ablation Instruments; Squirt Fluid Delivery System; StabiliT Bone Cement and Saturate Mixing System; StabiliT Cement Delivery Syringe; StabiliT ER2 Bone Cement and Saturate Mixing System; StabiliT Introducer and Delivery Instruments; StabiliT MX Fracture Kits; StabiliT MX Fracture Kits with PowerCURVE; StabiliT VP Fracture Kits; StabiliT VP Vertebrosplasty Kit; StayFix Fixation Device; Sterilized Convenience Kits; Stopcock One Port Manifold; Straightline Osteotome, VerteCOR Midline Osteotome; Stylet Wire; Stylette (rod obturator); SureCross Support Catheter; Surfacer Inside-Out Access Catheter System; SwiftNINJA Microcatheter; SwiftNINJA Steerable Microcatheter; TRAM; TRAM-P; Temno ACT; Temno Elite Biopsy Systems; Temno Evolution; Temno Original; Thoracentesis Tray (TAPS); Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al.; TruCut 14Ga; TruCut 18Ga; True Form Reshapable Guide Wire; Universal Coaxial Needles; VacLok AT Syringe; Valve Adapter; Ventrax Delivery System; VertecoR Bone Drill, 3; Vessel Dilator; Vessel Sizing Catheter (VSC); WOUNDSEAL; Westbrook™ Bone Biopsy System; Worley; Wrapsody Cell-Impermeable Endoprosthesis; X-Change Cement Dispensing Syringe; basixCompak Analog Inflation Syringe; basixSKY Inflation Device; basixTOUCH; basixTOUCH40 Inflation Syringe",1992-07-14,179,2026-01-09,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015225571%22&limit=1
Arthrex Australia Pty Ltd.,3019269298,3019269298,"Suite 501, 20 Rodborough Road",Frenchs Forest New South Wales,,2086,Australia,"ARTHREX, INC.",1220287,Exporter to the US,63,BWN; DXJ; EBW; EQH; FMF; FMP; FSM; FWB; FWZ; FZW; GAB; GAP; GAT; GAZ; GCJ; GEI; GFA; GFF; HIF; HRS; HRX; HSB; HSD; HST; HTC; HTD; HTJ; HTN; HTO; HTW; HTY; HTZ; HWC; HWE; HWQ; HWT; HXB; HXJ; IZI; JDQ; JDR; JQC; JQO; KQM; KQZ; KWD; KWS; LLZ; LMD; LRY; LXH; MAI; MBI; MDM; MNU; NBH; ORG; OSV; OUG; PHX; PKC; PLF; QHQ,"Table And Attachments, Operating-Room; Display, Cathode-Ray Tube, Medical; Controller, Foot, Handpiece And Cord; Source, Carrier, Fiberoptic Light; Syringe, Piston; Protector, Skin Pressure; Tray, Surgical, Instrument; Camera, Television, Surgical, Without Audio; Operating Room Accessories Table Tray; Expander, Surgical, Skin Graft; Needle, Suturing, Disposable; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyethylene; Tubing, Noninvasive; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Insufflator, Laparoscopic; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Pliers, Surgical; Forceps; Gauge, Depth; Washer, Bolt Nut; Reamer; Bit, Drill; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Passer; Template; Probe; Staple Driver; System, X-Ray, Angiographic; Cerclage, Fixation; Staple, Fixation, Bone; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Balance, Analytical; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; System, Image Processing, Radiological; System, Digital Image Communications, Radiological; Punch, Surgical; Orthopedic Manual Surgical Instrument; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Staple, Absorbable; Accessories, Arthroscopic; Platelet And Plasma Separator For Bone Graft Handling; Insufflator, Endoscopic Vessel Harvesting; Medical Device Data System; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Bone Wedge; Total Shoulder Arthroplasty System",1; 2,"ACL TightRope; ACL TightRope Double Bundle; ANATOEMIC PROSTHESIS; ARTHREX ANATOEMIC P; ARTHROERESIS IMPLANT; ARTHROSCOPY LEG HOLDER; Apparatus, Traction, Non-Powered; Arthrex Ankle Fusion Plating System; Arthrex BioComposite SutureTak; Arthrex Distal Extremity Plate System; Arthrex Fracture Plates; Arthrex Fracture Plates and Screws; Arthrex Fracture System; Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi; Arthrex Graft-Anchor; Arthrex Knotless SutureTak Anchor; Arthrex Low Profile Screws; Arthrex MicroSuture Anchors; Arthrex Mini TightRopes; Arthrex Minimally Invasive Ankle Fusion Plate; Arthrex PCL TightRope; Arthrex Plates, Screws, and Staples; Arthrex PushLock Tenodesis Anchor; Arthrex Pushlock; Arthrex RetroFusion Screw  Smooth or Threaded Metallic Bone Fixation Fastener; Arthrex Suture; Arthrex SwiveLock Anchors; Arthrex Tibial  GraftBolt; Arthrex Tibial GraftBolt; Arthrex Univers II Glenoid Components; Arthroscope; Arthroscopes; BI-CORTICAL BIO-POST AND WASHER; BIO-ABSORBABLE CORKSCREW; BIO-COMPRESSION SCREW; BIO-CORKSCREW FT; BIO-FASTAK SUTURE ANCHOR; BIO-PIN; BIO-POST AND WASHER; BIOCOMPOSITE INTERFERENCE SCREW; BIOCOMPOSITE SUTURE ANCHORS; Balance, Analytical; Bio-Composite SutureTak; Biosync; Biosync Bone wedge; CHONDRAL DART; COMPRESSION STAPLE; CORKSCREW ANCHORS; Camera Heads; Camera, Television, Surgical, Without Audio; Component, Traction, Non-Invasive; DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER; DOUBLE SYRINGE (ACP) SYSTEM; Dual Wave Pump; FASTAK SUTURE ANCHOR; FIBERWIRE BUTTON REPAIR KIT; Fastener, Fixation, nondegradable, soft tissue; FiberTape; FiberWire; Fiberstick; Fracture Plates & Screws; General Hospital and Personal Use Miscellaneous Devices; Graft Delivery Device with Integrated Stylet; HUMERAL FRACTURE PLATE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT; INTERFERENCE SCREWS; Instrument, manual, surgical, general use; Insufflator 50L FM134; LOW PROFILE PLATE AND SCREW SYSTEM; Laproscopes; MENISCAL CINCH; MENISCAL DART, DARTSTICK,; Metallic Bone Fixation; Mini TightRope CMC; OPES ELECTRODES AND ACCESSORIES; ORTHOPEDIC MANUAL INSTRUMENTS; OSTEOTOMY PLATE; OSTEOTOMY SYSTEM; Orthopedic Template; Orthopedic manual surgical instrument, Passer; PARS Needle; PUSHLOCK; Pliers, Surgical; Protector, Skin Pressure; RETROBUTTON; RF device, blade, hook; SHAVER BLADES; SHAVER SYSTEM; SHOULDER HOLDER; Shoulder joint metal/ polymer semi-constrained cemented prosthesis; Single/multiple component metallic bone fixation appliances and accessories; Source, Carrier, Fiberoptic Light; System, Digital Image Communications, Radiological; TAK FAMILY; TENODESIS FAMILY; Table Attachments, Operating-Room; UNIVERS FRACTURE; UNIVERS II; UNIVERS SHOULDER; Univers II; Univers Revers Shoulder Prosthesis System; VARIOUS BURS; VARIOUS IMPLANTS; VARIOUS INSTRUMENTS; WASHER; Weight, 2.5 lb (1.1kg); display, cathode-ray tube, medical; drill bit; fixation pin; fixation plate; iBalance; orthopedic manual instrument; single/ multiple component metallic bone fixation appliances and accessories; smooth or threaded metallic bone fixation fastener",1994-01-27,173,2024-07-25,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223019269298%22&limit=1
Bausch & Lomb Incorporated,1313525,1317628,1400 North Goodman Street,Rochester,NY,14609,United States,Bausch & Lomb Incorporated,9913003,Complaint file establishment; Manufacturer; Manufacturer for export; Specification developer,205,BWB; BYX; BYY; CAF; CAT; DWS; EID; EMF; EPY; EQJ; FFO; FGY; FHQ; FHR; FSM; FTY; FXE; FZO; FZS; FZX; GAB; GAC; GAD; GAZ; GBX; GDG; GDH; GDI; GDM; GDT; GDZ; GEA; GEG; GEI; GEN; GEX; GFF; GFI; GFJ; GWX; GXI; HBI; HKF; HKY; HLN; HMQ; HMR; HMX; HMZ; HNA; HNB; HNC; HND; HNE; HNF; HNG; HNH; HNI; HNJ; HNL; HNM; HNN; HNP; HNQ; HNR; HNS; HNW; HNX; HNY; HNZ; HOA; HOB; HOD; HOE; HOF; HOI; HOY; HPX; HQB; HQC; HQD; HQE; HQF; HQL; HQN; HRB; HRH; HRR; HRS; HRT; HTF; HXB; HXK; HXL; HXZ; IME; IMI; ISA; JBZ; JOL; JXS; JXT; JXX; JYA; JYE; JYF; JYG; JYH; JYJ; JYL; JYO; JYQ; JYR; JYS; JYT; JYW; JYY; JZB; JZD; JZF; KAA; KAC; KAD; KAE; KAG; KAI; KAJ; KAK; KAL; KAM; KAN; KAP; KAQ; KAS; KAW; KAY; KBA; KBB; KBD; KBE; KBH; KBJ; KBL; KBM; KBN; KBQ; KBR; KBS; KBT; KBZ; KCB; KCH; KCJ; KCP; KDD; KKX; KTE; KTF; KTG; KYB; KYG; KYZ; LFD; LPL; LPM; LPN; LRC; LRW; LRX; LRY; LWK; LWL; LXZ; LYL; LYX; LZP; MBI; MFK; MJP; MMO; MOE; MPA; MRC; MRH; MRJ; MSS; MUU; MUW; MVN; MWL; MXY; NAA; NCF; NGY; NNR; NPL; NPM; NUU; OHV; OJK; ONF; ONG; POE; PUI; QPB,"Forceps, Tube Introduction; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Nebulizer (Direct Patient Interface); Cannula, Nasal, Oxygen; Instruments, Surgical, Cardiovascular; Syringe, Restorative And Impression Material; Knife, Surgical; Speculum, Ent; Bur, Ear, Nose And Throat; Retractor, Self-Retaining; Cannula, Injection; Holder, Needle, Gastroenterologic; Needle, Gastro-Urology; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Speculum, Non-Illuminated; Chisel, Surgical, Manual; Curette, Surgical, General Use; Guide, Surgical, Instrument; Needle, Suturing, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Tubing, Noninvasive; Catheter, Irrigation; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Needle, Aspiration And Injection, Reusable; Staple, Removable (Skin); Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Powered Laser Surgical Instrument; Bur, Surgical, General & Plastic Surgery; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Fork, Tuning; Probe, Radiofrequency Lesion; Illuminator, Fiberoptic, Surgical Field; Mirror, Headband, Ophthalmic; Tonometer, Manual; Gauge, Lens, Ophthalmic; Marker, Sclera; Marker, Ocular; Cannula, Ophthalmic; Trabeculotome; Spud, Ophthalmic; Spoon, Ophthalmic; Specula, Ophthalmic; Spatula, Ophthalmic; Snare, Enucleating; Scissors, Ophthalmic; Rongeur, Lachrymal Sac; Ring, Ophthalmic (Flieringa); Retractor, Ophthalmic; Punch, Corneo-Scleral; Probe, Lachrymal; Needle, Ophthalmic Suturing; Knife, Ophthalmic; Introducer, Sphere; Hook, Ophthalmic; Forceps, Ophthalmic; Expressor; Dilator, Lachrymal; Depressor, Orbital; Cystotome; Curette, Ophthalmic; Compressor, Orbital; Clamp, Muscle, Ophthalmic; Clamp, Eyelid, Ophthalmic; Caliper, Ophthalmic; Burr, Corneal, Manual; Spectacle, Magnifying; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Lens, Contact (Polymethylmethacrylate); Photocoagulator And Accessories; Unit, Phacofragmentation; Lens, Contact (Other Material) - Daily; Instrument, Vitreous Aspiration And Cutting, Ac-Powered; Laser, Ophthalmic; Intraocular Lens; Conformer, Ophthalmic; Microscope, Operating, Non-Electric, Ophthalmic; Trephine, Manual, Ophthalmic; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Stripper, Surgical; Curette; Probe; Holder, Needle; Orthopedic; Mallet; Cutter, Wire; Pack, Hot Or Cold, Reusable; Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat; Massager, Therapeutic, Electric; Study, Platelet Adhesive; Catheter And Tip, Suction; Block, Cutting, Ent, Sterile; Crimper, Wire, Ent, Sterile; Forceps, Wire Closure, Ent, Sterile; Scissors, Wire Cutting, Ent, Sterile; Chisel, Middle-Ear; Clamp, Ossicle Holding; Curette, Ear; Excavator, Ear; Gauge, Measuring; Hook, Microsurgical Ear; Knife, Ear; Loop, Wire; Nipper, Malleus; Perforator, Ear-Lobe; Pick, Microsurgical Ear; Press, Vein; Rasp, Ear; Scissors, Ear; Snare, Ear; Tube, Ear Suction; Set, Laryngeal Injection; Tube, Laryngectomy; Elevator, Ent; Forceps, Ent; Holder, Speculum, Ent; Mirror, Ent; Mobilizer, Ent; Probe, Ent; Retractor, Ent; Cannula, Sinus; Chisel, Nasal; Curette, Nasal; Gouge, Nasal, Ent; Knife, Nasal; Punch, Antrum; Punch, Nasal; Rasp, Nasal; Rongeur, Nasal; Scissors, Nasal; Snare, Nasal; Adenotome; Curette, Adenoid; Depressor, Metal Tongue, Surgical; Dissector, Tonsil; Gag, Mouth; Knife, Tonsil; Needle, Tonsil Suturing; Punch, Adenoid; Punch, Tonsil; Snare, Tonsil; Tube, Tonsil Suction; Hook, Tracheal; Applicator, Ent; Syringe, Ent; Kit, Surgical Instrument, Disposable; Drape, Surgical, Antimicrobial; Trocar, Ent; Punch, Ent; Knife, Ent; Lens, Guide, Intraocular; Device, Irrigation, Ocular Surgery; Syringe, Irrigating (Non Dental); Saliva, Artificial; Lenses, Soft Contact, Daily Wear; Lenses, Soft Contact, Extended Wear; Accessories, Soft Lens Products; Instrument, Ent Manual Surgical; Scissors, General, Surgical; Case, Contact Lens; Punch, Surgical; Razor, Surgical; Fluid, Intraocular; Guard, Instrument; Accessories, Solution, Ultrasonic Cleaners For Lenses; Media, Corneal Storage; Aid, Surgical, Viscoelastic; Fastener, Fixation, Nondegradable, Soft Tissue; Lens, Multifocal Intraocular; Lens, Intraocular, Toric Optics; Tray, Surgical, Ent; Collagen Corneal Shield; Endoilluminator; Products, Contact Lens Care, Rigid Gas Permeable; Pump, Infusion, Ophthalmic; Ring, Endocapsular; Folders And Injectors, Intraocular Lens (Iol); System, Suction, Lipoplasty; Lens, Contact (Orthokeratology); Lens, Contact, (Disposable); Lens, Contact (Rigid Gas Permeable), Extended Wear; Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal; Lens, Intraocular, Accommodative; Aberrometer, Ophthalmic; Cannula, Trocar, Ophthalmic; Block, Cutting, Ent, Non-Sterile; Barrier, Animal Source, Intraoral; Bone Grafting Material, Animal Source; Lens, Contact, Orthokeratology, Overnight; Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption; Eye Tray; Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Powered Laser Surgical Instrument With MicrobeamFractional Output; Extended Depth Of Focus Intraocular Lens; Drape, Surgical, Exempt; System, Suction, Lipoplasty For Removal",1; 2; 3; U,CX9626 25GA SYST -6/box,1989-02-22,144,2026-03-25,29,25,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221313525%22&limit=1
"Bard Access Systems, Inc.",3006260740,3006260740,605 North 5600 West,Salt Lake City,UT,84116,United States,"C. R. Bard, Inc.",2212754,Complaint file establishment; Manufacturer; Manufacturer for export; Specification developer,50,BSP; DQY; DYB; EXF; EZD; FCN; FGE; FKA; FKC; FMI; FOS; FOX; FOZ; FPA; FTY; FZT; FZX; GAX; GBX; GEC; ITX; IYN; IYO; KDC; KDD; KGC; KGX; KGZ; KMK; KNT; LBJ; LFJ; LJS; LJT; LLZ; MDM; MHC; MPB; MSD; NAD; NFK; NIE; OXQ; PND; PTD; PTI; PUI; PVZ; QSY; SEF,"Needle, Conduction, Anesthetic (W/Wo Introducer); Catheter, Percutaneous; Introducer, Catheter; Bag, Bile Collecting; Catheter, Straight; Urinary Drainage Collection Kit, For Indwelling Catheter; Stents, Drains And Dilators For The Biliary Ducts; Dilator, Vessel; Clamp, Cannula; Needle, Hypodermic, Single Lumen; Catheter, Umbilical Artery; Stand, Infusion; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Tape, Measuring, Rulers And Calipers; Cutter, Surgical; Guide, Surgical, Instrument; Tourniquet, Nonpneumatic; Catheter, Irrigation; Brush, Scrub, Operating-Room; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Tube, Gastro-Enterostomy; Tape And Bandage, Adhesive; Accessories, Catheter; Device, Intravascular Catheter Securement; Tubes, Gastrointestinal (And Accessories); Device, Vein Stabilization; Catheter, Subclavian; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; System, Image Processing, Radiological; Instrument, Manual, Surgical, General Use; Needle, Interosseous; Catheter, Hemodialysis, Non-Implanted; Catheter, Hemodialysis, Implanted; Dressing, Wound, Occlusive; Kit, Repair, Catheter, Hemodialysis; Catheter, Hemodialysis, Triple Lumen, Non-Implanted; Dressing Change Tray; Midline Catheter; Subcutaneous Implanted Apheresis Port; Non-Coring (Huber) Needle; Drape, Surgical, Exempt; Non-Stainless Steel Needle; Hemostatic Wound Dressing Without Thrombin Or Other Biologics; Central Venous Catheter With Manual Insertion System",1; 2; U,"9.5 Fr. DL Chronoflex Polyurethane; Accessory - Foam Strips; AccuCath Ace™ Intravascular Catheter; Advance Introducer and SecureLoc Safety Introducer; Align Introducers; AllPoints™ Dressing Change Kit; Alphacurve; BD Intraosseous Vascular Access System EMS Powered Driver (D001003); BD Prevue™ II Peripheral Vascular Access System; Bard Button Gastrostomy Tube; Bard Davol ReliVac Stainless Steel Trocar; Bard Extension Set; Bard Jejunal Tube; BardPort Titanium Ports; Brevia; Broviac; Catheter Plug; Catheter Repair Kit with Replacement Connector; Catheter System; Cathlink 20 Titanium Port w/ Attachable Polyurethane Cathete; CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System; Cutter, surgical; Dilators; Dome Titanium Port; Drape, surgical; Dualator; Duet Long Term Hemodialysis; Fast Track Tunneler Set; Flexxicon; Footprint Medical Dual-Lumen Umbilical Catheter; Footprint Medical PICC Introducer; Footprint Medical Polyurethane Feeding Tube; Footprint Medical Polyurethane PICC; Footprint Medical Polyurethane Umbilical Catheter; Footprint Medical Silicone Feeding Tube; Footprint Medical Silicone PICC; Footprint Medical Silicone Umbilical Catheter; Footprint Medical Urinary Drainage Catheter; Gastrointestinal Tube; GlidePath™ Long Term Hemodialysis Catheter; Groshong; Groshong NXT; Groshong NXT ClearVue; Groshong PICC; HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS; HemoGlide Star; HemoSplit; HemoSplit XK; HemoStar; HemoStar XK™ Long Term Hemodialysis Catheter; HemoStar™ Long Term Hemodialysis Catheter; Hickman Trifusion; Hohn; Huber Plus; InSnare Introducers; Instrument, surgical, disposable; Intravascular Catheter Securement Device; Kit, surgical instrument, disposable; LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING (HemoStar, HemoSplit); MRI Hard Base Port; MRI Low Profile Port; MRI Port; MRI PowerPort; MidLine; Navarre Opti-Drain Drainage Catheter; Navarre Universal Drainage Catheter; Niagara; Niagara SlimCath; Non-Safety Needle; PelviSoft Introducers; Per-Q-Cath; Per-Q-Cath Catheter Introducer; Percutaneous Introducer Kit; Poly Per-Q-Cath; Poly Per-Q-Cath PICC & Midline; Ponsky Non-Balloon Replacement Gastrostomy Tube; Positioning System Stylet; PowerGlide Pro™ Midline Catheter; PowerGlide Pro™ Midline Catheter with Cue™ Needle Tracking System; PowerGroshong; PowerHickman; PowerHohn; PowerLine; PowerLoc; PowerLoc™ Max Power Injectable Infusion Set; PowerPICC; PowerPICC SV Catheter; PowerPort ClearVUE Slim Implantable Port; PowerPort duo MRI Implanted Port w/; PowerPort with Groshong Catheter; PowerPort™ ClearVUE™ Slim Implantable Ports; PowerPort™ ClearVUE™ isp Implantable Ports; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ duo M.R.I.™ Implantable Port; PowerPort™ isp Implantable Port; Provena Midline Catheter; Repair Kit; Rosenblatt Port; SafeStep™ Huber Needle Set; SecureLoc; Sensor & Sherlock 3CG Tip; Sensor Holder; Sentrinex™ 3D Port Dressing; Sherlock; Sherlock 3CG Tip Positioning System; Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly; Site-Rite Needle Guide Kits and Pro; SiteRite 9 Ultrasound System; SlimPort MRI Ultra Low Profile Port; Soft-Cell; Soft-Cell Dual Lumen Catheter; Statlock Stabilization Device; Titanium Low Profile Port; Titanium Port; Titanium PowerPort; Titanium PowerPort isp; Tourniquet, non-pneumatic; UDM-10 Urinary Drainage Monitoring; Urinary drainage collection kit, for in-dwelling catheter; VAS-CATH FLEXXICON DUAL LUMEN DIALYSIS CATHETER; Vaccess; Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; Vein Pick; Winged Infusion Set (WIS); Wound Closure Tape Strips; X-Port Duo MRI Port; X-Port Inline; X-Port Low Profile Port; X-Port duo Port; X-Port isp MRI Port",1992-07-22,172,2025-09-05,0,40,4,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006260740%22&limit=1
DHL Supply Chain (netherlands) B.V.,3009077524,3009077524,Zwenkgras 9,Beringe Limburg,,5986 PM,Netherlands,DHL Supply Chain (Netherlands) B.V.,10085309,Exporter to the US,94,BYH; BZC; BZQ; CBK; CBQ; CBR; CBS; CCK; CCL; DPS; DQA; DQK; DRG; DRJ; DRO; DRQ; DRS; DRT; DRW; DRX; DSA; DSB; DSF; DSH; DSI; DSJ; DSK; DSP; DXG; DXN; DXQ; FLL; FMZ; FZX; GDF; GWR; GWS; HBL; HFM; HFN; HGL; HGM; IKD; ITX; IXA; IXJ; IXR; IYE; IYN; IYO; IZI; IZL; IZW; JAA; JAK; JOM; KLK; KNW; KOI; KPR; KRB; KRC; LDD; LIX; LKD; LLZ; LNH; LNI; LPP; MHX; MIG; MKJ; MLC; MLD; MOS; MQB; MQM; MSX; MUJ; MWI; MWJ; NEU; NHO; NHP; NHQ; NOU; NSA; OBJ; OLT; OLW; OMC; ORT; OWB; QIH,"Drain, Tee (Water Trap); Calculator, Pulmonary Function Data; Monitor, Breathing Frequency; Ventilator, Continuous, Facility Use; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Electrocardiograph; Oximeter; Computer, Diagnostic, Programmable; Transmitters And Receivers, Physiological Signal, Radiofrequency; System, Signal Isolation; Pacemaker, Cardiac, External Transcutaneous (Non-Invasive); Amplifier And Signal Conditioner, Transducer Signal; Transducer, Blood-Pressure, Extravascular; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Adaptor, Lead Switching, Electrocardiograph; Electrode, Electrocardiograph; Cable, Transducer And Electrode, Patient, (Including Connector); Plethysmograph, Impedance; Recorder, Paper Chart; Recorder, Magnetic Tape, Medical; Detector And Alarm, Arrhythmia; Alarm, Blood-Pressure; Computer, Blood-Pressure; System, Balloon, Intra-Aortic And Control; Computer, Diagnostic, Pre-Programmed, Single-Function; System, Measurement, Blood-Pressure, Non-Invasive; Blood Pressure Cuff; Continuous Measurement Thermometer; Incubator, Neonatal; Guide, Surgical, Instrument; Guide, Needle, Surgical; Generator, Electroencephalograph Test Signal; Analyzer, Spectrum, Electroencephalogram Signal; Holder, Head, Neurosurgical (Skull Clamp); Monitor, Uterine Contraction, External (For Use In Clinic); Transducer, Pressure, Intrauterine; Transducer, Ultrasonic, Obstetric; System, Monitoring, Perinatal; Cable, Electrode; Transducer, Ultrasonic, Diagnostic; Cassette, Radiographic Film; Grid, Radiographic; Table, Radiographic, Tilting; Accelerator, Linear, Medical; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; System, X-Ray, Mobile; Collimator, Automatic, Radiographic; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Tomography, Computed; Plethysmograph, Photoelectric, Pneumatic Or Hydraulic; Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia; Instrument, Biopsy; Stimulator, Nerve, Peripheral, Electric; System, X-Ray, Stationary; Probe, Thermodilution; Tester, Electrode, Surface, Electrocardiographic; Dc-Defibrillator, Low-Energy, (Including Paddles); Aid, Cardiopulmonary Resuscitation; Monitor, Carbon-Dioxide, Cutaneous; System, Image Processing, Radiological; System, Nuclear Magnetic Resonance Imaging; System, Nuclear Magnetic Resonance Spectroscopic; Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Strip, Test Isoniazid; Automated External Defibrillators (Non-Wearable); Monitor, St Segment; Monitor, St Segment With Alarm; Coil, Magnetic Resonance, Specialty; Solid State X-Ray Imager (Flat Panel/Digital Imager); Bilirubin (Total And Unbound) In The Neonate Test System; System, Network And Communication, Physiological Monitors; System, Planning, Radiation Therapy Treatment; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Electrocardiograph, Ambulatory (Without Analysis); Marker, Radiographic, Implantable; Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration); Continuous, Ventilator, Home Use; Over-The-Counter Automated External Defibrillator; Catheter, Ultrasound, Intravascular; Non-Normalizing Quantitative Electroencephalograph Software; Index-Generating Electroencephalograph Software; Reduced- Montage Standard Electroencephalograph; Burst Suppression Detection Software For Electroencephalograph; Interventional Fluoroscopic X-Ray System; Automated Radiological Image Processing Software",1; 2; 3; U,"1.5T 16-CHANNEL HAND-WRIST COIL; 1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484; 1.5T AND 3T GENERAL PURPOSE FLEX COILS; 1.5T and 3T 16 CH GE Shoulder Coils; 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL; ACHIEVA 1.5T & INERA 1.5T FAMILY; ACHIEVA, INTERA AND PANORAMA 1T, RELEASE 2.5; ALLTECH ECHOSTAR 1.5 T MR SYSTEM; ALLURA XPER FD20; Achieva 1.5T, 3T and Intera 1.5T MR Systems; BIOPSY BREAST COIL, MODEL BBC; BIS EEG VISTA MONITOR SYSTEM AND BISX; BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM; BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160; CAPNOSTAT 5; CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16; CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM; CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376; CTL-63 AND CTL-128 SPINE ARRAY COILS; CX50 3 DIAGNOSTIC ULTRASOUND SYSTEM; CX50 DIAGNOSTIC ULTRASOUND SYSTEM; CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System; CX50 VERSION 2 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS; Cable, Electrode; ClearVue850 Diagnostic Ultrasound System; CombiDiagnost R90; DAUM BIOPSYGUN; DAUM BONE BIOPSY SET; DAUM DOUBLE-SHOOT BISOPSY GUN; DAUM MRI/CONVENTIONAL BIOPSY KIT; DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS); DL900 SERIES HOLTER RECORDER; DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium); DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L); DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3T; DURADIAGNOST; DigitalDiagnost C90; Drain, Tee (Water Trap); ECHELON OVAL MRI SYSTEM; EDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201; ENDOSONICS AUTOMATIC PULL BACK DEVICE; EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System; EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affin; EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affi; EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; EPIQ Diagnostic Ultrasound System; EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound Syste; EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30; EPIQ Series Diagnostic Ultrasound Systems; ESSENTIAL MRI PATIENT MONITOR; EXPRESSION MR200 MRI PATIENT MONITORING SYSTEM, EXPRESSION IP5 INFORMATION PORTAL; Expression MR400 MRI Patient Monitoring System; FUJI IP CASSETTE TYPE PC; FUJI ULTIMA EC-MA CASSETTE; GYROSCAN INTERA (R7.5); Grid, Radiographic; Guide, Needle, Surgical; Guide, Surgical, Instrument; HD11 DIAGNOSTIC ULTRASOUND SYSTEM; HD15 DIAGNOSTIC ULTRASOUND SYSTEM; HD7 DIAGNOSTIC ULTRASOUND SYSTEM; HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM; HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST; HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A; HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE; HILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A; HNC-63-INT NEUROVASCULAR ARRAY COIL; HRB-127-32 HIGH RESOLUTION BRAIN COIL; HRH-127-8 HEAD ARRAY COIL; HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM; HRH-63-8 HEAD ARRAY COIL; HRK-123 KNEE ARRAY COIL; HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL; HRK-63-8 KNEE ARRAY COIL; HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL; INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A; INTELLIVUE MX40 PATIENT MONITOR; INTELLIVUE PATIENT MONITOR; IU22 ULTRASOUND SYSTEM AND TRANSDUCERS; Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3; Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems; InnoSight Diagnostic Ultrasound System; IntelliVue Patient Monitor; K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60; K-DEFIB/PACE, MODEL KDP-60A; LBS-63-16 BREAST ARRAY COIL; LOFLO C5 CO2 SENSOR; Lumify Diagnostic Ultrasound System; Lumify Ultrasound System; M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540; M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN; MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL; MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS; MODEL BBC-127 BIOPSY BREAST COIL; MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE; MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR; MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS; MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS; MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS; MP5 INTELLIVUE PATIENT MONITOR; MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214; MRI PATIENT MONITORING SYSTEM (MODEL 865214); MobileDiagnost wDR 2.2; NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A; NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH; NVA-127-8-A NEUROVASCULAR ARRAY COIL; NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL; OBC-127 BREAST ARRAY COIL; OBC-250-PAN BREAST ARRAY COIL; P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil; PAGEWRITER CARDIOGRAPH; PANORAMA 1T; PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601; PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701; PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A; PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50; PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50; PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50; PHILIPS DUO DIAGNOST; PHILIPS EASY DIAGNOST; PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR; PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304; PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A; PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90; PHILIPS INTELLIVUE TCG10; PHILIPS IU22 ULTRASOUND SYSTEM; PHILIPS M5066A AND M5068A; PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER; PHILIPS PROGRADE; PHILIPS ELEVA WORKSPOT FOR DIGITAL DIAGNOST; POLYGEL ULTRASOUND GEL; PRACTIX CONVENIO; PUNCTURENEEDLE; PercuNav Image Fusion and Interventional Navigation; Philips CombiDiagnost R90; Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound Syst; Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System; Philips Lumify Diagnostic Ultrasound System; Pinnacle Radiation Therapy Planning System; Prodiva 1.5T CX and Prodiva 1.5T CS R5.4; ProxiDiagnost N90; QSC-127-INT SHOULDER ARRAY COIL SET; QSC-63-INT SHOULDER ARRAY COIL SET; QUADRATURE LOWER EXTREMITY COIL; QWH-250-PAN WRIST ARRAY COIL; RALCO, MODEL R225 ACS; RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER; SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645; SENSE MSK S 8CH 1.5T; SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS; SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING; SKINTACT ECG ELECTRODE; SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM; SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O; SURESIGNS VS3, SURESIGNS VS4; SYNERGY HEAD/NECK COIL; SyncVision System; THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS; TUMORLOCALIZER MRI; V-2200 INFANT INCUBATOR; VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51; VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS; VANTAGE TITAN, MODEL MRT-1504/S3; VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM; XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS; Xperius Ultrasound System; YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE; dS FootAnkle 16Ch Coils for 1.5T and 3T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3T, ds Small Extremity 16Ch Coil; dS FootAnkle I6CH 1.5T Coil; dS Small Extremity 16CH 1.5T Coil; dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T; ds Head 32ch 3T",2022-06-02,172,2021-12-23,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009077524%22&limit=1
Linvatec Corporation,1017294,1017294,11311 Concept Boulevard,Largo,FL,33773,United States,CONMED CORPORATION,1317214,Complaint file establishment; Contract manufacturer; Manufacturer; Repackager or relabeler; Specification developer,89,BYX; CAN; DZI; EQH; EQJ; ERL; FCW; FEM; FET; FMF; FRG; FSM; FST; FSY; FTL; FWZ; FXM; FXR; FYD; FZX; FZY; GAB; GAE; GAP; GAR; GAS; GAT; GAW; GAZ; GBX; GCJ; GCL; GCT; GCX; GDF; GDJ; GEA; GEI; GEN; GET; GEY; GFA; GFF; GFG; GYB; HAB; HAW; HBB; HBC; HET; HIF; HMX; HRX; HST; HSZ; HTJ; HTN; HTO; HTR; HTS; HTY; HTZ; HWC; HWE; HWQ; HWT; HWX; HXB; HXC; HXX; JDR; JOS; KCT; KDD; KFK; KQM; KYT; LXH; MAI; MBI; MDM; MNU; MOQ; NBH; NTN; ORQ; OWW; OWY; QWJ,"Tubing, Pressure And Accessories; Regulator, Pressure, Gas Cylinder; Drill, Bone, Powered; Source, Carrier, Fiberoptic Light; Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Light Source, Fiberoptic, Routine; Accessories, Photographic, For Endoscope (Exclude Light Sources); Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Syringe, Piston; Wrap, Sterilization; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Light, Surgical, Ceiling Mounted; Mesh, Surgical, Polymeric; Operating Room Accessories Table Tray; Camera, Still, Endoscopic; Holder, Camera, Surgical; Apparatus, Exhaust, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Needle, Suturing, Disposable; Snare, Surgical; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tubing, Noninvasive; Catheter, Irrigation; Laparoscope, General & Plastic Surgery; Esophagoscope, General & Plastic Surgery; Light Source, Endoscope, Xenon Arc; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Guide, Needle, Surgical; Clamp, Surgical, General & Plastic Surgery; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Motor, Surgical Instrument, Pneumatic Powered; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Media, Electroconductive; Saw, Powered, And Accessories; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Motor, Drill, Electric; Laparoscope, Gynecologic (And Accessories); Insufflator, Laparoscopic; Cannula, Ophthalmic; Arthroscope; Apparatus, Traction, Non-Powered; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Gauge, Depth; Washer, Bolt Nut; Reamer; Rasp; Knife, Orthopedic; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Passer; Template; Tap, Bone; Probe; Wrench; Screwdriver; Staple, Fixation, Bone; Electrode, Electrosurgical; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Saw, Pneumatically Powered; Camera, Surgical And Accessories; Light, Examination, Medical, Battery Powered; Orthopedic Manual Surgical Instrument; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Staple, Absorbable; Battery, Replacement, Rechargeable; Accessories, Arthroscopic; Led Light Source; Mesh, Surgical, Deployer; Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon; Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament",1; 2,"10K, Linvatec; 10k tubesets, 24k tubesets; 24K Irrigation; 24K Shaver sensor; 24K Tips Tubing Set; 3CCD EYECUP HEAD; 3DHD Light Guide; 3DHD Stereoscope System; 3DHD Video Cart, Coupler; 4K UHD Monitor; ABCFlex Flexible Endoscopy Probes; ACL CROSSPIN DRIVER; ACL CROSSPIN ROD; ACL DISPOSABLE KIT; ACROMIOPLASTY ELECTRODE; ADVANTAGE 2; AGGRESOR FORCEPS; AIrseal; ALLIGATOR GRASPER; APEX; APEX TUBING SET; ARC; ARGO KNOTLESS GENESYS PUNCH; ARTHOSCOPY SHEATH BODY; ARTHRO SCOPES QUICKLATCH; ARTHROSCOPE; ARTHROSCOPIC PISTON; ARTHROSCOPIC WRENCH; ARTHROSCOPY KNIFE, RETROGRADE; AUTOCLAVABLE TRAY; Ablator; Advantage Console; AirSeal; AirSeal Smoke Evac PLUS; AirSeal iFS; AnchorPort; AnchorPort SILK; Argo Knotless; Argo Knotless Anchor Kit; Argo Knotless GENESYS Anchor Kit; Argo Knotless Genesys Anchors; Artho Power Console; Artho Power Console with Irrigation Pump; Arthroscopy Cassette and Dual Spike; Articulating Arm; Aspen Gel; B-SCOOP FORCEPS; BADGER CANNULATED; BADGER DRILL BIT; BANANA KNIFE; BIO ANCHOR LOCATOR; BIO INSTABILITY BONE PUNCH; BIO INSTABILITY INTRUMENT TRAY; BIO INSTABILITY TAP; BIO-ANCHOR; BIO-ANCHOR DRILL GUIDE; BIO-ANCHOR DRIVER; BIO-STINGER-V; BIOANCHOR DRIVER; BIOANCHOR INSTRUMENT TRAY; BIOSCREW DRIVER; BIOSCREW FEMORAL SCREW; BIOSCREW INTERFERENCE SCREW; BIOSCREW TAP; BIOSCREW XTRALOK; BIOSTINGER; BLITZ SUTURE RETRIEVER; BLUNT FORCEPS; BONE TUNNEL SIZER; BREAKAWAY PINS; BULLSEYE; BULLSEYE AIMER; BULLSEYE GUIDE END PLUG; BULLSEYE TRAY; BUR BRUSH; Big Yank; Bio Mini-Revo; BioBrace Extra-Articular Ligament Augmentation Kit; BioBrace RC Delivery System; BioBrace Reinforced BioInductive Implant; BioBrace Reinforced Implant; BioBrace® Reinforced Implant; BioCuff TISSUE GRASPER; Bone Fixation; Broncho; C-SERTER; C-Wire; CANNUAL ADAPTER; CANNUAL SHAFT; CANNULA; CANNULA TIP; CANNULATED OBTURATOR; CEBOTOME BUR; CEBOTOME BUR EXTENSION; CEBOTOME BUR EXTENSION, SHORT; CEBOTOME METAL CUTTING BUR; CEBOTOME REVISION DRILL; CEBOTOME WRENCH; CHIP Camera; CIRCULAR RASP; CLAMP; CONCAVE RASP; CONCEPT CANNULATED INTERFERENCE SCREW; CONCEPT GRAFIX STRIPPER; CONCEPT GRASPER; CONCEPT LINEAR GASPER; CONCEPT SUTURE PASSER; CONCEPT VIDEO IMAGING SYSTEM; CONCEPT, GRAFIX; CONICAL OBTURATOR; CONMED Argo Knotless® Anchor; CONMED CrystalView; CONVEX RASP; CONVEX RESECTOR; COOLING BIN; CORTICAL GAUGE PUNCH; CRANIOPLATY BUR; CRESCENT HOOK; CRORSSFT PUNCH; CROSSFT TAP; CRUCIATE RECONST; CTS RELIEF KIT; CUFFED CURETTE; CUFFLINK; CYLINDRICAL BUR; Camera Head Eyecup; Camera Holder; Camera and Console; Cancellous Screw; Cannula; ConMed Mixing and Delivery Kit; Conmed; Contour Meniscus Arrow; Core; Cortical Screw; CrosFT Knotless; CrossFT; CrossFT Knotless; D4000 Drive System; D4000A-Drive System with Irrigation; DELUXE FORCEPS; DEPTH GUAGE; DERMABRADER; DIGIT TRAP; DRY-DOC CANNULA; DUAL STOPCOCK PRESSURE SENSING; Dispersive Electrode Adapters; Disposable Bipolar Cable; Double Armed Suture Needle; Dual Tank Gauge; E9000 BUR; E9000 BUR RACK; E9000 Console; E9000 Tubing set; EL BIO-INSTABILITY DRILL GUIDE; ELECTRODE; ELECTRODE BASIC KIT; ELECTRODE KIT; ENDOPEARL; ENDURA BUR; ENDURA CUDA; ENDURA GATOR; ENDURA RESECTOR; ENDURA VORTEX; ENHANCE Allograft Wedge Instrumentation Tray; EXOSHAPE; EXTENDED LENGTH CANNULA; EZ STITCH, HOOK; EZSTART; EZStart Interference Screw; EcoFlow; Electrode; Electronic Light Guide; Endoscopy Video Camera System; Endosite Digital; Excalibur; ExoShape; FEMORAL FOOTPRINT GUIDE; FEMORAL GUIDE; FENESTRATED CANNULA; FIXATION STRAP; FLAT WASHER; FLEX GUIDE WIRE; FLEXIBLE CANNULA; FLX-LITE; FOREARM STRAP; FULL HEMISPHERICAL REAMER; FULL RADIUS RESECTOR; GATOR MENISCUS CUTTER; GENESYS CROSSFT PUNCH; GENESYS MATRYX INTEREFERENCE SCREW TAP; GENESYS PRESSFT FLEX; GENESYS PRESSFT SUTURE ANCHOR; GRAFIX GRAFT INSTRUMENT TRAY; GRAFIX PREP TABLE; GRAFT GUIDE; GRAFT HARVESTING BLADE; GRAFT HARVESTING BLD; GRAFT TENSIONER; GRASPING FORCEPS; GUARDMAN GRAFT PROTECTOR; GUARDMAN INTERFERENCE SCREW; GUARDSMAN INTERFERENCE SCREW; Genesys CrossFT SUTURE ANCHOR; Genesys Matryx; GraftMax Button; Grasper; HALL; HALL 50 HANDPIECE; HALL BLADE OSCILLATING BLADE; HALL DRILL REAM ATTACHMENT; HALL LITHIUM BATTERY; HALL MICROFREE; HALL SAGITTAL BLADE; HALL SERIES 3 OSCILLATOR; HALL SERIES SAW BLADE; HD CARTRIDGE SCOPE; HD EYECUP CARTRIDGE LAPAROSCOPE; HD EYECUP LAPAROSCOPE; HD EYECUP SCOPE; HD Monitor; HD QUICKLATCH ARTHROSCOPE; HEX CANNULATED DRIVER; HEX FLEX CANNULA; HIP ARTHROSCOPY; HIP PRESERVATION SYSTEM; HIP PRESERVATION SYSTEM BANANA BLADE; HIP PRESERVATION SYSTEM NEEDLE PACK; HIP PRESERVATION SYSTEM STERLING GREAT WHITE; HOLDER PAD; HOSE ASSEMBLY; HOSE HANDLERS; HSW Laparoscopy Set; HYPERFLEX GUIDE WIRE; Hall Sterilization Tray; HandStand; Heatwave Electrode; HelixAR; HelixAR ABC System; IMPACT DRILL BIT; INFINITY; INFUSION ADAPTER; INSTABILITY POPLOK DRILL GUIDE; INSTABILITY TRAY; INSTILLING NEEDLE; INSTRUMENT CASE; INTREX BLADE; INTRUMENTS TRAY; IRRIGATION TUBING; Infinity; Infinity AIM; Irrigation Console 10K; K-WIRED; KATANA SUTURE CUTTER; LANZA; LEG STABILIZER; LIBERATOR KNIFE; LIGHT GUIDE; LOOPED KNOT PUSHER; Light Source; Lightwave Ablator; Linvatec Tube Set; Linvatec light source; Looking Glass Shelf; Looking Glass™; Low Impact; Luxtec; Luxtec MLX Light Source; M-CLASS OSCILLATING SAW BLADES; MENISCAL REPAIR NEEDLES; MENISCECTOMY ELECTRODE; MENISCUS ARROW; MENISCUS INSTRUMENT TRAY; MENISECTOMY ELECTRODE; MERLIN BENDER; MERLIN CUDA BLADE; MERLIN GATOR; MERLIN GREAT WHITE; MERLIN PREBENT; MERLING GREAT WHITE BENDABLE; MICRO 100 DRILL; MICRO 100 FOOT CONTROL; MICRO 100 OSCILLATOR SAW; MICRO 100 RECIPROCATOR SAW; MICRO 100 SAGITTAL SAW; MICRO 100 TUBING; MICRO 100 WIREDRIVER; MICRO DRIVER, MINOS BUR; MICRO MILL CUTTER; MICRO OSCILLATOR BLADE; MICRO RECIPRICATOR RASP; MICRO ROUND BUR; MICRO SAGITTAL BLADE; MICRO SCISSOR; MICRO SIDE CUTTING; MICRO TAPERED FISSURE BUR; MICROCHOICE; MICROCHOICE BUR GUARD; MICROCHOICE CONTROLLER; MICROCHOICE FOOT CONTROL; MICROCHOICE PIN DRIVER; MICROCHOICE POLE MOUNT; MICROCHOICE SHAVER HANDPIECE; MICROCHOICE STERN BLADE; MICROCHOICE UNIVERSAL DRILL; MICROCHOICE WIRE DRIVER; MICROCHOICE WIRE DRIVER DRILL; MICROFRACTURE AWL; MICROFREE; MICROLINK; MICROMITE DRILL; MICROMITE INSERTER; MICROMITE INSTRUMENT TRAY; MIN-REVO DRILL BIT; MINI -REVO DRIVER; MINI AGGRESSOR FORCEPS; MINI DRIVER HANDPIECE; MINI REVO BONE PUNCH; MINI REVO TAP; MINI- REVO DRIVER; MINI- REVO THREADER; MINI-REVO; MINI-REVO REMOVER; MINI-REVO SCREW; MINOS HANDPIECE; MOSQUITO GRASPER; MPOWER2 HANDPIECE; Micro; Micro Straight Side Cutting Bur; MicroLink; MicroPower; MicroPower Sagittal Saw; Mounting Brackets; NEXGEN OSCILLATOR BLADE; NITROGEN ADAPTER; NITROGEN CONNECTOR; NITROGEN COUPLER; NITROGEN HOSE; NITROGEN REGULATOR; NITROGEN TESTER; NURSES'S ASSISTANT; OSCILLATING BLADE; OSCILLATOR BLADE ME-92; OSTEON BUR; OSTEON HANDPIECE; OSTEON HOSE; OSTEOTOME; OVAL BUR; OrthoVAC; Osprey Drill; Osteoprep Sterilization Tray; PALADIN; PALADIN TAP; PERCUTANEOUS PISTON; PESSURE SENSING STOPCOCK SHEATH SET; PINN ACL DROSSPIN; PINN ACL GUIDE; POPLOK DRILL BIT; POPLOK PUNCH; POWERPRO; POWERPRO ATTACHMENT; POWERPRO BATTERY; POWERPRO BATTERY CHARGER; POWERPRO BATTERY FILTER; POWERPRO HIGH SPEED DRILL ATTACHMENT; POWERPRO KEYLESS ATTACHMENT; POWERPRO PNEUMATIC MODULAR HANDPIECE; POWERPRO PNEUMATIC OSCILLATOR HANDPIECE; POWERPRO REAMER ATTACHMENT; POWERPRO TRANSFER BATTERY CASE; POWERPROMAX DRIVER ATTACHMENT; POWERPROMAX TWO TRIGGER; PRESSFT; PRESSFT FLEX; PRIMECUT OSCILLATING BLADE; PROBE; PROBE ASSEMBLY; PROPEL INTERFERENCE SCREW; Paradigm; Paradigm All Suture Anchor; PenAdapt; Percutaneous Pack; Pin Index Yoke Mounted Valve; Pinn-ACL; Pinn-ACL TRAY; PlumePen; PopLok; Power Pro; PowerPro; PowerPro Attachments; PowerPro Battery; PowerPro Console; PowerPro Pneumatic; PowerPro Sterilization Case; Presto; Punch Removal; QUICK-CONNECT BLUNT OBTURATOR; QUICKLATCH ARTHROSCOPE; RASP; RASP LIBERATOR KNIFE; RAVEN SUTURE RETRIEVER; RCA MINI PLUG; RCR INSTRUMENT TRAY; REACT; REACT CUDA BLADE; RECIPROCATOR BLADE; RECTRIVAL FORCEPS; REPEAT STERNOTOMY SAW; RESTRAIN SET; RETRACTOR DRILL GUIDE; RETRACTOR GUARD; RETROGRADE FORCEPS; REVO; REVO BONE PUNCH; REVO DRILL BIT; REVO HOOK; REVO REMOVER; REVO REMOVER  MINI-REVO REMOVER  MINI-REVO REMOVER GUIDE; REVO SUTURE ANCHOR; RHINOTEC CUDA BLADE; RHINOTEC GATOR BENDABLE; RHINOTEC MICROXCISOR; RHINOTEC OVAL BURR; ROTATOR RASP; ROTATOR STERILIZATION TRAY; ROUND CUT CARBIDE BUR; Replacement Bulb; Resect Ablator Trident; Reusable Dispersive Electrode; Reusable Grounding Pad Cables; Reusable Pediatric Dispersive Electrode; SAGITTAL SAW; SAGITTAL SAW BLAD; SDI VIDEO CABLES; SENTINEL DRILL BIT; SEQUENT MENISCAL REPAIR; SHAVER BLADE DE-CLOGGER; SHUTT MASTER SET; SIDE CUT CARBIDE BUR; SINGLE JAW GRASPER; SLOTTED CANNULA; SMARTNAIL; SMARTNAIL ARTHROSCOPIC PISTON; SMARTNAIL PERCUTANEOUS TIP; SMARTPIN; SMARTPIN DRILL BIT; SMARTPIN K-WIRE; SPECTRUM II ROLLER WHEE; SPHERICAL BUR; SST FORCEPS; STABILIZER BALL; STANDARD SCISSOR; STAPLE CARRIER; STAPLE PRY; STAPLER SEATER; STAPLIZER CARTRIDGE; STAPLIZER HANDPC; STERLING CUDA; STERLING DRAGON; STERLING GATOR; STERLING OVAL BUR; STERLING REACT; STERLING VORTEX; STERNOTOMY BLADE; STERNUM SAW BLADE; STERNUM SAW HANDPIECE; STOPCOCK DOUBLELATCH BRIDGE; STOPCOCK SHEATH; STRESS POST; STRYKER OSCILLATING SAW BLADE; STRYKER SAGITTAL BLADE; SUPER REVO; SUPER REVO DRIVER; SUPER REVO GUIDE; SUPER REVO SUTURE ANCHOR; SUTURE PASSER; SmartGuard Irrigator; SmartNail; Smartnail; Smartpin; SnapEvac; Spectrum Instrument Tray; Spiked Washer; Staplizer Drill Guide; Sternum Saw guard; Super RevoFT SUTURE ANCHOR; Surgairtome II BUR GUARD; Surgairtome Two Handpiece; SurgiQuest DuoPort; SurgiQuest Laparoscope; Surgical Camera; Suture Loop Hi-Fi; Suture Snare; System 7550 ABC ESU; THROTTLE CLIP; TIBIAL PIN GUIDE; TRACTION TOWER; TRANSFER BATTERY CASE; TRANSFER CHARGE PLATFORM; TUBING SET; TUNNEL DILATOR; TenoLok; TenoLok Dual Expanding Tenodesis Anchor; TenoLok Tenodesis Kits; ThRevo Anchor; Trident Ablator; TruShot with Y-Knot; True HD 3MOS Camera System; Tubing; Tubing Set Gravity; ULTRACUT; ULTRACUT PREBENT; ULTRAFIX; ULTRAFIX DRILL; ULTRAFIX DRILL GUIDE; ULTRAFIX INSTRUMENT TRAY; ULTRAFIX Micromite; ULTRAFIX Minimite; ULTRAFIX Stitchpak; ULTRAFIX TAP; ULTRAGATOR; ULTRAGATOR SHAVER BLADE; ULTRAOWER DRILL W/O HOSE; ULTRAOWER PERFORATOR DRIVE W/O HOSE; ULTRAPOWER BUR; ULTRAPOWER HI-SPEED DRILL; ULTRAPOWER WRENCH; UNIVERSAL CABLE; UNIVERSAL HOSE; UPPERARM STRAP; USB PRINTER CABLE; UltraPower; Universal Cart Strap; Universal Modular Base Cart; Universal Modular Cart Cord Wraps; UtraAblator; VERSIPOWER PLUS BATTERY; VORTEX PRE BENT; VORTEX, MICROBLADE; VP1003 Video Extended Length Tray (RADEL); VP1005 Video Tray Single Level (RADEL); VP1006 Video Arthroscope Tray (RADEL); VP1007 Video Laparoscope Tray (RADEL); Valve with Hoses and Mounting Bracket; Viking; WEDGES; WIRE PASS DRILL; WIRED DRIVER BRUSH; WIREDRIVER 100 CHUCK ADAPTOR; WIREDRIVER GUARD; WIREDRIVER WIRE GUARD; XO BUTTON; XO BUTTON HOLDER; Y-KNOT; Y-KNOT ALL SUTURE ANCHOR; Y-KNOT DRILL BIT; Y-KNOT DRILL GUIDE; Y-KNOT FLEX ALL SUTURE ANCHOR; Y-KNOT FLEX DRILL BIT; Y-KNOT FLEX DRILL GUIDE; Y-KNOT FLEX OBTURATOR; Y-KNOT FLEX PERCUTANEOUS PACK; Y-KNOT PUNCH; Y-KNOT RC ALL-SUTURE ANCHOR; Y-Knot; Y-Knot OneStep Anchor; Y-Knotless™ Flex Anchors; YKnot TruShot; ZEN WIRELESS FOOTSWITCH; ZONE II CANNULA; ZONE SPECIFIC INSTRUMENT TRAY; Zone Specific AIM; cable; core; eLUma; hRevo-FT SUTURE ANCHOR; iFS Cart 6"" Bottle with Valve; iFS Cart with Valve; iFS Cart with Valve and two Bottle Racks; iFS House Gas Switching Valve; linvatec; puddle vac",1992-07-22,172,2026-05-13,0,35,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221017294%22&limit=1
"SunMed Group Holdings, LLC",1314417,1314417,2710 Northridge Dr NW Ste A,Grand Rapids,MI,49544,United States,"SunMed Group Holdings, LLC dba AirLife",10044795,Complaint file establishment; Contract manufacturer; Manufacturer; Repackager or relabeler; Reprocessor; Specification developer,132,BRW; BSB; BSJ; BSK; BSR; BSY; BTC; BTK; BTL; BTM; BTO; BTQ; BTR; BTT; BTY; BWF; BXJ; BXN; BYD; BYE; BYF; BYG; BYH; BYI; BYP; BYX; BYY; BZA; BZB; BZC; BZD; BZE; BZO; BZQ; BZR; BZS; CAE; CAF; CAH; CAI; CAP; CAT; CAX; CBC; CBH; CBI; CBK; CBP; CCK; CCQ; CCW; CCX; DPS; DQA; DQE; DXQ; EFW; EOQ; EXG; EZL; FFK; FLL; FMT; FPA; FQZ; FRL; FRN; FRO; FSM; GAJ; GAX; GAZ; GBX; GCX; GCY; GDJ; GDY; HGD; HLJ; HOY; HTD; IPM; IQE; IYT; JAY; JEH; JOH; JOL; JXL; KAE; KAK; KCT; KDH; KER; KFZ; KGB; KGX; KMK; KNH; KNT; KNX; KPD; KPJ; KPY; KXF; KYZ; KZD; LDE; LGZ; LHI; LRP; LSZ; LYU; MMO; MNR; NFB; NHK; NKC; NSB; NVP; OEV; OFO; OFP; OFS; OGG; OGL; OJU; OKI; OLO; OYI; QOP; QOV,"Protector, Dental; Warmer, Blood, Non-Electromagnetic Radiation; Mask, Gas, Anesthetic; Cuff, Tracheal Tube, Inflatable; Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Bag, Reservoir; Strap, Head, Gas Mask; Ventilator, Emergency, Powered (Resuscitator); Ventilator, Emergency, Manual (Resuscitator); Tube, Tracheostomy (W/Wo Connector); Airway, Nasopharyngeal; Tube, Tracheal (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Calculator, Predicted Values, Pulmonary Function; Spirometer, Therapeutic (Incentive); Clip, Nose; Stimulator, Nerve, Battery-Powered; Condenser, Heat And Moisture (Artificial Nose); Attachment, Breathing, Positive End Expiratory Pressure; Mask, Oxygen, Low Concentration, Venturi; Mask, Oxygen; Drain, Tee (Water Trap); Percussor, Powered-Electric; Mouthpiece, Breathing; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Connector, Airway (Extension); Catheter, Nasal, Oxygen; Calculator, Pulmonary Function Data; Ventilator, Non-Continuous (Respirator); Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer; Set, Tubing And Support, Ventilator (W Harness); Monitor, Breathing Frequency; Mixer, Breathing Gases, Anesthesia Inhalation; Stethoscope Head; Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Monitor, Airway Pressure (Includes Gauge And/Or Alarm); Cannula, Nasal, Oxygen; Flowmeter, Tube, Thorpe, Back-Pressure Compensated; Bottle, Collection And Trap, Breathing System (Uncalibrated); Device, Fixation, Tracheal Tube; Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector); Ventilator, Continuous, Facility Use; Valve, Non-Rebreathing; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Laryngoscope, Rigid; Support, Patient Position; Electrocardiograph; Oximeter; Catheter, Oximeter, Fiber-Optic; Blood Pressure Cuff; Toothbrush, Manual; Bronchoscope (Flexible Or Rigid); Bag, Urine Collecting, Ureterostomy; Catheter, Retention Type, Balloon; Lithotriptor, Electro-Hydraulic; Continuous Measurement Thermometer; Warmer, Infant Radiant; Set, Administration, Intravascular; Thermometer, Clinical Color Change; Fiber, Medical, Absorbent; Pump, Infusion; Dressing, Wound, Drug; Tray, Surgical, Instrument; Stripper, Vein, Disposable; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Irrigation; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Clamp, Surgical, General & Plastic Surgery; Gauze/Sponge, Internal, X-Ray Detectable; Applicator, Vaginal; Ophthalmoscope, Battery-Powered; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Forceps; Cover, Limb; Orthosis, Lumbar; System, Rebreathing, Radionuclide; Support, Breathing Tube; Plethysmograph, Volume; Tube Tracheostomy And Tube Cuff; Catheter And Tip, Suction; Block, Bite; Forceps, Ent; Probe, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration; Container, Embedding; Humidifier, Non-Direct Patient Interface (Home-Use); Mask, Oxygen, Non-Rebreathing; Tape And Bandage, Adhesive; Device, Intravascular Catheter Securement; Laparoscopic Contraceptive Tubal Occlusion Device; Tubes, Gastrointestinal (And Accessories); Collector, Urine, (And Accessories) For Indwelling Catheter; Strip, Temperature, Forehead, Liquid Crystal; Chamber, Oxygen, Topical, Extremity; Shield, Protective, Personnel; Applicator, Absorbent Tipped, Non-Sterile; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Stethoscope, Manual; Warmer, Thermal, Infusion Fluid; Set, I.V. Fluid Transfer; Tray, Surgical; Ventilator, High Frequency; Accessory, Surgical Apparel; Tray, Surgical, Ent; Ventilatory Effort Recorder; Conserver, Oxygen; Resuscitator, Manual, Non Self-Inflating; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Patient Personal Hygiene Kit; Holding Chambers, Direct Patient Interface; Cardiopulmonary Resuscitation Aid Kit; Airway Suction Kit; Anesthesia Breathing Circuit Kit (Adult & Pediatric); Tracheal Suction Set; Humidifier Nebulizer Kit; Oxygen Administration Kit; Skin Prep Tray; Emergency Response Safety Kit; Orthopedic Stereotaxic Instrument; Non-Bronchoscopic Bronchoalveolar Lavage Catheter; Respiratory Humidifier For Emergency Use; Critical Care Ventilator",1; 2; 3; N; U,"""Blue"" Latex Robertazzi Nasopharyngeal Airway; 1200 Infusion System; 500 Series Nebulizer; 8570127 (EOL) Unifilter S (Bulk), 557051200 (EOL) Y-filter Plus Edith 1000; ACCESSORY, SURGICAL APPAREL; AMBU CO2 Easy; AMBU Pedi CO2 Easy; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED; APPLICATOR, VAGINAL; Absorbent Medical Fiber; Adapter Trach T; Adapters And Connectors (Ventilation Accessories); Adhesive Tape and Bandage; Adult 7 FT Oral Nasal Cannual; Aerial MDI Spacer; Air-Q3; AirFlow Resuscitator; AirLife Bubble Humidifier; AirLife GSL; Airlife Infant Skin Temp Probe; Airlife Nebulizer; Airway suction kit; Aluminum Disposable Stylette; Aluminum Stylette; Ambu Hyperinflation System; Anesthesia breathing circuit kit (adult & pediatric); Aspirator; Attachment, breathing, positive end expiratory pressure; BAG, URINE COLLECTING, URETEROSTOMY; BL; BOTTLE, COLLECTION AND TRAP, BREATHING SYSTEM (UNCALIBRATED); Ballard Metered Dose Inhaler (MDI) Adapter; Ballard Single Dose Vials, 0.9% Sodium Chloride Solution; Berman Oropharyngeal Airway; Bio-Back; Bite; Blade, Laryn, Vs, Plastic, Mac 2; Blade, Laryn, Vs, Plastic, Mil 2 & 3; Block; BlockAid Pulmonary Function Filter; Breath Tech Mask; BreathTech BV Filter; BreathTech HME; BreathTech Hyperinflation System; BreatheRite MDI Spacer; Breathing Tube Support; Bronchoscope; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION; CALCULATOR, PULMONARY FUNCTION DATA; CANNULA, NASAL, OXYGEN; CATHETER AND TIP, SUCTION; CATHETER, IRRIGATION; CATHETER, NASAL, OXYGEN; CATHETER, RETENTION TYPE, BALLOON; CATHETERS, SUCTION, TRACHEOBRONCHIAL; CO2 Easy; CONDENSER, HEAT AND MOISTURE; CONNECTOR, AIRWAY; CONTAINER, EMBEDDING; Cannula Crvd N-flr Tip W/o Tb Disp; Cannulas Etco2; Cannulas O2; CapnoVue Masks; Cardiopulmonary resuscitation aid kit; Circuit, Breathing (W connector, adaptor, Y piece); Circuit, breathing (w/ connector, adapter, y piece); Circuits Anesthesia; Circuits Heated Wire; Clarity Infu-Surg Pressure Infusion Bag; Co2 Easy Ped; Coated Stylette; Combi-Port IV Bag Spike; Combiguard; Conserver, oxygen; Conventional Disposable Laryngoscope Blade; Conventional Disposable Laryngoscope Handle; Conventional Laryngoscope Blade; Conventional Laryngoscope Handle; Critical care ventilator; Cuff Sentry; Cyberwand Lithotripter with Sterile Probes; DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR; DEVICE, FIXATION, TRACHEAL TUBE; DRAIN, TEE (WATER TRAP); Dental Protector; Detectable Gauze; Disposable blood pressure cuff; Double Lumen Endobronchial Tube, Parker; Parker Standard Tip Endobronchial Tube; Dressing, wound, drug; E-Z Airway Laryngeal Mask; ENT Forceps; ET Tube Introducer; ETCO2 Cannula; ETHOX GASTRIC LAVAGE KIT; Emergency response safety kit; End Tidal CO2 Cannula; Endobronchial Tube; Endotracheal Tube; Etco2 Cannula 7' U/connect-it Adult,male; Ethox TUM-E-VAC Gastric Lavage Tubes; Eye Protector; FLEXTUBES; FLOCAP; FRB-30; Face Mask Neonate and Infant Disposable; Fiber Optic Laryngoscope Blade; Fiber Optic Laryngoscope Handle; Fiber Optic Stylette; Filter, bacterial, breathing-circuit; Filters, M1010541 Angled Uni-Filters/S; Finger Pulse Oximeter; Flex Tip (PFTVPUS); Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff & Stylet (PFTVVCS);; Flow Meter; Foley Catheter; Forceps; Genesis Low Temperature Reusable Rigid Container System; Genesis Reusable Rigid Container System; GreenLine® Disposable Fiber Optic Laryngoscope Blade; GreenLine® Disposable Fiber Optic Laryngoscope Handle; GreenLine® Fiber Optic Laryngoscope Blade; GreenLine® Fiber Optic Laryngoscope Handle; GreenLine®/D™ Fiber Optic Laryngoscope Blade; GreenLine®/D™ Fiber Optic Laryngoscope Handle; GreenLine®/D™ LED Conventional Laryngoscope Handle; GreenLine®/D™ LED Disposable Laryngoscope Handle; GreenLine®/D™ LED Laryngoscope Blade; Guedel Oropharyngeal Airway; HEART Nebulizer; HEATER, BREATHING SYSTEM W/WO CONTROLLER; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER; HMEF 1000, M1038637, M1010534, 8570230, 8570203, 557085500, 557071600, 557071500, 557050200 (EOL), 557019500; HMEF 500, 557070700, 557070500; HMEF 750, M1038639, M1010538, M1005260, M1004132; HMEF Mini/s; HUMIDIFIER, RESPIRATORY GAS; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE); Hollow Copper Stylette; Humidifier nebulizer kit; Humidifier, bubble, w/3PSI pop-off - 50/cs; Humidifiers Heated; IGuard; IV Catheter Securement; Infu-Surg Pressure Infusion Bag; InfuseOne Pressure Infusion Bag; InspiRx; Integrity Pressure Infusion Bag; Latex Free Adjustable Flange Nasopharyngeal Airway; Latex Free PVC Nasopharyngeal Airway; Latex Free Robertazzi Nasopharyngeal Airway; Lavage Tube; Lighted Stylette; M1003346 Uni-Filter Junior, M1003345 Uni-Filter Mini, 557022500 Uni-Filter/S, 557021200 U-Filters; MASK, GAS, ANESTHETIC; MASK, OXYGEN, LOW CONCENTRATION, VENTURI; MAXCAP; MAXCAP Neo; MAXCAP Ped; MONITOR, AIRWAY PRESSURE; MOUTHPIECE, BREATHING; Magill Closed Tip Forceps; Magill Open Tip Forceps; Malleable Introducer; Manual Pulmonary Resuscitator; Manual Resuscitator /w PEEP Valve; Mask Aerosol Hi-concent Disp Under Chin; Mask Air Entrain Adult W/u-connect-it; Mask Face Tent Disp; Masks Non-Invasive Full Face And Nasal; MedLine HME Filter; Medline BV Filter; Medline HME; Medline Supersoft Adult Co2 Cannula; MiniHEART Nebulizer; Mixer, breathing gases, anesthesia inhalation; Mouthpiece Universal Poly Disp; NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER); NO MES; Nebulizer; Nebulizers Large Volume Prefilled And Dry; Non-bronchoscopic bronchoalveolar lavage catheter; Nose Clip; Nox Medical Filter; O2 Delivery Adapters And Connectors; O2Boot; O2Sacral; Ophthalmoscope; Owens&Minor Breathing Circuit with Ventlab B/V Filter; Oxygen Cannula; Oxygen Mask; Oxygen Masks; Oxygen Tubing; Oxygen administration kit; PERCUSSOR; PFT Filters; PVC Guedel Oropharyngeal Airway; PVC Stylette; Parker Flex-it Directional Stylet; Parker Intubating Stylet, sheathed (STLT); Parker Laryngeal Mask, disposable, silicone; Parker Laryngeal Mask, Disposable, Wire Reinforced; Parker Nasopharyngeal Airway with Parker Flex-tip; Patient Circuits And Accessories Non-Heated; Patient personal hygiene kit; Peak Flow Meter; Ported ET Tube Introducer; Post-Op Socks; PressureChek; Protective Shield; Pulse Oximeter; Reservoir Bag; Respiratory humidifier for emergency use; Resuscitation Bags Flow-Inflating; SPIROMETER, THERAPEUTIC; STAT-Check II CO2 Indicator; STAT-Check Resuscitator; STRAP, HEAD, GAS MASK; STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL; SUPPORT, PATIENT POSITION; Salter Humidifier; Salter Labs 8900 Series Small Volume Jet Nebulizer; Salter Labs Bubble Humidifier; Salter Labs NebuTech HDN Reusable Nebulizer; Salter Labs Nebulizer Exhalation Filter, 8980 Series; Skin prep tray; Soft-Aire Mask; Solid Copper Stylette; Stainless Steel Stylette; Sterile Water for Inhalation; Stethoscope; Stethoscope Head; SunGlide Stylette; SunMed SafeT T-piece Resuscitator; SunOne™ System Laryngoscope Blade; SunOne™ System Laryngoscope Handle; SunSlip Stylette with Sheath; SunStim; SunStim Plus; Superno2va Nasal Interface; Surgi-Kit; Surgi-Press; Surgical Clamp; Surgical Instrument Tray; System, rebreathing, radionuclide; THERMOMETER, CLINICAL COLOR CHANGE; TIS-1200 Thermacor; TOOTHBRUSH, MANUAL; TRAY, SURGICAL; TUBE, ASPIRATING, FLEXIBLE, CONNECTING; TUBING, NONINVASIVE; Thermal Angel; Thermometer, electronic, clinical; Tongue Seizing Forceps; Tourniquet; Trach-Vac Endotracheal Tube with Flex Tip/PVC cuff (PFTVVC); Tracheal suction set; Tracheostomy Tube; Traditional Guedel Oropharyngeal Airway; Tube Tree; Tube tracheostomy and tube cuff; Tube, tracheal; Tubes, gastrointestinal (and accessories); Tubing/tubing with filter, insufflation, laparoscopic; Uni-Heart; Urine Collector and Accessories for Indwelling Catheter; VARIABLE NEBULIZER HEATER; VCare Resuscitator; VENTILATOR, HIGH FREQUENCY; VENTILATOR, NON-CONTINUOUS (RESPIRATOR); Valve, non-rebreathing; Vein Stripper; Vent Mask; Vent Mask II; Ventilator Set; Ventilator, emergency, manual; Ventilator, emergency, manual (resuscitator); Ventilator, non-continuous; Ventlab 6000 Series Humidifier; Ventlab BV Filter; Ventlab Co2 Cannula; Ventlab HME; Ventlab Hyperinflation System; Ventlab Nasal CPAP Interface; Ventlab Oxygen Mask; Ventlab PEEP Valve; Ventlab Pressure Infusion Bag; Ventlab Pressure Tubing and Accessories; Verify II; Vital Signs Pressure Infuser; Vital Signs™ cardiac output Probe; VixOne; Water Solutions Saline And Sterile; WaterPAP; Westmed Anesthesia Masks; Westmed Breathing Circuits; Westmed GSL; Westmed GSL (Salter); Williams Oropharyngeal Airway; Wound Flash, Sterile Water & Normal Saline; Zefon InfuseIT Pressure Infusion Bag; tube, tracheal (w/wo connector) - EasyCurve Endotracheal tube, articulating cord, cuffed (PFEC); Endotrachael Tube, High; tube, tracheal (w/wo connector) - Salter Labs Trach-Vac Endotracheal Tube; Trach-Vac Endotracheal Tube with",2013-08-01,171,2024-11-12,1,26,5,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221314417%22&limit=1
Boston Scientific Corporation,3005099803,3005099803,100 Boston Scientific Way,Marlborough,MA,01752,United States,Boston Scientific Corporation,9912058,Complaint file establishment; Specification developer,114,BTG; BWH; EOQ; ESW; EYB; EYK; EZB; EZN; EZY; FAD; FAE; FAJ; FBK; FBN; FCG; FCL; FDF; FDI; FDS; FDT; FDX; FED; FEM; FEQ; FET; FFA; FFD; FFK; FFL; FFY; FGA; FGB; FGD; FGE; FGO; FGX; FHN; FHQ; FHW; FPD; FQH; FYA; GAZ; GBA; GBM; GBO; GBZ; GCA; GCC; GCJ; GEI; GEX; HIG; ITX; IYE; IYO; JCT; JCW; KDQ; KGC; KGE; KME; KNQ; KNS; KNT; KOA; KOD; KOE; KOH; KQM; KQT; KTI; KYZ; LJE; LJH; LQC; LQR; LTI; LZC; MAV; MDM; MND; MNK; MNL; MQR; MUM; NTN; NWT; OCW; OCX; OCY; ODC; ODD; ODG; OHD; OOY; OTM; OTN; OTO; OVB; PAH; PCU; PID; PIF; PKL; PLL; PNB; PTM; PTS; PWI; PWJ; QGA; QGD; QTD,"Brush, Biopsy, Bronchoscope (Non-Rigid); Forceps, Biopsy, Bronchoscope (Non-Rigid); Bronchoscope (Flexible Or Rigid); Prosthesis, Esophageal; Catheter, Ureteral, Gastro-Urology; Connector, Ureteral Catheter; Stylet For Catheter, Gastro-Urology; Dilator, Catheter, Ureteral; Device, Incontinence, Mechanical/Hydraulic; Stent, Ureteral; Prosthesis, Penile; Cystoscope And Accessories, Flexible/Rigid; Endoscopic Injection Needle, Gastroenterology-Urology; Choledochoscope And Accessories, Flexible/Rigid; Biopsy Needle; Forceps, Biopsy, Non-Electric; Colonoscope And Accessories, Flexible/Rigid; Snare, Flexible; Gastroscope And Accessories, Flexible/Rigid; Duodenoscope And Accessories, Flexible/Rigid; Endoscopic Cytology Brush; Endoscopic Access Overtube, Gastroenterology-Urology; Accessories, Photographic, For Endoscope (Exclude Light Sources); Pump, Air, Non-Manual, For Endoscope; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Tube, Drainage, Suprapubic; Evacuator, Bladder, Manually Operated; Lithotriptor, Electro-Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Adaptor, Bulbs, Miscellaneous, For Endoscope; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Catheter, Retention, Barium Enema With Bag; Stents, Drains And Dilators For The Biliary Ducts; Dislodger, Stone, Flexible; Snare, Non-Electrical; Ligator, Hemorrhoidal; Holder, Needle, Gastroenterologic; Device, Impotence, Mechanical/Hydraulic; Tube, Feeding; Lavage, Jet; Gown, Surgical; Tubing, Noninvasive; Catheter, Balloon Type; Catheter, Urethral; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Cholangiography; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Dilator, Catheter; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Insufflator, Hysteroscopic; Transducer, Ultrasonic, Diagnostic; Accelerator, Linear, Medical; System, Imaging, Pulsed Echo, Ultrasonic; Prosthesis, Tracheal, Expandable; Prosthesis, Penis, Inflatable; Bottle, Collection, Vacuum; Tube, Gastro-Enterostomy; Forceps, Biopsy, Electric; Bedding, Disposable, Medical; Dilator, Esophageal; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Surgical Instruments, G-U, Manual (And Accessories); Catheter, Urological; Dilator, Urethral; Instrument, Manual, General Obstetric-Gynecologic; Camera, Surgical And Accessories; Evacuator, Gastro-Urology; Bronchoscope Accessory; Syringe, Irrigating (Non Dental); Catheter, Nephrostomy; System, Irrigation, Urological; Lithotriptor, Biliary Mechanical; Dislodger, Stone, Biliary; Implant, Intragastric For Morbid Obesity; Medical Glove, Specialty; Syringe, Balloon Inflation; Instrument, Manual, Surgical, General Use; Ligator, Esophageal; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Stent, Colonic, Metallic, Expandable; Stent, Metallic, Expandable, Duodenal; Led Light Source; Endoscopic Cholangiogram Kit; Endoscopic Tissue Approximation Device; Endoscopic Irrigation/Suction System; Endoscopic Guidewire, Gastroenterology-Urology; Endoscope Channel Accessory; Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula; Endoscopic Ultrasound System, Gastroenterology-Urology; Gynecological Laparoscopic Kit; Bronchial Thermoplasty System; Mesh, Surgical, For Stress Urinary Incontinence, Male; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator; Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed; Hydrogel Spacer; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling; Pancreatic Stent, Covered, Metallic, Removable; Esophageal Dilator Balloon With Or Without Electrode Sensors; Gastrointestinal Tubes With Enteral Specific Connectors; Hemostatic Metal Clip For The Gi Tract; Submucosal Injection Agent; Biliary Stent System For Benign Strictures; Syringe, Balloon Inflation, Exempt; Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt; Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse; Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence; Penile Implant Surgical Accessories; Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories; Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss",1; 2; 3; U,AMS 700 with Inhibizone; AMS 700 without Inhibizone; AMS 800 with Inhibizone; AMS 800 without Inhibizone; Alair Bronchial Thermoplasty Catheter; Alair Bronchial Thermoplasty Controller; Alair RF Controller Accessory Kit; Ambicor; Colpassist Vaginal Positioning Device; Connecting Tube; Connector Drainage Bag Connector; Connector Ureteral Catheter Connector; Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter; Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit; Flexima Nephrostomy Catheter System; Flexima Nephrostomy Catheter System Kit; Flexima Nephrostomy Catheter System Kit with Dissolving Tip; Flexima Nephrostomy Catheter System with Dissolving Tip; JINRO Pigtail Nephrostomy Catheter; JINRO Pigtail Nephrostomy Catheter Kit; JINRO Pigtail Nephrostomy Catheter Placement Kit; Malecot Nephrostomy Catheter Set; NaviGuide Percutaneous Access Needle; ORBERA Intragastric Balloon; Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip; Percuflex Locking Loop Nephrostomy Catheter; Percuflex Locking Loop Nephrostomy Catheter with Fader Tip; Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit; Percutaneous Access Needle; Percutaneous Access Needle with Echogenic Tip; Percutaneous Access Set; Pneumatic Inflator; Re-entry Malecot Nephrostomy Catheter Set; Stone Cone Nitinol Urological Retrieval Coil; TLA Introducer Needle and Sheath Set; Trapezoid RX Wireguided Retrieval Basket; Ureteral Stent Positioners; Urovac Bladder Evacuator; VTC Nephrostomy Catheters System; VTC Nephrostomy Catheters System Kit,1992-07-22,167,2026-09-11,4,82,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223005099803%22&limit=1
Stryker Endoscopy,2936485,2936485,5900 Optical Ct,San Jose,CA,95138,United States,STRYKER CORP.,1811755,Complaint file establishment; Manufacturer; Repackager or relabeler; Specification developer,110,BYX; BZN; EBA; EOB; EPT; EQH; ERL; FAJ; FAS; FCS; FCW; FCZ; FDC; FED; FEM; FET; FFS; FFY; FGB; FGO; FOX; FQO; FSM; FSS; FST; FSZ; FWB; FXM; FZX; GAD; GAT; GBZ; GCJ; GCX; GDZ; GEI; GEN; GES; GFA; GFF; GFG; GWG; HET; HIF; HIG; HIH; HRQ; HRR; HRT; HRX; HST; HTD; HTF; HTJ; HTR; HTS; HTW; HTY; HTZ; HWC; HWD; HWJ; HWQ; HWX; HXB; HXD; HXG; HXK; HXX; HXZ; IZI; JAA; JDR; JDW; JEB; JOL; KCT; KDD; KMA; KNF; KNS; KQM; KQT; KZD; LGZ; LJH; LLZ; LMB; LMD; LRO; MAI; MBI; MMP; NAY; NBH; NEU; NKC; NVT; NWB; OCW; OCZ; OLC; OSV; OWN; PTQ; PUI; PXN; QIH; QPQ; SIT,"Tubing, Pressure And Accessories; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Light, Surgical Headlight; Nasopharyngoscope (Flexible Or Rigid); Microscope, Surgical; Source, Carrier, Fiberoptic Light; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Cystoscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Light, Catheter, Fiberoptic, Glass, Ureteral; Light Source, Fiberoptic, Routine; Tube, Smoke Removal, Endoscopic; Resectoscope, Working Element; Endoscopic Access Overtube, Gastroenterology-Urology; Accessories, Photographic, For Endoscope (Exclude Light Sources); Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Image, Illumination, Fiberoptic, For Endoscope ; Adaptor, Bulbs, Miscellaneous, For Endoscope; Ureteroscope And Accessories, Flexible/Rigid; Dislodger, Stone, Flexible; Stand, Infusion; Table, Operating-Room, Ac-Powered; Tray, Surgical, Instrument; Light, Surgical, Floor Standing; Light, Surgical, Fiberoptic; Light, Surgical, Carrier; Camera, Television, Surgical, Without Audio; Camera, Still, Endoscopic; Guide, Surgical, Instrument; Retractor; Suture, Nonabsorbable, Synthetic, Polyethylene; Catheter, Cholangiography; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Handle, Scalpel; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Blade, Scalpel; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Endoscope, Neurological; Laparoscope, Gynecologic (And Accessories); Insufflator, Laparoscopic; Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Hemostat; Scissors, Orthopedic, Surgical; Stripper, Surgical; Arthroscope; Apparatus, Traction, Non-Powered; Forceps; Curette; Gauge, Depth; Rasp; Knife, Orthopedic; Bit, Drill; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Screw, Fixation, Bone; Starter, Bone Screw; Awl; Passer; Tap, Bone; Probe; Clamp; Tamp; Holder, Needle; Orthopedic; Screwdriver; Cutter, Wire; System, X-Ray, Angiographic; System, X-Ray, Fluoroscopic, Image-Intensified; Staple, Fixation, Bone; Pin, Fixation, Threaded; Table, Surgical With Orthopedic Accessories, Manual; Catheter And Tip, Suction; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Irrigator, Powered Nasal; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Camera, Surgical And Accessories; Evacuator, Gastro-Urology; Infusor, Pressure, For I.V. Bags; Warmer, Thermal, Infusion Fluid; System, Irrigation, Urological; System, Image Processing, Radiological; Device, Digital Image Storage, Radiological; System, Digital Image Communications, Radiological; General Surgery Tray; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Cover, Barrier, Protective; System, Surgical, Computer Controlled Instrument; Accessories, Arthroscopic; Marker, Radiographic, Implantable; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Tubing And Tubing/Filter Fits; Endoscope, Accessories, Narrow Band Spectrum; Endoscopic Tissue Approximation Device; Endoscopic Grasping/Cutting Instrument, Non-Powered; Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen; Insufflator, Endoscopic Vessel Harvesting; Confocal Optical Imaging; Endoscopic Magnetic Retriever, Exempt; Drape, Surgical, Exempt; Basic Set-Up Tray; Automated Radiological Image Processing Software; Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable,  Non-Fixed; Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System",1; 2,"01030100 HipCheck; 01030300 HipCheck Software; 0203-1000 SportsSuite Vision Software; 0220-240-300 L12 LED Light Source with Advanced Imaging Modality; 0220240300 PKG, L12 LED LIGHT SOURCE WITH AIM; 0240200100 0240200200 Connected OR Hub Device Management System 1; 0240200100 Connected OR Hub Device Management System; 0240200101 Connected OR Hub VIP Package; 0240200101, Connected OR Hub VIP Package; 0240200102 Voice Control Package; 0240200102, Voice Control Package; 0240200102: Connected OR Hub Voice Package; 0240200103 Device Control Package; 0240200103, Device Control Package; 0240200103: Connected OR Hub Device Control Package; 0240200200 Connected OR Hub Device Management System; 0240300100 SDC4K Information Management System; 0240300100, 0240300200 SDC4K Information Management System 1; 0240300200 SDC4K Information Management System; 0250-070-500 Suction Irrigator 2; 0250-070-520 StrykeFlow 2 With Tip; 0485-840-000 - XL Round Diamond Bur, 4 mm; 0485-860-000 - XL Round Diamond Bur, 5.5 mm; 0502-000-003 ThermaClear Spine; 0502-500-001 ThermaClear Main Module; 0502-652-010 Precision S 4K Sinuscope, Autoclavable, 3.1 mm x 0°, 170 mm; 0502-652-030 Precision S 4K Sinuscope, Autoclavable, 3.1 mm x 30°, 170 mm; 0502-652-045 Precision S 4K Sinuscope, Autoclavable, 3.1 mm x 45°, 170 mm; 0502-652-070 Precision S 4K Sinuscope, Autoclavable, 3.1 mm x 70°, 170 mm; 0502-652-130 Precision S 4K Sinuscope, Autoclavable, Reverse Cant, 3.1 mm x 30°, 170 mm; 0502-652-145 Precision S 4K Sinuscope, Autoclavable, Reverse Cant, 3.1 mm x 45°, 170 mm; 0502-652-170 Precision S 4K Sinuscope, Autoclavable, Reverse Cant, 3.1 mm x 70°, 170 mm; 0502-653-010 Precision S 4K Sinuscope, Autoclavable, 3.1 mm x 0°, 125 mm; 0502-653-030 Precision S 4K Sinuscope, Autoclavable, 3.1 mm x 30°, 125 mm; 0502-653-130 Precision S 4K Sinuscope, Autoclavable, 3.1 mm x 30°, 125 mm; 0502-654-010 Precision S 4K Sinuscope, Autoclavable, 4 mm x 0°, 155 mm; 0502-654-030 Precision S 4K Sinuscope, Autoclavable, 4 mm x 30°, 155 mm; 0502-654-045 Precision S 4K Sinuscope, Autoclavable, 4 mm x 45°, 155 mm; 0502-654-070 Precision S 4K Sinuscope, Autoclavable, 4 mm x 70°, 155 mm; 0502-654-130 Precision S 4K Sinuscope, Autoclavable, Reverse Cant, 4 mm x 30°, 155 mm; 0502-654-145 Precision S 4K Sinuscope, Autoclavable, Reverse Cant, 4 mm x 45°, 155 mm; 0502-654-170 Precision S 4K Sinuscope, Autoclavable, Reverse Cant, 4 mm x 70°, 155 mm; 0502-655-010 Precision S 4K Sinuscope, Autoclavable, 4 mm x 0°, 180 mm; 0502-655-030 Precision S 4K Sinuscope, Autoclavable, 4 mm x 30°, 180 mm; 0502-655-130 Precision S 4K Sinuscope, Autoclavable, Reverse Cant, 4 mm x 30°, 180 mm; 0502730000 2.9mm O-Adapter, Speed-lock, Cystoscope/Hysteroscope; 0502730010 SPY Cystoscope/Hysteroscope, Autoclavable Speed-lock 2.9 mm x 0 30 cm; 0502730012 SPY Cystoscope/Hysteroscope Autoclavable Speed-lock 2.9 mm x 12 30 cm; 0502730030 SPY Cystoscope/Hysteroscope Autoclavable Speed-lock 2.9 mm x 30 30 cm; 0502731010 SPY Cystoscope/Hysteroscope Autoclavable KS-Series 2.9 mm x 0 30 cm; 0502731012 SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 2.9 mm x 12, 30 cm; 0502731030 SPY Cystoscope/Hysteroscope, Autoclavable, KS-Series, 2.9 mm x 30, 30 cm; 0502752010 Precision S HydroFlow Cleaning Sheath for 3.1mm X 170mm 0° Sinuscope; 0502752030 Precision S HydroFlow Cleaning Sheath for 3.1mm X 170mm 30° Sinuscope; 0502752045 Precision S HydroFlow Cleaning Sheath for 3.1mm X 170mm 45° Sinuscope; 0502752070 Precision S HydroFlow Cleaning Sheath for 3.1mm X 170mm 70° Sinuscope; 0502752130 Precision S HydroFlow Cleaning Sheath for 3.1mm X 170mm 30° Reverse Cant Sinuscope; 0502752145 Precision S HydroFlow Cleaning Sheath for 3.1mm X 170mm 45° Reverse Cant Sinuscope; 0502752170 Precision S HydroFlow Cleaning Sheath for 3.1mm X 170mm 70° Reverse Cant Sinuscope; 0502754010 Precision S HydroFlow Cleaning Sheath for 4mm X 155mm 0° Sinuscope; 0502754030 Precision S HydroFlow Cleaning Sheath for 4mm X 155mm 30° Sinuscope; 0502754045 Precision S HydroFlow Cleaning Sheath for 4mm X 155mm 45° Sinuscope; 0502754070 Precision S HydroFlow Cleaning Sheath for 4mm X 155mm 70° Sinuscope; 0502754130 Precision S HydroFlow Cleaning Sheath for 4mm X 155mm 30° Reverse Cant Sinuscope; 0502754145 Precision S HydroFlow Cleaning Sheath for 4mm X 155mm 45° Reverse Cant Sinuscope; 0502754170 Precision S HydroFlow Cleaning Sheath for 4mm X 155mm 70° Reverse Cant Sinuscope; 0502755010 Precision S HydroFlow Cleaning Sheath for 4mm X 180mm 0° Sinuscope; 0502755030 Precision S HydroFlow Cleaning Sheath for 4mm X 180mm 30° Sinuscope; 0502755130 Precision S HydroFlow Cleaning Sheath for 4mm X 180mm 30° Reverse Cant Sinuscope; 0° (STRAIGHT) CUTTING LOOP ELECTRODE (6BX); 1.3MM X 35.6CM NITINOL GUIDE WIRE; 1.9MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK, C-MOUNT; 1.9MM OBTURATOR; 1.9MM SPEEDLOCK PENCIL TIP OBTURATOR; 1.9MM TROCAR; 1.9MM X 30º C-MOUNT, A/C; 1.9mm Speedlock Pencil Tip Obturator; 10 X 28mm Biosteon Screw; 10 X 35mm Biosteon Screw; 10.5MM FLEXIBLE REAMER; 100MM DRAIN CANNULA; 1088  1288  1488; 10MM 0° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM; 10MM 0° BARIATRIC LAPAROSCOPE, AC; 10MM 0° LAPAROSCOPE, AC; 10MM 0° OPERATIVE LAPAROSCOPE WITH 45° EYEPIECE; 10MM 30° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM; 10MM 30° AUTOCLAVABLE LAPAROSCOPE; 10MM 30° BARIATRIC LAPAROSCOPE, AC; 10MM 30° LAPAROSCOPE, AC; 10MM 45° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM; 10MM 45° AUTOCLAVABLE LAPAROSCOPE; 10MM 45° BARIATRIC LAPAROSCOPE, AC; 10MM 45° LAPAROSCOPE, AC; 10MM 90° OPERATING LAPAROSCOPE; 10MM CLIP-APPLYING FORCEPS, ETHICON ML( LC300 OR LT300 COMP); 10MM DRAIN CANNULA; 10MM FLEXIBLE REAMER; 10MM MONO, BABCOCK,PADDLE; 10MM MYOMA DRILL; 10MM PADDLE BABCOCK GRASPER; 10MM X 32CM POOL SUCTION TIP, METAL FINISH; 10MM X 32CM POOL SUCTION TIP, NON-REFLECTIVE FINISH; 10MM X 32CM REGULAR TIP, VENTED, METAL FINISH; 10MM X 32CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH; 10MM X 32CM STONE SCOOPER; 10MM, 33CM BIOPSY SPOON; 10MM, 33CM BIPOLAR ALLIS FORCEPS; 10MM, 33CM DOUBLE ACTION CLAW; 10MM, 33CM MARYLAND DISSECTOR; 10MM, 33CM MIXTER FORCEPS; 10MM, 33CM MONOPOLAR HANDLE; 10MM, 33CM OPERATING SCISSORS, SERRATED; 10MM, 33CM PEEK MONOPOLAR HANDLE; 10MM, 33CM PEEK MULTI-FUNCTION HANDLE; 10MM, 33CM RATCHETING HANDLE; 10MM, 33CM SINGLE ACTION CLAW; 10X23mm Biosteon Screw; 10mm Articulating Laparoscope; 11 X 35mm Biosteon Screw; 11.5MM FLEXIBLE REAMER; 11MM 90° OPERATING LAPAROSCOPE; 11MM CANNULA, AUTOMATIC VALVE, STOPCOCK WITHOUT TROCAR; 11MM FIXABLE CONE FOR HASSON CANNULA; 11MM FLEXIBLE REAMER; 11MM HASSON CANNULA, AUTOMATIC VALVE, STOPCOCK; 11MM OBTURATOR FOR HASSON CANNULA; 11X28mm Biosteon Screw; 12 INSTRUMENT STERILIZATION TRAY; 12 X 35mm Biosteon Screw; 120MM VERESS NEEDLE; 12MM FLEXIBLE REAMER; 12X28mm Biosteon Screw; 135 mm Reusable Slat, SE Retr, 10 Pack; 155 mm Reusable Slat, SE Retr, 10 Pack; 1588 AIM CAMERA CONTROL UNIT (CCU); 1588 AIM CAMERA HEAD WITH INTEGRATED COUPLER; 1588 AIM CAMERA HEAD, C-MOUNT; 1588 AIM Camera Extension Cable, 20ft; 1588 AIM INLINE CAMERA HEAD, C-MOUNT; 1588 PENDULUM CAMERA HEAD WITH INTEGRATED COUPLER; 16-L INSUFFLATOR TUBING; 16-LITER INSUFFLATOR TUBING (10BX); 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000); 1688 4K Camera Head, Inline; 1688 4K Camera Head, Pendulum; 1688 4K Pendulum Camera Head with Integrated Coupler; 1688 4K Pendulum Camera Head with Integrated Coupler (1688310130); 1688 AIM 4K AUTOCLAVABLE CAMERA HEAD, C-MOUNT; 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER; 1688 AIM 4K CAMERA HEAD, C-MOUNT; 1688 AIM 4K Camera Head with Integrated Coupler; 1688 AIM 4K Camera Head, C-Mount; 1688 AIM 4K INLINE CAMERA HEAD, C-MOUNT; 1688 AIM 4K Inline Camera Head, C-Mount; 1688 Camera Control Unit; 1688 Camera Control Unit (CCU); 1688 MICROSCOPE CAMERA HEAD; 1688 Pendulum Camera Head with Coupler; 1688 Pendulum Camera head with Integrated Coupler; 1688010000 1688 4K Camera Control Unit with Advanced Imaging Modality; 1688010000, 1688 Camera Control Unit (CCU); 1688020122 4K Coupler, C-Mount, with Advanced Imaging Modality; 1688210105 1688 4K Camera Head, C-Mount, with Advanced Imaging Modality; 1688310130 1688 4K Pendulum Camera Head with Integrated Coupler; 1688410105 AIM 4K Autoclave Camera Head, C-Mount; 1688410110 AIM 4K Autoclave Coupler, C-Mount; 1688610122 1688 4K Camera Head, Integrated Coupler, with Advanced Imaging Modality; 1688710105 1688 4K Inline Camera Head, C-Mount, with Advanced Imaging Modality; 175mm Reusable Slat, SE Retr, 10 Pack; 1788 4K CAMERA HEAD, C-MOUNT; 1788 4K PENDULUM CAMERA HEAD WITH INTEGRATED COUPLER; 1788 4K PENDULUM UROLOGY CAMERA HEAD WITH INTEGRATED COUPLER; 1788 Camera Control Unit (CCU); 1788010000 1788 4K Camera Control Unit with Advanced Imaging Modality; 1788010000 1788 Camera Control Unit (CCU); 1788020122 1788 4K Coupler, C-Mount; 1788020122 1788 4K Coupler, C-Mount, with Advanced Imaging Modality; 1788090000 780 nm SPY-PHI Camera Control Unit; 1788210080 1788 4K MICROSCOPE CAMERA HEAD; 1788210105 1788 4K CAMERA HEAD, C-MOUNT; 1788210105 1788 4K Standard Camera Head, C-Mount, with Advanced Imaging Modality; 1788310130 1788 4K PENDULUM CAMERA HEAD WITH INTEGRATED COUPLER; 1788310131 1788 4K Pendulum Urology Camera Head with Integrated Coupler; 1788610122 1788 4K CAMERA HEAD WITH INTEGRATED COUPLER; 1788610122 1788 4K Camera Head, Integrated Coupler, with Advanced Imaging Modality; 1788710105 1788 4K INLINE CAMERA HEAD, C-MOUNT; 1788710105 1788 4K Inline Camera Head, C-Mount, with Advanced Imaging Modality; 1788910105 780 nm SPY-PHI Imager; 17FR CYSTO STANDARD OBTURATOR; 17FR CYSTO VISUAL OBTURATOR; 17FR CYSTOSCOPE SHEATH; 19FR CYSTO STANDARD OBTURATOR; 19FR CYSTO VISUAL OBTURATOR; 19FR CYSTOSCOPE SHEATH; 2 SPIKE GRAVITY FLOW TUBE SET, DISPOSABLE (10BX); 2-0 Knot Pusher/Suture Cutter; 2.1MM BLUNT NOSE DOWN ASSY; 2.1MM BLUNT NOSE LEFT ASSY; 2.1MM BLUNT NOSE RIGHT ASSY; 2.1MM BLUNT NOSE STRAIGHT ASSY; 2.1MM BLUNT NOSE UP ASSY; 2.3MM  OBTURATOR; 2.3MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK,C-MOUNT; 2.3MM AUTOCLAVABLE BLUNT TIP OBTURATOR WITH SPEED-LOCK; 2.3MM AUTOCLAVABLE PENCIL TIP OBTURATOR WITH SPEED-LOCK; 2.3MM AUTOCLAVABLE TROCAR FOR 2.9MM CANNULA WITH SPEED-LOCK; 2.3MM TROCAR; 2.3MM X 0 DEG, A/C; 2.3MM X 0 DEG, C-,MOUNT, A/C; 2.3MM X 30 DEG, A/C; 2.3MM X 30 DEG, C-,MOUNT, A/C; 2.3MM X 30 DEG, C-,MOUNT, REVERSE CANT, A/C; 2.3MM X 70 DEG, C-,MOUNT, A/C; 2.4FR NITINOL BASKET, 115CM; 2.5MM GRASPER ASSY; 2.5MM SCISSORS ASSY; 2.7MM 0 DEG AUTOCLAVABLE ARTHROSCOPE; 2.7MM 0° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT; 2.7MM 0° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM; 2.7MM 0° C-MOUNT, ARTHROSCOPE; 2.7MM 0° C-MOUNT, STUBBY; 2.7MM 0° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT; 2.7MM 30 DEG AUTOCLAVABLE ARTHROSCOPE; 2.7MM 30° A/C STUBBY REVERSE CANT SCOPE W/ SPEEDLOCK,C-MOUNT; 2.7MM 30° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT; 2.7MM 30° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM; 2.7MM 30° C-MOUNT, STUBBY; 2.7MM 30° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT; 2.7MM 30°C-MOUNT, ARTHROSCOPE; 2.7MM 70 DEG AUTOCLAVABLE ARTHROSCOPE; 2.7MM 70° A/C STUBBY ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT; 2.7MM 70° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT; 2.7MM BLUNT NOSE STRAIGHT ASSY; 2.7MM BLUNT NOSE UP ASSY; 2.7MM HYSTERSCOPE OPERATIVE SHEATH (6MM DIAMETER); 2.7MM NORROW PUNCH; 2.7MM OBTURATOR; 2.7MM SCOPE BRIDGE; 2.7MM SPEEDLOCK PENCIL TIP OBTURATOR; 2.7MM STUBBY SCOPE AUTOCLAVABLE; 2.7MM TROCAR; 2.7MM X 0 DEG, C-MOUNT, A/C; 2.7MM X 30 DEG, C-MOUNT, A/C; 2.7MM X 30° STUBBY AUTOCLAVABLE STUBBY SCOPE REVERSE CANT; 2.7MM X 70DEG STUBBY, A/C; 2.8MM  TWO ROTATING STOPCOCKS; 2.8MM CANNULA WITH 1 FIXED STOPCOCK; 2.8MM CANNULA WITH 1 ROTATING STOPCOCK; 2.8MM CANNULA WITH 2 FIXED STOPCOCKS; 2.8MM CANNULA WITH 2 ROTATING STOPCOCKS; 2.9MM AUTOCLAVABLE CANNULA, 1 ROTATING STOPCOCK W/SPEEDLOCK; 2.9MM CANNULA WITH 1 ROTATING STOPCOCK; 2.9MM IDEAL EYES PRECISION HD AUTOCLAVABLE 200MM C-MOUNT ARTHROSCOPE - 30 DEG. WITH MODIFIED SPEEDLOCK; 21FR CYSTO STANDARD OBTURATOR; 21FR CYSTO VISUAL OBTURATOR; 21FR CYSTOSCOPE SHEATH; 21FR URETHROTOME STANDARD OBTURATOR; 21FR URETHROTOME VISUAL OBTURATOR; 21FR VISUAL URETHROTOME OPTICAL BRIDGE; 21FR VISUAL URETHROTOME SHEATH; 22 FR, 0 DEGREE (STRAIGHT) CUTTING LOOP ELECTRODE, 14; 22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, 14; 22 FR, COLLINGS KNIFE ELECTRODE; 22 FR, DIMPLED VAPORIZING ROLLER BALL ELECTRODE; 22 FR, GOLD COAGULATING ELECTRODE; 22 FR, ROLLING BALL ELECTRODE; 220240305: 780 nm SPY-PHI Light Source; 22FR., 30° (STRAIGHT) CUTTING LOOP ELECTRODE, 14; 22FR., 30° CUTTING LOOP ELECTRODE, 14; 22FR., COLLINGS KNIFE ELECTRODE; 22FR., ROLLER BALL ELECTRODE, 303MM; 22FR., ROLLER ELECTRODE, 3MM; 22FR., VAPORIZATION ELECTRODE; 23 POSITION STERILIZATION TRAY; 234-112-012 VersiQuad Tendon Cutter Blade; 234-112-100 VersiQuad Halo Retractor; 234-112-108 VersiQuad Parallel Blade 8mm Width x 10mm Thickness; 234-112-109 VersiQuad Parallel Blade 9mm Width x 10mm Thickness; 234-112-110 VersiQuad Parallel Blade 10mm Width x 10mm Thickness; 234-112-500 VersiQuad Tendon Cutter; 234-112-600 VersiQuad Parallel Blade Handle; 234-112-607 VersiQuad Parallel Blade 7mm Width x 6mm Thickness; 234-112-608 VersiQuad Parallel Blade 8mm Width x 6mm Thickness; 234-112-609 VersiQuad Parallel Blade 9mm Width x 6mm Thickness; 234-112-610 VersiQuad Parallel Blade 10mm Width x 6mm Thickness; 23FR CYSTO STANDARD OBTURATOR; 23FR CYSTO VISUAL OBTURATOR; 23FR CYSTOSCOPE SHEATH; 24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH; 24/26FR RESECTOSCOPE STANDARD OBTURATOR; 24/26FR RESECTOSCOPE TIMBERLAKE OBTURATOR; 24/26FR RESECTOSCOPE VISUAL OBTURATOR; 24FR 30° CUTTING LOOP ELECTRODE, 12 (6BX); 24FR 30° CUTTING LOOP ELECTRODE, 14 (6BX); 24FR 90° CUTTING LOOP ELECTRODE, 12 (6BX); 24FR 90° CUTTING LOOP ELECTRODE, 14 (6BX); 24FR DIMPLED VAPORIZING ELECTRODE; 24FR STANDARD FLOW RESECTOSCOPE SHEATH; 24FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER; 24FR. COLLINGS KNIFE ELECTRODES; 24FR., 0° (STRAIGHT) CUTTING LOOP ELECTRODE, 14; 24FR., 30° CUTTING LOOP ELECTRODE, 14; 24FR., 90° CUTTING LOOP ELECTRODE, 14; 24FR., COLLINGS KNIFE ELECTRODE; 24FR., ROLLER BALL ELECTRODE, 3.3MM; 24FR., ROLLER ELECTRODE, 3MM; 24FR., SPIKE ELECTRODE; 24FR., VAPORIZATION ELECTRODE; 25FR BALLOON CATHETER SHEATH; 25FR CYSTO STANDARD OBTURATOR; 25FR CYSTO VISUAL OBTURATOR; 25FR CYSTOSCOPE SHEATH; 25FR VISUAL URETHROTOME OUTER SHEATH; 266-719-000 PKG, WESSINGER ROD (SMALL); 266-720-000 PKG, WISSINGER ROD (LARGE); 266-721-000 PKG. WISSINGER HANDLE, SE3; 27/28FR CONTINUOUS FLOW INNER/OUTER SHEATH; 27/28FR RESECTOSCOPE STANDARD OBTURATOR; 27/28FR RESECTOSCOPE TIMBERLAKE OBTURATOR; 27/28FR RESECTOSCOPE VISUAL OBTURATOR; 27FR 30° DEGREE CUTTING LOOP ELECTRODE, 12 (6BX); 27FR 30° DEGREE CUTTING LOOP ELECTRODE, 14 (6BX); 27FR 90° CUTTING LOOP ELECTRODE, 12 (6BX); 27FR 90° CUTTING LOOP ELECTRODE, 14 (6BX); 27FR GOLD COAGULATING ELECTRODE (6BX); 27FR STANDARD FLOW RESECTOSCOPE SHEATH; 27FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER; 27FR., 0 DEG (STRAIGHT) CUTTING LOOP ELECTRODE, 14; 27FR., 30° CUTTING LOOP ELECTRODE, 14; 27FR., 90° CUTTING LOOP ELECTRIC, 14; 27FR., COLLINGS KNIFE ELECTRODE; 27FR., ROLLER BALL ELECTRODE, 3.3MM; 27FR., ROLLER ELECTRODE, 3MM; 27FR., SPIKE ELECTRODE; 27FR., VAPORIZATION ELECTRODE; 2FR LONG TIP ELECTRODE, 115CM (3BX); 2FR SHORT TIP ELECTRODE, 115CM (3BX); 2MM BASKET FORCEPS REV BIT; 2MM X 32CM REGULAR TIP WITH 1 HOLE, METAL FINISH; 2MM X 32CM REGULAR TIP WITH 2 HOLES, METAL FINISH; 2MM X 34CM REGULAR TIP WITH NO HOLES, METAL FINISH; 3.2MM CANNULA WITH 1 FIXED STOPCOCK; 3.2MM CANNULA WITH 1 ROTATING STOPCOCK; 3.2MM CANNULA WITH 2 FIXED STOPCOCKS; 3.2MM SPEEDLOCK PENCIL TIP OBTURATOR; 3.4MM 30 LEFT MENISCAL PUNCH; 3.4MM 30 RIGHT MENISCAL PUNCH; 3.4MM HIP GRASPER; 3.4MM HIP PUNCH - STRAIGHT; 3.4MM LOOSEBODY GRASPER W/ RATCHET; 3.4MM NARROW PUNCH-15° UP; 3.4MM NORROW PUNCH; 3.5MM CANNULA, AUTOMATIC VALVE, STOPCOCK, W/OUT TROCAR(55MM); 3.5MM FORMULA SERIES, SMALL JOINT CUTTER CANNULA; 3.5MM SWITCHING STICK; 3.9mm Omega Drill; 3.9mm Omega Tap; 3.9mm Omega and 4.75mm AlphaVent Awl; 30 S GRIZZLY FINAL PACKAGING; 3105-000-305 Pivot Guardian Direct PostFree Support; 3105-000-740 Pivot Guardian Safety Boot Liners, Small; 3105-000-741 Pivot Guardian Safety Boot Liners, Medium; 3105-000-742 Pivot Guardian Safety Boot Liners, Large; 3105001000 HipMap Femoroacetabular Impingement Analysis; 32"" 4K OLED Surgical Display; 3910-500-582, ICONIX DC Guide for 2.3mm anchor; 3910-500-583, ICONIX DC Obturator for 2.3mm anchor; 3911-824-408: KNOTILUS+ 2.4x8.9MM BIOCOMPOSITE, KNOTLESS ANCHOR, HIP; 3911-824-511: KNOTILUS+ 2.4x11.3MM BIOCOMPOSITE, KNOTLESS ANCHOR; 3911-829-412: KNOTILUS+ 2.9x12.5MM BIOCOMPOSITE, KNOTLESS ANCHOR, HIP; 3911-829-512: KNOTILUS+ 2.9x12.5MM BIOCOMPOSITE, KNOTLESS ANCHOR; 3911-829-515: KNOTILUS+ 2.9x15.5MM BIOCOMPOSITE, KNOTLESS ANCHOR; 3911-856-547 ALPHAVENT KNOTLESS SP 4.75MM BIOCOMPOSITE ANCHOR; 3911-856-555 ALPHAVENT KNOTLESS SP, 5.5MM, BIOCOMPOSITE ANCHOR; 3911-856-565 ALPHAVENT KNOTLESS SP, 6.5MM, BIOCOMPOSITE ANCHOR; 3FR 3-WIRE GRASPING FORCEP, 70CM; 3FR 3-WIRE GRASPING FORCEP, 90CM; 3FR FLAT WIRE BASKET, 115CM; 3FR FLAT WIRE BASKET, 70CM; 3FR FLAT WIRE BASKET, 90CM; 3FR FLEXIBLE BIOPSY CUP FORCEP 60CM; 3FR FLEXIBLE GRASPING FORCEP, 60CM; 3FR FLEXIBLE RAT TOOTH FORCEP, 60CM; 3FR LONG TIP ELECTRODE, 115CM (3BX); 3FR NITINOL BASKET, 115CM; 3FR NITINOL BASKET, 70CM; 3FR NITINOL BASKET, 90CM; 3FR SHORT TIP ELECTRODE, 115CM (3BX); 3MM BABCOCK GRASPER 29CM; 3MM BIOPSY PUNCH 20CM; 3MM BLUNT INSERT, WITH SPOON; 3MM DISSECTING FORCEPS 29CM; 3MM DOUBLE ACTION ATRAUMATIC GRASPER, 20CM; 3MM DOUBLE ACTION ATRAUMATIC GRASPER, 29CM; 3MM FENESTRATED SCHERTL GRASPER INSERT, 29CM; 3MM HOOK SCISSORS; 3MM HOOK SCISSORS INSERT 29CM; 3MM INSERT ALLIGATOR GRASPER 20CM; 3MM INSERT ALLIGATOR GRASPER 29CM; 3MM INSERT BIOPSY FORCEPS 20CM; 3MM INSERT BIOPSY FORCEPS 29CM; 3MM INSERT BIOPSY PUNCH 29CM; 3MM INSERT BLUNT GRASPER 20CM; 3MM INSERT BLUNT GRASPER 29CM; 3MM INSERT BLUNT SPOON GRASPER; 3MM INSERT COBRA GRASPER 20CM; 3MM INSERT CURVED METZENBAUM SCISSORS 20CM; 3MM INSERT DORSEY GRASPER 20CM; 3MM INSERT DORSEY GRASPER 29CM; 3MM INSERT FENESTRATED SCHERTEL GRASPER 20CM; 3MM INSERT FUNDUS GRASPER 29CM; 3MM INSERT MARYLAND DISSECTORS 20CM; 3MM INSERT MARYLAND DISSECTORS 29CM; 3MM INSERT NEEDLE NOSE DISSECTORS 20CM; 3MM INSERT NEEDLE NOSE DISSECTORS 29CM; 3MM INSERT RIGHT ANGLE DISSECTORS 29CM; 3MM INSERT RIGHT ANGLE DISSECTORS, 20CM; 3MM INSERT STRAIGHT NEEDLEHOLDER 20CM; 3MM INSERT STRAIGHT NEEDLEHOLDER 29CM; 3MM INSERT TAPERED BULLET 20CM; 3MM INSERT TAPERED BULLET 29CM; 3MM INSERT, CURVED METZENBAUM SCISSORS 29CM; 3MM INSERT, FUNDUS GRASPER 20CM; 3MM INSERT, PERITONEAL SCISSORS 29CM; 3MM PEEK MONOPOLAR HANDLE; 3MM SINGLE ACTION ATRAUMATIC GRASPER, 29CM; 3MM X 29CM MONOPOLAR ELECTROSURGICAL PROBE, L-TIP; 3MM X 29CM MONOPOLAR ELECTROSURGICAL PROBE, SPATULA TIP; 3MM X 32CM REGULAR TIP, NON-VENTED, METAL FINISH; 3MM X 32CM REGULAR TIP, VENTED, METAL FINISH; 4 SPIKE GRAVITY FLOW TUBE SET, DISPOSABLE (10BX); 4.4MM HIP OBTURATOR CANNULATED; 4.4MM HIP TROCAR CANNULATED; 4.5MM FLEXIBLE REAMER; 4.6 X 200 MM CANNULA, 1 FIXED STOPCOCK; 4.6 X 200 MM CANNULA, 1 FIXED STOPCOCK, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK; 4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS AT 95°; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS AT 95°, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS AT 95°; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS AT 95°, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS, NO DISTAL HOLES; 4.75 mm AlphaVent Suture Anchor PEEK 2 strands of 2 XBraid S Suture; 4.75mm AlphaVent Punch Tap; 4.75mm AlphaVent Suture Anchor PEEK 1 strand of 2mm XBraid TT Suture Tape and 1 Strand of 1.4mm XBraid TT Suture Tape; 4.75mm AlphaVent Suture Anchor PEEK 1 strand of 2mm XBraid TT Suture Tape and 1 Strand of 2 XBraid S Suture; 4.75mm AlphaVent Suture Anchor PEEK 2 strands of 1.4mm XBraid TT Suture Tape; 4.75mm AlphaVent Suture Anchor PEEK 2 strands of 2mm XBraid TT Suture Tape; 4.75mm AlphaVent Suture Anchor PEEK 2 strands of 2mm XBraid TT Suture Tape with Needles; 4.75mm AlphaVent Suture Anchor PEEK 3 strands of 1.4mm XBraid TT Suture Tape; 4.75mm AlphaVent Suture Anchor PEEK 3 strands of 1.4mm XBraid TT Suture Tape with Needles; 4.75mm AlphaVent Suture Anchor PEEK 3 strands of 2 XBraid S Suture; 4.75mm AlphaVent Suture Anchor PEEK 3 strands of 2 XBraid S Suture with Needles; 4.75mm AlphaVent Tap; 4.75mm AlphaVent and Omega Awl; 4.75mm AlphaVent and Omega Drill; 4.75mm Omega Tap; 45CM LAPAROSCOPIC INSTRUMENTS TRAY; 4K CAMERA HEAD WITH INTEGRATED COUPLER; 4K INLINE CAMERA HEAD, C-MOUNT; 4MM  0° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT; 4MM  0° C-MOUNT STYLE A ARTHROSCOPE; 4MM 0DEG C-MOUNT; 4MM 0° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM; 4MM 30° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT; 4MM 30° AUTOCLAVABLE HIP ARTHROSCOPE; 4MM 30° AUTOCLAVABLE REVERSE CANT ARTHROSCOPE, C-MOUNT; 4MM 30° C-MOUNT STYLE A ARTHROSCOPE; 4MM 30° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM; 4MM 70° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT; 4MM 70° C-MOUNT STYLE A ARTHROSCOPE; 4MM 70° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5 CM; 4MM 70° REV. CANT, STORZ; 4MM A/C ARTHROSCOPE; 4MM AUTOCLAVABLE ARTHROSCOPE; 4MM CANNULA WITH 1 FIXED STOPCOCK; 4MM CANNULA WITH 1 ROTATING STOPCOCK; 4MM CANNULA WITH 2 FIXED STOPCOCKS; 4MM CANNULA WITH 2 ROTATING STOPCOCKS; 4MM CANNULATED SWITCHING STICK; 4MM CYSTOSCOPE, KS SERIES 0DEG; 4MM CYSTOSCOPE, KS SERIES 12DEG; 4MM CYSTOSCOPE, KS SERIES 30DEG; 4MM CYSTOSCOPE, KS SERIES 70DEG; 4MM HYSTERSCOPE DIAGNOSTIC SHEATH (6MM DIAMETER); 4MM HYSTERSCOPE OPERATIVE SHEATH (7MM DIAMETER); 4MM X 0° LONG ARTHROSCOPE SPEEDLOCK A/C; 4MM X 24 SWITCHING STICK; 4MM X 30° LONG ARTHROSCOPE SPEEDLOCK A/C; 4MM X 70° LONG ARTHROSCOPE SPEEDLOCK A/C; 4MM, 30 HIP ARTHOSCOPE (HIPSCOPE); 4mm TomCat Shaver Blades; 5 MM BIPOLAR FORCEPS, SPRING HANDLE, MICRO TIP, 45 CM; 5 MM MICRO SCISSORS, CURVED INSERT; 5.5MM CANNULA, AUTOMATIC VALVE, STOPCOCK WITHOUT TROCAR; 5.5MM CANNULATED SWITCHING STICK; 5.5MM FLEXIBLE REAMER; 5.5MM HASSON CANNULA, AUTOMATIC VALVE, STOPCOCK; 5.5MM OBTURATOR FOR HASSON CANNULA; 5.5MM SLOTTED CANNULA; 5.5mm AlphaVent Suture Anchor PEEK 1 strands of 2mm XBraid TT Suture Tape and 1 strand of 1.4mm XBraid TT Suture Tape; 5.5mm AlphaVent Suture Anchor PEEK 1 strands of 2mm XBraid TT Suture Tape and 1 strand of 2 XBraid S Suture; 5.5mm AlphaVent Suture Anchor PEEK 2 Strands of 2 XBraid S Suture; 5.5mm AlphaVent Suture Anchor PEEK 2 strands of 1.4mm XBraid TT Suture Tape; 5.5mm AlphaVent Suture Anchor PEEK 2 strands of 2mm XBraid TT Suture Tape; 5.5mm AlphaVent Suture Anchor PEEK 3 Strands of 2 XBraid S Suture; 5.5mm AlphaVent Suture Anchor PEEK 3 Strands of 2 XBraid S Suture with Needle; 5.5mm AlphaVent Suture Anchor PEEK 3 strands of 1.4mm XBraid TT Suture Tape; 5.5mm AlphaVent Tap; 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill; 5.8 CANNULA, 2 ROTATING STOPCOCKS FOR 4MM LONG ARTHROSCOPE; 5.8MM CANNULA, 1 FIXED STOPCOCK; 5.8MM CANNULA, 2 FIXED STOPCOCKS; 5.8MM CANNULA, 2 ROTATING STOPCOCKS; 5.8MM HIPSCOPE CANNULA, 2 ROTATING STOPCOCKS; 50-S XL; 5FR BALL ELECTRODE, 65CM (3BX); 5FR BUGBEE ELECTRODE, 65CM (3BX); 5FR DOMED ELECTRODE, 65CM (3BX); 5FR FLEXIBLE BIOPSY CUP FORCEP, 60CM; 5FR FLEXIBLE GRASPING FORCEP, 60CM; 5FR FLEXIBLE RAT TOOTH FORCEP, 60CM; 5FR FLEXIBLE SCISSOR, 60CM; 5MM 0° AUTOCLAVABLE LAPAROSCOPE; 5MM 0° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE; 5MM 0° LAPAROSCOPE, AC; 5MM 30° AUTOCLAVABLE LAPAROSCOPE; 5MM 30° BARIATRIC LAPAROSCOPE, AC; 5MM 30° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE; 5MM 30° LAPAROSCOPE, AC; 5MM 45CM METZENBAUM MINI SCISSORS INSERT; 5MM 45° AUTOCLAVABLE LAPAROSCOPE; 5MM 45° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE; 5MM 45° LAPAROSCOPE, AC; 5MM ASPIRATION NEEDLE, 33CM LONG, 17 GAUGE NEEDLE; 5MM ASPIRATION NEEDLE, 45CM LONG, 17 GAUGE NEEDLE; 5MM CANNULA 1 ROT SPEEDLOCK; 5MM CANNULA 2 ROT STCK (SPEEDLOCK); 5MM CUFF ANCHOR; 5MM ENDOLOOP APPLICATOR; 5MM FLEXIBLE REAMER; 5MM MONOPOLAR HANDLE 33CM; 5MM MYOMA DRILL; 5MM PALPATION PROBE, 33CM LONG; 5MM PALPATION PROBE, 45CM LONG; 5MM PEEK 45CM MARYLAND FORCEPS; 5MM PEEK MULTIFUNCTION HANDLE; 5MM RATCHETED HANDLE 33CM; 5MM X 24CM REGULAR TIP, VENTED, METAL FINISH; 5MM X 28CM REGULAR TIP, VENTED, METAL FINISH; 5MM X 28CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH; 5MM X 32CM ASPIRATION NEEDLE TIP; 5MM X 32CM HYDRODISSECTION TIP, METAL FINISH; 5MM X 32CM HYDRODISSECTION TIP, NON-REFLECTIVE FINISH; 5MM X 32CM NON-CONDUCTIVE TIP, VENTED; 5MM X 32CM POOL SUCTION TIP, METAL FINISH; 5MM X 32CM POOL SUCTION TIP, NON-REFLECTIVE FINISH; 5MM X 32CM REGULAR TIP WITH NO HOLES, NON-REFLECTIVE FINISH; 5MM X 32CM REGULAR TIP, NON-VENTED, METAL FINISH; 5MM X 32CM REGULAR TIP, VENTED, METAL FINISH; 5MM X 32CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH; 5MM X 45CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW; 5MM X 45CM REGULAR TIP, VENTED, METAL FINISH; 5MM X 45CM REGULAR TIP, VENTED, NON-REFLECTIVE FINISH; 5MM X 45CM STRYKEPROBE ELECTROSURGICAL PROBE, J-TIP; 5MM X 45CM STRYKEPROBE ELECTROSURGICAL PROBE, L-TIP; 5MM X 45CM STRYKEPROBE ELECTROSURGICAL PROBE, SPATULA-TIP; 5MM, 33CM ALLIGATOR GRASPER; 5MM, 33CM ALLIS GRASPER (DOUBLE ROW OF TEETH); 5MM, 33CM ALLIS GRASPER (SINGLE ROW OF TEETH); 5MM, 33CM BABCOCK GRASPER; 5MM, 33CM BIOPSY PUNCH; 5MM, 33CM BIPOLAR BABCOCK FORCEPS; 5MM, 33CM BIPOLAR FENESTRATED FORCEPS (INSERT); 5MM, 33CM BIPOLAR FENESTRATED FORCEPS WITH RING HANDLE; 5MM, 33CM BIPOLAR FENESTRATED FORCEPS WITH SPRING HANDLE; 5MM, 33CM BIPOLAR MICRO TIP FORCEPS (INSERT); 5MM, 33CM BIPOLAR PADDLE FORCEPS (INSERT); 5MM, 33CM BIPOLAR PADDLE FORCEPS WITH RING HANDLE; 5MM, 33CM BIPOLAR PADDLE FORCEPS WITH SPRING HANDLE; 5MM, 33CM BIPOLAR PENNINGTON FORCEPS; 5MM, 33CM BIPOLAR RING HANDLE; 5MM, 33CM BIPOLAR SHAFT; 5MM, 33CM BIPOLAR SPRING HANDLE; 5MM, 33CM BLAKESLY BIOPSY; 5MM, 33CM BLUNT GRASPER WITH SPOON; 5MM, 33CM COBRA GRASPER; 5MM, 33CM CURVED KELLY DISSECTOR; 5MM, 33CM CURVED LEFT NEEDLEHOLDER; 5MM, 33CM CURVED METZENBAUM SCISSORS (LONG JAWS); 5MM, 33CM CURVED RIGHT NEEDLEHOLDER; 5MM, 33CM DEBAKEY GRASPER; 5MM, 33CM DOLPHIN WITH SPOON DISSECTOR; 5MM, 33CM DORSEY GRASPER; 5MM, 33CM DOUBLE ACTION ATRAUMATIC GRASPER; 5MM, 33CM DOUBLE ACTION BIOPSY SPOON WITH PIN; 5MM, 33CM ENDO METZENBAUM SCISSORS (CURVED); 5MM, 33CM FENESTRATED GRASPER; 5MM, 33CM FENESTRATED SCHERTL GRASPER; 5MM, 33CM FUNDUS GRASPER; 5MM, 33CM GRASPER, DELICATE, FENESTRATED; 5MM, 33CM HOOK SCISSORS; 5MM, 33CM JOHANN FORCEPS; 5MM, 33CM MARYLAND DISSECTOR; 5MM, 33CM MESO-OVARIAN FORCEPS; 5MM, 33CM MICRO GRASPER; 5MM, 33CM MICRO SCISSORS (STRAIGHT); 5MM, 33CM MINI METZENBAUM SCISSORS (CURVED); 5MM, 33CM MIXTER DISSECTOR; 5MM, 33CM NARROW JAW GRASPER; 5MM, 33CM NEEDLE NOSE DISSECTOR; 5MM, 33CM NEEDLEHOLDER HANDLE; 5MM, 33CM OVIDUCT FORCEPS; 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM; 5MM, 33CM PERITONEAL SCISSORS; 5MM, 33CM RIGHT ANGLE DISSECTOR; 5MM, 33CM SERRATED FENESTRATED GRASPER; 5MM, 33CM SERRATED GRASPER; 5MM, 33CM SINGLE ACTION ATRAUMATIC GRASPER; 5MM, 33CM SINGLE ACTION BIOPSY SPOON WITH PIN; 5MM, 33CM STRAIGHT METZENBAUM SCISSORS; 5MM, 33CM STRAIGHT METZENBAUM SCISSORS (LONG JAWS); 5MM, 33CM STRAIGHT NEEDLEHOLDER; 5MM, 33CM STRONG GRASPER (FENESTRATED); 5MM, 33CM TAPERED BULLET DISSECTOR; 5MM, 33CM TISSUE GRASPER DISSECTOR (45°); 5MM, 33CM, ENDO GRASPER; 5MM, 33CM, PADDLE BABCOCK GRASPER; 5MM, 33CM, PARK FORCEPS; 5MM, 33CM, RETENTION GRASPER; 5MM, 33CM, TENACULUM FORCEPS; 5MM, 45CM ALLIS GRASPER (DOUBLE ROW OF TEETH); 5MM, 45CM BABCOCK GRASPER; 5MM, 45CM BIOPSY PUNCH; 5MM, 45CM BIPOLAR FENESTRATED FORCEPS (INSERT); 5MM, 45CM BIPOLAR PADDLE FORCEPS (INSERT); 5MM, 45CM BIPOLAR SHAFT; 5MM, 45CM CURVED KELLY DISSECTOR; 5MM, 45CM CURVED LEFT NEEDLEHOLDER; 5MM, 45CM CURVED METZENBAUM (LONG JAWS) SCISSORS; 5MM, 45CM CURVED RIGHT NEEDLEHOLDER; 5MM, 45CM DEBAKEY GRASPER; 5MM, 45CM DISSECTING FORCEPS; 5MM, 45CM DOUBLE ACTION ATRAUMATIC GRASPER; 5MM, 45CM DOUBLE ACTION BIOPSY SPOON WITH PIN; 5MM, 45CM ENDO METZENBAUM SCISSORS CURVED; 5MM, 45CM HOOK SCISSORS; 5MM, 45CM MARYLAND DISSECTOR; 5MM, 45CM MONOPOLAR HANDLE; 5MM, 45CM OVIDUCT FORCEPS; 5MM, 45CM PARK FORCEPS; 5MM, 45CM PEEK MONOPOLAR HANDLE; 5MM, 45CM PEEK MULTI-FUNCTION HANDLE; 5MM, 45CM PERITONEAL SCISSORS; 5MM, 45CM RATCHETING HANDLE; 5MM, 45CM SERRATED GRASPER; 5MM, 45CM SINGLE ACTION ATRAUMATIC GRASPER; 5MM, 45CM STRAIGHT NEEDLEHOLDER; 5MM, 45CM, DORSEY GRASPER; 5MM, 45CM, ENDO GRASPER; 5MM, 45CM, FENESTRATED GRASPER; 5MM, 45CM, FUNDUS GRASPER; 5MM, 45CM, PADDLE BABCOCK GRASPER; 5MM, 45CM, RETENTION GRASPER; 5MM, 45CM, RIGHT ANGLE DISSECTOR; 5MM,33CM DISSECTING FORCEPS; 5MM,33CM RIGHT ANGLE (LONG JAW); 5mm Articulating Laparoscope; 5mm Bariatric Articulating Laparoscope; 5mm HellCat Shaver Blades; 6.5MM CANNULATED SWITCHING STICK; 6.5MM FLEXIBLE REAMER; 6.5MM SLOTTED CANNULA; 6.5MM X 75MM CANNULATED OBTURATOR ASSY.; 6.5MM X 90MM CANNULATED OBTURATOR ASSY.; 6.5mm AlphaVent Suture Anchor PEEK 1 strand of 2mm XBraid TT Suture Tape and 1 strand of 1.4mm XBraid TT Suture Tape; 6.5mm AlphaVent Suture Anchor PEEK 1 strand of 2mm XBraid TT Suture Tape and 1 strand of 2 XBraid S Suture; 6.5mm AlphaVent Suture Anchor PEEK 3 strands of 1.4mm XBraid TT Suture Tape; 6.5mm AlphaVent Suture Anchor PEEK 3 strands of 2 XBraid S Suture; 6MM FLEXIBLE REAMER; 6X23mm Biosteon Screw; 6X28mm Biosteon Screw; 7 X 23mm Biosteon Screw; 7 X 28mm Biosteon Screw; 7.5MM FLEXIBLE REAMER; 7FR BALL ELECTRODE, 40CM (3BX); 7FR BUGBEE ELECTRODE, 40CM (3BX); 7FR DOMED ELECTRODE, 40CM (3BX); 7MM FLEXIBLE REAMER; 8 X 23mm Biosteon Screw; 8 X 28mm Biosteon Screw; 8.5MM FLEXIBLE REAMER; 8MM FLEXIBLE REAMER; 8MM X 75MM CANNULATED OBTURATOR ASSY.",1977-12-29,170,2026-07-17,0,64,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222936485%22&limit=1
Ad Supply Group Limited,3030733800,3030733800,70-78 West Hendon Broadway,"London London, City of",,NW9 7BT,United Kingdom,AD Supply Group Limited,10090502,Exporter to the US,181,BSR; BSY; BTL; BTR; BTT; BWC; BYD; BYX; BZA; BZD; BZG; BZQ; CAE; CAF; CAT; CBH; CBK; CBL; CBQ; CBR; CBS; CCI; CCK; CCL; CCQ; CCW; DPS; DQA; DQO; DQX; DQY; DRC; DRX; DSA; DSK; DWH; DXN; DXO; DYB; EHK; ERL; EXB; EXE; EXF; EZN; EZR; FCG; FED; FER; FFL; FFY; FGE; FHN; FIL; FLG; FMH; FMI; FMT; FMZ; FOC; FON; FOZ; FPA; FQH; FQM; FRC; FSA; FTL; FXY; FYA; FZP; FZW; GAA; GAG; GAL; GAM; GAP; GAR; GAW; GBO; GCA; GCD; GCJ; GDT; GDW; GDX; GEI; GEX; GFA; GFD; GFF; GHO; GIO; GKR; GXD; GXI; GXZ; HAW; HBA; HBE; HBF; HBL; HBT; HFW; HGE; HIB; HIH; HMX; HNN; HNY; HOY; HRX; HWE; HYB; HYF; HYJ; HZJ; IDL; IKT; ITX; IYO; JCX; JDZ; JKA; JOH; JOJ; JOL; JXG; KAC; KCY; KDQ; KGO; KGX; KMF; KMK; KNS; KNW; KOB; KOD; KOE; KOI; KOX; KRA; KYZ; KZD; LED; LFL; LIX; LJE; LJH; LLZ; LQR; LWK; LYA; LYS; LYY; MEC; MEG; MGP; MKJ; MLD; MLR; MND; MNL; MQM; MTJ; NAC; NAD; NEC; NEU; NEW; NHO; NHP; NHQ; NUJ; ONB; PKL; PPM; PTI; PUI; QAU,"Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Ventilator, Emergency, Powered (Resuscitator); Tube, Tracheal (W/Wo Connector); Humidifier, Respiratory Gas, (Direct Patient Interface); Needle, Emergency Airway; Condenser, Heat And Moisture (Artificial Nose); Tubing, Pressure And Accessories; Connector, Airway (Extension); Ventilator, Non-Continuous (Respirator); Spirometer, Diagnostic; Monitor, Breathing Frequency; Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Cannula, Nasal, Oxygen; Device, Fixation, Tracheal Tube; Ventilator, Continuous, Facility Use; Absorbent, Carbon-Dioxide; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Analyzer, Gas, Nitrogen, Gaseous-Phase; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Laryngoscope, Rigid; Electrocardiograph; Oximeter; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Trocar; Electrode, Electrocardiograph; Cable, Transducer And Electrode, Patient, (Including Connector); Computer, Blood-Pressure; Blade, Saw, Surgical, Cardiovascular; System, Measurement, Blood-Pressure, Non-Invasive; Transducer, Pressure, Catheter Tip; Introducer, Catheter; Cup, Prophylaxis; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Collector, Ostomy; Protector, Ostomy; Bag, Bile Collecting; Dilator, Catheter, Ureteral; Cement, Stomal Appliance, Ostomy; Biopsy Needle; Endoscopic Access Overtube, Gastroenterology-Urology; Anoscope And Accessories; Dislodger, Stone, Basket, Ureteral, Metal; Adaptor, Bulbs, Miscellaneous, For Endoscope; Stents, Drains And Dilators For The Biliary Ducts; Ligator, Hemorrhoidal; System, Dialysate Delivery, Single Pass; Cleaner, Ultrasonic, Medical Instrument; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Warmer, Infant Radiant; Incubator, Neonatal; Bag, Urine Collection, Newborn; Bag, Drainage, With Adhesive, Ostomy; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Lavage, Jet; Bandage, Elastic; Indicator, Biological Sterilization Process; Lift, Patient, Non-Ac-Powered; Mesh, Surgical, Polymeric; Hood, Surgical; Gown, Surgical; Clip, Implantable; Expander, Surgical, Skin Graft; Needle, Aspiration And Injection, Disposable; Stapler, Surgical; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polypropylene; Catheter, Nephrostomy, General & Plastic Surgery; Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection; Connector, Catheter; Laparoscope, General & Plastic Surgery; Staple, Removable (Skin); Staple, Implantable; Scalpel, One-Piece; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Blade, Saw, General & Plastic Surgery, Surgical; Dermatome; Bur, Surgical, General & Plastic Surgery; Hemocytometer; Tube, Collection, Capillary Blood; System, Hemoglobin, Automated; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Electrode, Needle; Neurological Stereotaxic Instrument; Neurosurgical Paddie; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Compound, Powered); Holder, Head, Neurosurgical (Skull Clamp); Applier, Hemostatic Clip; Clamp, Umbilical; Amniotome; Speculum, Vaginal, Nonmetal; Hysteroscope (And Accessories); Cannula, Ophthalmic; Knife, Ophthalmic; Cystotome; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Arthroscope; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Eosin Y; Giemsa Stain; Hematoxylin; Stain, Papanicolau; Microtome, Accessories; Electrode, Needle, Diagnostic Electromyograph; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; Apparatus, Suction, Ward Use, Portable, Ac-Powered; Mixer, Cement, For Clinical Use; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tube Tracheostomy And Tube Cuff; Indicator, Physical/Chemical Sterilization Process; Catheter And Tip, Suction; Shunt, Central Nervous System And Components; Tube, Laryngectomy; Tourniquet, Pneumatic; Bottle, Collection, Vacuum; Surgeon'S Gloves; Tape And Bandage, Adhesive; Bandage, Liquid; Device, Intravascular Catheter Securement; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Instrument, Biopsy; Catheter, Suprapubic (And Accessories); Catheter, Urological; Dilator, Urethral; Stimulator, Nerve, Peripheral, Electric; Solvent, Adhesive Tape; Catheter, Continuous Flush; Syringe, Irrigating (Non Dental); Infusor, Pressure, For I.V. Bags; Stains, Chemical Solution; Instrument, Ultrasonic Surgical; Aid, Cardiopulmonary Resuscitation; Catheter, Nephrostomy; System, Irrigation, Urological; System, Image Processing, Radiological; Dislodger, Stone, Biliary; Razor, Surgical; Splint, Intranasal Septal; Bone Mill; Latex Patient Examination Glove; Disinfector, Medical Devices; Syringe, Antistick; Dressing, Wound And Burn, Occlusive; Automated External Defibrillators (Non-Wearable); Monitor, St Segment With Alarm; Sterilizer, Chemical; Ligator, Esophageal; Accessories, Cleaning Brushes, For Endoscope; Bilirubin (Total And Unbound) In The Neonate Test System; Wax, Bone; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Bandage, Liquid, Skin Protectant; Marker, Radiographic, Implantable; Suture, Surgical, Absorbable, Polydioxanone; Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration); Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Hemostatic Metal Clip For The Gi Tract; General Purpose Reagent; Non-Coring (Huber) Needle; Drape, Surgical, Exempt; Hemostatic Device For Endoscopic Gastrointestinal Use",1; 2; 3; U,"Clamp, umbilical; Clip, implantable; GENERAL AND PLASTIC SURGERY; Shunt, central nervous system and components; System, imaging, pulsed echo, ultrasonic",2024-04-05,166,2026-04-10,3,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223030733800%22&limit=1
Biomet Global Supply Chain Center B.V.,3013055499,3013055499,4836 LD Breda,Hazeldonk Noord-Brabant,,6530,Netherlands,ZIMMER GMBH,9064978,Exporter to the US,102,BTR; FSM; FTY; FZO; FZX; FZY; GAD; GDG; GDH; GEY; HAB; HRR; HRS; HRY; HSB; HSD; HSX; HTD; HTE; HTF; HTJ; HTN; HTO; HTR; HTT; HTW; HTY; HTZ; HWA; HWB; HWC; HWE; HWJ; HWT; HWW; HWX; HXC; HXO; HXP; HXT; HXW; HXX; JDI; JDK; JDL; JDO; JDQ; JDR; JDW; JEC; JWH; KRO; KRR; KTT; KTZ; KWA; KWL; KWP; KWQ; KWS; KWT; KWY; KWZ; LOD; LPH; LRY; LWG; LWJ; LXH; LXT; LYC; LYS; LZO; MAX; MAY; MBB; MBF; MBH; MBV; MEH; MJO; MNH; MNI; MOQ; MQP; MRW; NJL; NKB; NRA; ODP; OIY; OQG; OQH; OQI; OVD; OVE; OWI; PAO; PBI; PEK; PHX; PKC,"Tube, Tracheal (W/Wo Connector); Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Saw, Powered, And Accessories; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Forceps; Elevator; Curette; Gauge, Depth; Washer, Bolt Nut; Reamer; Rasp; Burr, Orthopedic; Bit, Drill; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Template; Countersink; Tap, Bone; Wrench; Pusher, Socket; Instrument, Bending Or Contouring; Tape, Orthopedic; Bender; Screwdriver; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Cement Restrictor; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Staple, Fixation, Bone; Pin, Fixation, Threaded; Component, Traction, Invasive; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Hemi-, Femoral, Metal; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Punch, Surgical; Surgical Table Cushion; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Bone Grafting Material, Synthetic; Bone Mill; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Battery, Replacement, Rechargeable; Spinal Vertebral Body Replacement Device; System, Facet Screw Spinal Device; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing; Thoracolumbosacral Pedicle Screw System; Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing; Intervertebral Fusion Device With Bone Graft, Cervical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Bone Fixation Cerclage, Sublaminar; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive; Spinous Process Plate; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained",1; 2; 3; U,"4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY; 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM; 6.5MM SOLID CANCELLOUS BONE SCREW; A. L. P. S. Clavicle Plating System; ABBOTT SPINE UNIVERSAL CLAMP SYSTEM; ACE 3.5MM CORTICAL BONE SCREW; ACE AIM TTC FUSION NAIL; ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM; ACE BIO WIN TIBIAL NAILING SYSTEM; ACE BROOKER BONE PLATING SYSTEM; ACE CANCELLOUS BONE SCREW; ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW; ACE CORTICAL BONE SCREW; ACE HUMERAL NAIL; ACE HUMERUS & RADIUS PLATES; ACE MULTIPLE PIN PLATE; ACE NANCY NAIL; ACE OPEN-BACK HALO RING; ACE RECONSTRUCTIVE PLATE; ACE VERSANAIL; ACE/KYLE CAPTURED HIP SCREW; AGC TOTAL KNEE PROSTHESIS; AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN; AIM SUPRACONDYLAR NAIL; ANATOMIC LOCKING PLATING SYSTEM; ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM; APPLICATOR TIP/DUAL SPRAYER KIT; ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS; ARCOMXL Polyethylene Liners and BIOLOX Delta Heads; ARCOS INTERLOCKING DISTAL STEMS; ARCPM 1050 RESIN-HIPS; ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System; Affixus Humeral Stem; Affixus® Natural Nail® System Humeral Nail; Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem; Anatomical Shoulder Keeled Glenoid; Anatomical Shoulder System; Avenir Complete Hip System; Avenir Complete Hip System, Size I Coxa Vera; Avenir Muller Stem, Avenir Cemented Hip Stem; Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System; Avenue® T TLIF Cage; BIOLOX DELTA CERAMIC HEADS; BIOLOX DELTA CERAMIC OPTION HEADS; BIOLOX DELTA OPTION CERAMIC HEADS; BIOLOX(R) DELTA CERAMIC HEADS; Biolox Delta Ceramic Femoral Heads, Biolox Option Ceramic Femoral Head System; Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads; Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling; Biomet Bone Cement R; Biomet Proximal Humerus Plating System; CEMENT RESTRICTOR; CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467; COMPREHENSIVE PRIMARY SHOULDER STEMS; DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL; DEPUY ACE AIM TITANIUM TIBIAL NAIL; DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL; DEPUY ACE TIMAX META PLATE; DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS; DEPUY ACE VERSANAIL TIBIAL NAIL; DEPUY AE TK2 HIP SCREW SYSTEM; EASYSPINE SYSTEM; EBI X FIX DYNAFIX SYSTEM (DFS); EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS; ENDOBON XENOGRAFT GRANULES; FRS SCREW; FacetBRIDGE System; FacetBRIDGE® System; Fitmore; Fitmore Hip Stem; G7 ACETABULAR SYSTEM; G7 Dual Mobility System; G7 Finned Acetabular Shell; G7 Freedom and Offset Liners, Freedom Head, Size 32; G7 OSSEOTI ACETUBLAR SHELLS; HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM; HIPLOC COMPRESSION HIP SCREW; INSTINCT JAVA SYSTEM; INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM; LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS; LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM; LDR SPINE EASYSPINE SYSTEM; LDR SPINE ROI INTERBODY FUSION SYSTEM; LDR SPINE ROI-A IMPLANT; LDR SPINE ROI-A INTERBODY FUSION SYSTEM; LDR SPINE ROI-C IMPLANT; LDR SPINE SPINETUNE TL SPINAL SYSTEM; LDR SPINE USA AVENUE L INTERBODY FUSION; LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM; LDR SPINE USA SPINE TUNE TL SPINE SYSTEM; LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S; LDR SPINE USA SPINETUNE TL SPINAL SYSTEM; LIGAFIX INTERFACE SCREW; LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM; MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM; MEMORY STAPLE; MEMORY STAPLE (20 SIZES AVAILABLE); MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE; MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM; MODIFICATION TO: LIGAFIX INTERFERENCE SCREW; MULTIPLICITY OF PRODUCTS; Mobi-C Cervical Disc Prosthesis; NANCY NAIL; NCB Plating System Distal Femur and Proximal Tibia; NCB Polyaxial Locking Plate System; NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES; NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS; NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO; NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS; NEXGEN LPS-FLEX MOBILE BEARING KNEE; NEXT GENERATION KNEE SYSTEM; NTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM; Normed; OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI); OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT; Orthopedic manual surgical instrument.; Oxford Partial Knee System; PE.R.I. II KNEE FRACTURE SYSTEM; POLYAX LOCKED PLATING SYSTEM; Persona Partial Knee System; REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW; ROI-C Titanium-Coated Implant System; Refobacin Bone Cement R; SCARF THREAD-HEAD SCREW; SMALL AND LARGE; SMALL BONE LOCKING PLATING SYSTEM; SMALL FRAGMENT LOCKING PLATING SYSTEM; STAPLE, FIXATION BONE; SCREW FIXATION BONE; Sidus Stem-Free Shoulder; Sulzer Ortho MS-30 Femoral Stem; TAPERLOC COMPLETE; TAPERLOC COMPLETE MICROPLASTY STEM; TAPERLOC COMPLETE SIZE 4MM AND XR 123; TAPERLOC COMPLETE, SIZE 5 AND 6; THACKRAY TITANIUM MINI-PLATING SYSTEM; TMARS Provisional Template; TRAUMA INTERNAL FIXATION SYSTEMS; TROCHANTERIC NAIL SYSTEM; TWIST-OFF (TM) SCREW; TWIST-OFF SCREW; Trabecular Metal Acetabular Revision; UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED; UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION; Universal Clamp Spinal System; VANGUARD 360 REVISION KNEE SYSTEM; VerteFIT Corpectomy Cage System; Wagner Revision Femoral Hip Prosthe; Wagner SL Revision Stem Lateral; Wagner SL and Wagner Cone Stems; Z Porolock MIS Stem; ZIMMER BIOMET; ZIMMER PERSONA KNEE SYSTEM; ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM; ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM; ZINDRICK IM ROD; ZINDRICK IM ROD INSTRUMENTS; Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head; Zimmer Biomet Ceramic Heads; Zimmer Biomet Select Ceramic Heads; Zimmer GmbH; Zimmer GmbH Hip Joint Replacement-MR Labeling; Zimmer Knee Joint Replacement Prostheses MR Labeling; Zimmer Natural Nail System Cephalomedullary Nails; Zimmer Persona Personalized Knee System; Zimmer, Inc. Hip Joint Prostheses MR Labeling I",1996-04-08,162,2025-04-18,4,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013055499%22&limit=1
Smith & Nephew Inc.,1643264,1643264,Endoscopy 76 S. Meridian Ave.,Oklahoma City,OK,73107,United States,"Smith & Nephew, Inc.",1020279,Contract manufacturer; Manufacturer; Remanufacturer; Repackager or relabeler,109,CCX; EMX; EOB; FEI; FET; FFS; FLN; FQH; FRG; FSM; FWF; FWW; FWZ; FZO; FZX; FZY; GAD; GAT; GCJ; GDC; GDZ; GEA; GEI; GEY; GFA; HAB; HAW; HET; HIF; HRR; HRS; HRX; HRY; HSB; HSD; HST; HSX; HTC; HTD; HTE; HTJ; HTN; HTO; HTW; HTY; HWB; HWC; HWE; HWJ; HWQ; HWR; HWT; HWX; HXB; HXC; HXD; HXG; HXK; HXL; HXW; HXX; HXY; JDG; JDI; JDJ; JDO; JDQ; JDS; JDW; JWH; KGS; KIJ; KIK; KMI; KQM; KQZ; KRO; KRQ; KRR; KTT; KWL; KWS; KWY; KWZ; LMB; LPH; LWJ; LXH; LXT; LYA; LZO; LZY; MAI; MBH; MBI; MBL; MEH; NBH; NDG; NFG; NJD; NPJ; ODA; OLL; OLO; OMP; OSN; OUG; SIQ,"Support, Patient Position; Balloon, Epistaxis; Nasopharyngoscope (Flexible Or Rigid); Instrument, Special Lens, For Endoscope; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Image, Illumination, Fiberoptic, For Endoscope ; Monitor, Electric For Gravity Flow Infusion Systems; Lavage, Jet; Wrap, Sterilization; Tray, Surgical, Instrument; Camera, Television, Endoscopic, Without Audio; Table, Operating-Room, Pneumatic; Operating Room Accessories Table Tray; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Table, Operating-Room, Electrical; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Saw, Powered, And Accessories; Neurological Stereotaxic Instrument; Laparoscope, Gynecologic (And Accessories); Insufflator, Laparoscopic; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Pliers, Surgical; Forceps; Elevator; Gauge, Depth; Washer, Bolt Nut; Reamer; Bit, Drill; Pin, Fixation, Smooth; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Passer; Driver, Prosthesis; Template; Tap, Bone; Probe; Wrench; Clamp; Tamp; Holder, Needle; Orthopedic; Mallet; Bender; Screwdriver; Brace, Drill; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Device, Fixation, Proximal Femoral, Implant; Cerclage, Fixation; Nail, Fixation, Bone; Pin, Fixation, Threaded; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Retention Device, Suture; Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment; Hook, Bone; Monitor, Bed Patient; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Device, Digital Image Storage, Radiological; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Splint, Intranasal Septal; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Accessories, Arthroscopic; Washer, Bolt, Nut, Non-Spinal, Metallic; Device, Communications, Images, Ophthalmic; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Endoscopic Central Control Unit; Septal Stapler/Absorbable Staples; Orthopedic Stereotaxic Instrument; Negative Pressure Wound Therapy Powered Suction Pump; Software For Diagnosis/Treatment; Medical Device Data System; Intra-Articular Orthopedic Stereotaxic Navigation Instrument",1; 2,"(curette, probe, rasp, osteotome ); 1.2 RAP-PAC A LATEX FREE; 1.2 RAP-PAC A, 72202796; 1.2 RAP-PAC B LATEX FREE; 1.2 RAP-PAC B, 72202797; 1.2 RAP-PAC C; 1.5 MM TENDON DRILL PIN; 1.5mm Guidewire, 12"", 72202189; 1.6MM DRILL & GUIDE DYNOMITE 2; 1.8MM DRILL & GUIDE SPYROMITE/MINI 2; 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (BLUE); 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (COBRAID WHITE); 10 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10 MM X 20 MM BIOSURE HA; 10 MM X 25 MM BIOSURE HA; 10 MM X 30 MM BIOSURE HA; 10 MM X 35 MM BIOSURE HA; 10.5 MM CANNULATED DRILL; 10.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 10.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10MM DILATOR; 11 MM GRAFT SIZING TUBE; 11 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11 MM X 25 MM BIOSURE HA; 11 MM X 30 MM BIOSURE HA; 11 MM X 35 MM BIOSURE HA; 11.5 MM CANNULATED DRILL; 11.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 11.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11MM DILATOR; 12 MM GRAFT SIZING TUBE; 12 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 12 MM X 35 MM BIOSURE HA; 12.5 MM CANNULATED DRILL; 12.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 12MM DILATOR; 13 MM GRAFT SIZING TUBE; 13 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 13.5 MM CANNULATED DRILL; 14 MM GRAFT SIZING TUBE; 15 DEGREE CLOSED CURETTE 3 MM; 15 DEGREE OPEN CURETTE 2.5 MM; 15 DEGREE OPEN CURETTE 4 MM; 15 DEGREE OSTEOTOME 3MM; 2 MM FULL RADIUS MINI BLADES, POWER/EP-1, BLUE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2-5 MM OFFSET GUIDE; 2.4 MM FLEXIBLE PASSING PINS, STERILE 5 PER PACKAGE; 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE; 2.4MM PASSING PIN WITH CALIBRATION MARKS; 2.6 MM TWIST DRILL BIT FOR 2.3 ANCHOR; 2.6MM DRILL & GUIDE RAPTORMITE 3; 2.7 MM CHISEL GUARD; 2.7 MM DILATOR; 2.7 MM DRILL GUIDE; 2.7 MM X 15 INCH 38 CM DRILL-TIP PASSING PIN, NON-STERILE 6 PER PACKAGE; 2.8MM Q-FIX ALL-SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE); 2.9 MM ABRADER MINI BURRS, POWER/EP-1, ORANGE, PACKAGED 6 PER BOX, STERILE; 2.9 MM BARREL ABRADER MINI BURRS, POWER/EP-1, PURPLE, PACKAGED 6 PER BOX, STERILE; 2.9 MM CUTTER MINI BLADES, POWER/EP-1, BEIGE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2.9 MM FULL RADIUS MINI BLADES RED, POWER/EP-1, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 20 DEGREE OSTEOTOME 4MM; 3.2MM DRILL & GUIDE RAPTORMITE 3.7; 3.5 MM ABRADER MINI BURRS, POWER/EP-1, AQUA, PACKAGED 6 PER BOX, STERILE; 3.5 MM CUTTER STRAIGHT BLADE; 3.5 MM DILATOR; 3.5 MM FULL RADIUS BLADE; 3.5 MM FULL RADIUS CURVED, CONCAVE, 8 CM MINI BLADES, POWER/EP-1, PLUM, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM HEX DRIVER, 2 MM CANNULATION; 3.5 MM INCISOR PLUS, 8 CM MINI BLADES, POWER/EP-1, SAGE GREEN, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM INCISOR STRAIGHT BLADE; 3.5 MM RAZORCUT STRAIGHT BLADE; 3.5 MM RAZORCUT, 8 CM MINI BLADES, POWER/EP-1, PUMPKIN/ORANGE, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 mm Bonecutter Platinum Blade; 3.5MM INCISOR PLUS PLAT BLD; 3.5MM SPADE TIP DRILL FOR USE WITH 4.5 MM ANCHOR HOLE PREPARATION DEVICE FOR HARD BONE; 3.5MM SYNOVATOR PLAT BLD; 3/S ELECTRODE 45DEG BLD (10BX); 30 DEGREE OPEN CURETTE 2.5 MM; 3D SPIDER CONNECTOR 1 REQUIRED PER EACH LEG ACCESORY; 4 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, SAGE GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4 MM ABRADER STRAIGHT BURR; 4 MM ACROMIONIZER STRAIGHT BURR; 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS; 4 MM PORTAL STICK X 12 INCH 30 CM LONG; 4 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, MAROON, PACKAGED 6 PER BOX, STERILE; 4 MM SHOULDER ROD X 12 INCH 30 CM LONG; 4 MM STONECUTTER STRAIGHT BURR; 4.5 ELITE, FULL RADIUS Electroblade Resector; 4.5 FULL RADIUS BONECUTTER BLADES, YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, CURVED, INCISOR CURVED BLADES, POWER/EP-1, LIME GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, FULL RADIUS, CURVE, CURVED BLADES, POWER/EP-1, YELLOW, CURVE LENGHTS 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, SYNOVATOR CURVED BLADES, POWER/EP-1, FOREST GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CUTTER STRAIGHT BLADE; 4.5 MM DILATOR; 4.5 MM DRILL GUIDE; 4.5 MM FULL RADIUS STRAIGHT BLADE; 4.5 MM HELICUT STRAIGHT BURRS, POWER/EP-1, SLATE, 5000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, VIOLET, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR STRAIGHT BLADE; 4.5 MM LONG CURVED FULL RADIUS CONCAVE SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM LONG FULL RADIUS SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM OBTURATOR, CONICAL TIP; 4.5 MM ORBIT FULL RADIUS CURVED BLADE; 4.5 MM ORBIT INCIISOR PLUS CURVED BLADES, POWER/EP-1, POWER/EP-1, VIOLET, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERIL; 4.5 MM ORBIT INCISOR CURVED BLADE; 4.5 MM ORBIT SYNOVATOR CURVED BLADE; 4.5 MM RAZORCUT STRAIGHT BLADE; 4.5 MM SYNOVATOR STRAIGHT BLADE; 4.5 MM TURBOTRIMMER STRAIGHT BLADE; 4.5 MM TURBOWHISKER STRAIGHT BLADE; 4.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, FOREST GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 mm Incisor Plus Platinum Curved Blade; 4.5 mm Synovator Platinum Curved Blade; 4.5MM FULL RADIUS PLATINUM SERIES; 4.5MM INCISOR PLUS PLATINUM BLADE; 4.5MM SYNOVATOR PLATINUM SERIES; 400 Insufflator System; 450/460 P camera Control Unit; 350/360 EnHanced NTSC CCU; 4KO ARTHROSCOPE DV AC 4 x 0 degree x 160mm; 4KO ARTHROSCOPE DV AC 4 x 30 degree x 160mm; 4KO ARTHROSCOPE DV AC 4 x 45 degree x 160mm; 4KO ARTHROSCOPE DV AC 4 x 70 degree x 160mm RND TIP; 4KO BARIATRIC LAPAROSCOPE AC 10 x 0 degree x 455mm; 4KO BARIATRIC LAPAROSCOPE AC 10 x 30 degree x 455mm; 4KO BARIATRIC LAPAROSCOPE AC 10 x 45 degree x 455mm; 4KO BARIATRIC LAPAROSCOPE AC 5.5 x 0 degree x 424mm; 4KO BARIATRIC LAPAROSCOPE AC 5.5 x 30 degree x 424mm; 4KO BARIATRIC LAPAROSCOPE AC 5.5 x 45 degree x 424mm; 4KO LAPAROSCOPE AC 10 x 0 degree x 330mm; 4KO LAPAROSCOPE AC 10 x 30 degree x 330mm, 72205164; 4KO LAPAROSCOPE AC 10 x 45 degree x 330mm; 4KO LAPAROSCOPE AC 5.5 x 0 degree x 300mm; 4KO LAPAROSCOPE AC 5.5 x 30 degree x 300mm; 4KO LAPAROSCOPE AC 5.5 x45 degree x 300mm; 4KO VIDEOARTHROSCOPE AC 4 x 30 degree x 160MM RP; 4KO VIDEOARTHROSCOPE AC 4 x 30 degree x 160mm; 4KO VIDEOARTHROSCOPE AC 4 x 70 degree x 160MM RP RND TIP; 4KO VIDEOARTHROSCOPE AC 4 x 70 degree x 160mm RND TIP; 4MM CANNULATED CAPTURED SCREW 32MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 34MM Stainless Stee; 4MM CANNULATED CAPTURED SCREW 38MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 42MM Stainless Steel; 4MM CANNULATED CAPTURED SCREW 44MM Stainless Steel; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 30MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 32MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 34MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 36MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 38MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 40MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 42MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 44MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 46MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 48MM; 4MM PARTIALLY THREADED CANNULATED SCREW 2.5 HEX SST 50MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 30MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 32MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 34MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 36MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 38MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 40MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 42MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 44MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 46MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 48MM; 4MM PARTIALLY THREADED SOLID SCREW 2.5 HEX SST 50MM; 4mm PLATINUM FLYER Blade; 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS; 5 MM CANNULATED DRILL; 5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, BLUE, LARGE DELRIN HANDLE; 5 MM FLEXIBLE DRILL; 5 MM HALF-ROUND RASP; 5.5 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, BRICK RED, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5 MM ABRADER STRAIGHT BURR; 5.5 MM ACROMIONIZER STRAIGHT BURR; 5.5 MM CANNULATED DRILL; 5.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 5.5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, RED, LARGE DELRIN HANDLE; 5.5 MM FULL RADIUS STRAIGHT BLADE; 5.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, TEAL, PACKAGED 6 PER BOX, STERILE; 5.5 MM INCISOR STRAIGHT BLADE; 5.5 MM OBTURATOR, CONICAL TIP, FOR CANNULAS WITH FLUID SEALS; 5.5 MM RAZORCUT STRAIGHT BLADE; 5.5 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, OLIVE, PACKAGED 6 PER BOX, STERILE; 5.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 5.5 MM STONECUTTER STRAIGHT BURR; 5.5 MM SYNOVATOR STRAIGHT BLADE; 5.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, MELON YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5MM FULL RADIUS PLATINUM SERIES; 5.5MM INCISOR PLUS PLATINUM SERIES; 5.5MM SYNOVATOR PLATINUM SERIES; 6 MM ENDOSCOPIC DRILL; 6 MM GRAFT SIZING TUBE; 6 MM OFFSET ENDOFEMORAL AIMER; 6 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6 MM X 20 MM BIOSURE HA; 6 MM X 25 MM BIOSURE HA; 6 MM X 25 MM BIOSURE HA REVERSE THREAD; 6.4 MM STRAIGHT GOUGE; 6.5 MM CANNULATED DRILL; 6.5 MM CHISEL GUARD; 6.5 MM DELIVERY TAMP; 6.5 MM DILATOR; 6.5 MM DRILL GUIDE; 6.5 MM ENDOSCOPIC DRILL; 6.5 MM HARVESTING TAMP; 6.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6.5 MM TREPHINE FOR HARD BONE; 6.5 MM TUBULAR CHISEL; 6.5MM DILATOR; 660HD Image Management System; 6MM DILATOR; 7 MM OFFSET ENDOFEMORAL AIMER; 7 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7 MM X 20 MM BIOSURE HA; 7 MM X 25 MM BIOSURE HA; 7 MM X 25 MM BIOSURE HA REVERSE THREAD; 7 MM X 30 MM BIOSURE HA; 7 X 20 MM SOFTSILK SCREW 1.5 STERILE; 7 X 25 MM SOFTSILK SCREW 1.5 STERILE; 7 X 30 MM SOFTSILK SCREW 1.5 STERILE; 7.5 MM CANNULATED DRILL; 7.5 MM ENDOSCOPIC DRILL; 7.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7.5MM DILATOR; 72205455 INTELLIO Tablet; 72205455 Intellio TABLET; 72205719 INTELLIO TABLET COUNTRY KIT EN US; 72205719 Intellio TABLET Country Kit (US); 72205777 TESSA ACL Femur Straight Aimer Kit; 72205778 TESSA ACL Femur Curved Aimer Kit; 72205780 TESSA Control Unit; 72205781 TESSA ACL Femur System License Software, No Cloud; 72205782 TESSA Marker A; 72205783 TESSA ACL Femur License Software, Cloud, with Imaging Center; 72205784 TESSA ACL Femur License Software, Cloud, No Imaging Center; 72205785 License for Imaging Center Only; 72205786 TRIAL TESSA ACL Femur License Software, Cloud, with Imaging Center; 72205787 TRIAL TESSA ACL Femur License Software, Cloud, No Imaging Center; 72205790 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON Adjustable Fixation Device; 72205791 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON QUAD Adjustable Fixation Device; 72205792 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON BB Adjustable Fixation Device; 72205793 TESSA ACL Femur Straight Aimer Kit with ENDOBUTTON CL Ultra, 15mm; 72205800 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON Adjustable Fixation Device; 72205801 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON QUAD Adjustable Fixation Device; 72205802 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON BB Adjustable Fixation Device; 72205803 TESSA ACL Femur Curved Aimer Kit with ENDOBUTTON CL Ultra, 15mm; 72205810 TESSA Control Unit Accessory Box; 72205811 TESSA Control Unit Country Kit, EN, UK; 72205911 TESSA Control Unit Country Kit, En, US; 72290007 Wired Foot Control; 72290008 Wireless Foot Contol; 72290037 Werewolf FLOW 50 Coblation Wand (E-beam); 72290057 Werewolf Power Cord/Manual - US English; 72290058 Werewolf Power Cord/Manual - N. America; 72290059 Werewolf Power Cord/Manual - W. Europe; 72290060 Werewolf Power Cord/Manual - EU Spanish; 72290061 Werewolf Power Cord/Manual - EU English; 72290062 Werewolf Power Cord/Manual - Scandinavia; 72290063 Werewolf Power Cord/Manual - Russia; 72290064 Werewolf Power Cord/Manual - Korea; 72290065 Werewolf Power Cord/Manual - Switzerlalnd; 72290066 Werewolf Power Cord/Manual - China; 72290067 Werewolf Power Cord/Manual -Australia; 72290068 Werewolf Power Cord/Manual - Japan; 72290105 Werewolf RF20000 Controller; 7MM BICEPTOR TAP; 7MM DILATOR; 7MM ENDOSCOPIC DRILL XL; 7MM TENDON FORK; 8 MM ENDOSCOPIC DRILL XL; 8 MM PL TIBIAL AIMER POST; 8 MM X 20 MM BIOSURE HA; 8 MM X 25 MM BIOSURE HA; 8 MM X 25 MM BIOSURE HA REVERSE THREAT; 8 MM X 30MM BIOSURE HA; 8 MM X 35MM BIOSURE HA; 8 X 20 MM SOFTSILK SCREW 1.5 STERILE; 8 X 25 MM SOFTSILK SCREW 1.5 STERILE; 8 X 30 MM SOFTSILK SCREW 1.5 STERILE; 8.5 MM CANNULATED DRILL; 8.5 MM DELIVERY TAMP; 8.5 MM DILATOR; 8.5 MM DRILL GUIDE; 8.5 MM ENDOSCOPIC DRILL; 8.5 MM HARVESTING TAMP; 8.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 8.5 MM TREPHINE FOR HARD BONE; 8.5 MM TUBULAR CHISEL; 8.5MM DILATOR; 8MM BICEPTOR TAP; 8MM DILATOR; 8MM TENDON FORK; 9 MM ENDOSCOPIC DRILL XL; 9 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9 MM X 20 MM BIOSURE HA; 9 MM X 25 MM BIOSURE HA; 9 MM X 30 MM BIOSURE HA; 9 MM X 35 MM BIOSURE HA; 9 X 20 MM SOFTSILK SCREW 1.5 STERILE; 9 X 25 MM SOFTSILK SCREW 1.5 STERILE; 9 X 30 MM SOFTSILK SCREW 1.5 STERILE; 9.5 MM CANNULATED DRILL; 9.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 9.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9.5MM DILATOR; 90 DEGREE CONNECTOR; 90 DEGREE CURETTE, ANTERIOR LESION; 9MM BICEPTOR TAP; 9MM DILATOR; 9MM TENDON FORK; A-Tech ACL Sterilization Tray; A-Tech Controlled Flexion Guidewire; A-Tech Femoral Locator Handle; ABLATOR E-FLEX VULCAN INTEGRATED; ABLATOR MICRO VULCAN INTEGRATED; ABLATOR VULCAN 60 DEG; ABLATOR VULCAN 60 DEG 2MM; ABLATOR VULCAN 90 DEG HP; ABLATOR-S 2MM 60DEG; ABLATOR-S MICRO VULCAN 2MM 60 DEG; ABLATOR-S VULCAN 60 DEG; ABLATOR-S VULCAN 90 DEG; ABLATOR-S VULCAN 90 DEG HP; AC Powered Instrument Motor; ACCESSORY, TRACTION; ACCORD; ACCU-PASS STR SHTL BIG C STERILE BOX 1; ACCU-PASS SUTURE SHUTTLE 70 DEGREE; ACCU-PASS SUTURE SHUTTLE J-HOOK STERIL; ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE; ACCUPASS STR SHUTL MONOFIL -SEE72201361; ACCURIS; ACL Bullet; ACL CHAMFERING RASP 7 MM, HALF-ROUND; ACL CHAMFERING RASP 8 MM, HALF-ROUND; ACL CHAMFERING RASP BONE TUNNEL; ACL CHAMFERING RASP CHAMFERING; ACL Closed Curette; ACL Disposables Guidewire Kit; ACL Disposables Kit; ACL Open Curette; ACL Tunnel Rasp; ACMI INSTRUMENT AI VERSITIP ADAPTOR FOR 4 MM AND 5 MM LIGHT GUIDES; ACTIVE HEEL TRACTION BOOT KNEE HOLDER; ACTIVE HEEL TRACTION BOOT REPLACEMENT KIT - PADS ONLY; ACUFEX; ACUFEX ACCESS LATERAL TRACTION BOOM; ACUFEX DIRECTOR ACL ELBOW AIMER; ACUFEX DIRECTOR ACL TIP AIMER; ACUFEX DIRECTOR ANGLED BULLET; ACUFEX DIRECTOR DRILL GUIDE. REQUIRES 1 AIMER AND 1 BULLET NOT INCLUDED; ACUFEX DIRECTOR PCL FEMORAL AIMER; ACUFEX DIRECTOR PCL SAFETY STOP; ACUFEX EXTRA ARTICULAR RECONSTRUCTION FEMORAL GUIDE; ACUFEX EXTRA ARTICULAR RECONSTRUCTION OFFSET GUIDE; ACUFEX Extra-Articular Reconstruction Fibular Guide; ACUFEX Extra-Articular Reconstruction Long Bullet; ACUFEX Extra-Articular Reconstruction Short Bullet; ACUFEX Extra-Articular Reconstruction System Tray; ACUFEX Extra-Articular Reconstruction Tibial Guide; ACUFEX Extra-Articular Retractor; ACUFEX GRAFTMASTER III PREPARATION BOARD; ACUFEX MTO PUNCH BASKET DUCKBILL UPBITER CURVED RIGHT PRO HANDLE; ACUFEX PINPOINT ADAPTER; ACUFEX PINPOINT BULLET 4 POINT - 6.5; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-6MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 6-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 7-8MM; ACUFEX PINPOINT DBL BNDL BULL SPT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-6MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 7-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-6MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 7-8MM; ACUFEX PINPOINT INSIDE-OUT HANDLE; ACUFEX PINPOINT OUTSIDE-IN AMR ARM LEFT; ACUFEX PINPOINT OUTSIDE-IN AMR ARM RT; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 10MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 6MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 8MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 9MM; ACUFEX PINPOINT SNGL BNDL GD 7MM; ACUFEX PUNCH BASKET CURVED RIGHT PRO HANDLE; ACUFEX PUNCH BASKET LEFT PRO HANDLE; ACUFEX PUNCH BASKET PRO RIGHT PRO HANDLE; ACUFEX PUNCH BASKET STRAIGHT PRO HANDLE; ACUFEX PUNCH BASKET UPBITER PRO HANDLE; ACUFEX PUNCH BASKET UPSWEPT PRO HANDLE; ACUFEX PUNCH OVAL STRAIGHT PRO HANDLE; ACUFEX PUNCH OVAL UPBITER PRO HANDLE; ACUFEX PUNCH SCISSOR STRAIGHT PRO HANDLE; ACUFEX PUNCH SCISSOR UPBITER PRO HANDLE; ACUFEX T-BAR; MTO KNOT PUSHER, SHOULDER; ACUFEX TUNNEL GAUGE; ACUFEX-PRO 3.4MM CUPPED GRASPR; ACUFEX-PRO NARROWLINE STR; ACUFEX-PRO NARROWLINE UPBITER; ACUFEX-PRO PITBULL GRASPER; ADAPTER D LEG KIT (2 UNITS)TENET 7404; ADAPTER JE LEG KIT(2 UNITS)TENET 7402; ADAPTER RAIL CLAMP(2 UNITS)TENET 7403; ADJUST ARM BRD GEL PAD RPLMNT KIT; ADJUSTABLE ARM BOARD HARDWARE KIT; ADJUSTABLE HEIGHT ROLLING MONITOR STAND; ADVANSYS; ADVANSYS DLP; ADVANSYS MLP; ADVANSYS TTC; AHTB UNIVERSAL HIP DISTRACTOR; AHTB WELL LEG HOLDER; AIMER ENDOFEMORAL 3MM OFFSET (BLUE); AIMER ENDOFEMORAL 4MM OFFSET (PURPLE); AIMER ENDOFEMORAL 5MM OFFSET (RED); AIMER REAR ENTRY RIGHT-ACL; AIMER REAR ENTRY-LEFT; AIMER TIBIAL PCL; AMBI; ANKLE ARTHROSCOPY ACCESSORY 2 UNITS; ANKLE STABILIZATION KITS, DISPOSABLE 6 UNITS; ANTHEM; ANTHOLOGY; ARO Osteotomy Guide Assembly; ARO Spacer Plate; ARTHRO-PIERCE STRAIGHT; ARTHROGARDE 4.5MM HIP CANNULA; ARTHROGARDE 5.5MM HIP CANNULA; ARTHROGARDE 5MM HIP CANNULA; ARTHROGARDE SLOTTLED CANNULA HIP; ARTHROPIERCE; ARTHROPIERCE 35 DEGREE UP; ARTHROPIERCE 45 DEG RIGHT; ARTHROPIERCE 45 DEGREE LEFT; ARTHROPIERCE INSTRUMENT CURVED LEFT; ARTHROPIERCE INSTRUMENT CURVED RIGHT; ARTHROPIERCE UTRATAPE; ARTHROPIERCE XL STRAIGHT; ARTHROSCOPIC LATARJET/BONE BLOCK LID; ARTHROSCOPIC LATARJET/BONE BLOCK TRAY; ARTHROSCOPIC NEEDLE STERILE; ASSEMBLY ENDOBUTTON INDICATOR; AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY 9.5 INCH LENGTH X 3 INCH WIDTH X 1.25 INCH HEIGHT; AWL STRAIGHT 3.8MM DISPOSABLE; AWL, INSERTION SITE MARKING, 45 DEGREES; Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361; Accu-pass suture shuttle 45 degree up, 7210425; Accu-pass suture shuttle 70 degree, Upbend, 72200419; Accu-pass suture shuttle J-hook; Accu-pass suture shuttle left 45 degree, 7210423; Accu-pass suture shuttle right 45 degree; Accu-pass suture shuttle, Big Curve; Accu-pass suture shuttle, crescent, 7210427; Accu-pass suture shuttle, straight, 7210426; Acufex Access Advanced Positioning Kit; Acufex Access Cart; Acufex Access Positioning Kit; Acufex Accss Positioning System; Acute QC Strut and Components; Adaptor; All- Suture 1.9mm Anchor with ULTRABRAID Suture; All-Suture 1.7mm Anchor with ULTRABRAID Suture; Ambient CoVac 50 IFS; Ambient CoVac 70 IFS; Ambient HipVac 50 IFS; Ambient Kvac IFS; Ambient MegaVac 90; Ambient Super TurboVac 90; Anatomic ACL Tray; Ankle Distractor; Ankle Distractor Strap; Arthroscopic needle, 72202825; Ascension; Awl; Awl straight 3.8mm, 72202986; Awl tapered 3.8mm; Awl, tap, driver, dilator; B-BOP; BANKART RASP; BENT STRAP SUPPORT REPLACEMENT KIT; BI-GRIP PIN PULLER; BICEPTOR DRIVER; BIORAPTOR INLINE DRILL GUIDE - OFFSET FISHMOUTH TIP 2.9 MM; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, CROWN TIP; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP; BIORAPTOR KNOTLESS INLINE OBTURATOR, BLUNT; BIORAPTOR TWIST DRILL, 2.9 MM INLINE; BIOSURE DRIVER; BIOSURE EASY TAP 10MM; BIOSURE EASY TAP 6MM; BIOSURE EASY TAP 7MM; BIOSURE EASY TAP 8MM; BIOSURE EASY TAP 9MM; BIOSURE RATCHET DRIVER; BIOSURE SYNC Inserter; BIOSURE TAP 10MM; BIOSURE TAP 6MM; BIOSURE TAP 7MM; BIOSURE TAP 8MM; BIOSURE TAP 9MM; BLADE 3.5 CURVED CONCAVE FULL RADIUS; BLADE 3.5MM ELITE FULL RADIUS; BLADE 4 ELITE ABRADER 6/BX; BLADE 5.5 FULL RADIUS ELITE DISPOSABLE; BLADE,4.5 BONECUTTER,FR,180MM LG,DSP; BLT ASSY. 4 POINT DIRECTOR; BLUNT NOSE JR. PUNCH; BOARD, PATIENT TRANSFER; BONE GRASPER; BONE TUNNEL PLUG; BONE TUNNEL PLUG NON-CANNULATED, LARGE 10-11 MM 3 PER PACKAGE; BONE TUNNEL PLUG NON-CANNULATED, SMALL 7-8 MM 3 PER PACKAGE; BONE TUNNEL PLUG XL 11-12 MM 3 PER PACKAGE; BOOT INSERT PAD; BURR 4MM ABRADER 180MML DISPOSABLE (3; BURR 5.5MM ABRADER 180MML DISPOSABLE; Beath pin 2.4mm, 72202815; Beluga Retro; Bilok Instrument Sterilization Tray; Bilok ST Graft Expander; Biosure 1.2mm x 18"", 72201201; Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile; Blade, Sheath, Burr, Abrader, Incisor, Synovator, Acromionizer, Tubowhisker, Bonecutter, Acromioblaster, Notchblaster; Blunt Nose Junior; Bone Hook; Bone Tap; CALF STRAP EQUIPMENT RPLT AHTB; CALIBRATED DEPTH GAGE; CAMERA COUPLER,16:9 HD REF; CAMERA HEAD LENS INT SYS; CANN 5.5 WO/HOLES LTX FREE ORANGE; CANN DIAG RTTBL DBL VLV 4.5 ASCOPE; CANN DV ROT HF STORZ INT 6MM; CANN H.F. DGNST 6MM RTBL SGL VLV; CANN M.F. DGNST 6MM HIP DBL VLV; CANNU-FLEX 6 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 6 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 6 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX 8 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 8 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX DRIVER SILK SCREW 7MM CANNULATED; CANNU-FLEX DRIVER SILK SCREW 9MM CANNULATED; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE; CANNULA; CANNULA 2.9MM LONG WINDOW ASSEMBLY; CANNULA 2.9MM SHORT WINDOW; CANNULA 5.5MM OPER. W/STOPCOCK; CANNULA 5.5MM W/FINGER POST; CANNULA 6MM FMS 4MM AS W/O STOPCK; CANNULA 6MM FMS4MM ASCOPE W/STPCK; CANNULA CLEARTRAC 4.5 X 72MM THREADED; CANNULA CLEARTRAC SMOOTH 7 X 72MM; CANNULA CLEARTRAC THREADED 8.5 X 45MM; CANNULA CLEARTRAC THREADED 8.5 X 90MM; CANNULA ECTR; CANNULA FINGER POSTED 4.5MM; CANNULA FINGER POSTED 5.5MM; CANNULA FMS 2.7 LONG ASCOPE; CANNULA FMS SHORT 2.7 AS 3.8; CANNULA FOR 3.6 OPERATIVE SET; CANNULA INTEL NON-SCOPE 3MM; CANNULA MED FLOW ROT DBL VLV 5MM; CANNULA OPERATIVE 4.5MM NO DISATLHOLES; CANNULA OPERATIVE 5.5MM FINGERPOST; CANNULA OPERATIVE 5.5MM NO DISTAL HOLE; CANNULA OPERATIVE 5MM NO DIS HOLES; CANNULA SMOOTH FLEX 5.5 X 55MM; CANNULA SMOOTH FLEX 6.5 X 72MM; CANNULA SMOOTH FLEX 8 X 72MM; CANNULA THREADED DISP 8.5 X 72MM; CANNULA THREADED FLEX 5.5 X 45MM; CANNULA THREADED FLEX 6.5 X 72MM; CANNULA THREADED FLEX 8 X 90MM; CANNULATED OBTURATOR W/DELRIN 4.5MM; CANNULATED OBTURATOR W/DELRIN 5.5MM; CANNULATED OTBURATOR 8MM; CANNULATED SCREWS; CANNULATED SCREWS CHS COMPRESSION HIP SCREW CONQUEST FN D-RAD PLATING SYSTEM EVOS PLATING SYSTEM; CAP-FIX Blade, Curved; CAP-FIX Blade, Curved, with Handle; CAP-FIX Blade, Curved, with Hip Pac; CAP-FIX Blade, Straight; CAP-FIX Blade, Straight, with Handle; CAP-FIX Blade, Straight, with Hip Pac; CAP-FIX SUTURE PASSER 45 DEG; CAP-FIX SUTURE PASSER 70 DEG; CAP-LIFT Cannula, 100mm; CAP-LIFT Cannula, 110mm; CAP-LIFT Cannula, 70mm; CAP-LIFT Cannula, 80mm; CAP-LIFT Cannula, 90mm; CARRIAGE REPLACEMENT KIT; CARRIAGE, RPLT, UNIV HIP DIST FOR AHTB; CART PROCEDURE W. ISOL. TRANSFORMER; CART TRANSPORT SPIDER; CHISEL E-FLEX VULCAN FINISHED STERILE; CHISEL GUARD; CHISEL MICRO CURVED VULCAN INTEGRATED; CHISEL MICRO VULCAN ANGLED INTEGRATED; CHISEL MICRO VULCAN HOOK INTEGRATED; CHISEL VULCAN ANGLED; CHISEL VULCAN CURVED; CHISEL VULCAN HOOK; CHISEL VULCAN STRAIGHT W/INTEGRATED CBL; CHONDRAL PICK, LARGE SHAFT 20 DEGREE; CHONDRAL PICK, LARGE SHAFT 40 DEGREE; CHONDRAL PICK, LARGE, 20 DEGREE; CHONDRAL PICK, LARGE, 40 DEGREE; CHONDRAL PICK, SMALL SHAFT 20 DEGREE; CHONDRAL PICK, SMALL SHAFT 40 DEGREE; CHONDRAL PICK, SMALL, 20 DEGREE; CHONDRAL PICK, SMALL, 40 DEGREE; CHONDRAL PICK, SMALL, 90 DEGREE; CHS COMPRESSION HIP SCREW; CIRCLE SUTURE MENISCAL MENDER II; CLAMP DENYERS RAIL TENET 7406; CLANCY 10 MM FLEXIBLE DRILL; CLANCY 10.5 MM FLEXIBLE DRILL; CLANCY 11 MM FLEXIBLE DRILL; CLANCY 12 MM FLEXIBLE DRILL; CLANCY 7.5 MM FLEXIBLE DRILL; CLANCY 9 MM FLEXIBLE DRILL; CLANCY 9.5 MM FLEXIBLE DRILL; CLANCY CURVED FEMORAL GUIDE, 42 DEGREE; CLEAR TRAC COMPLETE HIP CANNULA 7X110; CLEAR TRAC COMPLETE HIP CANNULA 8.5X110; CLEAR-TRAC CMPL. CANN. HIP OBT.8.5X110; CLEAR-TRAC CMPL.CANN. HIP OBT.7X110; CLEAR-TRAC DISPOSABLE STOPCOCK; CLEAR-TRAC MTO 5.5 MM X 72 MM REUSABLE OBTURATOR 4.3 MM CANNULATION; CLEAR-TRAC SCR CANN 8MM LTX FREE; CLEAR-TRAC THREADED CANNULA WITH OBTURATOR 5 MM X 76 MM, LATEX FREE, BOX OF 10; CLEARTRAC SCOPE/SHAVER CANNULA SMOOTH; COBLATION; COBLATOR; COFIELD; COMPASS; CONQUEST FN; CONTOUR; CONTROL UNIT, DYONICS 25; CORACOID DRILLING GUIDE; CORACOID DRILLING OFFSETGUIDE 10MM; CORI; COUPLER HD 17.2MM AUTOCLAVABLE; COUPLER, 19.5mm, 5:4 AUTOCLAVABLE, HD; COUPLER, HIGH DEFINITION, NON-AUTOCLAVABLE, 19.5 MM, BLACK RING; COUPLER, UROLOGY, HD; CPCS; CROSSTRAC HIP GUIDE; CROSSTRAC HIP GUIDE BULLET; CURETTE CLOSED 3MM; CURETTE CLOSED 5MM; CURETTE CURVED 90 DEG; CURETTE OPEN 6MM 15 DEG; CURETTE OPEN 7MM; CURRETTE OPEN 4MM; CURVED BLUNT DISSECTOR; CURVED DRILL GUIDE FOR 2.3 MM SUTURE ANCHORS, FISHMOUTH TIP; CURVED ELEVATOR; CURVED INCISOR PLUS ELITE BL 4.5MM; CURVED LONG INCISOR PLUS ELITE BLADE; CURVED PROBE 3MM; Cable, Monitor Adaptor, remote control, IMAGE MANAGEMENT COMPUTER; Camera coupler; Cannu-Flex Screw; Cannuflex 9"" Blunt Guidewire, 72202807; Cannula 5.5mm; Cannula Driver; Cannula set 4.5mm; Cannula set 5.5mm; Cannula set 7mm; Cannula, Obturator, Punch, Scissor, Suture cutter, Aimer, Gore smoother, Trephine adaptor, Guide, Knife; Cannula; post same as DOV, no holes; Cannulated Switching Stick; Caps-Lock Cannula Driver; Caps-Lock Ultra; Chisel; Chondral Pick; Chondral Pick Sterilization Tray; Clamp; Clear-Trac Screw Cannula 7mm; Clear-Trac Screw Cannula 9mm; Clear-Trac Threaded Cannula 8mm x 76mm; Clear-Trac Threaded Cannula Kit 5mm ID, 76mm LG; Clear-Trac Threaded Cannula Kit, 8mm I.D., 76mm LG; Clear-Trac cannula Stopcock; Clear-Trac scope/shaver cannula; Clear-Trac scope/shaver cannula w/rib; Clearcut Suture Cutter; Closed Tendon Harvester; CoVator 20; Cobb; Coblation; Crochet Hook; Crosstrac Flexible Passing Pin 13.50 x 2.4mm; Cuff Elevator; D-RAD; D-RAD PLATING SYSTEM; D-RAD SMART PACK; DART SUTURE PASSER; DELIVERY TAMP 3.5MM A.M.P.; DENYER RAIL CLAMP (LATERL DSTRCTR SYS); DENYER SUPINE RAIL CLAMPS 2; DETACHABLE OBTURATOR HANDLE ECTRA 2; DIA. 15MM CANNULA COVER; DIA. 15MM CANNULA TROCAR; DIA. 15MM CANNULA TUBE; DIAGNOSTIC CANNULAS 2.9MM; DIAMOND RASP 45 DEGREE; DIAMOND RASP 90 DEGREE; DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES; DII CONTROLLER; DILATOR; DILATOR 11-12MM BIOSURE SYNC; DILATOR 7-8MM BIOSURE SYNC; DILATOR 9-10MM BIOSURE SYNC; DIRECTOR PCL ELEVATOR WITH WIRE CATCHER; DISPOSABLE BL 4.5 ORBIT FR ELITE; DISPOSABLE BL 4.5MM CURVED FR ELITE (6); DISPOSABLE KNIFE; DISPOSABLE KNIFE HOOK STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE HOOK STRAIGHT 3 MM BOX OF 5, 10600; DISPOSABLE KNIFE ROSSETTE STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE SERRATED BANANA STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE SHARP TIP STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE V SHAPED; DISPOSABLE KNIFE V SHAPED, 10660; DISPOSABLE MULTI BAG ADAPTERS Y TUBING, STERILE, 2 TO A SET 6 SETS PER BOX; DISSECTOR BLUNT CURVED ECTR; DISTAL THIGH HOLDER; DISTRACTOR WARUPA DOUBLE 1.1MM&1.6MM; DOUBLE POSTERIOR GLENOID DRILL GUIDE; DPR SYSTEM; DRILL 2.6 MM BIORAPTOR 2.3 SUT ANC; DRILL 3.5MM SPADE TIP HEALICOIL SA; DRILL 4.5MM SPADE TIP; DRILL 4.5MM SPADE TIP HEALICOIL SA; DRILL 5.5MM SPADE TIP; DRILL ENDOBUTTON 4.5MM NON-CANN; DRILL FIXATION POSTERIOR STERILE BX OF 1; DRILL FLUTED 3MM WITH DEPTH STOP; DRILL GUIDE 3.5MM AMP; DRILL GUIDE AC JOINT LEFT; DRILL GUIDE CROWN TIP REUSABLE STANDARD; DRILL GUIDE CROWN TIP REUSABLE XL; DRILL GUIDE CRVD FOR 2.3 SA CROWN; DRILL GUIDE OFFSET; DRILL GUIDE PHALANGEAL EXTRA ARTICULAR; DRILL GUIDE PHALANGEAL LONG OFFSET; DRILL GUIDE PHALANGEAL SHORT OFFSET; DRILL GUIDE S FISHMOUTH REUSABLE; DRILL GUIDE SLOTTED SPIKE TIP 2.3MM; DRILL GUIDE SLOTTED SPIKE TIP SL; DRILL GUIDE XL SPIKE TIP; DRILL RAPTORMITE 3 SUTURE ANCHOR; DRILL SURETAC IXC 8MM; DRILL TIP PASSING PIN 2.7 MM X 15 INCH, STERILE 6 PER BOX; DRILL, 2.5 MM FOR 3.5 MM TWINFIX SUTURE ANCHOR, SL; DRIVER CANNULATED SCREW; DRIVER PIP MIDDLE PHALANX; DRIVER PIP PROXIMAL PHALANX; DRIVER PIP PROXIMAL PHALANX 10 DEGREE; DRIVER SILK SCREW 1.5MM; DRIVER,CANNULATED 2mm; DUCKBILL PUNCH BASKET UPBITER 1.5MM LOOP HANDLE; DUCKBILL PUNCH BASKET UPBITER CURVED LEFT 1.5 MM LOOP HANDLE; DUCKBILL PUNCH BASKET UPBITER CURVED RIGHT 1.5 MM LOOP HANDLE; DUCKLING PUNCH BASKET CURVED LEFT LOOP HANDLE; DUCKLING PUNCH BASKET CURVED RIGHT LOOP HANDLE; DUCKLING PUNCH BASKET ELEVATOR LOOP HANDLE; DUCKLING PUNCH BASKET STRAIGHT LOOP HANDLE; DUCKLING PUNCH BASKET UPBITER LOOP HANDLE; DUCKLING PUNCH BASKET UPSWEPT LOOP HANDLE; DYONICS 1/4 JCBS STL DRL SML BAT HND PC; DYONICS 2 MM FULL RADIUS BLADES, 7 CM LENGTH, BLUE, PACKAGED 6 PER BOX, STERILE; DYONICS 2 MM TURBOWHISKER BLADES, 7 CM LENGTH, YELLOW, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM ABRADER BURRS, 7 CM LENGTH, ORANGE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM BARREL BURRS, 7 CM LENGTH, PURPLE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM CUTTER BLADES, 7 CM LENGTH, BEIGE, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM FULL RADIUS BLADES, 7 CM LENGTH, RED, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM INCISOR PLUS ELITE BLADES, 7 CM LENGTH, PEACH, PACKAGED 6 PER BOX, STERILE; DYONICS 2.9 MM TURBOWHISKER BLADES, 7 CM LENGTH, GREEN, PACKAGED 6 PER BOX, STERILE; DYONICS 25; DYONICS 25 DAY TUBE SET (3); DYONICS 25 INFLOW ONLY TUBE SET (3); DYONICS 25 INFLOW/OUTFLOW TUBE SET (3); DYONICS 25 INFLW/OUTFLW FORK SUCTN (3)",1978-02-22,161,2026-09-08,0,4,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221643264%22&limit=1
Orthofix Us LLC,2183449,2183449,3451 Plano Parkway,Lewisville,TX,75056,United States,Orthofix US LLC,10028162,Complaint file establishment; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,95,FMF; FSM; FTY; FWZ; FZO; FZS; FZT; FZX; FZY; GAD; GAH; GCZ; GDG; GDH; GDI; GDW; GDZ; GEA; GEF; GEG; HAO; HRR; HRS; HRX; HSB; HTC; HTD; HTJ; HTO; HTQ; HTR; HTT; HTW; HTX; HTY; HWA; HWB; HWC; HWJ; HWK; HWM; HWN; HWQ; HWR; HWT; HWX; HXB; HXC; HXD; HXE; HXG; HXI; HXL; HXO; HXQ; HXR; HXW; HXX; HXY; IPY; JDO; JDS; JDW; JDX; JEC; JOL; KTT; KTW; KWP; KWQ; LLZ; LOF; LRY; LXH; LXT; LZV; MAX; MDM; MJO; MNH; MNI; MQP; NKB; NKG; NQW; OBT; ODP; OLO; OSH; OSN; OUG; OUR; OVD; OVE; QLQ,"Syringe, Piston; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Operating Room Accessories Table Tray; Chisel, Surgical, Manual; Curette, Surgical, General Use; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Stylet, Surgical, General & Plastic Surgery; Retainer, Surgical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Staple, Implantable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Applier, Staple, Surgical,; Elevator, Surgical, General & Plastic Surgery; Instrument, Surgical, Non-Powered; Scissors, Orthopedic, Surgical; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Pliers, Surgical; Forceps; Gauge, Depth; Reamer; Broach; Rasp; Burr, Orthopedic; Bit, Drill; Rongeur; Pin, Fixation, Smooth; Impactor; Extractor; Screw, Fixation, Bone; Awl; Trephine; Osteotome; Instrument, Compression; Passer; Driver, Prosthesis; Template; Tap, Bone; Probe; Wrench; Clamp; Fork; Tamp; Passer, Wire, Orthopedic; Mallet; Pusher, Socket; Crimper, Pin; Spatula, Orthopedic; Bender; Screwdriver; Brace, Drill; Orthosis, Lumbo-Sacral; Device, Fixation, Proximal Femoral, Implant; Nail, Fixation, Bone; Pin, Fixation, Threaded; Instrument, Surgical, Sonic And Accessory/Attachment; Component, Traction, Invasive; Catheter And Tip, Suction; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; System, Image Processing, Radiological; Stimulator, Bone Growth, Non-Invasive; Punch, Surgical; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; System, Cement Removal Extraction; Intervertebral Fusion Device With Bone Graft, Lumbar; Instrument, Manual, Surgical, General Use; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Orthosis, Spine, Plate, Laminoplasty, Metal; Plate, Bone, Growth Control, Pediatric, Epiphysiodesis; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Software For Diagnosis/Treatment; Medical Device Data System; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Manual Instruments Designed For Use With Total Disc Replacement Devices",1; 2; 3,"3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallma; ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS); AZURE ANTERIOR CERVICAL PLATE SYSTEM; Accelstim; Agile Nail; Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Def; Atlas Spine Expandable Interbody System; Azure Anterior Cervical Plate System; BIOTRONIK torque wrench; BITE compression screw; BLACKSTONE ASCENT MULTIAXIAL SCREWS; BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3MM SINGLE AXIAL CONNECTOR; BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION; BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER; BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR; BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM; BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE; BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM; BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM; BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER); BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER); BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM; BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM; BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM; BLACKSTONE PEDICLE SCREW SYSTEM; BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM; BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE; BLACKSTONE PILLAR XL PEEK SPACERS; BLACKSTONE POSTERIOR CERVICAL SYSTEM; BLACKSTONE SFS PARALLEL ROD CONNECTORS; BLACKSTONE SPINAL FIXATION SYSTEM; BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW; BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW; BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION); BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS; BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR; BLACKSTONE SPINAL FIXATION SYSTEM SPACER; BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER; BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR; BLACKSTONE SURGICAL TITANIUM MESH; BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS; BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM; BLAKSTONE LAMINOPLASTY FIXATION SYSTEM; CENTURION POCT SYSTEM; CERVICAL STAND ALONE SYSTEM; CETRA Anterior Cervical Plate System; CHIMAERA Hip Fracture System - Trochanteric Nailing System; CONSTRUX MINI PEEK SPACER SYSTEM; CONSTRUX MINI PEEK TI SPACER SYSTEM; CONSTRUX MINI PEEK VBR SYSTEM; CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM; CONSTRUX Mini PEEK Spacer System; CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System; CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer; CONSTRUX Mini PTC Spacer System; CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System; CONSTRUX Mini Ti Spacer System; CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM; CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System; CONTOURS LAPIDUS PLATING SYSTEM; CONTOURS Proximal humeral plate; CONTOURS VSP III VOLAR PLATING SYSTEM; Centurion POCT System; Cervical Stand Alone System; Cervicalstim; Class I instrument; Connector System; EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING; Electro-Biology; FEMORAL NAILING SYTEM; FIREBIRD SI Fusion System; FIREBIRD SPINAL FIXATION SYSTEM; FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY; FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM; FITBONE TAA; FITBONE(R) TAA; FITBONE® Transport and Lengthening System; FORZA PTC Spacer System; FORZA SPACER SYSTEM; FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System; FORZA Ti Spacer System; FORZA XP Expandable Spacer System; FORZA® XP Expandable Spacer System; Firebird SI Navigation System; Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System; Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spina; Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System; Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Pho; Fitbone Trochanteric; FitboneTM Trochanteric; G-Beam Fusion Beaming System; GALAXY UNYCO DIAPHYSEAL TIBIA KIT; GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM; GROWTH GUIDANCE PLATE; GUIDED GROWTH SYSTEM; GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL; Galaxy Fixation System; Galaxy UNYCO System; Galaxy wrist; Guided Growth Plate System Plus; HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES; HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM; ICON (TM) MODULAR PEDICLE SCREW SYSTEM; IPY; ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR); JPS JuniOrtho Plating System; JuniOrtho Plating System; KAWE stethoscope; M6-C Artificial Cervical Disc; M6-C Artificial Cervical Disc Instruments AS; M6-C™ Single Use, Disposable Instrumentation; MIOT plating system; MJ-FLEX THE NEW METAIZEAU NAIL; MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM; MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR; Medical device exempt; Navigated Instrument System; O-Genesis Graft Delivery System; ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM); ORTHOFIX MODULSYSTEM; ORTHOFIX VOLAR DISTAL RADIAL PLATE; Oscar 2; Oscar 3; PILLAR SA PTC; PILLAR SA Ti Spacer System; Physiostim and Spinalstim; REDUCE FRACTURE PLATING SYSTEM; RIVAL View Plating Systems and Reduce Fracture Plating Systems; RODEO Telescopic Nail; SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D; SKYHAWK INTERBODY FUSION SYSTEM; SKYHAWK LATERAL PLATE SYSTEM; SOLE Medial Column Fusion Plate; SambaScrew 3D SI Fusion System; TIBIAL NAILING SYSTEM; TRUE/LOK MONOLATERAL/BILATERAL FIXATOR; Titanium Nailing System; Titanium humeral plating system LSP; TrueLok Elevate; TrueLok Evo; TrueLok Hexapod System (TL-HEX) V2; UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM; VIEW and REDUCE plating system; additional accessories for Orthofix system; ankle hindfoot nailing system; plate bone pediatric; plate fixation bone",2009-01-05,155,2025-10-31,4,24,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222183449%22&limit=1
Schneider ASR B.V.,3016678045,3016678045,Willem Barentszstraat 31,Rotterdam-Albrandswaard Zuid-Holland,,NL-3165 AA,Netherlands,"Medical Wholsale Suplies, Inc",10046376,Exporter to the US,137,BSB; BSO; BTO; BYP; CAZ; CCK; CCW; DQA; DQK; DQO; DQX; DQY; DRF; DRX; DSA; DTB; DTE; DXQ; DYB; EMX; EOB; EOQ; EQJ; ERA; ETD; ETN; EWD; EXB; FAD; FAJ; FCG; FED; FER; FGE; FHN; FHQ; FMF; FMQ; FOZ; FQH; FQM; FRC; FRG; FRO; FSH; FTL; FXX; FXY; FYA; FYC; FYD; FZP; GAB; GAT; GAW; GAZ; GBO; GCJ; GDO; GDW; GEI; GEX; GFA; GFD; GFF; GXD; GXI; HAW; HBE; HBO; HIF; HIG; HIH; HMX; HOY; HOZ; HQB; HQF; HRX; HWC; IKD; ITX; IYN; IYO; JCX; JDZ; JKS; JOH; JOJ; JOS; JXG; KAP; KCY; KDI; KGW; KGX; KIH; KMF; KNW; KQZ; KWQ; KZF; LIT; LKF; LLZ; LOD; LOX; LQR; LWK; LYA; LZN; MAI; MBI; MDB; MDM; MNL; MPA; MSH; MTD; NAC; NBH; NEU; NIQ; NRY; NVN; NVY; NWB; OBJ; OCX; OLO; ORQ; OSV; OTN; PAH; PTS; PUI; SDV,"Warmer, Blood, Non-Electromagnetic Radiation; Catheter, Conduction, Anesthetic; Tube, Tracheostomy (W/Wo Connector); Mouthpiece, Breathing; Anesthesia Conduction Kit; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Laryngoscope, Rigid; Oximeter; Computer, Diagnostic, Programmable; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Electrode Recording, Or Probe, Electrode Recording; Electrode, Electrocardiograph; Cable, Transducer And Electrode, Patient, (Including Connector); Permanent Pacemaker Electrode; Pulse-Generator, Pacemaker, External; Blood Pressure Cuff; Introducer, Catheter; Balloon, Epistaxis; Nasopharyngoscope (Flexible Or Rigid); Bronchoscope (Flexible Or Rigid); Bur, Ear, Nose And Throat; Otoscope; Tube, Tympanostomy; Stimulator, Nerve; Protector, Hearing (Insert); Collector, Ostomy; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Biopsy Needle; Endoscopic Access Overtube, Gastroenterology-Urology; Anoscope And Accessories; Stents, Drains And Dilators For The Biliary Ducts; Ligator, Hemorrhoidal; Holder, Needle, Gastroenterologic; Syringe, Piston; Restraint, Protective; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Lavage, Jet; Bandage, Elastic; Indicator, Biological Sterilization Process; Wrap, Sterilization; Dressing, Wound, Drug; Tray, Surgical, Needle; Mesh, Surgical, Polymeric; Mask, Surgical; Hood, Surgical; Gown, Surgical; Gown, Isolation, Surgical; Apparatus, Exhaust, Surgical; Clip, Implantable; Needle, Suturing, Disposable; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tubing, Noninvasive; Catheter, Nephrostomy, General & Plastic Surgery; Laparoscope, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Implantable; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument; Blade, Saw, General & Plastic Surgery, Surgical; Dermatome; Bur, Surgical, General & Plastic Surgery; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Neurological Stereotaxic Instrument; Drills, Burrs, Trephines & Accessories (Simple, Powered); Clip, Scalp; Insufflator, Laparoscopic; Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Cannula, Ophthalmic; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Sponge, Ophthalmic; Photocoagulator And Accessories; Laser, Ophthalmic; Arthroscope; Screw, Fixation, Bone; Cable, Electrode; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Apparatus, Suction, Ward Use, Portable, Ac-Powered; Mixer, Cement, For Clinical Use; Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide; Tube Tracheostomy And Tube Cuff; Indicator, Physical/Chemical Sterilization Process; Electrode, Electrosurgical; Shunt, Central Nervous System And Components; Curette, Nasal; Tourniquet, Pneumatic; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Ring (Wound Protector), Drape Retention, Internal; Tape And Bandage, Adhesive; Dispenser, Cement; Bandage, Liquid; Instrument, Biopsy; Component, Traction, Non-Invasive; Appliance, Fixation, Spinal Intervertebral Body; Device, Medical Examination, Ac Powered; Catheter, Angioplasty, Peripheral, Transluminal; Cannula, Manipulator/Injector, Uterine; System, Image Processing, Radiological; Bone Cement; Catheters, Transluminal Coronary Angioplasty, Percutaneous; Dislodger, Stone, Biliary; Razor, Surgical; Splint, Intranasal Septal; Cement Obturator; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; System, Blood Culturing; Instrument, Manual, Surgical, General Use; Accessories, Cleaning Brushes, For Endoscope; Endoilluminator; Respirator, Surgical; Catheter, Intracardiac Mapping, High-Density Array; Dressing, Wound, Hydrophilic; Accessories, Arthroscopic; Marker, Radiographic, Implantable; Coronary Drug-Eluting Stent; Catheter, Thrombus Retriever; Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes; Permanent Defibrillator Electrodes; Endoscope, Accessories, Narrow Band Spectrum; Catheter, Ultrasound, Intravascular; Endoscopic Irrigation/Suction System; Orthopedic Stereotaxic Instrument; Mesh, Surgical, Deployer; Insufflator, Endoscopic Vessel Harvesting; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator; Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling; Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt; Drape, Surgical, Exempt; Clinical Electronic Thermometer",1; 2; 3; U,"APPARATUS, EXHAUST, SURGICAL; BAIR HUGGER BLOOD/FLUID WARMER; COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH; CROSSFLOW; Connecting Tubes and Pressure Monit; Filler Tubes, Various; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED, EXEMPT; Halyard; ISOLATION GOWN; SOFIA Plus Aspiration Catheter; TEMPO 4F Catheters; Ultrasound System; Ventralex ST Hernia",2014-03-14,157,2024-06-14,2,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223016678045%22&limit=1
"Carefusion 2200, Inc.",1423507,3008002452,75 North Fairway Drive,Vernon Hills,IL,60061,United States,CAREFUSION,10030506,Complaint file establishment; Specification developer,63,BRZ; BSO; BSP; CAZ; DWD; DWM; DYB; FCG; FEZ; FGY; FKO; FMF; FMG; FMI; FOX; FOZ; FPA; FPB; FQH; FRN; FRO; FSH; GDF; GDM; GEC; GEY; HEE; HFX; HIO; IZH; JKA; KDQ; KGZ; KMK; KNE; KNT; KNW; KPE; KPM; KYW; KYX; KYZ; LHI; LKB; LRS; LWE; LWK; MDM; MEG; MIA; MMK; NGT; NZW; OJT; ONB; PHC; PNG; PWY; PXI; QBP; QEH; QTI; SCL,"Set, Blood Transfusion; Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Anesthesia Conduction Kit; Suction Control, Intracardiac, Cardiopulmonary Bypass; Apparatus, Suction, Patient Care; Introducer, Catheter; Biopsy Needle; Catheter And Tube, Suprapubic; Cannula, Injection; Catheter, Peritoneal Dialysis, Single Use; Syringe, Piston; Stopcock, I.V. Set; Needle, Hypodermic, Single Lumen; Stand, Infusion; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Filter, Infusion Line; Lavage, Jet; Pump, Infusion; Dressing, Wound, Drug; Tray, Surgical, Needle; Guide, Needle, Surgical; Needle, Aspiration And Injection, Reusable; Brush, Scrub, Operating-Room; Motor, Surgical Instrument, Ac-Powered; Set, Anesthesia, Paracervical; Clamp, Circumcision; Sampler, Amniotic Fluid (Amniocentesis Tray); System, X-Ray, Mammographic; Tubes, Vials, Systems, Serum Separators, Blood Collection; Bottle, Collection, Vacuum; Accessories, Catheter; Device, Intravascular Catheter Securement; Set, Anesthesia, Obstetric; Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Container, I.V.; Shunt, Peritoneal; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Set, I.V. Fluid Transfer; Pad, Alcohol, Device Disinfectant; I.V. Start Kit; Bone Marrow Collection/Transfusion Kit; Razor, Surgical; Instrument, Manual, Surgical, General Use; Syringe, Antistick; Needle, Spinal, Short Term; Container, Sharps; Saline, Vascular Access Flush; Heparin, Vascular Access Flush; Aspiration Tray; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Infusion Safety Management Software; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Lumbar Puncture Tray (Adult & Pediatric); Thoracentesis Tray; Cap, Device Disinfectant; Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact  ; Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device; Allergen And Vaccine Delivery Needles",1; 2; U,"42-4012, Introducer Kit; 42-4016, Introducer Kit; Alcohol Swab; Axillary Block Needle; BD 1mL Luer-Lok"" Hypodermic Syringe; BD 27G and 29G Spinal Needles; BD Alaris Infusion Set; BD Alaris Pump Infusion Set; BD Bifurcated Needle; BD Biopsy Needles; BD Blunt Filter Needle; BD Cathena"" Safety IV Catheter; BD Cathena™ Safety IV Catheter; BD Catheter Tip Syringe; BD Curve Ascites Shunt; BD Durasafe Combined Anesthesia Kit; BD Durasafe Plus! Epidural Lock CSE; BD Eclipse Bifurcated Needle; BD Eclipse"" Hypodermic Needle; BD Epilor Syringe; BD Flu+; BD Hypodermic Needles; BD Hypodermic Syringe; BD Hypoint; BD IV Start Pak; BD Insyte Intravascular Catheter, BD Angiocath Intravascular Catheter, BD Intosyte, BD Introsyte Autoguard; BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter; BD Insyte™ Autoguard™ BC Shielded IV Catheter; BD Insyte™ Autoguard™ Shielded IV Catheter; BD Integra; BD Intelliport System; BD Interlink Syringe Cannula; BD Intosyte; BD Male/Female Luer Lock Cap; BD Neoflon™ Pro Safety IV Catheter; BD Nexiva Closed IV Catheter System; BD Nexiva Diffusics Closed IV Catheter System; BD Nexiva™ Closed IV Catheter System with NearPort™ IV Access; BD Nexiva™ Diffusics™ Closed IV Catheter System; BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™; BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector; BD ORAL SYRINGES; BD Oral/Enteral Syringe; BD Perisafe EpiduralAnesthesia Tray; BD Perisafe™ Tuohy Epidural Needle; BD Perisafe™ Weiss Epidural Needle; BD PhaSeal; BD PhaSeal Protector - P55; BD PhaSeal™ Optima Connecting Set (C83-O); BD Phaseal™ Optima spike Set (C180-O); BD PosiFlush; BD PosiFlush Heparin; BD PosiFlush™ SP Syringe; BD PosiFlush™ SafeScrub; BD Quincke Spinal Needle; BD Reusable Stopcocks and Adaptors; BD Saf-T-Intima; BD Saf-T-Intima Subcutaneous Catheter System; BD SafetyGlde Insulin Syringe; BD SafetyGlide Needle; BD SafetyLok; BD Sharps Collectors; BD Single Use, Hypodermic Syringe; BD SmartSite Needle-Free Connector; BD SmartSite™ 13mm Vial Access Device & BD SmartSite™ 20mm Vial Access Device; BD Spinal Needle; BD Syringe; BD Syringe NRFit Slip; BD Texium Needle-Free Syringe; BD Whitacre Spinal NRFit Needle; BD Whitacre Spinal Needle; BECTON DICKINSON INTE; Bonanno Suprapubic Bladder Drainage; Breast Lesion Localization Needle; CORNWALL; Catheter Adapter; Catheter Connector; Chemotherapy Sharps Collector; Connecta Stopcock IV Set; E-Z SCRUB; Eclipse; Eclipse Needle; Eclipse SmartSlip; Epilor LOR Syringe; Fast Track™ Tunneler Set; Glass LOR Syringe; HEIMLICH CHEST DRAIN VALVE; Heparin Lock Flush Solution, USP- BD PosiFlush"" Heparin Lock Flush Syringe; Illinois Bone Marrow Aspiration Needle; Illinois Bone Marrow Aspiration Tray; Interlink Blunt Plastic Cannula; Interlink Threaded Lock Cannula; Interlink Vial Access Cannula; Interlink Y Lock, Interlink Lever Lock; Introducer; Jamshidi Bone Marrow Biopsy/Aspiration Needle; Jamshidi Evolve Bone Marrow Biopsy and Aspiration Trays; Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle; LUER STUB ADAPTERS; MINIMED III INFUSION PUMP & UNI-SET ADMIN SET; McKesson IV Safety Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Cathete; NEEDLE, ASPIRATION AND INJECTION, REUSABLE; Nestable Sharps Collectors; Neuro Surgical Clipper Blade; Nexiva IV Catheter; One Piece Sharps Collector; PBBCS with Preattached Holder; PIVO™; PIVO™ Pro Needle-free Blood Collection Device; PeritX™ 2L Drainage Kit; PeritX™ 2L Drainage Starter Pack; PeritX™ 2L Drainage Starter Tote; PeritX™ Peritoneal Catheter System; PhaSeal Optima Infusion Clamp, M25-O; PhaSeal: Connector Luer Lock, C35, C45; PhaSeal: Hanger for IV Bag, M55; PhaSeal: Protector, P21, P28, P50, P14, P53, P50Multi, P21Multi, P14Multi; PleurX; Posiflush SF; Pudendal/Local Anesthesia Block; PureHub"" Disinfecting Cap; SURGIPHOR; Safe-T PLUS Tray; Safe-T PLUS Trays; Safe-T-Centesis™; Safe-T™ PLUS; SafetyLok Syringe; SensiClip; Set, administration, intravascular; SmartSite Bag; Surgical Clipper; Surgical Clipper Blade; Surgical Clipper Charging Adapter; Surgiphor; Surgiphor 1000mL; T-Handle Illinois Bone Marrow Aspiration Needle; T-Handle Illinois Bone Marrow Aspiration Tray; T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Tray; T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Trays; T-Handle Jamshidi Bone Marrow Biopsy/Aspiration Needle; TIVA™; Texium; Texium™ Closed Male Luer; Thora-Para; Tuohy; Twinpak; Ultra-Vue Needle w/ Spinal Point; Vacutainer Needle Disposl Container; Velano ExT™ Extension Set; Velano Vascular Q2® Extension Set; set, I.V., fluid transfer; set, administration, intravascular; set, blood transfusion; set, i.v. fluid transfer; set, i.v., fluid transfer; stopcock, IV, set",2009-10-12,157,2026-02-25,0,18,2,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221423507%22&limit=1
Teco Diagnostics,1832216,1832216,1268 North Lakeview Ave.,Anaheim,CA,92807,United States,TECO DIAGNOSTICS,1832216,Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,122,BSP; CDL; CDM; CDP; CDQ; CDT; CDZ; CEI; CEJ; CEK; CEN; CEO; CEP; CET; CFD; CFH; CFJ; CFL; CFR; CFT; CGA; CGJ; CGS; CGX; CHH; CHJ; CIC; CIG; CIO; CIQ; CIT; CIX; CJE; CKA; CKB; CKD; CKE; DBF; DCK; DCN; DGC; DHC; DHR; DIC; DIH; DIO; DIS; DJC; DJG; DJJ; DJR; DJZ; DKE; DKZ; DNK; DRR; GFO; GGN; GJZ; GMQ; GTQ; JFJ; JFY; JGJ; JHI; JHY; JIL; JIN; JIO; JIR; JIS; JIX; JIY; JJB; JJE; JJQ; JJR; JJW; JJX; JJY; JKA; JKZ; JLW; JMK; JMO; JMT; JNF; JNQ; JQB; JQW; JRE; JTS; JXA; JXM; JZG; KHE; KHS; KLI; KNK; KQO; KTN; LAF; LBR; LCL; LCM; LCP; LCX; LDJ; LJM; LJX; LXG; LYR; MID; MMI; MRR; MSV; MVO; NBW; NGA; QKO; QRK; QRL,"Needle, Conduction, Anesthetic (W/Wo Introducer); Berthelot Indophenol, Urea Nitrogen; Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.); Radioimmunoassay, Total Triiodothyronine; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Uranyl Acetate/Zinc Acetate, Sodium; Tetraphenyl Borate, Colorimetry, Potassium; Biuret (Colorimetric), Total Protein; Dye-Indicator, Ph (Urinary, Non-Quantitative); Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Olive Oil Emulsion (Turbidimetric), Lipase; Sulfophosphovanillin, Colorimetry, Total Lipids; Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Radioimmunoassay, Human Growth Hormone; Hexokinase, Glucose; Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Follicle-Stimulating Hormone; Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes; Alkaline Picrate, Colorimetry, Creatinine; Enzymatic Esterase--Oxidase, Cholesterol; Mercuric Thiocyanate, Colorimetry, Chloride; Cresolphthalein Complexone, Calcium; Diazo Colorimetry, Bilirubin; Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes; Diazo, Ast/Sgot; Nadh Oxidation/Nad Reduction, Ast/Sgot; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Acid Phosphatase, Naphthyl Phosphate; Hydrazone Colorimetry, Alt/Sgpt; Acid Phosphatase, Thymolphthale Inmonophosphate; Ferritin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; System, Test, C-Reactive Protein; Ige, Antigen, Antiserum, Control; System, Test, Systemic Lupus Erythematosus; System, Test, Rheumatoid Factor; Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Barbiturate; Thin Layer Chromatography, Methamphetamine; Enzyme Immunoassay, Opiates; Fluorometry, Morphine; Enzyme Immunoassay, Methadone; Devices, Breath Trapping, Alcohol; Reagents, Test, Tetrahydrocannabinol; Enzyme Immunoassay, Amphetamine; Thin Layer Chromatography, Morphine; Amplifier And Signal Conditioner, Biopotential; Activated Partial Thromboplastin; Plasma, Coagulation Control; Cyanomethemoglobin Reagent And Standard Solution; Antigens, Nontreponemal, All; Antistreptolysin - Titer/Streptolysin O Reagent; Catalytic Methods, Amylase; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Visual, Pregnancy Hcg, Prescription Use; Colorimetric Method, Cpk Or Isoenzymes; Method, Enzymatic, Glucose (Urinary, Non-Quantitative); Nitroprusside, Ketones (Urinary, Non-Quant.); Blood, Occult, Colorimetric, In Urine; Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Calibrator, Primary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Colorimeter, Photometer, Spectrophotometer For Clinical Use; Electrolyte Controls (Assayed And Unassayed); Urinalysis Controls (Assayed And Unassayed); Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Tubes, Vials, Systems, Serum Separators, Blood Collection; Diethyldithiocarbamate (Colorimetric), Copper; Radioimmunoassay, Thyroid-Stimulating Hormone; Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase; Ferrozine (Colorimetric) Iron Binding Capacity; Diazo (Colorimetric), Nitrite (Urinary, Non-Quant); Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen; Qualitative Chemical Reactions, Urinary Calculi (Stone); Kinetic Method, Gamma-Glutamyl Transpeptidase; Station, Pipetting And Diluting, For Clinical Use; Refractometer For Clinical Use; Stains, Microbiologic; Kit, Screening, Urine; Enzyme Immunoassay, Benzodiazepine; System, Test, Beta-2-Microglobulin Immunological; Reagent, Occult Blood; Enzymatic, Carbon-Dioxide; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Acid, Uric, Uricase (Colorimetric); Automated Urinalysis System; System, Test, Infectious Mononucleosis; Gas Chromatography, Methamphetamine; Ldl & Vldl Precipitation, Hdl; Radioimmunoassay, Phencyclidine; Enzyme Immunoassay, Phencyclidine; Assay, Glycosylated Hemoglobin; Kit, Test, Pregnancy, Hcg, Over The Counter; Enzyme Immunoassay, Cannabinoids; Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls; Test, Urine Leukocyte; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Helicobacter Pylori; System, Test, Anticardiolipin Immunological; Immunoassay Method, Troponin Subunit; System, Test, Low Density, Lipoprotein; System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi); Kit, Test, Multiple, Drugs Of Abuse, Over The Counter; System, Test, Blood Glucose, Over The Counter; Test, Follicle Stimulating Hormone (Fsh), Over The Counter; Reagent, Coronavirus Serological; Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature; Multiple Use Blood Lancet For Single Patient Use Only",1; 2; N; U,"ACID PHOSPHATASE REAGENT SET; ACTIVATED PARTIAL THROMBOPLASTIN; ALKALINE PHOSPHATASE; ALT (SGPT) Kinetic; ALT(SGPT), Color, End Point; ALT/SGPT; AMP Amphetamine Card; AMYLASE (COLORIMETRIC) REAGENT SET; AMYLASE LIQUID REAGENT; ANTISTREPTOLYSIN (ASO); ASPARTATE AMINOTRANSFERASE AST/SGOT; AST (SGOT) , Kinetic; AST(SGOT) Color Kinetic; AST/SGOT LIQUID REAGENT - KINETIC METHOD; ATHENESE URS-2K; AZO UTI test strips; Acid Phosphatase, Kinetic; Albumin; AlcoCheck Breath Alcohol Test; Alkaline Phosphatase Color; Alkaline Phosphatase, Liquid; Amphetamine Card Test; Amphetamine Card/Dipstick Test; Amylase, Kinetic; BAR Barbiturates Card; BILIRUBIN (DIRECT); BIURET (COLORIMETRIC), TOTAL PROTEIN; BLOOD GLUCOSE MONITORING SYSTEM; BUN, Kinetic; BUN, Urease, Color, End Point; BZD Benzodiazepine Card; BZD Benzodiazepine Dipstick; Barbiturate Card/Dipstick Test; Benzodiazepine Card Test; Bilirubin, Direct; Bilirubin, Direct and Total; Bilirubin, Total; C-REACTIVE PROTEIN RAPID TEST; C-Reactive protein (CRP); CARBON DIOXIDE (CO2); CHOLESTEROL (LIQUID) REAGENT SET; CK- NAC, Kinetic Liquid; CK-MB (NAC), Kinetic; CK-MB 2 Level Control; CLIAWAIVED URS-1G; CLINISTRIP; CLINISTRIP 10 SGL; COAGULATION CONTROL; COC Cocaine Card; COPPER REAGENT SET; CREATINE KINASE LIQUID REAGENT; CRESOLPHTHALEIN COMPLEXONE, CALCIUM; CRP RAPID TEST; CSF/URINE TOTAL PROTEIN; Calcium; Carbon Dioxide; Chloride; Cholesterol, Kinetic Liquid; Cholinesterase, Kinetic; Cliawaived 10SG; Cocaine Card Test; Cocaine Dipstick Test; Copper Control level I; Copper Control level II; Cortez CRP; Cortez Diagnostics URS-1G; Cortez Diagnostics URS-2K; Cortez IML; Cortez RF; Cortez RPR; Cortez URS-9; Creatine Kinase - NAC, Kinetic; Creatine Kinase, Color, End Point; Creatinine, Color, End Point; DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR; DIRECT LDL CHOLESTEROL; Drug Cup - Multi-Screen 10; Drug Cup - Multi-Screen 10 with Adulteration Strip; Drug Cup - Multi-Screen 3 - AMP/COC/OXY; Drug Scan 10 - Ten Parameter Panel; Drug Scan 2 - MDMA/MET Panel; Drug Scan 3 - THC/OPI/BZD Panel; Drug Scan 4 - Four Parameter Panel; Drug Scan 5 - COC/AMP/OPI/PCP/THC Panel; Drug Scan 5 - MET/AMP/THC/COC/OPI Panel; Drug Scan 6; Drug Scan 6 Test; Drug Scan 7 - Seven Parameter Panel; Drug Scan 8 - Eight Parameter Panel; Drug Scan 9 - Nine Parameter Panel; ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL; EXPRESS CLINICAL CHEMISTRY ANALYZER; FERRITIN; FERRITIN EIA KIT; FSH ELISA Test Kit; Fecal Occult Blood Test; GAMMA-GLUTAMYL TRANSPEPTIDASE AND ISOENZYMES TEST SYSTEM; GGT, Kinetic; GGT, Kinetic Liquid; GLUCOSE REAGENT SET; Gluco Check Basic; Gluco Check Smart; Gluco-Track; Glucopad TC-Smart+ Blood Glucose Monitoring System; Glucopad TC-Smart+ Lancets; Glucose Hexokinase; Glucose, Hexokinase. Liquid; Glucose, Oxidase; Glycohemoglobin; Glycohemoglobin Elevated Control; Glycohemoglobin Normal Control; HBDH - Kinetic; HDL Cholesterol; HEMA STAIN; HEMOGLOBIN A1C REAGENT SET, CONTROL AND CALIBRATOR; HGH EIA Kit; HIGH SENSITIVITY C-REACTIVE PROTEIN EIA TEST KIT; HS CRP; HbA1c DIRECT ENZYMATIC TEST KIT; Helicobacter Pylori Card Test; Hemoblobin; IDG CRP; IDG RF; IDG RPR; IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET; INFECTIOUS MONONUCLEOSIS (IML); IgE EIA Kit; Infectious Mononucleosis (IM); Inorganic Phosphorus, Color; Inorganic Phosphorus, UV; Iron/TIBC; JorVet URS-1G; KETO MOJO URS-1K; KISH URS-2K; LACTATE DEHYDROGENASE; LACTATE DEHYDROGENASE (LDH-L); LACTATE DEHYDROGENASE LDH-L; LACTATE DEHYDROGENASE-L; LDH-L; LDH-L Kinetic; LDH-L, Kinetic Liquid; LH Elisa Test kit; LIPASE REAGENT SET; LW Scientific URS-1B; LW Scientific URS-1G; LW Scientific URS-9; MAGNESIUM; MET Methamphetamine Card; MTD Methadone Card; MYOGLOBIN EIA KIT; Marijuana (THC) Card Test; Marijuana (THC) Dipstick Test; Multiple Drug Scan -5; NADH OXIDATION/NAD REDUCTION, ALT/SGPT; Nurse Hatty URS-1K; ONE STEP MARIJUANA CARD TEST; ONE STEP MIDSTREAM HCG PREGNANCY TEST; ONE STEP MORPHINE CARD TEST; ONE STEP PREGNANCY CARD TEST; ONE-STEP DIPSTICK PREGNANCY TEST; OPI Opiates Card; One-step combo pregnancy dipstick test; One-step urine/serum pregnancy card test; Opiates Card Test; PCP Phencyclidine Card; PHOSPHORUS (INORGANIC); POTASSIUM REAGENT SET; PROLACTIN ELISA Test Kit; Phencyclidine (PCP) Card Test; Pregnancy HCG test midstream; Pulse Scientific Inc URS-1G; Pulse Scientific Inc URS-2K; RAPID PLASMA REAGIN (RPR) SET; REAGENT, OCCULT BLOOD; Rapid Plasma Reagent (RPR); Rheumatoid Factor (RF); SARS-CoV-2 IgM & IgG Test System; SYSTEMIC LUPUS ERYTHEMATOSUS (SLE); Scanostics UTI Check Application Test System; Sodium; Systematic Lupus Erthematosus (SLE); T3/Free T3 Microtiter Test; T4/Free T4 Microtiter Test; TC Abnormal Serum Control (Human); TC Calibrator - I; TC Calibrator - II; TC Normal Serum Control (Human); TC-3300 Analyzer system; TC-84 analyzer system; TC-84+ Analyzer system; TC-94/96/PLUS Elisa Washer/Reader; TC-96 Analyzer system; TC-Matrix Chemistry Analyzer; TC-Thunderbolt automated urine analyzer system; TECO URINARY CALCULI TEST STRIPS; THC Marijuana Card; TOTAL PROTEIN (BIURET) REAGENT SET; TRIGLYCERIDES (GPO-TRINDER); TROPONIN I; TROPONIN I EIA KIT; TSH Microtiter Test; Teco Diagnostics UTI Test Strips; Teco Menopause Stage Indicator FSH Test; Teco Rapid Fecal Occult Blood (FOB) Card Test; Teco Saliva Alcohol Test; Testosterone Microtitier Test; Total Lipid reagent kit; Total T3 Elisa Test kit; Triglyceride, GPO; Troponin I Card Test; Tyiglyceride GPO liquid; U-TSH Microtiter; UREA NITROGEN (BUN) LIQUID REAGENT, KINETIC METHOD; UREA NITROGEN(BUN), COLORIMETRIC METHOD; URIC ACID; URINE REAGENT STRIP-3; URINE REAGENT STRIP-IK (URS-IK); URINE REAGENT STRIPS; URINE REAGENT STRIPS-8; URINE REAGENTS STRIPS-9; URISTAT UTI test strips; URITEK TC-101; URITEK TC-101 URINE ANALYZER; URITEK TC-201 URINE CHEMISTRY TEST SYSTEM; URITEK-720+ URINE ANALYZER; URS-10; URS-1B; URS-1G (GLUCOSE TEST); URS-1K; URS-1M Microalbumin; URS-2GP (GLUCOSE PROTEIN) URINE STRIPS; URS-2K; URS-2L; URS-2P-100; URS-5OB-100; URS-PBG; Uric Acid; Urine Controls Human Urine Level III (Dried); Urine Controls Human Urine level I (Dried); Urine control Level I, II, III; Uritek TC-201 Urine Chemistry Test System; VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE; VISUAL HCG PREGNANCY TEST; beta-2 Microglobulin Microtiter Test; hCG Microtiter Test",1983-09-27,157,2022-07-06,0,3,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221832216%22&limit=1
Smith & Nephew Inc.,3003604053,3003604053,ENDOSCOPY 150 Minuteman Rd,Andover,MA,01810,United States,"Smith & Nephew, Inc.",1020279,Manufacturer; Specification developer,66,CCX; EOB; FCX; FEI; FFS; FLN; FRG; FRL; FSM; FTM; FWF; FWW; FWZ; FZX; GAE; GAT; GCJ; GDC; GDW; GDZ; GEA; GEI; GEY; GFA; GFF; GFG; HAB; HIF; HRT; HRX; HST; HTJ; HTN; HTW; HTY; HWC; HWE; HWQ; HWR; HWT; HWX; JDR; KCT; KDD; KGS; KIJ; KQM; KQZ; LLZ; LMB; LXH; LYU; MAI; MBI; MDM; MIA; NBH; NFG; ODA; OLO; ORQ; OSV; OUG; OWY; QGY; SIQ,"Support, Patient Position; Nasopharyngoscope (Flexible Or Rigid); Insufflator, Automatic Carbon-Dioxide For Endoscope; Instrument, Special Lens, For Endoscope; Image, Illumination, Fiberoptic, For Endoscope ; Monitor, Electric For Gravity Flow Infusion Systems; Wrap, Sterilization; Fiber, Medical, Absorbent; Tray, Surgical, Instrument; Mesh, Surgical; Camera, Television, Endoscopic, Without Audio; Table, Operating-Room, Pneumatic; Operating Room Accessories Table Tray; Guide, Surgical, Instrument; Snare, Surgical; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Table, Operating-Room, Electrical; Staple, Implantable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Saw, Powered, And Accessories; Insufflator, Laparoscopic; Stripper, Surgical; Arthroscope; Apparatus, Traction, Non-Powered; Gauge, Depth; Washer, Bolt Nut; Bit, Drill; Pin, Fixation, Smooth; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Passer; Driver, Prosthesis; Template; Tap, Bone; Staple, Fixation, Bone; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Retention Device, Suture; Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; System, Image Processing, Radiological; Device, Digital Image Storage, Radiological; Orthopedic Manual Surgical Instrument; Accessory, Surgical Apparel; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Needle, Spinal, Short Term; Accessories, Arthroscopic; Device, Communications, Images, Ophthalmic; Endoscopic Central Control Unit; Orthopedic Stereotaxic Instrument; Mesh, Surgical, Deployer; Insufflator, Endoscopic Vessel Harvesting; Medical Device Data System; Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera; Intra-Articular Orthopedic Stereotaxic Navigation Instrument",1; 2,"""BIORAPTOR KNOTLESS SUTURE ANCHOR, SHOULDER CLOSE""; (6) MINITAPE (BLUE) 39.5; (6) MINITAPE (COBRAID BLUE) 39.5; (6) MINITAPE (COBRAID WHITE) 39.5; (curette, probe, rasp, osteotome ); 1.2 ENDOBUTTON CL ULTRA PAC; 1.2 RAP-PAC A LATEX FREE; 1.2 RAP-PAC A, 72202796; 1.2 RAP-PAC B LATEX FREE; 1.2 RAP-PAC B, 72202797; 1.2 RAP-PAC C; 1.5 MM TENDON DRILL PIN; 1.5mm Guidewire, 12"", 72202189; 1.6MM DRILL & GUIDE DYNOMITE 2; 1.8MM DRILL & GUIDE SPYROMITE/MINI 2; 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (BLUE); 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (COBRAID WHITE); 10 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10 MM X 20 MM BIOSURE HA; 10 MM X 25 MM BIOSURE HA; 10 MM X 30 MM BIOSURE HA; 10 MM X 35 MM BIOSURE HA; 10 X 30 MM BIORCI SCREW; 10.5 MM CANNULATED DRILL; 10.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 10.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10MM DILATOR; 10MM METAL ACL CANNULA; 10MM METAL ACL OBTURATOR; 11 MM GRAFT SIZING TUBE; 11 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11 MM X 25 MM BIOSURE HA; 11 MM X 30 MM BIOSURE HA; 11 MM X 35 MM BIOSURE HA; 11 X 30 MM BIORCI SCREW; 11.5 MM CANNULATED DRILL; 11.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 11.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11MM DILATOR; 12 MM GRAFT SIZING TUBE; 12 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 12 MM X 35 MM BIOSURE HA; 12 X 35 MM BIORCI SCREW; 12.5 MM CANNULATED DRILL; 12.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 12MM DILATOR; 13 MM GRAFT SIZING TUBE; 13 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 13.5 MM CANNULATED DRILL; 14 MM GRAFT SIZING TUBE; 15 DEGREE CLOSED CURETTE 3 MM; 15 DEGREE OPEN CURETTE 2.5 MM; 15 DEGREE OPEN CURETTE 4 MM; 15 DEGREE OSTEOTOME 3MM; 15 MM ENDOBUTTON CL BTB; 15MM SUTURE WASHER STER. BOX OF 1; 17MM SUTURE WASHER STER. BOX OF ONE; 2 MM FULL RADIUS MINI BLADES, POWER/EP-1, BLUE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2-5 MM OFFSET GUIDE; 2.3 MM BIORAPTOR PK SUTURE ANCHOR WITH ONE ULTRABRAID No.2 WHITE, SUTURE, STERILE; 2.4 MM FLEXIBLE PASSING PINS, STERILE 5 PER PACKAGE; 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE; 2.4MM PASSING PIN WITH CALIBRATION MARKS; 2.4MM X 10 INCH DRILL-TIP GUIDE WIRE; 2.4MM X 11 INCH 28 CM TROCAR-TIP PASSING PIN; 2.6 MM TWIST DRILL BIT FOR 2.3 ANCHOR; 2.6MM DRILL & GUIDE RAPTORMITE 3; 2.7 MM CHISEL GUARD; 2.7 MM DILATOR; 2.7 MM DRILL GUIDE; 2.7 MM HARVESTING TAMP; 2.7 MM TREPHINE FOR HARD BONE; 2.7 MM TUBULAR CHISEL; 2.7 MM X 15 INCH 38 CM DRILL-TIP PASSING PIN, NON-STERILE 6 PER PACKAGE; 2.8MM Q-FIX ALL-SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE); 2.8mm QFIX Knotless All Suture Anchor; 2.9 MM ABRADER MINI BURRS, POWER/EP-1, ORANGE, PACKAGED 6 PER BOX, STERILE; 2.9 MM BARREL ABRADER MINI BURRS, POWER/EP-1, PURPLE, PACKAGED 6 PER BOX, STERILE; 2.9 MM CUTTER MINI BLADES, POWER/EP-1, BEIGE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2.9 MM FULL RADIUS MINI BLADES RED, POWER/EP-1, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 20 DEGREE OSTEOTOME 4MM; 3.2MM DRILL & GUIDE RAPTORMITE 3.7; 3.5 MM ABRADER MINI BURRS, POWER/EP-1, AQUA, PACKAGED 6 PER BOX, STERILE; 3.5 MM CUTTER STRAIGHT BLADE; 3.5 MM DILATOR; 3.5 MM FULL RADIUS BLADE; 3.5 MM FULL RADIUS CURVED, CONCAVE, 8 CM MINI BLADES, POWER/EP-1, PLUM, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM HARVESTING TAMP; 3.5 MM HEX DRIVER, 2 MM CANNULATION; 3.5 MM INCISOR PLUS, 8 CM MINI BLADES, POWER/EP-1, SAGE GREEN, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM INCISOR STRAIGHT BLADE; 3.5 MM RAZORCUT STRAIGHT BLADE; 3.5 MM RAZORCUT, 8 CM MINI BLADES, POWER/EP-1, PUMPKIN/ORANGE, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM TREPHINE FOR HARD BONE; 3.5 MM TUBULAR CHISEL; 3.5 mm Bonecutter Platinum Blade; 3.5MM INCISOR PLUS PLAT BLD; 3.5MM SPADE TIP DRILL FOR USE WITH 4.5 MM ANCHOR HOLE PREPARATION DEVICE FOR HARD BONE; 3.5MM SYNOVATOR PLAT BLD; 3/S ELECTRODE 45DEG BLD (10BX); 30 DEGREE OPEN CURETTE 2.5 MM; 3D SPIDER CONNECTOR 1 REQUIRED PER EACH LEG ACCESORY; 4 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, SAGE GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4 MM ABRADER STRAIGHT BURR; 4 MM ACROMIONIZER STRAIGHT BURR; 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS; 4 MM PORTAL STICK X 12 INCH 30 CM LONG; 4 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, MAROON, PACKAGED 6 PER BOX, STERILE; 4 MM SHOULDER ROD X 12 INCH 30 CM LONG; 4 MM STONECUTTER STRAIGHT BURR; 4.5 ELITE, FULL RADIUS Electroblade Resector; 4.5 FULL RADIUS BONECUTTER BLADES, YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, CURVED, INCISOR CURVED BLADES, POWER/EP-1, LIME GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, FULL RADIUS, CURVE, CURVED BLADES, POWER/EP-1, YELLOW, CURVE LENGHTS 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, SYNOVATOR CURVED BLADES, POWER/EP-1, FOREST GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CUTTER STRAIGHT BLADE; 4.5 MM DILATOR; 4.5 MM DRILL GUIDE; 4.5 MM DYONICS BONECUTTER ELECTROBLADE, YELLOW, PACKAGED 3 PER BOX, STERILE; 4.5 MM FULL RADIUS STRAIGHT BLADE; 4.5 MM HARVESTING TAMP; 4.5 MM HELICUT STRAIGHT BURRS, POWER/EP-1, SLATE, 5000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, VIOLET, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR STRAIGHT BLADE; 4.5 MM LONG CURVED FULL RADIUS CONCAVE SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM LONG FULL RADIUS SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM OBTURATOR, CONICAL TIP; 4.5 MM ORBIT FULL RADIUS CURVED BLADE; 4.5 MM ORBIT INCIISOR PLUS CURVED BLADES, POWER/EP-1, POWER/EP-1, VIOLET, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERIL; 4.5 MM ORBIT INCISOR CURVED BLADE; 4.5 MM ORBIT SYNOVATOR CURVED BLADE; 4.5 MM RAZORCUT STRAIGHT BLADE; 4.5 MM SYNOVATOR STRAIGHT BLADE; 4.5 MM TREPHINE FOR HARD BONE; 4.5 MM TUBULAR CHISEL; 4.5 MM TURBOTRIMMER STRAIGHT BLADE; 4.5 MM TURBOWHISKER STRAIGHT BLADE; 4.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, FOREST GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 mm Incisor Plus Platinum Curved Blade; 4.5 mm Synovator Platinum Curved Blade; 4.5MM FULL RADIUS PLATINUM SERIES; 4.5MM INCISOR PLUS PLATINUM BLADE; 4.5MM SYNOVATOR PLATINUM SERIES; 4KO ARTHROSCOPE DV AC 4 x 0 degree x 160mm; 4KO ARTHROSCOPE DV AC 4 x 30 degree x 160mm; 4KO ARTHROSCOPE DV AC 4 x 45 degree x 160mm; 4KO ARTHROSCOPE DV AC 4 x 70 degree x 160mm RND TIP; 4KO BARIATRIC LAPAROSCOPE AC 10 x 0 degree x 455mm; 4KO BARIATRIC LAPAROSCOPE AC 10 x 30 degree x 455mm; 4KO BARIATRIC LAPAROSCOPE AC 10 x 45 degree x 455mm; 4KO BARIATRIC LAPAROSCOPE AC 5.5 x 0 degree x 424mm; 4KO BARIATRIC LAPAROSCOPE AC 5.5 x 30 degree x 424mm; 4KO BARIATRIC LAPAROSCOPE AC 5.5 x 45 degree x 424mm; 4KO LAPAROSCOPE AC 10 x 0 degree x 330mm; 4KO LAPAROSCOPE AC 10 x 30 degree x 330mm, 72205164; 4KO LAPAROSCOPE AC 10 x 45 degree x 330mm; 4KO LAPAROSCOPE AC 5.5 x 0 degree x 300mm; 4KO LAPAROSCOPE AC 5.5 x 30 degree x 300mm; 4KO LAPAROSCOPE AC 5.5 x45 degree x 300mm; 4KO VIDEOARTHROSCOPE AC 4 x 30 degree x 160MM RP; 4KO VIDEOARTHROSCOPE AC 4 x 30 degree x 160mm; 4KO VIDEOARTHROSCOPE AC 4 x 70 degree x 160MM RP RND TIP; 4KO VIDEOARTHROSCOPE AC 4 x 70 degree x 160mm RND TIP; 4mm PLATINUM FLYER Blade; 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS; 5 MM CANNULATED DRILL; 5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, BLUE, LARGE DELRIN HANDLE; 5 MM FLEXIBLE DRILL; 5 MM HALF-ROUND RASP; 5.5 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, BRICK RED, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5 MM ABRADER STRAIGHT BURR; 5.5 MM ACROMIONIZER STRAIGHT BURR; 5.5 MM CANNULATED DRILL; 5.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 5.5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, RED, LARGE DELRIN HANDLE; 5.5 MM FULL RADIUS STRAIGHT BLADE; 5.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, TEAL, PACKAGED 6 PER BOX, STERILE; 5.5 MM INCISOR STRAIGHT BLADE; 5.5 MM OBTURATOR, CONICAL TIP, FOR CANNULAS WITH FLUID SEALS; 5.5 MM RAZORCUT STRAIGHT BLADE; 5.5 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, OLIVE, PACKAGED 6 PER BOX, STERILE; 5.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 5.5 MM STONECUTTER STRAIGHT BURR; 5.5 MM SYNOVATOR STRAIGHT BLADE; 5.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, MELON YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5MM FULL RADIUS PLATINUM SERIES; 5.5MM INCISOR PLUS PLATINUM SERIES; 5.5MM SYNOVATOR PLATINUM SERIES; 6 MM ENDOSCOPIC DRILL; 6 MM GRAFT SIZING TUBE; 6 MM OFFSET ENDOFEMORAL AIMER; 6 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6 MM X 20 MM BIOSURE HA; 6 MM X 25 MM BIOSURE HA; 6 MM X 25 MM BIOSURE HA REVERSE THREAD; 6.4 MM STRAIGHT GOUGE; 6.5 MM CANNULATED DRILL; 6.5 MM CHISEL GUARD; 6.5 MM DELIVERY TAMP; 6.5 MM DILATOR; 6.5 MM DRILL GUIDE; 6.5 MM ENDOSCOPIC DRILL; 6.5 MM GRAFT SIZING TUBE; 6.5 MM HARVESTING TAMP; 6.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6.5 MM TREPHINE FOR HARD BONE; 6.5 MM TUBULAR CHISEL; 6.5MM DILATOR; 660HD Image Management System; 6MM DILATOR; 7 MM OFFSET ENDOFEMORAL AIMER; 7 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 7 MM X 20 MM BIOSURE HA; 7 MM X 25 MM BIOSURE HA; 7 MM X 25 MM BIOSURE HA REVERSE THREAD; 7 MM X 25 MM REVERSE THREAD BIORCI SCREW; 7 MM X 30 MM BIOSURE HA; 7 X 20 MM BIORCI SCREW; 7 X 20 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 20 MM SOFTSILK SCREW 1.5 STERILE; 7 X 25 MM BIORCI SCREW; 7 X 25 MM BIORCI SCREW WITH AN 8 MM HEAD; 7 X 25 MM RCI SCREW REVERSE THREAD 2 MM CANNULATION. STERILE, 1 PER BOX.; 7 X 25 MM RCI SCREW WITH 8 MM HEAD 2 MM CANNULATION. STERILE, 1 PER BOX; 7 X 25 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 25 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 25 MM SOFTSILK SCREW 1.5 STERILE; 7 X 30 MM BIORCI SCREW; 7 X 30 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 30 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 30 MM SOFTSILK SCREW 1.5 STERILE; 7 X 40 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 7.5 MM CANNULATED DRILL; 7.5 MM ENDOSCOPIC DRILL; 7.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7.5MM DILATOR; 72205455 INTELLIO Tablet; 72205455 Intellio TABLET; 72205719 INTELLIO TABLET COUNTRY KIT EN US; 72205719 Intellio TABLET Country Kit (US); 72205777 TESSA ACL Femur Straight Aimer Kit; 72205778 TESSA ACL Femur Curved Aimer Kit; 72205780 TESSA Control Unit; 72205781 TESSA ACL Femur System License Software, No Cloud; 72205782 TESSA Marker A; 72205783 TESSA ACL Femur License Software, Cloud, with Imaging Center; 72205784 TESSA ACL Femur License Software, Cloud, No Imaging Center; 72205785 License for Imaging Center Only; 72205786 TRIAL TESSA ACL Femur License Software, Cloud, with Imaging Center; 72205787 TRIAL TESSA ACL Femur License Software, Cloud, No Imaging Center; 72205790 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON Adjustable Fixation Device; 72205791 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON QUAD Adjustable Fixation Device; 72205792 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON BB Adjustable Fixation Device; 72205793 TESSA ACL Femur Straight Aimer Kit with ENDOBUTTON CL Ultra, 15mm; 72205800 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON Adjustable Fixation Device; 72205801 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON QUAD Adjustable Fixation Device; 72205802 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON BB Adjustable Fixation Device; 72205803 TESSA ACL Femur Curved Aimer Kit with ENDOBUTTON CL Ultra, 15mm; 72205810 TESSA Control Unit Accessory Box; 72205811 TESSA Control Unit Country Kit, EN, UK; 72205911 TESSA Control Unit Country Kit, En, US; 7MM BICEPTOR TAP; 7MM DILATOR; 7MM ENDOSCOPIC DRILL XL; 7MM TENDON FORK; 8 MM ENDOSCOPIC DRILL XL; 8 MM PL TIBIAL AIMER POST; 8 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 8 MM X 20 MM BIOSURE HA; 8 MM X 25 MM BIOSURE HA; 8 MM X 25 MM BIOSURE HA REVERSE THREAT; 8 MM X 30MM BIOSURE HA; 8 MM X 35MM BIOSURE HA; 8 X 20 MM BIORCI SCREW; 8 X 20 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 20 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 20 MM SOFTSILK SCREW 1.5 STERILE; 8 X 25 MM BIORCI SCREW; 8 X 25 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 8 X 25 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 25 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 25 MM SOFTSILK SCREW 1.5 STERILE; 8 X 30 MM BIORCI SCREW; 8 X 30 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 30 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 30 MM SOFTSILK SCREW 1.5 STERILE; 8 X 35 MM BIORCI SCREW; 8 X 40 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 8.5 MM CANNULATED DRILL; 8.5 MM DELIVERY TAMP; 8.5 MM DILATOR; 8.5 MM DRILL GUIDE; 8.5 MM ENDOSCOPIC DRILL; 8.5 MM GRAFT SIZING TUBE; 8.5 MM HARVESTING TAMP; 8.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 8.5 MM TREPHINE FOR HARD BONE; 8.5 MM TUBULAR CHISEL; 8.5MM DILATOR; 8MM BICEPTOR TAP; 8MM DILATOR; 8MM TENDON FORK; 9 MM ENDOSCOPIC DRILL XL; 9 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 9 MM X 20 MM BIOSURE HA; 9 MM X 25 MM BIOSURE HA; 9 MM X 30 MM BIOSURE HA; 9 MM X 35 MM BIOSURE HA; 9 X 20 MM BIORCI SCREW; 9 X 20 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 20 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 20 MM SOFTSILK SCREW 1.5 STERILE; 9 X 25 MM BIORCI SCREW; 9 X 25 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 25 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 25 MM SOFTSILK SCREW 1.5 STERILE; 9 X 30 MM BIORCI SCREW; 9 X 30 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 30 MM SOFTSILK 2 SCREW, WITH CLEAR-TRAC SCREW CANNULA LATEX FREE; 9 X 30 MM SOFTSILK SCREW 1.5 STERILE; 9 X 35 MM BIORCI SCREW; 9 x 25 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 9.5 MM CANNULATED DRILL; 9.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 9.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9.5MM DILATOR; 90 DEGREE CONNECTOR; 90 DEGREE CURETTE, ANTERIOR LESION; 9MM BICEPTOR TAP; 9MM DILATOR; 9MM METAL ACL CANNULA; 9MM METAL ACL OBTURATOR; 9MM TENDON FORK; A-Tech ACL Sterilization Tray; A-Tech Controlled Flexion Guidewire; A-Tech Femoral Locator Handle; ABLATOR E-FLEX VULCAN INTEGRATED; ABLATOR MICRO VULCAN INTEGRATED; ABLATOR VULCAN 60 DEG; ABLATOR VULCAN 60 DEG 2MM; ABLATOR VULCAN 90 DEG HP; ABLATOR-S 2MM 60DEG; ABLATOR-S MICRO VULCAN 2MM 60 DEG; ABLATOR-S VULCAN 60 DEG; ABLATOR-S VULCAN 90 DEG; ABLATOR-S VULCAN 90 DEG HP; ACCESSORY, TRACTION; ACCORD; ACCU-PASS STR SHTL BIG C STERILE BOX 1; ACCU-PASS SUTURE SHUTTLE 70 DEGREE; ACCU-PASS SUTURE SHUTTLE J-HOOK STERIL; ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE; ACCUPASS STR SHUTL MONOFIL -SEE72201361; ACL Bullet; ACL CHAMFERING RASP 7 MM, HALF-ROUND; ACL CHAMFERING RASP 8 MM, HALF-ROUND; ACL CHAMFERING RASP BONE TUNNEL; ACL CHAMFERING RASP CHAMFERING; ACL Closed Curette; ACL Disposables Guidewire Kit; ACL Disposables Kit; ACL Open Curette; ACL Tunnel Rasp; ACMI INSTRUMENT AI VERSITIP ADAPTOR FOR 4 MM AND 5 MM LIGHT GUIDES; ACTIVE HEEL TRACTION BOOT KNEE HOLDER; ACTIVE HEEL TRACTION BOOT REPLACEMENT KIT - PADS ONLY; ACUFEX; ACUFEX ACCESS LATERAL TRACTION BOOM; ACUFEX ANATOMIC ACL DOUBLE BUNDLE INSTRUMENT TRAY; ACUFEX CANNULATED BONE TUNNEL PLUGS; ACUFEX DIRECTOR ACL ELBOW AIMER; ACUFEX DIRECTOR ACL TIP AIMER; ACUFEX DIRECTOR ANGLED BULLET; ACUFEX DIRECTOR DRILL GUIDE. REQUIRES 1 AIMER AND 1 BULLET NOT INCLUDED; ACUFEX DIRECTOR PCL FEMORAL AIMER; ACUFEX DIRECTOR PCL SAFETY STOP; ACUFEX EXTRA ARTICULAR RECON SYSTEM TRAY; ACUFEX EXTRA ARTICULAR RECONSTRUCTION FEMORAL GUIDE; ACUFEX EXTRA ARTICULAR RECONSTRUCTION OFFSET GUIDE; ACUFEX Extra-Articular Reconstruction Fibular Guide; ACUFEX Extra-Articular Reconstruction Long Bullet; ACUFEX Extra-Articular Reconstruction Short Bullet; ACUFEX Extra-Articular Reconstruction System Tray; ACUFEX Extra-Articular Reconstruction Tibial Guide; ACUFEX Extra-Articular Retractor; ACUFEX GRAFTMASTER III PREPARATION BOARD; ACUFEX MTO PUNCH BASKET DUCKBILL UPBITER CURVED RIGHT PRO HANDLE; ACUFEX PINPOINT ADAPTER; ACUFEX PINPOINT BULLET 4 POINT - 6.5; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-6MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 6-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 7-8MM; ACUFEX PINPOINT DBL BNDL BULL SPT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-6MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 7-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-6MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 7-8MM; ACUFEX PINPOINT INSIDE-OUT HANDLE; ACUFEX PINPOINT OUTSIDE-IN AMR ARM LEFT; ACUFEX PINPOINT OUTSIDE-IN AMR ARM RT; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 10MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 6MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 8MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 9MM; ACUFEX PINPOINT SNGL BNDL GD 7MM; ACUFEX PUNCH BASKET CURVED RIGHT PRO HANDLE; ACUFEX PUNCH BASKET LEFT PRO HANDLE; ACUFEX PUNCH BASKET PRO RIGHT PRO HANDLE; ACUFEX PUNCH BASKET STRAIGHT PRO HANDLE; ACUFEX PUNCH BASKET UPBITER PRO HANDLE; ACUFEX PUNCH BASKET UPSWEPT PRO HANDLE; ACUFEX PUNCH OVAL STRAIGHT PRO HANDLE; ACUFEX PUNCH OVAL UPBITER PRO HANDLE; ACUFEX PUNCH SCISSOR STRAIGHT PRO HANDLE; ACUFEX PUNCH SCISSOR UPBITER PRO HANDLE; ACUFEX T-BAR; MTO KNOT PUSHER, SHOULDER; ACUFEX TRUNAV; ACUFEX TRUNAV RETROGRADE DRL 10.5MM; ACUFEX TRUNAV RETROGRADE DRL 10MM; ACUFEX TRUNAV RETROGRADE DRL 11.5MM; ACUFEX TRUNAV RETROGRADE DRL 11MM; ACUFEX TRUNAV RETROGRADE DRL 12MM; ACUFEX TRUNAV RETROGRADE DRL 6.5MM; ACUFEX TRUNAV RETROGRADE DRL 6MM; ACUFEX TRUNAV RETROGRADE DRL 7.5MM; ACUFEX TRUNAV RETROGRADE DRL 7MM; ACUFEX TRUNAV RETROGRADE DRL 8.5MM; ACUFEX TRUNAV RETROGRADE DRL 8MM; ACUFEX TRUNAV RETROGRADE DRL 9.5MM; ACUFEX TRUNAV RETROGRADE DRL 9MM; ACUFEX TUNNEL GAUGE; ACUFEX(R) ENDO-FEMORAL AIMER; ACUFEX-PRO 3.4MM CUPPED GRASPR; ACUFEX-PRO NARROWLINE STR; ACUFEX-PRO NARROWLINE UPBITER; ACUFEX-PRO PITBULL GRASPER; ADAPTER D LEG KIT (2 UNITS)TENET 7404; ADAPTER JE LEG KIT(2 UNITS)TENET 7402; ADAPTER RAIL CLAMP(2 UNITS)TENET 7403; ADJUST ARM BRD GEL PAD RPLMNT KIT; ADJUSTABLE ARM BOARD HARDWARE KIT; ADJUSTABLE HEIGHT ROLLING MONITOR STAND; ADVANSYS; ADVANSYS DLP; ADVANSYS MLP; ADVANSYS TTC; AHTB UNIVERSAL HIP DISTRACTOR; AHTB WELL LEG HOLDER; AIMER ENDOFEMORAL 3MM OFFSET (BLUE); AIMER ENDOFEMORAL 4MM OFFSET (PURPLE); AIMER ENDOFEMORAL 5MM OFFSET (RED); AIMER REAR ENTRY RIGHT-ACL; AIMER REAR ENTRY-LEFT; AIMER TIBIAL PCL; AIO Tray, 72205205; AMBI; ANKLE ARTHROSCOPY ACCESSORY 2 UNITS; ANKLE STABILIZATION KITS, DISPOSABLE 6 UNITS; ARM ENDO-FEMORAL AIMER 5MM OFFSET; ARM ENDO-FEMORAL AIMER 6MM OFFSET; ARM ENDO-FEMORAL AIMER 7MM OFFSET; ARO Osteotomy Guide Assembly; ARO Spacer Plate; ARTHRO-PIERCE STRAIGHT; ARTHRO-ROUND XL; ARTHROGARDE 4.5MM HIP CANNULA; ARTHROGARDE 5.5MM HIP CANNULA; ARTHROGARDE 5MM HIP CANNULA; ARTHROGARDE SLOTTLED CANNULA HIP; ARTHROPIERCE; ARTHROPIERCE 35 DEGREE UP; ARTHROPIERCE 45 DEG RIGHT; ARTHROPIERCE 45 DEGREE LEFT; ARTHROPIERCE INSTRUMENT CURVED LEFT; ARTHROPIERCE INSTRUMENT CURVED RIGHT; ARTHROPIERCE UTRATAPE; ARTHROPIERCE XL STRAIGHT; ARTHROSCOPIC LATARJET/BONE BLOCK LID; ARTHROSCOPIC LATARJET/BONE BLOCK TRAY; ARTHROSCOPIC NEEDLE STERILE; ASSEMBLY ENDOBUTTON INDICATOR; AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY 9.5 INCH LENGTH X 3 INCH WIDTH X 1.25 INCH HEIGHT; AWL STRAIGHT 3.8MM DISPOSABLE; AWL, INSERTION SITE MARKING, 45 DEGREES; Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361; Accu-pass suture shuttle 45 degree up, 7210425; Accu-pass suture shuttle 70 degree, Upbend, 72200419; Accu-pass suture shuttle J-hook; Accu-pass suture shuttle left 45 degree, 7210423; Accu-pass suture shuttle right 45 degree; Accu-pass suture shuttle, Big Curve; Accu-pass suture shuttle, crescent, 7210427; Accu-pass suture shuttle, straight, 7210426; Acufex Access Advanced Positioning Kit; Acufex Access Cart; Acufex Access Positioning Kit; Acufex Accss Positioning System; Adaptor; All- Suture 1.9mm Anchor with ULTRABRAID Suture; All-Suture 1.7mm Anchor with ULTRABRAID Suture; Anatomic ACL Tray; Ankle Distractor; Ankle Distractor Strap; Arthroscope; Arthroscopic needle, 72202825; Awl straight 3.8mm, 72202986; Awl tapered 3.8mm; Awl, tap, driver, dilator; B-BOP; BANKART RASP; BENDING TOOL; BENT STRAP SUPPORT REPLACEMENT KIT; BI-GRIP PIN PULLER; BICEPTOR 7 MM X 15 MM PK SCREW; BICEPTOR 7 MM X 25 MM PK SCREW; BICEPTOR 8 MM X 15 MM PK SCREW; BICEPTOR 8 MM X 25 MM PK SCREW; BICEPTOR 9 MM X 15 MM PK SCREW; BICEPTOR 9 MM X 25 MM PK SCREW; BICEPTOR DRIVER; BIORAPTOR 2.3 PK; BIORAPTOR 2.3 PK SUTURE ANCHOR WITH ONE No.2 PRELOADED ULTRABRAID SUTURE, COBRAID BLACK/WHITE; BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (Cobraid Black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (Cobraid Blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (White); BIORAPTOR 2.3 PK suture Anchor w/ULTRABRAID #2 Suture (cobraid blue); BIORAPTOR 2.9mm Suture Anchor with one 38” ULTRABRAID Co-Braid Suture (#2); BIORAPTOR 2.9mm Suture Anchor with two 38” DURABRAID Sutures (USP#2); BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures (#2); BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures and Needles; BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR WITH ONE 38 INCH ULTRABRAID No. 2 SUTURE COBRAID BLACK SHOULDER; BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR, WITH ONE ULTRABRAID No.2 SUTURE COBRAID-BLUE; BIORAPTOR Curved 2.3 PK; BIORAPTOR Curved 2.3 PK Suture Anchor w/ One ULTRABRAID Suture (Cobraid Black); BIORAPTOR Curved 2.3 PK Suture Anchor w/ One ULTRABRAID Suture (Cobraid Blue); BIORAPTOR INLINE DRILL GUIDE - OFFSET FISHMOUTH TIP 2.9 MM; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, CROWN TIP; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP; BIORAPTOR KNOTLESS INLINE OBTURATOR, BLUNT; BIORAPTOR KNOTLESS SUTURE ANCHOR; BIORAPTOR Knotless Suture Anchor; BIORAPTOR Knotless Suture Anchor, Hip; BIORAPTOR TWIST DRILL, 2.9 MM INLINE; BIORCI SCREW, Sterile; BIORCI-HA INTERFERENCE SCREW 8 INCH X 25 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 8 INCH X 30 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 8 INCH X 35 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 9 INCH X 25 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 9 INCH X 30 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 9 INCH X 35 INCH STERILE; BIORCI-HA INTERFERENCE SCREW,; BIORCI-HA INTERFERENCE SCREW, 7 MM X 25 MM 7 MM HEAD STERILE; BIORCI-HA INTERFERENCE SCREW, 7 MM X 25 MM 8 MM HEAD STERILE; BIORCI-HA INTERFERENCE SCREW, 7 MM X 30 MM 7 MM HEAD STERILE; BIORCI-HA INTERFERENCE SCREW, 7 MM X 30 MM 8 MM HEAD STERILE; BIORPTR 2.3 PK SUTR ANCR ONE 38 C/B BK; BIOSURE DRIVER; BIOSURE DRIVER 5MM; BIOSURE EASY TAP 10MM; BIOSURE EASY TAP 6MM; BIOSURE EASY TAP 7MM; BIOSURE EASY TAP 8MM; BIOSURE EASY TAP 9MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 10 X 20 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 10 X 35 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 11 X 30 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 11 X 35 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 12 X 35 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 6 X 25 MM, REVERSE THREAD; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 7 X 20 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 7 X 25 MM, REVERSE THREAD; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 7 X 30 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 8 X 20 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 8 X 25 MM, REVERSE THREAD; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 8 X 30 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 8 X 35 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 9 X 20 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 9 X 30 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 9 X 35 MM; BIOSURE PK SCREW 10 MM X 25 MM; BIOSURE PK SCREW 10 MM X 30 MM; BIOSURE PK SCREW 11 MM X 25 MM; BIOSURE PK SCREW 6 MM x 25 MM; BIOSURE PK SCREW 7 MM X 25 MM; BIOSURE PK SCREW 8 MM X 25 MM; BIOSURE PK SCREW 9 MM X 25 MM; BIOSURE RATCHET DRIVER; BIOSURE REGEN SCREW 5 X 20MM; BIOSURE REGENESORB; BIOSURE SYNC 11-12MM TIBIAL FIXATION; BIOSURE SYNC 5-6MM TIBIAL FIXATION; BIOSURE SYNC 7-8MM TIBIAL FIXATION; BIOSURE SYNC 9-10MM TIBIAL FIXATION; BIOSURE SYNC Inserter; BIOSURE TAP 10MM; BIOSURE TAP 6MM; BIOSURE TAP 7MM; BIOSURE TAP 8MM; BIOSURE TAP 9MM; BIOSURE TAP TRAY; BIRAPTR 2.3 PK SUTR ANCR ONE 38 C/B BL; BLACK FOCUS RING, 19.5MM FOCAL LENGTH, 4MM OD, 30 DEG DIRECTION OF VIEW, 115 DEG FIELD OF VIEW, 160MM, OPPOSITE, J-LOC; BLACK FOCUS RING, 19.5MM FOCAL LENGTH, 4MM OD, 30 DEG DIRECTION OF VIEW, 115 DEG FIELD OF VIEW, 160MM, SAME SIDE, J-LO; BLACK FOCUS RING, 19.5MM FOCAL LENGTH, 4MM OD, 70 DEG DIRECTION OF VIEW, 115 DEG FIELD OF VIEW, 160MM, SAME SIDE, J-LO; BLADE 3.5 CURVED CONCAVE FULL RADIUS; BLADE 3.5MM ELITE FULL RADIUS; BLADE 4 ELITE ABRADER 6/BX; BLADE 5.5 FULL RADIUS ELITE DISPOSABLE; BLADE,4.5 BONECUTTER,FR,180MM LG,DSP; BLT ASSY. 4 POINT DIRECTOR; BLUNT NOSE JR. PUNCH; BOARD, PATIENT TRANSFER; BONE ANCHORS 3 WITH ARTHROSCOPIC DELIVERY SYSTEM ADVANCED; BONE GRASPER; BONE TUNNEL PLUG; BONE TUNNEL PLUG NON-CANNULATED, LARGE 10-11 MM 3 PER PACKAGE; BONE TUNNEL PLUG NON-CANNULATED, SMALL 7-8 MM 3 PER PACKAGE; BONE TUNNEL PLUG XL 11-12 MM 3 PER PACKAGE; BOOT INSERT PAD; BURR 4MM ABRADER 180MML DISPOSABLE (3; BURR 5.5MM ABRADER 180MML DISPOSABLE; Beath pin 2.4mm, 72202815; Beluga Retro; Bilok Instrument Sterilization Tray; Bilok ST Graft Expander; Bioinductive Implant with Arthroscopic Delivery System - Large; Bioinductive Implant with Arthroscopic Delivery System - Medium; Bioinductive Implant; Collagen Tendon Sheet - Ddi; Biosure 1.2mm x 18"", 72201201; Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile; Blade, Sheath, Burr, Abrader, Incisor, Synovator, Acromionizer, Tubowhisker, Bonecutter, Acromioblaster, Notchblaster; Blunt Nose Junior; Bone Anchor Spare, 4403; Bone Anchor Spare, 72205199; Bone Tap; CALF STRAP EQUIPMENT RPLT AHTB; CALIBRATED DEPTH GAGE; CAMERA COUPLER,16:9 HD REF; CAMERA HEAD LENS INT SYS; CANN 5.5 WO/HOLES LTX FREE ORANGE; CANN DIAG RTTBL DBL VLV 4.5 ASCOPE; CANN DV ROT HF STORZ INT 6MM; CANN H.F. DGNST 6MM RTBL SGL VLV; CANN LUM DB ACSS PSTR; CANN LUM DB CRVD L/R; CANN LUM DB CRVD UP-L; CANN LUM DB CRVD UP-R; CANN LUM DB CRVD UP/DWN; CANN LUM DB STR; CANN M.F. DGNST 6MM HIP DBL VLV; CANN SGL STR; CANNU-FLEX 1.5 MM X 305 MM 62 INCH X 12 INCH GUIDE WIRE; CANNU-FLEX 6 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 6 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 6 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX 8 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 8 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX DRIVER SILK SCREW 7MM CANNULATED; CANNU-FLEX DRIVER SILK SCREW 9MM CANNULATED; CANNU-FLEX GDE WIRES 45X12; CANNU-FLEX SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM 6 PER PACKAGE; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 12 INCH 30 CM, BLUNT TIP, STERILE; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE; CANNULA; CANNULA 2.9MM LONG WINDOW ASSEMBLY; CANNULA 2.9MM SHORT WINDOW; CANNULA 5.5MM OPER. W/STOPCOCK; CANNULA 5.5MM W/FINGER POST; CANNULA 6MM FMS 4MM AS W/O STOPCK; CANNULA 6MM FMS4MM ASCOPE W/STPCK; CANNULA CLEARTRAC 4.5 X 72MM THREADED; CANNULA CLEARTRAC SMOOTH 7 X 72MM; CANNULA CLEARTRAC THREADED 8.5 X 45MM; CANNULA CLEARTRAC THREADED 8.5 X 90MM; CANNULA ECTR; CANNULA FINGER POSTED 4.5MM; CANNULA FINGER POSTED 5.5MM; CANNULA FMS 2.7 LONG ASCOPE; CANNULA FMS SHORT 2.7 AS 3.8; CANNULA FOR 3.6 OPERATIVE SET; CANNULA INTEL NON-SCOPE 3MM; CANNULA MED FLOW ROT DBL VLV 5MM; CANNULA OPERATIVE 4.5MM NO DISATLHOLES; CANNULA OPERATIVE 5.5MM FINGERPOST; CANNULA OPERATIVE 5.5MM NO DISTAL HOLE; CANNULA OPERATIVE 5MM NO DIS HOLES; CANNULA SMOOTH FLEX 5.5 X 55MM; CANNULA SMOOTH FLEX 6.5 X 72MM; CANNULA SMOOTH FLEX 8 X 72MM; CANNULA THREADED DISP 8.5 X 72MM; CANNULA THREADED FLEX 5.5 X 45MM; CANNULA THREADED FLEX 6.5 X 72MM; CANNULA THREADED FLEX 8 X 90MM; CANNULATED OBTURATOR W/DELRIN 4.5MM; CANNULATED OBTURATOR W/DELRIN 5.5MM; CANNULATED OTBURATOR 8MM; CAP-FIX Blade, Curved; CAP-FIX Blade, Curved, with Handle; CAP-FIX Blade, Curved, with Hip Pac; CAP-FIX Blade, Straight; CAP-FIX Blade, Straight, with Handle; CAP-FIX Blade, Straight, with Hip Pac; CAP-FIX SUTURE PASSER 45 DEG; CAP-FIX SUTURE PASSER 70 DEG; CAP-LIFT Cannula, 100mm; CAP-LIFT Cannula, 110mm; CAP-LIFT Cannula, 70mm; CAP-LIFT Cannula, 80mm; CAP-LIFT Cannula, 90mm; CARRIAGE REPLACEMENT KIT; CARRIAGE, RPLT, UNIV HIP DIST FOR AHTB; CART PROCEDURE W. ISOL. TRANSFORMER; CART TRANSPORT SPIDER; CHISEL E-FLEX VULCAN FINISHED STERILE; CHISEL GUARD; CHISEL MICRO CURVED VULCAN INTEGRATED; CHISEL MICRO VULCAN ANGLED INTEGRATED; CHISEL MICRO VULCAN HOOK INTEGRATED; CHISEL VULCAN ANGLED; CHISEL VULCAN CURVED; CHISEL VULCAN HOOK; CHISEL VULCAN STRAIGHT W/INTEGRATED CBL; CHONDRAL PICK, LARGE SHAFT 20 DEGREE; CHONDRAL PICK, LARGE SHAFT 40 DEGREE; CHONDRAL PICK, LARGE, 20 DEGREE; CHONDRAL PICK, LARGE, 40 DEGREE; CHONDRAL PICK, SMALL SHAFT 20 DEGREE; CHONDRAL PICK, SMALL SHAFT 40 DEGREE; CHONDRAL PICK, SMALL, 20 DEGREE; CHONDRAL PICK, SMALL, 40 DEGREE; CHONDRAL PICK, SMALL, 90 DEGREE; CIRCLE SUTURE MENISCAL MENDER II; CLAMP DENYERS RAIL TENET 7406",1978-02-22,155,2026-10-23,0,36,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003604053%22&limit=1
Institut Straumann AG,9613348,3004975279,Peter Merian-Weg 12,BASEL Basel-Stadt,,CH-4002,Switzerland,INSTITUT STRAUMANN AG,9005052,Complaint file establishment; Exporter to the US; Specification developer,26,DZE; DZI; DZL; EBG; EGG; EHO; EIH; EJH; EJL; EJX; EME; EMH; EMM; KCT; KCZ; KJJ; LYC; NDP; NHA; NOF; NPK; NPL; NPM; NQA; OAT; PNP,"Implant, Endosseous, Root-Form; Drill, Bone, Powered; Screw, Fixation, Intraosseous; Crown And Bridge, Temporary, Resin; Attachment, Precision, All; Bar, Preformed; Powder, Porcelain; Alloy, Metal, Base; Bur, Dental; Anchor, Preformed; Punch, Biopsy, Surgical; Forceps, Rongeur, Surgical; Chisel, Osteotome, Surgical; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Prosthesis, Breast, External, Used With Adhesive; Cleanser, Root Canal; Bone Grafting Material, Synthetic; Accessories, Implant, Dental, Endosseous; Abutment, Implant, Dental, Endosseous; System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations; Barrier, Synthetic, Intraoral; Barrier, Animal Source, Intraoral; Bone Grafting Material, Animal Source; Biologic Material, Dental; Implant, Endosseous, Orthodontic; Dental Abutment Design Software For Dental Laboratory",1; 2; 3; U,"033.530S Standard TL, RN, Ø4.1mm, SLActive 6mm, TiZr; 033.531S Standard TL, RN, Ø4.1mm, SLActive 8mm, TiZr; 033.532S Standard TL, RN, Ø4.1mm, SLActive 10mm, TiZr; 033.533S Standard TL, RN, Ø4.1mm, SLActive 12mm, TiZr; 033.534S Standard TL, RN, Ø4.1mm, SLActive 14mm, TiZr; 033.535S Standard TL, RN, Ø4.1mm, SLActive 16mm, TiZr; 033.560S Standard Plus TL, RN, Ø4.1mm, SLActive 6mm, TiZr; 033.561S Standard Plus TL, RN, Ø4.1mm, SLActive 8mm, TiZr; 033.562S Standard Plus TL, RN, Ø4.1mm, SLActive 10mm, TiZr; 033.563S Standard Plus TL, RN, Ø4.1mm, SLActive 12mm, TiZr; 033.564S Standard Plus TL, RN, Ø4.1mm, SLActive 14mm, TiZr; 033.571S Tapered Effect, TL, RN, Ø4.1mm, SLActive 8mm, TiZr; 033.572S Tapered Effect, TL, RN, Ø4.1mm, SLActive 10mm, TiZr; 033.573S Tapered Effect, TL, RN, Ø4.1mm, SLActive 12mm, TiZr; 033.574S Tapered Effect, TL, Ø4.1mm, SLActive 14mm, TiZr; 033.580S Standard TL, RN, Ø4.8mm, SLActive 6mm, TiZr; 033.581S Standard TL, RN, Ø4.8mm, SLActive 8mm, TiZr; 033.582S Standard TL, RN, Ø4.8mm, SLActive 10mm, TiZr; 033.583S Standard TL, RN, Ø4.8mm, SLActive 12mm, TiZr; 033.584S Standard TL, RN, Ø4.8mm, SLActive 14mm, TiZr; 033.590S Standard Plus TL, RN, Ø4.8mm, SLActive 6mm, TiZr; 033.591S Standard Plus TL, RN, Ø4.8mm, SLActive 8mm, TiZr; 033.592S Standard Plus TL, RN, Ø4.8mm, SLActive 10mm, TiZr; 033.593S Standard Plus TL, RN, Ø4.8mm, SLActive 12mm, TiZr; 033.594S Standard Plus TL, RN, Ø4.8mm, SLActive 14mm, TiZr; 033.600S Standard TL, WN Ø4.8mm, SLActive 6mm, TiZr; 033.601S Standard TL, WN Ø4.8mm, SLActive 8mm, TiZr; 033.602S Standard TL, WN Ø4.8mm, SLActive 10mm, TiZr; 033.603S Standard TL, WN Ø4.8mm, SLActive 12mm, TiZr; 033.610S Standard Plus TL, WN Ø4.8mm, SLActive 6mm, TiZr; 033.611S Standard Plus TL, WN Ø4.8mm, SLActive 8mm, TiZr; 033.612S Standard Plus TL, WN Ø4.8mm, SLActive 10mm, TiZr; 033.613S Standard Plus TL, WN Ø4.8mm, SLActive 12mm, TiZr; 033.614S Standard Plus TL, WN Ø4.8mm, SLActive 14mm, TiZr; 033.622S Tapered Effect, TL, WN, Ø4.1mm, SLActive 10mm, TiZr; 033.623S Tapered Effect, TL, WN, Ø4.1mm, SLActive 12mm, TiZr; 033.624S Tapered Effect, TL, WN, Ø4.1mm, SLActive 14mm, TiZr; AS200E; AS260; BLC Implant 3.75mm RB, SLActive® 18mm, Roxolid®; BLC Implant 3.75mm RB, SLA® 18mm, Roxolid®; BLC Implants; BLT 3.3 NC, SLActive 18mm, TiZr, Loxim; BLT 3.3mm NC, SLA 18mm, TiZr, Loxim; BLT 4.1 RC, SLActive 18mm, TiZr, Loxim; BLT 4.1mm RC, SLA 18mm, TiZr, Loxim; BLT 4.8 RC, SLActive 18mm, TiZr, Loxim; BLT 4.8mm RC, SLA 18mm, TiZr, Loxim; Bone Level Implant TiZr RC 4.1mm L 8,10,12, 14mm; Bone Level Implant TiZr RC 4.8mm L 8, 10, 12, 14mm; CARES Abutment; CARES TAN Abutment; DI-1; DWOS; Dental Implant Accesories; Equator Attachment; IPS Empress CAD; MEMFIX; MembraGel; NC Closure & Fixation Cap, diameter 5.5mm, Ti; NC Closure Cap; NC Closure Cap for Fixation Cap, Ti; NC Closure Screw, H0; NC Closure Screw, H0 (4-pack); NC Closure Screw, H0.5; NC Closure Screw, H0.5 (4-pack); NC Fixation Cap, Ti; NC GOLD ABUTMENT FOR CROWNS; NC Healing Abutment; NC Healing Abutment, bottle; NC Healing Abutment, conical; NC Healing Abutment, customizable; NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type A; NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type B; NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type A; NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type B; NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type A; NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type B; NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type A; NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type B; NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 0, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 1, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 0, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 1, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 0, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 1, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 0, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 1, ZrO2; NC Temporary Abutment, VITA CAD-Temp, PMMA; NC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN; NC Variobase™  Abutments, with screw, D 3.8mm, H 3.5mm, TAN; NC Variobase®, for crown, with screw, D 3.8mm, H 5.5mm, TAN; NC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type A; NC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type B; NC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type A; NC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type B; NNC Basel Screw for Cementable Abutments; NNC Cementable Abutment, 15 degree angle Type A; NNC Cementable Abutment, 15 degree angle Type B; NNC Cementable Abutment, straight; NNC Closure Cap; NNC Closure Screw, H0; NNC Closure Screw, H0 (4-pack); NNC Closure Screw, H0.5; NNC Closure Screw, H0.5 (4-pack); NNC Healing Cap; NNC Protective Cap; NNC Solid Abutment; NNC Temporary Abutment, VITA CAD-Temp, PMMA; NNC Temporary Coping; NNC Variobase Abutment, with screw, D 55mm, H 4mm, TAN; NNC Variobase™ Abutments, with screw, D 3.9mm, H 3.75mm, TAN; NNC Variobase®, for crown, with screw, D 3.9mm, H 5.75mm, TAN; Narrow Neck CrossFit (NNC) Gold Abutment for Bridges; Neodent Titanium Block for Medentika Holder; Novaloc; Optiloc; Porcelain powder; Pre-milled Abutment Blank for CARES®; RB/WB Screw-retained abutment, angled 17° & 30°, 4.6mm; RC Closure & Fixation Cap, diameter 5.5mm, Ti; RC Closure Cap; RC Closure Cap for Fixation Cap, Ti; RC Closure Screw, H0; RC Closure Screw, H0 (4-pack); RC Closure Screw, H0.5; RC Closure Screw, H0.5 (4-pack); RC Fixation Cap, Ti; RC Healing Abutment , bottle; RC Healing Abutment, conical; RC Healing Abutment, conical diameter 4.5, H2; RC Healing Abutment, conical diameter 4.5, H4; RC Healing Abutment, conical diameter 4.5, H6; RC Healing Abutment, conical diameter 6, H2; RC Healing Abutment, conical diameter 6, H4; RC Healing Abutment, conical diameter 6, H6; RC Healing Abutment, customizable; RC Temporary Abutment; RC Temporary Abutment, VITA CAD-Temp, PMMA; RC Variobase Abutment, with screw, D 4.5mm, 3.5mm, TAN; RC Variobase™ Abutments, with screw, D 4.5mm, 3.5mm, TAN; RC Variobase®, for crown, with screw, D 4.5mm, H 5.5mm, TAN; RC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type A; RC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type B; RC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type A; RC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type B; RN Closure Cap; RN Closure Cap, H1.5, Ti (4-pack); RN Gold Abutment, for Bridge; RN Healing Cap; RN Temporary Abutment, VITA CAD-Temp, PMMA; RN Variobase Abutment, with screw, D 55mm, H 4mm, TAN; RN Variobase™ Abutments, with screw, D 55mm, H 4mm, TAN; RN Variobase®, for crown, with screw, D 55mm, H 6mm, TAN; RN closure Cap, H0, Ti (4-pack); Roxolid BLX Implants; S300W; SIRIOS; SRBB Bone Level; ST 300E; ST200E; STRAUMANN DENTAL IMPLANT SYSTEM; STRAUMANN EMDOGAIN; STRAUMANN EXTRAORAL IMPLANT SYSTEM; Screw Retained Abutments; Screw-Retained Abutments; Smart Design; Strauamnn CARES Dolder Bar Titanium; Straumann 4 mm Short Implants; Straumann Anatomic Healing Abutments; Straumann BLC Implants; Straumann BLX 3.5 mm Implants; Straumann BLX Gold Abutment; Straumann BLX Implant System; Straumann BLX Surgical Cassette; Straumann Bone Level Tapered Implant; Straumann BoneCeramic; Straumann CARES Abutments; Straumann CARES CS2 Scanner; Straumann CARES Screw-Retained Bridge and Dolder Bar; Straumann CARES Screw-Retained Bridges and Bars; Straumann CARES Screw-retained Bridge Titanium; Straumann CARES TAN Abutment; Straumann CARES Visual; Straumann CARES Visual Chairside; Straumann CARES Visual and Nova Dental CAD; Straumann Ceramic Healing Abutments; Straumann Custom Abutment AS; Straumann Dental Implant System; Straumann Immediate Temporary Abutments; Straumann InLab Validated Workflow; Straumann Membrane Max; Straumann Modular Cassette; Straumann Narrow Neck CrossFit (NNC) Closure Screws; Straumann Narrow Neck CrossFit (NNC) Dental Implant System; Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Crown; Straumann Narrow Neck CrossFit (NNC) Healing Caps; Straumann Narrow Neck CrossFit (NNC) Temporary Abutments; Straumann PURE Ceramic Implants; Straumann PUREloc Abutments; Straumann Pre-Milled Abutment Blank for Medentika Holder; Straumann ProClean™ Cassette; Straumann Roxolid SLA Implants; Straumann Screw Retained Abutments; Straumann TLC Implants; Straumann Variobase Abutments; Straumann Variobase Abutments for Bridge/Bar; Straumann Variobase C; Straumann Variobase for CEREC; Straumann Variobase for Crown AS; Straumann XenoGraft; Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA; Straumann® PrefGel; Straumann® Retentive System – Novaloc TiN Abutments; Straumann® RidgeFit Implants; Synthetic Barrier, intraoral; TLC Implants; TLX Implant System; TLX Screw-Retained Abutments; Taper Effect Roxolid; Variobase for CEREC; Variobase® XC for Bridge/Bar, Variobase® XC for Bridge/Bar AS; WN Closure Cap; WN Gold Abutment, for Bridge; WN Healing Cap; WN Temporary Abutment, VITA CAD-Temp, PMMA; WN Variobase Abutment, with screw, D 7mm, H 4.5mm, TAN; WN Variobase™ Abutments, with screw, D 7mm, H 4.5mm, TAN; WN Variobase®, for crown, with screw, D 7mm, H 6.5mm, TAN; n!ce Crown; n!ce Inlay; n!ce Onlay; n!ce Partial Crown; n!ce Veneer; n!ce® for Planmill; polycon ae restoration; synOcta abutment; ticon and coron restorations; zerion HT elements; zerion and glass ceramic restorations",1999-03-10,152,2026-06-03,1,1,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229613348%22&limit=1
Arthrex New Zealand Limited,3020704423,3020704423,6 Fox Street,Auckland,,1052,New Zealand,"ARTHREX, INC.",1220287,Exporter to the US,45,BWN; DXJ; EQH; FMF; FMP; GAP; GAT; GAZ; GCJ; GEI; GFF; HIF; HRS; HRX; HSB; HSD; HTC; HTD; HTN; HTO; HTY; HWC; HWE; HWQ; HXJ; IZI; JDQ; JDR; JQC; JQO; KQM; KQZ; KWS; LLZ; LZB; MAI; MBI; ORG; OSV; OUG; PHX; PKC; PLF; QHE; QHQ,"Table And Attachments, Operating-Room; Display, Cathode-Ray Tube, Medical; Source, Carrier, Fiberoptic Light; Syringe, Piston; Protector, Skin Pressure; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyethylene; Tubing, Noninvasive; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Bur, Surgical, General & Plastic Surgery; Insufflator, Laparoscopic; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Pliers, Surgical; Forceps; Washer, Bolt Nut; Reamer; Pin, Fixation, Smooth; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Passer; Staple Driver; System, X-Ray, Angiographic; Cerclage, Fixation; Staple, Fixation, Bone; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Balance, Analytical; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; System, Image Processing, Radiological; Finger Cot; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Platelet And Plasma Separator For Bone Graft Handling; Insufflator, Endoscopic Vessel Harvesting; Medical Device Data System; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Bone Wedge; Shoulder Arthroplasty Implantation System; Total Shoulder Arthroplasty System",1; 2,"ACL TightRope; ARTHROERESIS IMPLANT; Arthrex Ankle Fusion Plating System; Arthrex BioComposite SutureTak; Arthrex BioSuture; Arthrex Distal Extremity Plate System; Arthrex Fracture Plates; Arthrex Fracture Plates and Screws; Arthrex Fracture System; Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi; Arthrex Knotless SutureTak Anchor; Arthrex Low Profile Screws; Arthrex MicroSuture Anchors; Arthrex Mini TightRopes; Arthrex Minimally Invasive Ankle Fusion Plate; Arthrex PCL TightRope; Arthrex Plates, Screws, and Staples; Arthrex Pushlock; Arthrex Suture; Arthrex SwiveLock Anchors; Arthrex Univers Apex; Arthrex Univers CA Heads; Arthroscopes; BI-CORTICAL BIO-POST AND WASHER; BIO-COMPRESSION SCREW; BIO-PIN; BIOCOMPOSITE INTERFERENCE SCREW; BIOCOMPOSITE SUTURE ANCHORS; Balance, Analytical; Bio-Composite SutureTak; Biosync; Biosync Bone wedge; CHONDRAL DART; COMPRESSION STAPLE; CONTINUOUS WAVE III; CORKSCREW ANCHORS; Camera Heads; Component, Traction, Non-Invasive; DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER; DOUBLE SYRINGE (ACP) SYSTEM; Dual Wave Pump; FASTAK SUTURE ANCHOR; FINGERSHIELD; Fastener, Fixation, nondegradable, soft tissue; Fracture Plates & Screws; General Hospital and Personal Use Miscellaneous Devices; Graft Delivery Device with Integrated Stylet; INTERFERENCE SCREWS; Insufflator 50L FM134; LOW PROFILE PLATE AND SCREW SYSTEM; MENISCAL DART, DARTSTICK,; MINI TIGHTROPE; Metallic Bone Fixation; Mini TightRope CMC; Nonabsorbable poly(ethylene terephthalate) Surgical Suture; OPES ELECTRODES AND ACCESSORIES; OSTEOTOMY PLATE; Orthopedic manual surgical instrument, Passer; PUSHLOCK; Pliers, Surgical; Protector, Skin Pressure; RETROBUTTON; RF device, blade, hook; SHAVER SYSTEM; Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis; Shoulder joint metal/ polymer semi-constrained cemented prosthesis; Single/multiple component metallic bone fixation appliances and accessories; Source, Carrier, Fiberoptic Light; TAK FAMILY; TENODESIS FAMILY; Table Attachments, Operating-Room; UNIVERS II; UNIVERS SHOULDER; Univers Revers Shoulder Prosthesis System; VARIOUS BURS; WASHER; Weight, 2.5 lb (1.1kg); display, cathode-ray tube, medical; fixation pin; fixation plate; orthopedic manual instrument; single/ multiple component metallic bone fixation appliances and accessories; smooth or threaded metallic bone fixation fastener",1994-01-27,151,2023-09-01,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223020704423%22&limit=1
B. Braun Medical Inc.,3013764800,3013764800,861 Marcon Blvd.,Allentown,PA,18109,United States,B. BRAUN MEDICAL INC.,9925035,Complaint file establishment,62,BSO; BSP; BXN; CAZ; DQO; DQX; DQY; DTK; DXT; DYB; DYG; FIP; FJK; FKQ; FMF; FMG; FMI; FMJ; FOX; FOZ; FPA; FRN; FRO; GAA; GBX; GCB; ITX; IYO; IZI; JCY; KDI; KGZ; KMK; KPE; KPO; KYX; KYZ; LCJ; LHI; LJH; LRJ; LRS; LYV; LZH; MEA; MEB; MON; MRZ; NEP; OFF; OFL; OFT; OFU; OGA; OGE; OGJ; ONB; OUG; OWL; OXQ; PTI; QEH,"Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Stimulator, Nerve, Battery-Powered; Anesthesia Conduction Kit; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Filter, Intravascular, Cardiovascular; Injector And Syringe, Angiographic; Introducer, Catheter; Catheter, Flow Directed; Subsystem, Water Purification; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve; System, Dialysate Delivery, Central Multiple Patient; Syringe, Piston; Stopcock, I.V. Set; Needle, Hypodermic, Single Lumen; Manometer, Spinal-Fluid; Stand, Infusion; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Pump, Infusion; Dressing, Wound, Drug; Needle, Aspiration And Injection, Disposable; Catheter, Irrigation; Needle, Catheter; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; Catheter, Infusion; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Accessories, Catheter; Device, Intravascular Catheter Securement; Container, I.V.; Dialysate Concentrate For Hemodialysis (Liquid Or Powder); Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Tissue Expander And Accessories; Set, I.V. Fluid Transfer; System, Irrigation, Urological; Disinfectant, Medical Devices; I.V. Start Kit; Label Or Tag, Sterile; Pump, Infusion, Enteral; Pump, Infusion, Pca; Pump, Infusion, Elastomeric; System, Hemodialysis, Remote Accessories; Accessories, Pump, Infusion; System/Device, Pharmacy Compounding; Central Venous Catheter Tray; Percutaneous Sheath Introducer Kit; Spinal Epidural Anesthesia Kit; Spinal Anesthesia Kit; Brachial Plexus Anesthesia Kit; Epidural Anesthesia Kit; Nerve Block Tray; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Medical Device Data System; Peripheral Catheter Insertion Kit; Dressing Change Tray; Non-Coring (Huber) Needle; Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact  ",1; 2; U,B-SMART,1992-08-27,150,2026-09-10,0,3,2,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013764800%22&limit=1
I-Medical Asia Company Limited,3015806723,3015806723,"Unit 18, 4/F, Block Bm Proficient Industrial Centre, 6 Wan Kwun Road",Kowloon Bay,,HKG,Hong Kong,I-Medical Asia Company Limited,10085603,Exporter to the US,50,BWN; FMF; FMP; FST; GAP; GAT; GCJ; GEI; GFA; GFF; HIF; HRS; HRX; HSB; HSD; HST; HSX; HTN; HTO; HTW; HTY; HWC; HWE; ITX; IYN; IYO; IZI; JDQ; JDR; JQC; JWH; KNW; KQM; KQZ; KRR; KWS; LLZ; LXH; MAI; MBF; MBH; MBI; MDM; NBH; OIY; PHX; PKC; PLF; QHE; QHQ,"Table And Attachments, Operating-Room; Syringe, Piston; Protector, Skin Pressure; Light, Surgical, Fiberoptic; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Insufflator, Laparoscopic; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Washer, Bolt Nut; Reamer; Bit, Drill; Pin, Fixation, Smooth; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; Cerclage, Fixation; Staple, Fixation, Bone; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Instrument, Biopsy; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; System, Image Processing, Radiological; Orthopedic Manual Surgical Instrument; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Accessories, Arthroscopic; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Bone Wedge; Shoulder Arthroplasty Implantation System; Total Shoulder Arthroplasty System",1; 2,"ARTHREX HUMERAL FRACTURE PLATES AND SCREWS; Accessories, Arthroscopic; Apparatus, Traction, Non-Powered; Arthrex 2.5 mm Tenodesis Screw; Arthrex Compression Screws; Arthrex Distal Radius System; Arthrex Fracture Plates; Arthrex Fracture System; Arthrex Knee Systems; Arthrex Low Profile Screws; Arthrex Mesh Plate System; Arthrex Minimally Invasive Ankle Fusion Plate; Arthrex Plates, Screws, and Staples; Arthrex Short Suture Anchors; Arthrex Tenodesis Button; Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads; BIT, DRILL; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Camera, Surgical And Accessories; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Component, Traction, Non-Invasive; FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE; Instrument, Manual, Surgical, General Use; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; LOW PROFILE PLATE AND SCREW SYSTEM; LOW PROFILE SCREWS; MINI TIGHTROPE; Orthopedic Manual Surgical Instrument; PCL TIGHTROPE; Protector, Skin Pressure; Reamer; TABLE AND ATTACHMENTS, OPERATING-ROOM; laparoscope, general & plastic surgery",2022-07-08,147,2023-11-15,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015806723%22&limit=1
"Aesculap, Inc.",2916714,2916714,3773 Corporate Pkwy.,Center Valley,PA,18034,United States,"AESCULAP, INC.",2916714,Complaint file establishment; Specification developer,318,DSS; DWH; DWP; DWS; DXC; DZC; DZM; DZN; EAX; EBR; ECN; ECP; EFK; EFL; EGN; EHY; EIF; EIG; EIK; EIR; EIS; EIX; EIY; EJG; EJY; EKB; EKC; EKF; EKG; EKH; EKI; EKJ; EKR; EMF; EMG; EMH; EMI; EMJ; EMK; EML; EMM; EMN; EMO; EMQ; EPY; EQH; EXX; EZM; FAX; FBM; FBQ; FBX; FER; FFN; FFO; FFP; FFQ; FFR; FFS; FGM; FGN; FHA; FHF; FHI; FHL; FHN; FHO; FHQ; FLE; FMA; FRG; FSE; FSM; FSO; FSP; FSS; FTX; FTY; FWZ; FXR; FZO; FZP; FZQ; FZS; FZT; FZW; FZX; FZY; FZZ; GAC; GAD; GAF; GAI; GAZ; GBX; GBY; GCJ; GCX; GCY; GDC; GDG; GDH; GDI; GDJ; GDL; GDM; GDN; GDO; GDR; GDZ; GEF; GEG; GEI; GEN; GES; GET; GEY; GFA; GFD; GFF; GFI; GFJ; GRX; GWG; GWM; GWO; GWX; GWZ; GXN; GXQ; GXR; GYK; GZT; GZX; HAB; HAD; HAE; HAO; HBB; HBC; HBE; HBI; HBM; HBO; HBQ; HBT; HBW; HCA; HCD; HCF; HCH; HCI; HCY; HCZ; HDA; HDF; HDJ; HDK; HDL; HDQ; HER; HET; HFB; HFW; HFX; HGC; HGE; HGI; HHM; HIF; HMX; HNA; HNC; HND; HNF; HNH; HNI; HNL; HNM; HNN; HNP; HNQ; HNR; HNW; HNX; HNZ; HOE; HRQ; HRR; HRT; HRX; HTC; HTD; HTE; HTJ; HTP; HTR; HTS; HTT; HTW; HTX; HTZ; HWA; HWB; HWE; HWI; HWJ; HWM; HWQ; HWW; HWX; HXB; HXC; HXD; HXG; HXK; HXL; HXP; HXS; HXW; HXX; HXY; HXZ; HYA; IZI; JEP; JEX; JEY; JKA; JOF; JOJ; JXG; JYA; JYE; JYF; JYG; JYH; JYL; JYO; JYP; JYQ; JYR; JYT; JYY; JYZ; JZB; JZD; JZF; JZY; KAD; KAE; KAI; KAK; KAL; KAN; KAP; KAR; KAS; KAT; KAW; KAY; KBA; KBB; KBC; KBD; KBE; KBH; KBJ; KBL; KBM; KBN; KBQ; KBR; KBS; KBT; KBZ; KCA; KCF; KCH; KCJ; KCT; KDG; KDQ; KGZ; KIJ; KIK; KKX; KNA; KNF; KNS; KOA; KOH; KQM; KQW; KTE; KTF; KTG; KTZ; KXF; KZD; LGG; LKF; LMB; LRC; LRW; LRY; LWF; LXH; LXK; LYS; MDM; MOQ; MWS; NBH; NNI; NNR; NWV; PUI,"Clip, Vascular; Blade, Saw, Surgical, Cardiovascular; Dilator, Vessel, Surgical; Instruments, Surgical, Cardiovascular; Clamp, Vascular; Wire, Orthodontic; Needle, Dental; Instruments, Dental Hand; Mirror, Mouth; Unit, Suction Operatory; Clamp, Wire, Orthodontic; Instrument, Ligature Tucking, Orthodontic; Forceps, Articulation Paper; Forceps, Dressing, Dental; Scissors, Surgical Tissue, Dental; Tray, Impression, Preformed; Accessories, Retractor, Dental; Retractor, All Types; Carver, Wax, Dental; Scissors, Collar And Crown; Remover, Crown; Probe, Periodontic; Instrument, Filling, Plastic, Dental; Forceps, Rubber Dam Clamp; Pliers, Operative; Explorer, Operative; Excavator, Dental, Operative; Instrument, Contouring, Matrix, Operative; Condenser, Amalgam And Foil, Operative; Carver, Dental Amalgam, Operative; Carrier, Amalgam, Operative; Burnisher, Operative; Plugger, Root Canal, Endodontic; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Forceps, Rongeur, Surgical; File, Bone, Surgical; Elevator, Surgical, Dental; Curette, Surgical, Dental; Chisel, Bone, Surgical; Chisel, Osteotome, Surgical; Scaler, Periodontic; Knife, Periodontic; Hoe, Periodontic; Speculum, Ent; Source, Carrier, Fiberoptic Light; Probe, Rectal, Non-Powered; Dilator, Esophageal (Metal Olive) Gastro-Urology; Bougie, Urological; Cannula And Trocar, Suprapubic, Non-Disposable; Trocar, Gastro-Urology; Sound, Urethral, Metal Or Plastic; Anoscope And Accessories; Clamp, Non-Electrical; Retractor, Self-Retaining; Dilator, Rectal; Speculum, Rectal; Device, Locking, For Intestinal Clamp; Image, Illumination, Fiberoptic, For Endoscope ; Probe And Director, Gastro-Urology; Retractor, Non-Self-Retaining; Clamp, Penile; System, Evacuator, Fluid; Ring, Laparotomy; Scoop; Ligator, Hemorrhoidal; Pneumoperitoneum Needle; Holder, Needle, Gastroenterologic; Sterilizer, Steam; Depressor, Tongue, Non-Surgical; Wrap, Sterilization; Table, Operating-Room, Manual; Tray, Surgical, Instrument; Microscope, Surgical, General & Plastic Surgery; Loupe, Diagnostic/Surgical; Light, Surgical, Floor Standing; Mirror, General & Plastic Surgery; Tape, Measuring, Rulers And Calipers; Operating Room Accessories Table Tray; Holder, Camera, Surgical; Chisel, Surgical, Manual; Clip, Implantable; Clip, Removable (Skin); Curette, Surgical, General Use; Cutter, Surgical; Expander, Surgical, Skin Graft; Guide, Surgical, Instrument; Hammer, Surgical; Marker, Skin; Rasp, Surgical, General & Plastic Surgery; Retractor; Spatula, Surgical, General & Plastic Surgery; Stripper, Vein, Reusable; Tubing, Noninvasive; Catheter, Irrigation; Catheter, Eustachian, General & Plastic Surgery; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Table, Operating-Room, Electrical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Needle, Suturing, Reusable; Needle, Aspiration And Injection, Reusable; Knife, Amputation; Applier, Surgical, Clip; Saw, Manual And Accessories; Handle, Scalpel; Applier, Staple, Surgical,; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Blade, Scalpel; Motor, Surgical Instrument, Pneumatic Powered; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Dermatome; Bur, Surgical, General & Plastic Surgery; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Antisera, All Leptospira Spp.; Endoscope, Neurological; Device, Monitoring, Intracranial Pressure; Plate, Cranioplasty, Preformed, Alterable; Fork, Tuning; Percussor; Plate, Cranioplasty, Preformed, Non-Alterable; Dura Substitute; Cover, Burr Hole; Instrument, Shunt System Implantation; Retractor, Self-Retaining, For Neurosurgery; Instrument, Microsurgical; Saw, Powered, And Accessories; Rongeur, Powered; Rongeur, Manual; Instrument, Surgical, Non-Powered; Motor, Drill, Pneumatic; Motor, Drill, Electric; Drills, Burrs, Trephines & Accessories (Simple, Powered); Illuminator, Fiberoptic, Surgical Field; Headrest, Neurosurgical; Clip, Scalp; Instrument, Clip Removal; Applier, Hemostatic Clip; Fastener, Plate, Cranioplasty; Catheter, Ventricular; Cannula, Ventricular; Instrument, Ligature Passing And Knot Tying; Clip, Aneurysm; Applier, Aneurysm Clip; Curette, Uterine; Forceps, Surgical, Gynecological; Forceps, Obstetrical; Speculum, Vaginal, Metal; Scissors, Umbilical; Scissors, Episiotomy; Retractor, Vaginal; Dilator, Cervical, Fixed Size; Pelvimeter, External; Laparoscope, Gynecologic (And Accessories); Forceps, Biopsy, Gynecological; Clamp, Umbilical; Clamp, Circumcision; Clamp, Uterine; Amniotome; Electrocautery, Gynecologic (And Accessories); Sound, Uterine; Insufflator, Laparoscopic; Cannula, Ophthalmic; Spud, Ophthalmic; Specula, Ophthalmic; Spatula, Ophthalmic; Scissors, Ophthalmic; Ring, Ophthalmic (Flieringa); Retractor, Ophthalmic; Probe, Lachrymal; Needle, Ophthalmic Suturing; Knife, Ophthalmic; Introducer, Sphere; Hook, Ophthalmic; Forceps, Ophthalmic; Dilator, Lachrymal; Depressor, Orbital; Curette, Ophthalmic; Caliper, Ophthalmic; Hemostat; Scissors, Orthopedic, Surgical; Stripper, Surgical; Arthroscope; Pliers, Surgical; Forceps; Elevator; Gauge, Depth; File; Rasp; Knife, Orthopedic; Burr, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Corkscrew; Awl; Osteotome; Passer; Countersink; Tap, Bone; Probe; Wrench; Clamp; Tamp; Holder, Needle; Orthopedic; Mallet; Instrument, Bending Or Contouring; Twister, Wire; Bender; Screwdriver; Brace, Drill; Cutter, Wire; Forceps, Wire Holding; System, X-Ray, Angiographic; Retainer, Matrix; Plier, Orthodontic; Plate, Bone; Tubes, Vials, Systems, Serum Separators, Blood Collection; Polymer, Ent Synthetic, Porous Polyethylene; Indicator, Physical/Chemical Sterilization Process; Shunt, Central Nervous System And Components; Scissors, Wire Cutting, Ent, Sterile; Chisel, Middle-Ear; Clamp, Ossicle Holding; Curette, Ear; Excavator, Ear; Hook, Microsurgical Ear; Knife, Ear; Knife, Myringotomy; Loop, Wire; Nipper, Malleus; Pick, Microsurgical Ear; Rasp, Ear; Rod, Measuring Ear; Scissors, Ear; Snare, Ear; Tube, Ear Suction; Knife, Laryngeal; Elevator, Ent; Forceps, Ent; Mirror, Ent; Probe, Ent; Retractor, Ent; Chisel, Nasal; Curette, Nasal; Irrigator, Sinus; Knife, Nasal; Perforator, Antrum; Punch, Antrum; Punch, Nasal; Rasp, Nasal; Rongeur, Nasal; Saw, Nasal; Scissors, Nasal; Snare, Nasal; Adenotome; Curette, Adenoid; Depressor, Metal Tongue, Surgical; Dissector, Tonsil; Gag, Mouth; Knife, Tonsil; Needle, Tonsil Suturing; Punch, Adenoid; Punch, Tonsil; Snare, Tonsil; Tonsillectome; Dilator, Esophageal, Ent; Hook, Tracheal; Applicator, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Chisel (Osteotome); Bottle, Collection, Vacuum; Accessories, Catheter; Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment; Hook, Bone; Drape, Surgical, Antimicrobial; Instrument, Manual, Specialized Obstetric-Gynecologic; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Surgical Instruments, G-U, Manual (And Accessories); Instrument, Manual, General Obstetric-Gynecologic; Camera, Surgical And Accessories; Goniometer, Nonpowered; Trocar, Ent; Punch, Ent; Knife, Ent; Caliper; Applicator, Absorbent Tipped, Non-Sterile; Infusor, Pressure, For I.V. Bags; Instrument, Cast Application/Removal, Manual; Cannula, Manipulator/Injector, Uterine; Device, Digital Image Storage, Radiological; Instrument, Ent Manual Surgical; Scissors, General, Surgical; Punch, Surgical; Dilator, Nasal; Orthopedic Manual Surgical Instrument; Scrapper, Skin Specimen; Bone Mill; Instrument, Manual, Surgical, General Use; Battery, Replacement, Rechargeable; Stabilizer, Heart; Accessories, Arthroscopic; Container, Specimen, Non-Sterile; Block, Cutting, Ent, Non-Sterile; Laparoscopic Accessories, Gynecologic; Drape, Surgical, Exempt",1; 2,",AC-POWERED MOTOR AND ACCESSORY; AESCULAP; AESCULAP GRASPER; AND THROAT; ARTHROSCOPIC ACCESSORIES; ATTACHMENT; ATTACHMENTS; Aesculap; BALLINGER CHISEL; BONE HOOK; CARRIER; CARVABLE SILICON BLOCK; CHAIR AND ACCESSORIES; CHMENT; DENTAL HAND INSTRUMENT; DENTAL INSTRUMENT; DENTAL RETRACTOR ACCESSORIES; EAR; ENT EAR; ET AL; FIBEROPTIC LIGHT; FORCEPS; HILAN; HMENTS; KERRISON RONGEUR; MANUAL GASTROENTEROLOGY-UROLOGY S; MANUAL GATROENTEROLOGY-UROLOGY SU; MANUAL OPERATING TABLE; NOSE; NOSE AND THROAT MANUAL SURGICAL INS; OBSTETRIC-GYNECOLOGIC SPE; ORTHOPEDIC; OSTEOTOME; PRESSURE INFUSOR FOR AN I.V. BAG; PROSPACE BONE ALIF; Prestige; RETRACTOR; RETRACTOR RICHARDSON APPENDS; SINOSCOPY; SKIN MARKER; SOURCE; STERNUM SAW BLADE; SUCTION UNIT; SURGICAL CAMERA AND ACCESSORIES; SURGICAL INSTRUMENT MOTORS AND ACCE; TROCAR; TRUMENT; TTACHMENT; VACUUM-POWERED BODY F; VARIOIUS; aesculap",1989-11-27,144,2026-10-02,0,66,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222916714%22&limit=1
Ceva Logistics Limited,3023272766,3023272766,"Danes Way, Dirft",Daventry Northamptonshire,,NN6 7GX,United Kingdom,CEVA Logistics Limited,10085484,Exporter to the US,62,BTI; BTK; BTT; BWF; BXP; BYE; BYG; BYH; BYI; BYP; BYT; BYX; BZA; BZC; BZD; BZE; BZG; BZH; BZK; BZO; BZQ; BZR; CAE; CAF; CAI; CAT; CAW; CBK; CCK; CCL; DPS; DQA; DQK; DRT; DRX; DSB; DSI; DXN; FLL; FMP; FOX; GWQ; HCC; IKK; ILQ; ISD; KGX; LRK; MHX; MNR; MNS; MNT; MQM; MYB; NHJ; NOU; NVP; NXQ; OLV; OLZ; OUG; SDT,"Compressor, Air, Portable; Strap, Head, Gas Mask; Humidifier, Respiratory Gas, (Direct Patient Interface); Spirometer, Therapeutic (Incentive); Transducer, Gas Flow; Attachment, Breathing, Positive End Expiratory Pressure; Mask, Oxygen; Drain, Tee (Water Trap); Percussor, Powered-Electric; Mouthpiece, Breathing; Ventilator, External Body, Negative Pressure, Adult (Cuirass); Tubing, Pressure And Accessories; Connector, Airway (Extension); Calculator, Pulmonary Function Data; Ventilator, Non-Continuous (Respirator); Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer; Spirometer, Diagnostic; Meter, Peak Flow, Spirometry; Spirometer, Monitoring (W/Wo Alarm); Set, Tubing And Support, Ventilator (W Harness); Monitor, Breathing Frequency; Mixer, Breathing Gases, Anesthesia Inhalation; Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Circuit, Breathing (W Connector, Adaptor, Y Piece); Cannula, Nasal, Oxygen; Generator, Oxygen, Portable; Ventilator, Continuous, Facility Use; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Electrocardiograph; Oximeter; Computer, Diagnostic, Programmable; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Electrode, Electrocardiograph; Plethysmograph, Impedance; Detector And Alarm, Arrhythmia; System, Measurement, Blood-Pressure, Non-Invasive; Continuous Measurement Thermometer; Protector, Skin Pressure; Stand, Infusion; Full-Montage Standard Electroencephalograph; Device, Biofeedback; System, Isokinetic Testing And Evaluation; System, Communication, Powered; Exerciser, Measuring; Tape And Bandage, Adhesive; Device, Anti-Snoring; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Ventilatory Effort Recorder; Ventilator, Continuous, Non-Life-Supporting; Continuous, Minimal Ventilatory Support, Facility Use Ventilator; Bilirubin (Total And Unbound) In The Neonate Test System; Pillow, Cervical (For Mild Sleep Apnea); Device, Positive Pressure Breathing, Intermittent; Continuous, Ventilator, Home Use; Holding Chambers, Direct Patient Interface; Reminder, Medication; Standard Polysomnograph With Electroencephalograph; Automatic Event Detection Software For Polysomnograph With Electroencephalograph; Medical Device Data System; Intra-Pulmonary Percussive Vibration (Ipv) Devices",1; 2,"AC611 High Flow Nasal Cannula; ADULT AIRWAY ADAPTER, QTY 1, MAQUET; AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10; Actiware;; Actiwatch Spectrum Pro/Plus + Dock; Actiwatch Spectrum Pro/Plus;; Adult Nasal/Oral CO2 Cannula Capnoflex; Airway Adapter - Single Patient Use - Adult/Pediatric; Airway Adapter - Single Patient Use - Neonatal; Airway Adapter Adult/Pediatric Capnoflex; Airway Adapter Adult/Pediatric Nafion Capnoflex; Airway Adapter Kit PED/INF 704-0024-00; Airway Adapter Pediatric/Infant Nafion Capnoflex; Airway, ADU-PED, SLM LoFlo, 10; Airway, Adult Pediatric, Zoll LoFlo, 10 Airway,; Airway, DEHUM TBG, ADU PED Zoll LoFlo 10; Airway, DEHUM TBG, PED INF Zoll LoFlo10; AirwayAdapter PED/INF Nafion 704-0026-00; BiPAP AVAPS ventilatory support system; BiPAP S/T ventilatory support system; C5 LoFlo Sidestream Module; CAPNOSTAT 5 Mainstream CO2 sensor; CAPNOSTAT 5 Mainstream Sensor, Maquet; CO2 Nasal Cannula - Infant; CO2 Nasal Cannula - Pediatric; CPAP VALVES; Cannula Nasal CO2 Adult 7040010-00; Cannula Nasal CO2 Adult Capnoflex; Cannula Nasal CO2 Only Pediatric Capnoflex; Cannula Nasal CO2 PED 704-0012-00; Cannula Nasal CO2 Ped Capnoflex; Cannula Nasal CO2/O2 ADU 704-0014-00; Cannula Nasal CO2/O2 Adult Capnoflex; Cannula Nasal CO2/O2 INF 704-0015-00; Cannula Nasal CO2/O2 PED 704-0016-00; Cannula Nasal CO2/O2 Ped Capnoflex; Cannula Nasal/Oral CO2 ADU 704-0017-00; Cannula Nasal/Oral CO2 Adult Capnoflex;; Cannula Nasal/Oral CO2/O2 Adu Capnoflex; Cannula Oral/Nasal CO2/O2 Adult Capnoflex D; Cannula, 02 CO2 Oral, ADU, Zoll LoFlo 10; Cannula, CO2 ORAL, ADU, Zoll LoFlo, 10; Cannula, CO2 Oral, PED, Zoll LoFlo, 10; Cannula, CO2, ADU, Zoll LoFlo, 10; Cannula, CO2, INF, Zoll LoFlo, 10; Cannula, CO2, PED, Zoll LoFlo, 10; Cannula, O2 CO2 ORAL, PED, Zoll LoFlo 10; Cannula, O2 CO2, ADU, Zoll LoFlo, 10; Cannula, O2 CO2, INF, 10, Zoll LoFlo; Cannula, O2 CO2, PED, Zoll LoFlo, 10; CannulaNasal/Oral CO2/O2 ADU 704-0020-00; CannulaNasal/Oral CO2/O2 PED 704-0022-00; CapnoTrak CO2 Nasal Cannula; CapnoTrak CO2 Oral Nasal Cannula; CapnoTrak CO2 Sampling Extension Line; CapnoTrak CO2/O2 Nasal Cannula; CapnoTrak CO2/O2 Oral Nasal Cannula; CapnoTrak Dehumidification Tubing; CapnoTrak O2 Delivery Extension Line; CapnoTrak Water Filter Assembly; Capnostat 5 Mainstream CO2 Sensor for Goldway Medical; Cap; Carescape CO2 - LoFlo; Communicator, autoalert help button, mobile help button, personal help button, handset; Dehumidification Tubing - 1 ft; Delivery Cannula INFANT/NEONATAL NASAL; Health Band; INFANT NASAL CO2 CANNULA CAPNOFLEX; INFANT NASAL CO2/O2 CANNULA; Infant Nasal CO2 Cannula Capnoflex; Infant Nasal CO2/O2 Cannula; Infant/Neonatal Airway Adapter Kit Capnoflex; Innospire Go; IntelliVue Patient Monitor; IntelliVue Patient Monitors;; Lifeline Personal Response System; LoFlo CO2 Sampling Cannula ADULT NASAL; LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL; LoFlo CO2 Sampling Cannula PEDIATRIC NASAL; LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL; LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL; LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL; LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL; LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL; LoFlo Module - RoHS - Private Label; M3014A Capnography Extension; Mainstream CO2 Sensor; Mask Cushion Adhesive (AF531); Medication Dispenser; Mini Pegaso A-Cough; Mini Pegaso A-Cough Perc;; Mini Pegaso Cough; NIVO Pro Nebulizer w/EE or SE Elbow; NIVO or NIVO Pro Nebulizer; Nasal Cannula; Neonatal Flow and CO2 Sensor, Disposable; Neonatal and Pediatric CO2 Airway Adapter, Reusable; Nonin Finger Oximeter; PEDI NASAL/ORAL CO2 CANNULA CAPNOFLEX; PEDI NASAL/ORAL CO2 CANULA CAPNOFLEX; Pediatric Infant, Zoll LoFlo, 10; Pediatric Nasal CO2/O2 Cannula Capnoflex; Pediatric Nasal/Oral CO2 Cannula Capnoflex; Pediatric and Adult CO2 Airway Adapter, Reusable; Pegaso A-Cough; Pegaso A-Cough Perc; Pegaso Cough; Pegaso V; Philips ADU Nasal CO2 Cannula, M2744A; Philips ADU Nasal CO2 O2 Cannula, M2750A; Philips ADU Oral Nas CO2 O2 Can, M2760A; Philips ADU Oral Nasal CO2 Can, M2756A; Philips ADU PED A ADPTR W Humid, M2772A;; Philips ADU PED Airway Adapter, M2768A; Philips INF Nasal CO2 O2 Cannula; Philips NM3 Respiratory Monitor w/VentAssist; Philips PED INF A ADPTR W HUMID, M2773A; Philips PED INF Airway Adapter;; Philips PED Nasal CO2 O2 Cannula, M2751A; Philips PED Oral Nas CO2 O2 Can, M2761A; Philips PED Oral Nasal CO2 Can, M2757A; Philips Sample Line Kit, M2776A; Philips Sample Line W HUMID Kit, M2777A; Pro-flow multi-purpose nasal cannula; Proximal Flow Sensor, Neonatal; Rapid Actigraphy Data Analyzer Service; Respironics Alice, LoFlo, C5 Sidestream Module; Respironics LoFlo Sidestream CO2 Module for GE; Respironics LoFlo Sidestream CO2 Module for Goldway; Respironics LoFlo Sidestream CO2 Module;; Reusable ADU-PED Airway Adapter, Philips; Reusable Adult/Pediatric Airway Adapter; Reusable NEO Airway Adapter, Philips; SAMPLING LINE MALE LUER-LOK ADAPTER DEH; Sample LIne Male Luer Capnoflex; Sample Line Male Luer 704-0027-00; Sample Line Male Luer Capnoflex; Sample Line Male Luer Nafion 704-0028-00; Single-Patient Use Adult Airway Adapter; Spirometer, monitoring (w/wo alarm); V680 Ventilator",2022-06-23,144,2024-12-30,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223023272766%22&limit=1
CEVA LOGISTICS NETHERLANDS BV (Venray),3018783526,3018783526,Edisonstraat 2-6,Oostrum Limburgh,,5807 GG,Netherlands,CEVA Logistics Netherlands BV,10086416,Exporter to the US,61,BTI; BTK; BTT; BWF; BXP; BYE; BYG; BYH; BYI; BYP; BYT; BYX; BZA; BZC; BZD; BZE; BZG; BZH; BZK; BZO; BZQ; BZR; CAE; CAF; CAI; CAT; CAW; CBK; CCK; CCL; DPS; DQA; DQK; DRT; DRX; DSB; DSI; DXN; FLL; FMP; FOX; GWQ; HCC; IKK; ILQ; ISD; KGX; LRK; MHX; MNR; MNS; MNT; MQM; MYB; NHJ; NOU; NVP; OLV; OLZ; OUG; SDT,"Compressor, Air, Portable; Strap, Head, Gas Mask; Humidifier, Respiratory Gas, (Direct Patient Interface); Spirometer, Therapeutic (Incentive); Transducer, Gas Flow; Attachment, Breathing, Positive End Expiratory Pressure; Mask, Oxygen; Drain, Tee (Water Trap); Percussor, Powered-Electric; Mouthpiece, Breathing; Ventilator, External Body, Negative Pressure, Adult (Cuirass); Tubing, Pressure And Accessories; Connector, Airway (Extension); Calculator, Pulmonary Function Data; Ventilator, Non-Continuous (Respirator); Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer; Spirometer, Diagnostic; Meter, Peak Flow, Spirometry; Spirometer, Monitoring (W/Wo Alarm); Set, Tubing And Support, Ventilator (W Harness); Monitor, Breathing Frequency; Mixer, Breathing Gases, Anesthesia Inhalation; Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Circuit, Breathing (W Connector, Adaptor, Y Piece); Cannula, Nasal, Oxygen; Generator, Oxygen, Portable; Ventilator, Continuous, Facility Use; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Electrocardiograph; Oximeter; Computer, Diagnostic, Programmable; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Electrode, Electrocardiograph; Plethysmograph, Impedance; Detector And Alarm, Arrhythmia; System, Measurement, Blood-Pressure, Non-Invasive; Continuous Measurement Thermometer; Protector, Skin Pressure; Stand, Infusion; Full-Montage Standard Electroencephalograph; Device, Biofeedback; System, Isokinetic Testing And Evaluation; System, Communication, Powered; Exerciser, Measuring; Tape And Bandage, Adhesive; Device, Anti-Snoring; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Ventilatory Effort Recorder; Ventilator, Continuous, Non-Life-Supporting; Continuous, Minimal Ventilatory Support, Facility Use Ventilator; Bilirubin (Total And Unbound) In The Neonate Test System; Pillow, Cervical (For Mild Sleep Apnea); Device, Positive Pressure Breathing, Intermittent; Continuous, Ventilator, Home Use; Holding Chambers, Direct Patient Interface; Standard Polysomnograph With Electroencephalograph; Automatic Event Detection Software For Polysomnograph With Electroencephalograph; Medical Device Data System; Intra-Pulmonary Percussive Vibration (Ipv) Devices",1; 2,"ADULT AIRWAY ADAPTER, QTY 1, MAQUET; AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10; AOM (RIMR); Actiware; Actiwatch Spectrum Pro/Plus; Actiwatch Spectrum Pro/Plus + Dock; Adult Nasal/Oral CO2 Cannula Capnoflex; Airway Adapter - Single Patient Use - Adult/Pediatric; Airway Adapter - Single Patient Use - Adult/Pediatric;; Airway Adapter - Single Patient Use - Neonatal; Airway Adapter Adult/Pediatric Capnoflex; Airway Adapter Adult/Pediatric Nafion Capnoflex; Airway Adapter Kit PED/INF 704-0024-00; Airway Adapter Pediatric/Infant Nafion Capnoflex; Airway, ADU-PED, SLM LoFlo, 10; Airway, Adult Pediatric, Zoll LoFlo, 10; Airway, DEHUM TBG, ADU PED Zoll LoFlo 10; Airway, DEHUM TBG, PED INF Zoll LoFlo10; Airway, Pediatric Infant, Zoll LoFlo, 10; AirwayAdapter PED/INF Nafion 704-0026-00; Asthma Check; Asthma Mentor; BiPAP Vision; C5 LoFlo Sidestream Module; LoFlo Module - RoHS - Private Label; CAPNOSTAT 5 Mainstream CO2 sensor; CAPNOSTAT 5 Mainstream Sensor, Maquet; CO2 Nasal Cannula - Infant; CO2/Flow Sensor Adult;; CO2/Flow Sensor Neonatal; CO2/Flow Sensor Pediatric; Cannula Nasal CO2 Adult 7040010-00;; Cannula Nasal CO2 Adult Capnoflex;; Cannula Nasal CO2 Adult Capnoflex; Cannula Nasal CO2 Ped Capnoflex; Cannula Nasal CO2 Only Pediatric Capnoflex; Cannula Nasal CO2 PED 704-0012-00;; Cannula Nasal CO2/O2 ADU 704-0014-00;; Cannula Nasal CO2/O2 Adult Capnoflex;; Cannula Nasal CO2/O2 Adult Capnoflex; Cannula Nasal CO2/O2 Ped Capnoflex; Cannula Nasal CO2/O2 INF 704-0015-00;; Cannula Nasal CO2/O2 PED 704-0016-00;; Cannula Nasal/Oral CO2 ADU 704-0017-00; Cannula Nasal/Oral CO2 Adult Capnoflex; Cannula Nasal/Oral CO2/O2 Adu Capnoflex; Cannula Oral/Nasal CO2/O2 Adult Capnoflex D; Cannula, 02 CO2 Oral, ADU, Zoll LoFlo 10; Cannula, CO2 ORAL, ADU, Zoll LoFlo, 10; Cannula, CO2 Oral, PED, Zoll LoFlo, 10; Cannula, CO2, ADU, Zoll LoFlo, 10; Cannula, CO2, INF, Zoll LoFlo, 10; Cannula, CO2, PED, Zoll LoFlo, 10; Cannula, O2 CO2 ORAL, PED, Zoll LoFlo 10; Cannula, O2 CO2, ADU, Zoll LoFlo, 10; Cannula, O2 CO2, INF, 10, Zoll LoFlo; Cannula, O2 CO2, PED, Zoll LoFlo, 10; CannulaNasal/Oral CO2/O2 ADU 704-0020-00;; CannulaNasal/Oral CO2/O2 PED 704-0022-00; CapnoTrak CO2 Nasal Cannula ;; CapnoTrak CO2 Oral Nasal Cannula;; CapnoTrak CO2 Sampling Extension Line;; CapnoTrak CO2/O2 Nasal Cannula ;; CapnoTrak CO2/O2 Oral Nasal Cannula; CapnoTrak Dehumidification Tubing; Dehumidification Tubing - 1 ft.;; CapnoTrak O2 Delivery Extension Line;; CapnoTrak Water Filter Assembly;; Capnography Sensor, Reusable; Capnostat 5 Mainstream CO2 Sensor; Capnostat 5 Mainstream CO2 Sensor for Goldway Medical; Capnostat 5 Mainstream CO2 Sensor for Mindray Medical; Carescape CO2 - LoFlo; Chin Strap; Communicator, autoalert help button, mobile help button, personal help button, handse; Delivery Cannula INFANT/NEONATAL NASAL;; Disposable 15 mm non-heated passive and heated active circuits; Disposable 15mm MPV circuit; Disposable 22mm non-heated passive and heated active circuits; Disposable Angled Mouthpiece; Disposable/FEP/Invasive Circuits; Drain, Tee (water trap); DreamStation 2 Roll Stand – RIST; DreamStation Cellular Modem (RIST); DreamStation Link Module (RIST); DreamStation Roll Stand - RIST; DreamStation Wi-Fi Accessory (RIST; Encore Basic (RIMR); Flex Trach Adaptor 15 cm, 22M/15; Flex Trach Adaptor 15 cm, 22M/15F-15F; FloTrak CO2 Sensor; FloTrak Elite Module wI Capnostat 5 C02 Sensor; Flow Sensor; HL7 Interface Utility (RIMR); Headgear; Health Band; I-neb TIM/General Purpose; INFANT NASAL CO2 CANNULA CAPNOFLEX; INFANT NASAL CO2/O2 CANNULA; Infant Nasal CO2 Cannula Capnoflex; Infant Nasal CO2/O2 Cannula; Infant/Neonatal Airway Adapter Kit Capnoflex; Innospire Elegance; Innospire Essence; Innospire Go; IntelliVue Patient Monito; IntelliVue Patient Monitors; Lifeline Personal Response System; LiquiCell CPAP Cushions; LoFlo CO2 Sampling Cannula ADULT NASAL;; LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL;; LoFlo CO2 Sampling Cannula PEDIATRIC NASAL;; LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL;; LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL; LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL;; LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL;; LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL;; Low Range Cabinet Flow Meter; M3014A Capnography Extension; Mainstream CO2 Sensor; Mask Cushion Adhesive (AF531); Mini Pegaso A-Cough; Mini Pegaso A-Cough Perc; Mini Pegaso Cough;; Mouthpiece Straight; Mouthpiece, Angled; Multiple - Invasive; NIVO Pro Nebulizer w/EE or SE Elbow; NIVO or NIVO Pro Nebulizer; NM3 Respiratory Profile Monitor; Nasal Cannula;; Nasal Cannula; AC611 High Flow Nasal Cannula;; Neonatal Combined CO2/Flow Sensor Series 3; Neonatal Flow Sensor Series 3; Neonatal Flow and CO2 Sensor, Disposable; Neonatal Flow and CO2 Sensor, Disposable;; Neonatal and Pediatric CO2 Airway Adapter, Reusable; Proximal Flow Sensor, Neonatal; Omnilab Conncect (RIMR); Oxygen Manifold Kit; PEDI NASAL/ORAL CO2 CANNULA CAPNOFLEX; PEDI NASAL/ORAL CO2 CANULA CAPNOFLEX; PR1 Wired/Wireless Modems (RIST); PTAF 2, 3, Lite; PTrak FFM; Patient Circuits; Payer Integration Software (RIMR); Payer Integration Software (RIMR);; Peak Flow Meter; Pediatric / Adult Combined CO2/Flow Sensor Series 3; Pediatric Combined CO2/Flow Sensor Series 3; Pediatric Nasal CO2/O2 Cannula Capnoflex; Pediatric Nasal/Oral CO2 Cannula Capnoflex; Pediatric and Adult CO2 Airway Adapter, Reusable; Pediatric/Adult Flow Sensor Series 3; Pegaso A-Cough; Pegaso A-Cough Perc; Pegaso Cough; Pegaso V; Performance Tubing 6; Performance Tubing;; Philips ADU Nasal CO2 Cannula, M2744A; Philips ADU Nasal CO2 O2 Cannula, M2750A; Philips ADU Oral Nas CO2 O2 Can, M2760A; Philips ADU Oral Nasal CO2 Can, M2756A; Philips ADU PED A ADPTR W Humid, M2772A; Philips ADU PED Airway Adapter, M2768A; Philips INF Nasal CO2 O2 Cannula; Philips NM3 Respiratory Monitor w/VentAssist; Philips PED INF A ADPTR W HUMID, M2773A; Philips PED INF Airway Adapter; Philips PED Nasal CO2 O2 Cannula, M2751A; Philips PED Oral Nas CO2 O2 Can, M2761A; Philips PED Oral Nasal CO2 Can, M2757A; Philips Sample Line Kit, M2776A; Philips Sample Line W HUMID Kit, M2777A; Pressure Transducer Airflow Sensor (PTAF); Pro-Flow and Pro-Flow Plus Cannula Sensors; Proximal Flow Sensor, Neonatal; Rapid Actigraphy Data Analyzer Service; Respironics Alice, LoFlo, C5 Sidestream Module; Respironics LoFlo Sidestream CO2 Module; Respironics LoFlo Sidestream CO2 Module for GE; Respironics LoFlo Sidestream CO2 Module for Goldway; Reusable ADU-PED Airway Adapter, Philips; Reusable Adult/Pediatric Airway Adapter; Reusable Mouthpiece; Reusable NEO Airway Adapter, Philip; Roll Stand, BiPAP A-series – RIMR; Roll Stand, OmniLab Advanced + - RIMR; SAMPLING LINE MALE LUER-LOK ADAPTER DEH; Sample LIne Male Luer Capnoflex; Sample Line Male Luer 704-0027-00; Sample Line Male Luer Capnoflex; Sample Line Male Luer Nafion 704-0028-00; Sampling Line Male Luer-lok Adapter Dehumidification; Sidestream Reusable Neb and Masks; Single-Patient Use Adult Airway Adapte; Single-Patient Use Adult Airway Adapter; Sleepmapper (RIMR); SmartSleep, Deep Sleep Headband; System 22 Aerosol Mask; Therapy Mask 3100 NC/SP; Threshold Pep; Trilogy Evo Mounting Bracket - RIMR; Trilogy Evo Roll Stand – RIMR; Trilogy Evo Wheelchair Mount – RIMR; Wisp Nasal Mask; Wisp SE Nasal Mask",2022-11-08,144,2024-12-30,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223018783526%22&limit=1
"Aspen Surgical Products, Inc.",1836161,3002750084,6945 Southbelt DR. S.E.,Caledonia,MI,49316,United States,Aspen Surgical Products,10061390,Complaint file establishment; Contract manufacturer; Manufacturer; Repackager or relabeler; Specification developer,655,BRW; BRY; BSR; BSY; BTK; BTO; BTQ; BWA; BWB; BWN; BXJ; BXP; BXW; BXX; BXY; BYF; BYG; BYH; BYL; BYP; BYW; BYX; BZB; BZO; CAE; CAI; CAM; CAN; CAT; CAX; CBH; CBL; CCN; CCQ; CCW; CCX; DDS; DRP; DTI; DTS; DWH; DWI; DWO; DWP; DWS; DXC; DZA; DZC; DZN; DZP; EAX; EBA; EBL; EBR; ECB; ECP; ECS; EEA; EEF; EFC; EFH; EFK; EFL; EFN; EFS; EFW; EGD; EGZ; EHJ; EHK; EHM; EHO; EHY; EHZ; EIC; EID; EIE; EIF; EIG; EIK; EIL; EIR; EIS; EIX; EIY; EJB; EJE; EJG; EJL; EJP; EJR; EJW; EJY; EJZ; EKB; EKC; EKD; EKE; EKF; EKG; EKH; EKI; EKJ; EKK; EKL; EKM; EKP; EKQ; EKR; EKS; EKT; EKW; ELA; ELR; EMB; EMD; EME; EMF; EMG; EMH; EMI; EMJ; EMK; EML; EMM; EMN; EMO; EMP; EMQ; EMR; EMS; EMX; EPE; EPP; EPT; EPY; EQH; EQJ; ERA; ETF; ETN; EXX; EYA; EYJ; EYR; EZB; FAQ; FAX; FBS; FBX; FCL; FCZ; FDG; FEM; FEX; FFD; FFN; FFO; FFP; FFQ; FFR; FFY; FGM; FGN; FGX; FGY; FHA; FHB; FHG; FHI; FHL; FHM; FHN; FHQ; FHR; FJR; FJY; FKC; FKG; FKK; FLG; FMA; FME; FMH; FMI; FML; FMP; FMR; FMW; FNJ; FNP; FNS; FNY; FOB; FOC; FOX; FPP; FPX; FPY; FQK; FQL; FQM; FRG; FRK; FRL; FRO; FSE; FSM; FSO; FSP; FSS; FSY; FTA; FTF; FTS; FTX; FTY; FTZ; FWC; FXE; FXF; FXG; FXM; FXP; FXR; FXX; FXZ; FYA; FYD; FYF; FYI; FZF; FZK; FZM; FZO; FZP; FZQ; FZR; FZS; FZT; FZW; FZX; FZY; FZZ; GAA; GAB; GAC; GAD; GAE; GAF; GAH; GAI; GAJ; GAX; GAZ; GBA; GBB; GBP; GBW; GBX; GBY; GBZ; GCB; GCC; GCE; GCJ; GCY; GCZ; GDC; GDF; GDG; GDH; GDI; GDJ; GDL; GDM; GDN; GDO; GDR; GDT; GDX; GDY; GDZ; GEA; GEC; GED; GEE; GEF; GEG; GEI; GEJ; GEN; GES; GET; GEY; GFA; GFC; GFD; GFE; GFF; GFI; GFJ; GHD; GWI; GWX; GWY; GWZ; GXJ; GXM; GYK; GZT; GZX; HAB; HAE; HAM; HAO; HAS; HAX; HBD; HBE; HBG; HBM; HBO; HBQ; HBR; HBT; HCD; HCF; HCH; HCY; HCZ; HDA; HDE; HDF; HDJ; HDK; HDL; HDM; HDQ; HER; HET; HEW; HFB; HFI; HFS; HFW; HFX; HGC; HGE; HGI; HGN; HHF; HHM; HIB; HIF; HIN; HIO; HJA; HJB; HJF; HJH; HJL; HJZ; HKF; HKN; HKO; HKR; HKS; HKY; HLE; HLM; HLN; HLS; HMP; HMQ; HMR; HMX; HMZ; HNA; HNB; HNC; HND; HNE; HNF; HNG; HNH; HNI; HNJ; HNK; HNL; HNM; HNN; HNP; HNQ; HNR; HNS; HNT; HNW; HNX; HNY; HNZ; HOB; HOC; HOD; HOE; HOF; HOG; HOO; HOX; HOY; HPA; HPB; HPC; HPN; HPP; HPT; HQH; HQP; HRH; HRJ; HRM; HRP; HRQ; HRR; HRT; HRW; HRX; HSO; HSP; HSS; HST; HSZ; HTC; HTD; HTE; HTF; HTJ; HTO; HTP; HTQ; HTR; HTS; HTT; HTW; HTX; HTZ; HWA; HWB; HWD; HWE; HWI; HWJ; HWK; HWL; HWM; HWN; HWO; HWP; HWQ; HWR; HWT; HWW; HWX; HXB; HXC; HXD; HXE; HXG; HXI; HXK; HXL; HXO; HXP; HXQ; HXR; HXS; HXW; HXX; HXY; HXZ; HYA; IAM; IGF; IKX; IKY; ILH; ILI; IMD; IME; INM; IPM; IQG; IQK; IRA; IRQ; ITG; ITJ; ITX; IWS; IWZ; IZD; JEB; JEP; JES; JET; JEX; JOJ; JOK; JOL; JPW; JQC; JRE; JRJ; JRL; JTQ; JXS; JXT; JXW; JXX; JXY; JYA; JYC; JYD; JYE; JYF; JYG; JYH; JYI; JYJ; JYK; JYL; JYM; JYO; JYP; JYQ; JYR; JYT; JYW; JYX; JYY; JYZ; JZA; JZB; JZC; JZD; JZE; JZF; JZY; KAA; KAB; KAC; KAD; KAE; KAG; KAI; KAJ; KAK; KAL; KAM; KAN; KAO; KAP; KAQ; KAR; KAS; KAT; KAW; KAX; KAY; KAZ; KBA; KBB; KBC; KBD; KBE; KBF; KBG; KBH; KBI; KBJ; KBL; KBM; KBN; KBP; KBQ; KBR; KBS; KBT; KBW; KBX; KBZ; KCA; KCB; KCC; KCD; KCE; KCF; KCG; KCH; KCI; KCJ; KCL; KCN; KCP; KCT; KDC; KDD; KDG; KDT; KFK; KFZ; KGB; KGS; KGX; KGZ; KHH; KHR; KIC; KID; KIK; KIL; KJR; KKX; KME; KMK; KMN; KMO; KMY; KOA; KOH; KPY; KQM; KQW; KQZ; KXG; KYR; KYT; KZF; LRP; LRW; LXH; LYU; LYV; MDM; MJG; MMK; MMP; MNL; MOE; MOQ; MQW; NAD; NNR; OCT; OEA,"Protector, Dental; Cabinet, Table And Tray, Anesthesia; Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Strap, Head, Gas Mask; Tube, Tracheostomy (W/Wo Connector); Airway, Nasopharyngeal; Unit, Electrosurgical And Coagulation, With Accessories; Forceps, Tube Introduction; Table And Attachments, Operating-Room; Clip, Nose; Transducer, Gas Flow; Calibrator, Volume, Gas; Calibrator, Pressure, Gas; Flowmeter, Calibration, Gas; Mask, Oxygen, Low Concentration, Venturi; Mask, Oxygen; Drain, Tee (Water Trap); Tent, Oxygen; Mouthpiece, Breathing; Device, Rebreathing; Tubing, Pressure And Accessories; Catheter, Nasal, Oxygen; Set, Tubing And Support, Ventilator (W Harness); Airway, Oropharyngeal, Anesthesiology; Circuit, Breathing (W Connector, Adaptor, Y Piece); Yoke Assembly, Medical Gas; Regulator, Pressure, Gas Cylinder; Cannula, Nasal, Oxygen; Flowmeter, Tube, Thorpe, Back-Pressure Compensated; Device, Fixation, Tracheal Tube; Absorbent, Carbon-Dioxide; Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge; Nebulizer, Medicinal, Non-Ventilatory (Atomizer); Laryngoscope, Rigid; Support, Patient Position; Prealbumin, Fitc, Antigen, Antiserum, Control; Tourniquet, Automatic Rotating; Sizer, Heart-Valve, Prosthesis; Sucker, Cardiotomy Return, Cardiopulmonary Bypass; Blade, Saw, Surgical, Cardiovascular; Saw, Electrically Powered; Needle, Biopsy, Cardiovascular; Dilator, Vessel, Surgical; Instruments, Surgical, Cardiovascular; Clamp, Vascular; Drill, Dental, Intraoral; Wire, Orthodontic; Instruments, Dental Hand; Instrument, Diamond, Dental; Mirror, Mouth; Light, Surgical Headlight; Pin, Retentive And Splinting, And Accessory Instruments; Unit, Suction Operatory; Unit, Syringe, Air And/Or Water; Instrument, Ligature Tucking, Orthodontic; Pusher, Band, Orthodontic; Plate, Base, Shellac; Clamp, Rubber Dam; Warmer, Anesthetic Tube; Paper, Articulation; Forceps, Articulation Paper; Forceps, Dressing, Dental; Cotton, Roll; Unit, Oral Irrigation; Toothbrush, Manual; Wax, Dental, Intraoral; Holder, Film, X-Ray; Disk, Abrasive; Cup, Prophylaxis; Strip, Polishing Agent; Bar, Preformed; Tray, Impression, Preformed; Evacuator, Oral Cavity; Syringe, Periodontic, Endodontic, Irrigating; Syringe, Restorative And Impression Material; Dam, Rubber; Accessories, Retractor, Dental; Retractor, All Types; Carver, Wax, Dental; Gauge, Depth, Instrument, Dental; Scissors, Collar And Crown; Remover, Crown; Probe, Periodontic; Instrument, Filling, Plastic, Dental; Handle, Instrument, Dental; Frame, Rubber Dam; Forceps, Rubber Dam Clamp; Bur, Dental; Articulators; Agent, Polishing, Abrasive, Oral Cavity; Clasp, Wire; Pliers, Operative; Knife, Margin Finishing, Operative; Explorer, Operative; Excavator, Dental, Operative; Instrument, Cutting, Operative; Curette, Operative; Instrument, Contouring, Matrix, Operative; Condenser, Amalgam And Foil, Operative; Carver, Dental Amalgam, Operative; Carrier, Amalgam, Operative; Burnisher, Operative; Spreader, Pulp Canal Filling Material, Endodontic; Point, Silver, Endodontic; Gutta-Percha; Reamer, Pulp Canal, Endodontic; Preparer, Root Canal Endodontic; Plugger, Root Canal, Endodontic; File, Pulp Canal, Endodontic; Curette, Endodontic; Broach, Endodontic; Instrument, Hand, Calculus Removal; Post, Root Canal; Zinc Oxide Eugenol; Hemostat, Surgical; Punch, Biopsy, Surgical; Knife, Surgical; Forceps, Tooth Extractor, Surgical; Forceps, Rongeur, Surgical; File, Bone, Surgical; Elevator, Surgical, Dental; Curette, Surgical, Dental; Chisel, Bone, Surgical; Chisel, Osteotome, Surgical; Scaler, Periodontic; Knife, Periodontic; Marker, Periodontic; Hoe, Periodontic; File, Periodontic; Curette, Periodontic; Balloon, Epistaxis; Brush, Cleaning, Tracheal Tube; Splint, Nasal; Microscope, Surgical; Speculum, Ent; Source, Carrier, Fiberoptic Light; Bur, Ear, Nose And Throat; Otoscope; Unit, Examining/Treatment, Ent; Stimulator, Nerve; Probe, Rectal, Non-Powered; Stylet, Ureteral; Holder, Ureteral Catheter; Tourniquet, Gastro-Urology; Stylet For Catheter, Gastro-Urology; Bag, Urine Collection, Leg, For External Use, Sterile; Bougie, Urological; Sound, Metal, Interconnected; Sound, Urethral, Metal Or Plastic; Forceps, Biopsy, Non-Electric; Tube, Smoke Removal, Endoscopic; Retractor, Fiberoptic; Accessories, Photographic, For Endoscope (Exclude Light Sources); Instrument, Catheter, Punch; Evacuator, Bladder, Manually Operated; Clamp, Non-Electrical; Retractor, Self-Retaining; Dilator, Rectal; Speculum, Rectal; Device, Locking, For Intestinal Clamp; Adaptor, Bulbs, Miscellaneous, For Endoscope; Probe And Director, Gastro-Urology; Retractor, Non-Self-Retaining; Snare, Non-Electrical; Cannula, Injection; Clamp, Penile; Hook, Gastro-Urology; Bell, Circumcision; Ring, Laparotomy; Scoop; Apparatus, Suturing, Stomach And Intestinal; Ligator, Hemorrhoidal; Holder, Needle, Gastroenterologic; Needle, Gastro-Urology; Forceps, Disconnect; Plier, Crimp; Clamp, Cannula; Tray, Start/Stop (Including Contents), Dialysis; Clamp, Line; Cleaner, Ultrasonic, Medical Instrument; Depressor, Tongue, Non-Surgical; Gown, Examination; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Chair, Blood Donor; Protector, Skin Pressure; Device, Transfer, Patient, Manual; Cover, Mattress (Medical Purposes); Bed, Manual; Urinal; Ring Cutter; Basin, Emesis; Bedpan; Bag, Urine Collection, Newborn; Stand, Infusion; Stretcher, Hand-Carried; Strip, Adhesive, Closure, Skin; Sheet, Burn; Binder, Perineal; Stocking, Medical Support (For General Medical Purposes); Bandage, Elastic; Wrap, Sterilization; Chair, Examination And Treatment; Fiber, Medical, Absorbent; Dressing, Wound, Drug; Table, Operating-Room, Manual; Tray, Surgical, Instrument; Microscope, Surgical, General & Plastic Surgery; Loupe, Diagnostic/Surgical; Light, Surgical, Floor Standing; Light, Surgical, Ceiling Mounted; Light, Surgical, Accessories; Illuminator, Non-Remote; Camera, Cine, Endoscopic, With Audio; Mirror, General & Plastic Surgery; Tape, Measuring, Rulers And Calipers; Locator, Magnetic; Camera, Television, Surgical, With Audio; Speculum, Non-Illuminated; Speculum, Illuminated; Specula Accessories; Camera, Still, Endoscopic; Cover, Shoe, Operating-Room; Holder, Camera, Surgical; Mask, Surgical; Helmet, Surgical; Gown, Surgical; Apparatus, Exhaust, Surgical; Cap, Surgical; Appliance, Facial Fracture, External; Splint, Extremity, Inflatable, External; Chair, Surgical, Non-Electrical; Stool, Operating-Room; Chisel, Surgical, Manual; Clip, Implantable; Clip, Removable (Skin); Contractor, Surgical; Curette, Surgical, General Use; Cutter, Surgical; Expander, Surgical, Skin Graft; Guide, Surgical, Instrument; Hammer, Surgical; Marker, Skin; Needle, Aspiration And Injection, Disposable; Needle, Suturing, Disposable; Rasp, Surgical, General & Plastic Surgery; Retractor; Snare, Surgical; Spatula, Surgical, General & Plastic Surgery; Stylet, Surgical, General & Plastic Surgery; Stripper, Vein, Reusable; Stripper, Vein, Disposable; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Balloon Type; Chair, Surgical, Ac-Powered; Catheter, Multiple Lumen; Catheter, Peritoneal; Catheter, Irrigation; Catheter, Eustachian, General & Plastic Surgery; Catheter, Cholangiography; Needle, Catheter; Dilator, Catheter; Adaptor, Catheter; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Retainer, Surgical; Table, Operating-Room, Electrical; Guide, Needle, Surgical; Hook, Surgical, General & Plastic Surgery; Gouge, Surgical, General & Plastic Surgery; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Needle, Suturing, Reusable; Needle, Aspiration And Injection, Reusable; Knife, Amputation; Applier, Surgical, Clip; Saw, Manual And Accessories; Staple, Removable (Skin); Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Brush, Scrub, Operating-Room; Brush, Dermabrasion, Manual; Brush, Biopsy, General & Plastic Surgery; Applier, Staple, Surgical,; Elevator, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Forceps, General & Plastic Surgery; Blade, Scalpel; Motor, Surgical Instrument, Pneumatic Powered; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Driver, Surgical, Pin; Dermatome; Brush, Dermabrasion, Powered; Bur, Surgical, General & Plastic Surgery; Osteotome, Manual; Mallet, Surgical, General & Plastic Surgery; Test, Leukocyte Alkaline Phosphatase; Discriminator, Two-Point; Fork, Tuning; Pinwheel; Percussor; Punch, Skull; Anvil, Skull Plate; Instrument, Shunt System Implantation; Retractor, Self-Retaining, For Neurosurgery; Instrument, Microsurgical; Saw, Powered, And Accessories; Rongeur, Manual; Apparatus, Electrosurgical; Instrument, Surgical, Non-Powered; Needle, Neurosurgical Suture; Tong, Skull For Traction; Handpiece (Brace), Drill; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Manual); Headrest, Neurosurgical; Clip, Scalp; Instrument, Clip Removal; Rack, Clip; Applier, Hemostatic Clip; Cannula, Ventricular; Instrument, Ligature Passing And Knot Tying; Clip, Aneurysm; Curette, Uterine; Forceps, Surgical, Gynecological; Forceps, Obstetrical; Hook, Fibroid, Gynecological; Speculum, Vaginal, Metal; Scissors, Umbilical; Scissors, Episiotomy; Retractor, Vaginal; Packer, Uterine; Dilator, Cervical, Fixed Size; Pelvimeter, External; Laparoscope, Gynecologic (And Accessories); Culdoscope (And Accessories); Forceps, Biopsy, Gynecological; Coagulator, Culdoscopic (And Accessories); Shield, Nipple; Clamp, Umbilical; Clamp, Circumcision; Clamp, Uterine; Amniotome; Electrocautery, Gynecologic (And Accessories); Stethoscope, Fetal; Remover, Intrauterine Device, Contraceptive, Hook-Type; Sound, Uterine; Speculum, Vaginal, Nonmetal; Insufflator, Laparoscopic; Coagulator-Cutter, Endoscopic, Bipolar (And Accessories); Sampler, Amniotic Fluid (Amniocentesis Tray); Photokeratoscope; Instrument, Measuring, Corneal Radius; Magnifier, Hand-Held, Low-Vision; Loupe, Binocular, Low Power; Lens, Condensing, Diagnostic; Crutch, Ptosis; Mirror, Headband, Ophthalmic; Refractor, Manual, Non-Powered, Including Phoropter; Refractometer, Ophthalmic; Lens, Maddox; Prism, Gonioscopic; Tonometer, Manual; Ruler, Nearpoint (Punctometer); Instrument, Measuring, Lens, Ac-Powered; Gauge, Lens, Ophthalmic; Exophthalmometer; Pad, Eye; Marker, Sclera; Marker, Ocular; Cannula, Ophthalmic; Trabeculotome; Spud, Ophthalmic; Spoon, Ophthalmic; Specula, Ophthalmic; Spatula, Ophthalmic; Snare, Enucleating; Scissors, Ophthalmic; Rongeur, Lachrymal Sac; Ring, Ophthalmic (Flieringa); Retractor, Ophthalmic; Punch, Corneo-Scleral; Probe, Trabeculotomy; Probe, Lachrymal; Needle, Ophthalmic Suturing; Knife, Ophthalmic; Introducer, Sphere; Hook, Ophthalmic; Forceps, Ophthalmic; Expressor; Erisophake; Dilator, Lachrymal; Depressor, Orbital; Cystotome; Curette, Ophthalmic; Clamp, Muscle, Ophthalmic; Clip, Iris Retractor; Clamp, Eyelid, Ophthalmic; Caliper, Ophthalmic; Burr, Corneal, Manual; Burr, Corneal, Battery-Powered; Perimeter, Ac-Powered; Chart, Visual Acuity; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Frame, Trial, Ophthalmic; Clip, Lens, Trial, Ophthalmic; Set, Lens, Trial, Ophthalmic; Magnet, Permanent; Headlamp, Operating, Battery-Operated; Perimeter, Automatic, Ac-Powered; Eye, Artificial, Non-Custom; Unit, Cautery, Thermal, Battery-Powered; Trephine, Manual, Ophthalmic; Table, Instrument, Powered, Ophthalmic; Microscope, Operating & Accessories, Ac-Powered, Ophthalmic; Pen, Marking, Surgical; Hemostat; Scissors, Orthopedic, Surgical; Stripper, Surgical; Dynamometer, Nonpowered; Arthroscope; Saw; Splint, Traction; Halter, Head, Traction; Apparatus, Traction, Non-Powered; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Reamer; File; Broach; Rasp; Knife, Orthopedic; Burr, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Corkscrew; Awl; Trephine; Set, Hollow Mill; Osteotome; Instrument, Compression; Skid, Bone; Punch, Femoral Neck; Passer; Driver, Prosthesis; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Fork; Tamp; Passer, Wire, Orthopedic; Holder, Needle; Orthopedic; Mallet; Pusher, Socket; Instrument, Bending Or Contouring; Crimper, Pin; Spatula, Orthopedic; Twister, Wire; Bender; Screwdriver; Brace, Drill; Cutter, Wire; Forceps, Wire Holding; Solution, Lugol'S; Solution, Formalin-Alcohol-Acetic Acid; Aid, Transfer; Mattress, Flotation Therapy, Non-Powered; Splint, Hand, And Components; Sling, Arm; Pack, Hot Or Cold, Disposable; Pack, Hot Or Cold, Reusable; Chair, With Casters; Cover, Limb; Adaptor, Holder, Syringe; Orthosis, Cervical; Hand, External Limb Component, Mechanical; Unit, Heating, Powered; Bandage, Cast; Walker, Mechanical; Transducer, Ultrasonic, Diagnostic; Shield, Eye, Radiological; Film, Radiographic; Probe, Uptake, Nuclear; Table, Surgical With Orthopedic Accessories, Manual; Retainer, Matrix; Floss, Dental; Pick, Massaging; Plier, Orthodontic; Indicator, Physical/Chemical Sterilization Process; Scissors, Medical, Disposable; Catheter And Tip, Suction; Pump, Nebulizer, Electrically Powered; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Refractometer For Clinical Use; Unit, Drying; Unit, Filter, Membrane; Bath, Incubators/Water, All; Block, Cutting, Ent, Sterile; Crimper, Wire, Ent, Sterile; Die, Wire Bending, Ent, Sterile; Forceps, Wire Closure, Ent, Sterile; Jig, Piston Cutting, Ent, Sterile; Scissors, Wire Cutting, Ent, Sterile; Cannula, Ear; Chisel, Mastoid; Chisel, Middle-Ear; Clamp, Ossicle Holding; Curette, Ear; Excavator, Ear; Gauge, Mastoid; Gauge, Measuring; Holder, Ear Speculum; Hook, Microsurgical Ear; Inserter, Myringotomy Tube; Knife, Ear; Knife, Myringotomy; Loop, Wire; Nipper, Malleus; Pick, Microsurgical Ear; Press, Vein; Punch, Attic; Rasp, Ear; Rod, Measuring Ear; Rongeur, Mastoid; Scissors, Ear; Searcher, Mastoid; Snare, Ear; Spoon, Ear; Tube, Ear Suction; Knife, Laryngeal; Set, Laryngeal Injection; Trocar, Laryngeal; Tube, Laryngectomy; Elevator, Ent; Forceps, Ent; Holder, Speculum, Ent; Mirror, Ent; Mobilizer, Ent; Probe, Ent; Retractor, Ent; Cannula, Sinus; Chisel, Nasal; Curette, Ethmoid; Curette, Nasal; Gouge, Nasal, Ent; Irrigator, Sinus; Knife, Nasal; Perforator, Antrum; Punch, Antrum; Punch, Ethmoid; Punch, Nasal; Rasp, Frontal-Sinus; Rasp, Nasal; Rongeur, Nasal; Saw, Nasal; Scissors, Nasal; Snare, Nasal; Trephine, Sinus; Trocar, Sinus; Adenotome; Bougie, Eustachian; Curette, Adenoid; Depressor, Metal Tongue, Surgical; Dissector, Tonsil; Gag, Mouth; Hook, Tonsil Suturing; Knife, Tonsil; Needle, Tonsil Suturing; Punch, Adenoid; Punch, Tonsil; Screw, Oral; Screw, Tonsil; Snare, Tonsil; Tonsillectome; Tube, Tonsil Suction; Bistoury, Tracheal; Bougie, Esophageal, Ent; Cannulae, Bronchial; Dilator, Esophageal, Ent; Dilator, Tracheal; Hook, Tracheal; Trocar, Tracheal; Applicator, Ent; Blower, Powder, Ent; Ear Wick; Syringe, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Chisel (Osteotome); Container, Specimen Mailer And Storage, Sterile; Saw, Pneumatically Powered; Humidifier, Non-Direct Patient Interface (Home-Use); Mask, Oxygen, Non-Rebreathing; Retention Device, Suture; Tape And Bandage, Adhesive; Accessories, Catheter; Stimulator, Caloric-Air; Absorber, Saliva, Paper; Cushion, Flotation; Restraint, Wheelchair, Non-Protective; Hook, Bone; Positioner, Socket; Erythrosin B; Drape, Surgical, Antimicrobial; Bedding, Disposable, Medical; Device, Intravascular Catheter Securement; Chair And Table, Medical; Binder, Elastic; Positioner, Tooth, Preformed; Surgical Instruments, G-U, Manual (And Accessories); Instrument, Manual, General Obstetric-Gynecologic; Shield, Protective, Personnel; Camera, Surgical And Accessories; Goniometer, Nonpowered; Component, Traction, Non-Invasive; Applicator, Absorbent Tipped, Sterile; Bag, Ice; Light, Examination, Medical, Battery Powered; Device, Medical Examination, Ac Powered; Tray, Surgical; Scissors, General, Surgical; Orthopedic Manual Surgical Instrument; Accessory, Surgical Apparel; Label Or Tag, Sterile; Instrument, Manual, Surgical, General Use; Device, Percutaneous, Biopsy; Container, Sharps; Cover, Barrier, Protective; Accessories, Cleaning Brushes, For Endoscope; Collagen Corneal Shield; Battery, Replacement, Rechargeable; Transilluminator, Fiber Optic; Dressing, Wound, Occlusive; Block, Cutting, Ent, Non-Sterile; Anti Fog Solution And Accessories, Endoscopy; Non-Surgical Gown",1; 2; U,"ALC Plus Disposable Light Handle Cover; AMNIHOOK AMNIOTIC MEMBRANE PERFORATOR; Adaptors; Aspen; Aspen Basin; Aspen Needle Container; Aspen Needle Counter; Bard-Parker; Bard-Parker Scalpel Blade Remover; Bard-Parker [Aspen]; Beach Chair Head and Chin Straps; Berkette Beach Chair Limb Positioner; Bethesda Face Mask; BlueMed; Bovie Medical; CS Medical; Cardinal; Carson Perineal Post Pad; Cautery Tip Cleaner; Collection Swab; ColorTrack identification Tape; ColorTrack identification tags; Cygnus Medical; DOUBLE-GRIP UMBILICAL CORD CLAMP; Dr Don's Arm Suspension Kit; Dr Don's Arm Suspension Kit Montana; Dr Don's Arm Suspension Kit Northern; Dr. Don's Arm Canoe; Dr. Don's Arm Canoe - V; Dr. Fog anti-fog; ErgoSupport Step Stool; Erin Mask; Erin Mask Replacement Strap; FIRST TIME URINE SPECIMEN COLLECTOR; Fluid bowl; Green Genie Suture Passer; Hana Hip Kit; Headband; Hermanator Knee Positioning Pad; Hoffee Suture Retriever; Indy Beach Chair Face Mask; Instrument Mat; Jessie Arm Suspension Kit; Laparoscope, Dr. Fog solution; Lateral Positioner Pad Set; Leg Comfort Pad; Lewiston Hip Kit; Light Handle Covers; Lindy Boot Liner; MABIS; MD Traction Rope; Marco Shoulder Stabilization Kit; Mini-Scalpel; Needle Guides, General Purpose; Needle Nest; Non-Sterile Medication Labels; Norton Arm Kit; OR Camera Cover and Accessories (Aspen); Olsen Medical; Oxboro Instrument Tip Protectors; PLASTIBELL CIRCUMCISION DEVICE; PREMIE URINE SPECIMEN COLLECTORS; Parent Post Pad; Patient Care Boot Insert; Perineal Post Cover; Pink XL Hermanator Knee Pad; Precept; Probe Cover; Probe Cover, Endocavity; Prone Face Pillow; Pull Up; Racine Pelvic Positioning Pad; Richard Allan Nasal Snare; Richard Allan Safety Pin; Richard Allan Skin Marker; Richard Allan Tonsil Snare; Richard Allan Vessel Loops; Richard-Allan Disposa-a-Tu; SafeClean brushes; Seattle Brachy Bed; Securline Skin Marker; Sedona Arm Cradle; Shields; Simeon Medical; Smoot Ankle Distraction Foot Strap; Sponge Bowl; Sterile Medication Label with or without Utility Marker; Sterion Clamp covers; Sterion Labels; Sterion Locking Tags; Sterion Pin Cover; Sterion Surgical Tape; Sterion Suture Boots; Sterion Syringe Cup; Sterion Syringe and Scalpel Holder; Sterion Tip Protectors; Sterion Tube Holder; Sterion Vessel Loops; Sterion Wound Closure; Surgical Light System (TruLight 3000, TruLight 5000, iLED7) and accessories [Trumpf]; Surgidyne Wound Drainage; Symmetry; Symmetry Surgical; Symmetry Surgical Inc.; System Drapes; TLC Distraction Pad Set; Thigh Holder Pad; Transfer Tray; Tube Holder with Removable Strap; U-BAG URINE SPECIMEN COLLECTORS; Umbilical Cord Clamp; Universal Head Restraint; Web Guards; Write On Labels; Write-Site Plus Skin Marker; Write-Site Skin Marker; kittner; transparent dressing",2019-10-14,143,2019-01-22,0,8,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221836161%22&limit=1
"Diagnostic Automation/ Cortez Diagnostics Inc,.",2029372,1000306617,21250 Califa St Suite 102 and 116,Woodland Hills,CA,91367,United States,Diagnostic Automation /Cortez Diagnostics Inc.,9011974,Manufacturer; Manufacturer for export; Remanufacturer; Repackager or relabeler,193,CDM; CDP; CDZ; CEC; CEE; CEN; CEP; CFL; CFP; CFT; CGA; CGF; CGI; CGJ; CHP; CIZ; DAM; DAP; DBE; DBF; DBL; DBM; DCK; DCN; DDC; DDN; DEL; DFC; DFJ; DHC; DHN; DHR; DHX; DIO; DIS; DJC; DJG; DJR; DKE; DKZ; DNK; DRR; GHM; GLZ; GMD; GMP; GMQ; GMS; GNC; GNH; GNW; GPD; GPE; GPF; GQG; GQH; GQL; GQO; GQW; GRX; GRY; GTQ; GTZ; JHI; JHT; JIL; JIN; JIO; JIR; JIT; JJB; JJQ; JJR; JKC; JKD; JLS; JLW; JLX; JMT; JNL; JQW; JRE; JRY; JSX; JTC; JWX; JWZ; JXM; JZO; KHE; KHQ; KIY; KLI; KQO; KSJ; KSX; KTN; LAF; LCM; LCS; LCX; LDJ; LFG; LFX; LFY; LFZ; LGC; LGD; LHL; LIB; LIM; LIP; LIQ; LJC; LJM; LJN; LJX; LJY; LJZ; LKQ; LKV; LLA; LLL; LLM; LOL; LOM; LQI; LQN; LRM; LSE; LSR; LYR; MCD; MDJ; MDT; MDU; MGM; MGX; MHI; MHJ; MID; MIU; MJH; MLK; MMI; MOB; MPQ; MRG; MRS; MST; MTF; MTN; MTP; MVO; MXB; MXJ; MYF; MZF; MZO; NCD; NCI; NFT; NFV; NFW; NFY; NGE; NGG; NGI; NGL; NGM; NOP; NSF; NXO; OAM; OHE; OSU; OUC; OUY; PCL; PIQ; PJD; PMT; PSZ; PTG; PTH; PVA; QAW; QCU; QKO; QKP; QMN; QST; SEA,"Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.); Radioimmunoassay, Total Triiodothyronine; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Radioimmunoassay, Thyroxine-Binding Globulin; Dye-Indicator, Ph (Urinary, Non-Quantitative); Radioimmunoassay, Luteinizing Hormone; Radioimmunoassay, Human Growth Hormone; Radioimmunoassay, Immunoreactive Insulin; Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Estrone; Radioimmunoassay, Estriol; Radioimmunoassay, Follicle-Stimulating Hormone; Radioimmunoassay, Estradiol; Radioimmunoassay, Androstenedione; Hemoglobin, Chain Specific, Antigen, Antiserum, Control; Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control; Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control; Ferritin, Antigen, Antiserum, Control; Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control; Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control; C-Reactive Protein, Antigen, Antiserum, And Control; System, Test, C-Reactive Protein; Thyroglobulin, Antigen, Antiserum, Control; Beta-2-Glycoprotein I, Antigen, Antiserum, Control; Lipoprotein X, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; Albumin, Rhodamine, Antigen, Antiserum, Control; System, Test, Systemic Lupus Erythematosus; Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Barbiturate; Thin Layer Chromatography, Methamphetamine; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Reagents, Test, Tetrahydrocannabinol; Enzyme Immunoassay, Amphetamine; Thin Layer Chromatography, Morphine; Amplifier And Signal Conditioner, Biopotential; Test, Sickle Cell; Antigens, If, Toxoplasma Gondii; Antisera, Latex Agglutination, Cryptococcus Neoformans; Antisera, Control For Nontreponemal Tests; Antigens, Nontreponemal, All; Anti-Human Globulin, Fta-Abs Test; Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.; Antigen, Fluorescent Antibody Test, Schistosoma Mansoni; Antisera, Cf, Influenza Virus A, B, C; Antigen, Indirect Fluorescent Antibody Test, Echinococcus Granulosus; Antisera, Positive Control, Echinococcus Spp.; Antigen, Agglutinating, Echinococcus Spp.; Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus; Antigen, Cf (Including Cf Control), Cytomegalovirus; Antisera, Fluorescent, Herpesvirus Hominis 1,2; Antisera, Cf, Herpesvirus Hominis 1,2; Antigen, Cf, (Including Cf Control), Varicella-Zoster; Antisera, All Leptospira Spp.; Antigens, All, Leptospira Spp.; Antistreptolysin - Titer/Streptolysin O Reagent; Antisera, All Groups, Streptococcus Spp.; Visual, Pregnancy Hcg, Prescription Use; Chromatographic Separation, Cpk Isoenzymes; Method, Enzymatic, Glucose (Urinary, Non-Quantitative); Nitroprusside, Ketones (Urinary, Non-Quant.); Blood, Occult, Colorimetric, In Urine; Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Calibrator, Secondary; Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.); Colorimeter, Photometer, Spectrophotometer For Clinical Use; Electrolyte Controls (Assayed And Unassayed); Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate); Radioimmunoassay, C-Peptides Of Proinsulin; Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Radioimmunoassay, 17-Hydroxyprogesterone; Diazo (Colorimetric), Nitrite (Urinary, Non-Quant); Immunochemical, Thyroglobulin Autoantibody; Station, Pipetting And Diluting, For Clinical Use; Refractometer For Clinical Use; Antiserum, Fluorescent, Epstein-Barr Virus; Kit, Identification, Neisseria Gonorrhoeae; Device, Microtiter Diluting/Dispensing; Kit, Screening, Staphylococcus Aureus; Kit, Screening, Trichomonas; Enzyme Immunoassay, Benzodiazepine; System, Test, Thyroid Autoantibody; Reagent, Occult Blood; Radioassay, Triiodothyronine Uptake; Chamber, Slide Culture; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Automated Urinalysis System; System, Identification, Hepatitis B Antigen; Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use; System, Test, Infectious Mononucleosis; Gas Chromatography, Methamphetamine; Enzyme Immunoassay, Phencyclidine; Radioimmunoassay, Digoxin (125-I); Kit, Test, Pregnancy, Hcg, Over The Counter; Enzyme Immunoassay, Cannabinoids; Radioimmunoassay, Tricyclic Antidepressant Drugs; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus; Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Reagents, Antibody, Legionella, Direct & Indirect Fluorescent; Device, General Purpose, Microbiology, Diagnostic; Test, Screening, For D Positive Fetal Rbc'S; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Enzyme Linked Immunoabsorbent Assay, Rotavirus; Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group); Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls; Antibody Igm, If, Epstein-Barr Virus; Test, Urine Leukocyte; Enzyme Linked Immunoabsorbent Assay, Mumps Virus; Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.; Antibody Igm,If, Cytomegalovirus Virus; Enzyme Immunoassay, Fetal Fibronectin; Direct Agglutination Test, Toxoplasma Gondii; Extractable Antinuclear Antibody, Antigen And Control; Test, Antigen, Nuclear, Epstein-Barr Virus; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Hepatitis Delta Serological Reagents; Latex Agglutination Assay, Rubella; Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control; Epstein-Barr Virus, Other; Reagent, Borrelia Serological Reagent; Helicobacter Pylori; Antigen, Ebv, Capsid; Reagents, Cysticercosis; Elisa, Trichinella Spiralis; Antigen, Elisa, Cryptococcus; C. Trachomatis (Chlamydia Group); Test System, For Drugs Of Abuse; Giardia Spp.; Cryptosporidium Spp.; System, Test, Anticardiolipin Immunological; Enzyme Linked Immunosorbent Assay, T. Cruzi; Legionella, Spp., Elisa; Thin Layer Chromatography, Tricyclic Antidepressant Drugs; Immunoassay Method, Troponin Subunit; Test System, Antineutrophil Cytoplasmic Antibodies (Anca); Container, Specimen, Urine, Drugs Of Abuse, Over The Counter; System, Test, Vitamin D; Test System, Nicotine, Cotinine, Metabolites; Antibodies, Gliadin; Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer; Test, Syphilis, Treponemal; Antibody To Htlv-1, Elisa; Kit, Test, Multiple, Drugs Of Abuse, Over The Counter; Test, Vaginal, Bacterial Sialidase; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis; NCI; Test, Amphetamine, Over The Counter; Test, Benzodiazepine, Over The Counter; Test, Cannabinoid, Over The Counter; Test, Cocaine And Cocaine Metabolites, Over The Counter; Test, Luteinizing Hormone (Lh), Over The Counter; Test, Methamphetamine, Over The Counter; Test, Morphine, Over The Counter; Test, Opiates, Over The Counter; Test, Phencyclidine (Pcp), Over The Counter; Elisa, Antibody, West Nile Virus; Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment; Calprotectin, Fecal; Immunoassay, Insulin-Like Growth Factor Binding Protein-1; Forensic Evidence Sexual Assault Kit; Dengue Serological Reagents; Norovirus Serological Reagent; Trichomonas Vaginalis Nucleic Acid Amplification Test System; Enzyme Linked Immunoabsorbent Assay, Rubeola Igm; Reagents For Detection Of Norovirus Nucleic Acid; Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; Devices Detecting Influenza A, B, And C Virus Antigens; Test, Methadone, Over The Counter; Test, Barbiturate, Over The Counter; Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt; Test, Tricyclic Antidepressants, Over The Counter; Dengue Virus Antigen Assay; Reagent, Coronavirus Serological; Coronavirus Antigen Detection Test System.; Covid-19 Multi-Analyte Antigen Device; Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test; Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users",1; 2; 3; N; U,"AFP Rapid Test; AMA; ANA; ANCA Screen; ASA; ASO Latex; AccuDiag Chlamydia; AccuDiag FSH ELISA; AccuDiag HBsAg; AccuDiag HIV NAT Elisa; AccuDiag™ ANA Screen Elisa; AccuDiag™ Cytomegalovirus IgG (CMV IgG) ELISA; AccuDiag™ Cytomegalovirus IgM (CMV IgM) ELISA; AccuDiag™ DHEA ELISA; AccuDiag™ Dengue NS1 ELISA; AccuDiag™ ECHINOCOCCUS; AccuDiag™ Enhanced Toxocara IgG ELISA; AccuDiag™ Estrone ELISA; AccuDiag™ Free T3 ELISA; AccuDiag™ Free Testosterone ELISA; AccuDiag™ HLTV Elisa; AccuDiag™ LH Elisa; AccuDiag™ Leptospira IgG ELISA; AccuDiag™ Mumps IgM Elisa; AccuDiag™ Prolactin Elisa; AccuDiag™ Rubella IgG ELISA; AccuDiag™ Rubella IgM ELISA; AccuDiag™ Strongyloides IgG ELISA; AccuDiag™ T4 ELISA; AccuDiag™ Thyrglobulin ELISA; AccuDiag™ Thyroid Binding Globulin (TBG) ELISA; AccuDiag™ Thyroid peroxidase (TPO); AccuDiag™ Toxoplasma IgG ELISA; AccuDiag™ Toxoplasma IgM ELISA; AccuDiag™ Varicella Zoster IgG (VZV IgG) ELISA; Alcohol Saliva rapid test; Alcohol Urine test; Ascaris; BZD card; BZD strip; Borrelia; C-reactive protein; CEA Rapid test; CMV; CMV ELISA; CRP Latex; CRP Latex InstaTest; Cardiolipin IgA; Cardiolipin IgG; Cardiolipin IgM; Chagas; Chagas Rapid test; Chemistry Analyzer SF4500; Chlamydia male/female rapid test; Chlamydia trachomatis IgG; Color Staph Latex; Crypto/Giardia; Cryptosporidium; D-Dimer Rapid test; Dengue IgM ELISA; Digoxin; EBNA IgG; EBNA IgM; EBV; EBV VCA IgG; EBV VCA IgM; ENA profile; Echinococcus IgG ELISA; FOB; FOB RapiCard™ InstaTest; FOB rapid test; FTA-ABS; Fecal Occult Blood InstaTest™; Ferritin; Filariasis IgG/IgM Rapid test; Free T4; Giardia ELISA; Gliadin; Glucose urine strip; Gonorrhea Rapid test; H. pylori Antigen; H. pylori IgG; H.pylori; HAV IgM rapid; HBsAg; HCG Combo RapiDip™ InstaTest (Urine/Serum); HCG Urine Midstream InstaTest; HCG Urine RapiCard™ InstaTest; HCG Urine RapiDip™ InstaTest; HDV IgM ELISA; HSV; HSV 1 IgG; HSV 1&2; Herpes; Herpes Simplex Virus Serological assay; IFA slides; Influenza A & B plus COVID-19 Antigen Combo RapiCard™ InstaTest; Influenza A&B rapid; InstaTest HCG; InstaTest Norovirus; InstaTest RSV RapidCard; InstaTestCotinine; InstaTestTM; InstaTest™; LH Urine RapiCard™ InstaTest; Legionella; Leptospira IgG/IgM RapidTest™ Cassette; Leptospira IgM ELISA; Lp (a); Lyme; MPO; Measles IgM; Methamphetamine; Microplate reader SF2100; Microplate washer; Microplate washer 2600; Mono rapid; Mult-Drug Combination Urine RapiCup™ -OTC Use/ Prescription Use; Mult-Drug combination Urine Panel (RapiCard™/ RapiDip™) & Multi-Drug RapiCup™- Home Use; Mult-Drug combination Urine Panel (RapiCard™/ RapiDip™/ RapiCup™)- Home Use; Mult-Drug combination Urine RapiCard™/ Multi-Drug combination Urine RapiDip™/ Multi-Drug combination Urine RapiCup™; Multi Drug Panel cup; Multi-Drug Panel (RapiCard™ and RapiDip™) (Laboratory/POC); Multi-Drug Panel RapiCup™; Multi-Drug test panel; Mumps IgG; Mycoplasma IgG; Mycoplasma IgM; Myoglobin; NeoNatal TSH ELISA; Norovirus Rapid test; OneStep CK-MB RapiCard™ InstaTest; OneStep D-dimer RapiCard™ InstaTest; OneStep FOB RapiCard™ InstaTest; OneStep Fentanyl RapidCard InstaTest (Urine); OneStep Filariasis IgG/IgM RapidTest; OneStep HBsAg /HCV /HIV /Syphilis Combo RapidCard InstaTest; OneStep HCG Combo RapiDip™ InstaTest (Urine/Serum); OneStep HCG Urine Midstream InstaTest; OneStep HCG Urine RapiCard™ InstaTest; OneStep HCG Urine RapiDip™ InstaTest; OneStep InstaTest HCG Combo Urine/Serum RapiCard; OneStep LH Urine RapiCard™ InstaTest; OneStep Mult-Drug Combination Urine RapiCup™ -OTC Use/ Prescription Use; OneStep Mult-Drug combination Urine Panel (RapiCard™/ RapiDip™) & Multi-Drug RapiCup™- Home Use; OneStep Mult-Drug combination Urine RapiCard™/ Multi-Drug combination Urine RapiDip™/ M-Drug combination Urine RapiCup™; OneStep Multi-Drug Panel (RapiCard™ and RapiDip™) (Laboratory/POC); OneStep Multi-Drug Panel RapiCup™; OneStep Single-Drug Urine RapiCard™/Single-Drug RapiDip™/Single-Drug RapiCup™ (Laboratory/POC); Onestep 2019-nCOV IgG/IgM Rapid Test Cassette InstaTest; Onestep Alcohol Saliva RapiCardTM InstaTest; Onestep Cannabinoids InstaTest; Onestep Cocaine Metabolites InstaTest; Onestep Cocaine RapiCardTM InstaTest; Onestep Flu A & B Antigen RapiCard™ InstaTest; Onestep HCG RapiCardTM InstaTest; Onestep LH RapiCardTM InstaTest; Onestep MDMA RapiCardTM InstaTest; Onestep Marijuana (THC) RapiCardTM InstaTest; Onestep Methadone InstaTest; Onestep Multi-Drug InstaTest; Onestep Tetrahydrocannabinol InstaTest; Onestep Toxoplasma RapiCardTM InstaTest; Onestep Vaginalis InstaTest; Opiate; PCP; PR3; PSA Rapid test; QMedix FSH ELISA; QMedix™ Cytomegalovirus IgG (CMV IgG) ELISA; QMedix™ Cytomegalovirus IgM (CMV IgM) ELISA; QMedix™ Dengue NS1 ELISA; QMedix™ Free T3 ELISA; QMedix™ LH ELISA; QMedix™ Rubella IgG ELISA; QMedix™ Rubella IgM ELISA; QMedix™ Thyroid Binding Globulin (TBG) ELISA; QMedix™ Toxoplasma IgG ELISA; QMedix™ Toxoplasma IgM ELISA; QMedix™ Varicella Zoster IgG (VZV IgG) ELISA; Qmedix OneStep hCG Combo (Urine/Serum/Plasma) RapiCardTM InstaTest; RF; RF Latex; RPR Latex; RSV RapidTest Cassette; Rotavirus ELISA; Rubella; Rubella ELISA; Rubella InstaTest; SS-A (Ro); Salmonella typhi rapid test; Schistosoma IgG; Scl-70; Sexual combo Transmitted Syphilis, Hepatitis, HIV; Single-Drug Urine RapiCard™/Single-Drug RapiDip™/Single-Drug RapiCup™ (Laboratory/POC); Sm/RNP ELISA; Strep A InstaTest™; Synthetic Marijuana; Syphilis IgG; Syphilis Rapid test; T. solium (Cysticercosis); T3; T3 Uptake; T4; TB; TCA; TPO IgG; TSH; Testosterone ELISA; Thyroglobulin; Thyroid autoantibody; Toxocara IgG; Toxoplasma ELISA; Toxoplasma IFA; Trichinella IgG; Troponin I; URS-1B; Ultra Sensitive TSH; Urine Analyzer; Urine InstaTest™ -Urine reagent strip; Urine strip reagents; VZV; VZV IgG; VZV IgM; Vitamin D Rapid test; West Nile IgM; ds-DNA; hCG pregnancy rapid test",2008-04-17,143,2025-07-03,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222029372%22&limit=1
Microport Orthopedics Inc.,3010536692,3010536692,5677 Airline RD,Arlington,TN,38002,United States,MicroPort Orthopedics Inc.,10045253,Complaint file establishment; Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler; Reprocessor; Specification developer,102,EML; FDG; FNS; FQH; FSM; FTY; FZO; FZT; FZX; FZY; GAC; GAD; GFA; GFF; GFG; GFI; HRR; HRT; HRY; HRZ; HSO; HSX; HTC; HTD; HTE; HTF; HTJ; HTO; HTP; HTQ; HTR; HTS; HTT; HTW; HTX; HTZ; HWA; HWB; HWC; HWD; HWE; HWJ; HWK; HWM; HWN; HWO; HWP; HWQ; HWR; HWT; HWW; HWX; HXB; HXC; HXD; HXG; HXI; HXL; HXN; HXO; HXR; HXS; HXW; HXX; HXY; HYA; ILH; JDI; JDL; JDT; JDZ; JWH; KDD; KGS; KIK; KQW; KQZ; KRO; KTZ; KWA; KWL; KWY; KXA; LOD; LPF; LPH; LRY; LWJ; LXH; LYS; LZN; LZO; MAY; MBH; MBL; MDM; MEH; MRA; NXT; OOG; OQG; OQI,"Chisel, Bone, Surgical; Retractor, Fiberoptic; Ring Cutter; Lavage, Jet; Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Chisel, Surgical, Manual; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Rasp, Surgical, General & Plastic Surgery; Retractor; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Osteotome, Manual; Scissors, Orthopedic, Surgical; Stripper, Surgical; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Hinged (Metal-Metal); Saw; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Pliers, Surgical; Forceps; Elevator; Curette; Gauge, Depth; Reamer; File; Broach; Rasp; Knife, Orthopedic; Burr, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Trephine; Osteotome; Instrument, Compression; Skid, Bone; Punch, Femoral Neck; Passer; Driver, Prosthesis; Template; Countersink; Tap, Bone; Probe; Wrench; Clamp; Tamp; Passer, Wire, Orthopedic; Mallet; Applier, Cerclage; Pusher, Socket; Spatula, Orthopedic; Twister, Wire; Bender; Screwdriver; Brace, Drill; Forceps, Wire Holding; Splint, Hand, And Components; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Cap, Bone; Mixer, Cement, For Clinical Use; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Kit, Surgical Instrument, Disposable; Retention Device, Suture; Hook, Bone; Goniometer, Nonpowered; Component, Traction, Non-Invasive; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Femoral, Resurfacing; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Punch, Surgical; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Bone Mill; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Instrument, Manual, Surgical, General Use; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing; Knee Arthroplasty Implantation System; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented",1; 2; 3,"18711131 STRYKER SAW BLADE 2000 NARROW STERILE; 18711132 STRYKER SAW BLADE 2000 WIDE STERILE; 18711133 HALL 7 HOLE SAW BLADE NARROW; 18951018 ADVANTIM® POST STAB FEM LG LEFT NONPOROUS OPEN HOUSING; ADVANCE® Double High Insert; AXIOM® Second Generation Knee System; Advance; Advantim; Applier, Cerclage; Awl; Axiom; BIOLOX Delta Option Heads and Sleeves; BIOLOX Delta Option XL Heads; BIT, DRILL; Bender; Biolox; Bone Cap; Brace, Drill; Broach; Bur; CANCELLOUS BONE SCREW; Caliper; Chisel; Compression Instrument; Conserve; Countersink; Cutter; Depth Gauge; Driver; Dynasty; Dynasty Additive Manufacturing Shells; Dynasty Dual Mobility System; E110041L EVOLUTION® MA DCF POS REF FEM SIZING GUIDE LEFT; E110041R EVOLUTION® MA DCF POS REF FEM SIZING GUIDE RIGHT; E1100431 EVOLUTION® MA SKI TIP STYLUS FOR AR & PR FEM SIZING GUIDE; E1204401 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK MONOLITHIC SIZE 1; E1204402 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 2; E1204403 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 3; E1204404 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 4; E1204405 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 5; E1204406 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 6; E1204407 EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 7; E1500010 EVOLUTION® KA EM TIBIAL RESECTION GUIDE; E1500020 EVOLUTION® KA EM TIBIAL SHIM UNIVERSAL; E1500030 EVOLUTION® KA EM ADJUSTABLE TIBIAL STYLUS; E1500031 EVOLUTION® KA EM ADJUSTABLE TIBIAL STYLUS W/SPOONS; E1500040 EVOLUTION® KA CARTILAGE THICKNESS GAUGE; E1500050 EVOLUTION® KA UNIVERSAL THICKNESS CALIPER; E1500060 EVOLUTION® KA RE-DRILL GUIDE SIZE 8; E150012L EVOLUTION® KA  EM TIBIAL SLOTTED SHIM LEFT; E150012R EVOLUTION® KA  EM TIBIAL SLOTTED SHIM RIGHT; E1501010 EVOLUTION® KA IM DISTAL FEM ALIGNMENT GUIDE W/ ADJ PADS; E1501020 EVOLUTION® KA IM ADJUSTABLE VALGUS BUSHING; E1502030 EVOLUTION® KA STRAIGHT EM TIBIAL ROD W/ STOP; E1502040 EVOLUTION® KA OFFSET EM TIBIAL ROD W/ STOP; E1503011 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 1MM; E1503012 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 2MM; E1503013 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 3MM; E1503014 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 4MM; E1503015 EVOLUTION® KA FLEX/EXT CURVED GAP SPACER 5MM; E1503021 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 1MM; E1503022 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 2MM; E1503023 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 3MM; E1503024 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 4MM; E1503025 EVOLUTION® KA SNAP-ON CURVED EXTENSION GAP SPACER 5MM; E1503030 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 0MM; E1503031 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 1MM; E1503032 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 2MM; E1503033 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 3MM; E1503034 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 4MM; E1503035 EVOLUTION® KA DISTAL REFERENCE CURVED EXT GAP SPACER 5MM; E2102007 EVOLUTION® TIBIA EM MOUNTED STABILIZER; E2102008 EVOLUTION® TIBIA EM MOUNTED STABILIZER STRAP; E2102009 EVOLUTION® KA TIBIA EM ANKLE CLAMP ASSEMBLY; ES00TR11 EVOLUTION® KINEMATIC ALIGNMENT INSTRUMENTATION TRAY; ES00TR12 EVOLUTION® KINEMATIC ALIGNMENT INSTRUMENTATION TRAY 2; ES00TR13 EVOLUTION® KINEMATIC ALIGNMENT INSTRUMENTATION TRAY 3; ES011040 EVOLUTION® KA CADDY CLASSIC GAP SPACERS; ES011041 EVOLUTION® KA CADDY DISTAL REF GAP SPACERS; ES01TR11 EVOLUTION® KINEMATIC ALIGNMENT ICE INSTRUMENTATION TRAY; ES01TR12 EVOLUTION® KINEMATIC ALIGNMENT ICE INSTRUMENTATION TRAY 2; ES01TR13 EVOLUTION® KINEMATIC ALIGNMENT ICE INSTRUMENTATION TRAY 3; ETIBCK00 - EVOLUTION® TIBIAL CEMENT KEEL; EVOLUTION REVISION CCK; EVOLUTION Stemmed CS Femur; EVOLUTION® BIOFOAM® Tibial System  ADVANCE® BIOFOAM® Tibia; EVOLUTION® Hinge Knee System; EVOLUTION® Kinematic Alignment Instruments; EVOLUTION® REV BROACH ADAPTERS (E203CN01-03); EVOLUTION® REV CEMENT KEEL TRIAL (E3500CK1); EVOLUTION® REV CONE EXTRACTOR (E233CN11); EVOLUTION® REV CONE INSERTER (E233CN01-06); EVOLUTION® REV CONE TRIALS (E3500CN1-6); EVOLUTION® REV CONICAL BROACHES (E223CN01-06); EVOLUTION® REV CONICAL REAMERS (E2432CN01-06); EVOLUTION® REV REAMER PILOT (E2432CN11-13); EVOLUTION® REV SPACERS (E5101CN1-4); EVOLUTION® TIBIAL CONES (ETKNCN01-06); EXTRACTOR; Elevator; Evolution; File; Forceps; General Use Manual Instrument; Guardian; Hammer; Impactor; Interseal; KNIFE, ORTHOPEDIC; Lineage; Mallet; Manual Surgical Instrument; MicroPort CoCr Femoral Heads; Mill; Nexus Hip Stem; OSTEOTOME; Odyssey; PROCOTYL® L-O Acetabular System; PROFEMUR Renaissance Classic Long Neck Hip Stems; PROFEMUR Z; PROFEMUR® Preserve Sizes 1-3 Hip Stems; PROFEMUR® TL Classic Long Neck Hip Stems; Passer; Passer, Wire; Path; Perfecta; Planar; Pliers; Powered Accessory; Prime Acetabular Cup System; Prime Additive Manufacturing Shells; Probe; Procotyl; Profemur; Profemur Gladiator Cemented Classic Stem; Profemur Gladiator Thin HA Classic Stems with Collar; Profemur Preserve Classic; Prosthesis, hip, semi-constrained (metal cemented acetabular component; Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented; Punch; Pusher; RASP; REPIPHYSIS® Limb Salvage System; RONGEUR; Reamer; SAW; STARTER, BONE SCREW; Scissors; Screwdriver; Serrated Clip; Skid; Spatula; Splint; Stripper; Superpath; Suture Button; Tamp; Tap; Template; Transcend; Trephine; Twister; Wrench; chisel; clamp; drill bit; goniometer; guide; osteotome; rasp; retractor; ring cutter; saw blade; tape, measuring",2013-10-31,140,2025-05-15,3,15,3,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010536692%22&limit=1
Medtronic Medical Costa Rica S.R.L.,3014725904,3014725904,"Coyol Free Zone Bldg B7 Multitenant 7-8, Module F",Coyol Alajuela,,20113,Costa Rica,"Medtronic, Inc.",2112641,Manufacturer,33,EZX; FSZ; FZT; GAD; HBE; HRX; HTW; HWE; HWT; KIH; KTT; KWP; KWQ; LRN; LXH; MAX; MNH; MNI; MQP; MRW; NBH; NDN; NKB; NKG; NQP; NQW; ODP; OLO; OSH; OUR; OVD; PGM; PML,"Mesh, Surgical, Metal; Light, Surgical, Carrier; Cutter, Surgical; Retractor; Drills, Burrs, Trephines & Accessories (Simple, Powered); Arthroscope; Bit, Drill; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Template; Dispenser, Cement; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Wire, Surgical; Orthopedic Manual Surgical Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; System, Facet Screw Spinal Device; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Posterior Metal/Polymer Spinal System, Fusion; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Sacroiliac Joint Fixation; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Growing Rod System; Bone Cement, Posterior Screw Augmentation",1; 2; U,"ARTHROSCOPE; Atlantis Translational Plate; Atlantis Vision Anterior Cervical; Atlas Cable; BIT DRILLS; Bone Graft Washer; CAPSTONE PTC™ SPINAL SYSTEM; CCD Spine System; CD 4.5 Crosslink Plates; CD 5.5mm Set Screws; CD Cannulated Screw; CD Cobalt Chrome; CD HORIZON ESSENCE; CD HORIZON ESSENTIALS™ Spinal System; CD HORIZON Fenestrated Screw Set; CD HORIZON Growth Rod Conversion Set; CD HORIZON Longitude 2 Instruments and Rods; CD HORIZON SOLERA SPINAL SYSTEM; CD HORIZON SOLERA Spinal System; CD HORIZON SOLERA""; CD HORIZON SPINAL SYSTEM; CD HORIZON Solera 5.5/6; CD HORIZON Spinal System; CD HORIZON Spinal System SDS Pre-Bent Rods; CD HORIZON Spinal System SOLERA; CD HORIZON(R) Spinal System; CD HORIZONSPINAL SYSTEM; CD HORIZONSpinal System; CD HORIZON™ Spinal System; CD HORIZON® Fenestrated Screw Set; CD HORIZON® SOLERA® Spinal System; CD HORIZON® Spinal System; CD Horizan Eclipse M8 Screws; CD Horizan M8 Screws; CD Horizan Spinal Ti Spinal System; CD Horizon 3.2/4.5 Connectors; CD Horizon 3.5 Rods; CD Horizon 6.35 Crosslink Plates; CD Horizon Advanta; CD Horizon Antares Spinal System; CD Horizon Eclipse; CD Horizon Ilio Sacral; CD Horizon Legacy 4.5; CD Horizon Legacy 6.35 Ti; CD Horizon M8 M10 Reduction Hooks; CD Horizon MAS Design Enhancement; CD Horizon Set Screws; CD Horizon Spinal System; CD Horizon Spinous Plate; CD Horizon- Spinal System; CD Horizon-Spinal System/ CD Horizon SOLERA; CD HorizonSpinal System; CD Horizon™ ModuLeX™ Spinal System; CD Horizon® Spinal System; CD Ilio Sacral Screws; CD Perc Trauma; CD Spinal System; CD Spire Spikes; CD Staples and Screws; CDH Legacy 5.5; CDH Solera 4.75; CRESCENT™ SPINAL SYSTEM; CRESCENT™ SPINAL SYSTEM TITANIUM; Catalyft™ PL Expandable Interbody System; DIVERGENCE(TM) Anterior Cervical Fusion System; DIVERGENCE-L"" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM; DRILL BIT (ORTHOPEDIC MA; Danek Precision Rod Set; Drill; Introducer Tool; ELEVATE"" Spinal System; ELEVATE™ SPINAL SYSTEM; Equation Fixation System; General Instrument; General Instruments; INFINITY™ OCT System; KYPHON Cement Delivery System; KyphX Bone Filler Device; Kyphon HV-R Fenestrated Screw Cement; LAMINOPLASTY; MAST QUADRANT™ Retractor System; METRx Endoscope; MICRO-FRANCE; MODIFICATION TO TENOR SPINAL SYSTEM-PLATES; MSB PYRAMESH® Implant System; MULTIPLE TWIST; Multi Axial Screw System; Orfil Spine Fixation system; PASS LP Spinal System; PIVOX"" Oblique Lateral Spinal System; PLATE; PYRAMID +4 Anterior Lumbar Plate S; Peek Rod; Pyramesh; Pyramesh C; Pyramesh Implant System; Pyramid +4 Anterior Lumbar Plate; RETRACTOR; RIALTO™ SI Fusion System; RadiaLux™; SOVEREIGN Spinal System; SPINE; Sovereign; Spacekeeper; Spinal System; TEMPLATE; TENOR SPINAL SYSDYNA-LOK PLUS Plate; TENOR Spinal System; TSRH; TSRH 3D Connectors; TSRH 3Dx 90 Degree Offset Connector; TSRH Chromaloy Plus Precut Contoured Rods; TSRH Cobalt Chrome Rods; TSRH Crosslink System; TSRH Expanded Pedicle Screw; TSRH Hook Holder; TSRH Osteogrip; TSRH Sentry Anterior/Posterior Spin; TSRH Silo; TSRH Spinal System; TSRH Spinal System MPA Screws; TSRH Spinal System Prebent/precut r; TSRH Spinal system Crosslink Plates; TSRH TC 3D MPA Screw; TSRH TC Splined Connectors & Screws; TSRH TC Threaded Screws; Tenor Spinal System; Thoracolumbosacral pedicle screw system; Titanium GDLH Posterior Spinal Syst; Townley Transfacetpedicular Screw; VENTURE™ Anterior Cervical Plate System; VERTEX; VERTEX Reconstruction System; VERTEX® Reconstruction System; Vantage Bolts; Vantage Plates; Venture Cervical Plate; Vertex Adjustable Plate; Vertex Cannulated Screw; Vertex Crosslinks; Vertex Keel Plate; Vertex Lateral Connectors; Vertex Max; Vertex OC MAS, Rods, Hooks; Vertex Occipital Components; Vertex Reconstruction Occipital; Vertex Reconstruction System; ZEVO Anterior Cervical Plate System; ZPlate II",2005-03-23,143,2022-05-25,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014725904%22&limit=1
Stryker Instruments,3015967359,3015967359,1941 Stryker Way,Portage,MI,49002,United States,STRYKER CORP.,1811755,Complaint file establishment; Manufacturer; Specification developer,101,BSP; BYY; BYZ; CCK; DWH; DZI; DZJ; EIA; EJL; EMX; EOB; EQJ; ERL; FMF; FMH; FOX; FQH; FSM; FST; FWL; FXX; FXY; FXZ; FYA; FYD; GAH; GBP; GBX; GCX; GDG; GDY; GEH; GEI; GEY; GFA; GFE; GFF; GFG; GWG; GXD; GXI; GZT; HAB; HAE; HAO; HBB; HBC; HBE; HBF; HBI; HRX; HSZ; HTY; HWE; HXG; JCX; JDZ; JQP; JRR; KCT; KCY; KDQ; KGX; KIH; KIJ; KNW; KYZ; LFL; LGG; LGH; LOD; LRC; LWH; LXG; LXH; LYA; LYU; LZN; MCY; MDM; MKY; MMO; MNI; MOQ; MRL; NDN; NHB; NKB; OAR; OCJ; OEA; OKO; OLO; PBZ; PGW; PML; PNZ; QFX; QGI; QLV; SFQ,"Needle, Conduction, Anesthetic (W/Wo Introducer); Tube, Aspirating, Flexible, Connecting; Trap, Sterile Specimen; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Blade, Saw, Surgical, Cardiovascular; Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Unit, Operative Dental; Bur, Dental; Balloon, Epistaxis; Nasopharyngoscope (Flexible Or Rigid); Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Syringe, Piston; Container, Specimen, Sterile; Stand, Infusion; Lavage, Jet; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Camera, Cine, Endoscopic, Without Audio; Mask, Surgical; Hood, Surgical; Helmet, Surgical; Gown, Surgical; Apparatus, Exhaust, Surgical; Stylet, Surgical, General & Plastic Surgery; Catheter, Multiple Lumen; Catheter, Irrigation; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Hook, Surgical, General & Plastic Surgery; Gauze/Sponge, Internal, X-Ray Detectable; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Brush, Dermabrasion, Powered; Bur, Surgical, General & Plastic Surgery; Bit, Surgical; Endoscope, Neurological; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Retractor, Self-Retaining, For Neurosurgery; Saw, Powered, And Accessories; Rongeur, Manual; Instrument, Surgical, Non-Powered; Motor, Drill, Pneumatic; Motor, Drill, Electric; Drills, Burrs, Trephines & Accessories (Simple, Powered); Drills, Burrs, Trephines & Accessories (Compound, Powered); Illuminator, Fiberoptic, Surgical Field; Arthroscope; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Pin, Fixation, Smooth; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Tamp; Apparatus, Suction, Ward Use, Portable, Ac-Powered; Mixer, Cement, For Clinical Use; Calculator/Data Processing Module, For Clinical Use; Regulator, Temperature; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Tourniquet, Pneumatic; Bottle, Collection, Vacuum; Tape And Bandage, Adhesive; Dispenser, Cement; Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment; Instrument, Biopsy; Syringe, Irrigating (Non Dental); Instrument, Ultrasonic Surgical; Instrument, Cast Application/Removal, Manual; Instrument, Cast Removal, Ac-Powered; Bone Cement; Instrument, Ent Manual Surgical; Counter, Sponge, Surgical; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Orthopedic Manual Surgical Instrument; Splint, Intranasal Septal; Accessory, Surgical Apparel; Cement Obturator; Wound Dressing Kit; Instrument, Manual, Surgical, General Use; System, Skin Closure; Tray, Surgical, Ent; Orthosis, Spinal Pedicle Fixation; Battery, Replacement, Rechargeable; Scale, Sponge, Surgical, Electrically-Powered; Cement, Bone, Vertebroplasty; Polymer, Ear, Nose And Throat, Synthetic, Absorbable; Thoracolumbosacral Pedicle Screw System; Injector, Vertebroplasty (Does Not Contain Cement); Spinal Channeling Instrument, Vertebroplasty; Non-Surgical Gown; Negative Pressure Wound Therapy Non-Powered Suction Apparatus; Orthopedic Stereotaxic Instrument; Image Processing Device For Estimation Of External Blood Loss; Ear, Nose, And Throat Stereotaxic Instrument; Bone Cement, Posterior Screw Augmentation; Eustachian Tube Balloon Dilation Device; Diagnostic Neurosurgical Microscope Filter; Air-Handling Apparatus Accessory; Field Generator Positioning Device; Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision",1; 2; U,"0250-070-500 Suction Irrigator 2; 0250-070-520 StrykeFlow 2 With Tip; 0485-840-000 - XL Round Diamond Bur, 4 mm; 0485-860-000 - XL Round Diamond Bur, 5.5 mm; 10 PC TRAY; 10.5MM FLEXIBLE REAMER; 10MM FLEXIBLE REAMER; 10cm iQ Broad Knife; 10mm SUBFIX TRIAL; 11.5MM FLEXIBLE REAMER; 11.5mm SUBFIX TRIAL; 11MM FLEXIBLE REAMER; 11cm iQ Apex Knife; 11cm iQ Knife; 12MM FLEXIBLE REAMER; 12cm iQ 120 Claw; 12cm iQ Apex 360; 12cm iQ Barracuda; 12cm iQ Claw; 12cm iQ Large; 12cm iQ Micro; 12cm iQ Micro Claw; 12cm iQ Serrated Large; 12cm iQ Standard; 18cm iQ Apex Micro Claw; 18cm iQ Micro Claw; 2 PC TRAY; 206-716 w/2 small sculps/pkg; 20cm iQ Apex 360; 20cm iQ Standard; 3MM DBL SLEEVE 80MM TROC/ASSY; 3mm PREDRILL ASSEMBLY LONG; 3mm PREDRILL ASSEMBLY SHORT; 4 mm ENT MicroDebrider JAGUAR; 4.5MM FLEXIBLE REAMER; 4102-452 w/no feet on bottom; 4MM DBL SLVE 180MM TROC/ASSY; 4cm Angled Irrigation Clip; 4cm Straight Irrigation Clip; 4mm DBL SLEEVE 150mm TROC/ASSY; 4mm PREDRILL ASSEMBLY EXTRA SHORT; 4mm PREDRILL ASSEMBLY LONG; 4mm PREDRILL ASSEMBLY SHORT; 4mm TomCat Shaver Blades; 5 PC TRAY; 5.5MM FLEXIBLE REAMER; 5MM FLEXIBLE REAMER; 5mm HellCat Shaver Blades; 5mm PREDRILL ASSEMBLY EXTRA SHORT; 5mm PREDRILL ASSEMBLY LONG; 5mm PREDRILL ASSEMBLY SHORT; 5mm SPANNER WRENCH; 6.5MM FLEXIBLE REAMER; 6.5mm SUBFIX TRIAL; 6MM FLEXIBLE REAMER; 6mm PREDRILL ASSEMBLY EXTRA SHORT; 6mm PREDRILL ASSEMBLY LONG; 6mm PREDRILL ASSEMBLY SHORT; 7.5MM FLEXIBLE REAMER; 7.5MM Round; 75K STRAIGHT DRILL; 7MM FLEXIBLE REAMER; 7MM SPANNER WRENCH; 7mm SPANNER WRENCH; 8.5MM FLEXIBLE REAMER; 8MM FLEXIBLE REAMER; 8mm SUBFIX TRIAL; 9.5MM FLEXIBLE REAMER; 95 mm Stylet; 9MM FLEXIBLE REAMER; 9mm SUBFIX TRIAL; A 2 DRILL BRACE W/O CHUCK; A 4 4MM CHUCK; A 5 T-WRENCH; A 51 T WRENCH W/35 EXTENSION; ACL Workstation; ACM; ACM CARTRIDGE & TIPs; ACM system with cancellous; AEQ FRAC LONG SUP IMP ENS; AEQ FRAC SUPPORT DE BRAS; AEQ FRACT GR AXE LIAISON; AEQ FRACT MESUREUR AMOVIB; AEQ FRACT NM FANT TIG; AEQ IMPACTEUR DE PROTHESE; AEQ TIGE FRA LG FANT; AEQ USA FANT CALO; AEQUALIS PERFORM; AEQUALIS REVERSED; AGM 6 6MM CHUCK; ALEUTIAN Interbody Systems Trays; ALIQUOT DELIVERY SYSTEM; ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS); ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE; ANCHORAGE CP LAPIDUS TEMPLATE; ANCHORAGE CP MTP PIVOTING DRILL GUIDE; ANCHORAGE CP MTP TEMPLATE; ANCHORAGE CP POLYAXIAL DRILL GUIDE; ANCHORAGE CP UTILITY TEMPLATE; ANCHORAGE FIXATION PIN; ANCHORAGE FIXED DRILL GUIDE 2.5MM; ANCHORAGE FIXED DRILL GUIDE 2MM; ANCHORAGE INSTRUMENTS RACK (LEVEL 1); ANCHORAGE INSTRUMENTS RACK (LEVEL 2); ANCHORAGE INSTRUMENTS RACK COVER; ANCHORAGE PLATE BENDER; ANCHORAGE PLATE GRIPPER; AO HANDLE - LENGTH 135MM; AO Quick Coupling with Elastosil Handle; AO/JACOBS QUICK RELEASE APEX CHUCK 3mm; AO/JACOBS QUICK RELEASE APEX CHUCK 4mm; AO/JACOBS QUICK RELEASE APEX CHUCK 5mm; AO/JACOBS QUICK RELEASE APEX CHUCK 6mm; APEX DRILL BRACE - 3/4/5/6mm; APEX DRILL GUIDE HANDLE; APEX TRAY BASE; APEX TRAY LID; APEX TRAY LOWER INSERT; APEX TRAY UPPER INSERT; ATP Disc Prep; ATTACHMENTS; AUTOPLEX; AXSOS ADAPTOR FOR TORQUE TESTER T20; AXSOS ADAPTOR FOR TORQUE TESTER T8/T15; AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK; Accolade II System Instrumentation; Aequalis Flex Revive; Aequalis Fracture; Aequalis Perform+; Aequalis Reversed Fracture; Aequalis Reversed II; Aequalis"" PerFORM; Aggressive Max Shaver Blade 3.5mm; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; All OrthoHelix Orthopedic Manual Surgical Instruments; All Tornier Orthopeadic Manual Surgical Instruments (exempt); Aluminum Lid - Universal; Anato Hip System Instrumentation; Anatomic Express Tray; Asnis® III Cannulated Screw System; Asnis® PRO Cannulated Screw System; Aspiration Line Assembly; Audion ET dilation system; AutoPlex M4 Kit A: Cement Mixer with VertaPlex ® HV; AutoPlex M4 Kit B: Cement Mixer with VertaPlex ® HV Manifold compatible; Autoplex with Vertaplex HV; AxSOS; AxSOS 3; AxSOS 3 AF System and AxSOS 3 Ti System, Plate; AxSOS 3 Ankle Fusion; AxSOS 3 Ti; BARREL REAMER ASSEMBLY STAND; BATTERY POWERED SCREWDRIVER II; BIOCOMPRESSION WRENCH 15mm TUBE; BIOCOMPRESSION WRENCH 20mm TUBE; BIOCOMPRESSION WRENCH 25mm TUBE; BIT; BLADES, PROBES; BONE BIOPSY NEEDLES; Battery Pack for VariSpeed; Battery Powered ScrewDriver II; Bioprep Cement Restrictor; Biosteon Wedge Interference Screw System; Bixcut, IM Reamer; Bone Biopsy Kit; Bone Plug Extractor; BrainPath Manipulation Tool; BriteField Depth Gauge; Broach and Inserter Handle; Bursector 4 mm; Bursector 5.5 mm; CANYON Retractor Systems Trays; CAPRI Corpectomy Cage System Trays; CASPIAN Spinal System Trays; CAST SPREADERS (VARIOUS SIZES); CASTVAC; CAYMAN Plate System Trays; CHESAPEAKE Stabilization System Trays; CHISELS; CONSTA VAC BLOOD CO; CORE System; CURSOR; CUTTING SCREWDRIVER 4.5; CYLINDRICAL BUSH HOLDER; CalcLock; CalcLock manual surgical instruments; Cannulated Countersink with AO Fitting; Cannulated Drill with AO Fitting; Cannulated Drill ø 2,7/3.5mm with AO Fitting; Cannulated Screwdriver with AO Fitting; Cannulated Screwdriver with Elastosil Handle; Cannulated Tap with AO Fitting; Cascadia Interbody System; Cement Pusher; ClariFix Cryotherapy Device; Colored Plugs; Compression Staple System; Constavac and Battery Charger; Counterbore Drill; Cross-Screw System; Cyclone Sinonasal Suction and Irrigation System; DENALI Spinal System Trays; DEPTH GAUGE; DEPTH GAUGE (DISTAL RADIUS); DEPTH GAUGE (HAND); DISPOSABLE CEMENT SCULPS; DISSECTORS; DJD II STORAGE CASE; DRILL GUIDE BLOCK COMPACT 4 HOLE; DRILL GUIDE BLOCK COMPACT PERI 4 HOLE; DRILL GUIDE BLOCK HII 10 HOLE; DRILL GUIDE BLOCK HII 5 HOLE; DRILL GUIDE BLOCK MONOTUBE 4 HOLE; DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE; DRILL GUIDE LOCK II 2.5; DUAL SPEED INJECTION GUN; DUALSPEED CEMENT INJECTION GUN; Depth Gauge (Foot/Elbow/Distal Fib); Direct Measuring Gauge; Disposable Bipolar Forceps Cable; Double Drill Guide ø 2,0/3,5mm; Drill Bit; Drill Bit ø 2,0 x 150mm; Drill Sleeve; Dual Edge Shaver Blade 3.5mm; Dual Edge Shaver Blade 4mm; Dual Edge Shaver Blade 5.5mm; Dual-sided Baseplate Centering Guide; E-TYPE SPEED REDUCER CONTRA ANGLE; EASY CLIP ANGLED DRILL GUIDE SIZE 15; EVEREST Spinal System Trays; Edgelock manual surgical instruments; Eikon LT SL Sterilization Tray; Eikon LT Sterilization Tray; Elastosil T-Handle with AO Coupling; Entellus Medical Reinforced Anesthesia Needle; Exeter Hip System Instrumentation; Express Humeral Stem Extractor; Express Insert; Extractor Rod; Extractor for Screws; FASCIA CUTTER; FEMORAL CANAL BRUSH, STANDARD; FEMORAL CANAL BRUSH,STANDARD; FEMORAL SPONGE PKG 6; FIXOS 4 MV DEPTH GAUGE; FLEXIBLE GUIDE PIN; FLYTE BATTERIES; FLYTE CHARGER; FLYTE HELMETS; FLYTE HOODS; FLYTE TOGAS; FORCEPS; Fluid Safe 3000CC Canister; Fluid Suction HEPA Filter; Flyte SurgiCool Hoods; Flyte SurgiCool Togas; FoCESS HD Wireless Camera System; FocESS Sinuscopes; Footed Attachment 12mm; Footed Attachment 16mm; Footed Attachment 25mm; Friction Cement Gun; GUIDE FOR HALF-PINS; General Instruments; General Surgical Bits; Graft box body; Graft box compression screw; Graft box locking screw; Graft box washer; Graft box wedge; Graft sizer; Guide Wire; Guide Wire Pusher; Guide Wire Ruler; Guide Wire Targeter; Guide Wire Targeter - Crown; Guide Wire Targeter - Sleeve; Guide Wire, Threaded; HANDPIECE STERILIZATION CASE; HII 7mm T-WRENCH / 5+6mm SOCKET; HII COMPACT 5mm WRENCH/3&4mm SOCKET; HII COMPACT GUIDE BLOCK W/AO; HII COMPACT MRI STORAGE CASE BASE; HII COMPACT MRI STORAGE CASE LID; HII COMPACT MRI STORAGE CASE UPPER INSERT; HII COMPACT STORAGE CASE BASE; HII COMPACT STORAGE CASE LID; HII COMPACT STORAGE CASE UPPER INSERT; HII MICRO 2mm PIN DRIVER; HII MICRO DRILL GUIDE ASSEMBLY; HII MICRO NUT DRIVER; HII MICRO STORAGE CASE BASE; HII MICRO STORAGE CASE DRILL BIT HOLDER; HII MICRO STORAGE CASE LID; HII MICRO STORAGE CASE LOWER INSERT; HII MICRO STORAGE CASE UPPER INSERT; HII MRI TRAY BASE; HII MRI TRAY LID; HII MRI TRAY LOWER INSERT; HII TRAY BASE; HII TRAY LID; HII TRAY LOWER INSERT; HII TRAY UPPER INSERT; HLS KNEETEC; HM MINI 4 SPANNER WRENCH; HMENTS; HOFFMANN LRF INFO BOARD; HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT; HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY; HOFFMANN LRF RATCHET WRENCH - HEX 10; HOFFMANN LRF SPANNER WRENCH - 5 mm; HOFFMANN LRF SPANNER WRENCH - 7/10 mm; HOFFMANN LRF TELES. STRUT WRENCH; HOFFMANN LRF THUMBWHEEL - HEX 10; HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS; HOFFMANN LRF UNIVERSAL COMPONENTS INSERT; HOFFMANN LRF UNIVERSAL COMPONENTS TRAY; HOFFMANN LRF WIRE BOLT WRENCH; HOFFMANN LRF WIRE TENS. NOSE - LONG; HOFFMANN LRF WIRE TENS. NOSE - SHORT; HOFFMANN LRF WIRE TENSIONER; HOFFMANN XPRESS SILICON MAT; HOFFMANN XPRESS SILICON THUMBWHEEL; HOFFMANN XPRESS SPANNER WRENCH; HOFFMANN XPRESS STORAGE CASE BASE; HOFFMANN XPRESS STORAGE CASE INSERT; HOFFMANN XPRESS STORAGE CASE LID; HOFFMANN XPRESS TORQUE WRENCH; HOFFMANN3 TRAY FOR STANDARD COMPOMENTS; HOLDING SPANNER 4.5; HOWMEDICA MIX KIT I TM 10PK; HUMMER IV; Hoffmann LRF; Hoffmann LRF System, Insert; Hoffmann LRF System, Instrument; Hoffmann LRF System, Ruler; Hoffmann LRF System, Wire Tensioner; Hoffmann LRF System, Wrench; Holding Sleeve; Humeral Express Tray; Hydro Disposable Irrigation Cassette; Hydro Foot Switch; Hydro Irrigation Console; Hydro Pole Mount; IDET ADAPTER; IMN Instruments Percutaneous guide wire inserter; IMN Instruments Self-Holding Screwdriver T20; IMN™ Instruments drill; INBONE; INCLINED DRILL GUIDE SCREW EZ18; INCLINED DRILLING GUIDE + SCREW EZ20; INSTRUMENT TRAY BASE 4.5; INSTRUMENT TRAY LID FIXOS; INTERMEDIATE PROSTHESIS HOLDER LEFT; INTERMEDIATE PROSTHESIS HOLDER RIGHT; INTERPULSE; INTRAMEDULLARY BRUSH STANDARD 14MM OD; IRRIGATION; IV Pole; Infusion Stand; Injector Transfer Tube; Insertion Sleeve for Guide Wire; Instruments for Coverloc Volar Plat; Inter-Lock System; Intraosseous Fixation system manual surgical instruments; JA FANTOME CALOTTE; KW BENDING IRON ICS; Kirschner Wire; LATE INJECTION CEMENT GUN; LATERA; LID FOR INSTRUMENT TRAY; LID FOR PLATE RACK - COMPRESSION PLATES; LID FOR PLATE RACK - GENERIC; LID FOR PLATE RACK - SPECIAL PLATES; LITe BIO Delivery System - Loading Funnel; LITe BIO Delivery System - Loading Tool; LITe BIO Delivery System - Sterilization Tray and Lid; Lag Screw Sleeve; Large AO Coupling - Hall Fitting; Latera Absorbable Nasal Implant System; Latitude EV; M/T TRIAX LNG HANDLE WRENCH BLUE; M/T TRIAX LNG HANDLE WRENCH RED; M/T TRIAX LNG HANDLE WRENCH YELLOW; MANUAL SURGICAL INSTRUMENTS; MESA Spinal System Trays; MILITARY EXTERNAL FIXATION CASE; MIS 13 cm Angled Nose Tube; MIS 13 cm Curved Nose Tube; MIS 13 cm Modified Curved Nose Tube; MIS 13 cm Straight Hooded Nose Tube; MIS 13 cm Straight Nose Tube; MIS 16 cm Angled Nose Tube; MIS 16 cm Curved Nose Tube; MIS 16 cm Straight Hooded Nose Tube; MIS 16 cm Straight Nose Tube; MIXER; MIXEVAC CEMENT MIXERS AND KITS; MONOTUBE TRIAX YELLOW CASE; MS -00017 MOLLI Pole Clamp; Made-To-Order; Mako Instrument Trays; MaxLock; MaxLock Extreme manual surgical instruments; MaxTorque; Meniscal Transplant Set; Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini; Mini MaxLock manual surgical instruments; MiniFESS Light Seeker; Modular Glenoid Surface Trial; Modular Humeral Head Trial; Modular Humeral Head Trial Post; Monopolar Return Electrode Cable; Multiple Drill Guide; Myriad Illumination Pack; Myriad SPECTRA LightSource; NAPA Access System; NEPTUNE WASTE MGMT(SMOKE EVACUATOR); NICO BrainPath Sheath; NICO Brainpath Obturator; NICO Fluid System; NICO Myriad Console; NICO Myriad Handpiece; NICO Myriad NOVUS Console; NICO Myriad NOVUS Handpiece; NICO Myriad NOVUS: Illumination Pack; NICO Myriad NOVUS: Myriad-LX; NICO SecureHold; NICO Specimen Preserver; NPSeal; Navigated Spine Instruments Trays; Navigation Instruments Trays; Neptune 2 4-Port Manifold; Neptune 2 Docking Station (120V); Neptune 2 Docking Station (230V); Neptune 2 Rover (120V); Neptune 2 Rover (230V); Neptune 2 Single-Port Manifold; Neptune 2 Specimen Collection 4-Port Manifold; Neptune Bronze; Neptune Smart Docking Station (120V); NexFix; Nico Shepherd's Hook; Non-Footed Attachment 8cm; Non-Footed Attachment 9cm; Non-sterile Flyte Hoods and Togas; OBLONG DRILL GUIDE DIAMETER 2MM; OMEGA PLUS 145 DRILL GUIDE INSERT; OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-NEUTRAL; OMEGA PLUS DRILL GUIDE HANDLE; OMEGA PLUS HEAD; OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm; OMEGA PLUS LAG SCREW ADAPTER; OMEGA PLUS SCREW EXTRACTION BOLT; OMEGA PLUS SUPRACONDYLAR DRILL GUIDE; OMEGA PLUS SUPRACONDYLAR PIN GUIDE; OMEGA PLUS TAP GUIDE 4.5mm; OMEGA PLUS TAP GUIDE 6.5mm; OMEGA PLUS TRIAL PLATE 150; OMEGA+ BARREL REAM ASSY SHORT; OMEGA+ PIN W/THREAD 2.8X230MM; OMEGA+ VAR ANGLE GUID REPL KIT; ORTHOPEDIC MANUAL; ORTHOVAC; OSTEOTOMES; OZARK Cervical Plate System Trays; Office Sinus Procedure Pack; OmniCurve 10G- 15mm Extra Level; OmniCurve 10G- 15mm Fracture Kit; OmniCurve 10G- 20mm Extra Level; OmniCurve 10G- 20mm Fracture Kit; OmniCurve 10G- 30mm Extra Level; OmniCurve 10G- 30mm Fracture Kit; OmniCurve 11G –15 mm Balloon Kit; OmniCurve 11G –15 mm Extra Level Kit; OmniCurve 11G –20 mm Balloon Kit; OmniCurve 11G –20 mm Extra Level Kit; OmniCurve 11G –30 mm Balloon Kit; OmniCurve 11G –30 mm Extra Level Kit; Opening Guide; Opening Reamer; Opening Sleeve; OptaBlate Radiofrequency (RF) Generator; Orthopaedic Manual Instrumentation; Overdrill for 4.5mm Screws, AO; PCD; PCD Kit Long tube with VertaPlex HV; PCD PREC. SYS LONG TUBE W/VertaPlex HV; PCD kit Short tube with Vertaplex HV; PEDIATRIC CORTICAL REAMER; PERCUTANEOUS CEMENT GUN; PIN CUTTER / HA PINS; PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM; PKG., DUAL EDGE SHAVER BLADE - 5.5MM; PLATE BENDING IRONS; PRECISION DOWEL BONE GRAFT SYSTEM; PRO Plating System; PROTRACTOR; PYRENEES Cervical Plate System Trays; Pangea Femur Reconstruction System Bender; Pangea Femur Reconstruction System K-Wire; Pangea Femur Reconstruction System Tray; Pangea Platform; Pangea T-Handle; Pangea Torque Limiting Adapter; Parallel Guide for ø 1,4mm/2mm Wires; Perc. Double Wire Guide; PeriPROTM Femur; Pi Drive 2 Motor; Pi Drive 2 Plus Motor; Pi Drive Extender; Pi Drive Plus Motor; Plastic Tray; Posterior TLIF; PreLoc 2 Wound Closure Device; Q Pedicle Instruments; QBL Software License; Quick Release Driver Hall Fitting; RACK FOR OPEN WEDGE PLATES (LEVEL 2); RACK FOR PLP UTILITY/MTP (LEVEL 2); RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2); RAVINE Access System Trays; RED & BLUE INTL M/T CASE; REDUCTION HANDLES B & R CLAMPS; REPLACEMENT COMPONENTS; REPLACEMENT KNOB FOR DRILL BRACE; REVOLUTION; REVOLUTION TIPS; RING DRIVER 4.5; Reduction Tray; Reduction Tray Insert for Jaw Clamps; Reduction Tray Insert for Weber Clamps; Reduction Tray generic Insert; RemB Micro Drill; Restoration ADM/MDM Instrumentation; Restoration Modular Instrument Trays; Reusable Bipolar Forceps Cable; Reverse Express Tray; Revolution Cement Gun; Rotating Footed Attachment 12mm; Rotating Footed Attachment 16mm; Rotating Footed Attachment 25mm; SAHARA Stabilization System Trays; SAW BLADE; SCREW CADDY FOR 2 / 2.5 FIXO TRAY; SCREW RACK ANCHORAGE; SCREW RACK WS + CS (2MM+3.5MM); SCREW TRAY 4.5; SCREW-HOLDING FORCEPS FIXOS; SET ANCILLARY IMPLANT SUBTALAR; SET SCREW FOR HUMERUS AIMING BLOCK; SET SCREW FOR TIBIA AIMING BLOCK; SILICONE MAT; SMALL RULER FOR MEASUREMNET; SMALL SWIVEL JOINT; SMART TOE 1 INSTRUMENT KIT; SMOKE EVACUATION TUBING/WAND; SMOOTH BITE SHAVER BLADE - 3.5MM; SONOPET IQ CONSOLE; SPARE SET SCREW HUMERUS TS AIMING BLOCK; SPARE SHAFT TEMP. PLATE HOLDER; SPIKE SCREW INSERTER FOR 4.5MM SCREWS; SPS BENDING SLEEVE - SLOTTED STEEL; STAINLESS STEEL INSERTER; STANDARD BENDING SLEEVE; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM; STERI-SHIELD SYSTEM; STRAIGHT FEMORAL CANAL BRUSH; STRYKER AUTOPSY SAW; STRYKER CAST CUTTER; STRYKER CEMENT INJECTOR; STRYKER DISCMONITOR; STRYKER DRILL; STRYKER SUCTION IRRIGATOR; SUBFIX INSERTION INSTRUMENT; SUCTION MAT; SUCTION MAT,LOW PROFILE50""X34""; SUCTION RING; SUCTION RING WITH TUBING; SUCTION RING WITHOUT TUBING; SURGICAL INSTRUMENT MOTORS AND ACCE; SURGICAL KNIVES; SURGILAV; SWEAT BANDS 24/PKG; SWEAT BANDS 36/PKG; SYSTEM STERILIZATION BASKET; Safety Sponge; Screw Holder; Screw Insertion Sleeve; Screwdriver Blade, AO, T10; Silicon Mat, Generic Insert; Silicon Mat, Insert for Jaw Clamps; Silicon Mat, Insert for Weber Clamps; Smoke (Evacuator) Tubing, 3/8 inch x 10 feet; Smoke (Evacuator) Tubing, 7/8 inch x 10 feet; Smoke Evacuator ULPA Filter; Smooth Bite Shaver Blade 3.5mm; Solid Screwdriver with AO Fitting; Specimen Collector with Filter Element; Specimen Infusion Valve; Stanmore Face Cutter and Alignment Tool; SteriShield; Sterilization Box, Lightweight; Stryker Aria Pneumatic System; Stryker CORE System; Stryker Maestro Air Motor; Stryker Maestro Air Motor with Handswitch; Stryker Maestro System; Stryker Orthopaedics Instrument Trays; Stryker Smart Pump; Stryker Trauma Pelvic Set (Matta); Stryker VariSpeed; Stryker(R) Consolidated Operating Room Equipment (CORE) System; Strykevac; Stylet; Suction Mat, Comfort,50""X34""; SurgiCount Tablet and Accessories; SurgiCount Tablet and accessories; SurgiCount+ QBL/EMR Application; SurgiCounter; Syringe; System 4000; T-HANDLE PIN INSERTER; T-HANDLE STEM HOLDER; T2 Alpha Femur Retrograde Nailing System, Nail Adapter SPI; T2 Alpha Femur Retrograde Nailing System, Nail Holding Screw SPI; T2 Alpha Femur Retrograde Nailing System, Target Device; T2 Alpha Femur Retrograde Nailing System, Tissue Protection Sleeve; T4/T5 HYTREL TOGA; T4/T5 HYTREL TOGAS; T5 HELMETS; T7 Surgical Personal Protective Equipment Hoods and Togas; TAMP; TENSION DEVICE 16MM; TGS Field Generator Stand; TGS Guidewire; TGS Universal Headrest with Mounting Arm; THC5 Stand; TIGE FRACTURE N.M; TPS Console; TPS Micro Drill/Elite Attachment Brush; TPS Standard Attachment Brush; TPS Unidirectional Footswitch; TPS2 Stand; TRAY; TRAY FOR MV SCREWS; TRIAL ANCHORAGE PLP10341; TRIAL ANCHORAGE PLP10342; TRIAL ANCHORAGE PLP10461; TRIAL ANCHORAGE PLP10462; TRIAL ANCHORAGE PLP11341; TRIAL ANCHORAGE PLP11342; TRIAL ANCHORAGE PLP30141; TRIAL ANCHORAGE PLP30142; TRIAL ANCHORAGE PLP30171; TRIAL ANCHORAGE PLP30172; TRIAL ANCHORAGE PLP30201; TRIAL ANCHORAGE PLP30202; TRIAL ANCHORAGE PLP40160; TRIAL ANCHORAGE PLP40220; TRIAL ANCHORAGE PLP40280; TRIAL ANCHORAGE PLP40340; TRIAL ANCHORAGE PLP40400; TRIAL ANCHORAGE PLP40460; Terra Nova, Ravine, Serengeti, VCR, Cricket; Threaded Guide Wire; Tissue Protection Sleeve; Tomcat HC Shaver Blade 4mm; Tornier; Tornier Extraction; Tornier Flex Shoulder System; Tornier Humeral Nail; Tornier Perform Anatomic Glenoid; Tornier Perform Humeral System; Tornier Perform Reversed; Tornier Pyrocarbon; Tornier Simpliciti Shoulder System; Total Performance System; Total Performance System (TPS); Tray - Silicon Mat; Tray insert; Triathlon MSI Tray; Triathlon System Instrument trays; Triton QBL System; Acaia Pearl Scale; Trocar; TwinLoop Anchor System; Twist-drill cannulated ø8/L300mm; UNIVERSAL BENDING SLEEVE; UNIVERSAL PIN-WIRE CASE; UniVise; Universal ACL Instrumentation; Universal Neuro III Accessory Tray; VARIOUS SIZES OF CAST SPREA; VERSITOMIC STERILE FLEXIBLE PIN; VariAX 2, Lid For Sterilizing Container; VariAx 2 Compression Plating System, Plate Insert; VariAx 2 Compression Plating System, Plate Trial; VariAx 2 Foot, Drawer; VariAx 2 Foot, Insert; VariAx 2 Foot, Instrument Kit; VariAx 2 Foot, Labeling Clip; VariAx 2 Foot, Module; VariAx 2 Foot, Module Lid; VariAx 2 Foot, Screw Rack; VariAx 2 Foot, Tap for 2.7mm screws; VariAx 2 foot, Depth Gauge; VariAx 2, Aiming Block Fixation Pin; VariAx 2, Clip; VariAx 2, Depth Gauge; VariAx 2, Distal Radius Container Half-Size; VariAx 2, Distal Radius Implant Module; VariAx 2, Drill Bit; VariAx 2, Drill Guide K-Wire; VariAx 2, Fixed Angle Drill Guide 2.3/2.7mm; VariAx 2, Handle With 2.3mm Drill And K-Wire Guide; VariAx 2, Handle With Drill Guides; VariAx 2, Inlay; VariAx 2, Insert; VariAx 2, Joystick; VariAx 2, Pliers; VariAx 2, Reduction Instrument Insert; VariAx 2, Screw Rack; VariAx 2, Screw Rack Locking Screws; VariAx 2, Screw Rack Non-Locking Screws; VariAx 2, ScrewDriver Blade; VariAx 2, Screwdriver Blade; VariAx 2, Tap For 2.7mm Screws; VariAx Foot, Countersink; VariAx Foot, Holding Sleeve; VariAx, Drill; VariAx, Drill Guide; VariAx, Handle; VariAx, Safety Shield; VariAx, Screw Length Marker; VariAx, Screwdriver; VariAx, Tension Plier; VariAx, Tension Sheath; VariAx, Trial; Variable Angle Fixation; Variax 2, Steinmann Pin; WALL SUCTION KIT - CBC; WIRE CADDY; XeroGel Nasal/Epistaxis Pack; XprESS Dilitation; XprESS ENT Dilation System; XprESS Multi-Sinus Dilation System; YUKON OCT Spinal System Trays; ZipSeal 16 Surgical Skin Closure Kit; ZipSeal 24 Surgical Skin Closure Kit; extraction shaft; lag screw driver; lag screw reamer; meniGLIDE; mild Device Kit; mini sterilization case; precision pin; precision sleeve; screw depth gauge; set screw driver; sterilization case; tray base",1977-12-29,143,2026-10-20,0,18,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015967359%22&limit=1
"Deroyal Industries, Inc.",2320762,3003040625,1595 Highway 33 S,New Tazewell,TN,37825,United States,"DEROYAL INDUSTRIES, INC.",1044833,Contract manufacturer; Repackager or relabeler,203,BSJ; BSP; BTC; BYG; BYX; BYY; CAE; CAH; CAI; CCK; CCX; DQO; DRX; DTL; DWF; DWJ; DWS; DXC; DXO; DXT; DXZ; DYB; EBR; EFN; EFQ; EIC; EMD; EMX; EYC; EYH; EYQ; EZC; EZL; FAM; FCM; FCN; FDE; FGY; FHO; FHQ; FHX; FLL; FMA; FMF; FMG; FMH; FMI; FMP; FMQ; FNY; FOD; FOZ; FPA; FQH; FQM; FRG; FRL; FRO; FSA; FSM; FTA; FTY; FWZ; FXP; FYA; FYC; FYD; FZP; FZZ; GAA; GAD; GAL; GAM; GAP; GAQ; GAR; GAT; GAW; GAX; GAZ; GBM; GBQ; GBX; GCD; GCI; GCJ; GCX; GCY; GDI; GDJ; GDO; GDT; GDX; GDY; GDZ; GEI; GEN; GES; GFA; GIM; HBA; HBX; HCF; HDF; HET; HFG; HGE; HGI; HHD; HHM; HIB; HIF; HIS; HMP; HNC; HOY; HOZ; HRQ; HRX; HXD; ILG; ILO; IMD; IPM; ITG; IYO; JAA; JCX; JKA; JOK; JOL; KCY; KDC; KDD; KDQ; KDT; KEW; KGX; KGZ; KHR; KKX; KME; KMJ; KNX; KOD; KOX; KPD; KPE; KQZ; KXF; KXG; KYX; KYZ; LIO; LJH; LKB; LKF; LRO; LRP; LRW; LWK; LXH; LYU; MCY; MDM; MGQ; MHW; MJC; MMP; MPN; MPO; MTJ; NAB; NAC; NAD; NEC; NGT; NKC; NNI; NNW; NWV; OCT; OEQ; OFA; OFP; OGR; OHD; OHL; OJJ; OJK; OJS; OJT; OJU; OKH; OMP; OSV; OXQ; PEZ; PPB; PUI; PWU; QQS; SEL,"Mask, Gas, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Bag, Reservoir; Mask, Oxygen; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Airway, Oropharyngeal, Anesthesiology; Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Support, Patient Position; Catheter, Intravascular, Diagnostic; Electrode, Electrocardiograph; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; System, Thermal Regulating; Instruments, Surgical, Cardiovascular; Clamp, Vascular; Transducer, Pressure, Catheter Tip; Injector And Syringe, Angiographic; Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene; Introducer, Catheter; Unit, Suction Operatory; Cotton, Roll; Gauze/Sponge, Internal; Syringe, Periodontic, Endodontic, Irrigating; Hemostat, Surgical; Balloon, Epistaxis; Catheter, Upper Urinary Tract; Table, Cysto, Non-Electrical; Garment, Protective, For Incontinence; Catheter, Coude; Catheter, Retention Type, Balloon; Sigmoidoscope And Accessories, Flexible/Rigid; Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Urinary Drainage Collection Kit, For Indwelling Catheter; Laparoscopy Kit; Cannula, Injection; Pneumoperitoneum Needle; Holder, Needle, Gastroenterologic; Jelly, Lubricating, For Transurethral Surgical Instrument; Continuous Measurement Thermometer; Depressor, Tongue, Non-Surgical; Syringe, Piston; Stopcock, I.V. Set; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Protector, Skin Pressure; Restraint, Protective; Basin, Emesis; Device, Occlusion, Umbilical; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Lavage, Jet; Bandage, Elastic; Wrap, Sterilization; Fiber, Medical, Absorbent; Dressing, Wound, Drug; Lift, Patient, Non-Ac-Powered; Tray, Surgical, Instrument; Light, Surgical, Accessories; Tape, Measuring, Rulers And Calipers; Operating Room Accessories Table Tray; Cover, Shoe, Operating-Room; Gown, Surgical; Gown, Isolation, Surgical; Apparatus, Exhaust, Surgical; Clip, Implantable; Marker, Skin; Needle, Aspiration And Injection, Disposable; Retractor; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tourniquet, Nonpneumatic; Tubing, Noninvasive; Catheter, Urethral; Catheter, Continuous Irrigation; Catheter, Irrigation; Connector, Catheter; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Dissector, Surgical, General & Plastic Surgery; Clamp, Surgical, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Removable (Skin); Scalpel, One-Piece; Gauze/Sponge, Internal, X-Ray Detectable; Handle, Scalpel; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Blade, Scalpel; Blade, Saw, General & Plastic Surgery, Surgical; Tubes, Vacuum Sample, With Anticoagulant; Neurosurgical Paddie; Instrument, Cranioplasty Material Forming; Instrument, Ligature Passing And Knot Tying; Speculum, Vaginal, Metal; Laparoscope, Gynecologic (And Accessories); Coagulator, Laparoscopic, Unipolar (And Accessories); Amniotome; Electrocautery, Gynecologic (And Accessories); Pad, Menstrual, Unscented; Sound, Uterine; Speculum, Vaginal, Nonmetal; Insufflator, Laparoscopic; Condom; Pad, Eye; Specula, Ophthalmic; Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Sponge, Ophthalmic; Hemostat; Arthroscope; Clamp; Stocking, Elastic; Pack, Hot Or Cold, Water Circulating; Pack, Hot Or Cold, Disposable; Cover, Limb; Bandage, Cast; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Fluoroscopic, Image-Intensified; Apparatus, Suction, Ward Use, Portable, Ac-Powered; Tubes, Vials, Systems, Serum Separators, Blood Collection; Scissors, Medical, Disposable; Catheter And Tip, Suction; Tourniquet, Pneumatic; Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Bottle, Collection, Vacuum; Container, Specimen Mailer And Storage, Sterile; Slides, Microscope; Tape And Bandage, Adhesive; Accessories, Catheter; Absorber, Saliva, Paper; Drape, Surgical, Antimicrobial; Bedding, Disposable, Medical; Lubricant, Patient; Collector, Urine, (And Accessories) For Indwelling Catheter; Catheter, Urological; Solvent, Adhesive Tape; Strip, Temperature, Forehead, Liquid Crystal; Container, I.V.; Component, Traction, Non-Invasive; Applicator, Absorbent Tipped, Non-Sterile; Applicator, Absorbent Tipped, Sterile; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Device, Specimen Collection; System, Irrigation, Urological; Pad, Alcohol, Device Disinfectant; Cannula, Manipulator/Injector, Uterine; General Surgery Tray; Tray, Surgical; Scissors, General, Surgical; Razor, Surgical; Orthopedic Manual Surgical Instrument; Accessory, Surgical Apparel; Wound Dressing Kit; Instrument, Manual, Surgical, General Use; Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic; Dressing, Compression; Catheter, Urological (Antimicrobial) And Accessories; Cover, Barrier, Protective; Tissue Adhesive For The Topical Approximation Of Skin; Infant Heel Warmer (Chemical Heat Pack); Wax, Bone; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Bandage, Liquid, Skin Protectant; Saline, Vascular Access Flush; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Container, Specimen, Non-Sterile; Bag, Urine Collection, Leg, For External Use, Non-Sterile; Laparoscopic Accessories, Gynecologic; Anti Fog Solution And Accessories, Endoscopy; Angiography/Angioplasty Kit; Cardiovascular Surgical Instruments Tray; Anesthesia Breathing Circuit Kit (Adult & Pediatric); Ear, Nose, And Throat Surgical Tray; Gynecological Laparoscopic Kit; Pap Smear Kit; Burn Kit Without Drug; Eye Tray; Tourniquet Kit; Aspiration Tray; Skin Prep Tray; Body Fluids Barrier Kit; Negative Pressure Wound Therapy Powered Suction Pump; Insufflator, Endoscopic Vessel Harvesting; Dressing Change Tray; Central Venous Catheter Dressing Change Kit; Foley Catheter Kit (Excludes Hiv Testing); Drape, Surgical, Exempt; Clean-Up Kit; Stapler, Skin; Securement Wound Dressing For Reduction Of Infection",1; 2; U,"Absorber, Saliva, Paper - DeRoyal; Accessories, Catheter - DeRoyal; Accessories, Operating-Room, Table (Kit) - DeRoyal; Accessory, Surgical Apparel - DeRoyal; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - DeRoyal; Airway, Oropharyngeal, Anesthesiology - DeRoyal; Amniotome - DeRoyal; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - DeRoyal; Anesthesia Breathing Circuit Kit (Adult & Pediatric) - DeRoyal; Angiography/Angioplasty Kit - DeRoyal; Anti Fog Solution and Accessories, Endoscopy - DeRoyal; Apparatus, Exhaust, Surgical - DeRoyal; Apparatus, Suction, Operating-Room, Wall Vacuum Powered - DeRoyal; Apparatus, Suction, Single Patient Use, Portable, Nonpowered - DeRoyal; Applicator, Absorbent Tipped, Non-Sterile - DeRoyal; Applicator, Absorbent Tipped, Sterile - DeRoyal; Applier, Surgical, Clip - DeRoyal; Aspiration Tray (Kit) - DeRoyal; Bag, Reservoir - DeRoyal; Bag, Urine Collection, Leg, For External Use, Non-Sterile - DeRoyal; Balloon, Epistaxis - DeRoyal; Bandage, Cast - DeRoyal; Bandage, Elastic - DeRoyal; Bandage, Liquid, Skin Protectant - DeRoyal; Basin, Emesis - DeRoyal; Bedding Disposable, Medical - DeRoyal; Blade, Saw, General & Plastic Surgery, Surgical - DeRoyal; Blade, Scalpel - DeRoyal; Body Fluid Barrier Kit - DeRoyal; Bottle, Collection, Vacuum - DeRoyal; Burn Kit without Drug - DeRoyal; CLAMP - DeRoyal; Cannula Vial Access - DeRoyal; Cannula, Manipulator/Injector, Uterine - DeRoyal; Cardiovascular Surgical Instruments Tray - DeRoyal; Catheter and Tip, Suction - DeRoyal; Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass - DeRoyal; Catheter, Cannula and Tubing, Vascular, Cardiopulmonary bypass - DeRoyal; Catheter, Continuous Irrigation - DeRoyal; Catheter, Coude - DeRoyal; Catheter, Intravascular, Diagnostic - DeRoyal; Catheter, Intravascular, Therapeutic, Short-term Less than 30 days - DeRoyal; Catheter, Intravascular, Therapeutic, Short-term less than 30 days - DeRoyal; Catheter, Irrigation - DeRoyal; Catheter, Retention Type, Balloon - DeRoyal; Catheter, Upper Urinary Tract - DeRoyal; Catheter, Urethral - DeRoyal; Catheter, Urological (antimicrobial) and Accessories - DeRoyal; Catheter, Urological - DeRoyal; Central Venous Catheter Dressing Change Kit - DeRoyal; Circuit, Breathing (w Connector, Adaptor, Y Piece) - DeRoyal; Clamp, Surgical, General & Plastic Surgery - DeRoyal; Clamp, Vascular - DeRoyal; Clean-up Kit - DeRoyal; Clip, Implantable - Add; Clip, Implantable - DeRoyal; Coagulator, Laparoscopic, Unipolar (and accessories) - DeRoyal; Collector, Urine, (And Accessories) for Indwelling Catheter - DeRoyal; Collector, Urine, (and Accessories) for Indwell Cath/ Tray, Catheteriz, Sterile Urethral, w/wo Catheter (kit)- DeRoyal; Component, Traction, Non-Invasive - DeRoyal; Condom - DeRoyal; Connector, Catheter - DeRoyal; Container, I. V. - DeRoyal; Container, Specimen Mailer and Storage, Sterile - DeRoyal; Container, Specimen, Non-Sterile - DeRoyal; Container, Specimen, Sterile - DeRoyal; Cotton, Roll - DeRoyal; Cover, Barrier, Protective - DeRoyal; Cover, Limb - DeRoyal; Cover, Shoe, Operating-room - DeRoyal; DEROYAL THERMO-COLD S; Depressor, Tongue, Non-Surgical - DeRoyal; Device, Occlusion, Umbilical - DeRoyal; Device, Specimen Collection - DeRoyal; Dispenser, Liquid Medication - DeRoyal; Dissector, Surgical, General & Plastic Surgery - DeRoyal; Drape, Surgical - DeRoyal; Drape, Surgical, Exempt - DeRoyal; Dressing Change Tray - DeRoyal; Dressing, Compression - DeRoyal; Dressing, Wound and Burn, Hydrogel W/Drug and/or Biologic - DeRoyal; Dressing, Wound and Burn, Occlusive - DeRoyal; Dressing, Wound, Drug - Burn, Hydrogel w/Drug and/or Biologic - DeRoyal; Dressing, Wound, Drug - DeRoyal; Dressing, Wound, Drug - DeRoyal / Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic - DeRoyal; Dressing, Wound, Drug, Lavage, Jet - DeRoyal; Dressing, Wound, Hydrophilic - DeRoyal; Dressing, Wound, Occlusive - DeRoyal; Ear, Nose, and Throat Surgical Tray - DeRoyal; Electrocautery, Gynecologic (and Accessories) - DeRoyal; Electrode Electrocardiograph - DeRoyal; Electrosurgical, Cutting & Coagulation & Accessories - DeRoyal; Eye Tray - DeRoyal; Fiber, Medical, Absorbent - DeRoyal; Filter, Bacterial, Breathing - Circuit - DeRoyal; Foley Catheter Kit (excludes HIV testing) - DeRoyal; Forceps, General & Plastic Surgery - DeRoyal; Garment, Protective, for Incontinence - DeRoyal; Gas Mask-Anesthesia - DeRoyal; Gauze/Sponge, Internal - DeRoyal; Gauze/Sponge, Internal, X-Ray Detectable - DeRoyal; Gauze/Sponge, Nonresorbable for External Use - DeRoyal; General Surgery Tray (Kit) - DeRoyal; General Surgery Tray - DeRoyal; General surgery tray - DeRoyal; Gown, Surgical - DeRoyal; Grounding Pad; Gynecological Laparoscopic Kit - DeRoyal; Handle, Scalpel - DeRoyal; Hemostat - DeRoyal; Hemostat, Surgical - DeRoyal; Holder, Needle, Gastroenterologic - DeRoyal; IMD - Pack, Hot or Cold, Disposable - DeRoyal; Infant Heel Warmer (Chemical Heat Pack) - DeRoyal; Injector and Syringe, Angiographic - DeRoyal; Instrument, Cranioplasty Material Forming - DeRoyal; Instrument, Ligature Passing & Knot Typing - DeRoyal; Instrument, Manual, Surgical, General Use - DeRoyal; Instrument, Surgical, Disposable - DeRoyal; Instruments, Surgical, Cardiovascular - DeRoyal; Insufflator, Laparoscopic - DeRoyal; Introducer, Catheter - DeRoyal; Jelly, Lubricating, For Transurethral Surgical Instrument - DeRoyal; Kit, Surgical Instrument, Disposable - DeRoyal; Kit, Wound Dressing - DeRoyal; Laparoscope General and Plastic Surgery - DeRoyal; Laparoscope, General & Plastic Surgery - DeRoyal; Laparoscope, Gynecologic (and accessories) - DeRoyal; Laparoscopic Accessories, Gynecologic - DeRoyal; Laparoscopy Kit - DeRoyal; Laryngoscope, Endoscope - DeRoyal; Lavage, Jet - DeRoyal; Lift, Patient, Non-AC-Powered - DeRoyal; Light, Surgical, Accessories - DeRoyal; Lubricant, Patient - DeRoyal; MICROSCOPE SLIDES - DeRoyal; Marker, Skin - DeRoyal; Mask, Oxygen - DeRoyal; Multidex; Needle, Aspiration and Injection, Disposable - DeRoyal; Needle, Conduction, Anesthetic (W/WO Introducer)- DeRoyal; Needle, Conduction, Anesthetic (w/wo Introducer)- DeRoyal; Needle, Hypodermic, Single Lumen - DeRoyal; Negative Pressure Wound Therapy Powered Suction Pump - DeRoyal; Nepcell; Neurosurgical Paddie - DeRoyal; Ortho Manual Surgical Instrument - DeRoyal; Pack, Hot and Cold, Disposable - DeRoyal; Pack, Hot or Cold, Water Circulating - DeRoyal; Pad, Alcohol, Device Disinfectant - DeRoyal; Pad, Eye - DeRoyal; Pad, Menstrual, Unscented - DeRoyal; Pap Smear Kit - DeRoyal; Patch, Pledget and Intracardiac, PETP, PTFE, Polypropylene - DeRoyal; Pneumoperitoneum Needle - DeRoyal; Pro-II NPWT Powered Suction Pump, Collection canisters, hoses, Y-connectors & tubing, and foam/gauze dressings – DeRoyal; Protector, Skin Pressure - DeRoyal; Razor, Surgical - DeRoyal; Restraint, Protective - DeRoyal; Retractor - DeRoyal; Saline, Vascular Access Flush - DeRoyal; Scalpel, One-Piece - DeRoyal; Scissors, General, Surgical - DeRoyal; Scissors, Medical, Disposable - DeRoyal; Sensostrip Temperature Sensor; Set, Administration, Intravascular - DeRoyal; Shield, Eye, Ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) - DeRoyal; Sigmoidoscope and Accessories, Flexible/Rigid - DeRoyal; Silver Alginate Cath Patch Dressing - DeRoyal; Skin Prep Tray (Kit)- DeRoyal; Solvent, Adhesive Tape - DeRoyal; Sound, Uterine - DeRoyal; Specula, Ophthalmic - DeRoyal; Speculum, Vaginal, Metal - DeRoyal; Speculum, Vaginal, Nonmetal - DeRoyal; Sponge, Ophthalmic - DeRoyal; Staple, Removable (Skin) - DeRoyal; Staple, Removeable (Skin) - DeRoyal; Stapler, Skin - DeRoyal; Stocking, Elastic - DeRoyal; Stopcock 1 Way High Pressure; Stopcock, IV Set - DeRoyal; Streamway; Strip, Temperature, Forehead, Liquid Crystal - DeRoyal; Support, Patient Position - DeRoyal; Suture, Nonabsorbable, Silk - DeRoyal; Syringe Piston - DeRoyal; Syringe, Irrigating (Non Dental) - DeRoyal; Syringe, Periodontic, Endodontic, Irrigating - DeRoyal; Syringe, Piston - DeRoyal; Syringe, Piston - Needle, Hypodermic, Single Lumen - DeRoyal; System, Imaging, Pulsed Echo, Ultrasonic - DeRoyal; System, Thermal Regulating - DeRoyal; System, X-Ray, Fluoroscopic, Image-Intensified - DeRoyal; System, irrigation, Urological - DeRoyal; Table, Cysto, Non-Electrical - DeRoyal; Tape and Bandage, Adhesive - DeRoyal; Tape, Measuring, Rulers and Calipers - DeRoyal; Thermometer, electronic, clinical - DeRoyal; Tissue Adhesive for the Topical Approximation of Skin - DeRoyal; Tourniquet Kit - DeRoyal; Tourniquet, Nonpneumatic - DeRoyal; Tourniquet, Pneumatic - DeRoyal; Transducer, Pressure, Catheter Tip - DeRoyal; Tray, Surgical - DeRoyal; Tray, Surgical, Instrument - DeRoyal; Tube, Aspirating, Flexible, Connecting - DeRoyal; Tubes, Vacuum Sample, with Anticoagulant - DeRoyal; Tubes, Vials, Systems, Serum Separators, Blood Collection - DeRoyal; Tubing, Noninvasive - DeRoyal; Tubing, Pressure and Accessories - DeRoyal; Tubing/Tubing with Filter, Insufflation, Laparoscopic - DeRoyal; Unit, Suction Operatory - DeRoyal; Urinary Drainage Collection Kit, for Indwelling Catheter - DeRoyal; Wax, Bone - DeRoyal; Wrap, Sterilization - DeRoyal; Yankauer - DeRoyal",1991-07-15,141,2024-03-25,0,3,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222320762%22&limit=1
"Encore Medical, L.P.",1644408,1000116912,9800 Metric BLVD.,Austin,TX,78758,United States,"ENCORE MEDICAL, L.P.",9002203,Complaint file establishment; Contract manufacturer; Manufacturer; Specification developer,69,EML; FSM; FZO; FZX; FZY; GAD; GEO; GFA; HAO; HRY; HSB; HSD; HSX; HTD; HTJ; HTO; HTP; HTQ; HTR; HTT; HTW; HTX; HTZ; HWA; HWB; HWC; HWE; HWJ; HWM; HWR; HWT; HWX; HXC; HXX; JDC; JDG; JDI; JWH; KIH; KTZ; KWA; KWL; KWS; KWT; KWY; KWZ; LLZ; LOD; LPH; LRY; LWJ; LXH; LXT; LZO; MBB; MBF; MBH; MBL; MEH; MPK; MRA; NTG; OIY; OLO; OQG; PAO; PHX; PKC; QIH,"Chisel, Bone, Surgical; Tray, Surgical, Instrument; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; File, Surgical, General & Plastic Surgery; Blade, Saw, General & Plastic Surgery, Surgical; Instrument, Surgical, Non-Powered; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Forceps; Gauge, Depth; Reamer; File; Broach; Rasp; Burr, Orthopedic; Bit, Drill; Rongeur; Instrument, Cutting, Orthopedic; Impactor; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Osteotome; Driver, Prosthesis; Template; Tap, Bone; Wrench; Screwdriver; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Dispenser, Cement; Caliper; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; System, Image Processing, Radiological; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Punch, Surgical; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Bone Cement, Antibiotic; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Semi-Constrained Metal/Polymer Finger Joint Prosthesis; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented; Prosthesis, Ankle, Uncemented, Non-Constrained; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Orthopedic Stereotaxic Instrument; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Automated Radiological Image Processing Software",1; 2; 3; f,"& TRUE; , HIP; , TRUE; ,SHOULDER INSTRUMENT SYSTEMS; 3DKNEE PC Femoral Component; 3DKNEE System; 3DKnee e+ Tibial Inserts; 3DKnee e+ Tri Peg Sombrero Patella; 6.5 Cancellous Bone Screw; ALFA Hip Stem; ALTIVATE REVERSE GLENOID ANGLED REAMER; AND SHOULDER INSTRUMENT SYSTEMS; ARVIS Surgical Navigation System; ARVIS® Shoulder; Alfa II Hip Stem; All Poly Tri Peg Sombrero Patella; AltiVate CS Edge Shoulder; AltiVate Conversion Module; AltiVate Reverse Cannulated Glenoid Reamer; AltiVate Reverse Glenoid Baseplate Inserter; AltiVate Reverse Glenoid Baseplate Rim Planer; AltiVate Reverse Glenoid Cannulated Boss Drill; AltiVate Reverse Glenoid Hood Rasp; AltiVate Reverse Glenoid Hood Rasp Guide; AltiVate Reverse Glenoid Peripheral Drill Guide; AltiVate Reverse Glenoid Peripheral Drill/Screw Guide Replacement Thumbscrew; AltiVate Reverse Short Stem; AltiVate Reverse Small Shell System; AltiVate Reverse Wedge Glenoid Reamer Boss Drill; AltiVate Reverse Wedge Glenoid Reamer Head; AltiVate Reverse Wedge Glenoid Reamer Sleeve; AltiVate Reverse® Glenoid; AltiVate™ Anatomic Shoulder System; AltiVate® Anatomic Shoulder AG e+™ with Markers; AltiVate® Anatomic Shoulder AG e+™ with Markers (FW); Awl; Biolox Forte Ceramic Heads; Bipolar Hip; Bone Tap; CLP Hip Stem; CLP Hip System; CLP III; CLP Offset Hip System; Cemented Calcar Hip System; Chisel; Cobalt G-HV Bone Cement; Cobalt G-MV Bone Cement; Cobalt HV Bone Cement; Cobalt MV Bone Cement; Compression Hip/Supracondylar Screw; DJO Surgical / Encore Medical Powered Instrument; DJO Surgical / Encore Medical Surgical Punch; DJO Surgical / Encore Medical Wrench; DJO Surgical Instrument Tray; Delta Femoral Heads & Offset Sleeve; Depth Gauge; Discovery Elbow; Distractor; EMPOWR 3DKNEE; EMPOWR Acetabular System; EMPOWR Acetabular® Liner Extension; EMPOWR Dual Mobility; EMPOWR PS Knee System; EMPOWR Partial Knee; EMPOWR Porous Femur with HAnano Surface; EMPOWR Porous Knee System; EMPOWR Revision Knee™; EMPOWR Revision Knee™ Symmetric TT Cones; EMPOWR Revision Symmetric Knee Cones; EMPOWR Stem Extender, 50mm; EMPOWR Universal Tibial Baseplate; EMPOWR VVC Insert; EMPOWR™ Blade Stem; ENCORE CHISEL; ENCORE IMPACTORS; ENCORE IMPLANT SYST; ENCORE RONGEURS; ENCORE SAW BLADES; ENCORE SCREWDRIVER; ENCORE TEMPLATE; EPIK - Unicondylar Knee; EXPRT 5mm Femoral Augment, 400 Stem Extension; EXPRT Revision Hip; EXPRT™ Revision Hip System; Empowr CR Knee™ Tibial Insert; Encore Humeral Shoulder Stem; Exprt Knee System; FEMORAL CUTTING CHISEL; FMP Acetabular Shells with P2; FMP Acetabulatr Shells with 3DMatrix; FMP Constrained Liners; FMP Extended Liner; FMP Metal/Metal Acetabular Insert; FMP Porous Coated Flared Rim Shells; FMP Shells; FMP e+ Acetabular Liner; FMP/Foundation Porous Acetabular; FMP/Foundation Porous Hemispherical; FOUNDATION & VITALITY HIP & SHOULDE; FOUNDATION AND VITALITY HIP; FOUNDATION KNEE; File; Forceps; Foundation  Glenoid Component; Foundation All-Poly Cup; Foundation All-Poly Cup w/PMMA Spac; Foundation Augmentation Blocks; Foundation Cemented Stem, Size 8; Foundation Distal Centralizer; Foundation Forged Cemented Stem 9mm; Foundation Fracture Hip Stem; Foundation HA Coated Stems; Foundation Humeral Stem; Foundation Knee, Foundation PS Knee, 3DKnee with TiNbN Coating; Foundation Lateral Pivot Insert; Foundation Metal Backed Patella; Foundation Modular Hip Stem; Foundation Modular Stem Extensions; Foundation Modular Tibial Baseplate; Foundation NP Femur; Foundation Non-Porous Stem; Foundation PS Knee; Foundation Plasma Metalbacked Patel; Foundation Plasma Sprayed Femoral; Foundation Plasma Sprayed Shoulder; Foundation Plasma Tibial Component; Foundation Porous Hip Stem; Foundation Porous Stem; Foundation Porous Stem w/Metal Head; Foundation Porous Stems; Foundation Total Shoulder System; Foundation Ultra-Congruent; Foundation Unipolar; Foundation Zirconia Heads; Foundation and 3DKnee All Poly Patella (standard poly and e+); Foundation e+ Tri Peg Sombrero Patella; HIP; HXe-Plus Acetabular Liner; Hammer; Hemi Shoulder Prosthesis; ITALITY HIP INSTRUMENTS SYSTEM; IX; IX INSTRUMENAN; KNEE; Keramos Ceramic-on-Ceramic Hip System; LSF BROACH; LSF FEMORAL NECK CUTTING GUIDE; LSF FEMORAL TEMPLATE; Large CoCr Heads; Lima Acetabular Cage; Lima Modular Revision Stem; Linear HA Coated Stems; Linear Hip Stem; Linear Hip Stem with P2, Size 5; Linear Hip Stem, sz 5; Linear Hip Stems with P2; Linear Plasma Sprayed Hip Stem; MTS Knee; MULTIPLE  (PROSTHESIS IMPACTOR); Manual Surgical Instrument; Metal/Metal Hip System; Modular Femoral Neck; Movation Knee System; Movation e+ Tibial Insert; Movation e+ Tri Peg Domed Patella; OPTIGUN; ORTHOPEDIC REAMER; Omega HA Total Hip System; Osteotome; Porous Patella; R120 Hip Stem; R120 PC Hip Stem; RSP Baseplate with P2; RSP Monoblock; RSP Monoblock 8mm Spacer; RSP Monoblock Fracture Indication; RSP Monoblock Hemi Adapter; RSP Monoblock Press Fit Indication; RSP Monoblock to Turon Conversion Adapter; RSP Size 44 Constrained Liner; RSP Size 44 Heads; RSP Size 44 Offset Insert; RSP Size 44 Socket Shells; RSP e+ Liner; RSP to Foundation Humeral Stem Adapter; Rasp; Revelation HA Coated Stems; Revelation Hip Stem; Revelation Hip Stem, Sz 8; Revelation Hip Stems with P2; Revelation Size 8 Hip Stem with P2; Revelation microMAX; Reverse Shoulder Prosthesis; Reverse Shoulder Prosthesis (RSP); SHOULDER INSTRUMENTATION TRUE/FLEX; SR MCP; SR PIP; STAR Scandinavian Total Ankle Replacement Prosthesis; Size 8; Spiked; Surgical File/Planer/Rasp; TRUE/FLEX & TRUE/FIT INSTU; TaperFill Hip Stem; True/Fix Bone Screws; True/Fix Humeral Intramedullary Rod; True/Fix Large Screw; TrueFix; TrueFix Distal Femoral Intramedullary Rod System; Turon Primary and Revision System; Turon Revision Glenoid; Turon e+ Glenoid; UNIVERSAL JOINT SCREWDRIVER; X-alt Hip System; Z-SERIES MODULAR HIP; Z-SERIES MODULAR TOTAL HIP SYSTEM; ceramys™ femoral head system",1997-02-21,139,2025-11-12,2,96,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221644408%22&limit=1
Smith & Nephew Inc.,1219602,1219602,Endoscopy 120 Forbes BLVD. Suite 150 / 130 Forbes BLVD.,Mansfield,MA,02048,United States,"Smith & Nephew, Inc.",1020279,Manufacturer; Specification developer,51,FEI; FRL; FRN; FSM; FWZ; FZX; GAE; GAS; GAT; GCJ; GDW; GDZ; GEA; GEI; GEY; GFG; HAB; HET; HRT; HRX; HRY; HST; HSX; HTJ; HTN; HTW; HWC; HWE; HWQ; HWR; HWT; JDR; JWH; KCT; KDD; KGS; KIJ; KNS; KQZ; LXH; LYU; MAI; MBH; MBI; MDM; MIA; NBH; NJD; NPJ; OLO; SIQ,"Instrument, Special Lens, For Endoscope; Fiber, Medical, Absorbent; Pump, Infusion; Tray, Surgical, Instrument; Operating Room Accessories Table Tray; Guide, Surgical, Instrument; Snare, Surgical; Suture, Nonabsorbable, Synthetic, Polyester; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Staple, Implantable; Handle, Scalpel; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Ac-Powered; Bit, Surgical; Saw, Powered, And Accessories; Laparoscope, Gynecologic (And Accessories); Stripper, Surgical; Arthroscope; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Gauge, Depth; Washer, Bolt Nut; Bit, Drill; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Passer; Driver, Prosthesis; Template; Staple, Fixation, Bone; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Kit, Surgical Instrument, Disposable; Retention Device, Suture; Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Component, Traction, Non-Invasive; Orthopedic Manual Surgical Instrument; Accessory, Surgical Apparel; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Needle, Spinal, Short Term; Accessories, Arthroscopic; Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Orthopedic Stereotaxic Instrument; Intra-Articular Orthopedic Stereotaxic Navigation Instrument",1; 2,"""BIORAPTOR KNOTLESS SUTURE ANCHOR, SHOULDER CLOSE""; (6) MINITAPE (BLUE) 39.5; (6) MINITAPE (COBRAID BLUE) 39.5; (6) MINITAPE (COBRAID WHITE) 39.5; (curette, probe, rasp, osteotome ); 1.2 ENDOBUTTON CL ULTRA PAC; 1.2 RAP-PAC A LATEX FREE; 1.2 RAP-PAC A, 72202796; 1.2 RAP-PAC B LATEX FREE; 1.2 RAP-PAC B, 72202797; 1.2 RAP-PAC C; 1.5 MM TENDON DRILL PIN; 1.5mm Guidewire, 12"", 72202189; 1.6MM DRILL & GUIDE DYNOMITE 2; 1.8MM DRILL & GUIDE SPYROMITE/MINI 2; 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (BLUE); 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (COBRAID WHITE); 10 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10 MM X 20 MM BIOSURE HA; 10 MM X 25 MM BIOSURE HA; 10 MM X 30 MM BIOSURE HA; 10 MM X 35 MM BIOSURE HA; 10 X 30 MM BIORCI SCREW; 10.5 MM CANNULATED DRILL; 10.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 10.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10MM DILATOR; 10MM METAL ACL CANNULA; 10MM METAL ACL OBTURATOR; 11 MM GRAFT SIZING TUBE; 11 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11 MM X 25 MM BIOSURE HA; 11 MM X 30 MM BIOSURE HA; 11 MM X 35 MM BIOSURE HA; 11 X 30 MM BIORCI SCREW; 11.5 MM CANNULATED DRILL; 11.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 11.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11MM DILATOR; 12 MM GRAFT SIZING TUBE; 12 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 12 MM X 35 MM BIOSURE HA; 12 X 35 MM BIORCI SCREW; 12.5 MM CANNULATED DRILL; 12.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 12MM DILATOR; 13 MM GRAFT SIZING TUBE; 13 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 13.5 MM CANNULATED DRILL; 14 MM GRAFT SIZING TUBE; 15 DEGREE CLOSED CURETTE 3 MM; 15 DEGREE OPEN CURETTE 2.5 MM; 15 DEGREE OPEN CURETTE 4 MM; 15 DEGREE OSTEOTOME 3MM; 15 MM ENDOBUTTON CL BTB; 15MM SUTURE WASHER STER. BOX OF 1; 17MM SUTURE WASHER STER. BOX OF ONE; 2 MM FULL RADIUS MINI BLADES, POWER/EP-1, BLUE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2-5 MM OFFSET GUIDE; 2.3 MM BIORAPTOR PK SUTURE ANCHOR WITH ONE ULTRABRAID No.2 WHITE, SUTURE, STERILE; 2.4 MM FLEXIBLE PASSING PINS, STERILE 5 PER PACKAGE; 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE; 2.4MM PASSING PIN WITH CALIBRATION MARKS; 2.4MM X 10 INCH DRILL-TIP GUIDE WIRE; 2.4MM X 11 INCH 28 CM TROCAR-TIP PASSING PIN; 2.6 MM TWIST DRILL BIT FOR 2.3 ANCHOR; 2.6MM DRILL & GUIDE RAPTORMITE 3; 2.7 MM CHISEL GUARD; 2.7 MM DILATOR; 2.7 MM DRILL GUIDE; 2.7 MM HARVESTING TAMP; 2.7 MM TREPHINE FOR HARD BONE; 2.7 MM TUBULAR CHISEL; 2.7 MM X 15 INCH 38 CM DRILL-TIP PASSING PIN, NON-STERILE 6 PER PACKAGE; 2.8MM Q-FIX ALL-SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE); 2.8mm QFIX Knotless All Suture Anchor; 2.9 MM ABRADER MINI BURRS, POWER/EP-1, ORANGE, PACKAGED 6 PER BOX, STERILE; 2.9 MM BARREL ABRADER MINI BURRS, POWER/EP-1, PURPLE, PACKAGED 6 PER BOX, STERILE; 2.9 MM CUTTER MINI BLADES, POWER/EP-1, BEIGE, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 2.9 MM FULL RADIUS MINI BLADES RED, POWER/EP-1, 7 CM LONG, PACKAGED 6 PER BOX, STERILE; 20 DEGREE OSTEOTOME 4MM; 3.2MM DRILL & GUIDE RAPTORMITE 3.7; 3.5 MM ABRADER MINI BURRS, POWER/EP-1, AQUA, PACKAGED 6 PER BOX, STERILE; 3.5 MM CUTTER STRAIGHT BLADE; 3.5 MM DILATOR; 3.5 MM FULL RADIUS BLADE; 3.5 MM FULL RADIUS CURVED, CONCAVE, 8 CM MINI BLADES, POWER/EP-1, PLUM, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM HARVESTING TAMP; 3.5 MM HEX DRIVER, 2 MM CANNULATION; 3.5 MM INCISOR PLUS, 8 CM MINI BLADES, POWER/EP-1, SAGE GREEN, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM INCISOR STRAIGHT BLADE; 3.5 MM RAZORCUT STRAIGHT BLADE; 3.5 MM RAZORCUT, 8 CM MINI BLADES, POWER/EP-1, PUMPKIN/ORANGE, 7 CM LENGTH, PACKAGED 6 PER BOX, STERILE; 3.5 MM TREPHINE FOR HARD BONE; 3.5 MM TUBULAR CHISEL; 3.5 mm Bonecutter Platinum Blade; 3.5MM INCISOR PLUS PLAT BLD; 3.5MM SPADE TIP DRILL FOR USE WITH 4.5 MM ANCHOR HOLE PREPARATION DEVICE FOR HARD BONE; 3.5MM SYNOVATOR PLAT BLD; 30 DEGREE OPEN CURETTE 2.5 MM; 3D SPIDER CONNECTOR 1 REQUIRED PER EACH LEG ACCESORY; 4 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, SAGE GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4 MM ABRADER STRAIGHT BURR; 4 MM ACROMIONIZER STRAIGHT BURR; 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS; 4 MM PORTAL STICK X 12 INCH 30 CM LONG; 4 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, MAROON, PACKAGED 6 PER BOX, STERILE; 4 MM SHOULDER ROD X 12 INCH 30 CM LONG; 4 MM STONECUTTER STRAIGHT BURR; 4.5 FULL RADIUS BONECUTTER BLADES, YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, CURVED, INCISOR CURVED BLADES, POWER/EP-1, LIME GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, FULL RADIUS, CURVE, CURVED BLADES, POWER/EP-1, YELLOW, CURVE LENGHTS 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CONCAVE, SYNOVATOR CURVED BLADES, POWER/EP-1, FOREST GREEN, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERILE; 4.5 MM CUTTER STRAIGHT BLADE; 4.5 MM DILATOR; 4.5 MM DRILL GUIDE; 4.5 MM DYONICS BONECUTTER ELECTROBLADE, YELLOW, PACKAGED 3 PER BOX, STERILE; 4.5 MM FULL RADIUS STRAIGHT BLADE; 4.5 MM HARVESTING TAMP; 4.5 MM HELICUT STRAIGHT BURRS, POWER/EP-1, SLATE, 5000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, VIOLET, PACKAGED 6 PER BOX, STERILE; 4.5 MM INCISOR STRAIGHT BLADE; 4.5 MM LONG CURVED FULL RADIUS CONCAVE SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM LONG FULL RADIUS SHAVER BLADES, 18 CM WORKING LENGTH, PACKAGED 3 PER BOX, STERILE; 4.5 MM OBTURATOR, CONICAL TIP; 4.5 MM ORBIT FULL RADIUS CURVED BLADE; 4.5 MM ORBIT INCIISOR PLUS CURVED BLADES, POWER/EP-1, POWER/EP-1, VIOLET, CURVE LENGTH 17 MM, PACKAGED 6 PER BOX, STERIL; 4.5 MM ORBIT INCISOR CURVED BLADE; 4.5 MM ORBIT SYNOVATOR CURVED BLADE; 4.5 MM RAZORCUT STRAIGHT BLADE; 4.5 MM SYNOVATOR STRAIGHT BLADE; 4.5 MM TREPHINE FOR HARD BONE; 4.5 MM TUBULAR CHISEL; 4.5 MM TURBOTRIMMER STRAIGHT BLADE; 4.5 MM TURBOWHISKER STRAIGHT BLADE; 4.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, FOREST GREEN, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 4.5 mm Incisor Plus Platinum Curved Blade; 4.5 mm Synovator Platinum Curved Blade; 4.5MM FULL RADIUS PLATINUM SERIES; 4.5MM INCISOR PLUS PLATINUM BLADE; 4.5MM SYNOVATOR PLATINUM SERIES; 4mm PLATINUM FLYER Blade; 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS; 5 MM CANNULATED DRILL; 5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, BLUE, LARGE DELRIN HANDLE; 5 MM FLEXIBLE DRILL; 5 MM HALF-ROUND RASP; 5.5 CM ACROMIOBLASTER STRAIGHT BURRS, POWER/EP-1, BRICK RED, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5 MM ABRADER STRAIGHT BURR; 5.5 MM ACROMIONIZER STRAIGHT BURR; 5.5 MM CANNULATED DRILL; 5.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 5.5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, RED, LARGE DELRIN HANDLE; 5.5 MM FULL RADIUS STRAIGHT BLADE; 5.5 MM INCISOR PLUS STRAIGHT BLADES, POWER/EP-1, TEAL, PACKAGED 6 PER BOX, STERILE; 5.5 MM INCISOR STRAIGHT BLADE; 5.5 MM OBTURATOR, CONICAL TIP, FOR CANNULAS WITH FLUID SEALS; 5.5 MM RAZORCUT STRAIGHT BLADE; 5.5 MM SHORT SHEATH AND OBTURATOR HANDLE, POWER/EP-1, OLIVE, PACKAGED 6 PER BOX, STERILE; 5.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 5.5 MM STONECUTTER STRAIGHT BURR; 5.5 MM SYNOVATOR STRAIGHT BLADE; 5.5 SYNOVATOR WITH A FULL RADIUS INNER BONECUTTER BLADES, MELON YELLOW, 8000 MAXIMUM RPM, PACKAGED 6 PER BOX, STERILE; 5.5MM FULL RADIUS PLATINUM SERIES; 5.5MM INCISOR PLUS PLATINUM SERIES; 5.5MM SYNOVATOR PLATINUM SERIES; 6 MM ENDOSCOPIC DRILL; 6 MM GRAFT SIZING TUBE; 6 MM OFFSET ENDOFEMORAL AIMER; 6 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6 MM X 20 MM BIOSURE HA; 6 MM X 25 MM BIOSURE HA; 6 MM X 25 MM BIOSURE HA REVERSE THREAD; 6.4 MM STRAIGHT GOUGE; 6.5 MM CANNULATED DRILL; 6.5 MM CHISEL GUARD; 6.5 MM DELIVERY TAMP; 6.5 MM DILATOR; 6.5 MM DRILL GUIDE; 6.5 MM ENDOSCOPIC DRILL; 6.5 MM GRAFT SIZING TUBE; 6.5 MM HARVESTING TAMP; 6.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6.5 MM TREPHINE FOR HARD BONE; 6.5 MM TUBULAR CHISEL; 6.5MM DILATOR; 6MM DILATOR; 7 MM OFFSET ENDOFEMORAL AIMER; 7 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 7 MM X 20 MM BIOSURE HA; 7 MM X 25 MM BIOSURE HA; 7 MM X 25 MM BIOSURE HA REVERSE THREAD; 7 MM X 25 MM REVERSE THREAD BIORCI SCREW; 7 MM X 30 MM BIOSURE HA; 7 X 20 MM BIORCI SCREW; 7 X 20 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 20 MM SOFTSILK SCREW 1.5 STERILE; 7 X 25 MM BIORCI SCREW; 7 X 25 MM BIORCI SCREW WITH AN 8 MM HEAD; 7 X 25 MM RCI SCREW REVERSE THREAD 2 MM CANNULATION. STERILE, 1 PER BOX.; 7 X 25 MM RCI SCREW WITH 8 MM HEAD 2 MM CANNULATION. STERILE, 1 PER BOX; 7 X 25 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 25 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 25 MM SOFTSILK SCREW 1.5 STERILE; 7 X 30 MM BIORCI SCREW; 7 X 30 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 30 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 30 MM SOFTSILK SCREW 1.5 STERILE; 7 X 40 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 7.5 MM CANNULATED DRILL; 7.5 MM ENDOSCOPIC DRILL; 7.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7.5MM DILATOR; 72205455 INTELLIO Tablet; 72205719 INTELLIO TABLET COUNTRY KIT EN US; 72205777 TESSA ACL Femur Straight Aimer Kit; 72205778 TESSA ACL Femur Curved Aimer Kit; 72205780 TESSA Control Unit; 72205781 TESSA ACL Femur System License Software, No Cloud; 72205782 TESSA Marker A; 72205783 TESSA ACL Femur License Software, Cloud, with Imaging Center; 72205784 TESSA ACL Femur License Software, Cloud, No Imaging Center; 72205785 License for Imaging Center Only; 72205786 TRIAL TESSA ACL Femur License Software, Cloud, with Imaging Center; 72205787 TRIAL TESSA ACL Femur License Software, Cloud, No Imaging Center; 72205790 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON Adjustable Fixation Device; 72205791 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON QUAD Adjustable Fixation Device; 72205792 TESSA ACL Femur Straight Aimer Kit with ULTRABUTTON BB Adjustable Fixation Device; 72205793 TESSA ACL Femur Straight Aimer Kit with ENDOBUTTON CL Ultra, 15mm; 72205800 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON Adjustable Fixation Device; 72205801 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON QUAD Adjustable Fixation Device; 72205802 TESSA ACL Femur Curved Aimer Kit with ULTRABUTTON BB Adjustable Fixation Device; 72205803 TESSA ACL Femur Curved Aimer Kit with ENDOBUTTON CL Ultra, 15mm; 72205810 TESSA Control Unit Accessory Box; 72205811 TESSA Control Unit Country Kit, EN, UK; 72205911 TESSA Control Unit Country Kit, En, US; 7MM BICEPTOR TAP; 7MM DILATOR; 7MM ENDOSCOPIC DRILL XL; 7MM TENDON FORK; 8 MM ENDOSCOPIC DRILL XL; 8 MM PL TIBIAL AIMER POST; 8 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 8 MM X 20 MM BIOSURE HA; 8 MM X 25 MM BIOSURE HA; 8 MM X 25 MM BIOSURE HA REVERSE THREAT; 8 MM X 30MM BIOSURE HA; 8 MM X 35MM BIOSURE HA; 8 X 20 MM BIORCI SCREW; 8 X 20 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 20 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 20 MM SOFTSILK SCREW 1.5 STERILE; 8 X 25 MM BIORCI SCREW; 8 X 25 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 8 X 25 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 25 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 25 MM SOFTSILK SCREW 1.5 STERILE; 8 X 30 MM BIORCI SCREW; 8 X 30 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 30 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 30 MM SOFTSILK SCREW 1.5 STERILE; 8 X 35 MM BIORCI SCREW; 8 X 40 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 8.5 MM CANNULATED DRILL; 8.5 MM DELIVERY TAMP; 8.5 MM DILATOR; 8.5 MM DRILL GUIDE; 8.5 MM ENDOSCOPIC DRILL; 8.5 MM GRAFT SIZING TUBE; 8.5 MM HARVESTING TAMP; 8.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 8.5 MM TREPHINE FOR HARD BONE; 8.5 MM TUBULAR CHISEL; 8.5MM DILATOR; 8MM BICEPTOR TAP; 8MM DILATOR; 8MM TENDON FORK; 9 MM ENDOSCOPIC DRILL XL; 9 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 9 MM X 20 MM BIOSURE HA; 9 MM X 25 MM BIOSURE HA; 9 MM X 30 MM BIOSURE HA; 9 MM X 35 MM BIOSURE HA; 9 X 20 MM BIORCI SCREW; 9 X 20 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 20 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 20 MM SOFTSILK SCREW 1.5 STERILE; 9 X 25 MM BIORCI SCREW; 9 X 25 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 25 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 25 MM SOFTSILK SCREW 1.5 STERILE; 9 X 30 MM BIORCI SCREW; 9 X 30 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 30 MM SOFTSILK 2 SCREW, WITH CLEAR-TRAC SCREW CANNULA LATEX FREE; 9 X 30 MM SOFTSILK SCREW 1.5 STERILE; 9 X 35 MM BIORCI SCREW; 9 x 25 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 9.5 MM CANNULATED DRILL; 9.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 9.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9.5MM DILATOR; 90 DEGREE CONNECTOR; 90 DEGREE CURETTE, ANTERIOR LESION; 9MM BICEPTOR TAP; 9MM DILATOR; 9MM METAL ACL CANNULA; 9MM METAL ACL OBTURATOR; 9MM TENDON FORK; A-Tech ACL Sterilization Tray; A-Tech Controlled Flexion Guidewire; A-Tech Femoral Locator Handle; ACCESSORY, TRACTION; ACCORD; ACCU-PASS STR SHTL BIG C STERILE BOX 1; ACCU-PASS SUTURE SHUTTLE 70 DEGREE; ACCU-PASS SUTURE SHUTTLE J-HOOK STERIL; ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE; ACCUPASS STR SHUTL MONOFIL -SEE72201361; ACL Bullet; ACL CHAMFERING RASP 7 MM, HALF-ROUND; ACL CHAMFERING RASP 8 MM, HALF-ROUND; ACL CHAMFERING RASP BONE TUNNEL; ACL CHAMFERING RASP CHAMFERING; ACL Closed Curette; ACL Disposables Guidewire Kit; ACL Disposables Kit; ACL Open Curette; ACL Tunnel Rasp; ACTIVE HEEL TRACTION BOOT KNEE HOLDER; ACTIVE HEEL TRACTION BOOT REPLACEMENT KIT - PADS ONLY; ACUFEX; ACUFEX ANATOMIC ACL DOUBLE BUNDLE INSTRUMENT TRAY; ACUFEX CANNULATED BONE TUNNEL PLUGS; ACUFEX DIRECTOR ACL ELBOW AIMER; ACUFEX DIRECTOR ACL TIP AIMER; ACUFEX DIRECTOR ANGLED BULLET; ACUFEX DIRECTOR DRILL GUIDE. REQUIRES 1 AIMER AND 1 BULLET NOT INCLUDED; ACUFEX DIRECTOR PCL FEMORAL AIMER; ACUFEX DIRECTOR PCL SAFETY STOP; ACUFEX EXTRA ARTICULAR RECON SYSTEM TRAY; ACUFEX EXTRA ARTICULAR RECONSTRUCTION FEMORAL GUIDE; ACUFEX EXTRA ARTICULAR RECONSTRUCTION OFFSET GUIDE; ACUFEX Extra-Articular Reconstruction Fibular Guide; ACUFEX Extra-Articular Reconstruction Long Bullet; ACUFEX Extra-Articular Reconstruction Short Bullet; ACUFEX Extra-Articular Reconstruction System Tray; ACUFEX Extra-Articular Reconstruction Tibial Guide; ACUFEX Extra-Articular Retractor; ACUFEX GRAFTMASTER III PREPARATION BOARD; ACUFEX MTO PUNCH BASKET DUCKBILL UPBITER CURVED RIGHT PRO HANDLE; ACUFEX PINPOINT ADAPTER; ACUFEX PINPOINT BULLET 4 POINT - 6.5; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-6MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 6-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 7-8MM; ACUFEX PINPOINT DBL BNDL BULL SPT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-6MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 7-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-6MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 7-8MM; ACUFEX PINPOINT INSIDE-OUT HANDLE; ACUFEX PINPOINT OUTSIDE-IN AMR ARM LEFT; ACUFEX PINPOINT OUTSIDE-IN AMR ARM RT; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 10MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 6MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 8MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 9MM; ACUFEX PINPOINT SNGL BNDL GD 7MM; ACUFEX PUNCH BASKET CURVED RIGHT PRO HANDLE; ACUFEX PUNCH BASKET LEFT PRO HANDLE; ACUFEX PUNCH BASKET PRO RIGHT PRO HANDLE; ACUFEX PUNCH BASKET STRAIGHT PRO HANDLE; ACUFEX PUNCH BASKET UPBITER PRO HANDLE; ACUFEX PUNCH BASKET UPSWEPT PRO HANDLE; ACUFEX PUNCH OVAL STRAIGHT PRO HANDLE; ACUFEX PUNCH OVAL UPBITER PRO HANDLE; ACUFEX PUNCH SCISSOR STRAIGHT PRO HANDLE; ACUFEX PUNCH SCISSOR UPBITER PRO HANDLE; ACUFEX T-BAR; MTO KNOT PUSHER, SHOULDER; ACUFEX TRUNAV; ACUFEX TRUNAV RETROGRADE DRL 10.5MM; ACUFEX TRUNAV RETROGRADE DRL 10MM; ACUFEX TRUNAV RETROGRADE DRL 11.5MM; ACUFEX TRUNAV RETROGRADE DRL 11MM; ACUFEX TRUNAV RETROGRADE DRL 12MM; ACUFEX TRUNAV RETROGRADE DRL 6.5MM; ACUFEX TRUNAV RETROGRADE DRL 6MM; ACUFEX TRUNAV RETROGRADE DRL 7.5MM; ACUFEX TRUNAV RETROGRADE DRL 7MM; ACUFEX TRUNAV RETROGRADE DRL 8.5MM; ACUFEX TRUNAV RETROGRADE DRL 8MM; ACUFEX TRUNAV RETROGRADE DRL 9.5MM; ACUFEX TRUNAV RETROGRADE DRL 9MM; ACUFEX TUNNEL GAUGE; ACUFEX(R) ENDO-FEMORAL AIMER; ACUFEX-PRO 3.4MM CUPPED GRASPR; ACUFEX-PRO NARROWLINE STR; ACUFEX-PRO NARROWLINE UPBITER; ACUFEX-PRO PITBULL GRASPER; ADAPTER D LEG KIT (2 UNITS)TENET 7404; ADAPTER JE LEG KIT(2 UNITS)TENET 7402; ADAPTER RAIL CLAMP(2 UNITS)TENET 7403; ADJUST ARM BRD GEL PAD RPLMNT KIT; ADJUSTABLE ARM BOARD HARDWARE KIT; ADVANSYS; ADVANSYS DLP; ADVANSYS MLP; ADVANSYS TTC; AHTB UNIVERSAL HIP DISTRACTOR; AHTB WELL LEG HOLDER; AIMER ENDOFEMORAL 3MM OFFSET (BLUE); AIMER ENDOFEMORAL 4MM OFFSET (PURPLE); AIMER ENDOFEMORAL 5MM OFFSET (RED); AIMER REAR ENTRY RIGHT-ACL; AIMER REAR ENTRY-LEFT; AIMER TIBIAL PCL; AMBI; ANKLE ARTHROSCOPY ACCESSORY 2 UNITS; ANKLE STABILIZATION KITS, DISPOSABLE 6 UNITS; ARM ENDO-FEMORAL AIMER 5MM OFFSET; ARM ENDO-FEMORAL AIMER 6MM OFFSET; ARM ENDO-FEMORAL AIMER 7MM OFFSET; ARO Osteotomy Guide Assembly; ARO Spacer Plate; ARTHRO-PIERCE STRAIGHT; ARTHRO-ROUND XL; ARTHROGARDE 4.5MM HIP CANNULA; ARTHROGARDE 5.5MM HIP CANNULA; ARTHROGARDE 5MM HIP CANNULA; ARTHROGARDE SLOTTLED CANNULA HIP; ARTHROPIERCE; ARTHROPIERCE 35 DEGREE UP; ARTHROPIERCE 45 DEG RIGHT; ARTHROPIERCE 45 DEGREE LEFT; ARTHROPIERCE INSTRUMENT CURVED LEFT; ARTHROPIERCE INSTRUMENT CURVED RIGHT; ARTHROPIERCE UTRATAPE; ARTHROPIERCE XL STRAIGHT; ARTHROSCOPIC LATARJET/BONE BLOCK LID; ARTHROSCOPIC LATARJET/BONE BLOCK TRAY; ARTHROSCOPIC NEEDLE STERILE; ASSEMBLY ENDOBUTTON INDICATOR; AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY 9.5 INCH LENGTH X 3 INCH WIDTH X 1.25 INCH HEIGHT; AWL STRAIGHT 3.8MM DISPOSABLE; AWL, INSERTION SITE MARKING, 45 DEGREES; Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361; Accu-pass suture shuttle 45 degree up, 7210425; Accu-pass suture shuttle 70 degree, Upbend, 72200419; Accu-pass suture shuttle J-hook; Accu-pass suture shuttle left 45 degree, 7210423; Accu-pass suture shuttle right 45 degree; Accu-pass suture shuttle, Big Curve; Accu-pass suture shuttle, crescent, 7210427; Accu-pass suture shuttle, straight, 7210426; Acufex Access Advanced Positioning Kit; Acufex Access Cart; Acufex Access Positioning Kit; Adaptor; All- Suture 1.9mm Anchor with ULTRABRAID Suture; All-Suture 1.7mm Anchor with ULTRABRAID Suture; Anatomic ACL Tray; Ankle Distractor; Ankle Distractor Strap; Arthroscopic needle, 72202825; Awl straight 3.8mm, 72202986; Awl tapered 3.8mm; Awl, tap, driver, dilator; B-BOP; BANKART RASP; BENDING TOOL; BENT STRAP SUPPORT REPLACEMENT KIT; BI-GRIP PIN PULLER; BICEPTOR 7 MM X 15 MM PK SCREW; BICEPTOR 7 MM X 25 MM PK SCREW; BICEPTOR 8 MM X 15 MM PK SCREW; BICEPTOR 8 MM X 25 MM PK SCREW; BICEPTOR 9 MM X 15 MM PK SCREW; BICEPTOR 9 MM X 25 MM PK SCREW; BICEPTOR DRIVER; BIOABSORBABLE INTERFERENCE SCREWS; BIORAPTOR 2.3 PK; BIORAPTOR 2.3 PK SUTURE ANCHOR WITH ONE No.2 PRELOADED ULTRABRAID SUTURE, COBRAID BLACK/WHITE; BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (Cobraid Black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (Cobraid Blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (White); BIORAPTOR 2.3 PK suture Anchor w/ULTRABRAID #2 Suture (cobraid blue); BIORAPTOR 2.9mm Suture Anchor with one 38” ULTRABRAID Co-Braid Suture (#2); BIORAPTOR 2.9mm Suture Anchor with two 38” DURABRAID Sutures (USP#2); BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures (#2); BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures and Needles; BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR WITH ONE 38 INCH ULTRABRAID No. 2 SUTURE COBRAID BLACK SHOULDER; BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR, WITH ONE ULTRABRAID No.2 SUTURE COBRAID-BLUE; BIORAPTOR Curved 2.3 PK; BIORAPTOR Curved 2.3 PK Suture Anchor w/ One ULTRABRAID Suture (Cobraid Black); BIORAPTOR Curved 2.3 PK Suture Anchor w/ One ULTRABRAID Suture (Cobraid Blue); BIORAPTOR INLINE DRILL GUIDE - OFFSET FISHMOUTH TIP 2.9 MM; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, CROWN TIP; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP; BIORAPTOR KNOTLESS INLINE OBTURATOR, BLUNT; BIORAPTOR KNOTLESS SUTURE ANCHOR; BIORAPTOR Knotless Suture Anchor; BIORAPTOR Knotless Suture Anchor, Hip; BIORAPTOR TWIST DRILL, 2.9 MM INLINE; BIORCI; BIORCI SCREW, Sterile; BIORCI-HA INTERFERENCE SCREW 8 INCH X 25 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 8 INCH X 30 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 8 INCH X 35 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 9 INCH X 25 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 9 INCH X 30 INCH STERILE; BIORCI-HA INTERFERENCE SCREW 9 INCH X 35 INCH STERILE; BIORCI-HA INTERFERENCE SCREW,; BIORCI-HA INTERFERENCE SCREW, 7 MM X 25 MM 7 MM HEAD STERILE; BIORCI-HA INTERFERENCE SCREW, 7 MM X 25 MM 8 MM HEAD STERILE; BIORCI-HA INTERFERENCE SCREW, 7 MM X 30 MM 7 MM HEAD STERILE; BIORCI-HA INTERFERENCE SCREW, 7 MM X 30 MM 8 MM HEAD STERILE; BIORPTR 2.3 PK SUTR ANCR ONE 38 C/B BK; BIOSURE; BIOSURE DRIVER; BIOSURE DRIVER 5MM; BIOSURE EASY TAP 10MM; BIOSURE EASY TAP 6MM; BIOSURE EASY TAP 7MM; BIOSURE EASY TAP 8MM; BIOSURE EASY TAP 9MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 10 X 20 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 10 X 35 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 11 X 30 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 11 X 35 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 12 X 35 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 6 X 25 MM, REVERSE THREAD; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 7 X 20 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 7 X 25 MM, REVERSE THREAD; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 7 X 30 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 8 X 20 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 8 X 25 MM, REVERSE THREAD; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 8 X 30 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 8 X 35 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 9 X 20 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 9 X 30 MM; BIOSURE PK PEEK OPTIMA INTERFERENCE SCREW 9 X 35 MM; BIOSURE PK SCREW 10 MM X 25 MM; BIOSURE PK SCREW 10 MM X 30 MM; BIOSURE PK SCREW 11 MM X 25 MM; BIOSURE PK SCREW 6 MM x 25 MM; BIOSURE PK SCREW 7 MM X 25 MM; BIOSURE PK SCREW 8 MM X 25 MM; BIOSURE PK SCREW 9 MM X 25 MM; BIOSURE RATCHET DRIVER; BIOSURE REGEN SCREW 5 X 20MM; BIOSURE REGENESORB; BIOSURE SYNC 11-12MM TIBIAL FIXATION; BIOSURE SYNC 5-6MM TIBIAL FIXATION; BIOSURE SYNC 7-8MM TIBIAL FIXATION; BIOSURE SYNC 9-10MM TIBIAL FIXATION; BIOSURE SYNC Inserter; BIOSURE TAP 10MM; BIOSURE TAP 6MM; BIOSURE TAP 7MM; BIOSURE TAP 8MM; BIOSURE TAP 9MM; BIOSURE TAP TRAY; BIRAPTR 2.3 PK SUTR ANCR ONE 38 C/B BL; BLADE 3.5 CURVED CONCAVE FULL RADIUS; BLADE 3.5MM ELITE FULL RADIUS; BLADE 4 ELITE ABRADER 6/BX; BLADE 5.5 FULL RADIUS ELITE DISPOSABLE; BLADE,4.5 BONECUTTER,FR,180MM LG,DSP; BLT ASSY. 4 POINT DIRECTOR; BLUNT NOSE JR. PUNCH; BOARD, PATIENT TRANSFER; BONE GRASPER; BONE TUNNEL PLUG; BONE TUNNEL PLUG NON-CANNULATED, LARGE 10-11 MM 3 PER PACKAGE; BONE TUNNEL PLUG NON-CANNULATED, SMALL 7-8 MM 3 PER PACKAGE; BONE TUNNEL PLUG XL 11-12 MM 3 PER PACKAGE; BOOT INSERT PAD; BURR 4MM ABRADER 180MML DISPOSABLE (3; BURR 5.5MM ABRADER 180MML DISPOSABLE; Beath pin 2.4mm, 72202815; Beluga Retro; Bilok Instrument Sterilization Tray; Bilok ST Graft Expander; BioRaptor 2.9 Suture Anchor w/ 1 38"" ULTRABRAID COBRAID suture, HIP; Biosure 1.2mm x 18"", 72201201; Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile; Blade, Sheath, Burr, Abrader, Incisor, Synovator, Acromionizer, Tubowhisker, Bonecutter, Acromioblaster, Notchblaster; Blunt Nose Junior; Bone Tap; CALF STRAP EQUIPMENT RPLT AHTB; CALIBRATED DEPTH GAGE; CAMERA COUPLER,16:9 HD REF; CANN 5.5 WO/HOLES LTX FREE ORANGE; CANN DIAG RTTBL DBL VLV 4.5 ASCOPE; CANN DV ROT HF STORZ INT 6MM; CANN H.F. DGNST 6MM RTBL SGL VLV; CANN LUM DB ACSS PSTR; CANN LUM DB CRVD L/R; CANN LUM DB CRVD UP-L; CANN LUM DB CRVD UP-R; CANN LUM DB CRVD UP/DWN; CANN LUM DB STR; CANN M.F. DGNST 6MM HIP DBL VLV; CANN SGL STR; CANNU-FLEX 1.5 MM X 305 MM 62 INCH X 12 INCH GUIDE WIRE; CANNU-FLEX 6 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 6 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 6 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX 8 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 8 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX DRIVER SILK SCREW 7MM CANNULATED; CANNU-FLEX DRIVER SILK SCREW 9MM CANNULATED; CANNU-FLEX GDE WIRES 45X12; CANNU-FLEX SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM 6 PER PACKAGE; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 12 INCH 30 CM, BLUNT TIP, STERILE; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE; CANNULA; CANNULA 2.9MM LONG WINDOW ASSEMBLY; CANNULA 2.9MM SHORT WINDOW; CANNULA 5.5MM OPER. W/STOPCOCK; CANNULA 5.5MM W/FINGER POST; CANNULA 6MM FMS 4MM AS W/O STOPCK; CANNULA 6MM FMS4MM ASCOPE W/STPCK; CANNULA CLEARTRAC 4.5 X 72MM THREADED; CANNULA CLEARTRAC SMOOTH 7 X 72MM; CANNULA CLEARTRAC THREADED 8.5 X 45MM; CANNULA CLEARTRAC THREADED 8.5 X 90MM; CANNULA ECTR; CANNULA FINGER POSTED 4.5MM; CANNULA FINGER POSTED 5.5MM; CANNULA FMS 2.7 LONG ASCOPE; CANNULA FMS SHORT 2.7 AS 3.8; CANNULA FOR 3.6 OPERATIVE SET; CANNULA INTEL NON-SCOPE 3MM; CANNULA MED FLOW ROT DBL VLV 5MM; CANNULA OPERATIVE 4.5MM NO DISATLHOLES; CANNULA OPERATIVE 5.5MM FINGERPOST; CANNULA OPERATIVE 5.5MM NO DISTAL HOLE; CANNULA OPERATIVE 5MM NO DIS HOLES; CANNULA SMOOTH FLEX 5.5 X 55MM; CANNULA SMOOTH FLEX 6.5 X 72MM; CANNULA SMOOTH FLEX 8 X 72MM; CANNULA THREADED DISP 8.5 X 72MM; CANNULA THREADED FLEX 5.5 X 45MM; CANNULA THREADED FLEX 6.5 X 72MM; CANNULA THREADED FLEX 8 X 90MM; CANNULATED OBTURATOR W/DELRIN 4.5MM; CANNULATED OBTURATOR W/DELRIN 5.5MM; CANNULATED OTBURATOR 8MM; CAP-FIX Blade, Curved; CAP-FIX Blade, Curved, with Handle; CAP-FIX Blade, Curved, with Hip Pac; CAP-FIX Blade, Straight; CAP-FIX Blade, Straight, with Handle; CAP-FIX Blade, Straight, with Hip Pac; CAP-FIX SUTURE PASSER 45 DEG; CAP-FIX SUTURE PASSER 70 DEG; CAP-LIFT Cannula, 100mm; CAP-LIFT Cannula, 110mm; CAP-LIFT Cannula, 70mm; CAP-LIFT Cannula, 80mm; CAP-LIFT Cannula, 90mm; CARRIAGE REPLACEMENT KIT; CARRIAGE, RPLT, UNIV HIP DIST FOR AHTB; CART PROCEDURE W. ISOL. TRANSFORMER; CART TRANSPORT SPIDER; CHISEL GUARD; CHONDRAL PICK, LARGE SHAFT 20 DEGREE; CHONDRAL PICK, LARGE SHAFT 40 DEGREE; CHONDRAL PICK, LARGE, 20 DEGREE; CHONDRAL PICK, LARGE, 40 DEGREE; CHONDRAL PICK, SMALL SHAFT 20 DEGREE; CHONDRAL PICK, SMALL SHAFT 40 DEGREE; CHONDRAL PICK, SMALL, 20 DEGREE; CHONDRAL PICK, SMALL, 40 DEGREE; CHONDRAL PICK, SMALL, 90 DEGREE; CIRCLE SUTURE MENISCAL MENDER II; CLAMP DENYERS RAIL TENET 7406; CLANCY 10 MM FLEXIBLE DRILL; CLANCY 10.5 MM FLEXIBLE DRILL; CLANCY 11 MM FLEXIBLE DRILL; CLANCY 12 MM FLEXIBLE DRILL; CLANCY 7.5 MM FLEXIBLE DRILL; CLANCY 9 MM FLEXIBLE DRILL; CLANCY 9.5 MM FLEXIBLE DRILL; CLANCY CURVED FEMORAL GUIDE, 42 DEGREE; CLANCY INSTRUMENT TRAY SYSTEM; CLEAR TRAC COMPLETE HIP CANNULA 7X110; CLEAR TRAC COMPLETE HIP CANNULA 8.5X110; CLEAR-TRAC CMPL. CANN. HIP OBT.8.5X110; CLEAR-TRAC CMPL.CANN. HIP OBT.7X110; CLEAR-TRAC DISPOSABLE STOPCOCK; CLEAR-TRAC MTO 5.5 MM X 72 MM REUSABLE OBTURATOR 4.3 MM CANNULATION; CLEAR-TRAC SCR CANN 8MM LTX FREE; CLEAR-TRAC THREADED CANNULA WITH OBTURATOR 5 MM X 76 MM, LATEX FREE, BOX OF 10; CLEARTRAC SCOPE/SHAVER CANNULA SMOOTH; CLOUD-9 ROLL 40 INCH X 200 FEET 2 ROLLS PER PACKAGE 40 X 100 EACH; MAT ABSORPTION CLOUD 9(10247)(CS OF 25); CORACOID DRILLING GUIDE; CORACOID DRILLING OFFSETGUIDE 10MM; CORI; COUPLER, 19.5mm, 5:4 AUTOCLAVABLE, HD; COUPLER, HIGH DEFINITION, NON-AUTOCLAVABLE, 19.5 MM, BLACK RING; COUPLER, UROLOGY, HD; CROSSTRAC HIP GUIDE; CROSSTRAC HIP GUIDE BULLET; CROSSTRAC TRAY INCLUDED IN SYSTEM; CURETTE CLOSED 3MM; CURETTE CLOSED 5MM; CURETTE CURVED 90 DEG; CURETTE OPEN 6MM 15 DEG; CURETTE OPEN 7MM; CURRETTE OPEN 4MM; CURVED BLUNT DISSECTOR; CURVED DRILL GUIDE FOR 2.3 MM SUTURE ANCHORS, FISHMOUTH TIP; CURVED ELEVATOR; CURVED INCISOR PLUS ELITE BL 4.5MM; CURVED LONG INCISOR PLUS ELITE BLADE; CURVED PROBE 3MM; Camera coupler; Cannu-Flex Screw; Cannuflex 9"" Blunt Guidewire, 72202807; Cannula 5.5mm; Cannula Driver; Cannula set 4.5mm; Cannula set 5.5mm; Cannula set 7mm; Cannula, Obturator, Punch, Scissor, Suture cutter, Aimer, Gore smoother, Trephine adaptor, Guide, Knife; Cannula; post same as DOV, no holes; Cannulated Switching Stick; Caps-Lock Cannula Driver; Caps-Lock Ultra; Chondral Pick; Chondral Pick Sterilization Tray; Clear-Trac Screw Cannula 7mm; Clear-Trac Screw Cannula 9mm; Clear-Trac Threaded Cannula 8mm x 76mm; Clear-Trac Threaded Cannula Kit 5mm ID, 76mm LG; Clear-Trac Threaded Cannula Kit, 8mm I.D., 76mm LG; Clear-Trac cannula Stopcock; Clear-Trac scope/shaver cannula; Clear-Trac scope/shaver cannula w/rib; Clearcut Suture Cutter; Closed Tendon Harvester; Crawford Cannula; Crochet Hook; Crosstrac Flexible Passing Pin 13.50 x 2.4mm; Cuff Elevator; D-RAD; DART SUTURE PASSER; DELIVERY TAMP 3.5MM A.M.P.; DENYER RAIL CLAMP (LATERL DSTRCTR SYS); DENYER SUPINE RAIL CLAMPS 2; DETACHABLE OBTURATOR HANDLE ECTRA 2; DIA. 15MM CANNULA COVER; DIA. 15MM CANNULA TROCAR; DIA. 15MM CANNULA TUBE",1978-02-22,140,2026-10-23,0,14,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221219602%22&limit=1
"Arrow International, LLC (subsidiary of Teleflex Incorporated)",3015859709,3015859709,35 Innovation Way,Wyomissing,PA,19610,United States,Arrow International LLC (subsidiary of Teleflex Incorporated,2518433,Specification developer,49,BSO; BSP; CAZ; DOY; DQO; DQX; DQY; DRB; DRF; DSP; DXE; DYB; DYG; FMF; FMI; FOZ; FPA; FYA; GAA; GAP; GBW; GBX; GDT; GDX; GEA; GXZ; IPY; JDC; JOL; KDD; KGZ; KKX; KMK; LDF; LJS; LJT; MPB; MSD; NFK; NIE; OBJ; OFB; OFC; OFK; OGE; OWL; PAD; PND; PPO,"Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Anesthesia Conduction Kit; Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Stylet, Catheter; Catheter, Electrode Recording, Or Probe, Electrode Recording; System, Balloon, Intra-Aortic And Control; Catheter, Embolectomy; Introducer, Catheter; Catheter, Flow Directed; Syringe, Piston; Needle, Hypodermic, Single Lumen; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Gown, Surgical; Needle, Aspiration And Injection, Disposable; Suture, Nonabsorbable, Silk; Catheter, Peritoneal; Catheter, Irrigation; Staple, Removable (Skin); Scalpel, One-Piece; Cannula, Surgical, General & Plastic Surgery; Electrode, Needle; Orthosis, Lumbo-Sacral; Prosthesis, Elbow, Constrained, Cemented; Catheter And Tip, Suction; Kit, Surgical Instrument, Disposable; Accessories, Catheter; Drape, Surgical, Antimicrobial; Device, Intravascular Catheter Securement; Electrode, Pacemaker, Temporary; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Catheter, Hemodialysis, Non-Implanted; Catheter, Hemodialysis, Implanted; Kit, Repair, Catheter, Hemodialysis; Catheter, Hemodialysis, Triple Lumen, Non-Implanted; Catheter, Ultrasound, Intravascular; Catheter Guide Wire Kit; Catheter Introducer Kit; Percutaneous Atrial Catheter Kit; Epidural Anesthesia Kit; Peripheral Catheter Insertion Kit; Chest Drainage Kit; Midline Catheter; Multi-Lumen Hemodialysis Catheterization Kit",1; 2,"'- Arrow PICC Powered by Arrow VPS Stylet; 14 Fr 2-L Hemodialysis Catheters; 2 LUMEN/PSI KIT; 2- Lumen PICC Products w/ Blue Flex; 2-L MAC KIT; 2-Lumen Central Venous Access (MAC); AC3 Optimus™; AC3 Series IABP System; AC3™; ACCESS KIT; ACCESS TRAY; ACCESSORY KIT; AGB MAC KIT; AGB+ Multi-Lumen CVC Kit; AGB+ Quad Lumen CVC Kit; AGB+ Two-Lumen CVC Kit; AGBA PI MIDLINE; AGBA PI PICC KIT; AGBA PICC; AHDC AGB CURVED KIT; AHDC AGB KIT; AHDC AGB U-BEND KIT; AHDC KIT; AM PICC; AM PICC SET; AM/AT PI MIDLINE; AM/AT PICC; ARROW PERITONEAL LAVAGE KIT; ARROW Radial Artery Catheterization Set with Integral Needle Protection; ARROW THORACENTESIS KIT; ARROW(R) VPS(R) ACCESS KIT; ARROWg+ard 2-L Access (MAC); ARROWg+ard Blue Plus Multi-Lumen CVC Extreme Kit; ARROWg+ard Blue Plus Multi-Lumen CVC Kit; ARROWg+ard Blue Plus Multi-Lumen CVC Set; ARROWg+ard Blue Plus Multi-Lumen CVC Super Kit; ARROWg+ard Blue Plus Quad-Lumen CVC; ARROWg+ard Blue Plus Quad-Lumen CVC Set; ARROWg+ard Blue Plus Quad-Lumen CVC Super Kit; ARROWg+ard Blue Plus Two-Lumen CVC; ARROWg+ard Blue Plus Two-Lumen CVC Kit; ARROWg+ard Blue Plus Two-Lumen CVC Set; ARROWg+ard Blue Plus Two-Lumen CVC Super Kit; ARROWg+ard CVCs; ARROWg+ard Evolution Antimicrobial Pressure Injectable PICC; ARROWg+ard Hemodialysis Catheters; ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter; ARROW® FlexBlock Continuous Peripheral Nerve Block Kits; ARROW® FlexBlock Continuous Peripheral Nerve Block Sets; Abdominal Paracentesis Kit; Ag+ & Ag+BP Pressure Injectable CVC; Ag+ Blue Plus ML CVCs; Ag+ Quad Lumen CVCs; Ag+ Super ArrowFlex PSIs; Anesthesia Conduct Kit; Antecubital Central Venous Catheterization Kit with Heparin-Coated Catheter; Arrow ""No Leak"" Sheath Adapter with Side Port; Arrow Access Tray; Arrow Catheter Clamp for 5, 6, 7 and 8 Fr. Catheters; Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter; Arrow Central Venous Catheterization Kit; Arrow Continuous Nerve Block Needle; Arrow Continuous Peripheral Nerve Block Kit; Arrow Echogenic Introducer Needle; Arrow Endurance Extended Dwell Peripheral Catheter System; Arrow Epidural Anesthesia Kit; Arrow Epidural Catheterization Kit; Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter; Arrow Epidural Catheterization Kit with TheraCath®; Arrow Epidural Catheterization Kit with TheraCath® Catheter; Arrow Epidural Catheterization Kit/Set with FlexTip Plus® Catheter; Arrow Epidural Catheterization Set with FlexTip Plus® Closed Tip Multi-Port Catheter; Arrow Epidural Needle; Arrow Epidural Needle Kit; Arrow FlexBlock Continous Peripheral Nerve Block Kits; Arrow Jugular Puncture Kit; Arrow Large Bore Multi-lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter; Arrow MAC(TM) Two-Lumen Central Venous Access Kit; Arrow MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Nerve Block Prep Tray; Arrow Non-Absorbable Silk Suture; Arrow PICC; Arrow PSI; Arrow Peripherally Inserted Central Catheter; Arrow Peritoneal Lavage Catheterization Kit; Arrow Prep Tray; Arrow Pressure Injectable Central Venous Catheterization Kit; Arrow Pressure Injectable Midline; Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Radial Artery; Arrow Raulerson Syringe; Arrow Seldinger Arterial Catheterization Device; Arrow Select Kits; Arrow SharpsAwayII¿ Locking Disposal Cup; Arrow Single Shot Epidural Anesthesia Kit; Arrow Single Shot or Continuous (Intermittent) Brachial Plexus Set; Arrow SnapLock¿ Clamp Fastener (Bulk Non-Sterile); Arrow Stiffening Stylet; Arrow StimuCath® Continuous Nerve Block Set; Arrow StimuQuik Echo Insulated Peripheral Nerve Block Needle; Arrow StimuQuik Insulated Peripheral Nerve Block Needle; Arrow StimuQuik® Echo Insulated Peripheral Nerve Block Needle; Arrow StimuQuik® Insulated Peripheral Nerve Block Needle; Arrow Stimulator Adapter Cable; Arrow TheraCath® Epidural Catheter; Arrow Thoracentesis Kit; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis Set; Arrow Twin-Cath(R) 20/22 Multiple-Lumen Peripheral Catheter; Arrow UserGard(R) Needle-Free Injection Hub; Arrow VPS G4; Arrow VPS Stylet PLUS and CG+ Arrow PICC powered by Arrow VPS Stylet PLUS; Arrow(TM) Endurance(TM) Extended Dwell Peripheral Catheter System; Arrow-Clarke Pleura-Seal Thoracentesis Kit; Arrow-Clarke™ Pleura-Seal® Thoracentesis Set; Arrow-Clark™ VectorFlow™ Antegrade Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Replacement Hub Set; Arrow-Johans ECG Adapter; Arrow-Johans¿ ECG Adapter for Right Atrial Electrocardiography; ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC); Arrowg+ard Blue Advance ™ PICC Kit; Arrowg+ard Blue Advance™ JACC; Arrowg+ard Blue Advance™ Midline; Arrowg+ard Blue Advance™ PICC; Arrowg+ard Blue Advance™ PICC pre-loaded with ARROW® VPS® Stylet; Arrowg+ard Blue Advance™ PICC pre-loaded with Arrow® TipTracker™ Stylet; Arrowg+ard Blue Advance™ PICC pre-loaded with Arrow® VPS Precision™ Stylet; Arrowg+ard Blue Advance™ PICC with 130 cm Hydrophilic-Coated Nitinol Guidewire; Arrowg+ard Blue Advance™ PICC with 80 cm Hydrophilic-Coated Nitinol Guidewire; Arrow® 10 mL Luer-Slip Loss of Resistance Syringe; Arrow® 5 mL Luer-Slip Loss of Resistance Syringe; Arrow® Access Tray; Arrow® Arterial Catheterization Set; Arrow® BiPolar Pacing Catheters; Arrow® Continuous Epidural Needle; Arrow® Continuous Nerve Block Kit; Arrow® Continuous Nerve Block Set; Arrow® Emergency Infusion Device - EID¿; Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter; Arrow® Epidural Needle; Arrow® MultiPolar Electrode Catheter; Arrow® MultiPolar Electrode Catheter; Arrow® MultiPolar Mapping/Pacing Catheter; Arrow® MultiPolar Mapping/Pacing Catheter; Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath; Arrow® QuadPolar Electrode Catheter; Arrow® QuadPolar Mapping/Pacing Catheter; Arrow® Sheath Adapter with Cath-Gard® Catheter Contamination Shield; Arrow® SnapLock™ Catheter/Syringe Adapter; Arrow® Temporary Pacing Catheters,; Arrow® Thermodilution Catheters; Arrow® Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer Set; Arrow® Wedge Pressure Catheter,; Art./Venous Cath Set; Arterial Access Tray; Arterial Cath Kit; Arterial Catheter; Arterial Catheter Kit; Arterial Catheterization Kit; Arterial Line Kit; Balloon Wedge Pressure Catheter; Brachial Plexus Catheter; CELERITY SYSYEM; CG+ PICC; CG+ PICC SET; CVC KIT; CVC Kit; CVC SET; Cannon Hemodialysis Catheter; Cannon II Plus; Cannon II Plus Replacement Hub Set; Cannon II Plus; Edge; CathGuard; Catheter Clamp with Fastener; Catheter Hemodialysis; Celerity PICC Tip Confirmation System; Continuous Epidural Anesthesia Kits; Drape surgical; Drape, surgical; EF-05510N: FILTER COMPONENT NRFit GVS; EMERGENCY INFUSION DEVICE; EZ-IO; EZ-IO INTRAOSSEOUS INFUSION SYSTEM; EZ-IO Intraosseous Vascular Access System; EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION; EZ-MIO MANUAL DRIVER; EZ-MIO STERNAL; EZ-MIO, EZ-IO DISTAL TIBIA; Echogenic Introducer Needle; Echogenic Introducer needle; Edge; Embolectomy Catheter; Emergency Infusion Device; Epidural Catheterization Kit; Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature; Extension Tubing; FAST™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device; FlexTip Plus & Accessories; FlexTip Plus Combined Spinal Epidural Catheterization Kit; FlexTip Plus Epidural Catheter; FlexTip Plus Epidural Catheterization Kit; FlexTip Plus(R) Epidural Catheterization Kit for Lumbar Placement; FlexTip Plus® Combined Spinal Epidural Catheterizaiton Kit; FlexTip Plus® Epidural Catheterization Kit; FlexTip Plus® Epidural Catheterization Kit for Caudal Placement; GLIDETHRU; HEMODIALYSIS KIT; HEMODIALYSIS SET; HUMERAL HEAD, MANUAL DRIVER; Hands-off Thermodilution Catheters; Heparin Coated Thermodilution Ballo; High Flow Fluid Administration Set; INTRAVENOUS SET; INTRODUCER & INJECTION NEEDLES; Internal Jugular Kit; Intravascular catheter securement; LBCVC AGB KIT; LBCVC KIT; Large Bore Multi-Lumen CVCs; M-L CVC w/BlueFlex Tip; MAC KIT; MAC SEMI KIT; MAC SET; MANUAL PD-IO; POWERED PD-IO; MIDLINE CATHETER KIT; MIDLINE CATHETERS; MULTI LUMEN CVC KIT; MULTI-LUMEN/PSI KIT; MULTILUMEN PI CVC KIT; MULTILUMEN/MAC KIT; Micro Introducer Set; Multi-Lumen CVC; Multiple; NEW HYDROPHILIC COATING FOR WIRE GUIDES; NaviCurve Stylet; NextStep Antegrade; NextStep Retrograde; NextStep Retrograde (femoral lengths); NextStep Retrograde Replacement Hub Set; ORTHOSIS, LUMBO-SACRAL; PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE; PERCUTANEOUS CAVITY DRAI; PERCUTANEOUS SHEATH INTRODUCER; PI AGBA PICC KIT; PI CATHETER; PI CG+ PICC SET; PI CVC KIT; PI CVC SET; PI JACC KIT; PI MIDLINE; PI MULTI LUMEN CVC; PI PICC; PICC; PICC KIT; PICC SET; PICC v2; PICC with Chlorag+ard Technology; POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO; POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM; PREP KIT; PREP TRAY; PSI ACCESS TRAY; PSI KIT; PSI KIT/AGB CVC KIT; PSI SEMI KIT; PSI SET; PSI/CVC KIT; Pediatric 2-L Hemodialysis Catheter; Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter; Percutaneous Cavity DRAI; Percutaneous Cavity Drainage Catheterization Set/Kit; Percutaneous Cavity Drainage Catheterization Set/Kit; Percutaneous Sheath Introducers; Percutaneous TPN Kit; Peripherally Inserted Central Catheter; Peripherally Inserted central catheter (PICC) with Blue; Peripherally inserted central catheter (PICC) Product with Blue Flex Tip and integral needle protection; Pneumothorax Kit; Pneumothorax Set; Pneumothorax kit w/Sutures; Preox LOR Syringe; Pressure Injectable PICC; Pressure Injectable Peripherally Inserted Catheter; Puncture Kit, Disposable Vein; QUAD LUMEN PI CVC KIT; RA Cath Kit; RA Catheter w/Integral Ndl Protect; Radial Artery Catheter; Radiopaque polyurethane multi-lumen indwelling catheter with heparing coating; Raulerson Syringe; S-02200-010: FILTER COMM: .2 MICRON FLAT, GVS; S-02200-010N: FILTER COMM: 0.2. MICRON FLAT NRFit, GVS; STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES; SWG; SharpsAway Needle Disposal Cups; Sheath Adapter; Silk Suture; Single Lumen CVCs; Single Shot Epidural; Single Shot Epidural Anesthesia Kit; SnapLock™ Clamp Fastener; Spring Wire Guide; Spring Wire Guide Component; Staple Anchoring Device; StimuCath (19 Ga); StimuCath PNB Catheter; Super Arrow-Flex® Percutaneous Sheath Introducer Set; Super ArrowFlex PSIs; TFX MEDICAL INTRODUCER ASSEMBLY; THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE; TRAUMA SET; TipTracker Stylet; Transduction probe; Transseptal Super ArrowFlex PSI; Trauma Kit; TwinCath Intravenous Catheters; Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter,; USER-GARD NEEDLESS INJECTION HUB; UltraCath Continuous Nerve Block Catheter; UltraCath Continuous Nerve Block Kit; VESSEL CATH KIT; VIDAPORT INTRAOSSEOUS INFUSION SYSTEM; VPS Rhythm DLX Device with TipTracker Technology; VPS Vascular Positioning System; Vascular Positioning System¿ (VPS¿) Stylet; VectorFlow Antegrade Chronic Hemodialysis Catheter; VectorFlow Retrograde Chronic Hemodialysis Catheter; VectorFlow Retrograde Replacement Hub Set; Vessel catheterization Kit/Set; Walrus Multi-Lumen Intravenous Infu; Walrus Percutaneous Introducer Set; Walrus embolectomy catheter; You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; You-Bend Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter; none",1995-02-02,138,2025-03-14,0,116,3,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015859709%22&limit=1
Can Technomed Trading Ltd.,3015276088,3015276088,1025-11111 Twigg Pl.,Richmond British Columbia,,V6V 0B7,Canada,Can Technomed Trading LTD.,10059827,Exporter to the US,31,DXT; HQC; HQE; ITX; IXL; IXR; IYN; IYO; IZF; IZH; IZI; IZL; IZO; IZQ; JAA; JAK; KGI; KPR; KPS; LLZ; LMC; LNH; LNI; MOS; MQB; MUE; OBJ; OTE; OWB; OXO; QIH,"Injector And Syringe, Angiographic; Unit, Phacofragmentation; Instrument, Vitreous Aspiration And Cutting, Ac-Powered; Transducer, Ultrasonic, Diagnostic; Device, Spot-Film; Table, Radiographic, Tilting; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Tomographic; System, X-Ray, Mammographic; System, X-Ray, Angiographic; System, X-Ray, Mobile; Generator, High-Voltage, X-Ray, Diagnostic; Injector, Contrast Medium, Automatic; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Tomography, Computed; Densitometer, Bone; System, X-Ray, Stationary; System, Tomography, Computed, Emission; System, Image Processing, Radiological; Camera, Multi Format, Radiological; System, Nuclear Magnetic Resonance Imaging; System, Nuclear Magnetic Resonance Spectroscopic; Coil, Magnetic Resonance, Specialty; Solid State X-Ray Imager (Flat Panel/Digital Imager); Full Field Digital, System, X-Ray, Mammographic; Catheter, Ultrasound, Intravascular; Digital Breast Tomosynthesis; Interventional Fluoroscopic X-Ray System; Image-Intensified Fluoroscopic X-Ray System, Mobile; Automated Radiological Image Processing Software",1; 2; 3,"1.5T 12 CHANNEL BODY ARRAY; 1.5t 16 channel brain-spine array coil; 123; ACHIEVA 1.5T; ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES; ALLURACLARITY XPER FD SERIES X-RAY SYSTEM; Achieva 1.5 Tesla MR System; Achieva MR System; Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems; Achieva; Intera; Ingenia 1.5T; Ingenia 3T; Ingenia 1.5T CX; Ingenia 3T CX; Ingenia Elition S; BMD Hologic QDR-4500; Bone Densitometry GE Prodigy; C-Arm ARCADIS; C-Arm ARCADIS Varic; C-Arm Arcadis Avantic; C-Arm OEC 9800 Spare Parts; C-Arm OEC 9900; CP BODY; CProbe; CT scan Injector; Canon; Canon (Toshiba) Aquilion CT System; Canon (Toshiba) Aquilion CXL CT System; Canon (Toshiba) TSX-301A Aquilion ONE CT System; Canon Aquilion ONE; Coils and Accessories; Digital Spot Mammography System; Discovery MR750 3T; Discovery MR750w 3T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist; Dual-Head CT Injector; FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM; FORTE GAMMA CAMERA SYSTEM; GE; GE 3T Signa HDx MRI; GE BMD Lunar Series; GE BRIGHTSPEED CT SCANNER SYSTEM; GE Bone Densitomerey Lunar; GE Brivo; GE C-Arm 9900; GE C-Arm OEC 9800; GE C-Arm OEC 9800 PLUS; GE C-Arm OEC BRIVO; GE C-Arm  OEC 9900 Elite; GE CT BrightSpeed Elite; GE CT Scan Discovery 750 HD; GE CT Scan Optima 520; GE CT Scan Optima 660; GE CT Scan Revolution EVO; GE CT Scan VCT; GE CT Scanner OPTIMA CT660; GE DISCOVERY CT750 HD; GE DISCOVERY MODEL NM/CT 670; GE DISCOVERY VCT SYSTEM; GE Digital Radiology Discovery XR650; GE Digital Radiology Discovery XR656; GE Discovery CT750 HD CT; GE Discovery IGS 730; GE Healthcare Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert; GE Infinia Hawkeye; GE LIGHTSPEED CT750 HD (LIGHTSPEED 8) or (GE CT LightSpeed VCT); GE LIGHTSPEED RT16; GE Lightspeed VCT; GE Lunar Prodigy BMD; GE Mammo Senograph; GE Medical Systems LLC; GE Medical Systems Optima 660 CT Scanner; GE OEC 9900 C-Arm; GE Revolution CT; GE Senograph Pristina; GE Senographe Essential Mammo; GE VCT CT Scanner; Gantry Philips CT Incisive; Gemini PET/CT Imaging System; HOLOGIC SELENIA DIMENSIONS 2D FULL DIGITAL MAMMOGRAPHY SYSTEM; Head/Neck 20 MR Coil 1.5T; Hitachi; Hologic Dimension; Hologic Mammography  Dimension; Hologic Selenia Dimensions 3D System; Hologic Selenia Dimensions System; IGC; Ingenia 1.5T parts; Ingenia 1.5T parts (Gradient Cabinet Copley 781); Ingenia 1.5T parts (RF Amplifier MKS S23); Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems; L.F optivantage injector; LOGIQ E9 Diagnostic Ultrasound System; MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit; MRC200 0407 Philips X-Ray Tube for ALLURA XPER FD20 SERIES; MRI 1.5T SIGNA HDXT; MRI Medrad Injector Spectris-Solaris-ep; Mammography GE; Mammography Hologic Dimension; Mammography Hologic Selenia; Mammography Siemens Inspiration; Medical Equipment and Parts; Medrad Spectris Solaris EP; Medrad Spectris Solaris Ep Mr Injector System; Medrad Spectris Solaris Mr Injector System; Medrad Stellant Ct Injector System; Medrad Veris Mr Injector System; Medrad Vistron Ct Injector System; Neurovasculer Array Coil; O-ARM IMAGING SYSTEM; OEC 9800; OEC 9900 Elite; OPTIMA CT660; ORTHOSCAN MINI C-ARM; Optistar L.E injector; PHILIPS BV C-Arm; PHILIPS BV PULSERA/ENDURA; PHILIPS IU22 ULTRASOUND SYSTEM; Phacofragmentation Unit; Philips; Philips Achieva, Intera And Panorama 1t, Release 2.5; Philips Brilliance CT; Philips Brilliance CT Scan; Philips CT Big Bore; Philips CT Brilliance; Philips CT Brilliance 64 X-Ray; Philips CT Incisive; Philips CT Scan Ingenuity; Philips Eleva; Philips Extremity Coil; Philips Flex Coil; Philips Head Neck Coil; Philips Ingenuity Core 128 CT; Philips Ingenuity TF; Philips MRI Ingenia; Philips MRI Ingenia 1.5T; Philips MRI Ingenia 3T; Philips Mammo; Philips PET-CT GEMINI GXL; Philips SPECT/CT Brightview XCT or BV-XCT; Philips Synergy Spine Array Coil; Philips Ultrasound LLC; Philips VERADIUS C-Arm; Revolution CT Scanner; SHIMADZU MOBILE X-RAY SYSTEM MOBILE ART EVOLUTION; SHOULDER COIL; SIEMENS MAGNETOM SYMPHONY A TIM SYSTEM; SIEMENS MAMMOMAT 3000; SIEMENS Mammomat Inspiration; SOMATOM Edge Plus/Confidence/Definition Edge/Definition AS/AS+/Definition AS Open/Drive/Force/Definition Flash; SOMATOM Sensation 64; SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed; SONY ELECTRONICS, INC.; Sectra Microdose Mammography; Selenia 2D; Siemens Artis zee; Siemens Biograph mCT PET/CT System; Siemens C-Arm CIOS; Siemens C-Arm SieroMobile; Siemens CT SOMATOM Emotion and Parts; Siemens CT SOMATOM Sensation; Siemens CT Scan Definition AS; Siemens Emotion 16; Siemens MAGNETOM ESPREE System; Siemens Mammo MAMMOMAT Revelation; Siemens Mammo Mammomat; Siemens Mammo Mammomat Inspiration; Siemens Mammography MAMMOMAT; Siemens Mammography Mammomat Inspiration PRIME; Siemens Mammomat Inspiration; Siemens Mobile X-Ray MOBILETT MIRA; Siemens SIREMOBIL; Siemens SIREMOBIL COMPACT; Siemens SOMATOM Emotion 16; Siemens Symbia; Siemens Symbia T6 Spare Parts; Siemens TxRx Knee 15 Flare MR Coil 3T; Somatom Emotion; Spare Part- Siemens Definition AS Gantry; Spine Array; Stellant Injector; Symbia SPECT and SPECT CT Systems; Syngo.CT Dual Energy; TXRX 15CH KNEE COIL (1.5T AND 3T); Torso Coil; Toshiba CT Aquilion; Toshiba CT Aquilion 32, TSX-101AH; Toshiba CT Aquilion 64; Toshiba CT Scan Aquilion; Ultimate Ultrasound; siemens",2019-02-27,133,2025-07-11,5,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015276088%22&limit=1
"Exactech, Inc.",1038671,1038671,2320 N.W. 66TH CT.,Gainesville,FL,32653,United States,"EXACTECH, INC.",1038671,Complaint file establishment; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,63,FSM; FZS; FZX; GAD; GDH; GFA; HRS; HRT; HRY; HSD; HSN; HSZ; HTE; HTJ; HTO; HTP; HTQ; HTR; HTW; HWA; HWB; HWC; HWD; HWE; HWM; HWN; HWP; HWR; HWT; HXC; HXG; HXX; HXY; JDI; JDR; JWH; KDD; KDG; KIK; KIL; KWL; KWS; KWT; KWY; KWZ; LPH; LWJ; LXH; LZO; MBH; MBL; MBP; MDM; MEH; MQV; NJL; NTG; NUN; OIY; OQI; PAO; PHX; PKC,"Tray, Surgical, Instrument; Curette, Surgical, General Use; Guide, Surgical, Instrument; Retractor; Gouge, Surgical, General & Plastic Surgery; Blade, Saw, General & Plastic Surgery, Surgical; Plate, Fixation, Bone; Stripper, Surgical; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Elevator; Gauge, Depth; Reamer; File; Broach; Rasp; Bit, Drill; Impactor; Extractor; Screw, Fixation, Bone; Starter, Bone Screw; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Osteotome; Instrument, Compression; Punch, Femoral Neck; Driver, Prosthesis; Template; Wrench; Tamp; Screwdriver; Brace, Drill; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Staple, Fixation, Bone; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Kit, Surgical Instrument, Disposable; Chisel (Osteotome); Hook, Bone; Positioner, Socket; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Filler, Bone Void, Osteoinduction (W/O Human Growth Factor); Instrument, Manual, Surgical, General Use; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Filler, Bone Void, Calcium Compound; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing; Prosthesis, Ankle, Uncemented, Non-Constrained; Bone Grafting Material, Human Source; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained",1; 2; 3,"12/14 Alumina Femoral Head; 12/14 Alumina Femoral Heads 36mm; 12/14 Total Hip System; AcuMacth 12/14 Cemented Femrl Stems; AcuMatch 12/14 Press-Fit Femrl Stem; AcuMatch A-Series /MCS Con Ace Linr; AcuMatch A-Series Enhnced Polyethyl; AcuMatch L-Series Bipolar; AcuMatch L-Series Unipolar; AcuMatch M-Series ExSml Metaphyseal; AcuMatch MSeries 12/14 Neck Segment; AcuMatch MSeries LPB 12/14 Femoral; AcuMatch MSeries Offset Neck Sgmnts; Advanced Patella; Alteon; Alteon Bone Screws; Alteon HA Femoral Stem; Alteon Highly Polished Femoral Stem; Alteon Monobloc Revision Stem; Alteon Neck Preserving Femoral Stem; Alteon Tapered Wedge Femoral Stem; Alteon® HA Femoral Stems; AuRa Hip System Cemented Femrl Stem; BIT; BRACE; BROACH; Biolox Delta; Biolox Option; Bone Hook; Bone curette; Cemented Total Knee Sys Tibial Comp; Chrome Cobalt Ball Head; Cruciate Retaining Cemented Knee; Cruciate Retaining Cemented Tibial; DEPTH; EPIC; EXACTECH ACETABULAR LINER INSERTER; EXACTECH HIP; EXACTECH IMPACTOR; EXACTECH IMPLANT ASSEMBLER PLIERS; EXACTECH STERILE MODULAR DRILL BITS; EXACTECH SURGICAL SCREWDRIVER; EXACTECH TIBIAL TAMPS; EXTRACTOR; Equinoxe; Equinoxe Cage Glenoid; Equinoxe Cast Glenospheres; Equinoxe Cast Humeral Heads; Equinoxe Extra Short Humeral Heads; Equinoxe Fixed Angle Replicator Plates; Equinoxe Fracture Plate; Equinoxe Humeral Reconstruction Prosthesis; Equinoxe Laser Cage Glenoid; Equinoxe Platform Fracture Stem; Equinoxe Preserve Stem; Equinoxe Rev. Shoulder Fracture Hum; Equinoxe Reverse +15mm Adapter Tray; Equinoxe Reverse Shoulder 38mm and 42mm Glensopheres; Equinoxe Reverse Shoulder Compression Screw; Equinoxe Reverse Shoulder Glenoid Plate; Equinoxe Reverse Shoulder Posterior Augment Glenoid Plate; Equinoxe Reverse Shoulder Superior Augment Glenoid Plate; Equinoxe Reverse Shoulder System; Equinoxe Shoulder System; Equinoxe Small Reverse Shoulder; Equinoxe Stemless Shoulder; Equinoxe UHMWPE 16 degree Posterior Augment Pegged Glenoids; Equinoxe UHMWPE Posterior Augment Pegged Glenoids; Exactech AcuMatch XLE Acetabular Liners; Exactech Bipolar Hip Prosthesis; Exactech Bone Screws; Exactech Equinoxe 12degree Posterior Augment Pegged Glenoid; Exactech Equinoxe Resurfacing Humeral Head System; Exactech Equinoxe Reverse Shoulder; Exactech Equinoxe Short Replicator Plates; Exactech Equinoxe Shoulder System; Exactech Novation XLE Acetabular Liners; Exactech Optetrak Logic CC Knee System; Exactech Optetrak Logic Metaphyseal Cones; Exactech Total Hip System; Exactech Truliant Porous Femur; ExactechGPS; FEMORAL STEM DRIVER; Femoral Heads and Novation Crown Cup Acetabular Liners; Femoral Stem Centralizer; Guide; Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies; Instrument Tray; Integrated Hip System; Intgrtd Hip Sys M-Sers Fmrl Stm Com; KNEE ORTHOPEDIC SURGICAL INSTRUMEN; Logic PS; Logic PSC Tibial Insert; M-SERIES ROUND OSTEOTOME; Novation 12/14 Cemented Femrl Stems; Novation 12/14 Press Fit Femrl Stem; Novation CFS Cemented Stems; Novation CFS Press-Fit Stems; Novation Crown Cup; Novation Crown Cup Constrained L&R; Novation Crown Cup and Liners; Novation Element Press Fit Stem; Novation Element Press-Fit Femoral Stem; Novation Element Reduced Offet Press-Fit Femoral Stems; Novation Empire Acetabular Augments with InteGrip; Novation InteGrip Acetabular Augments; Novation LPI Prime Femoral Stems; Novation Splined RDD Femoral Stems; Novation Tapered 12/14 Press-Fit Femoral Stem; Novation cemented plus femoral stem; OPTECURE; OPTETRAK UNICONDYLAR KNEE; Optecure; Optecure +CCC; Optecure Dental; Optecure Dental +CCC; Optecure and Optecure +CCC; Optecure+CCC; Optetrak 9mm CR Tibial Insert Slope; Optetrak Constrained Condylar Knee; Optetrak HiFlex Aysm PS Cemnt Fmrl; Optetrak HiFlex PS Tibial Insert; Optetrak Knee offset Tibial Tray; Optetrak Logic; Optetrak Logic CR; Optetrak Logic CR Knee System; Optetrak Logic CRC Tibial Inserts; Optetrak Logic Combo Tibial Tray; Optetrak Logic Fit Tray; Optetrak Logic Porous Femoral Component; Optetrak Logic Porous Femoral Components; Optetrak Logic RBK; Optetrak Proximal Tibial Spacer; Optetrak RBK; Optetrak Total Knee System; Optetrak Total Knee Sz 0/1 Delta; Orthopaedic Bone curette, reusable; Orthopaedic Bone file/rasp, manual; Orthopaedic Hand-held retractor; Orthopaedic implant/instrument dismantling device; Orthopaedic osteotome; Osteotome; Porous Coated Curciate Retained Fem; Postr Stablizd Cementd CoCr UHMWPE; Prous Coate Postr Stablizd Fmrl Com; REAMER; RESORBABLE ROOM TEM; Surgical power tool; TEMPLATE; TRULIANT Porous Tibial Tray; TRULIANT®; TS; Tibial Bone Removal Screw; Truliant; Truliant CR Cemented Femoral, size 0 Left; Truliant CR Cemented Femoral, size 0 Right; Truliant CR Cemented Femoral, size 1 Left; Truliant CR Cemented Femoral, size 1 Right; Truliant CR Cemented Femoral, size 1.5 Left; Truliant CR Cemented Femoral, size 1.5 Right; Truliant CR Cemented Femoral, size 2 Left; Truliant CR Cemented Femoral, size 2 Right; Truliant CR Cemented Femoral, size 2.5 Left; Truliant CR Cemented Femoral, size 2.5 Right; Truliant CR Cemented Femoral, size 3 Left; Truliant CR Cemented Femoral, size 3 Right; Truliant CR Cemented Femoral, size 3.5 Left; Truliant CR Cemented Femoral, size 3.5 Right; Truliant CR Cemented Femoral, size 4 Left; Truliant CR Cemented Femoral, size 4 Right; Truliant CR Cemented Femoral, size 4.5 Left; Truliant CR Cemented Femoral, size 4.5 Right; Truliant CR Cemented Femoral, size 5 Left; Truliant CR Cemented Femoral, size 5 Right; Truliant CR Cemented Femoral, size 6 Left; Truliant CR Cemented Femoral, size 6 Right; Truliant CR Neutral tibial insert, size 0, 10mm; Truliant CR Neutral tibial insert, size 0, 12mm; Truliant CR Neutral tibial insert, size 0, 14mm; Truliant CR Neutral tibial insert, size 1, 10mm; Truliant CR Neutral tibial insert, size 1, 12mm; Truliant CR Neutral tibial insert, size 1, 14mm; Truliant CR Neutral tibial insert, size 1.5, 10mm; Truliant CR Neutral tibial insert, size 1.5, 12mm; Truliant CR Neutral tibial insert, size 1.5, 14mm; Truliant CR Neutral tibial insert, size 2, 10mm; Truliant CR Neutral tibial insert, size 2, 12mm; Truliant CR Neutral tibial insert, size 2, 14mm; Truliant CR Neutral tibial insert, size 2.5, 10mm; Truliant CR Neutral tibial insert, size 2.5, 12mm; Truliant CR Neutral tibial insert, size 2.5, 14mm; Truliant CR Neutral tibial insert, size 3, 10mm; Truliant CR Neutral tibial insert, size 3, 12mm; Truliant CR Neutral tibial insert, size 3, 14mm; Truliant CR Neutral tibial insert, size 3.5, 10mm; Truliant CR Neutral tibial insert, size 3.5, 12mm; Truliant CR Neutral tibial insert, size 3.5, 14mm; Truliant CR Neutral tibial insert, size 4, 10mm; Truliant CR Neutral tibial insert, size 4, 12mm; Truliant CR Neutral tibial insert, size 4, 14mm; Truliant CR Neutral tibial insert, size 4.5, 10mm; Truliant CR Neutral tibial insert, size 4.5, 11mm; Truliant CR Neutral tibial insert, size 4.5, 12mm; Truliant CR Neutral tibial insert, size 4.5, 13mm; Truliant CR Neutral tibial insert, size 4.5, 14mm; Truliant CR Neutral tibial insert, size 4.5, 15mm; Truliant CR Neutral tibial insert, size 4.5, 17mm; Truliant CR Neutral tibial insert, size 4.5, 9mm; Truliant CR Neutral tibial insert, size 5, 10mm; Truliant CR Neutral tibial insert, size 5, 12mm; Truliant CR Neutral tibial insert, size 5, 14mm; Truliant CR Neutral tibial insert, size 6, 10mm; Truliant CR Neutral tibial insert, size 6, 12mm; Truliant CR Neutral tibial insert, size 6, 14mm; Truliant CR Slope + tibial insert, size 0, 10mm; Truliant CR Slope + tibial insert, size 0, 12mm; Truliant CR Slope + tibial insert, size 1, 10mm; Truliant CR Slope + tibial insert, size 1, 12mm; Truliant CR Slope + tibial insert, size 1.5, 10mm; Truliant CR Slope + tibial insert, size 1.5, 12mm; Truliant CR Slope + tibial insert, size 2, 10mm; Truliant CR Slope + tibial insert, size 2, 12mm; Truliant CR Slope + tibial insert, size 2.5, 10mm; Truliant CR Slope + tibial insert, size 2.5, 12mm; Truliant CR Slope + tibial insert, size 3, 10mm; Truliant CR Slope + tibial insert, size 3, 12mm; Truliant CR Slope + tibial insert, size 3.5, 10mm; Truliant CR Slope + tibial insert, size 3.5, 12mm; Truliant CR Slope + tibial insert, size 4, 10mm; Truliant CR Slope + tibial insert, size 4, 12mm; Truliant CR Slope + tibial insert, size 4.5, 10mm; Truliant CR Slope + tibial insert, size 4.5, 11mm; Truliant CR Slope + tibial insert, size 4.5, 12mm; Truliant CR Slope + tibial insert, size 4.5, 13mm; Truliant CR Slope + tibial insert, size 4.5, 9mm; Truliant CR Slope + tibial insert, size 5, 10mm; Truliant CR Slope + tibial insert, size 5, 12mm; Truliant CR Slope + tibial insert, size 6, 12mm; Truliant CR Slope ++ tibial insert, size 0, 10mm; Truliant CR Slope ++ tibial insert, size 0, 12mm; Truliant CR Slope ++ tibial insert, size 1, 10mm; Truliant CR Slope ++ tibial insert, size 1, 12mm; Truliant CR Slope ++ tibial insert, size 1.5, 10mm; Truliant CR Slope ++ tibial insert, size 1.5, 12mm; Truliant CR Slope ++ tibial insert, size 2, 10mm; Truliant CR Slope ++ tibial insert, size 2, 12mm; Truliant CR Slope ++ tibial insert, size 2.5, 10mm; Truliant CR Slope ++ tibial insert, size 2.5, 12mm; Truliant CR Slope ++ tibial insert, size 3, 10mm; Truliant CR Slope ++ tibial insert, size 3, 12mm; Truliant CR Slope ++ tibial insert, size 3.5, 10mm; Truliant CR Slope ++ tibial insert, size 3.5, 12mm; Truliant CR Slope ++ tibial insert, size 4, 10mm; Truliant CR Slope ++ tibial insert, size 4, 12mm; Truliant CR Slope ++ tibial insert, size 4.5, 10mm; Truliant CR Slope ++ tibial insert, size 4.5, 11mm; Truliant CR Slope ++ tibial insert, size 4.5, 12mm; Truliant CR Slope ++ tibial insert, size 4.5, 13mm; Truliant CR Slope ++ tibial insert, size 4.5, 9mm; Truliant CR Slope ++ tibial insert, size 5, 10mm; Truliant CR Slope ++ tibial insert, size 5, 12mm; Truliant CR Slope ++ tibial insert, size 6, 12mm; Truliant CRC tibial insert, size 0, 10mm; Truliant CRC tibial insert, size 0, 12mm; Truliant CRC tibial insert, size 0, 14mm; Truliant CRC tibial insert, size 1, 10mm; Truliant CRC tibial insert, size 1, 12mm; Truliant CRC tibial insert, size 1, 14mm; Truliant CRC tibial insert, size 1.5, 10mm; Truliant CRC tibial insert, size 1.5, 12mm; Truliant CRC tibial insert, size 1.5, 14mm; Truliant CRC tibial insert, size 2, 10mm; Truliant CRC tibial insert, size 2, 12mm; Truliant CRC tibial insert, size 2, 14mm; Truliant CRC tibial insert, size 2.5, 10mm; Truliant CRC tibial insert, size 2.5, 12mm; Truliant CRC tibial insert, size 2.5, 14mm; Truliant CRC tibial insert, size 3, 10mm; Truliant CRC tibial insert, size 3, 12mm; Truliant CRC tibial insert, size 3, 14mm; Truliant CRC tibial insert, size 3.5, 10mm; Truliant CRC tibial insert, size 3.5, 12mm; Truliant CRC tibial insert, size 3.5, 14mm; Truliant CRC tibial insert, size 4, 10mm; Truliant CRC tibial insert, size 4, 12mm; Truliant CRC tibial insert, size 4, 14mm; Truliant CRC tibial insert, size 4.5, 10mm; Truliant CRC tibial insert, size 4.5, 11mm; Truliant CRC tibial insert, size 4.5, 12mm; Truliant CRC tibial insert, size 4.5, 13mm; Truliant CRC tibial insert, size 4.5, 14mm; Truliant CRC tibial insert, size 4.5, 15mm; Truliant CRC tibial insert, size 4.5, 17mm; Truliant CRC tibial insert, size 4.5, 19mm; Truliant CRC tibial insert, size 4.5, 9mm; Truliant CRC tibial insert, size 5, 10mm; Truliant CRC tibial insert, size 5, 12mm; Truliant CRC tibial insert, size 5, 14mm; Truliant CRC tibial insert, size 6, 10mm; Truliant CRC tibial insert, size 6, 12mm; Truliant CRC tibial insert, size 6, 14mm; Truliant Cemented Femoral Component; Truliant Fit tibial tray, cemented, size 4.5F/3.5T; Truliant Fit tibial tray, cemented, size 4.5F/4.5T; Truliant Fit tibial tray, cemented, size 4.5F/5.5T; Truliant PS Cemented Femoral, size 0 Left; Truliant PS Cemented Femoral, size 0 Right; Truliant PS Cemented Femoral, size 1 Left; Truliant PS Cemented Femoral, size 1 Right; Truliant PS Cemented Femoral, size 1.5 Left; Truliant PS Cemented Femoral, size 1.5 Right; Truliant PS Cemented Femoral, size 2 Left; Truliant PS Cemented Femoral, size 2 Right; Truliant PS Cemented Femoral, size 2.5 Left; Truliant PS Cemented Femoral, size 2.5 Right; Truliant PS Cemented Femoral, size 3 Left; Truliant PS Cemented Femoral, size 3 Right; Truliant PS Cemented Femoral, size 3.5 Left; Truliant PS Cemented Femoral, size 3.5 Right; Truliant PS Cemented Femoral, size 4 Left; Truliant PS Cemented Femoral, size 4 Right; Truliant PS Cemented Femoral, size 4.5 Left; Truliant PS Cemented Femoral, size 4.5 Right; Truliant PS Cemented Femoral, size 5 Left; Truliant PS Cemented Femoral, size 5 Right; Truliant PS Cemented Femoral, size 6 Left; Truliant PS Cemented Femoral, size 6 Right; Truliant PS tibial insert, size 0, 10mm; Truliant PS tibial insert, size 0, 12mm; Truliant PS tibial insert, size 0, 14mm; Truliant PS tibial insert, size 1, 10mm; Truliant PS tibial insert, size 1, 12mm; Truliant PS tibial insert, size 1, 14mm; Truliant PS tibial insert, size 1.5, 10mm; Truliant PS tibial insert, size 1.5, 12mm; Truliant PS tibial insert, size 1.5, 14mm; Truliant PS tibial insert, size 2, 10mm; Truliant PS tibial insert, size 2, 12mm; Truliant PS tibial insert, size 2, 14mm; Truliant PS tibial insert, size 2.5, 10mm; Truliant PS tibial insert, size 2.5, 12mm; Truliant PS tibial insert, size 2.5, 14mm; Truliant PS tibial insert, size 3, 10mm; Truliant PS tibial insert, size 3, 12mm; Truliant PS tibial insert, size 3, 14mm; Truliant PS tibial insert, size 3.5, 10mm; Truliant PS tibial insert, size 3.5, 12mm; Truliant PS tibial insert, size 3.5, 14mm; Truliant PS tibial insert, size 4, 10mm; Truliant PS tibial insert, size 4, 12mm; Truliant PS tibial insert, size 4, 14mm; Truliant PS tibial insert, size 4.5, 10mm; Truliant PS tibial insert, size 4.5, 11mm; Truliant PS tibial insert, size 4.5, 12mm; Truliant PS tibial insert, size 4.5, 13mm; Truliant PS tibial insert, size 4.5, 14mm; Truliant PS tibial insert, size 4.5, 15mm; Truliant PS tibial insert, size 4.5, 17mm; Truliant PS tibial insert, size 4.5, 19mm; Truliant PS tibial insert, size 4.5, 9mm; Truliant PS tibial insert, size 5, 10mm; Truliant PS tibial insert, size 5, 12mm; Truliant PS tibial insert, size 5, 14mm; Truliant PS tibial insert, size 6, 10mm; Truliant PS tibial insert, size 6, 12mm; Truliant PS tibial insert, size 6, 14mm; Truliant PSC tibial insert, size 0, 10mm; Truliant PSC tibial insert, size 0, 12mm; Truliant PSC tibial insert, size 0, 14mm; Truliant PSC tibial insert, size 1, 10mm; Truliant PSC tibial insert, size 1, 12mm; Truliant PSC tibial insert, size 1, 14mm; Truliant PSC tibial insert, size 1.5, 10mm; Truliant PSC tibial insert, size 1.5, 12mm; Truliant PSC tibial insert, size 1.5, 14mm; Truliant PSC tibial insert, size 2, 10mm; Truliant PSC tibial insert, size 2, 12mm; Truliant PSC tibial insert, size 2, 14mm; Truliant PSC tibial insert, size 2.5, 10mm; Truliant PSC tibial insert, size 2.5, 12mm; Truliant PSC tibial insert, size 2.5, 14mm; Truliant PSC tibial insert, size 3, 10mm; Truliant PSC tibial insert, size 3, 12mm; Truliant PSC tibial insert, size 3, 14mm; Truliant PSC tibial insert, size 3.5, 10mm; Truliant PSC tibial insert, size 3.5, 12mm; Truliant PSC tibial insert, size 3.5, 14mm; Truliant PSC tibial insert, size 4, 10mm; Truliant PSC tibial insert, size 4, 12mm; Truliant PSC tibial insert, size 4, 14mm; Truliant PSC tibial insert, size 4.5, 10mm; Truliant PSC tibial insert, size 4.5, 11mm; Truliant PSC tibial insert, size 4.5, 12mm; Truliant PSC tibial insert, size 4.5, 13mm; Truliant PSC tibial insert, size 4.5, 14mm; Truliant PSC tibial insert, size 4.5, 15mm; Truliant PSC tibial insert, size 4.5, 17mm; Truliant PSC tibial insert, size 4.5, 19mm; Truliant PSC tibial insert, size 4.5, 9mm; Truliant PSC tibial insert, size 5, 10mm; Truliant PSC tibial insert, size 5, 12mm; Truliant PSC tibial insert, size 5, 14mm; Truliant PSC tibial insert, size 6, 10mm; Truliant PSC tibial insert, size 6, 12mm; Truliant PSC tibial insert, size 6, 14mm; Vantage; Vantage Mobile Bearing Ankle; Vantage Total Ankle System; Ziramic Zirconia 12/14 Femoral Head; Ziramic Zirconia 12/14 femoral Head",1992-07-15,137,2026-04-14,0,71,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221038671%22&limit=1
"St. Jude Medical, Cardiology Division, Inc.",3005334138,3005334138,5050 Nathan Lane North,Plymouth,MN,55442,United States,ABBOTT LABORATORIES,1415939,Complaint file establishment; Manufacturer; Manufacturer for export; Specification developer,43,DQK; DQR; DQX; DQY; DRA; DRC; DRE; DRF; DRG; DRJ; DSK; DWZ; DXC; DXJ; DXO; DXY; DYB; GAX; GEI; GXD; GXI; IKD; ITX; IYN; IYO; JOQ; KGZ; KRG; LPB; LWP; LWS; MGB; MOM; MTD; NGV; NIK; NKE; NVZ; OAD; OAE; OBJ; OWQ; QZI,"Computer, Diagnostic, Programmable; Cannula, Catheter; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Catheter, Electrode Recording, Or Probe, Electrode Recording; Transmitters And Receivers, Physiological Signal, Radiofrequency; System, Signal Isolation; Computer, Blood-Pressure; Device, Biopsy, Endomyocardial; Clamp, Vascular; Display, Cathode-Ray Tube, Medical; Transducer, Pressure, Catheter Tip; Implantable Pacemaker Pulse-Generator; Introducer, Catheter; Tourniquet, Nonpneumatic; Electrosurgical, Cutting & Coagulation & Accessories; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Cable, Electrode; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only); Accessories, Catheter; Programmer, Pacemaker; Cardiac Ablation Percutaneous Catheter; Implantable Pulse Generator, Pacemaker (Non-Crt); Implantable Cardioverter Defibrillator (Non-Crt); Device, Hemostasis, Vascular; System, Hemodynamic, Implantable; Catheter, Intracardiac Mapping, High-Density Array; System, Appendage Closure, Left Atrial; Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D); Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P); Pulse Generator, Permanent, Implantable; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation; Catheter, Ultrasound, Intravascular; Reprocessed Intravascular Ultrasound Catheter; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",1; 2; 3,"'PEEL-AWY INTRO KIT; 2-port DVI splitter; 4 Outlet Reverse IEC Accessory Power Str; AMPLATZER Guidewires; ANGIO-SEAL HEMOSTATIC; AO USB Receiver; Abbott Medical Grounding Pad; Additional Monitor Stand Kit; Advisor FL Mapping Catheter, Sensor Enabled Software Installation; Advisor FL Mapping Catheter, Sensor Enabled Software Installation, H702507; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation; Advisor HD Grid Mapping Catheter, Sensor Enbled Software Installation, H702519; Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled; Advisor HD/VL Mapping Catheter, Catheter Catalog Installation Sensor Enabled, H702532; Advisor HD™ Grid High Density Mapping Catheter, Sensor Enabled™, D-AVHD-DF16; Advisor VL Circular Mapping Catheter, Sensor Enabled; Advisor™ FL Circular Mapping Catheter, Sensor Enabled™; Advisor™ FL Circular Mapping Catheter, Sensor Enabled™, D-AVSE-D10-F15; Advisor™ FL Circular Mapping Catheter, Sensor Enabled™, D-AVSE-D10-F20; Advisor™ FL Circular Mapping Catheter, Sensor Enabled™, D-AVSE-DF10-F15; Advisor™ FL Circular Mapping Catheter, Sensor Enabled™, D-AVSE-DF10-F20; Advisor™ HD Grid Sensor Enabled™, High Density Mapping Catheter; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X, Sensor Enabled™ High Density Mapping Catheter; Advisor™ HD Grid X, Sensor Enabled™, High Density Mapping Catheter; Advisor™ VL Circular Mapping Catheter, Sensor Enabled™, D-AVSE-D10-V1525; Advisor™ VL Circular Mapping Catheter, Sensor Enabled™, D-AVSE-D20-V1525; Advisor™ VL Circular Mapping Catheter, Sensor Enabled™, D-AVSE-DF10-V1525; Advisor™ VL Circular Mapping Catheter, Sensor Enabled™, D-AVSE-DF20-V1525; Agilis NxT; Agilis NxT Introducer; Agilis NxT Steerable Introducer; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual Reach™, Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™, Steerable Introducer; Agilis™ NxT, Steerable Introducer; Ampere Generator; Ampere RF Ablation Generator; Ampere™ Footswitch; Ampere™ Generator; Ampere™ Generator Accessories; Ampere™ Generator Fiber Cord Assembly Remote; Ampere™ Generator Kit; Ampere™ Generator Software Upgrade; Ampere™ Remote Control; Amulet™ 360 Left Atrial Appendage Occluder; AutoMark Installation Kit; AutoMark Installation Kit, H702499-HW; AutoMark Software Installation v.1; AutoMark Software Installation v.1, H702499; BRK Transseptal Needle G407215; BRK-1™ Transseptal Needle 407201; BRK-1™ Transseptal Needle 407207; BRK-1™ XS Series Transseptal Needle G407209; BRK-1™ XS Series Transseptal Needle G407212; BRK-1™ XS Series Transseptal Needle G407216; BRK™ Transseptal Needle 407200; BRK™ Transseptal Needle 407205; BRK™ Transseptal Needle 407206; BRK™ XS Series Transseptal Needle G407208; BRK™ XS Series Transseptal Needle G407210; BRK™ XS Series Transseptal Needle G407211; CPS Direct SL Outer Catheter-410190; Cable Assy, IBP,  Abbott Transpac IV; Cable Assy, IBP, Baxter Truwave; Cable Assy, IBP, Maxxim Cobe; Cable Assy, IBP, Medex 860; Cable Assy, IBP, Medex 950; Cable Assy, IBP, Medex 960; Cable Assy, IBP, Merit Meritrans; Cable Assy, IBP, Namic Preceptors DT; Cable Assy, IBP, Omedha DTXX; Cable Assy, IBP, Utah Deltran; Cable Assy, Stim, EP4; Cable Equipotential; Cable, COAX; Cable, Serial, 3 ft DB9; Cables; CardioMEMS™ HERO Device; CardioMEMS™ HF System; CardioMEMS™ Hospital Electronics System; CardioMEMS™ Hospital System; CardioMEMS™ PA Sensor and Delivery System; CardioMEMS™ Patient Electronics System; Catheter Input Module 1-56; Catheter Input Module 57-120; Classic Radiofrequency Cannula; Contamination Cover/Protective Cap; Cool Point Irrigation Pump; Cool Point Tubing Set; Cool Point™ Irrigation Pump Pressure Alarm Adapter Cable; Current™ PFA Ampere™ Return Electrode Cable; Current™ PFA Catheter Input Module; Current™ PFA ECG Trunk Cable; Current™ PFA Generator; Current™ PFA Generator Cart; Current™ PFA Generator Software Upgrade; Current™ PFA Overlay; Current™ PFA Radiolucent ECG Lead Set; Current™ PFA Radiopaque ECG Lead Set; Current™ PFA Recording System Connect Cable; Current™ PFA TactiSys™ Connect Cable; Current™ PFA Unified Cable; DMS59 to Dual DVI SPlitter Video Cable; DVI to DisplayPort Adapter; DVI to HDMI Adapter; Disposable Electrodes; Disposable RF Electrode (RFDE-5, RFDE-10, RFDE-15, RFDE-20); EE3000; ENSITE-AAF-01 EnSite™ X Amplifier Air Filter; ENSITE-ACBL-160-01 EnSite™ X EP System Connect Cable; ENSITE-ACBL-60-01 EnSite™ X EP System Connect Cable; ENSITE-ADAS-01 ADAS 3D Base License Software License; ENSITE-ADASLA-01 ADAS 3D LA License Software License; ENSITE-ADASLV-01 ADAS 3D LV License Software License; ENSITE-AM-2 EnSite™ X EP System Advanced Mapping Software License; ENSITE-AMD-01 EnSite™ X EP System, AutoMark Distance, Software License; ENSITE-AMP-01 EnSite™ X EP System Amplifier; ENSITE-AMP-02 EnSite™ X EP System Amplifier; ENSITE-AMP-EPM-01 EnSite™ X EP System Amplifier Power Module; ENSITE-AMPCART1-01 EnSite™ X EP System Amplifier Cart; ENSITE-AMPCART3-01 EnSite™ X EP System Amplifier Cart; ENSITE-CECG-144-01 EnSite™ X EP System ECG Cable; ENSITE-CECG-60-01 EnSite™ X EP System ECG Cable; ENSITE-CF-01 EnSite™ X EP System Contact Force Software License; ENSITE-CIM-20-01 EnSite™ X EP System Catheter Input Module; ENSITE-CIM-80-01 EnSite™ X EP System Catheter Input Module; ENSITE-CL-01 EnSite™ X EP System EnSite Cloud Software License; ENSITE-CR-56-01 EnSite™ X EP System Recording System IC Output Cable; ENSITE-CR-64-01 EnSite™ X EP System Recording System IC Output Cable; ENSITE-D-ADASLA-01 ADAS 3D LA License Temporary Software License; ENSITE-D-ADASLV-01 ADAS 3D LV License Temporary Software License; ENSITE-D-AM-2 EnSite™ X EP System Advanced Mapping Demo Software License; ENSITE-D-AMD-01 EnSite™ X EP System, AutoMark Distance Demo, Software License; ENSITE-D-CF-01 EnSite™ X EP System Contact Force Software License; ENSITE-D-FLEX-01 EnSite™ X EP System, VoXel Flex Demo, Software License; ENSITE-D-FWV-01 EnSite™ X EP System, EnSite™ PFA Catheter Visualization Temporary, Software License; ENSITE-D-FWV-02 EnSite™ X EP System EnSite™ PFA Catheter Visualization Temporary Software License; ENSITE-D-FWV-03 EnSite™ X EP System EnSite™ PFA Catheter Visualization Temporary Software License; ENSITE-D-IMP-01 EnSite™ X EP System, Averaged Impedance Drop Demo, Software License; ENSITE-D-LS-01 EnSite™ X EP System, LiveSync Demo, Software License; ENSITE-D-LV-01 EnSite™ X EP System EnSite™ LiveView Dynamic Display Demo Software License; ENSITE-D-OT-01 EnSite™ X EP System EnSite™ Omnipolar Technology Demo Software License; ENSITE-D-WS-01 EnSite™ X EP System Wave Speed Map Demo Software License; ENSITE-DMMK-01 EnSite™ X EP System Dual Monitor Mount; ENSITE-DWS-01 EnSite™ X EP System Display Workstation; ENSITE-DWS-04 EnSite™ X EP System Display Workstation; ENSITE-DWS-1.1 EnSite™ X EP System Display Workstation; ENSITE-DWS-2.1 EnSite™ X EP System Display Workstation; ENSITE-DWS-3.1 EnSite™ X EP System, Display Workstation; ENSITE-DWSCART-01 EnSite™ X EP System Display Workstation Cart; ENSITE-ECGOUT-01 EnSite™ X EP System ECG Output Module; ENSITE-ECGRL-01 EnSite™ X EP System Radio-lucent ECG Lead set; ENSITE-ECGRL-01 EnSite™ X EP System, Radio-lucent ECG Lead Set; ENSITE-ECGRO-01 EnSite™ X EP System Radio-opaque ECG Lead set; ENSITE-FF-01 EnSite™ X EP System Field Frame; ENSITE-FF-3MC-01 EnSite™ X EP System Field Frame Cable; ENSITE-FF-4.5C-01 EnSite™ X EP System Field Frame Cable; ENSITE-FF-ABRKT-01 EnSite™ Adjustable Field Frame Bracket; ENSITE-FF-BRCKT-01 EnSite™ Fixed Field Frame Bracket; ENSITE-FLEX-01 EnSite™ X EP System, VoXel Flex, Software License; ENSITE-FWV-01 EnSite™ X EP System EnSite™ PFA Catheter Visualization, Software License; ENSITE-FWV-02 EnSite™ X EP System, EnSite™ PFA Catheter Visualization Software License; ENSITE-FWV-03 EnSite™ X EP System EnSite™ PFA Catheter Visualization Software License; ENSITE-GENECG-NAM EnSite™ X EP System PFA ECG Signal Splitter; ENSITE-HDGX-01 EnSite™ X EP System Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, Software License; ENSITE-IMP-01 EnSite™ X EP System, Averaged Impedance Drop, Software License; ENSITE-LE-01 EnSite™ X EP System Live Export Software License; ENSITE-LS-01 EnSite™ X EP System, LiveSync, Software License; ENSITE-LV-01 EnSite™ X Ep System EnSite™ LiveView Dynamic Display Software License; ENSITE-MONPOLE-01 EnSite™ X EP System Monitor Pole; ENSITE-OT-01 EnSite™ X EP System EnSite™ Omnipolar Technology Software License; ENSITE-OTAC-01 EnSite™ X EP System OTA Certificate Software License; ENSITE-OTAC-02 EnSite™ X EP System OTA Certificate Software License; ENSITE-OTAC-03 EnSite™ X EP System OTA Certificate Software License; ENSITE-OTEXPORT-01 EnSite™ X EP System EnSite™ Omnipolar Technology Data Export Software License; ENSITE-PFAGEN-01 EnSite™ X EP System PFA Generator Connect Cable; ENSITE-PRSBACK-01 EnSite™ X EP System Patient Reference Sensor; ENSITE-PRSFRNT-01 EnSite™ X EP System Patient Reference Sensor; ENSITE-R-AMP-01 EnSite™ X EP System Amplifier; ENSITE-R-AMP-02 EnSite™ X EP System Amplifier; ENSITE-R-DWS-01 EnSite™ X EP System Display Workstation; ENSITE-R-DWS-04 EnSite™ X EP System Display Workstation; ENSITE-R-DWS-1.1 EnSite™ X EP System Display WorkStation; ENSITE-R-DWS-2.1 EnSite™ X EP System Display Workstation; ENSITE-R-DWS-3.1 EnSite™ X EP System, Display Workstation; ENSITE-R-FF-01 EnSite™ X EP System Field Frame; ENSITE-R-SYS-04 EnSite™ X EP System; ENSITE-R-SYS-3.1 EnSite™ X EP System; ENSITE-RAILMNT-01 EnSite™ X EP System Bedrail Mount; ENSITE-RMS-01 EnSite™ X EP System Remote Monitor Stand; ENSITE-SEK-5-01 EnSite™ X EP System Surface Electrode Kit; ENSITE-SMMK-01 EnSite™ X EP System Single Monitor Mount; ENSITE-SRFLNK-01 EnSite™ X EP System SurfaceLink Module; ENSITE-SW-03 EnSite™ X EP System Software Upgrade; ENSITE-SW-1.1 EnSite™ X EP System Software Upgrade; ENSITE-SW-1.1.1 EnSite™ X EP System Software Upgrade; ENSITE-SW-1.1.2 EnSite™ X EP System, Software Upgrade; ENSITE-SW-1.2 EnSite™ X EP System Software Upgrade; ENSITE-SW-2 EnSite™ X EP System Software Upgrade; ENSITE-SW-2.1 EnSite™ X EP System Software Upgrade; ENSITE-SW-3.1 EnSite™ X EP System, Software Upgrade; ENSITE-SW-3.1.1 EnSite™ X EP System Software Upgrade; ENSITE-SW-3.2 EnSite™ X EP System Software Upgrade v3.2; ENSITE-SYSTEM-04 EnSite™ X EP System; ENSITE-SYSTEM-111 EnSite™ X EP System; ENSITE-SYSTEM-201 EnSite™ X EP System; ENSITE-SYSTEM-3.1 EnSite™ X EP System; ENSITE-TF-02 EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ Software License; ENSITE-TFM-02 EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™ Software Upgrade; ENSITE-TFM-03 EnSite™ X EP System, TactiFlex™ Ablation Catheter, Sensor Enabled™ Software Upgrade; ENSITE-TFM-3.1 EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; ENSITE-TFM-3.2 EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade; ENSITE-TMMK-01 EnSite™ X EP System Triple Monitor Mount Kit; ENSITE-WM56-144-01 EnSite™ X EP System IC Output Cable; ENSITE-WM56-60-01 EnSite™ X EP System IC Output Cable; ENSITE-WM64-144-01 EnSite™ X EP System IC Output Cable; ENSITE-WM64-60-01 EnSite™ X EP System IC Output Cable; ENSITE-WS-01 EnSite™ X EP System Wave Speed Map Software License; EP-4 Cardiac Stimulator; EP-4 Stimulator System 110V; EP-4 Touch Screen Computer; EP-4™ Cardiac Stimulator, Cardiac Stimulator; EP-4™ Cardiac Stimulator, Cardiac Stimulator Cable; EP-4™ Cardiac Stimulator, Keyboard; EP-4™ Cardiac Stimulator, Touch Screen Computer; EP-NurseMate; EP-NurseMate with Physio Module; EP-WorkMate System; EP-WorkMate/EP-4 USB Keyboard; Electrophysiology Cable; Electrophysiology Cable 1779; Electrophysiology Extension Cable; EnSite Array Catheter; EnSite Array Multi-electrode Diagnostic Catheter; EnSite Contact Force Module; EnSite NavX Surface Electrode Kit; EnSite Precision Mapping Module; EnSite Precision Mapping Module Upgrade Kit; EnSite Precision Surface Electrode Kit; EnSite Precision™ Adjustable Field Frame Bracket; EnSite Precision™ Cardiac Mapping System, v2.1; EnSite Precision™ Module, Sensor Enabled™ Module; EnSite Precision™ Patient Reference Sensor SURF-ELEC-2PRS; EnSite Precision™ Software Installation v.2.7 H702701; EnSite Precision™ Software Installation v2.6; EnSite Precision™ Software Upgrade v2.7.1; EnSite Precision™ Surface Electrode Kit, PRCN-SEK-A; EnSite Precision™ System Software Upgrade v.2.6.1, H702602; EnSite System Reference Electrode, SYS-REF-V1; EnSite Velocity Surface Electrode Kit Large, 5 Pack EN0010-10000331; EnSite Velocity System; EnSite Velocity System OneModel; EnSite Velocity System Version 4; EnSite Velocity System v.3; EnSite Velocity System v.4; EnSite Velocity System v.4.2; EnSite X EP System, Catheter Connector Cable, A-ENS-MAGEXT-CBL; EnSite™ Adjustable Field Frame Bracket, ENSITE-FF-ABRKT-01; EnSite™ ArrayLink™ Module, Catheter Input Module; EnSite™ CathLink™ Module, Catheter Input Module; EnSite™ Fixed Field Frame Bracket, ENSITE-FF-BRCKT-01; EnSite™ GenConnect Module, Generator Connector; EnSite™ LiveView Dynamic Display Software License; EnSite™ NavLink™ Module, Surface Electrode Connector; EnSite™ RecordConnect Module, Recording System Connector; EnSite™ X EP System; EnSite™ X EP System  Bedrail Mount, ENSITE-RAILMNT-01; EnSite™ X EP System  Monitor Pole, ENSITE-MONPOLE-01; EnSite™ X EP System  Surface Electrode Kit, ENSITE-SEK-5-01; EnSite™ X EP System Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™, Software License; EnSite™ X EP System Amplifier; EnSite™ X EP System Amplifier Cart, ENSITE-AMPCART1-01; EnSite™ X EP System Amplifier Cart, ENSITE-AMPCART3-01; EnSite™ X EP System Amplifier Power Module, ENSITE-AMP-EPM-01; EnSite™ X EP System Amplifier, ENSITE-AMP-01; EnSite™ X EP System Amplifier, ENSITE-AMP-02; EnSite™ X EP System Amplifier, ENSITE-R-AMP-01; EnSite™ X EP System Amplifier, ENSITE-R-AMP-02; EnSite™ X EP System Cable Kit; EnSite™ X EP System Catheter Connector Cable, D-ENS-AVHDX-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-AVSE-5-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-AVSE-6-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-INQ-DD-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-INQ-OD-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-INQ-Q-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-L/R-BQ-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-L/R-DDY-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-L/R-HOD-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-SUP-D-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-SUP-DDY-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-SUP-H-CBL; EnSite™ X EP System Catheter Connector Cable, D-ENS-SUP-Q-CBL; EnSite™ X EP System Catheter Connector Cable, ICE-VFSE-2D-CBL; EnSite™ X EP System Catheter Input Module, ENSITE-CIM-20-01; EnSite™ X EP System Catheter Input Module, ENSITE-CIM-80-01; EnSite™ X EP System Connect Cable, ENSITE-ACBL-160-01; EnSite™ X EP System Connect Cable, ENSITE-ACBL-60-01; EnSite™ X EP System Contact Force Software License, ENSITE-CF-01; EnSite™ X EP System Contact Force Software License, ENSITE-D-CF-01; EnSite™ X EP System Display Workstation; EnSite™ X EP System Display Workstation Cart, ENSITE-DWSCART-01; EnSite™ X EP System Display Workstation, ENSITE-DWS-01; EnSite™ X EP System Display Workstation, ENSITE-DWS-1.1; EnSite™ X EP System Display Workstation, ENSITE-R-DWS-01; EnSite™ X EP System Display Workstation, ENSITE-R-DWS-1.1; EnSite™ X EP System Dual Monitor Mount, ENSITE-DMMK-01; EnSite™ X EP System ECG Cable, ENSITE-CECG-144-01; EnSite™ X EP System ECG Cable, ENSITE-CECG-60-01; EnSite™ X EP System ECG Output Module, ENSITE-ECGOUT-01; EnSite™ X EP System EnSite X Dual Monitor Software License; EnSite™ X EP System EnSite™ AI Geo Software License; EnSite™ X EP System EnSite™ AI Geo Temporary Software License; EnSite™ X EP System EnSite™ Echo Module Software License; EnSite™ X EP System EnSite™ Echo Module Temporary Software License; EnSite™ X EP System EnSite™ LiveView Dynamic Display Demo, ENSITE-D-LV-01; EnSite™ X EP System EnSite™ LiveView Dynamic Display, ENSITE-LV-01; EnSite™ X EP System EnSite™ Omnipolar Technology Data Export, ENSITE-OTEXPORT-01; EnSite™ X EP System EnSite™ Omnipolar Technology Demo, ENSITE-D-OT-01; EnSite™ X EP System EnSite™ Omnipolar Technology, ENSITE-OT-01; EnSite™ X EP System Field Frame Cable, ENSITE-FF-3MC-01; EnSite™ X EP System Field Frame Cable, ENSITE-FF-4.5C-01; EnSite™ X EP System Field Frame, ENSITE-FF-01; EnSite™ X EP System Field Frame, ENSITE-R-FF-01; EnSite™ X EP System IC Output Cable, ENSITE-WM56-144-01; EnSite™ X EP System IC Output Cable, ENSITE-WM56-60-01; EnSite™ X EP System IC Output Cable, ENSITE-WM64-144-01; EnSite™ X EP System IC Output Cable, ENSITE-WM64-60-01; EnSite™ X EP System Level Order Number ENSITE-SYSTEM-111; EnSite™ X EP System Level Order Number ENSITE-SYSTEM-201; EnSite™ X EP System Live Export Software License, ENSITE-LE-01; EnSite™ X EP System Patient Reference Sensor, ENSITE-PRSBACK-01; EnSite™ X EP System Patient Reference Sensor, ENSITE-PRSFRNT-01; EnSite™ X EP System RL ECG Electrode; EnSite™ X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-01; EnSite™ X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-01; EnSite™ X EP System Recording System IC Output Cable, ENSITE-CR-56-01; EnSite™ X EP System Recording System IC Output Cable, ENSITE-CR-64-01; EnSite™ X EP System Remote Monitor Stand, ENSITE-RMS-01; EnSite™ X EP System Single Monitor Mount, ENSITE-SMMK-01; EnSite™ X EP System Software Upgrade; EnSite™ X EP System Software Upgrade, ENSITE-SW-1.1; EnSite™ X EP System Software Upgrade, ENSITE-SW-1.1.1; EnSite™ X EP System Software Upgrade, ENSITE-SW-1.1.2; EnSite™ X EP System Surface Electrode Kit; EnSite™ X EP System SurfaceLink Module, ENSITE-SRFLNK-01; EnSite™ X EP System Triple Monitor Mount, ENSITE-TMMK-01; EnSite™ X EP System Upgrade Kit; EnSite™ X EP System Wave Speed Map Demo, ENSITE-D-WS-01; EnSite™ X EP System Wave Speed Map, ENSITE-WS-01; EnSite™ X EP System, AutoMark Index Temporary, Software License, ENSITE-D-AMI-01; EnSite™ X EP System, AutoMark Index, Software License, ENSITE-AMI-01; EnSite™ X EP System, PFA Index Temporary, Software License; EnSite™ X EP System, PFA Index, Software License; EnSite™ X EP System, Software Upgrade; EnSite™ X EP System, TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ Temporary, Software License; EnSite™ X EP System, TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, Software License; Engage Introducer; Engage TR Introducer; Engage/Engage TR Introducer; Ensite Velocity Cardiac Mapping System V.2, Ensite Precision Cardiac Mapping System V2.2; Ensite™ Amplifier and Display Workstation; Ensite™ Amplifier and Display Workstation, EE3000; Ensite™ AutoMap Module v.1; Ensite™ AutoMap Module v.1 30 Day Trial; Ensite™ AutoMap Module v.1 30 Day Trial, H702498-T; Ensite™ AutoMap Module v.1, H702498; Ensite™ Contact  Force Module Software Installation v.2 30 Day License; Ensite™ Contact  Force Module Software Installation v.2 30 Day License, H702500-T; Ensite™ Contact Force Module Installation Kit; Ensite™ Contact Force Module Installation Kit, H702500-HW; Ensite™ Contact Force Module Software Installation; Ensite™ Contact Force Module Software Installation, H702500; Ensite™ Contact Force Module Software Installation, v.2; Ensite™ Contact Force Module Software Installation, v.2, H702500; Ensite™ Courier Software Installation v.3; Ensite™ Courier Software Installation v.3 30 Day Trial; Ensite™ Courier Software Installation v.3 30 Day Trial, H702501-T; Ensite™ Courier Software Installation v.3, H702501; Ensite™ Derexi Module v.1.3.1; Ensite™ Derexi Module v.1.3.1, H702502; Ensite™ Display Workstation; Ensite™ Display Workstation, EE3000; Ensite™ Fusion Software Upgrade Kit v.7.1; Ensite™ Fusion Software Upgrade Kit v.7.1, H702506; Ensite™ MediGuide Interface Module Software Installation v.1.1; Ensite™ MediGuide Interface Module Software Installation v.1.1, H702503; Ensite™ Precision Bedrail Mount Kit; Ensite™ Precision Bedrail Mount Kit, H702474; Ensite™ Precision Field Fram Bracket; Ensite™ Precision Field Frame; Ensite™ Precision Field Frame Bracket; Ensite™ Precision Field Frame Bracket, H702472; Ensite™ Precision Field Frame Bracket, H702472-E; Ensite™ Precision Field Frame Cable; Ensite™ Precision Field Frame Cable,; Ensite™ Precision Field Frame Storage Bracket; Ensite™ Precision Field Frame, H702469; Ensite™ Precision Link, Sensor Enabled Link; Ensite™ Precision Module, Sensor Enabled Module; Ensite™ Precision Patient Reference Sensor; Ensite™ Precision Power Supply Kit; Ensite™ Precision Software Installation; Ensite™ Precision Software Installation v.2 30 Day Trial; Ensite™ Precision Software Installation v.2.1; Ensite™ Precision Software Installation v.2.1 30 Day Trial; Ensite™ Precision Software Installation v.2.2; Ensite™ Precision Software Installation v.2.2 30 Day Trial; Ensite™ System GenConnect (GenConnect Interface to EPT generator.); Ensite™ System GenConnect (GenConnect Interface to EPT generator.) RFB; Ensite™ System GenConnect (GenConnect interface to Atakr generator.); Ensite™ System GenConnect (GenConnect interface to Atakr generator.) RFB; Ensite™ System RecordConnect; Ensite™ System RecordConnect (RecordConnect interface to Bard Stamp recording system.); Ensite™ System RecordConnect (RecordConnect interface to Bard Stamp recording system.) RFB; Ensite™ System RecordConnect RFB; Ensite™ Velcity System Display Workstation Kit; Ensite™ Velcity System GenConnect (GenConnect interface to Stockert generator.); Ensite™ Velocity Amplifier; Ensite™ Velocity Amplifier Cart; Ensite™ Velocity Amplifier and DWS; Ensite™ Velocity Amplifier and Display Workstation; Ensite™ Velocity ArrayLink Module; Ensite™ Velocity Bard Clearsign RecordConnect; Ensite™ Velocity Cable Assembly Kit, T Series; Ensite™ Velocity CathLink Module; Ensite™ Velocity DWS HDD; Ensite™ Velocity Display Workstation; Ensite™ Velocity Display Workstation (DWS); Ensite™ Velocity Display Workstation DWS Kit; Ensite™ Velocity EP-WorkMate Record Connect; Ensite™ Velocity Kit, GenConnect, Stockert, NST; Ensite™ Velocity NavLink Module; Ensite™ Velocity RecordConnect; Ensite™ Velocity RecordConnect For Use With WorkMate Claris System; Ensite™ Velocity Remote Monitor Stand; Ensite™ Velocity Software Upgrade Kit, v5.1; Ensite™ Velocity Software Upgrade Kit, v5.2; Ensite™ Velocity Software Upgrade Kit, v5.2.1; Ensite™ Velocity System  EP-WorkMate RecordConnect; Ensite™ Velocity System Amplifier Cart; Ensite™ Velocity System Amplifier Kit; Ensite™ Velocity System Cable Accessory Kit; Ensite™ Velocity System CathLink Module; Ensite™ Velocity System DWS Kit; Ensite™ Velocity System Equipotential Cable; Ensite™ Velocity System GE CardioLab RecordConnect; Ensite™ Velocity System GenConnect; Ensite™ Velocity System GenConnect (GenConnect interface to Stockert SmartAblate generator.); Ensite™ Velocity System GenConnect (GenConnect interface to Stockert generator.); Ensite™ Velocity System GenConnect (GenConnect interface to T-series generator.); Ensite™ Velocity System GenConnect Kit IBI; Ensite™ Velocity System Monitor 24""; Ensite™ Velocity System RecordConnect; Ensite™ Velocity System RecordConnect (RecordConnect interface to Bard Clearsign recording system.); Ensite™ Velocity System RecordConnect Kit Universal; Ensite™ Velocity System Remote Monitor Stand; Ensite™ Velocity System Siemens RecordConnect; Ensite™ Velocity System Workstation; Ensite™ Velocity System Workstation Accessory Kit; Ensite™ Velocity System Workstation Cart; Ensite™ Velocity Sytstem Workstation; Ensite™ Velocity Workstation Cart; Ensite™ Verismo Software Upgrade Kit v.2.1; Epicardial Catheter System; Fast-Cath Guiding Introducer; Fast-Cath Hemostasis Introducer; Fast-Cath Transseptal Guiding Introducer; Fast-Cath Trio Hemostasis Introducer; Fast-Cath™ Duo Hemostasis Introducer; Fast-Cath™ Guiding Introducer; Fast-Cath™ Hemostasis Introducer; Fast-Cath™ Transseptal Guiding Introducer; Fast-Cath™ Trio Hemostasis Introducer; FastCath Hemostasis Introducer; FemoStop Gold; Ferrite round cable snap its 1 to 300MHz; Ferrite, Round Cable Snap-its, 200MHz-10; Fiber Optic Cable - Duplex LC/LC; Fiber Optic Cable - Duplex LC/LC 30m; FlexAbility Ablation Catheter; FlexAbility Ablation Catheter, Sensor Enabled; FlexAbility Ablation Catheter, Sensor Enabled Software Installation; GenConnect; Grounding Cable 1710; GuideRight GuideWires; GuiderRight Guidewires; Hemostasis Valve Adapter; HydroSteer; IBI 1500T9-CP V1.6 Cardiac Ablation Generator; IBI-1100 Bi-Directional Steerable Electrophysiology Catheter System; Inquiry; Inquiry AFocus; Inquiry AFocus II; Inquiry Afocus; Inquiry Luma-Cath; Inquiry Optima; Inquiry Optima PLUS; Inquiry™ AFocus II™ Diagnostic Catheter; Inquiry™ Steerable Diagnostic Catheter; IonicRF Generator; Keyboard, PS2, Wired; Kit ECG Cable Radio-Translucent 36in Brn; Kit WM Claris V1.1 Upgrade; LCD Dual Monitor Mount Kit; Livewire Steerable Electrophysiology Catheter; Livewire TC Ablation Catheter; Livewire™ Steerable Electrophysiology Catheter; MG1000; Maximum; Maximum Hemostasis Introducer; MediGuide Enabled Livewire Steerable EP Catheter; MediGuide Enabled Livewire Steerable Electrophysiology Catheter; MediGuide Technology; Media Conv, DB9 to Fiber SC; Media Conv, SC Fiber to DB9; Merlin Patient Care System Software Model 3330 Version 18.1.1; Merlin.net™ Patient Care Network Heart Failure Portal; Monitor, LCD, 16:9 1920x1080 Resolution; Monitor, Touch Screen LCD, 19 Inch; Mouse, PS2, Wired; PFA-GEN-OVERLAY Current™ PFA Overlay; PW USB Receiver; Peel Away Introducer kit replacement syringe accessory Models 405104, 405108, 405112, 405116, 405118, 405119, 405120, 40; Peel-Away Introducer; Peel-Awy; Percutaneous Catheter Introducer & Removable Hemo; Power Conditioner, 120 VAC, 1440 VA Medi; Power Conditioner, 120 VAC, 600 VA,; Power Cord, Compatible with St. Jude Medical Electrophysiology Products; Power Supply Connector Adapter; Power Supply, 5V MG with 2.5MM I.D.; PressureWire Aeris / Certus (Gen 8); PressureWire Aeris Agile Tip; PressureWire Certus Agile Tip; PressureWire Net; PressureWire X; PressureWire™ Receiver; Printer; Procure Endomyocardial Biopsy Forceps; QUANTIEN™ Measurement System with Software Version 1.12.1; Quantien Measurement System; Quantien Measurement System AUX IN Cable C12500-C12510; Quantien Measurement System AUX OUT Cable C12796; Quantien Measurement System Adapter C12600 series; Quantien Measurement System C12787; Quantien Measurement System Monitor Cables C12900 Series; Quantien Mounting Stands and Brackets; REPOSITIONING SLEEVE; RF Grounding Pad (model RF-DGP-IZ); Radi Analyzer Xpress Adapter 12748; RadiAnalyzer Adapter Cables 12600 series; RadiAnalyzer Xpress Cable Converter C12784; RadiAnalyzer Xpress Monitor Cable 12900 Series; RadiStop; Radiotranslucent Leadwire; Record Connect; Reflexion HD Mapping Catheter; Reflexion Spiral; Reflexion Spiral EP Extension Adaptor; Reflexion Spiral Variable Radius Ca; Regency family of pacemakers; Remote Monitor Stand; Repositioning Sleeve; Response Electrophysiology Extension Cable; Response with Lumen; Response ™ Electrophysiology Catheter; Response ™ Electrophysiology Catheter with Lumen; Response™ Electrophysiology Catheter; Reverse IEC Accessory Power Strip; S-Video to VGA Signal Converter; SCU II Assembly 448 Channel; SCU II Assembly 96 Channel; SJM Vessel Dilator; SMK Radiofrequency Needle; Safire BLU Duo Ablation Catheter; Safire Bi-Directional Catheter; Safire Catheter Extension Cable; Safire™ TX Ablation Catheter; Seal-Away Introducer; Sensor Enabled Cable, Diagnostic Catheter Cable; Sensor Enabled™ Ablation Connection Cable; Sensor Enabled™ Diagnostic Connection Cable; Sheath Obturator; Stim Cable, WorkMate Claris Generic; Supreme Electrophysiology Cable; Supreme™ Electrophysiology Catheter; Swartz™ Braided Transseptal Guiding Introducer; TactiCath™ Ablation Catheter, Sensor Enabled Catheter Catalog Installation, v.1; TactiCath™ Ablation Catheter, Sensor Enabled Software Installation; TactiCath™ Ablation Catheter, Sensor Enabled Software Installation 30 Day Trial; TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™; TactiFlex™ Duo Sensor Enabled™ Ablation Catheter; TactiFlex™ Sensor Enabled™ Ablation Catheter; TactiSys Quartz Equipment; TactiSys™ Quartz Equipment; TactiSys™ Quartz Equipment Software Upgrade; TactiSys™ Quartz TactiFlex™ Radiofrequency Cable; Telesheath Guiding Introducer; Therapy Ablation Catheter; Therapy Cool Flex Ablation Catheter; Therapy Cool Path Duo Ablation Catheter; Therapy Dual-8 Ablation Catheter; Therapy™ Ablation Catheter; TigerWire GuideWires; USB Keyboard, Wired, English; USB Optical Scroll Mouse, Wired; Ultimum; Ultimum EV Hemostasis Introducer; Ultimum Hemostasis Introducer; Ultimum Introducer; Unified Connector RF SE Cable, Radiofrequency Cable; VantageView; ViewFlex Eco Reprocessed ICE catheter; ViewFlex™ Catheter Interface Module; ViewFlex™ Eco Reprocessed ICE Catheter D087031-R; ViewFlex™ Eco, Reprocessed ICE Catheter; ViewFlex™ X ICE Catheter, Sensor Enabled™; ViewFlex™ Xtra ICE Catheter; ViewFlex™ Xtra ICE Catheter D087031; ViewFlex™ Xtra, ICE Catheter; ViewMate Ultrasound Console; Volt™ PFA Catheter, Sensor Enabled™; Volt™ PFA Kit; WM Claris Additional Monitor Cable Kit; WM Claris CPU; WM Claris Power Kit, 110; WM Claris Z440 v.1.2 Upgrade Kit; WM Claris Z620 v.1.2 Upgrade Kit; WM Scribe Onyx v.1.2 Upgrade Kit; WM Unity Review Mod - Sgl User License; WM Unity Review Module - 10 User License; WM Unity Review Module - Site License; Wi-Box AO Transmitter, Signal Transmitter; Wi-box; WorkMate Claris Bed Rail Kit; WorkMate Claris OS Patch SW Kit; WorkMate Claris PM Kit DWG 90169898; WorkMate Claris System; WorkMate Claris™ System",1992-08-17,126,2026-09-17,11,25,2,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223005334138%22&limit=1
Arthrex GmbH,3002579136,3002579136,Erwin-Hielscher-Strasse 9,Munich Bavaria,,81249,Germany,"ARTHREX, INC.",1220287,Exporter to the US; Specification developer,65,BWN; BZN; DXJ; FEI; FLE; FMF; FRG; FSM; FWB; FWL; FWZ; FZW; GAP; GAT; GAZ; GCJ; GEI; GFA; GFF; HAB; HRS; HRX; HSD; HST; HSX; HTD; HTJ; HTN; HTO; HTW; HTY; HTZ; HWC; HWE; HWQ; HWT; HXB; HXD; HXJ; IZI; JDQ; JDR; JQC; JQO; KQM; KQZ; KRR; KWD; KWS; KYZ; LLZ; LXH; LXI; MAI; MBF; MBH; MBI; MDM; NBH; ORG; OUG; PHX; PKC; QHE; QHQ,"Table And Attachments, Operating-Room; Cart, Emergency, Cardiopulmonary (Excluding Equipment); Display, Cathode-Ray Tube, Medical; Instrument, Special Lens, For Endoscope; Sterilizer, Steam; Syringe, Piston; Wrap, Sterilization; Tray, Surgical, Instrument; Camera, Television, Surgical, Without Audio; Camera, Cine, Endoscopic, Without Audio; Operating Room Accessories Table Tray; Expander, Surgical, Skin Graft; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Synthetic, Polyethylene; Tubing, Noninvasive; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Saw, Powered, And Accessories; Plate, Fixation, Bone; Arthroscope; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Apparatus, Traction, Non-Powered; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Forceps; Gauge, Depth; Washer, Bolt Nut; Reamer; Bit, Drill; Pin, Fixation, Smooth; Instrument, Cutting, Orthopedic; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Passer; Template; Probe; Clamp; Staple Driver; System, X-Ray, Angiographic; Cerclage, Fixation; Staple, Fixation, Bone; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Balance, Analytical; Camera, Surgical And Accessories; Component, Traction, Non-Invasive; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Toe, Hemi-, Phalangeal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Syringe, Irrigating (Non Dental); System, Image Processing, Radiological; Orthopedic Manual Surgical Instrument; Guide, Drill, Ligament; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Accessories, Arthroscopic; Platelet And Plasma Separator For Bone Graft Handling; Medical Device Data System; Shoulder Prosthesis, Reverse Configuration; Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained; Shoulder Arthroplasty Implantation System; Total Shoulder Arthroplasty System",1; 2,"AESCULAP STERILCONTAINER SYSTEM; ANATOEMIC PROSTHESIS; ARTHREX ANATOEMIC P; ARTHROSCOPY LEG HOLDER; ARTHROSCOPY PUMP; Apparatus, Traction, Non-Powered; Arthrex Ankle Fusion Plating System; Arthrex BioComposite SutureTak; Arthrex Biocomposite Transfix; Arthrex Fracture Plates; Arthrex Fracture Plates and Screws; Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi; Arthrex Low Profile Screws; Arthrex MicroSuture Anchors; Arthrex Mini TightRopes; Arthrex Plates, Screws, and Staples; Arthrex PushLock; Arthrex Pushlock; Arthrex Suture; Arthrex SwiveLock Anchors; Arthrex Univers Apex; Arthrex Univers II Glenoid Components; Arthrex iBalance BiCompartmental Arthroplasty System; Arthroscope; Arthroscope  Sheath; Arthroscopes; BI-CORTICAL BIO-POST AND WASHER; BIO-ABSORBABLE CORKSCREW; BIO-COMPRESSION SCREW; BIO-CORKSCREW FT; BIO-PIN; BIOCOMPOSITE INTERFERENCE SCREW; BIOCOMPOSITE SUTURE ANCHORS; Balance, Analytical; Bio-Composite SutureTak; CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO; CHONDRAL DART; CONTAINER SYSTEM; CONTINUOUS WAVE III; CORKSCREW ANCHORS; Camera Heads; Camera, Television, Surgical, Without Audio; Clamp; Component, Traction, Non-Invasive; DOUBLE SYRINGE (ACP) SYSTEM; Dual Wave Pump; Fastener, Fixation, nondegradable, soft tissue; FiberStitch Implant; FiberTape; FiberWire; Fiberstick; Fracture Plates & Screws; HUMERAL FRACTURE PLATE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT; INTERFERENCE SCREWS; Instrument, Special Lens, For Endoscope; Instrument, manual, surgical, general use; LOW PROFILE PLATE AND SCREW SYSTEM; Laproscopes; MENISCAL CINCH; MENISCAL DART, DARTSTICK,; MINI BIO-ANCHOR; Mini TightRope CMC; ORTHOPEDIC MANUAL INSTRUMENTS; Orthopedic Template; Orthopedic manual surgical instrument, Passer; PUSHLOCK; RETROBUTTON; SHAVER BLADES; SHAVER SYSTEM; SHOULDER HOLDER; Shoulder joint metal/ polymer semi-constrained cemented prosthesis; Single/multiple component metallic bone fixation appliances and accessories; Sutter CURIS RF Generator; Syringe, Irrigating (Non Dental); Syringe, piston; TAK FAMILY; TENODESIS FAMILY; Table Attachments, Operating-Room; UNIVERS FRACTURE; UNIVERS II; UNIVERS SHOULDER; Univers II; Univers Revers Shoulder Prosthesis System; VARIOUS BURS; VARIOUS INSTRUMENTS; Viscogel/Viscospray; WASHER; cart, emergency, cardiopulmonary; display, cathode-ray tube, medical; drill bit; fixation pin; fixation plate; orthopedic manual instrument; saw blade; single/ multiple component metallic bone fixation appliances and accessories",1994-01-27,136,2024-07-25,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223002579136%22&limit=1
Stryker Ireland Osteonics,9616680,3002459190,"Tullagreen Building, IDA Business & Technology Park Carrigtwohill",County Cork,,T45 HE42,Ireland,STRYKER CORP.,1811755,Contract manufacturer; Manufacturer; Specification developer,43,FSM; FTY; FZX; GAD; GFA; HRS; HRY; HSD; HSX; HTW; HWC; HWT; HXC; JDG; JDI; JDJ; JDL; JDQ; JWH; KRO; KRR; KTT; KWL; KWS; KWY; KWZ; LPH; LRN; LWJ; LXH; LYT; LZN; LZO; MAX; MAY; MBH; MBL; MEH; MRA; NPJ; ODP; OVD; PHX,"Tray, Surgical, Instrument; Tape, Measuring, Rulers And Calipers; Guide, Surgical, Instrument; Retractor; Blade, Saw, General & Plastic Surgery, Surgical; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Bit, Drill; Screw, Fixation, Bone; Template; Wrench; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Mesh, Surgical, Acetabular, Hip, Prosthesis; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Cerclage, Fixation; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Wire, Surgical; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Orthopedic Manual Surgical Instrument; Fixation Accessory; Cement Obturator; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented; Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Intervertebral Fusion Device With Bone Graft, Cervical; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Shoulder Prosthesis, Reverse Configuration",1; 2; 3,".; 10mm SUBFIX TRIAL; 11.5mm SUBFIX TRIAL; 135 mm Reusable Slat, SE Retr, 10 Pack; 155 mm Reusable Slat, SE Retr, 10 Pack; 175mm Reusable Slat, SE Retr, 10 Pack; 206-716 w/2 small sculps/pkg; 234-112-100 VersiQuad Halo Retractor; 3.9mm Omega Drill; 3MM DBL SLEEVE 80MM TROC/ASSY; 3mm PREDRILL ASSEMBLY LONG; 3mm PREDRILL ASSEMBLY SHORT; 4.75mm AlphaVent and Omega Drill; 4MM DBL SLVE 180MM TROC/ASSY; 4mm DBL SLEEVE 150mm TROC/ASSY; 4mm PREDRILL ASSEMBLY EXTRA SHORT; 4mm PREDRILL ASSEMBLY LONG; 4mm PREDRILL ASSEMBLY SHORT; 4mm TomCat Shaver Blades; 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill; 5mm HellCat Shaver Blades; 5mm PREDRILL ASSEMBLY EXTRA SHORT; 5mm PREDRILL ASSEMBLY LONG; 5mm PREDRILL ASSEMBLY SHORT; 5mm SPANNER WRENCH; 6.5mm SUBFIX TRIAL; 6mm PREDRILL ASSEMBLY EXTRA SHORT; 6mm PREDRILL ASSEMBLY LONG; 6mm PREDRILL ASSEMBLY SHORT; 7MM SPANNER WRENCH; 7mm SPANNER WRENCH; 8mm SUBFIX TRIAL; 90 mm Reusable Slat, SE Retr, 10 Pack; 9mm SUBFIX TRIAL; A 2 DRILL BRACE W/O CHUCK; A 4 4MM CHUCK; A 5 T-WRENCH; A 51 T WRENCH W/35 EXTENSION; ABGII Monolithic Hip Stems; ACCOLADE DISTAL SPACER; ACL Workstation; ADM MDM Acetabular Systems; ADM MDM Insert; AEQ FRAC LONG SUP IMP ENS; AEQ FRAC SUPPORT DE BRAS; AEQ FRACT GR AXE LIAISON; AEQ FRACT MESUREUR AMOVIB; AEQ FRACT NM FANT TIG; AEQ IMPACTEUR DE PROTHESE; AEQ TIGE FRA LG FANT; AEQ USA FANT CALO; AEQUALIS RESURFACING HEAD; AEQUALIS REVERSED; AGM 6 6MM CHUCK; ALEUTIAN Interbody Systems Trays; ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS); ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE; ANCHORAGE CP LAPIDUS TEMPLATE; ANCHORAGE CP MTP PIVOTING DRILL GUIDE; ANCHORAGE CP MTP TEMPLATE; ANCHORAGE CP POLYAXIAL DRILL GUIDE; ANCHORAGE CP UTILITY TEMPLATE; ANCHORAGE FIXATION PIN; ANCHORAGE FIXED DRILL GUIDE 2.5MM; ANCHORAGE FIXED DRILL GUIDE 2MM; ANCHORAGE INSTRUMENTS RACK (LEVEL 1); ANCHORAGE INSTRUMENTS RACK (LEVEL 2); ANCHORAGE INSTRUMENTS RACK COVER; ANCHORAGE PLATE BENDER; ANCHORAGE PLATE GRIPPER; ANTEVERSION GUIDE; AO HANDLE - LENGTH 135MM; AO Quick Coupling with Elastosil Handle; AO/JACOBS QUICK RELEASE APEX CHUCK 3mm; AO/JACOBS QUICK RELEASE APEX CHUCK 4mm; AO/JACOBS QUICK RELEASE APEX CHUCK 5mm; AO/JACOBS QUICK RELEASE APEX CHUCK 6mm; APEX DRILL BRACE - 3/4/5/6mm; APEX DRILL GUIDE HANDLE; APEX TRAY BASE; APEX TRAY LID; APEX TRAY LOWER INSERT; APEX TRAY UPPER INSERT; ATP Disc Prep; ATTACHMENTS; AXSOS ADAPTOR FOR TORQUE TESTER T20; AXSOS ADAPTOR FOR TORQUE TESTER T8/T15; AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK; Accolade C Hip Stems; Accolade Hfx Hip Stems; Accolade Hip System; Accolade II Hip Stem; Accolade II Hip Stems; Accolade II System Instrumentation; Aequalis Fracture; Aequalis Reversed Fracture; Aequalis Reversed II; Aequalis"" Instrument; Aequalis"" Retractor Shoulder System; Aggressive Max Shaver Blade 3.5mm; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; All OrthoHelix Orthopedic Manual Surgical Instruments; All Tornier Orthopeadic Manual Surgical Instruments (exempt); Aluminum Lid - Universal; Anato Hip Stem; Anato Hip System Instrumentation; Anatomic Express Tray; Anato¿ Hip System; Anato¿ Hip System Instrumentation; Angled Ruler; Artisan Bone Plug; Artisan Bone Plug; UHR Bipolar Component; Artisan Bone Plug; Universal Cement Restrictor; Asnis® III Cannulated Screw System; Asnis® PRO Cannulated Screw System; Associated instrumentation; Avon Patella-Femoral Joint; AxSOS; AxSOS 3; AxSOS 3 AF System and AxSOS 3 Ti System, Plate; AxSOS 3 Ankle Fusion; AxSOS 3 Ti; BARREL REAMER ASSEMBLY STAND; BIOCOMPRESSION WRENCH 15mm TUBE; BIOCOMPRESSION WRENCH 20mm TUBE; BIOCOMPRESSION WRENCH 25mm TUBE; BioZip System; Biolox Delta Heads; Biosteon Wedge Interference Screw System; Bixcut Reamers; Bixcut, IM Reamer; Bone Plug Extractor; BriteField Depth Gauge; Broach and Inserter Handle; C-Taper Alumina Heads; C-Taper Biolox Delta Ceramic Heads; C-Taper Femoral Heads; CANYON Retractor Systems Trays; CAPRI Corpectomy Cage System Trays; CASPIAN Spinal System Trays; CAYMAN Plate System Trays; CHESAPEAKE Stabilization System Trays; CURSOR; CUTTING SCREWDRIVER 4.5; CYLINDRICAL BUSH HOLDER; CalcLock manual surgical instruments; Cannulated Countersink with AO Fitting; Cannulated Drill with AO Fitting; Cannulated Drill ø 2,7/3.5mm with AO Fitting; Cannulated Screwdriver with AO Fitting; Cannulated Screwdriver with Elastosil Handle; Cannulated Tap with AO Fitting; Cascadia Interbody System; Cement Plug; Centrax; Ceramic C-Taper Femoral Head; Ceramic V40™ Femoral Head; CinchLock; Citation Hip Stem; Citation TMZF Hip Stems; Colored Plugs; Constrained Acetabular Insert; Trident Crossfire 0 deg Polyethylene Insert; Counterbore Drill; Cross-Screw System; Cut Guide; DENALI Spinal System Trays; DEPTH GAUGE; DEPTH GAUGE (DISTAL RADIUS); DEPTH GAUGE (HAND); DISPOSABLE CEMENT SCULPS; DJD II STORAGE CASE; DRILL BIT; DRILL GUIDE; DRILL GUIDE BLOCK COMPACT 4 HOLE; DRILL GUIDE BLOCK COMPACT PERI 4 HOLE; DRILL GUIDE BLOCK HII 10 HOLE; DRILL GUIDE BLOCK HII 5 HOLE; DRILL GUIDE BLOCK MONOTUBE 4 HOLE; DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE; DRILL GUIDE LOCK II 2.5; DRILL SLEEVE; Dall Miles Cable Grip System Implants; Dall Miles Cable System; Dall Miles System; Definition Hip Stem; Depth Gauge (Foot/Elbow/Distal Fib); Direct Anterior Instruments; Direct Measuring Gauge; Distal Femoral Growing Prosthesis; Dome Hole Plug; Double Drill Guide ø 2,0/3,5mm; Drill Bit; Drill Bit ø 2,0 x 150mm; Drill Guide Non Sterile; Drill Sleeve; Dual Edge Shaver Blade 3.5mm; Dual Edge Shaver Blade 4mm; Dual Edge Shaver Blade 5.5mm; Dual-sided Baseplate Centering Guide; Duracon Knee System; EASY CLIP ANGLED DRILL GUIDE SIZE 15; EVEREST Spinal System Trays; Eccentric 10 Degree Cup Insert Crossfire; Edgelock manual surgical instruments; Eiberg Retractor, Standard; Eiberg Retractor, Standard, Long; Eikon LT Adapt SE 135 mm, Wide Retractor; Eikon LT Adapt SE 135mm Retractor; Eikon LT Adapt SE 135mm, Teeth Retractor; Eikon LT Adapt SE 155 mm, Wide Retractor; Eikon LT Adapt SE 155 mm,Wide,Teeth Retr; Eikon LT Adapt SE 155mm Retractor; Eikon LT Adapt SE 155mm, Teeth Retractor; Eikon LT Adapt SE 175 mm, Wide Retractor; Eikon LT Adapt SE 175 mm,Wide,Teeth Retr; Eikon LT Adapt SE 175mm Retractor; Eikon LT Adapt SE 175mm, Teeth Retractor; Eikon LT Adapt SE 90 mm, Wide Retractor; Eikon LT Adapt SE 90 mm, Wide Teeth Retr; Eikon LT Adapt SE 90mm Retractor; Eikon LT Adapt SE 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 135mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 155mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 175mm, Wide, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Teeth Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide Retractor; Eikon LT Adapt Smoke Evacuation 90mm, Wide, Teeth Retractor; Eikon LT Adapt, 135 mm; Eikon LT Adapt, 135 mm, Teeth; Eikon LT Adapt, 135 mm, Wide; Eikon LT Adapt, 135 mm, Wide, Teeth; Eikon LT Adapt, 175 mm; Eikon LT Adapt, 175 mm, Teeth; Eikon LT Adapt, 90 mm; Eikon LT Adapt, 90 mm, Teeth; Eikon LT Adapt, 90 mm, Wide; Eikon LT Adapt, 90 mm, Wide, Teeth; Eikon LT FF 135mm Retractor; Eikon LT FF 135mm, Wide Retractor; Eikon LT FF 175mm Retractor; Eikon LT FF 90mm Retractor; Eikon LT FF 90mm, Wide Retractor; Eikon LT FF Replacement Screw; Eikon LT Fixed Frame Retractor, 135mm Eval; Eikon LT Fixed Frame Retractor, 135mm Wide Eval; Eikon LT Fixed Frame Retractor, 90mm Eval; Eikon LT Fixed Frame Retractor, 90mm Wide Eval; Eikon LT Retractor, 135 mm; Eikon LT Retractor, 135 mm, Narrow; Eikon LT Retractor, 135 mm, Narrow Teeth; Eikon LT Retractor, 135 mm, Sweetheart; Eikon LT Retractor, 135 mm, Teeth; Eikon LT Retractor, 135 mm, Wide; Eikon LT Retractor, 135 mm, Wide, Teeth; Eikon LT Retractor, 175 mm; Eikon LT Retractor, 175 mm, Teeth; Eikon LT Retractor, 40 mm, Extra Narrow; Eikon LT Retractor, 40 mm, Narrow; Eikon LT Retractor, 50 mm; Eikon LT Retractor, 50 mm, Teeth; Eikon LT Retractor, 90 mm; Eikon LT Retractor, 90 mm, Narrow; Eikon LT Retractor, 90 mm, Narrow Teeth; Eikon LT Retractor, 90 mm, Teeth; Eikon LT Retractor, 90 mm, Wide; Eikon LT Retractor, 90 mm, Wide, Teeth; Eikon LT Retractor, A-N, 35 mm & 50 mm; Eikon LT Retractor, Rich, 40mm x 38mm; Eikon LT Retractor, Rich, 60mm x 45mm; Eikon LT Retractor, Rich, 80mm x 60mm; Eikon LT SL Sterilization Tray; Eikon LT Sterilization Tray; Elastosil T-Handle with AO Coupling; Exeter Femoral Heads; Exeter Hip Stem; Exeter Hip System; Exeter Hip System Instrumentation; Exeter IM Plug; Exeter Mesh; Exeter Related Instrumentation; Exeter Screws; Exeter V40 Femoral Stem; Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads; Exeter X3 RimFit All Poly Cup; Exeter X3 RimFit Cup; Express Humeral Stem Extractor; Express Insert; Extractor Rod; Extractor for Screws; FEMORAL CANAL BRUSH, STANDARD; FIXOS 4 MV DEPTH GAUGE; FUNNEL; GUIDE FOR HALF-PINS; Gap II Shell; General Instruments; Glenoid Retractor; Glenoid pin guide; Graft box body; Graft box compression screw; Graft box locking screw; Graft box washer; Graft box wedge; Graft sizer; Guide Wire; Guide Wire Pusher; Guide Wire Ruler; Guide Wire Targeter; Guide Wire Targeter - Crown; Guide Wire Targeter - Sleeve; Guide Wire, Threaded; HII 7mm T-WRENCH / 5+6mm SOCKET; HII COMPACT 5mm WRENCH/3&4mm SOCKET; HII COMPACT GUIDE BLOCK W/AO; HII COMPACT MRI STORAGE CASE BASE; HII COMPACT MRI STORAGE CASE LID; HII COMPACT MRI STORAGE CASE UPPER INSERT; HII COMPACT STORAGE CASE BASE; HII COMPACT STORAGE CASE LID; HII COMPACT STORAGE CASE UPPER INSERT; HII MICRO 2mm PIN DRIVER; HII MICRO DRILL GUIDE ASSEMBLY; HII MICRO NUT DRIVER; HII MICRO STORAGE CASE BASE; HII MICRO STORAGE CASE DRILL BIT HOLDER; HII MICRO STORAGE CASE LID; HII MICRO STORAGE CASE LOWER INSERT; HII MICRO STORAGE CASE UPPER INSERT; HII MRI TRAY BASE; HII MRI TRAY LID; HII MRI TRAY LOWER INSERT; HII TRAY BASE; HII TRAY LID; HII TRAY LOWER INSERT; HII TRAY UPPER INSERT; HLS KNEETEC; HLS NOETOS; HLS UNI EVOLUTION; HM MINI 4 SPANNER WRENCH; HMENTS; HOFFMANN LRF INFO BOARD; HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT; HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY; HOFFMANN LRF RATCHET WRENCH - HEX 10; HOFFMANN LRF SPANNER WRENCH - 5 mm; HOFFMANN LRF SPANNER WRENCH - 7/10 mm; HOFFMANN LRF TELES. STRUT WRENCH; HOFFMANN LRF THUMBWHEEL - HEX 10; HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS; HOFFMANN LRF UNIVERSAL COMPONENTS INSERT; HOFFMANN LRF UNIVERSAL COMPONENTS TRAY; HOFFMANN LRF WIRE BOLT WRENCH; HOFFMANN LRF WIRE TENS. NOSE - LONG; HOFFMANN LRF WIRE TENS. NOSE - SHORT; HOFFMANN LRF WIRE TENSIONER; HOFFMANN XPRESS SILICON MAT; HOFFMANN XPRESS SILICON THUMBWHEEL; HOFFMANN XPRESS SPANNER WRENCH; HOFFMANN XPRESS STORAGE CASE BASE; HOFFMANN XPRESS STORAGE CASE INSERT; HOFFMANN XPRESS STORAGE CASE LID; HOFFMANN XPRESS TORQUE WRENCH; HOFFMANN3 TRAY FOR STANDARD COMPOMENTS; HOLDING SPANNER 4.5; HOWMEDICA MIX KIT I TM 10PK; Hoffmann LRF; Hoffmann LRF System, Insert; Hoffmann LRF System, Instrument; Hoffmann LRF System, Ruler; Hoffmann LRF System, Wire Tensioner; Hoffmann LRF System, Wrench; Holding Sleeve; Humeral Express Tray; ICONIX All Suture Anchor System; IMN Instruments Percutaneous guide wire inserter; IMN Instruments Self-Holding Screwdriver T20; INBONE; INCLINED DRILL GUIDE SCREW EZ18; INCLINED DRILLING GUIDE + SCREW EZ20; INFINITY; INSTRUMENT TRAY BASE 4.5; INSTRUMENT TRAY LID FIXOS; INTERMEDIATE PROSTHESIS HOLDER LEFT; INTERMEDIATE PROSTHESIS HOLDER RIGHT; INTRAMEDULLARY BRUSH STANDARD 14MM OD; Insertion Sleeve for Guide Wire; Insignia Hip Stem; Insignia Instruments; Instrument Guides; Inter-Lock System; Intraosseous Fixation system manual surgical instruments; Invuity A-N, 35mm & 50mm Extra Narrow Re; Invuity A-N, 35mm & 50mm Extra Narrow Retractor; Invuity A-N, 35mm & 50mm Narrow Retracto; Invuity A-N, 35mm & 50mm Narrow Retractor; Invuity Breisky 130mm; Invuity Breisky 170mm; Invuity Deaver 25mm Wide Retractor; Invuity Deaver 38mm Wide Retractor; Invuity St. Marks 11 in Retractor; Invuity St. Marks 9 in Retractor; JA FANTOME CALOTTE; K2M General Instruments; KW BENDING IRON ICS; Kerboull Acetabular Cross Plate; Kinematic Knee System; Kinemax Knee System; Kinemax Plus Knee System; Knotilus+ 2.4X11.3mm Drill, Hard Bone; Knotilus+ 2.4x11.3mm Drill; Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip; Knotilus+ 2.4x8.9mm Drill, Hip; Knotilus+ 2.9x12.5mm Drill; Knotilus+ 2.9x12.5mm Drill, Hard Bone; Knotilus+ 2.9x12.5mm Drill, Hard Bone, Hip; Knotilus+ 2.9x12.5mm Drill, Hip; Knotilus+ 2.9x15.5mm Drill; Knotilus+ 2.9x15.5mm Drill, Hard Bone; Knotilus+ Crown Tip Guide; Knotilus+ Crown Tip Guide, Hip; Knotilus+ Fishmouth Tip Guide; Knotilus+ Fork Tip Guide, Hip; Knotilus+ Offset Tip Guide; LFIT V40 Femoral Heads; LID FOR INSTRUMENT TRAY; LID FOR PLATE RACK - COMPRESSION PLATES; LID FOR PLATE RACK - GENERIC; LID FOR PLATE RACK - SPECIAL PLATES; LITe BIO Delivery System - Sterilization Tray and Lid; Lag Screw Sleeve; Large AO Coupling - Hall Fitting; M/T TRIAX LNG HANDLE WRENCH BLUE; M/T TRIAX LNG HANDLE WRENCH RED; M/T TRIAX LNG HANDLE WRENCH YELLOW; MANUAL DRILL BIT; MDM Acetabular Liner; MESA Spinal System Trays; MILITARY EXTERNAL FIXATION CASE; MONOTUBE TRIAX YELLOW CASE; Mainstay Zip Anchor System; Mako Instrument Trays; MaxLock Extreme manual surgical instruments; Meniscal Transplant Set; Meridian Hip Stem; Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini; MicroFX™; Mini MaxLock manual surgical instruments; Modular Glenoid Surface Trial; Modular Humeral Head Trial; Modular Humeral Head Trial Post; Modular Replacement System; Monterey AL Interbody System; Morse Taper Alumina Head; Muller Acetabular Cup; Multiple Drill Guide; NAPA Access System; NEEDLE GUIDE; NanoTack; NanoTack Flex; Navigated Spine Instruments Trays; Navigation Instruments Trays; OBLONG DRILL GUIDE DIAMETER 2MM; OMEGA PLUS 145 DRILL GUIDE INSERT; OMEGA PLUS DRILL GUIDE 3.2mm DIA-1mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.2mm DIA-2mm COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-COMPRESSION; OMEGA PLUS DRILL GUIDE 3.6mm DIA-NEUTRAL; OMEGA PLUS DRILL GUIDE HANDLE; OMEGA PLUS HEAD; OMEGA PLUS HEX POWERBIT W/TRKLE END 3.5mm; OMEGA PLUS LAG SCREW ADAPTER; OMEGA PLUS SCREW EXTRACTION BOLT; OMEGA PLUS SUPRACONDYLAR DRILL GUIDE; OMEGA PLUS SUPRACONDYLAR PIN GUIDE; OMEGA PLUS TAP GUIDE 4.5mm; OMEGA PLUS TAP GUIDE 6.5mm; OMEGA PLUS TRIAL PLATE 150; OMEGA+ BARREL REAM ASSY SHORT; OMEGA+ PIN W/THREAD 2.8X230MM; OMEGA+ VAR ANGLE GUID REPL KIT; ORTHOPEDIC MANUAL; OSTEONICS; OZARK Cervical Plate System Trays; OmniFIt Acetabular System; OmniFit Acetabular Inserts; OmniFit Crossfire Inserts; OmniFit Hip System; OmniFit Knee System; Omnifit 20 degree Series I insert; Omnifit Crossfire 10 deg Series II Insert; Opening Guide; Opening Reamer; Opening Sleeve; Orthinox V40 Femoral Heads; Orthopaedic Manual Instrumentation; Osteocolock Acetabular System; Osteolock Acetabular System; Osteolock Screws; Overdrill for 4.5mm Screws, AO; PCA Acetabular System; PCA Duration Insert; PCA Femoral Head; PCA Femoral Heads; PCA Knee System; PEDIATRIC CORTICAL REAMER; PIN CUTTER / HA PINS; PKG., AGGRESSIVE MAX SHAVER BLADE - 3.5MM; PKG., DUAL EDGE SHAVER BLADE - 5.5MM; PLATE BENDING IRONS; PRO Plating System; PROTRACTOR; PYRENEES Cervical Plate System Trays; Pangea Femur Reconstruction System Bender; Pangea Femur Reconstruction System K-Wire; Pangea Femur Reconstruction System Tray; Pangea Platform; Pangea T-Handle; Parallel Guide for ø 1,4mm/2mm Wires; Perc. Double Wire Guide; PeriPROTM Femur; Phoenix; Plastic Tray; Posterior TLIF; Precision Acetabular System; Premise Acetabular System; Q Pedicle Instruments; Quick Release Driver Hall Fitting; RACK FOR OPEN WEDGE PLATES (LEVEL 2); RACK FOR PLP UTILITY/MTP (LEVEL 2); RACK FOR UTILITY/LISFRANC PLATES (LEVEL 2); RAVINE Access System Trays; RED & BLUE INTL M/T CASE; REDUCTION HANDLES B & R CLAMPS; REPLACEMENT COMPONENTS; REPLACEMENT KNOB FOR DRILL BRACE; RESECTION GUIDE; RETRACTOR; RING DRIVER 4.5; ReUnion; Reduction Tray; Reduction Tray Insert for Jaw Clamps; Reduction Tray Insert for Weber Clamps; Reduction Tray generic Insert; Reliance Hip Stem; Restoration ADM Acetabular System; Restoration ADM and MDM System; Restoration ADM/MDM Instrumentation; Restoration Acetabular Augments; Restoration Anatomic Acetabular Shell; Restoration MDM Acetabular System; Restoration Modular Hip Stem System; Restoration Modular Hip System; Restoration Modular Hip System, Plasma Distal Stem, Bowed; Restoration Modular Instrument Trays; Restoration Modular System; Restoration Modular Total Hip System implants - proximal bodies and distal stems; Restoration Modular Trials; Restoris MCK; Restoris MCK Knee System; Retractor; Reusable Slat for Eikon LT Adapt Smoke Evacuation 135 mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 155mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 175mm Retractor, 10 Pack; Reusable Slat for Eikon LT Adapt Smoke Evacuation 90mm Retractor, 10 Pack; Reverse Express Tray; SAHARA Stabilization System Trays; SAW BLADE; SCR Unicompartmental Knee; SCREW CADDY FOR 2 / 2.5 FIXO TRAY; SCREW RACK ANCHORAGE; SCREW RACK WS + CS (2MM+3.5MM); SCREW TRAY 4.5; SCREW-HOLDING FORCEPS FIXOS; SET ANCILLARY IMPLANT SUBTALAR; SET SCREW FOR HUMERUS AIMING BLOCK; SET SCREW FOR TIBIA AIMING BLOCK; SILICONE MAT; SMALL RULER FOR MEASUREMNET; SMALL SWIVEL JOINT; SMART TOE 1 INSTRUMENT KIT; SMOOTH BITE SHAVER BLADE - 3.5MM; SPARE SET SCREW HUMERUS TS AIMING BLOCK; SPARE SHAFT TEMP. PLATE HOLDER; SPIKE SCREW INSERTER FOR 4.5MM SCREWS; SPS BENDING SLEEVE - SLOTTED STEEL; STANDARD BENDING SLEEVE; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2.5MM; STANDARD DRILL GUIDE ANCHORAGE DIAMETER 2MM; STERNUM SAW REPLACEMENT GUIDE; STRAIGHT FEMORAL CANAL BRUSH; SUBFIX INSERTION INSTRUMENT; SURGICAL INSTRUMENT MOTORS AND ACCE; SYSTEM 12 CROSSFIRE Inserts; Scorpio Flex CR and PS Tibial Insert; Scorpio NRG CR and PS Tibial Insert; Scorpio Knee System; Scorpio Universal Dome Patella; Screw Holder; Screw Insertion Sleeve; Screwdriver Blade, AO, T10; SecurFit AD HA Shell; SecurFit Acetabular System; SecurFit Hip System; Serf Hip Systems; Series 7000 Knee System; Silicon Mat, Generic Insert; Silicon Mat, Insert for Jaw Clamps; Silicon Mat, Insert for Weber Clamps; Smooth Bite Shaver Blade 3.5mm; Solid Screwdriver with AO Fitting; St. Mark’s 11 in. Retractor; St. Mark’s 9 in. Retractor; Stanmore Face Cutter and Alignment Tool; Sterilization Box, Lightweight; Stryker Orthopaedics Instrument Trays; Stryker Orthopaedics Instruments; Stryker Orthopaedics Templates; Stryker Orthopaedics Trials; Stryker Trauma Pelvic Set (Matta); Stylet; System 12 Acetabular System; T-HANDLE PIN INSERTER; T-HANDLE STEM HOLDER; T2 Alpha Femur Retrograde Nailing System, Nail Adapter SPI; T2 Alpha Femur Retrograde Nailing System, Nail Holding Screw SPI; T2 Alpha Femur Retrograde Nailing System, Target Device; T2 Alpha Femur Retrograde Nailing System, Tissue Protection Sleeve; T2 Guide Wire Ball Tip; TENSION DEVICE 16MM; TIGE FRACTURE N.M; TRAY; TRAY FOR MV SCREWS; TRIAL ANCHORAGE PLP10341; TRIAL ANCHORAGE PLP10342; TRIAL ANCHORAGE PLP10461; TRIAL ANCHORAGE PLP10462; TRIAL ANCHORAGE PLP11341; TRIAL ANCHORAGE PLP11342; TRIAL ANCHORAGE PLP30141; TRIAL ANCHORAGE PLP30142; TRIAL ANCHORAGE PLP30171; TRIAL ANCHORAGE PLP30172; TRIAL ANCHORAGE PLP30201; TRIAL ANCHORAGE PLP30202; TRIAL ANCHORAGE PLP40160; TRIAL ANCHORAGE PLP40220; TRIAL ANCHORAGE PLP40280; TRIAL ANCHORAGE PLP40340; TRIAL ANCHORAGE PLP40400; TRIAL ANCHORAGE PLP40460; Terra Nova, Ravine, Serengeti, VCR, Cricket; Threaded Guide Wire; Tissue Protection Sleeve; Tomcat HC Shaver Blade 4mm; Tornier; Tornier Approach; Tornier Drill bits (all); Tornier Extraction; Tornier Flex Shoulder System; Tornier Perform Anatomic Glenoid; Tornier Pyrocarbon; Tornier Radial Head System; Tray - Silicon Mat; Tray insert; Triathlon; Triathlon All Poly Tibial Component - CR and PS; Triathlon CR Tibial Insert, Triathlon CS Tibial Insert, Triathlon PS Tibial Insert; Triathlon Femoral Distal Augments; Triathlon Hinge Bumper; Triathlon Hinge Knee Bushing and Axle; Triathlon Hinge Knee Tibial Insert; Triathlon Instrumentation; Triathlon Knee System; Triathlon Knee System Instrumentation; Triathlon MSI Tray; Triathlon MSI Trials; Triathlon PKR; Triathlon PKR System; Triathlon Single-Use Instrumentation; Triathlon Symmetric and Asymmetric Patella; Triathlon System Instrument trays; Triathlon Total Knee System; Triathlon Tritanium Central Femoral Cone Augments;; Triathlon Tritanium Metal-Backed Patella; Triathlon Tritanium Patella; Trident 0 deg Constrained Acetabular Insert; Trident Constrained Acetabular Liner; Trident Acetabular Inserts; Trident Acetabular System; Trident All Poly Constrained Acetabular Insert; Crossfire Eccentric Insert 10 deg; Trident Crossfire 10 deg Poly Insert; System 12 Crossfire 10 deg Insert; Trident II; Trident II Acetabular System; Trident II Acetabular System (acetabular shells and related instruments); Trident II Tritanium Acetabular Cup System and 6.5mm Low Profile Hex Screws (Solidback, Clusterhole and Multihole); Trident X3 UHMWPE Acetabular Inserts, Restoration ADM and MDM X3 UHMWPE Acetabular Inserts, Accolade II Hip System,; Tritanium Acetabular Shells; Tritanium C Anterior Cervical Cage; Tritanium PL Cage; Tritanium PL Cages; Tritanium Shell; Tritanium TL Curved Posterior Lumbar Cage; Trocar; TwinLoop Anchor System; TwinLoop FLEX; Twist-drill cannulated ø8/L300mm; UHR BIPOLAR; UHR BiPolar; UHR Bipolar Femoral Heads; UNIVERSAL BENDING SLEEVE; UNIVERSAL PIN-WIRE CASE; UniVise; Unitrax; Unitrax Modular Endo Heads; Unitrax Sleeve; Unitrax System; Unitrax V40 Head; Unitrax V40 Modular Adaptor; Universal ACL Instrumentation; Universal Adaptor Sleeve; Universal C-Taper Adapter Sleeve; Universal Cement Spacer; Universal Neuro III Accessory Tray; Universal Taper Biolox Delta Femoral Head; Universal Taper Femoral Head; Universal V40™ Taper Adapter Sleeve; Unix Unicompartmental Knee; V40 Alumina Heads; V40 Femoral Heads; V40 Taper Alumina Ceramic Head; VARIOUS TWIST DRILLS; VariAX 2, Lid For Sterilizing Container; VariAx 2 Compression Plating System, Plate Insert; VariAx 2 Compression Plating System, Plate Trial; VariAx 2 Foot, Drawer; VariAx 2 Foot, Insert; VariAx 2 Foot, Instrument Kit; VariAx 2 Foot, Labeling Clip; VariAx 2 Foot, Module; VariAx 2 Foot, Module Lid; VariAx 2 Foot, Screw Rack; VariAx 2 Foot, SpeedGuide; VariAx 2 Foot, Tap for 2.7mm screws; VariAx 2 foot, Depth Gauge; VariAx 2, Aiming Block Fixation Pin; VariAx 2, Clip; VariAx 2, Depth Gauge; VariAx 2, Distal Radius Container Half-Size; VariAx 2, Distal Radius Implant Module; VariAx 2, Drill Bit; VariAx 2, Drill Guide; VariAx 2, Drill Guide K-Wire; VariAx 2, Fixed Angle Drill Guide 2.3/2.7mm; VariAx 2, Handle With 2.3mm Drill And K-Wire Guide; VariAx 2, Handle With Drill Guides; VariAx 2, Inlay; VariAx 2, Insert; VariAx 2, Joystick; VariAx 2, K-Wire; VariAx 2, K-Wire with Olive Stop; VariAx 2, Pliers; VariAx 2, Reduction Instrument Insert; VariAx 2, Screw Rack; VariAx 2, Screw Rack Locking Screws; VariAx 2, Screw Rack Non-Locking Screws; VariAx 2, ScrewDriver Blade; VariAx 2, Screwdriver Blade; VariAx 2, SpeedGuide; VariAx 2, Tap For 2.7mm Screws; VariAx Foot, Countersink; VariAx Foot, Holding Sleeve; VariAx Foot, K-Wire; VariAx, Drill; VariAx, Drill Guide; VariAx, Handle; VariAx, Kirschner Wire; VariAx, Safety Shield; VariAx, Screw Length Marker; VariAx, Screwdriver; VariAx, Tap For Bone Screws; VariAx, Tension Plier; VariAx, Tension Sheath; VariAx, Trial; Variable Angle Fixation; Variax 2, Steinmann Pin; Vikos Allograft System; Vitalock Acetabular System; WIRE AND DRILL GUIDE; XIA Rod Template; Xcel Anchor System; Xia Blocker Inserter; YUKON OCT Spinal System Trays; extraction shaft; lag screw driver; lag screw reamer; precision pin; precision sleeve; screw depth gauge; set screw driver; tray base",1992-11-23,135,2026-08-06,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229616680%22&limit=1
Arvato SE,3013247477,3013247477,Werner-Schroeder Str 1,Hamburg,,21035,Germany,Arvato SE,10053073,Repackager or relabeler,95,CCW; DQI; DXJ; EBA; EOB; EPY; EQH; EQJ; EQL; EWY; EZO; FAJ; FAS; FBN; FBO; FBP; FCW; FCZ; FDC; FDS; FED; FEQ; FET; FFY; FGA; FGB; FGC; FGE; FJL; FSM; FYD; FZO; GAF; GCJ; GCM; GCP; GEA; GEI; GWG; GWX; HBI; HCF; HET; HFG; HFI; HIG; HIH; HIN; HKF; HRX; HTD; HTR; HXL; JOL; JOS; JYJ; JYL; JYM; JYO; JYS; KAD; KAE; KAI; KAK; KAL; KAP; KBB; KBC; KBM; KCG; KCT; KGE; KNF; KNS; KOA; KOB; KTE; KTF; KTG; KYZ; LFL; LMD; LRC; LRP; LRW; MMO; MNL; MQW; NKC; NMH; NNR; NTN; NWB; NWW; OWN,"Laryngoscope, Rigid; Withdrawal/Infusion Pump; Display, Cathode-Ray Tube, Medical; Light, Surgical Headlight; Nasopharyngoscope (Flexible Or Rigid); Speculum, Ent; Source, Carrier, Fiberoptic Light; Bur, Ear, Nose And Throat; Laryngostroboscope; Mediastinoscope, Surgical; Urethrotome; Cystoscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Choledochoscope And Accessories, Flexible/Rigid; Cystourethroscope; Telescope, Rigid, Endoscopic; Light Source, Fiberoptic, Routine; Tube, Smoke Removal, Endoscopic; Resectoscope, Working Element; Gastroscope And Accessories, Flexible/Rigid; Endoscopic Access Overtube, Gastroenterology-Urology; Pump, Air, Non-Manual, For Endoscope; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Adaptor, Bulbs, Miscellaneous, For Endoscope; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Urethroscope; Stents, Drains And Dilators For The Biliary Ducts; Resectoscope; Tray, Surgical, Instrument; Apparatus, Exhaust, Surgical; Chisel, Surgical, Manual; Spatula, Surgical, General & Plastic Surgery; Laparoscope, General & Plastic Surgery; Endoscope, Rigid; Endoscope, Ac-Powered And Accessories; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Endoscope, Neurological; Fork, Tuning; Illuminator, Fiberoptic, Surgical Field; Instrument, Ligature Passing And Knot Tying; Laparoscope, Gynecologic (And Accessories); Coagulator, Laparoscopic, Unipolar (And Accessories); Coagulator, Culdoscopic (And Accessories); Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Coagulator-Cutter, Endoscopic, Bipolar (And Accessories); Mirror, Headband, Ophthalmic; Arthroscope; Forceps; Rasp; Mallet; Catheter And Tip, Suction; Electrode, Electrosurgical; Gauge, Measuring; Hook, Microsurgical Ear; Inserter, Myringotomy Tube; Knife, Ear; Perforator, Ear-Lobe; Elevator, Ent; Forceps, Ent; Mirror, Ent; Probe, Ent; Retractor, Ent; Curette, Nasal; Rongeur, Nasal; Saw, Nasal; Dissector, Tonsil; Dilator, Tracheal; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Forceps, Biopsy, Electric; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Surgical Instruments, G-U, Manual (And Accessories); Catheter, Suprapubic (And Accessories); Trocar, Ent; Punch, Ent; Knife, Ent; Syringe, Irrigating (Non Dental); Instrument, Ultrasonic Surgical; System, Digital Image Communications, Radiological; Instrument, Ent Manual Surgical; Tray, Surgical; Scissors, General, Surgical; Tray, Surgical, Ent; Accessories, Cleaning Brushes, For Endoscope; Transilluminator, Fiber Optic; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Laparoscope And Accessories, Gynecologic, Reprocessed; Block, Cutting, Ent, Non-Sterile; Led Light Source; Endoscope, Accessories, Narrow Band Spectrum; Hysteroscope Accessories; Confocal Optical Imaging",1; 2; U,"Adapter; Adenoid forceps; Adenotome; Artery forceps; Arthroscopes, CLV-S20 light source; Articulated arm and accessories; BALL ELECTRODE (5 PACK); Bandage scissors; Biopsy forceps; Bipolar Applicator CELON ProCurve V; Bipolar Grasping Forceps BiQ+; Bone rongeur; Burr; CELON ELITE ESG-200; CELON ENT SYSTEM; CLL-V1 LED Light Source; Cannula; Cartilage crusher; Chest support; Chisel; Choledochoscope, flexible and rigid; Cleaning Accessories; Cleaning Accessory; Clip applier; Cogent 1; CoolPulse 90 Electrode with Hand Controls; CoolPulse 90 Electrode without Hand Controls; Cord; Gyrus PK Footswitch; Cotton applicator; Cutting block; Cutting jig; Cysto-urethroscopes and forceps; Cystofiberscope and nephrofiberscope; Dermabrader; Dilator; Dissection forceps; Dissection scissors; Dissector; Dressing forceps; ENDOEYE HD II; ESG-100 AFU-100; ESG-100, AFU-100; Ear curette; Ear forceps; Ear forceps, inserter for ventilation tubes; Ear hook; Ear knife; Ear loop; Ear scissors; Electrosurgical Generator ESG-150; Electrosurgical Generator ESG-400 and Accessories; Electrosurgical Generator ESG-410 and Accessories; Electrosurgical loops; Elevator; EndoLED Light Source; Ethmoid scissors; FOOTSWITCH (SMALL); Flexible Tipe Thoraroscope; Flexible and rigid ureterotome system; G400 Workstation; GVAP ELECTRODE (5 PACK) (VRS RESECTOSCOPE ELECTRODE); GVAP LOOP ELECTRODE (5 PACK) (VRS ANGLED LOOP RESECTOSCOPE ELECTRODE); GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE; Gauge pin; Gelfoam pressure forceps; Glass tray; Gouge; Grasping Forceps; Grasping forceps; Gyrus G3 Generator; Gyrus Plasma Sect Urology; Gyrus Plasma V; Gyrus Urology Kit; Plasma Cise; Plasma Cut; HD Endoeye; HF Resection Electrode; HF Resection Electrode Loop with Runner; HF Resection Electrode Loop with runner; HF Resection Electrodes; HF Resection electrode, cylinder; HF-cables (reusable); HF-resection electrodes; HI-Q HAND INSTRUMENTS, OB/GYN USE; HYF Hysteroscopes and telescopes; HYSTEROSCOPIC BRIDGE (VISUAL OBTURATOR) ROTATABLE OUTER SHEATH; HYSTEROSCOPY PUMP; Hand perforator; Head band; Head light; Head mirror; Hi-Q Instruments; HiCura Hand Instruments; Hook; Hysteroscope accessories; Hysteroscopes, forceps; Hysteroscopic Sheath; INNER SHEATH (RESECTOSCOPE SHEATH, INNER - 24 Fr.; Incision knife; Infant resectoscope; Inserter, for T-Tubes; Instrument basket, for EndoEYE; Instrument tray, for semi-rigid ureteroscope; Introducer; Iris scissors; Jar, stainless steel; Kidney bowl; Knife; Knot pusher; LAPAROSCOPIC SCISSORS; LARYNGOSTROBOSCOPE; LIGHT SOURCE FOR STROBOSCOPY; LPS electrode; Suction electrode; Lancet knife; Laryngeal forceps; Laryngeal knife; Laryngeal scissors; Leakage Tester; Ligature scissors; Light carrier; Light carrier, fiber optic; Light clip; Light source; Light-guide Adapter; Light-guide cable; Loop; MAPC Probes; MAXPASS BILIARY CATHETER; MCEND0550; MINI LAPAROSCOPY FOR GENERAL SURGERY; MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE; MNA-120 ENC DP AUDIO; Mallet; Mandrin, for Suction tubes; Measuring instrument; Mediastinoscope; Medicine cup; Micro-biopsy forceps; Mini PCNL-System; Mirror; Monopolar single-use HF cable; Nasal forceps; Nasal scissors; Needle; Needle holder; Needle, for fascial closure; Neuroscopes; Neutral electrode cable; Noise apparatus; OES ELITE Cystoscope and Accessories; OES ELITE Telescopes, Protective Tube; OES Elite Ureteroscopes and Accessories; OES LAPARO-THORACO VIDEOSCOPE (RIGID); OLYMPUS BIPOLAR FORCEPS AND ACCESSORIES; OLYMPUS NASAL AND SINUS ENDOSCOPES; OLYMPUS OES LAPAROSCOPY SYSTEM; OLYMPUS RIGID URETERORENOSCOPE; OLYMPUS STERILIZATION TRAYS; ONE PIECE LOW PROFILE SUCTION (LPS) ELECTRODE ONE PIECE S50 PLUS ELECTRODE; ONE PIECE SIDE EFFECT ELECTRODE; Olympus KeyMed Instrument Tray; Operation laryngoscope; Optical Obturator; Osteotome; P50 Hand Switching; PENADAPT 10; PK Button; PK Cord; PK generator; SuperLoop; SuperPulse generator; SuperSect; PK Generator; PlasmaKinetic System; PK Lap Loop; PK PLASMA-V INSTRUMENT; PK Superpulse System Generator Model 744000; PKS BiLL; PKS PlasmaSORD; PORTA PLUMESAFE(TM) 601 SMOKE EVACUATION SYSTEM; Perforator; Pharyngeal forceps; Pick; Plastic Surgery System; Plastic Surgery System hand instruments; Polyp snare; Probe; Punch forceps; RD END ELECTRODE (2.3 VAPR END EFFECT); RD SHORT WEDGE (2.3mm WEDGE (SHORT)) RD STANDARD WEDGE 2.3mm WEDGE; RD SIDE ELECTRODE (2.3 VAPR SIDE EFFECT); Rack; Rasp; Raspatory; Resection Electrodes With HF Cable; Resection Electrodes with HF cable; Resection Sheath for Hysteroscopy; Resection Sheath for Urology; Retractor and accessories; Rhinoplasty scissors; Rigid and percutaneous nephroscope; Roller Electrodes for OB/Gyn; Roller knife; Round bowl; Round knife; Rule; SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND; SPRING ELECTRODE (5 PACK); Saw; Scalpel handle; Scissors; Scoring instrument; Semi-rigid scissors; Septum cannula; Septum forceps; Septum needle; Sheehy Flap Knife; Sheehy Weapon; Sickle knife; Sinuscope; Spatula; Speculum and accessories; Steritray; Strabismus scissors; Suction elevator; Suction tube; Superview Laparoscope System for General Surgery; Suprapubic flow controller; Swab forceps; Swivel knife; Syringe; TWIZZLE ELECTRODE (5 PACK); Teeth protector; Telescope ""IR""; Telescope ""ULTRA""; Telescope ""V-DOV""; Thorascoscope system; Throat microphone; Thumb forceps; Tongue depressor; Tonsil dissector and retractor; Tonsil forceps; Tonsil knife; Tonsil needle; Tonsil scissors; Towel forceps; Tracheal hook; Tray; Trocar; Trocar System; Hasson; Tube set; Tubing; Tubing, sterile, for UHI smoke evacuation; Tuning fork; Turbinate forceps; ULTRA Telescopes (Arthroscopes); ULTRA Telescopes (Sinuscopes); Ultra telescopes; Unipolar Optical Biopsy Forceps; Ureteroscopes, flexible and rigid, light source, video processor; VAPR ARCTIC articulating hip electrode with dome tip; VAPR COOLPULSE Curve Suction Electrode; VAPR TC ELECTRODE; VAPRFLEX END EFFECT (FLEX END EFFECT); VERSAPOINT GENERATOR; VICROSAFE 6 AND VICROSAFE 12; VISICLEAR SMOKE EVACUATION SYSTEM; VMC accessories; VMC-3; Versapoint; Vide ureteroscope; Visera Elite II Endoeye 3D; WB990310; WB990311; WB990210;WB990211; Wire curring scissors; Working Elements and insert; XUES-41 ENDOSCOPIC ELECTROSURGICAL UNIT",2016-10-28,135,2026-05-21,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013247477%22&limit=1
"Shenzhen Mindray Bio-Medical Electronics Co.,LTD",3007603826,3007603826,"Mindray Building,keji 12TH Road South Hi-Tech Industrial Park,nanshan",SHENZHEN Guangdong,,518057,China,"SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD",9058402,Exporter to the US; Repackager or relabeler; Specification developer,61,BSZ; BZK; CAD; CBK; CBQ; CBR; CBS; CCK; CCL; CDQ; CEM; CFR; CGZ; DPZ; DQA; DQK; DRG; DRQ; DRS; DRT; DSB; DSI; DSJ; DSK; DXG; DXN; FLL; GGK; GIF; GKZ; GWM; GXY; ITX; IYN; IYO; JCB; JGS; JJE; JPK; KDP; KOI; KRC; KRX; KRY; KRZ; KSA; LLZ; MHX; MLC; MLD; MNT; MSX; MUD; MWI; NHO; NHP; NHQ; OLT; OLW; OMC; ORT,"Gas-Machine, Anesthesia; Spirometer, Monitoring (W/Wo Alarm); Vaporizer, Anesthesia, Non-Heated; Ventilator, Continuous, Facility Use; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Electrode, Ion Specific, Potassium; Hexokinase, Glucose; Electrode, Ion-Specific, Chloride; Oximeter, Ear; Oximeter; Computer, Diagnostic, Programmable; Transmitters And Receivers, Physiological Signal, Radiofrequency; Amplifier And Signal Conditioner, Transducer Signal; Transducer, Blood-Pressure, Extravascular; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Plethysmograph, Impedance; Detector And Alarm, Arrhythmia; Alarm, Blood-Pressure; Computer, Blood-Pressure; Computer, Diagnostic, Pre-Programmed, Single-Function; System, Measurement, Blood-Pressure, Non-Invasive; Continuous Measurement Thermometer; Products, Red-Cell Lysing Products; Diluent, Blood Cell; Counter, Differential Cell; Device, Monitoring, Intracranial Pressure; Electrode, Cutaneous; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Detergent; Electrode, Ion Specific, Sodium; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Mixture, Hematology Quality Control; Regulator, Vacuum; Stimulator, Nerve, Peripheral, Electric; Tester, Electrode, Surface, Electrocardiographic; Calibrator For Cell Indices; Calibrator For Platelet Counting; Calibrator For Hemoglobin And Hematocrit Measurement; Calibrator For Red-Cell And White-Cell Counting; System, Image Processing, Radiological; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Monitor, St Segment; Monitor, St Segment With Alarm; Continuous, Minimal Ventilatory Support, Facility Use Ventilator; System, Network And Communication, Physiological Monitors; Oximeter, Tissue Saturation; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration); Non-Normalizing Quantitative Electroencephalograph Software; Index-Generating Electroencephalograph Software; Reduced- Montage Standard Electroencephalograph; Burst Suppression Detection Software For Electroencephalograph",1; 2,"A3 ANESTHESIA DELIVERY SYSTEM; A4 Anesthesia System; A5 ANESTHESIA DELIVERY SYSTEM; A5 Anesthesia System; A7 Anesthesia System; A8, A9 Anesthesia System; ACCUTORR 7,VS-900 VITAL SIGNS MONITOR; ACUSON Bonsai Diagnostic Ultrasound System; Accutorr 3,VS-600 Vital Signs Monitor; Accutorr 7 Vital Signs Monitor; Accutorr 7/VS-900/VS-900c Vital Signs Monitor; Anesthesia System(A5,A7,A4); Anesus I9 Easi/Eagus I9 Diagnostic Ultrasound System; BA-480 Chemistry Analyzer; BC-3200 Auto Hematology Analyzer; BC-3600 Auto Hematology Analyzer; BC-3D CONTROL (Low, Normal and High); BC-5390 Auto Hematology Analyzer; BC-5D hematology control; BS-200 Chemistry Analyzer,Pointe c2000 Chemistry Analyzer; BS-400/CLC 720 Chemistry Analyzer; BS-480 Chemistry Analyzer; BS-490 Chemistry Analyzer; BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer; BeneVision Central Monitoring System; BeneVision Central Monitoring System(BeneVision/ TMS-6016/Telepack-608/TMS60/TM80/TM70); BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 ); BeneVision N Series Patient Monitor (BeneVision N19, BeneVision N22, BeneVision N1); BeneVision N Series Patient Monitor (BeneVision N19, BeneVision N22,BeneVision N1); BeneVision N Series Patient Monitors (Including BeneVision M12 , BeneVision M12C); BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C); BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17); BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17); BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo); BeneVision N Series Patient Monitors (Including BeneVision N15 ICU, BeneVision N15 OR, BeneVision N15 Neo); BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo); BeneVision N Series Patient Monitors (Including BeneVision N19 ICU,BeneVision M22 ,BeneVision M22C); BeneVision N Series Patient Monitors (Including BeneVision N19, BeneVision N22, BeneVision N1); BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU); CD 80 Detergent; CLC720i Chemistry Analyzer; Consona AE, Consona AT, Consona N6 Exp, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System; Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S Diagnostic Ultrasound System; Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System; Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR Diagnostic Ultrasound System; Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S Diagnostic Ultrasound System; Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite Diagnostic Ultrasound System; Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite Diagnostic Ultrasound System; Crius R9 CV, Anesus R9 CV, Recho R9 Super, Recho R9 Lumi, Recho R CV, Recho R CVx Diagnostic Ultrasound System; DC-3/DC-3T Diagnostic Ultrasound System; DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System; DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic; DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System; DC-41/DC-42/DC-40T/ DC-33/DC-36/DC-38/DC-39 Diagnostic Ultrasound System; DC-50/DC-50S/DC-51/DC-52/DC-56/DC-65/DC-65S/DC-62/DC-63/DC-65T Diagnostic Ultrasound System; DC-7 Diagonostic Ultrasound System; DC-70; DC-70 Pro; DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System; DC-70/DC-70T/DC-70 PRO/DC-70 EXP DIAGNOSTIC ULTRASOUND SYSTEM; DC-70Exp; DC-70T; DC-8,DC-8 PRO,DC-8 CV,DC-8 EXP,DC-8S Diagnostic Ultrasound System; DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System; DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System; DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System; DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System; DC-90/DC-90S/DC-90Q/DC-95/DC-95S Diagnostic Ultrasound System; DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System; DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM; DC-N3 PRO DIAGNOSTIC ULTRASOUND SYSTEM; DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM; DC-T6 Diagnostic Ultrasound System; DP-10/DP-20/DP-30/DP-25 Digital Ultrasonic Diagnostic Imaging System; DP-20,DP-30 Digital Ultrasonic Diagnostic Imaging System; DP-5, DP-7 Digital Ultrasonic Diagnostic Imaging System; DP-6900 Digital Ultrasonic Diagnostic Imaging System; DP-6900,DP-50 Digital Ultrasonic Diagnostic Imaging System; Diagnostic Ultrasound System (MU7 Pro); Diagnostic Ultrasound System (MU7 Super); Diagnostic Ultrasound System (MU7P); Diagnostic Ultrasound System (MU7A); Diagnostic Ultrasound System (MU7S); Diagnostic Ultrasound System (MU7T); Diagnostic Ultrasound System (MU7 Exp); Diagnostic Ultrasound System (MU9 Exp); Diagnostic Ultrasound System (MU9 Pro); Diagnostic Ultrasound System (MU9 Super); Diagnostic Ultrasound System (MU9); Diagnostic Ultrasound System (MU9S); Diagnostic Ultrasound System (MU9T); Diagnostic Ultrasound System (MU9P); Diagnostic Ultrasound System (MU9A); Diagnostic Ultrasound System (MU7); Diagnostic Ultrasound System Anesus ME7; Diagnostic Ultrasound System Anesus ME7T; Diagnostic Ultrasound System Aquila; Diagnostic Ultrasound System ME7; Diagnostic Ultrasound System ME8; Diagnostic Ultrasound System MX7; Diagnostic Ultrasound System MX7P; Diagnostic Ultrasound System MX7T; Diagnostic Ultrasound System MX7W; Diagnostic Ultrasound System MX8; Diagnostic Ultrasound System MX8T; Diagnostic Ultrasound System Malody; Diagnostic Ultrasound System Nuda; Diagnostic Ultrasound System Vaus7; Diagnostic Ultrasound System Vaus8; Diagnostic Ultrasound System Zeus; Diagnostic Ultrasound System( Resona A MV, Eagus A20W, Eagus A20); Diagnostic Ultrasound System( Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite); Diagnostic Ultrasound System(Consona EI/Consona EF/Consona N5 Elite/Consona N5 Ultra/Consona N3/Consona N3 Exp); Diagnostic Ultrasound System(Consona N5/Consona N5 Pro/Consona N5 Super/Consona N5 Exp/Consona ER/Consona N5S); Diagnostic Ultrasound System(DC-60/DC-60S/DC-60 Exp/DC-55 ); Diagnostic Ultrasound System(Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares); Diagnostic Ultrasound System(Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M); Diagnostic Ultrasound System(Hepatus 6,Hepatus 7T,Hepatus 6S,Hepatus 5S); Diagnostic Ultrasound System(Hepatus 6T,Fibrous 7,Fibrous 5,Fibrous 6,Hepatus 7S,Hepatus 5T,Hepatus 7,Hepatus 5); Diagnostic Ultrasound System(Imagyn A20S); Diagnostic Ultrasound System(Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp); Diagnostic Ultrasound System(MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/AnesusME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8); Diagnostic Ultrasound System(Nuewa A Elite, Nuewa A MS, Nuewa A20 Premium, Nuewa A20 Plus, Nuewa A18W, Nuewa A20 Pro); Diagnostic Ultrasound System(Nuewa A20T, Nuewa A20S, Nuewa A Lumi, Nuewa AR, Imagyn A20 Exp, Imagyn A20, Imagyn A20T); Diagnostic Ultrasound System(Nuewa A20W, Nuewa A20, Nuewa A20 Exp, Nuewa A20 Elite, Nuewa A20Q, Nuewa A MV); Diagnostic Ultrasound System(Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W); Diagnostic Ultrasound System(Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T); Diagnostic Ultrasound System(Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W); Diagnostic Ultrasound System(Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20); Diagnostic Ultrasound System(Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite); Diagnostic Ultrasound System(Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20); Diagnostic Ultrasound System(Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa,Resona IV); Diagnostic Ultrasound System(TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T); Diagnostic Ultrasound System(TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite); Diagnostic Ultrasound System(TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite); Drager D-Vap DES; Drager Vapor 2000 SERVO and Vapor 2000 ISO; Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Nuewa IY Diagnostic Ultrasound System; Emerus MX5,Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp Diagnostic Ultrasound System; Emerus MX6,Emerus MX6 Exp, Anesus MX6,Anesus MX6 Exp, Crius MX6, Crius MX6 Exp Diagnostic Ultrasound System; FUKUDA Vital Signs Monitor; Gas Module 3; Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S Diagnostic Ultrasound System; Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/ Fibrous 5 Diagnostic Ultrasound System; Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp Diagnostic Ultrasound System; Imagyn I9S/Imagyn I9 Easi/Nuewa I9/Nuewa I9S Diagnostic Ultrasound System; M-30 E-Z CLEANSER; M-30CFL LYSE, M-5LEO(I) LYSE, M-5LEO(II) LYSE, M-53LH LYSE; M-30D DILUENT,M-53D DILUENT; M-30P PROBE CLEANSER; M-30R Rinse; M5 Diagnostic Ultrasound System,Various Names and Models; M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System; M7 Diagnostic Ultrasound System; M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM; M9 Diagnostic Ultrasound System; M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System; M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/ Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System; M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System; M9CV Diagnostic Ultrasound System; M9T Diagnostic Ultrasound System; MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2,MX2 BW Diagnostic Ultrasound System; MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI Diagnostic Ultrasound System; MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG Diagnostic Ultrasound System; MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System; MX7P/MX7W Diagnostic Ultrasound System; Mindray SV600 Ventilator, Mindray SV800 Ventilator; Nuewa I9T/Nuewa I9 Exp/Nuewa I9 Easi/Anesus I9 Diagnostic Ultrasound System; Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S Diagnostic Ultrasound System; Nuewa R9/Nuewa R9 Exp/Nuewa R9 Pro/Nuewa R9S Diagnostic Ultrasound System; PROBE CLEANSER; Panorama Patient Monitoring Network; Passport 12; Passport 12m,DPM6+; Passport 17m,DPM7+; Passport 8; Passport Series Patient Monitors (Passport 12m, Passport 17m); Passport Series Patient Monitors (T1); Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1); Passport Series Patient Monitors(Passport 8 and Passport 12); Patient Monitors cPM 8 and cPM 12; Recho R9W, Recho R9, Recho R9 Pro, Recho R9 Exp, Recho R9S, Recho R9T Diagnostic Ultrasound System; Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System; Resona 7/Resona 7CV/Resona 7EXP/Resona 7S Diagnostic Ultrasound Syste; Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System; Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB/ Resona 8 Diagnostic Ultrasound System; Resona 7OB/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System; Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi Diagnostic Ultrasound System; Resona I9 Easi/Resona I9 Nasa/Resona IV/Imagyn I9 Diagnostic Ultrasound System; Resona I9/Resona I9 Exp/Resona I9S/Resona I9T Diagnostic Ultrasound System; Resona I9W Diagnostic Ultrasound System; Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super Diagnostic Ultrasound System; Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S Diagnostic Ultrasound System; Resona R9/Resona R9 Exp/Resona R9 Pro/Resona R9S Diagnostic Ultrasound System; Resona R9W, Resona R7W, Nuewa R9W, Nuewa R7W Diagnostic Ultrasound System; Rosebud VC; Rosie 4; Rosie 4 Vital Signs Monitor; SC-CAL Plus Calibrator; SV70 Ventilator (SV70); T1; TE Air Diagnostic Ultrasound System; TE7 Diagnostic Ultrasound System; TE7 Diagnostic Ultrasound System,TE5 Diagnostic Ultrasound System,J5 Diagnostic Ultrasound System; TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System, J5 Diagnostic Ultrasound System; TE7/TE5/TE7 Max/ TE5 Max/TE9 Diagnostic Ultrasound System; TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System; TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System; V SERIES MONITORING SYSTEM; V60 Anesthetic Vaporizer; V80 Anesthetic Vaporizer; VS Series Vital Signs Monitors (Including VS 9/VS 8/VS 8A); VS-900 Vital Signs Monitor; VS-900c Vital Signs Monitor; Ventilator(SV600,SV800,SV700,SV900); ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Ultrasound System; ViewMateTM Ultrasound System; ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02); Vital Signs Monitors (specifically Accutorr 3, Rosebud); Vital Signs Monitors(Including VS 9, VS 8, VS 8A); Wash Solution; Yumizen C560 Chemistry Analyzer; Z.ONE PRO; Z5 DIAGNOSTIC ULTRASOUND SYSTEM; Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System; Z6 Diagnostic Ultrasound System; Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System; ZS3 /z.one pro/ ViewMate Ultrasound Systems; ZS3 Ultrasound System; ZS3 and z.one pro Ultrasound Systems; ZS3KP Elite/ ZS3 Elite /ZS4 Ultrasound Systems; ePM 15A,ePM 15C,ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC,ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC; ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ); ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC); ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M ePM 15A,ePM 15C); ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M); ePM Series Patient Monitors (Including ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC); ePM Series Patient Monitors (Including ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC); uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors; uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S); z.onepro Ultrasound System",2008-02-17,134,2026-10-16,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223007603826%22&limit=1
Siemens Healthineers AG,3002808157,3002808157,Allee am Rothelheimpark 2,ERLANGEN Bavaria,,91052,Germany,Siemens Healthineers AG,8010024,Complaint file establishment; Contract manufacturer; Exporter to the US; Manufacturer; Specification developer,19,FOX; HAW; HBL; ITY; IXJ; IYE; IZO; JAK; KPS; LLZ; LNH; LNI; MOH; MOS; MUJ; OUG; OUO; QIH; QKB,"Stand, Infusion; Neurological Stereotaxic Instrument; Holder, Head, Neurosurgical (Skull Clamp); Assembly, Tube Housing, X-Ray, Diagnostic; Grid, Radiographic; Accelerator, Linear, Medical; Generator, High-Voltage, X-Ray, Diagnostic; System, X-Ray, Tomography, Computed; System, Tomography, Computed, Emission; System, Image Processing, Radiological; System, Nuclear Magnetic Resonance Imaging; System, Nuclear Magnetic Resonance Spectroscopic; Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use); Coil, Magnetic Resonance, Specialty; System, Planning, Radiation Therapy Treatment; Medical Device Data System; Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance; Automated Radiological Image Processing Software; Radiological Image Processing Software For Radiation Therapy",1; 2,"098 1.5T Foot Ankle Coil; 098 1.5T Foot Ankle Coil Set; 1.5T Shoulder 16 Large; 13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA; 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA; 6 CHANNEL BODY COIL; ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS; AI-Rad Companion (Cardiovascular) VA20; AI-Rad Companion (Musculoskeletal) VA20; AI-Rad Companion (Pulmonary) VA20; AI-Rad Companion (Pulmonary) VA40; AI-Rad Companion Brain MR (VA60); AI-Rad Companion Brain MR VA20; AI-Rad Companion Brain MR VA40; AI-Rad Companion Brain MR VA50; AI-Rad Companion Engine; AI-Rad Companion Organs RT (VA20); AI-Rad Companion Organs RT (VA40); AI-Rad Companion Organs RT (VA50); AI-Rad Companion Organs RT (VA60); AI-Rad Companion Organs RT (VA70A); AI-Rad Companion Prostate MR; AI-Rad Companion Prostate MR (VA60); AP02 Compressed Sensing; Angiolux Family; Athlon Family; BIOGRAPH One; BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS; Biograph mMR; Biograph mMR VB20P; Biograph mMR with mMR Angio Transfer Option; Biograph mMR with syngo MR E11P System software; Biograph mMR with syngo MR E11P-AP01 system software; CHRONON Family; CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM; CORDLESS COIL - Magnetom; CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM; CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS; CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM; Chapot Table System; Chondral Quant; DURA Family; Endomap; FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR; Flex Loop Coil Set 3 T; Flex and Loop Coil Set 1.5 T; Gigalix Family; Hand/Wrist 16 1.5T; Hand/Wrist 16 1.5T Coil set; Head/Neck 64, Breast 18 and Body 18 long; IDEA DVD E11A; INTERACTIVE REAL TIME SCANNING PACKAGE; Innovision Audio; Innovision Display; LungMaps; MAGNEITOM Systems I -class and] T-class releases; MAGNETIC CONCERTO; MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016; MAGNETOM ALLEGRA SYSTEM; MAGNETOM AVANTO MR SYSTEM; MAGNETOM Aera; MAGNETOM Aera (MR E11C-AP01); MAGNETOM Aera - Mobile Solution with Tim Dockable Table; MAGNETOM Aera 1.5T System; MAGNETOM Aera with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow; MAGNETOM Aera with software syngo MR D13A with add'l coils; MAGNETOM Aera with syngo MR; MAGNETOM Aera with syngo MR D11; MAGNETOM Aera with syngo MR D13E; MAGNETOM Aera with syngo MR E11C-AP04 SW; MAGNETOM Aera with syngo MR XA60A; MAGNETOM Aera with syngo SW XA30A; MAGNETOM Altea; MAGNETOM Altea with SW syngo MR XA11B; MAGNETOM Altea with software syngo MR XA20A; MAGNETOM Altea with syngo MR XA31A; MAGNETOM Altea with syngo MR XA51A; MAGNETOM Altea with syngo MR XA61A; MAGNETOM Amira; MAGNETOM Amira (syngo MR XA12M); MAGNETOM Amira with software syngo MR E11S; MAGNETOM Artis Combi Suite; MAGNETOM Avanto; MAGNETOM Avanto Fit; MAGNETOM Avanto Fit with syngo MR XA50A; MAGNETOM Avanto MR E11D; MAGNETOM Avanto fit with syngo XA61A; MAGNETOM Avanto w/syngo MR E11D; MAGNETOM Avantofit with SW syngo VE11E; MAGNETOM Avantofit with syngo MR E11C-AP04 SW; MAGNETOM Cima.X; MAGNETOM Cima.X Fit; MAGNETOM Combi Suite Neurosurgery for MAGNETOM systems Aera and Skyra.; MAGNETOM ESPREE SYSTEM; MAGNETOM ESSENZA WITH SYNGO MR D14; MAGNETOM Espree; MAGNETOM Flow.Ace; MAGNETOM Flow.Elite; MAGNETOM Flow.Elite (SW syngo MR XB20A); MAGNETOM Flow.Neo; MAGNETOM Flow.Neo (SW syngo MR XB20A); MAGNETOM Flow.Plus; MAGNETOM Flow.Plus Z; MAGNETOM Flow.Pure (SW syngo MR XB20A); MAGNETOM Flow.Rise; MAGNETOM Flow.Rise (SW syngo MR XB20A); MAGNETOM Free.Max; MAGNETOM Free.Max with syngo MR XA50A; MAGNETOM Free.Max with syngo XA60A; MAGNETOM Free.Star; MAGNETOM Free.Star with syngo MR XA50A; MAGNETOM Free.Star with syngo XA60A; MAGNETOM Lumina; MAGNETOM Lumina (syngo MR XA11B); MAGNETOM Lumina with syngo MR XA31A; MAGNETOM Lumina with syngo MR XA50A; MAGNETOM Lumina with syngo MR XA60A; MAGNETOM Mica; MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE); MAGNETOM Prisma Fit with syngo MR XA60A; MAGNETOM Prisma with syngo MR E11C-AP04 SW; MAGNETOM Prisma with syngo MR XA60A; MAGNETOM Prisma/ Prismafit with syngo SW XA30A; MAGNETOM Prismafit with syngo MR E11C-AP04 SW; MAGNETOM SOLA; MAGNETOM SYMPHONY A TIM SYSTEM; MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION; MAGNETOM Sempra; MAGNETOM Sempra (syngo MR XA12M); MAGNETOM Skyra; MAGNETOM Skyra Fit; MAGNETOM Skyra Fit with syngo MR XA50A; MAGNETOM Skyra fit with syngo XA61A; MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow; MAGNETOM Skyra with software syngo MR D13A with add'l coils; MAGNETOM Skyra with syngo MR; MAGNETOM Skyra with syngo MR D11; MAGNETOM Skyra with syngo MR E11C-AP04 SW; MAGNETOM Skyra with syngo MR XA60A; MAGNETOM Skyra with syngo SW XA30A; MAGNETOM Skyrafit with syngo MR E11C-AP04 SW; MAGNETOM Sola; MAGNETOM Sola Fit; MAGNETOM Sola Fit with software syngo MR XA20A; MAGNETOM Sola Fit with syngo MR XA51A; MAGNETOM Sola w/XJ gradient system; MAGNETOM Sola w/syngo MR XA11A; MAGNETOM Sola with Nexaris Angio-MR; MAGNETOM Sola with software syngo MR XA20A; MAGNETOM Sola with syngo MR XA31A; MAGNETOM Sola with syngo MR XA51A; MAGNETOM Sola with syngo MR XA61A; MAGNETOM Spectra; MAGNETOM Spectra with syngo MR E11M; MAGNETOM Symphony; MAGNETOM Systems with SW syngo MR 2006A (SW VB13); MAGNETOM TRIO A TIM SYSTEM; MAGNETOM Terra; MAGNETOM Terra (syngo MR E12U); MAGNETOM Terra with syngo MR XA60A; MAGNETOM Terra.X (7T) with syngo MR XA60A; MAGNETOM Trio; MAGNETOM VERIO; MAGNETOM VIDA; MAGNETOM Verio; MAGNETOM Verio MR E11D; MAGNETOM Verio w/syngo MR E11D; MAGNETOM Viato.Mobile; MAGNETOM Viato.Mobile with syngo MR XA51A with XQ Gradient; MAGNETOM Vida; MAGNETOM Vida (syngo MR XA11B); MAGNETOM Vida Fit; MAGNETOM Vida Fit with syngo MR XA50A; MAGNETOM Vida with Compressed Sensing GRASP-VIBE; MAGNETOM Vida with Nexaris Angio-MR; MAGNETOM Vida with syngo MR XA31A; MAGNETOM Vida with syngo MR XA50A; MAGNETOM Vida with syngo MR XA60A; MR VB10 software upgrade; MRI Patient Positioning Device; MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A; Magnetom Prisma; Magnetom Prisma fit; Magnetom Spectra; Megalix Cat Family; Megalix Cat Plus Family; Megalix Family; NORAS Head Coil-Bottom Half Only; NORAS OR HEAD HOLDER - for Symphony/Sonata Table/Miyabi transport/Espree or TIM Trio; NORAS Surgery Head Coil, Set, 3T; NUMARIS 4VA15A software; Noras - OR HEAD COIL 1.5 T; Noras OR Head Holder + Coil Set 3T; OPTIPHOS Family; OR 8-channel coil #Es; OR Head Coil 3T; OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS; Opti Family; Optilix Family; Optitop Family; P40 MoW-100G; Polydoros A100 Family; Polydoros ACX; Polydoros F / Polydoros R Family; Polydoros RF Family; Polydoros RFX; RAY Family; RAYCAST® Immobilization Systems Hardware and Thermoplastic Materials; S3P-Monoblock; SIREPHOS Family; SMB Family; SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/ VERIO; SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM; STRATON Family; SYNGO MR B17; SYNGO.MR SPECTRO ENGINE SYNGO.MR SPECTRO SVS SYNGO.MR SPECTRO CSI SYNGO.MR SPECTRO EXTENSION; Shoulder Shape 16; Shoulder shape 16 coil set 1.5T; Software syngo MR B19 for MAGNETOM Avanto; Software syngo MR B19 for MAGNETOM Espree; Software syngo MR B19 for MAGNETOM Symphony A Tim System; Software syngo MR B19 for MAGNETOM Trio A Tim System; Software syngo MR B19 for MAGNETOM Verio; Software syngo MR B20P for Biograph mMR; Software syngo MR E11A for the MAGNETOM systems Aera/Skyra; Stationary X-Ray Grid; Syngo MR E11; Syngo MR E11 for MAGNETOM Aera (24) (1.5T), MAGNETOM  Avantofit (1.5T), MAGNETOM Skyrafit (3T) and MAGNETOM  Prisma/Prismafit (3T); Syngo MR XB10; Syngo MR XB10A; TR Family; TX/RX Knee 18; TX/RX Knee 18 Coil Set 1.5T; Tim TX TrueShape and VD13C for MAGNETOM Skyra; VA10A; VD13A Quiet MRI and Fast Reliable Body MRI; Vectron Family; XA70A; XA80A; XB10; syngo BreVis Biopsy MRWP # Tim; syngo BreVis MRWP # Tim; syngo Comp. HW Upgrade E11 AWP+MRWP; syngo Computer HW Upgrade E11 AWP; syngo Dynamics (VA41D); syngo MR 2002B; syngo MR BI 5; syngo MR E11C; syngo MR E11C software for MAGNETOM Aera MR Systems; syngo MR E11C software for MAGNETOM Avantofit MR Systems; syngo MR E11C software for MAGNETOM Prisma/Prismafit MR Systems; syngo MR E11C software for MAGNETOM Skyra MR Systems; syngo MR E11C software for MAGNETOM Skyrafit MR Systems; syngo MR E11Q; syngo MR E11Q SW for the MAGNETOM ESSENZA; syngo MR XA10A; syngo mMR General; syngo.MR Applications; syngo.MR Applications with new software version SMR VB40A; syngo.MR Brain; syngo.MR BreVis; syngo.MR Cardiology; syngo.MR General; syngo.MR General VB20; syngo.MR Neurology; syngo.MR Oncology; syngo.MR Vascular; syngo.mMR General; syngo.via VA20 (without Alpha Algorithm)",2003-03-26,134,2026-09-01,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223002808157%22&limit=1
Voma Ecza Deposu Medikal Urunler San. Tic. A.S.,3017210488,3017210488,Fatih Mah. 1191 SK. 26/2 A Blok Gaziemir,Izmir,,35410,Turkey,VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S.,10076888,Exporter to the US,67,BSP; DQO; DQX; DQY; DWM; EQJ; ERL; ETN; EZB; FAD; FCG; FDF; FDT; FFL; FGB; FHO; FMI; FMK; FPA; FTL; FZP; GAG; GAT; GCI; GCJ; GDO; GDT; GDW; GEI; GET; GXY; GXZ; HAW; HBB; HBC; HBE; HDA; HRX; HWC; HWE; IKT; JDR; JKA; JOH; KDW; KFK; KGX; KNQ; KNW; KRA; LRC; LXH; MBI; MOF; MSD; NBH; NIQ; NUJ; NYU; OCT; OCW; OCY; ODD; OXJ; PKL; QEW; QJP,"Needle, Conduction, Anesthetic (W/Wo Introducer); Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Apparatus, Suction, Patient Care; Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Stimulator, Nerve; Stylet For Catheter, Gastro-Urology; Stent, Ureteral; Biopsy Needle; Colonoscope And Accessories, Flexible/Rigid; Duodenoscope And Accessories, Flexible/Rigid; Dislodger, Stone, Basket, Ureteral, Metal; Ureteroscope And Accessories, Flexible/Rigid; Pneumoperitoneum Needle; Needle, Hypodermic, Single Lumen; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Set, Administration, Intravascular; Mesh, Surgical, Polymeric; Clip, Implantable; Stapler, Surgical; Suture, Nonabsorbable, Synthetic, Polyethylene; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Removable (Skin); Staple, Implantable; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Pneumatic Powered; Electrode, Cutaneous; Electrode, Needle; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Motor, Drill, Electric; Drills, Burrs, Trephines & Accessories (Simple, Powered); Forceps, Obstetrical; Arthroscope; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Electrode, Needle, Diagnostic Electromyograph; Staple, Fixation, Bone; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tube Tracheostomy And Tube Cuff; Container, Specimen Mailer And Storage, Temperature Controlled, Sterile; Saw, Pneumatically Powered; Tape And Bandage, Adhesive; Dilator, Esophageal; Instrument, Biopsy; Catheter, Continuous Flush; Instrument, Ent Manual Surgical; Orthopedic Manual Surgical Instrument; Fastener, Fixation, Nondegradable, Soft Tissue; Guide, Wire, Catheter, Neurovasculature; Catheter, Hemodialysis, Implanted; Accessories, Arthroscopic; Coronary Drug-Eluting Stent; Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed; Catheter, Hemodialysis, Implanted, Coated; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Tissue Approximation Device; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula; Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects; Hemostatic Metal Clip For The Gi Tract; Peripheral Mechanical Thrombectomy With Aspiration; Catheter, Percutaneous, Neurovasculature",1; 2; 3,,2020-08-04,133,2025-10-16,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223017210488%22&limit=1
Arthrocare Corporation,3012358417,3012358417,"B32.1, St2 Zona Franca Coyol",Coyol Alajuela,,20101,Costa Rica,"Smith & Nephew, Inc.",1020279,Contract manufacturer; Manufacturer; Remanufacturer; Repackager or relabeler,42,EMX; FEI; FMP; FSM; FTM; GAE; GAT; GEA; GEI; GFG; HRR; HRX; HTN; HTW; HTY; HWB; HWC; HWE; HWQ; HWX; HXB; HXG; HXK; HXL; HXY; JDR; KDD; KGS; KQZ; LXH; LYA; LYU; MAI; MBI; MDM; NAD; NBH; OCW; OMP; ORQ; OWY; QFC,"Balloon, Epistaxis; Instrument, Special Lens, For Endoscope; Protector, Skin Pressure; Tray, Surgical, Instrument; Mesh, Surgical; Snare, Surgical; Suture, Nonabsorbable, Synthetic, Polyethylene; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Bit, Surgical; Scissors, Orthopedic, Surgical; Arthroscope; Washer, Bolt Nut; Bit, Drill; Pin, Fixation, Smooth; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Passer; Tap, Bone; Probe; Tamp; Holder, Needle; Orthopedic; Mallet; Brace, Drill; Staple, Fixation, Bone; Kit, Surgical Instrument, Disposable; Retention Device, Suture; Component, Traction, Non-Invasive; Orthopedic Manual Surgical Instrument; Splint, Intranasal Septal; Accessory, Surgical Apparel; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Instrument, Manual, Surgical, General Use; Dressing, Wound, Occlusive; Accessories, Arthroscopic; Endoscopic Tissue Approximation Device; Negative Pressure Wound Therapy Powered Suction Pump; Mesh, Surgical, Deployer; Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon; Negative Pressure Wound Therapy Device For Reduction Of Wound Complications",1; 2,"""BIORAPTOR KNOTLESS SUTURE ANCHOR, SHOULDER CLOSE""; (6) MINITAPE (BLUE) 39.5; (6) MINITAPE (COBRAID BLUE) 39.5; (6) MINITAPE (COBRAID WHITE) 39.5; 1.2 ENDOBUTTON CL ULTRA PAC; 1.2 RAP-PAC A LATEX FREE; 1.2 RAP-PAC A, 72202796; 1.2 RAP-PAC B LATEX FREE; 1.2 RAP-PAC B, 72202797; 1.2 RAP-PAC C; 1.5 MM TENDON DRILL PIN; 1.5mm Guidewire, 12"", 72202189; 1.6MM DRILL & GUIDE DYNOMITE 2; 1.8MM DRILL & GUIDE SPYROMITE/MINI 2; 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (BLUE); 1.8MM Q-FIX ALL-SUTURE ANCHOR WITH ONE MINITAPE SUTURE (COBRAID WHITE); 10 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10 X 30 MM BIORCI SCREW; 10.5 MM CANNULATED DRILL; 10.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 10.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 10MM DILATOR; 11 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11.5 MM CANNULATED DRILL; 11.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 11.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 11MM DILATOR; 12 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 12.5 MM CANNULATED DRILL; 12.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 12MM DILATOR; 13 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 13.5 MM CANNULATED DRILL; 15 DEGREE CLOSED CURETTE 3 MM; 15 DEGREE OPEN CURETTE 2.5 MM; 15 DEGREE OPEN CURETTE 4 MM; 15 DEGREE OSTEOTOME 3MM; 15 MM ENDOBUTTON CL BTB; 15MM SUTURE WASHER STER. BOX OF 1; 17MM SUTURE WASHER STER. BOX OF ONE; 2-5 MM OFFSET GUIDE; 2.3 MM BIORAPTOR PK SUTURE ANCHOR WITH ONE ULTRABRAID No.2 WHITE, SUTURE, STERILE; 2.4 MM FLEXIBLE PASSING PINS, STERILE 5 PER PACKAGE; 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE; 2.4MM PASSING PIN WITH CALIBRATION MARKS; 2.4MM X 10 INCH DRILL-TIP GUIDE WIRE; 2.4MM X 11 INCH 28 CM TROCAR-TIP PASSING PIN; 2.6 MM TWIST DRILL BIT FOR 2.3 ANCHOR; 2.6MM DRILL & GUIDE RAPTORMITE 3; 2.7 MM CHISEL GUARD; 2.7 MM DILATOR; 2.7 MM DRILL GUIDE; 2.7 MM X 15 INCH 38 CM DRILL-TIP PASSING PIN, NON-STERILE 6 PER PACKAGE; 2.8MM Q-FIX ALL-SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE); 2.8mm QFIX Knotless All Suture Anchor; 20 DEGREE OSTEOTOME 4MM; 3.2MM DRILL & GUIDE RAPTORMITE 3.7; 3.5 MM DILATOR; 3.5MM SPADE TIP DRILL FOR USE WITH 4.5 MM ANCHOR HOLE PREPARATION DEVICE FOR HARD BONE; 30 DEGREE OPEN CURETTE 2.5 MM; 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS; 4 MM PORTAL STICK X 12 INCH 30 CM LONG; 4 MM SHOULDER ROD X 12 INCH 30 CM LONG; 4.5 MM DILATOR; 4.5 MM DRILL GUIDE; 4.5 MM OBTURATOR, CONICAL TIP; 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS; 5 MM CANNULATED DRILL; 5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, BLUE, LARGE DELRIN HANDLE; 5 MM FLEXIBLE DRILL; 5 MM HALF-ROUND RASP; 5.5 MM CANNULATED DRILL; 5.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 5.5 MM EXTENDED LENGTH OBTURATOR, CANNULATED, RED, LARGE DELRIN HANDLE; 5.5 MM OBTURATOR, CONICAL TIP, FOR CANNULAS WITH FLUID SEALS; 5.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6 MM ENDOSCOPIC DRILL; 6 MM OFFSET ENDOFEMORAL AIMER; 6 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6.5 MM CANNULATED DRILL; 6.5 MM CHISEL GUARD; 6.5 MM DELIVERY TAMP; 6.5 MM DILATOR; 6.5 MM DRILL GUIDE; 6.5 MM ENDOSCOPIC DRILL; 6.5 MM HARVESTING TAMP; 6.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 6.5 MM TREPHINE FOR HARD BONE; 6.5 MM TUBULAR CHISEL; 6.5MM DILATOR; 6MM DILATOR; 7 MM OFFSET ENDOFEMORAL AIMER; 7 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 7 MM X 25 MM REVERSE THREAD BIORCI SCREW; 7 X 20 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 20 MM SOFTSILK SCREW 1.5 STERILE; 7 X 25 MM BIORCI SCREW; 7 X 25 MM BIORCI SCREW WITH AN 8 MM HEAD; 7 X 25 MM RCI SCREW REVERSE THREAD 2 MM CANNULATION. STERILE, 1 PER BOX.; 7 X 25 MM RCI SCREW WITH 8 MM HEAD 2 MM CANNULATION. STERILE, 1 PER BOX; 7 X 25 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 25 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 25 MM SOFTSILK SCREW 1.5 STERILE; 7 X 30 MM BIORCI SCREW; 7 X 30 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 30 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 7 X 30 MM SOFTSILK SCREW 1.5 STERILE; 7 X 40 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 7.5 MM CANNULATED DRILL; 7.5 MM ENDOSCOPIC DRILL; 7.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 7.5MM DILATOR; 72290007 Wired Foot Control; 72290008 Wireless Foot Contol; 72290037 Werewolf FLOW 50 Coblation Wand (E-beam); 72290057 Werewolf Power Cord/Manual - US English; 72290058 Werewolf Power Cord/Manual - N. America; 72290059 Werewolf Power Cord/Manual - W. Europe; 72290060 Werewolf Power Cord/Manual - EU Spanish; 72290061 Werewolf Power Cord/Manual - EU English; 72290062 Werewolf Power Cord/Manual - Scandinavia; 72290063 Werewolf Power Cord/Manual - Russia; 72290064 Werewolf Power Cord/Manual - Korea; 72290065 Werewolf Power Cord/Manual - Switzerlalnd; 72290066 Werewolf Power Cord/Manual - China; 72290067 Werewolf Power Cord/Manual -Australia; 72290068 Werewolf Power Cord/Manual - Japan; 72290105 Werewolf RF20000 Controller; 7MM BICEPTOR TAP; 7MM DILATOR; 7MM ENDOSCOPIC DRILL XL; 7MM TENDON FORK; 8 MM ENDOSCOPIC DRILL XL; 8 MM PL TIBIAL AIMER POST; 8 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 8 X 20 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 20 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 20 MM SOFTSILK SCREW 1.5 STERILE; 8 X 25 MM BIORCI SCREW; 8 X 25 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 8 X 25 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 25 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 25 MM SOFTSILK SCREW 1.5 STERILE; 8 X 30 MM BIORCI SCREW; 8 X 30 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 30 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 8 X 30 MM SOFTSILK SCREW 1.5 STERILE; 8 X 35 MM BIORCI SCREW; 8 X 40 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 8.5 MM CANNULATED DRILL; 8.5 MM DELIVERY TAMP; 8.5 MM DILATOR; 8.5 MM DRILL GUIDE; 8.5 MM ENDOSCOPIC DRILL; 8.5 MM HARVESTING TAMP; 8.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 8.5 MM TREPHINE FOR HARD BONE; 8.5 MM TUBULAR CHISEL; 8.5MM DILATOR; 8MM BICEPTOR TAP; 8MM DILATOR; 8MM TENDON FORK; 9 MM ENDOSCOPIC DRILL XL; 9 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9 MM X 15 MM BICEPTOR REPAIR KIT, INCLUDES BIOSURE PK INTERFERENCE SCREW, 1.5 MM GUIDE PIN, AND 2.4 MM GUIDE WIRE; 9 X 20 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 20 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 20 MM SOFTSILK SCREW 1.5 STERILE; 9 X 25 MM BIORCI SCREW; 9 X 25 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 25 MM SOFTSILK 2 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 25 MM SOFTSILK SCREW 1.5 STERILE; 9 X 30 MM BIORCI SCREW; 9 X 30 MM SOFTSILK 1.5 SCREW CANNULA LATEX FREE. SHEATED IN CLEAR-TRAC; 9 X 30 MM SOFTSILK 2 SCREW, WITH CLEAR-TRAC SCREW CANNULA LATEX FREE; 9 X 30 MM SOFTSILK SCREW 1.5 STERILE; 9 X 35 MM BIORCI SCREW; 9 x 25 MM RCI SCREW 2 MM CANNULATION. STERILE, 1 PER BOX; 9.5 MM CANNULATED DRILL; 9.5 MM ENDOSCOPIC CANNULATED DRILL BIT; 9.5 MM SINGLE FLUTE DRILL BIT, ENDOSCOPIC CANNULATED; 9.5MM DILATOR; 90 DEGREE CURETTE, ANTERIOR LESION; 9MM BICEPTOR TAP; 9MM DILATOR; 9MM TENDON FORK; A-Tech ACL Sterilization Tray; A-Tech Controlled Flexion Guidewire; A-Tech Femoral Locator Handle; ABLATOR E-FLEX VULCAN INTEGRATED; ABLATOR MICRO VULCAN INTEGRATED; ABLATOR VULCAN 60 DEG; ABLATOR VULCAN 60 DEG 2MM; ABLATOR VULCAN 90 DEG HP; ABLATOR-S 2MM 60DEG; ABLATOR-S MICRO VULCAN 2MM 60 DEG; ABLATOR-S VULCAN 60 DEG; ABLATOR-S VULCAN 90 DEG; ABLATOR-S VULCAN 90 DEG HP; ACCORD; ACCU-PASS STR SHTL BIG C STERILE BOX 1; ACCU-PASS SUTURE SHUTTLE 70 DEGREE; ACCU-PASS SUTURE SHUTTLE J-HOOK STERIL; ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE; ACCUPASS STR SHUTL MONOFIL -SEE72201361; ACL Bullet; ACL Closed Curette; ACL Disposables Guidewire Kit; ACL Disposables Kit; ACL Open Curette; ACL Tunnel Rasp; ACUFEX CANNULATED BONE TUNNEL PLUGS; ACUFEX DIRECTOR ACL ELBOW AIMER; ACUFEX DIRECTOR ACL TIP AIMER; ACUFEX DIRECTOR ANGLED BULLET; ACUFEX DIRECTOR DRILL GUIDE. REQUIRES 1 AIMER AND 1 BULLET NOT INCLUDED; ACUFEX DIRECTOR PCL FEMORAL AIMER; ACUFEX DIRECTOR PCL SAFETY STOP; ACUFEX EXTRA ARTICULAR RECONSTRUCTION FEMORAL GUIDE; ACUFEX EXTRA ARTICULAR RECONSTRUCTION OFFSET GUIDE; ACUFEX Extra-Articular Reconstruction Fibular Guide; ACUFEX Extra-Articular Reconstruction Long Bullet; ACUFEX Extra-Articular Reconstruction Short Bullet; ACUFEX Extra-Articular Reconstruction System Tray; ACUFEX Extra-Articular Reconstruction Tibial Guide; ACUFEX Extra-Articular Retractor; ACUFEX MTO PUNCH BASKET DUCKBILL UPBITER CURVED RIGHT PRO HANDLE; ACUFEX PINPOINT ADAPTER; ACUFEX PINPOINT BULLET 4 POINT - 6.5; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-6MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 5-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 6-7MM; ACUFEX PINPOINT DBL BNDL BLT SUPRT 7-8MM; ACUFEX PINPOINT DBL BNDL BULL SPT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-6MM; ACUFEX PINPOINT DBL BNDL GD LEFT 5-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-7MM; ACUFEX PINPOINT DBL BNDL GD LEFT 6-8MM; ACUFEX PINPOINT DBL BNDL GD LEFT 7-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-6MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 5-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-7MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 6-8MM; ACUFEX PINPOINT DBL BNDL GD RIGHT 7-8MM; ACUFEX PINPOINT INSIDE-OUT HANDLE; ACUFEX PINPOINT OUTSIDE-IN AMR ARM LEFT; ACUFEX PINPOINT OUTSIDE-IN AMR ARM RT; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 10MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 6MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 8MM; ACUFEX PINPOINT SINGLE BUNDLE GUIDE 9MM; ACUFEX PINPOINT SNGL BNDL GD 7MM; ACUFEX PUNCH BASKET CURVED RIGHT PRO HANDLE; ACUFEX PUNCH BASKET LEFT PRO HANDLE; ACUFEX PUNCH BASKET PRO RIGHT PRO HANDLE; ACUFEX PUNCH BASKET STRAIGHT PRO HANDLE; ACUFEX PUNCH BASKET UPBITER PRO HANDLE; ACUFEX PUNCH BASKET UPSWEPT PRO HANDLE; ACUFEX PUNCH OVAL STRAIGHT PRO HANDLE; ACUFEX PUNCH OVAL UPBITER PRO HANDLE; ACUFEX PUNCH SCISSOR STRAIGHT PRO HANDLE; ACUFEX PUNCH SCISSOR UPBITER PRO HANDLE; ACUFEX TRUNAV; ACUFEX TRUNAV RETROGRADE DRL 10.5MM; ACUFEX TRUNAV RETROGRADE DRL 10MM; ACUFEX TRUNAV RETROGRADE DRL 11.5MM; ACUFEX TRUNAV RETROGRADE DRL 11MM; ACUFEX TRUNAV RETROGRADE DRL 12MM; ACUFEX TRUNAV RETROGRADE DRL 6.5MM; ACUFEX TRUNAV RETROGRADE DRL 6MM; ACUFEX TRUNAV RETROGRADE DRL 7.5MM; ACUFEX TRUNAV RETROGRADE DRL 7MM; ACUFEX TRUNAV RETROGRADE DRL 8.5MM; ACUFEX TRUNAV RETROGRADE DRL 8MM; ACUFEX TRUNAV RETROGRADE DRL 9.5MM; ACUFEX TRUNAV RETROGRADE DRL 9MM; ACUFEX TUNNEL GAUGE; ACUFEX-PRO 3.4MM CUPPED GRASPR; ACUFEX-PRO NARROWLINE STR; ACUFEX-PRO NARROWLINE UPBITER; ACUFEX-PRO PITBULL GRASPER; ADVANSYS; ADVANSYS TTC; AIMER ENDOFEMORAL 3MM OFFSET (BLUE); AIMER ENDOFEMORAL 4MM OFFSET (PURPLE); AIMER ENDOFEMORAL 5MM OFFSET (RED); AIMER REAR ENTRY RIGHT-ACL; AIMER REAR ENTRY-LEFT; AIMER TIBIAL PCL; AIO Tray, 72205205; AMBI; AMBIENT™ Super MULTIVAC 50™ Wand with Integrated Finger Switches; ANKLE ARTHROSCOPY ACCESSORY 2 UNITS; ARIS COBLATION Turbinate Reduction Wand; ARTHRO-PIERCE STRAIGHT; ARTHRO-ROUND XL; ARTHROGARDE 4.5MM HIP CANNULA; ARTHROGARDE 5.5MM HIP CANNULA; ARTHROGARDE 5MM HIP CANNULA; ARTHROGARDE SLOTTLED CANNULA HIP; ARTHROPIERCE; ARTHROPIERCE 35 DEGREE UP; ARTHROPIERCE 45 DEG RIGHT; ARTHROPIERCE 45 DEGREE LEFT; ARTHROPIERCE INSTRUMENT CURVED LEFT; ARTHROPIERCE INSTRUMENT CURVED RIGHT; ARTHROPIERCE UTRATAPE; ARTHROPIERCE XL STRAIGHT; ARTHROSCOPIC LATARJET/BONE BLOCK LID; ARTHROSCOPIC LATARJET/BONE BLOCK TRAY; ARTHROSCOPIC NEEDLE STERILE; AUTOCLAVABLE ARTHROSCOPE STERILIZATION TRAY 9.5 INCH LENGTH X 3 INCH WIDTH X 1.25 INCH HEIGHT; AWL STRAIGHT 3.8MM DISPOSABLE; AWL, INSERTION SITE MARKING, 45 DEGREES; Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361; Accu-pass suture shuttle 45 degree up, 7210425; Accu-pass suture shuttle 70 degree, Upbend, 72200419; Accu-pass suture shuttle J-hook; Accu-pass suture shuttle left 45 degree, 7210423; Accu-pass suture shuttle right 45 degree; Accu-pass suture shuttle, Big Curve; Accu-pass suture shuttle, crescent, 7210427; Accu-pass suture shuttle, straight, 7210426; Acufex Access Advanced Positioning Kit; Acufex Access Cart; Acufex Access Positioning Kit; Adaptor; All- Suture 1.9mm Anchor with ULTRABRAID Suture; All-Suture 1.7mm Anchor with ULTRABRAID Suture; Ambient CoVac 50 IFS; Ambient CoVac 70 IFS; Ambient HipVac 50 IFS; Ambient HipVac 50 Wand with Integrated Finger Switches; Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS); Ambient Kvac IFS; Ambient MegaVac 90; Ambient Super TurboVac 90; Anatomic ACL Tray; Ankle Distractor; Ankle Distractor Strap; Arthroscopic needle, 72202825; Ascension; Awl straight 3.8mm, 72202986; Awl tapered 3.8mm; Awl, tap, driver, dilator; BANKART RASP; BI-GRIP PIN PULLER; BICEPTOR 7 MM X 15 MM PK SCREW; BICEPTOR 7 MM X 25 MM PK SCREW; BICEPTOR 8 MM X 15 MM PK SCREW; BICEPTOR 8 MM X 25 MM PK SCREW; BICEPTOR 9 MM X 15 MM PK SCREW; BICEPTOR 9 MM X 25 MM PK SCREW; BICEPTOR DRIVER; BIORAPTOR 2.3 PK; BIORAPTOR 2.3 PK SUTURE ANCHOR WITH ONE No.2 PRELOADED ULTRABRAID SUTURE, COBRAID BLACK/WHITE; BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (Cobraid Black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (Cobraid Blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (White); BIORAPTOR 2.3 PK suture Anchor w/ULTRABRAID #2 Suture (cobraid blue); BIORAPTOR 2.9mm Suture Anchor with one 38” ULTRABRAID Co-Braid Suture (#2); BIORAPTOR 2.9mm Suture Anchor with two 38” DURABRAID Sutures (USP#2); BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures (#2); BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures and Needles; BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR WITH ONE 38 INCH ULTRABRAID No. 2 SUTURE COBRAID BLACK SHOULDER; BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR, WITH ONE ULTRABRAID No.2 SUTURE COBRAID-BLUE; BIORAPTOR Curved 2.3 PK; BIORAPTOR Curved 2.3 PK Suture Anchor w/ One ULTRABRAID Suture (Cobraid Black); BIORAPTOR Curved 2.3 PK Suture Anchor w/ One ULTRABRAID Suture (Cobraid Blue); BIORAPTOR INLINE DRILL GUIDE - OFFSET FISHMOUTH TIP 2.9 MM; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, CROWN TIP; BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP; BIORAPTOR KNOTLESS INLINE OBTURATOR, BLUNT; BIORAPTOR KNOTLESS SUTURE ANCHOR; BIORAPTOR Knotless Suture Anchor; BIORAPTOR Knotless Suture Anchor, Hip; BIORAPTOR TWIST DRILL, 2.9 MM INLINE; BIORCI SCREW, Sterile; BIORPTR 2.3 PK SUTR ANCR ONE 38 C/B BK; BIOSURE EASY TAP 10MM; BIOSURE EASY TAP 6MM; BIOSURE EASY TAP 7MM; BIOSURE EASY TAP 8MM; BIOSURE EASY TAP 9MM; BIOSURE RATCHET DRIVER; BIOSURE SYNC Inserter; BIOSURE TAP 10MM; BIOSURE TAP 6MM; BIOSURE TAP 7MM; BIOSURE TAP 8MM; BIOSURE TAP 9MM; BIRAPTR 2.3 PK SUTR ANCR ONE 38 C/B BL; BLT ASSY. 4 POINT DIRECTOR; BLUNT NOSE JR. PUNCH; BOARD, PATIENT TRANSFER; BONE ANCHORS 3 WITH ARTHROSCOPIC DELIVERY SYSTEM ADVANCED; BONE GRASPER; BONE TUNNEL PLUG; BONE TUNNEL PLUG NON-CANNULATED, LARGE 10-11 MM 3 PER PACKAGE; BONE TUNNEL PLUG NON-CANNULATED, SMALL 7-8 MM 3 PER PACKAGE; BONE TUNNEL PLUG XL 11-12 MM 3 PER PACKAGE; BOOT INSERT PAD; Beath pin 2.4mm, 72202815; Beluga Retro; Bilok Instrument Sterilization Tray; Bilok ST Graft Expander; Bioinductive Implant with Arthroscopic Delivery System - Large; Bioinductive Implant with Arthroscopic Delivery System - Medium; Bioinductive Implant; Collagen Tendon Sheet - Ddi; Biosure 1.2mm x 18"", 72201201; Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile; Blunt Nose Junior; Bone Anchor Spare, 4403; Bone Anchor Spare, 72205199; Bone Tap; CAMERA COUPLER,16:9 HD REF; CANN 5.5 WO/HOLES LTX FREE ORANGE; CANN DIAG RTTBL DBL VLV 4.5 ASCOPE; CANN DV ROT HF STORZ INT 6MM; CANN H.F. DGNST 6MM RTBL SGL VLV; CANN M.F. DGNST 6MM HIP DBL VLV; CANNU-FLEX 1.5 MM X 305 MM 62 INCH X 12 INCH GUIDE WIRE; CANNU-FLEX 6 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 6 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 6 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 7 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX 8 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 8 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 20 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 25 MM 1 SCREW, STERILE; CANNU-FLEX 9 MM X 30 MM 1 SCREW, STERILE; CANNU-FLEX DRIVER SILK SCREW 7MM CANNULATED; CANNU-FLEX DRIVER SILK SCREW 9MM CANNULATED; CANNU-FLEX GDE WIRES 45X12; CANNU-FLEX SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM 6 PER PACKAGE; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 12 INCH 30 CM, BLUNT TIP, STERILE; CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE; CANNULA; CANNULA 2.9MM LONG WINDOW ASSEMBLY; CANNULA 2.9MM SHORT WINDOW; CANNULA 5.5MM OPER. W/STOPCOCK; CANNULA 5.5MM W/FINGER POST; CANNULA 6MM FMS 4MM AS W/O STOPCK; CANNULA 6MM FMS4MM ASCOPE W/STPCK; CANNULA CLEARTRAC 4.5 X 72MM THREADED; CANNULA CLEARTRAC SMOOTH 7 X 72MM; CANNULA CLEARTRAC THREADED 8.5 X 45MM; CANNULA CLEARTRAC THREADED 8.5 X 90MM; CANNULA ECTR; CANNULA FINGER POSTED 4.5MM; CANNULA FINGER POSTED 5.5MM; CANNULA FMS 2.7 LONG ASCOPE; CANNULA FMS SHORT 2.7 AS 3.8; CANNULA FOR 3.6 OPERATIVE SET; CANNULA INTEL NON-SCOPE 3MM; CANNULA MED FLOW ROT DBL VLV 5MM; CANNULA OPERATIVE 4.5MM NO DISATLHOLES; CANNULA OPERATIVE 5.5MM FINGERPOST; CANNULA OPERATIVE 5.5MM NO DISTAL HOLE; CANNULA OPERATIVE 5MM NO DIS HOLES; CANNULA SMOOTH FLEX 5.5 X 55MM; CANNULA SMOOTH FLEX 6.5 X 72MM; CANNULA SMOOTH FLEX 8 X 72MM; CANNULA THREADED DISP 8.5 X 72MM; CANNULA THREADED FLEX 5.5 X 45MM; CANNULA THREADED FLEX 6.5 X 72MM; CANNULA THREADED FLEX 8 X 90MM; CANNULATED OBTURATOR W/DELRIN 4.5MM; CANNULATED OBTURATOR W/DELRIN 5.5MM; CANNULATED OTBURATOR 8MM; CAP-FIX Blade, Curved; CAP-FIX Blade, Curved, with Handle; CAP-FIX Blade, Curved, with Hip Pac; CAP-FIX Blade, Straight; CAP-FIX Blade, Straight, with Handle; CAP-FIX Blade, Straight, with Hip Pac; CAP-FIX SUTURE PASSER 45 DEG; CAP-FIX SUTURE PASSER 70 DEG; CAP-LIFT Cannula, 100mm; CAP-LIFT Cannula, 110mm; CAP-LIFT Cannula, 70mm; CAP-LIFT Cannula, 80mm; CAP-LIFT Cannula, 90mm; CARRIAGE, RPLT, UNIV HIP DIST FOR AHTB; CART PROCEDURE W. ISOL. TRANSFORMER; CART TRANSPORT SPIDER; CHISEL E-FLEX VULCAN FINISHED STERILE; CHISEL GUARD; CHISEL MICRO CURVED VULCAN INTEGRATED; CHISEL MICRO VULCAN ANGLED INTEGRATED; CHISEL MICRO VULCAN HOOK INTEGRATED; CHISEL VULCAN ANGLED; CHISEL VULCAN CURVED; CHISEL VULCAN HOOK; CHISEL VULCAN STRAIGHT W/INTEGRATED CBL; CHONDRAL PICK, LARGE, 20 DEGREE; CHONDRAL PICK, LARGE, 40 DEGREE; CHONDRAL PICK, SMALL, 20 DEGREE; CHONDRAL PICK, SMALL, 40 DEGREE; CHONDRAL PICK, SMALL, 90 DEGREE; CIRCLE SUTURE MENISCAL MENDER II; CLANCY 10 MM FLEXIBLE DRILL; CLANCY 10.5 MM FLEXIBLE DRILL; CLANCY 11 MM FLEXIBLE DRILL; CLANCY 12 MM FLEXIBLE DRILL; CLANCY 7.5 MM FLEXIBLE DRILL; CLANCY 9 MM FLEXIBLE DRILL; CLANCY 9.5 MM FLEXIBLE DRILL; CLANCY CURVED FEMORAL GUIDE, 42 DEGREE; CLEAR TRAC COMPLETE HIP CANNULA 7X110; CLEAR TRAC COMPLETE HIP CANNULA 8.5X110; CLEAR-TRAC CMPL. CANN. HIP OBT.8.5X110; CLEAR-TRAC CMPL.CANN. HIP OBT.7X110; CLEAR-TRAC DISPOSABLE STOPCOCK; CLEAR-TRAC MTO 5.5 MM X 72 MM REUSABLE OBTURATOR 4.3 MM CANNULATION; CLEAR-TRAC SCR CANN 8MM LTX FREE; CLEAR-TRAC THREADED CANNULA WITH OBTURATOR 5 MM X 76 MM, LATEX FREE, BOX OF 10; CLEARTRAC SCOPE/SHAVER CANNULA SMOOTH; COBLATION; COBLATOR; CORACOID DRILLING GUIDE; CORACOID DRILLING OFFSETGUIDE 10MM; COUPLER, 19.5mm, 5:4 AUTOCLAVABLE, HD; COUPLER, HIGH DEFINITION, NON-AUTOCLAVABLE, 19.5 MM, BLACK RING; COUPLER, UROLOGY, HD; CROSSTRAC HIP GUIDE; CROSSTRAC HIP GUIDE BULLET; CURETTE CURVED 90 DEG; CURETTE OPEN 6MM 15 DEG; CURVED BLUNT DISSECTOR; CURVED DRILL GUIDE FOR 2.3 MM SUTURE ANCHORS, FISHMOUTH TIP; CURVED ELEVATOR; CURVED PROBE 3MM; Camera coupler; Cannu-Flex Screw; Cannuflex 9"" Blunt Guidewire, 72202807; Cannula 5.5mm; Cannula Driver; Cannula set 4.5mm; Cannula set 5.5mm; Cannula set 7mm; Cannula, Obturator, Punch, Scissor, Suture cutter, Aimer, Gore smoother, Trephine adaptor, Guide, Knife; Cannula; post same as DOV, no holes; Cannulated Switching Stick; Caps-Lock Cannula Driver; Caps-Lock Ultra; Chondral Pick; Chondral Pick Sterilization Tray; Clear-Trac Screw Cannula 7mm; Clear-Trac Screw Cannula 9mm; Clear-Trac Threaded Cannula 8mm x 76mm; Clear-Trac Threaded Cannula Kit 5mm ID, 76mm LG; Clear-Trac Threaded Cannula Kit, 8mm I.D., 76mm LG; Clear-Trac cannula Stopcock; Clear-Trac scope/shaver cannula; Clear-Trac scope/shaver cannula w/rib; Clearcut Suture Cutter; Closed Tendon Harvester; CoVator 20; Coblation; Crawford Cannula; Crochet Hook; Crosstrac Flexible Passing Pin 13.50 x 2.4mm; Cuff Elevator; D-RAD; DELIVERY TAMP 3.5MM A.M.P.; DENYER RAIL CLAMP (LATERL DSTRCTR SYS); DENYER SUPINE RAIL CLAMPS 2; DETACHABLE OBTURATOR HANDLE ECTRA 2; DIA. 15MM CANNULA COVER; DIA. 15MM CANNULA TROCAR; DIA. 15MM CANNULA TUBE; DIAGNOSTIC CANNULAS 2.9MM; DILATOR; DILATOR 11-12MM BIOSURE SYNC; DILATOR 7-8MM BIOSURE SYNC; DILATOR 9-10MM BIOSURE SYNC; DIRECTOR PCL ELEVATOR WITH WIRE CATCHER; DISPOSABLE KNIFE; DISPOSABLE KNIFE HOOK STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE HOOK STRAIGHT 3 MM BOX OF 5, 10600; DISPOSABLE KNIFE ROSSETTE STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE SERRATED BANANA STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE SHARP TIP STRAIGHT 3 MM BOX OF 5; DISPOSABLE KNIFE V SHAPED; DISPOSABLE KNIFE V SHAPED, 10660; DISSECTOR BLUNT CURVED ECTR; DOUBLE POSTERIOR GLENOID DRILL GUIDE; DPR SYSTEM; DRILL 2.6 MM BIORAPTOR 2.3 SUT ANC; DRILL 4.5MM FOR 5.5MM ANCHOR SL-PLUS; DRILL 4MM FOR 4.5MM ANCHOR SL-PLUS; DRILL ENDOBUTTON 4.5MM NON-CANN; DRILL FIXATION POSTERIOR STERILE BX OF 1; DRILL GUIDE 3.5MM AMP; DRILL GUIDE AC JOINT LEFT; DRILL GUIDE CROWN TIP REUSABLE STANDARD; DRILL GUIDE CROWN TIP REUSABLE XL; DRILL GUIDE CRVD FOR 2.3 SA CROWN; DRILL GUIDE OFFSET; DRILL GUIDE S FISHMOUTH REUSABLE; DRILL GUIDE SLOTTED SPIKE TIP 2.3MM; DRILL GUIDE SLOTTED SPIKE TIP SL; DRILL GUIDE XL SPIKE TIP; DRILL MICRORAPTOR HARD BONE 1.8MM; DRILL RAPTORMITE 3 SUTURE ANCHOR; DRILL SURETAC IXC 8MM; DRILL TIP PASSING PIN 2.7 MM X 15 INCH, STERILE 6 PER BOX; DRILL, 2.5 MM FOR 3.5 MM TWINFIX SUTURE ANCHOR, SL; DRIVER SILK SCREW 1.5MM; DRIVER,CANNULATED 2mm; DUCKBILL PUNCH BASKET UPBITER 1.5MM LOOP HANDLE; DUCKBILL PUNCH BASKET UPBITER CURVED LEFT 1.5 MM LOOP HANDLE; DUCKBILL PUNCH BASKET UPBITER CURVED RIGHT 1.5 MM LOOP HANDLE; DUCKLING PUNCH BASKET CURVED LEFT LOOP HANDLE; DUCKLING PUNCH BASKET CURVED RIGHT LOOP HANDLE; DUCKLING PUNCH BASKET ELEVATOR LOOP HANDLE; DUCKLING PUNCH BASKET STRAIGHT LOOP HANDLE; DUCKLING PUNCH BASKET UPBITER LOOP HANDLE; DUCKLING PUNCH BASKET UPSWEPT LOOP HANDLE; DYNOMITE; DYNOMITE 2 MM PEEK WITH 1 ULTRABRAID SUTURE SIZES 2-0 AND NEEDLES; DYONICS 1/4 JCBS STL DRL SML BAT HND PC; DYONICS 5/32 JACOBS STYLE DRL SML BATT; DYONICS POWERMAX ELITE HANDPIECE HAND-CONTROLLED WITH OPPOSITE-SIDE SUCTION LEVER; DYONICS POWERMAX ELITE HANDPIECE HAND-CONTROLLED WITH OPPOSITE-SIDE SUCTION LEVER REFURBISHED; DYONICS SYNTHS QUCK CON DRL SM BAT HNDPC; DYONICS WIRE DRVR SM BAT HANDPIECE; DYONICS ZIMMER HT RMR SML BAT HNDPC; DYOVAC KIT CLEANING BRUSHES FOR 5.2 MM SUCTION PUNCH, 10 PER BOX; DYOVAC SUCTION PUNCH 3.4MM STRAIGHT; DYOVAC SUCTION PUNCH 5.2MM STRAIGHT; Depth Probe; Dilator, HEALICOIL REGENESORB 5.5mm, Disposable, 72203952; Drill Bit; Drill Tip Passing Pin; Drill for Q-FIX with Needles; Drill tip, passing pin w/graduation to 180mm; Drill, 1.7mm S, Disposable 72203855; Dynomite 1.6mm drill & guide; ECHELON; ECTRA HAND HOLDER/STERILIZATION TRAY WITH COVER; ELEVATOR CURVED TEARDROP; ELEVATOR XL; ELITE KNOT PUSHER XL; ELITE MTO SHOULDER ELEVATOR BLUNT DOWN; ELITE MTO SHOULDER ELEVATOR BLUNT UP; ELITE MTO SHOULDER ELEVATOR DOWN; ELITE MTO SHOULDER ELEVATOR UP; ELITE PREMIUM ALLIGATOR GRASPER; ELITE PREMIUM COMBINATION GRASPER; ELITE PREMIUM CROCHET HOOK; ELITE PREMIUM KNOT MANIPULATOR; EMPERION; ENDOBUTTON CL 35MM; ENDOBUTTON CL 40MM; ENDOBUTTON CL 45MM; ENDOBUTTON CL 50MM; ENDOBUTTON CL FIXATION BUTTON WITH 20 MM CONTINUOUS LOOP SUTURE; ENDOBUTTON CL FIXATION BUTTON WITH 25 MM CONTINUOUS LOOP SUTURE; ENDOBUTTON CL FIXATION BUTTON WITH 30 MM CONTINUOUS LOOP SUTURE; ENDOBUTTON CL ULTRA 10MM; ENDOBUTTON CL ULTRA 15MM; ENDOBUTTON CL ULTRA 20MM; ENDOBUTTON CL ULTRA 25MM; ENDOBUTTON CL ULTRA 30MM; ENDOBUTTON CL ULTRA 35MM; ENDOBUTTON CL ULTRA 40MM; ENDOBUTTON CL ULTRA 45MM; ENDOBUTTON CL ULTRA 50MM; ENDOBUTTON CL ULTRA 55MM; ENDOBUTTON CL ULTRA 60MM; ENDOBUTTON CL/BTB/Ultra; ENDOBUTTON PAC LTX FREE; ENDOBUTTON, 4 MM X 12 MM; ENDOFEMORAL AIMER, NO OFFSET; ENDOSCOPIC CANNULATED DRILL BIT, 4.5 MM, STERILE; ENDOSCOPIC FEMORAL AIM ARM 3MM OFFSET; ENDOSCOPIC FEMORAL AIM ARM 4MM OFFSET; ENDOSCOPIC FEMORAL GUIDE HANDLE; ENGAGE; EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH; EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS); EVAC; EXCISE; Elevator Rasp; Endobutton Direct Fixation Device; Endobutton Pin Passing 2.4mm Trocar; Endobutton drill tip, passing pin 2.4mm x 15; Endobutton drill tip, passing pin 2.7mm x 15; Endobutton, sterile, non-sterile; Endoscopic Cannula Drill Bit 4.5mm; Extractor; Extremities Guide, Universal; FAST-FIX 360 CURVED KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS; FAST-FIX 360 CURVED MENISCAL REPAIR SYSTEM; FAST-FIX 360 CURVED NDL DELIVERY SYSTEM; FAST-FIX 360 REVERSE CURVE NDL DELIVERY SYSTEM; FAST-FIX 360 REVERSED CURVE MENISCAL REPAIR SYSTEM; FAST-FIX 360 STRAIGHT KNOT PUSHER/CUTTER AND SLOTTED CANNULA SETS; FAST-FIX 360 STRAIGHT MENISCAL REPAIR SYSTEM; FAST-FIX 360 STRAIGHT NDL DELIVERY SYSTEM; FAST-FIX FLEX Curved Inserter; FAST-FIX FLEX Curved Inserter, Bender, Cannula Set; FAST-FIX FLEX Reverse Curved Inserter; FAST-FIX FLEX Reverse Curved Inserter, Bender, Cannula Set; FEMORAL AIMER; FERKEL 15 DEGREE ANTERIOR LESION CURETTE, 2.5 MM; FERKEL 15 DEGREE OPEN CURETTE, 2.5 MM; FERKEL 15 DEGREE OPEN CURETTE, 4 MM; FERKEL 30 DEGREE OPEN CURETTE, 2.5 MM; FERKEL MICROFRACTURE PICK 40 DEGREE; FERKEL MICROFRACTURE PICK 65 DEGREE; FERKEL MICROFRACTURE PICK 90 DEGREE; FIRSTPASS MINI Suture Passer; FIRSTPASS Suture Passer; FLEXIBLE DRILL; FLOW 50 Wand; FLOW 90 Wand; FLUID MAN EXT DIAG CANN W/INFLOW & VALVE; FLUID SEAL ADAPTOR; FLUSH SUTURE CUTTER; FLUSH SUTURE CUTTER XL; FOOTPRINT 6.5 MM PK SUTURE ANCHOR; FOOTPRINT MINI Drill, 3.5mm; FOOTPRINT MINI Drill, 3.7mm; FOOTPRINT MINI PK, 3.5mm Suture Anchor; FOOTPRINT PK 6.5 MM Suture Anchor; FOOTPRINT ULR 4.5 PK SUT SL; FOOTPRINT ULR 5.5 PK SUT SL; FOOTPRINT Ultra PK Suture Anchor 4.5mm SL; FOOTPRINT Ultra PK Suture Anchor 5.5mm SL; FOOTPRINT Ultra PK Suture Anchor, 4.5 MM; FOOTPRINT Ultra PK Suture Anchor, 5.5 MM; FOREFOOT; Face Shield; Fluid Barrier Boots,; Femoral Aimer; Femoral Locator; FirstPass Mini Suture Passer Left Curved; FirstPass Mini Suture Passer Right Curved; FirstPass Needle and Suture Capture; Fixation post drill, 72202879; Forefoot II; GD WIRE NITINOL 1.2 X 45CM; GENESIS; GLENOID DRILL GUIDE LONG BULLET; GLENOID DRILL GUIDE SHORT BULLET; GRAFTMASTER II SYSTEN TRAY; GRASPER ALLIGATOR MAX EXTENDED; GRASPER CUPPED 3.4MM EXTENDED 2.25; GRASPER EXTENDED 2.25; GRSPR ALGTR MAX; GRSPR ALGTR STR 2.7MM; GRSPR ALGTR UPBTR; GRSPR ATRMTC CANLTD TNSNR TIS; GRSPR ATRMTC TNSNR TIS; GRSPR CUPD 2.7MM; GRSPR CUPD 3.4MM; GRSPR FRCP LOOSEBODY PTBLL; GRSPR JT SM; GTS TAPERED SCREW; SLEEVE; GUHL ANKLE DISTRACTOR FOOT STRAPS, STERILE, LATEX FREE BOX OF 6; GUHL NON-INVASIVE ANKLE DISTRACTOR; GUHL NON-INVASIVE ANKLE DISTRACTOR STERILIZATION TRAY; GUIDE 2.3MM INLINE DRILL CROWN TIP; GUIDE 2.3MM INLINE DRILL F MOUTH TIP; GUIDE 2.3MM INLINE DRILL SPIKE TIP; GUIDE WIRE 1.2MM X 9 BOX OF 5 STERILE; GUIDE WIRE 1.2MM X18 BX OF 5 STER.; GUIDE WIRE ALIGNER 45 MVECT; GUIDE WIRE ALIGNER 62 MVECT; GUIDE WIRE BEATH PIN 2.4 MM STERILE; GUIDE WIRE PCL 2.4MM X10; GUIDE WR 1.2MM X 12 BOX OF 5 STERILE; GUIDE, 4MM INLINE DRILL BIORAPTOR, HIP; GUIDEWIRE CANNFLEX 9 BLUNT TIP; Glenoid Holder; Graft Assist, Board; Graft Bar Drill; Graft Bar Holder; Graft Board Hook; Graft, Base Lock; Graft, Suture Clamp; Graft, Tissue Clamp; Graftologer Tray; Grasper, Irrigation extender w valve, Trocar, Hook probe, Chisel guard, Tap, Cuff stitch, Dilator; Guide wire 2mm, 15"", 7207222; Guidewire 1.5mm x 229mm; Guidewire 2.4mm Drill Tip, guide wire, 12"", 7207221; Guidewire Aimer; Guidewire, Nitinol 1.2mm x 45cm; HALF CANNULA - SHORT; HALF CANNULA OBTURATOR - SHORT; HALLU LOCK; HALLU-FIX; HALLU-LOCK; HALLU-REAM; HALO COBLATION Wand; HAMMER SLAP DILATOR SYSTEM; HEALICOIL; HEALICOIL Knotless Drill, 4.75mm, 72205308; HEALICOIL Knotless PK Suture Anchor, 5mm; HEALICOIL Knotless PK Suture Anchor, 5mm, Self-Tapping; HEALICOIL Knotless REGENESORB Suture Anchor, 5.5mm; HEALICOIL Knotless REGENESORB Suture Anchor, 5.5mm, Self-Tapping; HEALICOIL PK 4.5 MM Suture Anchor with Two ULTRABRAID Sutures (Blue/Cobraid Blue); HEALICOIL PK 4.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE); HEALICOIL PK 4.5MM W/ ULTRA TAPE BLUE; HEALICOIL PK 4.5MM W/ ULTRA TAPE CBRD; HEALICOIL PK 5.5 MM Suture Anchor with Three ULTRABRAID Sutures (Blue/Cobraid Blue/Cobraid Black); HEALICOIL PK 5.5 MM Suture Anchor with Two ULTRABRAID Sutures (Blue/Cobraid Blue); HEALICOIL PK 5.5MM SUTURE ANCHOR WITH THREE MINITAPE SUTURES (BLUE, COBRAID WHITE, COBRAID BLUE); HEALICOIL PK 5.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE); HEALICOIL PK 5.5MM W/ UB2-BL UTP CBRD; HEALICOIL PK 5.5MM W/ UB2-CBR BLK UTP BL; HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL REGENESORB 4.75 MM SUTURE ANCHOR WITH ONE ULTRATAPE SUTURE COBRAID BLUE AND ONE ULTRABRAID SUTURE No.2; HEALICOIL REGENESORB 4.75 MM THREADED DILATOR, DISPOSABLE; HEALICOIL REGENESORB 4.75 MM THREADED DILATOR, REUSABLE",1978-02-22,133,2026-10-23,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012358417%22&limit=1
Biomet Chile S.A.,3014302784,3014302784,Av. Santa Clara No. 085 Floor 7 HUECHURABA,Santiago de Chile Region Metropolitana,,8580000,Chile,ZimmerBiomet Americas DFE,10056779,Exporter to the US,62,FSM; FZX; HRS; HRY; HSB; HSD; HSX; HTN; HTO; HTW; HTY; HWC; HWD; HWP; HWQ; HWR; HWT; HWX; HXX; JDC; JDG; JDI; JDL; JDQ; JDR; JDW; JDX; JWH; JWJ; KRO; KRR; KTT; KWA; KWB; KWI; KWL; KWS; KWT; KWY; KWZ; KXA; LOD; LPH; LWJ; LXT; LZO; LZY; MAI; MAY; MBF; MBH; MBI; MBL; MBV; MEH; MLR; OIY; OQG; OQH; OQI; PBI; PHX,"Tray, Surgical, Instrument; Guide, Surgical, Instrument; Plate, Fixation, Bone; Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer; Rod, Fixation, Intramedullary And Accessories; Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented; Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer; Washer, Bolt Nut; Reamer; Bit, Drill; Pin, Fixation, Smooth; Screw, Fixation, Bone; Starter, Bone Screw; Punch, Femoral Neck; Passer; Driver, Prosthesis; Template; Tap, Bone; Screwdriver; Prosthesis, Elbow, Constrained, Cemented; Prosthesis, Hip, Femoral Component, Cemented, Metal; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component); Cerclage, Fixation; Staple, Fixation, Bone; Pin, Fixation, Threaded; Instrument, Surgical, Sonic And Accessory/Attachment; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained; Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal; Prosthesis, Elbow, Hemi-, Radial, Polymer; Prosthesis, Hip, Hemi-, Femoral, Metal; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented; Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer; Prosthesis, Hip, Femoral, Resurfacing; Bone Cement; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented; Prosthesis, Hip, Hemi-, Femoral, Metal Ball; Fastener, Fixation, Biodegradable, Soft Tissue; Prosthesis,  Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer; Fastener, Fixation, Nondegradable, Soft Tissue; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous; Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer; Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate; Sterilizer, Chemical; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive; Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented; Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented; Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented; Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive; Shoulder Prosthesis, Reverse Configuration",1; 2; 3,"100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL; 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES; 100KGY E-POLY MAXROM ACETABULAR LINERS; 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM; ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS; AGC TOTAL KNEE PROSTHESIS; ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS; ARCOS INTERLOCKING DISTAL STEMS; ARCOS TROCHANTER BUTTON; ARCPM 1050 RESIN-HIPS; ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED; BIO-MODULAR SHOULDER SYSTEM; BIOMET BIPOLAR PROSTHESIS; BIOMET FEMORAL LOCKING NAIL SYSTEM; BIOMET HUMERAL CABLE PLATES; BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS; BIOMET MODULAR FEMORAL REVISION SYSTEM; BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER; BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL; BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS; BIOMET TIBIAL LOCKING NAIL SYSTEM; Biomet Knee Joint Replacement Prostheses; Biomet Proximal Humerus Plating System; Biomet Tibial trays; CEMENTED FEMORAL HEAD RESURFING DEVICE; CO-CR ANSWER FEMORAL COMPONENT; COBALT G HV BONE CEMENT; COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT; COLLARLESS POLISHED TAPER HIP PROSTHESIS; COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE; COMPREHENSIVE HUMERAL FRACTURE SYSTEM; COMPREHENSIVE PRIMARY SHOULDER STEMS; COMPREHENSIVE REVERSE SHOULDER; COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY; COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS); COMPRESS ANTI-ROTATION SPINDLES; COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM; COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG); COONRAD III TOTAL ELBOW; COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES; CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK); DISCOVERY ELBOW; DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES; DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW; DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM; DISTAL VOLAR RADIUS PLATING SYSTEMS; EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM; EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE; FEMORAL HOOK; FINN KNEE PROSTHESIS; FIXED BEARING UNI COMPONENT; G7 ACETABULAR SYSTEM; G7 Dual Mobility System, Active Articulation System; G7 Freedom and Offset Liners, Freedom Head, Size 32; G7 OSSEOTI ACETUBLAR SHELLS; GAMMA SYSTEM; HARRIS-GALANTE POROUS TOTAL HIP SYS; HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING; HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ; HERITAGE HIP SYSTEM; HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM; Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini; INSALL/BURSTEIN(TM)* II TIBIAL WEDGES; JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF; LACTOSORB BONE PIN; LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT); MAESTRO TOTAL WRIST; MAESTRO WRIST FRACTURE IMPLANT; MALLORY-HEAD TOTAL HIP SYSTEM; MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA; MAXIM ACCEL KNEE SYSTEM; MG II POROUS TOTAL KNEE SYSTEM; MODIFIED DISTAL RADIUS PLATING SYSTEM; MODULAR HYBRID GLENOID; MOORE HIP PROSTHESIS, PMMA COATED; NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES; NEXGEN COMPLETE KNEE SOLUTION; NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO; NEXT GENERATION KNEE SYSTEM; ONCOLOGY SALVAGE SYSTEM; ORTHOPEDIC SALVAGE SYSTEM- OSS; OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS; OSS-BODIES PROXIMAL TIBIAL SLEEVE; OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS); PATRIOT PROTRUSIO CAGE; PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES; POROUS COATED DISCOVERY ELBOW; POROUS TITANIUM ACETABULAR AUGMENTS; PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS; Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer; REACH HIP COMPONENT; REDUCED SIZE ONCOLOGY SALVAGE SYSTEM; RESORBABLE INTERFERENCE SCREW; RINGLOC + HYBRID ACETABULAR SYSTEM; RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS; Reamer; SIRIUS FEMORAL STEM; Screwdriver; Starter, Bone Screw; TA HIP PROSTHESIS; TAPER 2 POROUS FEMORAL STEM; TAPERLOC 12/14 TAPER FEMORAL COMPONENTS; TITANIUM LOW PROFILE SCREWS; TRABECULAR METAL REVISION SHELL LINERS; TRILOGY ACETABULAR SHELL & LINERS 36MM; TRILOGY ACETABULAR SYSTEM; TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE; TRILOGY LONGEVITY CONSTRAINED LINER; Tap, bone; Template; Tray, Surgical, Instrument; ULTRA-DRIVE 3; UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED; UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION; UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS; UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS; VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT; VANGUARD 360 REVISION KNEE SYSTEM; VANGUARD COMPLETE KNEE SYSTEM; VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS; VANGUARD SSK 360 REVISION KNEE SYSTEM; VANGUARD SSK KNEE SYSTEM; VERSA-DIAL HUMERAL HEAD PROSTHESIS; VERSYS HIP SYSTEM BEADED HIP PROSTHESIS; VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS; WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE; XR-SERIES BI-METRIC FEMORAL COMPONENTS; ZCH ALPHA SYSTEM; ZIMMER M/L TAPER HIP PROSTHESIS; ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES; ZIMMER PERIARTICULAR LOCKING SYSTEM; ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS; ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM; ZIMMER UNICOMPARTMENTAL KNEE SYSTEM; ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS; ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER; Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers; bit, drill; driver, prosthesis; guide, surgical, instrument; passer; punch, femoral neck",2018-01-16,132,2017-07-28,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014302784%22&limit=1
"Ge Medical Systems (china) Co., Ltd.",9710602,3003513129,No. 19 Changjiang Road National Hi-Tech Dev. Zone,WUXI Jiangsu,,214028,China,GE HealthCare Technologies Inc.,9912004,Contract manufacturer; Manufacturer; Specification developer,57,BSF; BSZ; BZK; BZL; BZQ; CAP; CBK; CBQ; CBR; CBS; CCK; CCL; DPS; DPZ; DQA; DQK; DQO; DRT; DSA; DSF; DSI; DSJ; DSK; DXG; DXH; DXN; FLL; FMT; FMZ; GWJ; GWQ; GXY; HGM; IKD; ITO; ITX; IYN; IYO; KOI; KRB; LLZ; MHX; MLD; MUA; MUD; MWI; NHO; NHP; NHQ; OBJ; OLT; OLW; OMC; ORT; PAA; QEM; QIH,"Absorber, Carbon-Dioxide; Gas-Machine, Anesthesia; Spirometer, Monitoring (W/Wo Alarm); Computer, Oxygen-Uptake; Monitor, Breathing Frequency; Monitor, Airway Pressure (Includes Gauge And/Or Alarm); Ventilator, Continuous, Facility Use; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Electrocardiograph; Oximeter, Ear; Oximeter; Computer, Diagnostic, Programmable; Catheter, Intravascular, Diagnostic; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Cable, Transducer And Electrode, Patient, (Including Connector); Recorder, Paper Chart; Detector And Alarm, Arrhythmia; Alarm, Blood-Pressure; Computer, Blood-Pressure; Computer, Diagnostic, Pre-Programmed, Single-Function; Transmitters And Receivers, Electrocardiograph, Telephone; System, Measurement, Blood-Pressure, Non-Invasive; Continuous Measurement Thermometer; Warmer, Infant Radiant; Incubator, Neonatal; Stimulator, Auditory, Evoked Response; Full-Montage Standard Electroencephalograph; Electrode, Cutaneous; System, Monitoring, Perinatal; Cable, Electrode; Twister, Brace Setting; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Stimulator, Nerve, Peripheral, Electric; Probe, Thermodilution; System, Image Processing, Radiological; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Monitor, St Segment With Alarm; Bone Sonometer; Oximeter, Tissue Saturation; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration); Catheter, Ultrasound, Intravascular; Non-Normalizing Quantitative Electroencephalograph Software; Index-Generating Electroencephalograph Software; Reduced- Montage Standard Electroencephalograph; Burst Suppression Detection Software For Electroencephalograph; Automated Breast Ultrasound; Cerebral Oximeter; Automated Radiological Image Processing Software",1; 2; 3,"10-D; 10L; 10T-D; 11L; 11L-D; 11M3; 12L; 12L-RS; 12L-SC; 12S-D; 12S-RS; 2006644-001 SpO2 Interconnect cable; 2021406-001 SpO2 Interconnect cable; 2021406-002 SpO2 Interconnect cable; 2025350-001 SpO2 Interconnect cable, Nellcor OxiMax, 3m/10ft, Corometrics only; 3.5C; 3CRF; 3S; 3S-SC; 3Sc-RS; 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in.; 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in.; 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in.; 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in.; 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in.; 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in.; 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in.; 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in.; 4C; 4C-RS; 4C-SC; 4D ICE catheter; 4D3C-L; 4Sc-RS; 4V-D; 4Vc-D; 5CS; 6S-D; 6S-RS; 6Sc-D; 6Tc; 6Tc-RS; 6VT-D; 6Vc-D; 7S; 8C; 8C-RS; 9L; 9L-D; 9L-RS; 9T; 9T-RS; 9VT-D; ABS Reusable Absorbent Canister; ABUS Single-Use Stabilization Membrane - non Sterile; AEP Ear Tips for Earphone Set (8001233); Absorber canister assembly; Achilles EXPII; Achilles OsteoReportN; B105M Patient Monitor; B105P Patient Monitor; B125M Patient Monitor; B125P Patient Monitor; B155M Patient Monitor; B1X5-F2, Second Frame; B1X5-REC, Recorder; BE9CS; BE9CS-D; BE9CS-RS; C1-5-D; C1-5-RS; C1-5-RS (only for Vivid T9); C1-6-D; C1-6VN-D; C2-9-D; C2-9-RS; C2-9VN-D; C3-10-D; C4-8-D; CARESCAPE Canvas 1000; CARESCAPE Canvas D19; CARESCAPE Canvas Smart Display; CARESCAPE R860; CARESCAPE R860 Ventilator; CBS Reusable Absorbent Canister; CLAB ECG Trunk Cable 12-lead AHA 10ft; CLAB ECG Trunk Cable 12-lead IEC 10ft; CONTINUOUS CARDIAC OUTPUT MODULE, E-PiCCO-00; Cable assembly ECG 3 lead neo AHA long, 3.6 m; Cable assembly ECG 3 lead neo AHA short, 1.8 m; Cable assembly ECG 3 lead neo IEC long, 3.6 m; Cable assembly ECG 3 lead neo IEC short, 1.8 m; Carestation 620; Carestation 620 A1; Carestation 620/650/650c; Carestation 650; Carestation 650 A1; Carestation 650c; Carestation 650c A1; Carestation 750; Carestation 750 A1; Carestation 750/750c; Carestation 750c; Carestation 750c A1; DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT; Datex-Ohmeda S/5 EEG Module; Disposable Infant Skin Temperature Probe; E-EEG Datex-Ohmeda S/5 EEG Headbox; E7C8L-RS; E8C; E8C-RS; E8CS; E8CS-RS; E8CS-SC; E8Cs-RS; E8Cs-RS (only for Vivid T9); ECG Adapter Cable; ECG Trunk Cables and Leadwires; EEG Lead set 1 (898050); EEG Lead set 3 (898052); ERB; F2 Frame (F2-01); FECG Cable; G3S, Deep Scanning Transducer; G3S, deep scanning transducer; G8L, Shallow Scanning Transducer; G8L, shallow scanning transducer; GE ENTROPY CABLE (REF M1050784); GE ENTROPY SENSOR (REFM1038681); Giraffe Incubator Carestation; Giraffe Incubator Carestation CS1; Giraffe OmniBed Carestation; Giraffe OmniBed Carestation CS1; Giraffe Panda Disposable Infant Skin Temperature Probe; Giraffe Warmer; IC5-9-D; IC9-D; IC9-RS; IC9B-RS; Invenia ABUS; Invenia ABUS 2; Invenia ABUS Premium; Invenia ABUS Prime; Invenia ABUS Review Software; Invenia ABUS Scan Station; Invenia ABUS Viewer; Invenia ABUS Workstation; L10-22-RS; L12n-RS; L12n-SC; L2-9-D; L2-9VN-D; L3-12-D; L3-12-RS; L4-12t-RS; L4-20t-D; L4-20t-RS; L6-12-RS; L6-24-D; L8-18i-D; L8-18i-RS; L8-18i-SC; L8-18t-RS; LK760-RS; LOGIQ E10; LOGIQ E10s; LOGIQ E10s R2 to R3 UPG; LOGIQ E10s R2R3 to R4 HW Upgrade; LOGIQ E10s R2R3 to R4 HW Upgrade W; LOGIQ E10s R2R3 to R4 SW Upgrade; LOGIQ E10s R2R3 to R4 SW Upgrade W; LOGIQ E10s R3R4_R5 UPG SW + GPU; LOGIQ E10s R3R4_R5 UPG SW + GPU + Wifi; LOGIQ E10s R3R4_R5 UPG SW + Wifi; LOGIQ E10s R3R4_R5 UPG SW Only; LOGIQ E9; LOGIQ E9 XDClear 2; LOGIQ F; LOGIQ F6; LOGIQ F8; LOGIQ F8 Expert; LOGIQ Focus; LOGIQ Fortis; LOGIQ Fortis R3 to R4 HW Upgrade; LOGIQ Fortis R3 to R4 HW Upgrade W; LOGIQ Fortis R3 to R4 SW Upgrade; LOGIQ Fortis R3 to R4 SW Upgrade W; LOGIQ Fortis R3-R5 SW & WiFi Upgrade; LOGIQ Fortis R3-R5 SW HW Upgrade; LOGIQ Fortis R3-R5 SW, HW & WiFi Upgrade; LOGIQ Fortis R5 SW Upgrade; LOGIQ P10; LOGIQ P10 R4 to R4.5 UPG; LOGIQ P5; LOGIQ P7; LOGIQ P8; LOGIQ P8 R4 to R4.5 UPG; LOGIQ P9; LOGIQ P9 R4 to R4.5 UPG; LOGIQ S20; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power; LOGIQ S20 Pro; LOGIQ S7 Expert; LOGIQ S8; LOGIQ Totus; LOGIQ V1; LOGIQ V2; LOGIQ V3; LOGIQ V5; LOGIQ V5 Expert; LOGIQ Vita; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ Vita Pro; LOGIQ e; LOGIQ e NextGen; M5Sc-D; M5Sc-RS; M5sc-RS; M6C-D; MAC 5 A4; MAC 5 A4 Resting ECG Analysis System; MAC 5 A5; MAC 5 A5 Resting ECG Analysis System; MAC 5 Lite; MAC 5 Lite Resting ECG Analysis System; MAC 7 - Resting ECG Analysis System; MAC 7 15 Leads UPG KIT; MAC 7 Resting ECG Analysis System; MECG Cable; ML4-20-D; ML4-20VN-D; ML6-15; ML6-15-D; ML6-15-RS; Monitor B105M; Monitor B105P; Monitor B125M; Monitor B125P; Monitor B155M; Multi Absorber Canister; Multi-Absorber canister reusable; NEUROMUSCULAR TRANSMISSION MODULE, E-NMT; NMT ElectroSensor 0.3m/1ft; NMT Electrodes, Solid Gel, Ag/AgCl, 30/pkg; NMT MechanoSensor 0.3m/1ft; NMT Pediatric MechanoSensor 0.3m/1ft; NMT Regional Block Adapter 0.5m/1.5ft; NMT Sensor Cable 3.3m/11ft; NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA; Nellcor OxiMax, 1.2m/3.9ft; Nellcor OxiMax, 3m/10ft; Nellcor OxiSmart, 2.9m/9.5ft; NextGen LOGIQ e; Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA); P2D; P6D; Panda Freestanding Warmer; Panda Ires Warmer; Panda Wall Mount Warmer; Panda Warmer; PiCCO Continuous Cardiac Output Cable (M1154585); PiCCO Injectate Sensor Cable (M1182448); Portrait VSM; Portrait VSM Vital Signs Monitor; Portrait™ VSM; R860; RAB2-5-D; RAB2-5-RS; RAB2-6-RS; RAB4-8-D; RAB4-8-RS; RAB6-D; RAB6-RS; RAB7-D; RIC10-D; RIC12-D; RIC5-9-D; RIC5-9A-RS; RIC5-9W-RS; RIC6-12-D; RM6C; RM7C; RNA5-9-D; RNA5-9-RS; RSP6-16-D; Reusable Absorbent Canister; Reusable Absorber Canister; Reusable CO2 Absorber Canister; S4-10-D; TRAM 2001 Module; TruSignal SpO2 Ear Sensor (TS-E-D); TruSignal SpO2 Finger Sensor (TS-F-D); TruSignal SpO2 Interconnect Cable with GE connector (TS-G3); TruSignal SpO2 Sensitive Skin (TS-SE-3); TruSignal SpO2 attachment accessories (TS-HB-3, TS-RWL-24, TS-RTW-100, TS-SND-3, TS-RWS-24, TS-RWM-24); Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables); VSP 4 Upgrade Software; Venue; Venue 50; Venue Fit; Venue Go; Venue Sprint; Venue Trident; Versana Active; Versana Balance; Versana Essential; Versana Premier; Versana Premier Lotus; Vivid Advanced; Vivid E80; Vivid E90; Vivid E95; Vivid Explorer; Vivid Focus; Vivid Pioneer; Vivid S60; Vivid S60N; Vivid S70; Vivid S70N; Vivid S70N Dimension; Vivid T8; Vivid T8 T9 v204 v205 to v206 UPG; Vivid T8 T9 v204 v205 to v206 UPG SW only; Vivid T8 T9 v206 to v208 SW only UPG; Vivid T9; Vivid iq; Vivid iq v203 to v206 UPG; Vivid iq v204 to v206 UPG; Vivid iq v204 to v206 UPG SW only; Vivid iq v206 to v208 HW+SW UPG; Vivid iq v206 to v208 SW only UPG; Voluson E series; Voluson E series BT15; Voluson E series BT16; Voluson E10; Voluson E10 BT16; Voluson E6; Voluson E6 BT16; Voluson E8; Voluson E8 BT16; Voluson Expert 18; Voluson Expert 20; Voluson Expert 22; Voluson P6; Voluson P8; Voluson Performance 16; Voluson Performance 18; Voluson S series; Voluson S series BT16; Voluson S10; Voluson S10 BT16; Voluson S10 Expert; Voluson S6; Voluson S6 BT16; Voluson S8; Voluson S8 BT16; Voluson S8t; Voluson SWIFT; Voluson SWIFT+; Voluson Signature 18; Voluson Signature 20; Voluson e; Voluson i; Vscan Extend; Vscan Extend dual probe; dual probe; eM6C; eM6C G2; eM6C G3; eM6CG2; eX7C; iC5-9-D; reusable; t739",1995-07-11,131,2026-10-02,1,7,2,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229710602%22&limit=1
Randox Laboratories Limited,3004493545,3004493545,36 / 44 Largy Road,"CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey",,BT29 4RN,United Kingdom,"RANDOX LABORATORIES, LTD.",8020890,Contract manufacturer; Manufacturer; Repackager or relabeler; Specification developer,123,CDQ; CDT; CEI; CEJ; CEK; CEM; CEO; CFJ; CFN; CFO; CFR; CGA; CGS; CGX; CGZ; CHH; CHI; CIC; CIG; CIJ; CIS; CIT; CIX; CJC; CJE; CJK; CJO; CJY; CKA; CKB; CZP; CZW; DAD; DBF; DBI; DCK; DCN; DDG; DDR; DDZ; DEM; DEW; DFC; DFT; DGC; DHR; DIF; DIH; DIO; DIP; DIS; DJC; DJG; DJR; DKB; DKZ; DLJ; DLZ; GGM; GIG; GTQ; JFJ; JFM; JFY; JGJ; JGS; JHN; JIF; JII; JIN; JIR; JIS; JIT; JIX; JIY; JJB; JJE; JJF; JJS; JJT; JJW; JJX; JJY; JLB; JLG; JLH; JLO; JMK; JMO; JNM; JPZ; JQA; JRA; JXM; JZG; JZJ; KHM; KHP; KHS; KLS; KLT; KNK; KQF; KXT; LAS; LBS; LCD; LCM; LCP; LDJ; LEG; LEH; LFM; LKL; LPS; MRR; MSJ; MVU; NDY; NQD; OHQ; PQD; SES,"Urease And Glutamic Dehydrogenase, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Uranyl Acetate/Zinc Acetate, Sodium; Tetraphenyl Borate, Colorimetry, Potassium; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Method, Nephelometric, Immunoglobulins (G, A, M); Titrimetric, Magnesium; Hexokinase, Glucose; Glucose Oxidase, Glucose; Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Cresolphthalein Complexone, Calcium; Diazo Colorimetry, Bilirubin; Saccharogenic, Amylase; Hydrazone Colorimetry, Ast/Sgot; Nadh Oxidation/Nad Reduction, Ast/Sgot; Bromcresol Green Dye-Binding, Albumin; Fructose-1, 6-Diphosphate And Nadh (U.V.), Aldolase; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes; Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes; Azo Dye, Calcium; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Acid Phosphatase, Naphthyl Phosphate; Iga, Antigen, Antiserum, Control; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; System, Test, C-Reactive Protein; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Albumin, Fitc, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Igg, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; Igm, Antigen, Antiserum, Control; Ige, Antigen, Antiserum, Control; System, Test, Rheumatoid Factor; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Thin Layer Chromatography, Methamphetamine; Enzyme Immunoassay, Opiates; 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(LDH P-L); RANDOX LIPASE; RANDOX LIPASE (LPS); RANDOX LIPOPROTEIN A; RANDOX LIQUID CHEMISTRY PREMIUM CONTROLS; RANDOX LIQUID CHEMISTRY PREMIUM PLUS CONTROLS; RANDOX LITHIUM; RANDOX MAGNESIUM; RANDOX MICROALBUMIN; RANDOX MICROALBUMIN (mALB); RANDOX MYOGLOBIN; RANDOX NITROGEN; RANDOX Non-Esterified Fatty Acids (NEFA); RANDOX PHENOBARBITAL; RANDOX PHENYTOIN; RANDOX POTASSIUM; RANDOX PREALBUMIN; RANDOX PRECISION CHEMISTRY PREMIUM PLUS CONTROLS; RANDOX RHEUMATOID FA; RANDOX RHEUMATOID FACTOR; RANDOX SERUM DILUENT (DIL SM); RANDOX SODIUM; RANDOX THEOPHYLLINE; RANDOX THERAPEUTIC DRUG CALIBRATORS; RANDOX TOTAL IRON BINDING CAPACITY; RANDOX TOTAL IRON BINDING CAPACITY 2; RANDOX TOTAL IRON BINDING CAPACITY 2 (TIBC_2); RANDOX TOTAL PROTEIN (UP); RANDOX TOTAL PROTEIN 2 (TP 2); RANDOX TOTAL-IRON BINDING CAPACITY (TIBC); RANDOX TRANSFERRIN; RANDOX TRIGLYCERID; RANDOX TRIGLYCERIDE; RANDOX TRIGLYCERIDES (TRIGS); RANDOX UREA; RANDOX URIC ACID; RANDOX URIC ACID (UA); RANDOX URINARY PROTEIN; RANDOX URINE CONTROLS; RANDOX VALPROIC ACID; RANSEL CALIBRATOR (RANSEL CAL); RANSEL CONTROL; RANSOD CONTROL; REFERENCE SOLUTION (REF SOLN); RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV); RX DAYTONA; RX IMOLA; RX daytona plus (with ISE); RX daytona plus (without ISE); Randox Adiponectin Control; Randox Aldolase; Randox Aldolase Controls Levels 2 and 3; Randox Ammonia; Randox Apolipoprotein B; Randox Aspartate Aminotransferase; Randox C.S.F. Controls Levels 2 and 3; Randox CK-NAC Activated; Randox CRP Controls; Randox CRP Immunoturbidimetric kit; Randox Calcium (Ca); Randox Cardiac Controls; Randox Cholesterol; Randox Digoxin; Randox Direct HDL Cholesterol (liqu; Randox Direct LDL and HDL Cholesterol Calibrator; Randox Ecstasy (MDMA) Assay, calibrators and controls; Randox Fructosamine; Randox G6PDH Control; Randox Haemoglobin Control; Randox Haptoglobin; Randox HbA1c Control level 1 and level 2; Randox Homocysteine; Randox Immunoassay Controls; Randox LDL Cholesterol (Liquid); Randox Liquid Chemistry Premium Plus levels 1,2 and 3; Randox Liquid Protein Calibrator; Randox Maternal Controls Level 1, 2 and 3; Randox Microalbumin Control Level 1 and Level 2; Randox Pancreatic Amylase; Randox Parathyroid Hormone control; Randox RF Immunoturbidimetric; Randox RX Daytona Plus Alkaline Phosphatase (ALP); Randox Rx Daytona Plus Magnesium (MG); Randox Tri Level Lipid Controls; Randox Triglycerides; Randox Urinalysis Control; Randox Urine Controls; Randox multisera, human, assayed an; Rheumatoid Factor (RF) Reagents; SALINE DILUENT (NS); SARS CoV-2 Controls (SARS-CoV-2); SC019 Microtitre Plates; SC020 Conjugate Solution; SEROLOGY I POSITIVE CONTROL (SEROLOGY I CONTROL +); SEROLOGY II POSITIVE CONTROL (SEROLOGY II CONTROL +); SEROLOGY III POSITIVE CONTROL (SEROLOGY III CONTROL +); SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -); SEROLOGY ToRCH EBV POSITIVE CONTROL (ToRCH EBV CONTROL +); SEROLOGY ToRCH IgG POSITIVE CONTROL (ToRCH IgG CONTROL +); SEROLOGY ToRCH IgM POSITIVE CONTROL (ToRCH IgM CONTROL +); SEROLOGY ToRCH NEGATIVE CONTROL (ToRCH CONTROL -); SERUM INDICES (SERUM INDICES); SODIUM ELECTRODE (I.S.E. Na); SODIUM ISE; SOLUBLE TRANSFERRIN RECEPTORS CALIBRATOR SERIES (STFR CAL); SOLUBLE TRANSFERRIN RECEPTORS CONTROLS (STFR CONTROLS); SPECIFIC PROTEIN CONTROL - LEVEL 1 (SP CONTROL 1); SPECIFIC PROTEIN CONTROL - LEVEL 2 (SP CONTROL 2); SPECIFIC PROTEIN CONTROL - LEVEL 3 (SP CONTROL 3); Special Chemistry Calibrators; Synthetic Cannabinoids Conjugate; Synthetic Cannabinoids Microtitre Plate; TDM Calibrators; THERAPEUTIC DRUG MARKERS LINEARITY VERIFIERS (For Roche Systems) (TDM LIN VER ROCHE); TMB005 One Shot Substrate; TOTAL ANTIOXIDANT STATUS (TAS CONTROL); Therapeutic Drug Monitoring Linearity Verifiers; Total Bilirubin (TBIL); Total Bilirubin_2 (TBIL_2) Reagents; Triglycerides; Triglycerides (TRIG) Reagents; Vancomycin; Wide Range C-Reactive Protein (wrCRP) Calibrators; Wide Range C-Reactive Protein (wrCRP) Reagents; XANTHOCHROMIA NEGATIVE CONTROL (XANTHOCHROMIA CONTROL -); XANTHOCHROMIA POSITIVE CONTROL (XANTHOCHROMIA CONTROL +); sLDL CALIBRATOR (sLDL CAL); sLDL CONTROL LEVEL 1 (sLDL CONTROL 1); sLDL CONTROL LEVEL 2 (sLDL CONTROL 2); sLDL CONTROL LEVEL 3 (sLDL CONTROL 3)",1997-03-04,132,2026-01-23,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004493545%22&limit=1
Toyo Medical Co.,1054713,1000114111,10645 NW 37th Ter CANTEL WEST INDUSTRIAL PARK,Doral,FL,33178,United States,TOYO MEDICAL CO.,9000332,Repackager or relabeler,90,BSZ; BXO; CCW; DPS; DQA; DQC; DQK; DRT; DXN; DXQ; DXT; DZA; DZI; DZP; EAZ; EBW; EFB; EGS; EHD; EIA; EJL; EKP; EKS; EKX; ELC; EPT; ERA; FCT; FMT; FMZ; FNL; FPL; FQO; FRN; FRW; FSO; FSY; GBB; GEX; GEY; GZJ; HJH; HJO; HKI; HKO; HLI; HLJ; HLM; HLQ; HME; HMF; HOX; HQC; HQF; IBJ; IMG; INN; IPF; ITX; IXA; IYN; IYO; IZI; IZQ; JAA; JAK; JOO; KMW; KPR; KYT; LDE; LMC; LNH; LQY; MHX; MQB; MUH; MWI; NFF; NFG; NGX; NKX; NOF; NQE; NRD; OBO; OHV; OWB; OXO; PUE,"Gas-Machine, Anesthesia; Transducer, Gas Pressure; Laryngoscope, Rigid; Electrocardiograph; Oximeter; Phonocardiograph; Computer, Diagnostic, Programmable; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); System, Measurement, Blood-Pressure, Non-Invasive; Blood Pressure Cuff; Injector And Syringe, Angiographic; Drill, Dental, Intraoral; Drill, Bone, Powered; Instrument, Diamond, Dental; Light, Operating, Dental; Controller, Foot, Handpiece And Cord; Handpiece, Air-Powered, Dental; Handpiece, Contra- And Right-Angle Attachment, Dental; Unit, X-Ray, Extraoral With Timer; Unit, Operative Dental; Bur, Dental; Reamer, Pulp Canal, Endodontic; File, Pulp Canal, Endodontic; Handpiece, Direct Drive, Ac-Powered; Scaler, Ultrasonic; Microscope, Surgical; Otoscope; Headlight, Fiberoptic Focusing; Warmer, Infant Radiant; Incubator, Neonatal; Bed, Ac-Powered Adjustable Hospital; Incubator, Neonatal Transport; Table, Operating-Room, Ac-Powered; Pump, Infusion; Scale, Patient; Microscope, Surgical, General & Plastic Surgery; Light, Surgical, Ceiling Mounted; Chair, Surgical, Ac-Powered; Powered Laser Surgical Instrument; Motor, Surgical Instrument, Ac-Powered; Stimulator, Nerve, Transcutaneous, For Pain Relief; Loupe, Binocular, Low Power; Biomicroscope, Slit-Lamp, Ac-Powered; Camera, Ophthalmic, Ac-Powered; Refractometer, Ophthalmic; Ophthalmoscope, Ac-Powered; Ophthalmoscope, Battery-Powered; Instrument, Measuring, Lens, Ac-Powered; Keratoscope, Ac-Powered; Chair, Ophthalmic, Ac-Powered; Stand, Instrument, Ac-Powered, Ophthalmic; Chart, Visual Acuity; Unit, Phacofragmentation; Laser, Ophthalmic; Light, Microscope; Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat; Chair, Adjustable, Mechanical; Stimulator, Muscle, Powered; Transducer, Ultrasonic, Diagnostic; Cassette, Radiographic Film; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Angiographic; Injector, Contrast Medium, Automatic; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Tomography, Computed; Transducer, Heart Sound; Handpiece, Rotary Bone Cutting; System, X-Ray, Stationary; Light, Examination, Medical, Battery Powered; Stethoscope, Manual; Camera, Multi Format, Radiological; System, Nuclear Magnetic Resonance Imaging; Locator, Root Apex; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Solid State X-Ray Imager (Flat Panel/Digital Imager); System, X-Ray, Extraoral Source, Digital; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Device, Storage, Images, Ophthalmic; Device, Communications, Images, Ophthalmic; Stimulator, Muscle, Powered, For Muscle Conditioning; Needle, Phacoemulsification, Reprocessed; System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations; Microscope, Specular; Unit, Operative Dental, Accessories; Tomography, Optical Coherence; Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption; Interventional Fluoroscopic X-Ray System; Image-Intensified Fluoroscopic X-Ray System, Mobile; Biomicroscope, Slit-Lamp, Ac-Powered, Exempt",1; 2; U,"Atom Medical Inc; CANON MEDICAL SYSTEM CORPORATION; Canon Medical System Corporation; Canon Medical Systems Corporation; Canon Medical Systems Corrporation; Carl Zeiss Meditec AG; DRGEM CORPORATION; ENRAF-NONIUS B.V.; FOTOFINDER SYSTEM GMBH; Guangdong Biolight Meditech Co., Ltd.; HEINE OPTOTECHNIK; HEINE OPTOTECHNIK GMBH & CO. KG; Heine; Heine Optotechnik GMBH & CO; Heine Optotechnik GMBH & Co; MIPM Mammendorfer Institut fur Physik und Medizin GmbH; NAKANISHI INC; Nakanishi Inc; Nakanishi Inc.; Nidek; Nidek Co., Ltd; Nihon Kohden; PARAMOUNT BED CO., LTD.; PENLON LTD; Planmeca Oy; SECA; SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO; SOFWAVE MEDICAL LTD.; TAKARA BEMONT CO.; TOYO MEDICAL CO; TOYO MEDICAL CO.; Takagi Seiko Co; Takagi Seiko Co., LTD; Takara Belmont Co; Takara Belmont Company; Takara Belmont Corporation; Toshiba Medical; Toshiba Medical Co; Toshiba Medical Co.; Toshiba Medical System Corporation; Toyo Medical Co; Toyo Medical Co.; Toyo Medical Company; nakanishi; nidek",2011-05-18,132,2025-04-18,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221054713%22&limit=1
Ansell Healthcare Products LLC,3011209798,3011209798,2301 Robb Drive,Reno,NV,89523,United States,ANSELL HEALTHCARE PRODUCTS LLC,8020065,Manufacturer; Specification developer,16,CCX; FZZ; GAX; IWP; KGO; KME; LYU; LYY; LYZ; LZA; LZC; MSH; NNW; OEA; OPJ; QDO,"Support, Patient Position; Marker, Skin; Tourniquet, Nonpneumatic; Radiographic Protective Glove; Surgeon'S Gloves; Bedding, Disposable, Medical; Accessory, Surgical Apparel; Latex Patient Examination Glove; Vinyl Patient Examination Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; Respirator, Surgical; Bag, Urine Collection, Leg, For External Use, Non-Sterile; Non-Surgical Gown; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Fentanyl And Other Opioid  Protection Glove",1; 2,"Cobalt ® N19X; FISHER 19-041-171X; GAMMEX PI PLUS GLOVE-IN-GLOVE SYSTEM TESTED FOR USE WITH CHEMOTHERAPY DRUGS; KIT TURNOVER STAT-PAC; LATEX EXAMINATION GLOVE, POWDER FREE WITH PROTEN CONTENT LABELING CLAIM (50 ug/g or less of total extractable Protein); MICROFLEX MIDKNIGHT MK-296; Micro-Touch Royal Blue; PI Hybrid Micro; POWDER FREE NITRILE EXAMINATION GLOVE BLACK AND DURAL COLOR WHITE-BLUE; POWDER FREE NITRILE EXAMINATION GLOVE WHITE (colored); Supreno SE SU-690",2007-11-21,131,2023-10-20,0,3,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011209798%22&limit=1
"Biomerieux, Inc.",1950204,1950204,595 Anglum RD.,Hazelwood,MO,63042,United States,BIOMERIEUX SA,8020790,Contract manufacturer; Manufacturer; Manufacturer for export; Specification developer,19,JQP; JSP; JST; JTA; JTS; JXB; LON; LQL; LQM; LRG; LRH; LTT; LTW; LXG; LXH; MDB; NGZ; QBN; SAN,"Calculator/Data Processing Module, For Clinical Use; Kit, Anaerobic Identification; Kit, Fastidious Organisms; Monitor, Microbial Growth; Stains, Microbiologic; Kit, Identification, Yeast; System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Gram Positive Identification Panel; Gram Negative Identification Panel; Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems; Instrument For Auto Reader Of Overnight Microorganism Identification System; Panels, Test, Susceptibility, Antimicrobial; Susceptibility Test Cards, Antimicrobial; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Orthopedic Manual Surgical Instrument; System, Blood Culturing; Susceptibility Test Plate, Antifungal; Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates; Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples",1; 2,"(240),; (<= 0.12 - >= 8 mcg/ml); (CA-SFM); , 3D MB; 3D Combination; ACETONE FUCHSIN-A; ACETONE SAFRANIN-A (NA); ACT; ARGENE connect Goldmaster RP5810 V1; AST Cefotaxime; AST Clindamycin; AST Penicillin; AST Streptococcus Vancomycin; AST-GN Imipenem; Amoxicillin; Ampicillin/Sulbactam; BACT MYCOBACTERIA DETECTION SYSTEM; BACT/ALERT; BACT/ALERT 120/140; BACT/ALERT-120; BacT/ALERT 3D with Mycobacterium; BacT/ALERT Blood Culturing System; BacT/ALERT VIRTUO Microbial Detection System; CRYSTAL VIOLET-C (NA); Cefperazone/Sulbactam; Coryneform Bacteria; DensiCHEK Plus; Dry Blood Spot Puncher; FUCHSIN-A (NA); Gatifloxacin; HOOK STAGING TRAY; IODINE-B (NA); Imipenem; Indication; MB; ML); NSV2 instal DVD eM W7; NucliSENTRAL; OBSERVA; Ofloxacin; Pipercillin/Sulbactam; Plus Card (GNI+); PreviISOLA; Quinupristin / Dalfopristin; Rapid Coryne System for Ident. of; S. pneumo; SAFRANIN-A (NA); Trimethoprim / Sulfamethoxazole; Trimethoprim/Sulfamethoxazole; VIDAS 3 ASSAY DILUTION CUP; VIDAS 3 SAMPLE TIP; VITEK 2 AST - Gram Negative Colistin; VITEK 2 AST - Gram Negative Ertapenem; VITEK 2 AST - Gram Negative Imipenem; VITEK 2 AST Gram Negative Cefotaxime; VITEK 2 AST Streptococcus Ceftriaxone; VITEK 2 AST- Gram Negative Polymyxin B; VITEK 2 AST- Gram Positive Telavancin; VITEK 2 AST- Streptococcus Cefotaxime; VITEK 2 AST-GN Amikacin; VITEK 2 AST-GN Amox/Clav; VITEK 2 AST-GN Amoxicillin/Clavulanic Acid; VITEK 2 AST-GN Amp/Sulbactam; VITEK 2 AST-GN Ampicillin; VITEK 2 AST-GN Ampicillin/Sulbactam; VITEK 2 AST-GN Aztreonam; VITEK 2 AST-GN Cefaclor; VITEK 2 AST-GN Cefalexin; VITEK 2 AST-GN Cefalotin; VITEK 2 AST-GN Cefazolin; VITEK 2 AST-GN Cefcapene; VITEK 2 AST-GN Cefditoren; VITEK 2 AST-GN Cefepime; VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL); VITEK 2 AST-GN Cefixime; VITEK 2 AST-GN Cefmetazole; VITEK 2 AST-GN Cefoperazone; VITEK 2 AST-GN Cefoperazone/ Sulbactam; VITEK 2 AST-GN Cefotaxime; VITEK 2 AST-GN Cefotetan; VITEK 2 AST-GN Cefotiam; VITEK 2 AST-GN Cefoxitin; VITEK 2 AST-GN Cefozopran; VITEK 2 AST-GN Cefpirome; VITEK 2 AST-GN Cefpodoxime; VITEK 2 AST-GN Ceftazidime; VITEK 2 AST-GN Ceftazidime/Avibactam; VITEK 2 AST-GN Cefteram; VITEK 2 AST-GN Ceftizoxime; VITEK 2 AST-GN Ceftolozane/Tazobactam; VITEK 2 AST-GN Ceftriaxone; VITEK 2 AST-GN Cefuroxime; VITEK 2 AST-GN Chloramphenicol; VITEK 2 AST-GN Ciprofloxacin; VITEK 2 AST-GN Colistin; VITEK 2 AST-GN Ertapenem; VITEK 2 AST-GN Faropenem; VITEK 2 AST-GN Flomoxef; VITEK 2 AST-GN Fosfomycin; VITEK 2 AST-GN Gentamicin; VITEK 2 AST-GN Imipenem; VITEK 2 AST-GN Isepamicin; VITEK 2 AST-GN Latamoxef; VITEK 2 AST-GN Levofloxacin; VITEK 2 AST-GN Mecillinam; VITEK 2 AST-GN Meropenem; VITEK 2 AST-GN Minocycline; VITEK 2 AST-GN Nalidixic Acid; VITEK 2 AST-GN Netilmicin; VITEK 2 AST-GN Nitrofurantoin; VITEK 2 AST-GN Norfloxacin; VITEK 2 AST-GN Ofloxacin; VITEK 2 AST-GN Panipenem; VITEK 2 AST-GN Pefloxacin; VITEK 2 AST-GN Pip/Tazob.; VITEK 2 AST-GN Piperacillin; VITEK 2 AST-GN Piperacillin/ Sulbactam; VITEK 2 AST-GN Piperacillin/ Tazobactam; VITEK 2 AST-GN Piperacillin/tazobactam; VITEK 2 AST-GN Polymyxin B; VITEK 2 AST-GN Rifampicin; VITEK 2 AST-GN Temocillin; VITEK 2 AST-GN Tetracycline; VITEK 2 AST-GN Ticarcillin; VITEK 2 AST-GN Ticarcillin/ Clavulanic Acid; VITEK 2 AST-GN Tigecycline; VITEK 2 AST-GN Tobramycin; VITEK 2 AST-GN Tosufloxacin; VITEK 2 AST-GN Trimeth./sulfa; VITEK 2 AST-GN Trimethoprim; VITEK 2 AST-GP Amikacin; VITEK 2 AST-GP Amoxicillin; VITEK 2 AST-GP Amoxicillin/ Clavulanic Acid; VITEK 2 AST-GP Amp/Sulbactam; VITEK 2 AST-GP Ampicillin; VITEK 2 AST-GP Cefalotin; VITEK 2 AST-GP Cefazolin; VITEK 2 AST-GP Cefmetazole; VITEK 2 AST-GP Cefotaxime; VITEK 2 AST-GP Cefpodoxime; VITEK 2 AST-GP Ceftaroline; VITEK 2 AST-GP Cefuroxime; VITEK 2 AST-GP Chloramphenicol; VITEK 2 AST-GP Ciprofloxacin; VITEK 2 AST-GP Clarithromycin; VITEK 2 AST-GP Clindamycin; VITEK 2 AST-GP Ertapenem; VITEK 2 AST-GP Erythromycin; VITEK 2 AST-GP Flomoxef; VITEK 2 AST-GP Fosfomycin; VITEK 2 AST-GP Fusidic Acid; VITEK 2 AST-GP Gatifloxacin; VITEK 2 AST-GP Gentamicin; VITEK 2 AST-GP Gentamicin High-Level Resistance; VITEK 2 AST-GP Gentamicin, HL; VITEK 2 AST-GP Habekacin; VITEK 2 AST-GP Imipenem; VITEK 2 AST-GP Kanamycin; VITEK 2 AST-GP Kanamycin High Level (synergy); VITEK 2 AST-GP Levofloxacin; VITEK 2 AST-GP Lincomycin; VITEK 2 AST-GP Minocycline; VITEK 2 AST-GP Mupirocin; VITEK 2 AST-GP Netilmicin; VITEK 2 AST-GP Nitrofurantoin; VITEK 2 AST-GP Norfloxacin; VITEK 2 AST-GP Ofloxacin; VITEK 2 AST-GP Oxacillin; VITEK 2 AST-GP Pefloxacin; VITEK 2 AST-GP Penicillin G; VITEK 2 AST-GP Pristinamycin; VITEK 2 AST-GP Quinupristin/ Dalfopristin; VITEK 2 AST-GP Rifampicin; VITEK 2 AST-GP Rifampin; VITEK 2 AST-GP Sparfloxacin; VITEK 2 AST-GP Streptomycin, HL; VITEK 2 AST-GP Teicoplanin; VITEK 2 AST-GP Telithromycin; VITEK 2 AST-GP Tetracycline; VITEK 2 AST-GP Tobramycin; VITEK 2 AST-GP Trimethoprim; VITEK 2 AST-GP Trimethoprim/ Sulfamethoxazole; VITEK 2 AST-GP Vancomycin; VITEK 2 AST-GP for S.pn Cefotaxime; VITEK 2 AST-GP for S.pn Ceftriaxone; VITEK 2 AST-GP for S.pn Chloramphenicol; VITEK 2 AST-GP for S.pn Ofloxacin; VITEK 2 AST-GP for S.pn Penicillin G; VITEK 2 AST-GP for S.pn Tetracycline; VITEK 2 AST-GP for S.pn Trimeth./sulfa; VITEK 2 AST-GP for S.pn Vancomycin; VITEK 2 AST-Gram Negative Cefazolin; VITEK 2 AST-Gram Negative Ceftazidime; VITEK 2 AST-Gram Negative Ciprofloxacin; VITEK 2 AST-Gram Negative Eravacycline; VITEK 2 AST-Gram Negative Fosfomycin; VITEK 2 AST-Gram Negative Imipenem/Relebactam; VITEK 2 AST-Gram Negative Levofloxacin; VITEK 2 AST-Gram Negative Meropenem; VITEK 2 AST-Gram Negative Meropenem/Vaborbactam; VITEK 2 AST-Gram Negative Minocycline; VITEK 2 AST-Gram Negative Omadacycline; VITEK 2 AST-Gram Negative Piperacillin / Tazobactam; VITEK 2 AST-Gram Negative Plazomicin; VITEK 2 AST-Gram Negative Tobramycin; VITEK 2 AST-Gram Positive Cefoxitin Screen; VITEK 2 AST-Gram Positive Dalbavancin; VITEK 2 AST-Gram Positive Daptomycin; VITEK 2 AST-Gram Positive Delafloxacin; VITEK 2 AST-Gram Positive Fosfomycin; VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance; VITEK 2 AST-Gram Positive Lefamulin; VITEK 2 AST-Gram Positive Linezolid; VITEK 2 AST-Gram Positive Moxifloxacin; VITEK 2 AST-ST Ampicillin; VITEK 2 AST-ST Chloramphenicol; VITEK 2 AST-ST Clindamycin; VITEK 2 AST-ST Erythromycin; VITEK 2 AST-ST Gentamicin; VITEK 2 AST-ST Inducible Clindamycin Resistance; VITEK 2 AST-ST Levofloxacin; VITEK 2 AST-ST Linezolid; VITEK 2 AST-ST Meropenem; VITEK 2 AST-ST Moxifloxacin; VITEK 2 AST-ST Rifampicin; VITEK 2 AST-ST Teicoplanin; VITEK 2 AST-ST Tigecycline; VITEK 2 AST-Streptococcus Cefepime; VITEK 2 AST-Streptococcus Cefuroxime; VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance; VITEK 2 AST-Streptococcus Meropenem; VITEK 2 AST-Streptococcus Penicillin; VITEK 2 AST-YS Amphotericin B; VITEK 2 AST-YS Caspofungin; VITEK 2 AST-YS Flucytosine; VITEK 2 AST-YS Micafungin; VITEK 2 AST-Yeast Anidulafungin; VITEK 2 AST-Yeast Caspofungin; VITEK 2 AST-Yeast Fluconazole; VITEK 2 AST-Yeast Voriconazole; VITEK 2 Antimicrobial Susceptibility Test Device (GN, GP, and GP for S.pn); VITEK 2 Compact; VITEK 2 ESBL Test; VITEK 2 GN AST for; VITEK 2 GN AST for Cefaclor; VITEK 2 GN AST for Cefalexine; VITEK 2 GN AST for Cefcapene; VITEK 2 GN AST for Cefditoren; VITEK 2 GN AST for Cefepime; VITEK 2 GN AST for Cefixime; VITEK 2 GN AST for Cefotiam; VITEK 2 GN AST for Cefozopran; VITEK 2 GN AST for Cefperazone; VITEK 2 GN AST for Cefpirome; VITEK 2 GN AST for Cefsulodin; VITEK 2 GN AST for Cefteram; VITEK 2 GN AST for Chloramphenicol; VITEK 2 GN AST for Colistin; VITEK 2 GN AST for Faropenem; VITEK 2 GN AST for Flomoxef; VITEK 2 GN AST for Fosfomycin; VITEK 2 GN AST for Isepamicin; VITEK 2 GN AST for Mecillinam; VITEK 2 GN AST for Mezlocillin; VITEK 2 GN AST for Minocycline; VITEK 2 GN AST for Netilmicin; VITEK 2 GN AST for Nitrofurantoin; VITEK 2 GN AST for Ofloxacin; VITEK 2 GN AST for Polymyxin B; VITEK 2 GN AST for Tosufloxacin; VITEK 2 GN Doxycycline; VITEK 2 GP AST for Amikacin; VITEK 2 GP AST for Cefaclor; VITEK 2 GP AST for Cefmetazole; VITEK 2 GP AST for Cefotaxime; VITEK 2 GP AST for Cefuroxime; VITEK 2 GP AST for Ertapenem; VITEK 2 GP AST for Fosfomycin; VITEK 2 GP AST for Fusidic Acid; VITEK 2 GP AST for Habekacin; VITEK 2 GP AST for Imipenem; VITEK 2 GP AST for Kanamycin; VITEK 2 GP AST for Kanamycin HL; VITEK 2 GP AST for Lincomycin; VITEK 2 GP AST for Minocycline; VITEK 2 GP AST for Mupirocin; VITEK 2 GP AST for Netilmicin; VITEK 2 GP AST for Nitrofurantoin; VITEK 2 GP AST for Oxacillin Screen; VITEK 2 GP Amoxicillin for S pneumo; VITEK 2 GP Cefoxitin Screen; VITEK 2 GP Ertapenem for S. pneumo; VITEK 2 GP Erythromycin for; VITEK 2 GP Levofloxacin for; VITEK 2 GP Linezolid for S. pneumo; VITEK 2 GP Meropenem for; VITEK 2 GP Moxifloxacin for; VITEK 2 GP S. pneumo AST for; VITEK 2 GP Sparfloxacin for S.pn; VITEK 2 GP Telithromycin for; VITEK 2 GP for; VITEK 2 GP for S. pneumo AST for; VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE; VITEK 2 GRAM POSITIVE DOXCYCLINE; VITEK 2 Gram Negative; VITEK 2 Gram Negative Ceftriaxone; VITEK 2 Gram Negative Doripenem; VITEK 2 Gram Negative Ertapenem; VITEK 2 Gram Negative Gatifloxacin; VITEK 2 Gram Negative Levofloxacin; VITEK 2 Gram Negative Meropenem; VITEK 2 Gram Negative Moxifloxacin; VITEK 2 Gram Negative Piperacillin; VITEK 2 Gram Negative Tigecycline; VITEK 2 Gram Positive; VITEK 2 Gram Positive Daptomycin; VITEK 2 Gram Positive Ertapenem; VITEK 2 Gram Positive Erythromycin; VITEK 2 Gram Positive Gatifloxacin; VITEK 2 Gram Positive Identification (GP); VITEK 2 Gram Positive Inducible Clindamycin Resistance; VITEK 2 Gram Positive Linezolid; VITEK 2 Gram Positive Meropenem; VITEK 2 Gram Positive Moxifloxacin; VITEK 2 Gram Positive Tigecycline; VITEK 2 Gram Positive VRSA Screen; VITEK 2 Gram Positive Vancomycin; VITEK 2 Streptococcus Penicillin; VITEK 2 Streptococcus Tetracycline; VITEK 2 Streptococcus Trimethoprim/Sulfamethoxazole; VITEK 2 YEAST CASPOFUNGIN; VITEK 2 YEAST VORICONAZOLE; VITEK 2 Yeast AST - Amphotericin B; VITEK 2 Yeast AST for Flucytosine; VITEK DENSICHEK; VITEK Gram Negative Identification; VITEK MS Prime; VITEK REVEAL; VITEK REVEAL BC GN02-AST; VITEK REVEAL GN01-AST; VITEK REVEAL Sealer; VITEK REVEAL Sensor Panel; VITEK(R) 2 YEAST FLUCONAZOLE (1-64U; VITEK2 AST-Gram Negative Delafloxacin; VITEK® 2 AST-GN Gentamicin; VITEK® 2 AST-YS Caspofungin; VITEK® 2 Anaerobic and Corynebacteria identification card (ANC); VITEK® 2 Gram-Negative identification card (GN); VITEK® 2 Neisseria-Haemophilus identification card (NH); VITEK® 2 Yeast identification card (YST); VITEK®2 AST-YS Fluconazole; VITEK®2 AST-YS Flucytosine; Vitek 2 AST Gram Negative Cefazolin; Vitek 2 AST-Yeast Micafungin; Vitek Compact Pro; and BacT/ALERT 3D60 Instrument; easySTREAM NSV2 RP5800 Master; for Pipercillin/Tazobactam",2003-11-04,129,2026-10-01,1,41,2,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221950204%22&limit=1
Cook Incorporated,1825146,1825146,1100 W Morgan St,Spencer,IN,47460,United States,"COOK, INC.",1820334,Complaint file establishment; Contract manufacturer; Manufacturer; Manufacturer for export,100,BSR; BTO; BTR; EXB; EXG; EYB; EYI; EYJ; EYK; EZB; EZL; EZN; FAD; FAJ; FAP; FBK; FBQ; FBW; FCG; FCN; FDI; FDX; FED; FEN; FEW; FEX; FFH; FFK; FFL; FFS; FGA; FGB; FHA; FHQ; FHR; FSM; FZX; GAA; GBM; GBO; GBW; GBX; GBZ; GCD; GCJ; GCY; GED; GEI; GEJ; GEX; HDQ; HDR; HES; HET; HFC; HFE; HFF; HGE; HHM; HHO; HIO; IWJ; JOL; JRL; KGY; KGZ; KNA; KNS; KNT; KNW; KOA; KOB; KOD; KOE; KPY; KQT; KYZ; LJE; LKF; LLX; LRC; MAV; MFD; MIJ; MJG; MOV; MPR; MQF; MQG; MQH; MQJ; NNX; NTN; NWV; NWW; OCY; OCZ; ODC; OQY; PGK,"Stylet, Tracheal Tube; Tube, Tracheostomy (W/Wo Connector); Tube, Tracheal (W/Wo Connector); Collector, Ostomy; Bag, Urine Collecting, Ureterostomy; Catheter, Ureteral, Gastro-Urology; Adaptor, Ureteral Catheter; Holder, Ureteral Catheter; Connector, Ureteral Catheter; Stylet For Catheter, Gastro-Urology; Catheter, Retention Type, Balloon; Dilator, Catheter, Ureteral; Stent, Ureteral; Cystoscope And Accessories, Flexible/Rigid; Cystometric Gas (Carbon-Dioxide) On Hydraulic Device; Endoscopic Injection Needle, Gastroenterology-Urology; Trocar, Gastro-Urology; Filiform And Filiform Follower; Biopsy Needle; Urinary Drainage Collection Kit, For Indwelling Catheter; Snare, Flexible; Endoscopic Cytology Brush; Endoscopic Access Overtube, Gastroenterology-Urology; Device, Cystometric, Hydraulic; Catheter, Malecot; Instrument, Catheter, Punch; Collector, Urine, Pediatric, For Indwelling Catheter; Lithotriptor, Electro-Hydraulic; Dislodger, Stone, Basket, Ureteral, Metal; Image, Illumination, Fiberoptic, For Endoscope ; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Clamp, Penile; Holder, Needle, Gastroenterologic; Needle, Gastro-Urology; Tray, Surgical, Instrument; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Catheter, Urethral; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Peritoneal; Catheter, Irrigation; Catheter, Cholangiography; Connector, Catheter; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Brush, Dermabrasion, Manual; Electrosurgical, Cutting & Coagulation & Accessories; Carrier, Ligature; Powered Laser Surgical Instrument; Dilator, Cervical, Fixed Size; Cap, Cervical; Insufflator, Carbon-Dioxide, Uterotubal (And Accessories); Laparoscope, Gynecologic (And Accessories); Aspirator, Endocervical; Brush, Endometrial; Aspirator, Endometrial; Amniotome; Sound, Uterine; Screw, Fibroid, Gynecological; Sampler, Amniotic Fluid (Amniocentesis Tray); System, Applicator, Radionuclide, Manual; Catheter And Tip, Suction; Unit, Filter, Membrane; Bag, Intestine; Accessories, Catheter; Instrument, Manual, Specialized Obstetric-Gynecologic; Unit, Electrosurgical, Endoscopic (With Or Without Accessories); Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Surgical Instruments, G-U, Manual (And Accessories); Catheter, Suprapubic (And Accessories); Catheter, Urological; Dilator, Urethral; Shield, Protective, Personnel; Evacuator, Gastro-Urology; Syringe, Irrigating (Non Dental); Catheter, Nephrostomy; Cannula, Manipulator/Injector, Uterine; Catheter, Sampling, Chorionic Villus; Instrument, Ent Manual Surgical; Syringe, Balloon Inflation; Cannula, Intrauterine Insemination; Needle, Tumor Localization; Device, Percutaneous, Biopsy; Catheters, Salpingography; Stent, Bladder, Fetal; Catheter, Assisted Reproduction; Accessory, Assisted Reproduction; Microtools, Assisted Reproduction (Pipettes); Micromanipulators And Microinjectors, Assisted Reproduction; Device, Incontinence, Urosheath Type, Non-Sterile; Led Light Source; Laparoscopic Accessories, Gynecologic; Hysteroscope Accessories; Endoscopic Guidewire, Gastroenterology-Urology; Endoscopic Grasping/Cutting Instrument, Non-Powered; Endoscope Channel Accessory; Intrauterine Tamponade Balloon; Cannula, Injector, Uterine, Endometrial Biopsy",1; 2; 3; U; f,"ACROBAT 2 CALIBRATED TIP WIRE GUIDE; ACROBAT CALIBRATED TIP WIRE GUIDE; AQ Hydrophilic Dual Lumen Ureteral Access Catheter; Aintree Intubation Catheter with Rapi-Fit Adapter; Amplatz Dilator; Amplatz Radiopaque TFE Sheath; Amplatz Renal Dilator Set; Amplatz Renal Introducer; Anesthetic Gel Adapter; Angled Tip Ureteral Catheter Set; Angled Tip Ureteral Catheter Set With Bentson PTFE Wire Guide; Angled Tip Ureteral Catheter with Bentson PTFE-Coated Wire Guide; Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters; Ascent AQ Ureteral Dilation Balloon; Aspiration Needle Set; Bakri Essential Postpartum Balloon; Ball Tip Fulgurating Electrode; Balloon Ureteral Dilator; Balloon Ureteral Dilator Set; Bander Ureteral Diversion Open-End Stent Set; Bander Ureteral Diversion Stent Set; Bander Ureteral Diversion Stent Set Wire Guide With Hydrophilic Coating; Black Silicone Filiform Double Pigtail Ureteral Stent Set; Brush Biopsy Set; CHIBA DECOMPRESSION SET; Catheter for Use with Amplatz Renal Dilator Set; Cervical Mucus Aspiration Set; Check-Flo® Adapter; Check-Flo® Adapter with Side-Arm and Stopcock; Clear Amplatz Sheath with Radiopaque Stripe; Cone Tip Ureteral Catheter; Cone Tip Ureteral Catheter with Open-End; Connecting Tube; Connecting Tube - Double Use With Cook Drainage Pouch; Connecting Tube - Single Use With Cook Drainage Pouch; Cook 810 Set; Cook Airway Exchange Catheter with Rapi-Fit Adapters; Cook Chorionic Villus Sampling Set; Cook Coagulator Probe; Cook Cope Loop Suprapubic Catheter Set; Cook Cystostomy Catheter Set; Cook Drainage Pouch Set; Cook Fallopian Tube Catheterization Wire Guide with Platinum Tip; Cook Silicone Balloon HSG Catheter; Cook Silicone Balloon HSG Catheter With Closed End And Sideport; Cook Sterilization Case; Cook-Cope Loop Nephrostomy Catheter; Cook-Cope Loop Nephrostomy Set; Cook® SP Tube Introducer Set; Cup Biopsy Forcepts; Cystic Duct Introducer Set; DELTA WIRE GUIDE; Deflectable Biopsy Set; Deflectable Brush Biopsy Set; Desilets-Hoffman Introducer Set; Desilets-Hoffman Introducer Set With Radiopaque Band; Disposable Cervical Dilators; Disposable Stopcock; Disposable Trocar Needle; Disposable Two-Part Trocar Needle; Dretler Ureteroscopy Stent Set; Dual Check Valve; Dual Lumen Ureteral Access Catheter; Dual Lumen Ureteral Catheter With AQ® Hydrophilic Coating; Dual Male Luer Lock Adapter; EchoTip® Disposable Two-Part Trocar Needle; EchoTip®Skinny Needle® with Chiba Tip; Echotip® Open-End Ureteral Catheter; Elongated Cup Biopsy Forceps; Embryo Transfer Catheter; Endoscopic Cap; Endoscopic Introducer/Extractor; Endoscopic Splash Shield; Endoscopic Tuohy Borst Adapter; Endosnare; FUSION LITHOTRIPSY EXTRACTION BASKET; FUSION WIRE GUIDE LOCKING DEVICE; Fair Urethral Stent; Fallopian Tube Catheterization Set; Fascial Incising Needle; Female Luer Lock Cap; Firlit-Kluge Urethral Stent; Firlit-Sugar Intermittent Catheter; Flexi-Tip® Dual Lumen Ureteral Access Catheter; Flexi-Tip® Dual Lumen Ureteral Access Catheter With AQ® Hydrophilic Coating; Flexi-Tip® Ureteral Catheter (Left); Flexi-Tip® Ureteral Catheter (Right); Flexipet, Adjustable Handle Set; Flexor Parallel Rapid Release Ureteral Access Sheath with AQ Hydrophilic Coating; Flexor Ureteral Access Sheath with AQ Hydrophilic Coating; Flexor Vision; Flushing Catheter; Foley Adapter/Connector; Frova Intubating Introducer with Rapi-Fit Adapters; Frova Intubating Introducer with Stiffening Cannula; Gift Catheter Set; Goldstein SonoBiopsy Catheter; Greene Renal Transplant Stent Set Wire Guide With Hydrophilic Coating; Guardia Access Embryo Transfer Catheter; Guardia Access Embryo Transfer Catheter With Internal Support Cannula; Guardia Access Malleable Obturator; Guardia Access Nano Embryo Transfer Catheter; Guardia AccessET Embryo Transfer Catheter; Guardia Obturator Malleable Adjustable Obturator; Hatter Flexible Cystoscopy Aspiration Tube; Holmium Laser Fiber Multi Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems; Holmium Laser Fiber Single Use For Use with Rhapsody H-30 with Smart Sync Technology and SMA-905 Laser Systems; Hysteroscopic Myoma Screw; Insemi-Cath; Intratubal Transfer Set; Intrauterine Access Balloon Catheter; Jansen-Anderson Insemination Set; Kaye Nephrostomy Tamponade Balloon Catheter Set; Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set; Kidney Biopsy Brush; Kish Urethral Illuminated Catheter; Koyle Diaper Stent; Kwart Retro-Inject Ureteral Stent Set; Laparoscopic Myoma Screw; Laser Ureteral Catheter; Lieberman Introducer; Luer Lock Cap; MAC-LOC MULTIPURPOS; MADDURI URETERAL STONE PUSHING CATHETER; MEMORY HARD WIRE BASKET; MEMORY SOFT WIRE BASKET; MagniCore Precision Chiba iMRI Needle; MagniCore Precision Coaxial iMRI Needle; Malecot Nephrostomy Catheter/Stent Set; Margolin HSG Cannula; Mitty Pollack Needle Set; Modified Novy Cornual Cannulation Set; Non-Toxic Syringe; Novy Corneal Cannulation Set; OBrien Suprapubic Peel-Away® Access Set; Odyssey Holmium Laser System; Offset Cervical Needle; One-Step Suprapubic Introducer; Onik-Cohen Percutaneous Access Set; Open-End Beveled Flexi-Tip® Ureteral Catheter; Open-End Flexi-Tip® Ureteral Catheter; Open-End Ureteral Catheter; Open-End Ureteral Catheter Sof-Flex®; Pediatric Flexor Ureteral Access Sheath; Pediatric Nephrostomy Stent Set; Pediatric Ureteral Catheter; Peel Away Introducer; Percutaneous Entry Needle; Percutaneous Entry Set; Percutaneous Entry Set (EchoTip); Percutaneous Malecot Nephrostomy Catheter Set; Percutaneous Neonatal Pigtail Nephrostomy Set; Pigtail Ureteral Catheter Set; Pigtail Ureteral Catheter Set, Left; Pigtail Ureteral Catheter Set, Right; Pigtail Ureteral Catheter With Sof-Flex® AQ®; Pivet Guide Embryo Transfer Catheter Set; Pursuit Balloon Dilation Catheter; ROADRUNNER WIRE GUIDE; Replacement O-Ring Set Use With K-MPH-1000; Rhapsody® H-30® Holmium Laser System; Roadrunner Biliary Wire Guide; Round Tip Ureteral Catheter (Left); Round Tip Ureteral Catheter (Right); Rutner Universal Wedge Catheter; STANDARD WIRE GUIDE; Safety Wire Guide Introducer; Salle Intraoperative Pyeloplasty Stent Set With 3cm Stylet; Salle Intraoperative Pyeloplasty Stent Set With 6cm Stylet; San Antonio Stopcock; Seidmon Antegrade AQ® Stent Set; Selective Salpingography Catheter; Selikowtiz Ureteroscopic Knife; Shepard Intrauterine Insemination Catheter; Side Arm Adapter; Side-Arm Adapter - Male Luer Lock and Touhy-Borst Adapter; Silhouette® Transitionless Peel-Away® Introducer; Silicone Rectal Balloon; Skinny Needle; Skinny Needle® with Chiba Tip; Sof-Flex® Double Pigtail Ureteral Stent Set; Sof-Flex® Multi-Length Ureteral Stent Set; Sof-flex Loop Suprapubic Catheter Set; Soft-Pass Coaxial Insemination Catheter; Soft-Pass EchoTip Embryo Transfer Catheter; Soft-Pass EchoTip Embryo Transfer Catheter Set; Soft-Pass Embryo Transfer Catheter Set; Soft-Pass™ Embryo Mock Transfer Catheter Set; Soft-Pass™ Embryo Mock Transfer Catheter Set with Echogenic Tip; Soules Intrauterine Insemination Catheter; Spiral Tip Ureteral Access Catheter; Stamey Percutaneous Loop TURP Suprapubic Catheter Set; Stamey Percutaneous Suprapubic Catheter Set; Stonebreaker Pneumatic Lithotripter; Straight Forming Wire; Surgical Urine Drain Pouch Set; TAO Brush I.U.M.C. Endometrial Sampler; TFE Sheathed Needle; THE WEB EXTRACTION BASKET; TRACER METRO DIRECT WIRE GUIDE; Tao Brush I.U.M.C. Endometrial Sampler; Taylor Gel Adapter; Transmyometrial Embryo Transfer Catheter; Tuohy-Borst Adapter; Two Part Needle; UPJ Occlusion Balloon Catheter Set; Ultrathane Endoureterotomy Stent Set; Ultrathane® Nephrostomy Set With Mac-Loc®; Ultrathane® Suprapubic Set With Mac-Loc®; Ultraxx Nephrostomy Balloon Set; Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath with Radiopaque Stripe; Ultraxx Nephrostomy Balloon Set with TFE Sheath; Ultraxx Nephrostomy Balloon with TFE Sheath; Universa 2-Way Silicone Foley Catheter; Universa 3-Way Silicone Folly Catheter; Universa Firm Ureteral Stent Set with Hydrophilic Coating; Universa Firm Ureteral Stent Set with Hydrophilic Coating and Monofilament Tether; Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating; Universa Firm Ureteral Stent and Positioner with Hydrophilic Coating and Monofilament Tether; Universal Check Flo Adapter; Universal Check-Flo® Adapter; Ureteral Dilation Balloon; Urethral Dilator Set; UroStream Hydrophilic Wire Guide; Vacuum Syringe; VersaTube Tapered Tracheostomy Tube with Disposable Inner Ca; Wayne Pleural Drainage Set; Whistle Tip Ureteral Catheter; Whistle Tip Ureteral Catheter (Left); Whistle Tip Ureteral Catheter (Right); Williams Cystoscopic Injection Needle; Zaontz Urerthral Stent",1992-12-12,129,2022-10-28,1,9,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221825146%22&limit=1
Philips Medical Systems Nederland B.V.,3042177665,3042177665,Veenpluis 6,BEST Noord-Brabant,,5684 PC,Netherlands,Philips Medical Systems International BV,1217116,Complaint file establishment; Exporter to the US; Specification developer,7,GDF; LHI; LNH; LNI; MOS; MUJ; PXP,"Guide, Needle, Surgical; Set, I.V. Fluid Transfer; System, Nuclear Magnetic Resonance Imaging; System, Nuclear Magnetic Resonance Spectroscopic; Coil, Magnetic Resonance, Specialty; System, Planning, Radiation Therapy Treatment; Breast Biopsy / Localization Tray",1; 2,"0.6T Marconi Wrist and Hand Array; 0.6T Panorama 4Ch Breast Array; 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil; 1.5T 16CH Cardiac Coil- Anterior; 1.5T 16CH Cardiac Coil- Posterior; 1.5T 16Ch GE Shoulder Coil; 1.5T 32CH Cardiac Coil- Anterior; 1.5T 32Ch Cardiac Coil- Anterior; 1.5T 8CH Obelix digital shoulder coil; 1.5T AND 3T GENERAL PURPOSE FLEX COILS; 1.5T Array Upper Extremity (MSK Coil); 1.5T Breast Coil Assembly; 1.5T Breast Speeder 8ch; 1.5T GE COMPATIBLE HNC COIL SYS; 1.5T HD 8HR Brain Array for HDe (Receive Only); 1.5T HD T/R KNEE ARRAY; 1.5T HD T/R Knee Coil (flat base); 1.5T HD T/R QUAD EXTREMITY COIL (flat base); 1.5T Musculoskeletal Array; 1.5T Precision Shoulder Array; 1.5T QUAD EXTREMITY COIL T/R; 1.5T SENSE GP Flex 8; 1.5T/3T 8 ch medium general purpose Flex Coil; 16 Breast Coil; 16 Ch Body Array Anterior 1.5T; 16 Ch Body Array Anterior 3T; 16Ch Interface Box Breast Coil Sen 1.5T; 16Ch Interface Box Breast Coil Sen 3T; 16Ch Shoulder Coil; 1Ch Left Coil Element Sen 1.5T; 1Ch Left Coil Element Sen 3T; 1Ch Right Coil Element Sen 1.5T; 1Ch Right Coil Element Sen 3T; 32 Ch Head; 3Ch Left Coil Element Sen 1.5T; 3Ch Left Coil Element Sen 3T; 3Ch Right Coil Element Sen 1.5T; 3Ch Right Coil Element Sen 3T; 3T 16Ch GE Shoulder Coil; 3T 32Ch CardiaC Coil- Anterior; 3T 32Ch Cardiac Coil - Anterior; 3T 32Ch Cardiac Coil- Posterior; 3T HD T/R KNEE ARRAY; 3T HD T/R Knee Coil (flat base); 3T HD T/R Quad Extremity Coil (flat base); 3T Precision Shoulder Array; 3T QUAD EXTREMITY COIL T/R; 3T SENSE MEDIUM GP FLEX 8; 4 CH Shoulder Large - 4 CH Shoulder Small; 4-ch SENSE Breast Coil 3T; 4-ch SENSE Shoulder Coil 3T; 4-ch SENSE Wrist Coil 1.5T; 459801507722 Biospy Grid, Sterilized; 459801508642 Breast Grid (User-Sterilized); 4Ch Left Lateral Coil Sen 1.5T; 4Ch Left Lateral Coil Sen 3T; 4Ch Right Lateral Coil Sen 1.5T; 4Ch Right Lateral Coil Sen 3T; 4ch SENSE Shoulder Coil 1.5T; 4ch SENSE Shoulder Coil 3T; 528GE Series; 7 CHANNEL BREAST COIL 3T; 7 Channel Breast MR Coil Kit 3T, GE Exite HDx 3T 7CH BBC, Philips 7ch SENSE Breast Coil 3T; 8 CH HR Brain Array 3 T; 8 CHANNEL FOOT ANKLE COIL 1.5T; 8 CHANNEL KNEE COIL; 8 CHANNEL WRIST COIL 1.5T; 8 CHANNEL WRIST COIL 3T; 8 Ch High Resolution Knee Array; 8 Channel Foot Ankle MR Coil Kit 1.5T; 8 Channel Foot Ankle MR Coil Kit 3T; 8 Channel Head Array; 8 Channel High Resolution Brain Coil; 8 Channel Knee Array MR Coil Kit Avanto, Siemens HRK, AVANTO 1.5T 8CH PA; 8 Channel Wrist Coil; 8 Channel Wrist MR Coil Kit 1.5T; 8 Channel Wrist MR Coil Kit 3T; 8CH FOOT ANKLE MR COIL 3T; 8CH HIGH RESOLUTION KNEE ARRAY; 8Ch High Resolution Brain Array; 8Ch High Resolution Brain Array (Receive Only); 8Ch Medial Coil Sen 1.5T; 8Ch Medial Coil Sen 3T; 8Ch Neuro Vasculat Array (Receive Only); 8ch Wrist Array; 8ch Wrist Coil; 989603203464 MRI Needle Block 12G; 989603203474MRI Needle Block 14G; 989603203484 MRI Needle Block 18G; 989603203524 Grid Immobilization Plate; 989603203574 Pillar Immobilization Plate OBC; 989603203584 Mammotome Immobilization Plate; 989603203594 OBC Grid Immobilization Plate; 989603204304 MRI Needle Block 16G; 989603209064 Grid Immobilization Plate LBS; 989603209104 Pillar Immobilization Plate; 989603209144 Lateral Grid dS Breast 16CH I/T; 989603214204 Biospy Grid, Sterilized; ANTERIOR - SYN HEAD/NECK COIL 4598-000-5192x; AVANTO BIOPSY BREAST ARRAY; Accessories, SENSE Head Coil, 6Ch 3T; Achieva; Achieva 1.5T family; Achieva 1.5T, 3T, and Intera 1.5T; Achieva Family; Achieva R4 1.5T (Ingenia); Achieva R4 3T (ingenia); Achieva TX Interventional Coil 3T; Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems; Achieva, Intera,&Panaroma 1T R2; Acoustic Hood; Airis Elite Rapid Extremity Coil; Airis Elite Rapid Head Coil; Altaire Rapid Head Coil; Avanto/Espree 1.5T 8Ch High Resolution Knee Array; BREAST ARRAY COIL (Receive Only); BREAST ARRAY COIL, Philips 4-ch SENSE Breast Coil 3T; BREAST SPEEDER; Biopsy Breast Coil; Biopsy Grid; BlueSeal QE; BlueSeal SE; BlueSeal XE; Brain Array 3T den; Breast 7 Biopsy Pack, 1.5T; Breast Array Coil; Breast Grid (User-Sterilized); Breast MRI 8ch Table for GE 1.5T; Breast MRI 8ch Tabletop for Siemens 1.5T; CIRC.COIL C1 1.5T 4598-000-5184x; CIRC.COIL C3 1.5T 4598-000-5196x; Cable Tray HYP VG ST; Cable Tray HYP VG STR; Cable Tray VG GE450; Coil Lateral 8CH Array Left VT 3T; Coil Medial Array VT 3T; Coil/ASM/Breast Coil for Echelon; Evolution Upgrade 1.5T; Evolution Upgrade 3T; Expert Shoulder Array Baseplate; Explorer gradients for Gyroscan Intera 1.5T; Extremity Coil 3T; FRU, COIL ASSY, PHC 1.5T 16CH; Fiducial Holder; Fiducial Holder, Needle Hub Assembly,; Fiducial Marker Grid Block Assembly; Fiducial Marker Sleeve Assembly; FlexTrak; GE 0.35T MFO 4C PA OBC; GE 0.35T MFO PA WRIST; GE 0.5T SP Tx/Rx INTERVENTIONAL SPINE ARRAY; GE 0.7T LARGE OPENSPEED GENERAL PURPOSE COIL,; GE 0.7T MEDIUM OPENSPEED GENERAL PURPOSE COIL,; GE 0.7T OPENSPEED (HFO) WRIST; GE 0.7T OPENSPEED HFO 3C WRIST; GE 0.7T SMALL OPENSPEED GENERAL PURPOSE COIL,; GE 1.5T 32 Channel Cardiac Coil; GE 1.5T 32 Channel Cardiac Coil (Anterior); GE 1.5T 32 Channel Cardiac Coil (Posterior); GE 1.5T 32 Channel Cardiac Coil- Anterior Only; GE 1.5T 4C PA WRIST (OEM); GE 1.5T 4Ch Shoulder Coil; GE 1.5T 8C HEAD / BRAIN COIL VALUE; GE 1.5T 8CH WRIST COIL; GE 1.5T Excite HDx 1.5T KFC DS (Quadrature Lower Extremity Coil); GE 1.5T HDMR2-VALUE 4C NVA COIL VALUE; GE 1.5T HDMR2-VALUE 4C WRIST COIL; GE 1.5T HDMR2-VALUE 8C HEAD / BRAIN, MA Head Coil, GE 1.5T LXI 8C HEAD (OEM); GE 1.5T HDMR2-VALUE 8C NVA, MA Neurovascular Coil,; GE 1.5T HDMR2-VALUE 8C WRIST; GE 1.5T HNC - OPENVIEW; GE 1.5T Quadrature Lower Extremity Coil (KFC DS); GE 1.5T SIGNA 4C PA OBC; GE 1.5T SIGNA 4C PA SHOULDER; GE 1.5T SIGNA EXCITE 8C NVA COIL (OEM), GE Excite HD 1.5T 8-CHANNEL NVA COIL; GE 1.5T Signa Excite 8CH Shoulder; GE 16 Ch Knee Coil 1.5T; GE 16 Ch Knee Coil 3T; GE 16-CH 1.5T Hand/Wrist Coil; GE 1T HNC - OPENVIEW; GE 1T SIGNA 4C PA WRIST (OEM); GE 1T Signa 4CH OBC; GE 3T 32 Channel Cardiac Coil; GE 3T 32 Channel Cardiac Coil (Anterior Only); GE 3T 32 Channel Cardiac Coil (Anterior); GE 3T 32 Channel Cardiac Coil (Posterior); GE 3T 32 Channel Cardiac Coil- Anterior Only; GE 3T 32 Channel Cardiac Coil- Anterior and Posterior; GE 3T HD Tx/Rx 8C KNEE; GE 3T HDMR2-VALUE 8C HEAD / BRAIN; GE 3T SIGNA EXCITE 8C WRIST; GE 3T Signa Excite 8CH Shoulder; GE 3T VHI 8C HEAD / BRAIN (OEM); GE Cardiac Coil, 1.5T, 16ch; GE EXCITE 1.5T 8 CHANNEL T/R , High Res Knee Array Coil (HRK); GE EXCITE 1.5T SIGNA HD 8C Tx/Rx KNEE (OEM); GE Excite 1.5T 7CH BBC; GE Excite 1.5T 7Ch Biopsy Breast Array; GE Excite 1.5T 8Ch Foot and Ankle Coil (FAC); GE Excite 3T HDx 8Ch FAC; GE Excite 3T HDx Tx Rx KNEE COIL; GE Excite HD 1.5T 4 Channel Breast Coil; GE Excite HD 1.5T 4 Channel Musculoskeletal Array; GE Excite HD 1.5T 4 Channel Shoulder Coil; GE Excite HD 1.5T 4 Channel Wrist Coil (HRW-GE SIGNA); GE Excite HD 1.5T 8 Channel Wrist (PRECISION EIGHT WRIST ARRAY); GE Excite HDe 1.5T 4CH (HDMR2-VALUE 4C OBC); GE Excite HDx 1.5T 3Ch PHASED ARRAY UPPER EXTREMI; GE Excite HDx 1.5T 7ch BBC; GE Excite HDx 1.5T 8 Channel Neurovascular Array; GE Excite HDx 1.5T HDx 7CH BBC; GE Excite HDx 1.5T HDx 8Ch 1.5T FAC; GE Excite HDx 3T Hi Res Wrist Array Coil; GE Excite HDx 8 Channel High Res Head Array (1.5T); GE Excite HDx PRECISION EIGHT WRIST ARRAY (8CH 1.5T); GE HD 1.5T 8C Foot and Ankle; GE HD 3T 8C Foot and Ankle; GE HDx 3T 7Ch Biopsy Breast; GE LBS 1.5T16CH; GE LBS 3T 16CH; GE LBS 3T 7CH; GE Signa 1.5T 4Ch Shoulder Coil; GE Signa Excite I Brain Coil; GE Signa Excite II Brain Coil; GE Signa Excite III Brain Coil; GE, 1.5T 8CH T/R Knee COIL; GE, 1.5T HD, 8-Channel, Quad Extremity Coil; GE, 3T 8CH T/R Knee COIL; GE, 3T 8CH WRIST COIL; GE, 3T HD, 8-Channel, Quad Lower Extremity Coil; Grid Immobilization Plate BBC; Grid Immobilization Plate BBC, Pillar Immobilization Plate BBC, Pillar Immobilization Plate,; Grid Immobilization Plate LBS C-C; Grid Immobilization Plate LBS M-L; Grid Immobilization Plate LBS, Pillar Immobilization Plate LBS, Needle Block Holder,; Grid Immobilization Plate OBC; Grid Plate, Enhanced Access Lateral; Grid Plate, Enhanced Access Medial; Grid dS Breast 16CH I/T; Gyroscan Intera; Gyroscan Intera (7.5); Gyroscan Intera 3T; HA Flex Trak; HA FlexTrak II; HAC-300 Head Array Coil; HD 4CH Wrist Array (Receive Only); HD 8CH Foot Ankle Coil (Receive Only); HD 8Ch Foot Ankle Coil; HD 8Ch HiRes BRAIN array; HD 8Ch HiRes Brain Array (Receive Only); HD 8Ch NV ARRAY; HD 8Ch WRIST ARRAY (Receive Only); HD 8Ch Wrist Array; HD T/R QUAD EXTREMITY COIL; HIGH RESOLUTION T/R KNEE COIL; HIGH RESOLUTION WRIST COIL(Receive Only); HITACHI 1.5T 7C BREAST; HITACHI 1.5T 8C TORSO; HRW-127-8 WRIST ARRAY COIL; HRW-63-8; Hitachi 1.5T Echelong PA Shoulder; INTERA 1.5T High Res Wrist Coil PA, Philips 4-ch SENSE Wrist Coil 1.5T; INTERA 1.5T Shoulder Coil Set 4Ch PA, Philips 4-ch SENSE Shoulder Coil 1.5T; INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly Skyra, SHC; INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, GEMS; INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, HITACHI; INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, PHC; INVIVO (FLORIDA, USA): DynaTRIM Baseplate assembly, SMS; INVIVO (FLORIDA, USA): DynaTRIM Clamp stand assembly; INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly GEMS and Clamp Stand; INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly PHC and Clamp Stand; INVIVO (FLORIDA, USA): DynaTRIM Complete, Baseplate assembly SMS and Clamp Stand; INVIVO (FLORIDA, USA): DynaTRIM Complete, GEMS DynaTRIM; INVIVO (FLORIDA, USA): DynaTRIM Complete, HITACHI DynaTRIM; INVIVO (FLORIDA, USA): DynaTRIM Complete, Skyra Baseplate assembly SHC and Clamp Stand; INgenia 1.5T CX and Ingenia 3T CX R5.3; INgenia 1.5T, Ingenia 1.5T S and Ingenia 3T R5.3; Ingenia; Ingenia 1.5T; Ingenia 1.5T - 781-341; Ingenia 1.5T CX; Ingenia 1.5T S; Ingenia 1.5T S - 781-347; Ingenia 3T; Ingenia 3T CX; Ingenia 3T CX R5.4; Ingenia 3TCX; Ingenia Ambition; Ingenia Ambition S; Ingenia Ambition X; Ingenia CX 1.5T; Ingenia CX 3T; Ingenia Elition; Ingenia Elition R5.7.1 SP4 MR Systems; Ingenia Elition S; Ingenia Elition X; Ingenia Elition X R5.4; Ingenia Elition and MR 7700 MR Systems; Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems; Ingneia CX; Intera; Intera 1.5T family; Intera Family; Intera I/T MR system; Intera Sensation Family; Interface Box Breast Coil Sen 1.5T; Interface Box Breast Coil Sen 3T; Interface Box VG GE750; Interface Box VGTT 8Ch; Interface Box VS 16Ch; Interface Box VS 8Ch; Interface Box VT; KFA-63 Knee and Foot Array; Kit, Enhanced Access, Bilateral Upgrade; LBS 3T SMS 7 ch; Large Shoulder Array Coil (Receive Only); Lateral Array Coil; Lateral Array Coil Left; Lateral Array Coil Left VG GE450; Lateral Array Coil Left VG GE750; Lateral Array Coil Left VG STR; Lateral Array Coil Left VGTT; Lateral Array Coil Left VS 16Ch; Lateral Array Coil Left VS 8Ch; Lateral Array Coil Left VT; Lateral Array Coil Right; Lateral Array Coil Right VG GE450; Lateral Array Coil Right VG GE750; Lateral Array Coil Right VG STR; Lateral Array Coil Right VGTT; Lateral Array Coil Right VS 16Ch; Lateral Array Coil Right VS 8Ch; Lateral Array Coil Right VT; Lateral Grid dS Breast 16CH 1/T; Lateral Grid, Lower dS Breast 16CH I/T; Lateral Grid, Upper dS Breast 16CH I/T; Lateral Single Loop Coil Left VG GE450; Lateral Single Loop Coil Left VG GE750; Lateral Single Loop Coil Left VG STR; Lateral Single Loop Coil Left VGTT; Lateral Single Loop Coil Right VG GE450; Lateral Single Loop Coil Right VG GE750; Lateral Single Loop Coil Right VG STR; Lateral Single Loop Coil Right VGTT; MA Extremity Coil, Siemens 1.5T 8-CH HRK COIL; MA Wrist Coil; MICRO 23MM COIL 4598-000-5197x; MICRO 47MM COIL 4598-000-5198x; MICROSCOPY COIL SET, INGENIA 1.5T; MICROSCOPY COIL SET, INGENIA 3T; MODELS EXL AND EXS EXTREMITY COIL SET; MR 5300; MR 5300 and MR 7700 R11 MR Systems; MR 7700; MR 7700 with Distributed Multi Nuclei; MR-OR 1.5T; MR-OR 3T; MR-RT CouchTop; MRCAT Brain / RTgo 4; MRCAT Head & Neck/RTgo 5; MRCAT Pelvis / RTgo 3; MRI COILS; MRI Needle Block 8G; MRI Needle Sleeve 12G; MammoTrak Diagnostic Breast Coil 1.5T; MammoTrak Interventional Breast Coil 1.5T; MammoTrak Interventional Breast Coil 3T; Mammotrak Diagnostic Coil 1.5T; Mammotrak Diagnostic Coil 3T; Mammotrak Interventional Coil 1.5T; Mammotrak Interventional Coil 3T; Medial Array Coil VG GE450; Medial Array Coil VG GE750; Medial Array Coil VG STR; Medial Array Coil VGTT; Medial Array Coil VS; Medial Array Coil VS 16Ch; Medial Array Coil VS 8Ch; Medial Array Coil VT; Medial Coil Element Sen 1.5T; Medial Coil Element Sen 3T; Medial Grid dS Breast 16CH 1/T; Medial Plug Sen 1.5T; Medial Plug Sen 3T; Medial Plug VG GE450; Medial Plug VG GE750; Medial Plug VG STR; Medial Plug VGTT; Medial Plug VS; Medial Plug VT; Medial Single Loop Coil Left VG STR; Medial Single Loop Coil Right VG STR; NEUROVASCULAR ARRAY COIL (Receive Only); Needle Block Holder; Needle Block, 12G; Needle Block, 14G; Needle Block, 16G; Needle Block, 18G; Needle Hub Assembly; Needle Sleeve 12G; Needle Sleeve 14G; Needle Sleeve 16G; Needle Sleeve 18G; OBC-250-PAN BREAST ARRAY COIL; OBC-300 Breast Array Coil; PATIENT SUPPORT BREAST SEN; PHILIPS 1.5T INTERA (BDAS) 6C KNEE ARRAY, Philips dS Knee 8ch 3T, Philips dS Knee 8ch 1.5T; PHILIPS 1.5T INTERA ACHIEVA (CDAS) BBC; PHILIPS 3T INTERA ACHIEVA 32C CARDIOVASCULAR; POSTERIOR - SYN HEAD/NECK COIL 4598-000-5193x; PRECISION EIGHT WRIST ARRAY; Panorama 0.23T 4Ch OBC; Panorama 1T; Panorama HFO; Phased Array Shoulder Coil; Philip Interventional Coil 3T, PHC, Achieva TX; Philips 1.5T Intera 16ch SENSE NV Array; Philips 1.5T SENSE Intera 8 Ch Head Coil; Philips 1.5TSENSE Intera High Res Knee Array; Philips 3T SENSE GP Flex 8; Philips 4-ch SENSE NeuroVascular Coil 3T; Philips 4-ch SENSE Wrist Coil 3T; Philips 7ch SENSE Breast Coil 1.5T; Philips Array Coil Interface Box; Philips INTERA 1.5T HNC 4Ch PA; Philips MRCAT; Philips MammoTrak Interventional Breast Coil, 3T, 16CH; Philips MammoTrak Interventional Breast Coil, 3T, 7CH; Philips SENSE Breast Coil 1.5T 4-ch, Philips INTERA 1.5T Breast Coil 4Ch PA; Philips SENSE Foot-Ankle Coil 1.5T 8ch; Philips SENSE Foot-Ankle Coil 3T 8ch; Philips SENSE Head Coil, 8Ch 3T; Philips SENSE Head Coil, 8Ch 3T, SENSE Head Coil, 6Ch 3T; Philips SENSE Intera Achieva  3T Brain Coil; Philips SENSE Knee Coil 16Ch 1.5T; Philips SENSE Knee Coil 16Ch 3T; Philips SENSE NV Coil 3T 16Ch; Philips SENSE NV Coil 3T 8Ch; Philips SENSE NV Coil, 1.5T 8Ch; Philips SENSE NV Coil, 1.5T 8Ch, Philips 1.5T Intera 16ch SENSE NV Array; Philips SENSE SPINE COIL 3T 15-ch, Philips SENSE SPINE COIL, 1.5T 15-CH; Philips SENSE Shoulder Coil 1.5T; Philips SENSE Shoulder Coil 3T; Philips SENSE Small Extremity 1.5T 8Ch; Philips SENSE Small Extremity 3T 8CH; Philips SENSE Torso/Cardiac Coil 1.5T; Philips SENSE Wrist Coil 1.5T 8Ch; Philips SENSE Wrist Coil 3T 8Ch; Philips ST SENSE Wrist Coil; Philips Sense Head / Neck 16; Philips Sense Head / Neck 8; Philips Sense Spine 16; Philips Sense Spine 8; Philips Sense Torso 16; Philips Sense Torso 8; Philips dS 1.5T 8-ch Foot Ankle Coil; Philips dS 1.5T 8-ch Wrist Coil; Philips dS 3T 8-ch Foot Ankle Coil; Philips dS 3T 8-ch Wrist Coil; Philips dS 3T MIRA 8C SENSE SHOULDER- Philips; Philips dS Breast 16ch 1.5T; Philips dS Breast 16ch 3T; Philips dS Breast 7ch 1.5T; Philips dS Breast 7ch 3T; Philips dS Head 32ch 3T; Philips dS Knee 16ch 1.5T; Philips dS Shoulder 8ch 1.5T; Philips dS Small Extremity 8ch 1.5T; Philips dS Small Extremity 8ch 3T; Philips dS T/R Knee 16ch 3T; Pillar Immobilization Plate; Pillar Immobilization Plate BBC; Pillar Immobilization Plate LBS C-C; Pillar Immobilization Plate LBS M-L; Pillar Immobilization Plate BBC; QSC-085 Shoulder Array Coil; QUAD HEAD COIL 1.5T 4522-133-1727x; QUADRATURE KNEE / FOOT COIL; Quad Abdominal Flex Coil; Quad Lower Extremity Coil (3T); Quardrature Knee/Foot Coil; RT couchTop XD; RTgo; SENSE Breast Coil; SENSE Breast Coil 7ch; SENSE CARDIAC COIL 4522-133-1725x; SENSE CARDIAC COIL 4522-133-1726x; SENSE FLEX L COIL 1.5T 4522-133-1714x; SENSE FLEX L COIL 1.5T ODU 4522-133-1715x; SENSE FLEX L COIL 3T ODU 4522-133-1722x; SENSE FLEX M COIL 1.5T 4522-133-1716x; SENSE FLEX M COIL 1.5T ODU 4522-133-1717x; SENSE FLEX M COIL 3T ODU 4522-133-1721x; SENSE FLEX S COIL 1.5T 4522-133-1718x; SENSE FLEX S COIL 1.5T ODU 4522-133-1719x; SENSE FLEX S COIL 3T ODU 4522-133-1720x; SENSE Foot-Ankle Coil; SENSE Head 16; SENSE Head Coil 1.5T/8CH; SENSE Head Coil 3T 32; SENSE Head Coil 3T/8CH; SENSE Head Coil, 6Ch 3T; SENSE Knee Coil 1.5T/8CH; SENSE Knee Coil 16CH; SENSE Knee Coil 16CH TX; SENSE Knee Coil 3T/8CH; SENSE MASK M 8Ch 1.5T; SENSE MSK S 8ch 1.5T; SENSE NV Coil 1.5T/16ch; SENSE NV Coil 1.5T/8ch; SENSE NV Coil 3T/16ch; SENSE NV Coil 3T/8ch; SENSE SPINE COIL 1.5T 4522-133-1723x; SENSE SPINE COIL 1.5T ODU 4522-133-1724x; SENSE SPINE COIL, 1.5T 15-CH; SENSE Shoulder Coil 1.5T; SENSE Shoulder Coil 3T; SENSE Small Extremity 3T 8; SENSE Spine 16; SENSE Spine Coil 3T 15-ch; SENSE Spine coil 1.5T 15-ch; SENSE Torso/Cardiac Anterior Coil; SENSE Torso/Cardiac Posterior Coil; SENSE Wrist Coil 1.5T 8Ch; SENSE Wrist Coil 3T 8Ch; SENSE XL Torso Coil; SENTINELLE BREAST MRI 16CH Table for GE 1.5T; SENTINELLE BREAST MRI 16CH Tabletop for GE 3T; SENTINELLE BREAST MRI 16CH Tabletop for Siemens 1.5T; SENTINELLE BREAST MRI 16CH Tabletop for Siemens 3T; SENTINELLE BREAST MRI 8CH Table for GE 3T; SENTINELLE BREAST MRI 8CH Tabletop 3T; SENTINELLE BREAST MRI 8CH Tabletop for SIEMENS 3T; SENTINELLE BREAST MRI 8CH Tabletop for Siemens 1.5T; SHNC DRIVERBOX 1.5T 4598-000-5181x; SHNC DRIVERBOX 1.5T ODU 4598-000-5182x; SHOULDER ARRAY COIL SET; SHOULDER ARRAY LARGE; SHOULDER ARRAY SMALL; SIEMENS 8 CHANNEL FOOT AND ANKLE ARRAY; SIEMENS SYMPHONY HIGH RESOLUTION WRIST ARRAY; SMS 1.5T 32 Channel Cardiac Coil; SMS 1.5T Espree 8Ch FAC (Foot/Ankle Coil); SMS 3T 32 Channel Cardiac Coil; ST SENSE Breast Coil; ST SENSE Breast Dx Coil; ST SENSE Wrist Coil; SYN.BODY COIL 1.5T ODU 4598-005-5189x; SYN.BODY COIL 1.5T ODU WITH SLEEVE 4598-009-6978x; SYN.BODY COIL 1.5T WITH SLEEVE 4598-000-5187x; Sense Breast Coil 3T 7ch; Sense Knee 8ch 3T; Sense Knee Coil 1.5T; Sense NV 16 channels; Sense NV Coil 3T; Sense Small Extremity 1.5T 8; Sense head coil 3T; Sentinelle Breast MRI 8CH Table for GE 1.5T; Sentinelle Breast MRI 8CH Tabletop 1.5T; Sentinelle Breast MRI 8CH Tabletop for Siemens 1.5T; Sentinelle Breast MRI Tabletop with 16 Channel Coil Array For Siemens 1.5/3T MRI Systems; Sentinelle Endo Coil Array for Pelvic Imaging; Sentinelle, Biopsy Grid; Shoulder Array Coil; Shoulder Array Coil Large; Shoulder Array Coil Set; Shoulder Array Coil Small; Shoulder Array MR Coil kit VERIO, Siemens 3T VERIO, QSC, Siemens QSC SET, TRIO/TIM 3T 4CH; Siemens 1.5T 16 Channel Knee Coil; Siemens 1.5T 32 CHANNEL CARDIAC; Siemens 1.5T 8Ch Avanto/Espree Precision Eight Wrist Array; Siemens 1.5T AVANTO 32C CARDIOVASCULAR; Siemens 1.5T AVANTO 8Ch FAC; Siemens 1.5T AVANTO QUAD SHOULDER COIL S; Siemens 1.5T ESPREE 8Ch FAC; Siemens 1.5T ESPREE QUAD SHOULDER COIL S; Siemens 1.5T HIGH-RESOLUTION SHOULDER ARRAY; Siemens 1.5T Precision Shoulder Array; Siemens 1.5T Symphony 7Ch BBC (Breast Biopsy Coil); Siemens 1.5T Symphony 8Ch FAC; Siemens 1.5T VISION SHOULDER [DIR]; Siemens 16 CH Breast 3T (LBS); Siemens 3T 16 Channel Knee Coil; Siemens 3T 32 CH BAC; Siemens 3T 8-CHANNEL HRH COIL (High Res Head Array); Siemens 3T 8-CHANNEL HRH COIL (High Res Head Array), 8 Channel Head Array; Siemens 3T 8CH SHOULDER; Siemens 3T 8Ch High Resolution Knee Array; Siemens 3T Biopsy Breast Coil (7CH); Siemens 3T Precision Shoulder Array (8Ch); Siemens 3T TIM/TRIO 8Ch FAC; Siemens 3T TRIO A TIM 32C CARDIOVASCULAR; Siemens 3T Tim/Trio 8Ch FAC (Foot/Ankle Coil); Siemens 8 Channel Foot Ankle MR Coil Kit Verio 3T; Siemens AVANTO 1.5T BBC; Siemens AVANTO SHOULDER ARRAY COIL SET; Siemens AVANTO SHOULDER COIL BASEPLATE UPGRADE; Siemens AVANTO/ESPREE 1.5T 8CH HRW ARRAY; Siemens Avanto 1.5T 8Ch FAC (Foot/Ankle Coil); Siemens ESPREE SHOULDER ARRAY COIL SET; Siemens HRK, TRIO/TIM 3T 8CH; Siemens Luminescence 1.5T Breast Coil 16 Ch; Siemens Luminescence 1.5T Breast Coil 7 Ch; Siemens Luminescence 3T Breast Coil 16 Ch; Siemens SYMPHONY 1.5T 8CH HRW ARRAY; Siemens SYMPHONY 1.5T BBC; Siemens SYMPHONY SMALL EXTREMITY ARRAY; Siemens Symphony 1.5T 8Ch HRW Array; Siemens Symphony Shoulder Coil; Siemens TRIO/TIM 3T 8CH HRW ARRAY; Siemens Trio 3T 8 Channel T/R HRK (High Res Knee); Siemens Trio 3T Brain Coil; Siemens TrioPrecision Eight Wrist Array (3T); Siemens Verio 3T Brain Coil; Signa 1.5T 4Ch Shoulder Coil; Single Loop Coil Left VS; Single Loop Coil Left VT; Single Loop Coil Right VS; Single Loop Coil Right VT; Small extremity 8ch 1.5T; Small extremity 8ch 3T; Smart Fit Shoulder 1.5T; Smart Fit TorsoCardiac 1.5T; SmartPath to Ingenia Elition X; SmartPath to MR 7700; SmartPath to dStream for 1.5T; SmartPath to dStream for 3T; SmartPath to dStream for XR and 3T; Symphony HR Wrist Array Coil 1.5T; Synergy Head/Neck Coil; Synergy Shoulder Coil; T/R HEAD COIL 3T 4598-001-5223x; T/R Head Coil 1.5T (QHC 1H T/R ACS-NT-L) 4598-002-0529x; TRIO BIOPSY BREAST ARRAY; Tabletop Extender; Toshiba 1.5T 2Ch Breast Coil; Toshiba 1.5T 4Ch Shoulder Coil; Toshiba 1.5T 7CH BBC; Toshiba 1.5T 7Ch BBC; Toshiba 1.5T GP Flex Coil; Toshiba 1.5T Knee SPEEDER, Philips SENSE Knee Coil 3T 8Ch, Phililps 6-ch SENSE Knee Coil 3T; Toshiba 585 Series Phased Array coils.; Trolley; Upgrade to MR 7700; Upgrades Achieva/Intera to R5.7; Upgrades dStream to R12; Upgrades dStream to R13; Upgrades dStream to R5.7; VG BREAST 1.5T 16CH GE450 FUL SET w GRID; VG BRST TABLE 1.5T 16CH GE450 FULSET GRD; VS BREAST 3T 8CH TT FULL SET w PACKAGING; VS BRST 1.5T 8CH TT FUL SET w ESPREE RSR; VS BRST 1.5T 8CH TT FUL SET w SHALOW RSR; VS BRST 1.5T 8CH TT FULL SET w TIM4G RSR; VS BRST 3T 4CH TT BIOPSY SET w PACKAGING; VS BRST 3T 8CH TT FULL SET w ESPREE RSR; VS BRST 3T 8CH TT FULL SET w SHALLOW RSR; VS BRST 3T 8CH TT FULL SET w TIM4G RSR; VS BRST 3T TT UPGRADE BIOPSY SET w PACKG; VT1.5T 8CH TT TITAN FULL SET w GRID; Vanguard Atlas/Titan; Vanguard Breast MRI Auxiliary Table with 16 Channel Coil Array for GE 3T MRI System Model 4000451-51; Vanguard Breast MRI Table; Vanguard Breast MRI Tabletop Coil; Vanguard MRI Auxiliary Patient Table with 4 and 8 Channel Coil Array for GE Signa Systems; Vanguard for Siemens Breast MRI Auxillary Table; Wrist Array Coil; dS 1.5T 16CH SHOULDER, COIL; dS 1.5T 1CH Lateral Left; dS 1.5T 1CH Lateral Right; dS 1.5T 4CH Lateral Left; dS 1.5T 4CH Lateral Right; dS 1.5T 8CH Medial; dS 1.5T Interface Box; dS 1.5T Medial Plug; dS 3T 16CH SHOULDER, COIL; dS 3T 1CH Lateral Left; dS 3T 1CH Lateral Right; dS 3T 4CH Lateral Left; dS 3T 4CH Lateral Right; dS 3T 8CH Medial; dS 3T Interface Box; dS 3T Medial Plug; dS Anterior 1.5T; dS Anterior 3T; dS Anterior Coil (1.5T); dS Anterior Coil (3T); dS Anterior Coil (3T), dS Base Coil (1.5T), dS Base Coil (3T), dS Head-Neck Coil (1.5T); dS Base 1.5T; dS Base 3T; dS Breast 16 CH I/T 1.5T; dS Breast 16 CH I/T 3T; dS Breast 16CH 1.5T; dS Breast 16CH 3T I/T; dS Breast 16ch 1.5T; dS Breast 16ch 3T; dS Breast 7ch 1.5T; dS Breast 7ch 3T; dS Breast Adaptive 16CH 1.5T; dS Breast Adaptive 16CH 3T; dS Breast Coil 7ch 1.5T; dS FLEX-L 1.5T; dS FLEX-L 3T; dS FLEX-M 1.5T; dS FLEX-M 3T; dS FLEX-S; dS FLEX-S 1.5T; dS FOOTANKLE 8CH 1.5T; dS Flex Coil L (3T); dS Flex Coil S (1.5T); dS Flex Coil S (3T), dS Flex Coil M (1.5T), dS Flex Coil M (3T), dS Flex Coil L (1.5T); dS Foot-Ankle Coil 8ch 3T; dS FootAnkle 16 CH 1.5T; dS FootAnkle 16 CH 3T; dS FootAnkle 16 Ch 1.5T Coil; dS FootAnkle 16CH 1.5T; dS FootAnkle 16CH 3T; dS FootAnkle 16Ch 1.5T; dS FootAnkle 16Ch 3T; dS FootAnkle 8Ch 3T; dS FootAnkle Coil 8ch 1.5T; dS Head 1.5T; dS Head 32ch 3T; dS Head 3T; dS Head-Neck Coil (3T), dS Head Coil (1.5T), dS Head Coil (3T), dS Flex Coil S (1.5T); dS HeadNeck 1.5T; dS HeadNeck 3T; dS Headrest; dS HiRes Hand/Wrist 16CH 3T; dS HiRes Hand/Wrist 16Ch 1.5T; dS HiRes Hand/Wrist 16Ch 3T; dS Knee 16 ch 1.5T; dS Knee Coil 1.5T/8ch; dS Knee Coil 16ch 1.5T; dS Knee Coil 8ch 1.5T; dS MICROSCOPY 23MM COIL, INGENIA 1.5T; dS MICROSCOPY 23MM COIL, INGENIA 3T; dS MICROSCOPY 47MM COIL, INGENIA 1.5T; dS MICROSCOPY 47MM COIL, INGENIA 3T; dS Patient Support; dS SMALL EXTREMITY 16CH 1.5T; dS Sentinelle Breast 16ch 1.5T; dS Sentinelle Breast 16ch 3T; dS Shoulder 16Ch 1.5T; dS Shoulder 16Ch 3T; dS Shoulder 8ch 1.5T; dS Shoulder 8ch 3T; dS Small Extremity 16CH 3T; dS Small Extremity 16Ch 1.5T; dS Small Extremity 16Ch 1.5T Coil; dS Small Extremity 16Ch 3T; dS Small Extremity 16ch 3T; dS SmallExtr 8ch 1.5T; dS SmallExtr 8ch 3T; dS T/R Knee 16ch 3T; dS WRIST 8CH 3T; dS Wrist 1.5T; dS Wrist 8CH 1.5T; dS Wrist Coil 8ch 1.5T; ds Wrist Coil 8ch 1.5T, Dlisting D551129; wBTS Sensor Set, ECG 1 meter - 98980319364X; wBTS wPPU Sensor Accessories - 98980319363X; wBTU PPU + RESP Module - 98980319445X; wBTU VCG Module - 98980319444X",1992-11-19,130,2026-07-30,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223042177665%22&limit=1
"K2M, Inc.",3004774118,3008599177,600 Hope Pkwy SE,Leesburg,VA,20175,United States,"VB Spine, LLC",10093189,Complaint file establishment; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,46,ERL; FSM; HTJ; HTS; HTW; HTX; HWA; HWB; HWE; HWJ; HWN; HWT; HWX; HXB; HXC; HXE; HXG; HXI; HXW; HXX; HXY; HXZ; JDQ; KNW; KTZ; KWP; KWQ; LXH; MAX; MJO; MNH; MNI; MQP; MQV; NKB; NKG; OAR; ODP; OLO; OSH; OVD; OVE; OWI; PGM; PLR; PWG,"Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Tray, Surgical, Instrument; Gauge, Depth; Knife, Orthopedic; Bit, Drill; Rongeur; Impactor; Extractor; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Instrument, Compression; Template; Tap, Bone; Probe; Wrench; Fork; Tamp; Passer, Wire, Orthopedic; Bender; Screwdriver; Brace, Drill; Cutter, Wire; Cerclage, Fixation; Instrument, Biopsy; Caliper; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Orthopedic Manual Surgical Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Prosthesis, Intervertebral Disc; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Injector, Vertebroplasty (Does Not Contain Cement); Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Bone Fixation Cerclage, Sublaminar; Growing Rod System; Spinal Vertebral Body Replacement Device - Cervical; Spinal Fixation System",1; 2; 3; N,"ADJUSTMENT FORK; ALEUTIAN; ALEUTIAN AN SPACER SYSTEM; ALEUTIAN IBF SYSTEM; ALEUTIAN Interbody Systems Trays; ALEUTIAN SPACER SYSTEM; ALEUTIAN SYSTEM; AVS® AL PEEK Spacer; AVS® AS PEEK Spacer; AVS® Anchor-C Cervical Cage System; AVS® Anchor-L Spacer; AVS® Aria PEEK Spacer; AVS® Navigator PEEK Spacer; AVS® PL PEEK Spacer; AVS® TL PEEK Spacer; AVS® UniLIF PEEK Spacer; AWL; Aero™-AL Lumbar Cage System; Aero™-LL Lumbar Cage System; Aero®-C Cervical Cage System; Aleutian; Aleutian IBF System; Aleutian Spacer System; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; Ascential IBD PEEKc Spacer; Bender; Brainlab; CANYON Retractor Systems Trays; CAPRI Corpectomy Cage System; CAPRI Corpectomy Cage System Trays; CASPIAN; CASPIAN SPINAL SYSTEM; CASPIAN Spinal System Trays; CAYMAN; CAYMAN BUTTRESS; CAYMAN LP Plate System; CAYMAN Plate System Trays; CAYMAN SPINAL SYSTEM; CHESAPEAKE Stabilization System Trays; COMPACTOR/COMPRESSION; COMPRESSOR; Caliper; Capri; Capri Corpectomy Cage System; Cascadia; Cascadia Interbody System; Cascadia, Cayman United; Caspian; Caspian OCT Spinal System; Caspian OCT, Mesa Mini, Denali Mini; Caspian OCT/Mesa mini/Denali mini; Caspian Spinal System; Caspian, Mesa mini, Denali mini; Cayman; Chesapeake; Chesapeake Cervical; Chesapeake Lumbar; Chesapeake Spinal System; Chesapeake Stabilization System; DENALI; DENALI DEFORMITY SYSTEM; DENALI Spinal System Trays; DRILL BIT; DRILL GUIDE; Depth Gauge; Drill Bit; EVEREST SPINAL SYSTEM; EVEREST Spinal System; EVEREST Spinal System Trays; Everest; Everest Spinal System; Everest, Range, Mesa, Denali; Extractor; Fenestrated Tap System; General Instruments; Impactor, Orthopedic Manual Surgical Instrument; K2M General Instruments; K2M Growing Spine System; K2M Mesa Modular Hooks; K2M Navigation Instruments; K2M Patient Specific Rods; KNIFE; MANUAL DRILL BIT; MESA; MESA SPINAL SYSTEM; MESA SPINAL SYSTEM (KEYSTONE RAIL RODS); MESA Spinal System Trays; Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini; Mojave; Mojave Expandable Interbody System; Monterey™ AL Interbody System; NAPA Access System; NATURAL BRIDGE; NILE CoCr Wire; Napa Access System; Navigated Spine Instruments; Navigated Spine Instruments Trays; Nile; Nile Alternative Fixation; ORTHOPEDIC MANUAL; OZARK Cervical Plate System Trays; Orthopaedic Manual Instrumentation; Ozark; PALO ALTO Corpectomy Cage System; PROBE; PYRENEES CERVICAL PLATE SYSTEM; PYRENEES Cervical Plate System Trays; PYRENEES SPINAL SYSTEM; Pyrenees; Pyrenees, Blue Ridge; Q Interbody Instruments; Q Pedicle Instruments; RANGE COCR ROD; RANGE SPINAL SYSTEM; RANGE SPINAL SYSTEM (MESA AND DENALI); RANGE SPINAL SYSTEM, SMALL STATURE; RAVINE Access System Trays; RONGEUR; Range (Mesa, Denali); Range (Mesa, Denali) Everest; Range Mesa Denali; Range Spinal System; Range Spinal System; with pediatric indications; Range, Ari; Range, Denali, Mesa; Range, Mesa, Denali, Natural Bridge; Range, Small Stature, Mesa; Range/Mesa.Denali Spinal System; Range/Mesa/Denali; Range/Mesa/Denali Spinal System; Rhine; Rigid Rail; SAHARA Stabilization System; SAHARA Stabilization System Trays; SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System; Sahara; Sahara Stabilization System; Santorini; Santorini Corpectomy Cage System; Screw Insertion Sleeve; Screwdriver; Stryker Spine VLIFT™ Vertebral Body Replacement System; TAMP; TAP; Terra Nova, Ravine, Serengeti, VCR, Cricket; Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Tritanium® X PL Expandable Posterior Lumbar Cage; Tritanium® X TL Expandable Curved Posterior Lumbar Cage; UniVise; VLIFT®-s Vertebral Body Replacement System; Venado; Vikos Allograft System; Vulcan Spinal System; WIRE (ALL); WIRE CUTTER; XIA 3; XIA Rod Template; Xia Blocker Inserter; YUKON OCT Spinal System; YUKON OCT Spinal System Trays; Yukon; Yukon OCT Spinal System",2025-04-11,129,2026-03-17,0,12,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004774118%22&limit=1
Horiba Instruments Incorporated,1827821,1827821,5449 Research Dr,Canton,MI,48188,United States,HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical,10083022,Complaint file establishment; Manufacturer; Repackager or relabeler; Specification developer,98,CDL; CDP; CDQ; CDT; CDZ; CEC; CEK; CEM; CEO; CEP; CFJ; CFR; CFT; CGA; CGJ; CGS; CGX; CGZ; CHA; CHH; CHI; CHP; CIC; CIG; CIJ; CIT; CIX; CJE; CKA; DBF; DCK; DDG; DDZ; DFC; DGC; DHR; DIC; DIF; DIO; DIS; DJG; DJR; DKB; DKC; DKZ; DLJ; DNN; DRR; GFS; GTQ; JBF; JFH; JFY; JGJ; JGP; JGS; JHI; JHW; JIF; JIN; JIS; JIT; JIX; JIY; JJE; JJQ; JJS; JJW; JJX; JJY; JLS; JLW; JMO; JPK; JQB; JXM; JXN; KHG; KHS; KLI; KNK; KSA; LAF; LAS; LBR; LBS; LCM; LCP; LDJ; LFX; LFZ; LGC; LGD; LPS; MMI; MRR; NDY; QBK,"Berthelot Indophenol, Urea Nitrogen; Radioimmunoassay, Total Triiodothyronine; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Hexokinase, Glucose; Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Follicle-Stimulating Hormone; Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Radioimmunoassay, Corticosterone; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Radioimmunoassay, Estradiol; Cresolphthalein Complexone, Calcium; Diazo Colorimetry, Bilirubin; Saccharogenic, Amylase; Nadh Oxidation/Nad Reduction, Ast/Sgot; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Ferritin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; Transferrin, Antigen, Antiserum, Control; Albumin, Fitc, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; Ige, Antigen, Antiserum, Control; System, Test, Rheumatoid Factor; Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method; Drug Mixture Control Materials; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Alcohol Control Materials; Enzyme Immunoassay, Amphetamine; Calibrators, Drug Specific; Calibrators, Ethyl Alcohol; Amplifier And Signal Conditioner, Biopotential; Standards And Controls, Hemoglobin, Normal And Abnormal; Antistreptolysin - Titer/Streptolysin O Reagent; Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening; Acid Phosphatase (Prostatic), Tartrate Inhibited; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Lowry (Colorimetric), Total Protein; Electrode, Ion Specific, Sodium; Visual, Pregnancy Hcg, Prescription Use; U.V. Method, Cpk Isoenzymes; Enzymatic Method, Ammonia; Nitroprusside, Ketones (Urinary, Non-Quant.); Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Colorimeter, Photometer, Spectrophotometer For Clinical Use; Controls For Blood-Gases, (Assayed And Unassayed); Urinalysis Controls (Assayed And Unassayed); Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Ferrozine (Colorimetric) Iron Binding Capacity; Mixture, Hematology Quality Control; Kinetic Method, Gamma-Glutamyl Transpeptidase; Enzyme Immunoassay, Benzodiazepine; Enzyme Immunoassay, Propoxyphene; Whole Blood Hemoglobin Determination; Enzymatic, Carbon-Dioxide; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Acid, Uric, Uricase (Colorimetric); Calibrator For Red-Cell And White-Cell Counting; Gas Chromatography, Methamphetamine; Drug Specific Control Materials; Ldl & Vldl Precipitation, Hdl; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Phencyclidine; Assay, Glycosylated Hemoglobin; Enzyme Immunoassay, Cannabinoids; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus; Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Urinary Homocystine (Nonquantitative) Test System; Immunoassay Method, Troponin Subunit; System, Test, Low Density, Lipoprotein; Test, Cystatin C; Meprobamate Test System",1; 2; U,"60--BA0288 Pointe Barbiturate Calibrator/Control (Secobarbital 300 ng/mL); 60-AC0580 Pointe 6-Acetylmorphine Reagent; 60-AC0584 Pointe 6-Acetylmorphine Calibrator (5 ng/mL) Low; 60-AC0586 Pointe 6-Acetylmorphine Calibrator (10 ng/mL) Cutoff; 60-AC0588 Pointe 6-Acetylmorphine Calibrator (20 ng/mL) Intermediate; 60-AC0590 Pointe 6-Acetylmorphine Calibrator (40 ng/mL) High; 60-AC0594 Pointe 6-Acetylmorphine Control (7.5 ng/mL) Level 1; 60-AC0596 Pointe 6-Acetylmorphine Control (12.5 ng/mL) Level 2; 60-AC0598 Pointe 6-Acetylmorphine Calibrator (0 ng/mL) Negative; 60-AM0080 Pointe Amphetamines 1000 Reagent; 60-AM0084 Pointe Amphetamines 1000 Calibrator (MAMP 500 ng/mL); 60-AM0086 Pointe Amphetamines 1000 Calibrator (MAMP 1000 ng/mL); 60-AM0088 Pointe Amphetamines 1000 Calibrator (MAMP 1500 ng/mL); 60-AM0090 Pointe Amphetamines 1000 Calibrator (MAMP 2000 ng/mL); 60-AM0094 Pointe Amphetamines 1000 Level 1 Control (MAMP 750 ng/mL); 60-AM0096 Pointe Amphetamines 1000 Level 2 Control (MAMP 1250 ng/mL); 60-AM0200 Pointe Amphetamines 500 Reagent; 60-AM0204 Pointe Amphetamines 500 Calibrator (MAMP 250 ng/mL); 60-AM0206 Pointe Amphetamines 500 Calibrator (MAMP 500 ng/mL); 60-AM0208 Pointe Amphetamines 500 Calibrator (MAMP 1000 ng/mL); 60-AM0210 Pointe Amphetamines 500 Calibrator (MAMP 2000 ng/mL); 60-AM0214 Pointe Amphetamines 500 Level 1 Control (MAMP 375 ng/mL); 60-AM0216 Pointe Amphetamines 500 Level 2 Control (MAMP 625 ng/mL); 60-BA0280 Pointe Barbiturate Reagent; 60-BA0284 Pointe Barbiturate Calibrator/Control (Secobarbital 100 ng/mL); 60-BA0286 Pointe Barbiturate Calibrator/Control (Secobarbital 200 ng/mL); 60-BA0290 Pointe Barbiturate Calibrator (Secobarbital 1000 ng/mL); 60-BA0292 Pointe Barbiturate Control (Secobarbital 400 ng/mL); 60-BP0540, Pointe Buprenorphine Reagent; 60-BZ0260 Pointe Benzodiazepine Reagent; 60-BZ0264 Pointe Benzodiazepine Calibrator/Control (Oxazepam 100 ng/mL); 60-BZ0266 Pointe Benzodiazepine Calibrator/Control (Oxazepam 200 ng/mL); 60-BZ0268 Pointe Benzodiazepine Calibrator/Control (Oxazepam 300 ng/mL); 60-BZ0270 Pointe Benzodiazepine Calibrator (Oxazepam 1000 ng/mL); 60-BZ0272 Pointe Benzodiazepine Control (Oxazepam 400 ng/mL); 60-CA0140 Pointe Cannabinoid (THC) Reagent; 60-CC0060 Pointe Cocaine Metabolite Reagent; 60-CC0064 Pointe Cocaine Calibrator (BE 150 ng/mL); 60-CC0066 Pointe Cocaine Calibrator (BE 300 ng/mL); 60-CC0068 Pointe Cocaine Calibrator (BE 1000 ng/mL); 60-CC0070 Pointe Cocaine Calibrator (BE 3000 ng/mL); 60-CC0074 Pointe Cocaine Level 1 Control (BE 225 ng/mL); 60-CC0076 Pointe Cocaine Level 2 Control (BE 375 ng/mL); 60-CC0680 Pointe Cocaine Metabolite 150 Reagent; 60-CC0684 Pointe Cocaine Metabolite 150 Calibrator (BE 75 ng/mL); 60-CC0686 Pointe Cocaine Metabolite 150 Calibrator (BE 150 ng/mL); 60-CC0688 Pointe Cocaine Metabolite 150 Calibrator (BE 300 ng/mL); 60-CC0690 Pointe Cocaine Metabolite 150 Calibrator (BE 1000 ng/mL); 60-CC0694 Pointe Cocaine Metabolite 150 Level 1 Control (BE 112.5 ng/mL); 60-CC0696 Pointe Cocaine Metabolite 150 Level 2 Control (BE 187.5 ng/mL); 60-CM0740 Pointe Carisporodol Metabolite (SOMA) Reagent; 60-EA0440 Pointe Ethyl Alcohol Reagent; 60-EA0446 Pointe Ethyl Alcohol Calibrator (100 mg/dL); 60-EA0448 Pointe Ethyl Alcohol Level 1 Control (50 mg/dL); 60-EA0450 Pointe Ethyl Alcohol Level 2 Control (300 mg/dL); 60-EC0320 Pointe Ecstasy (MDMA) Reagent; 60-EC0324 Pointe Ecstasy (MDMA) Calibrator (100 ng/mL) Low; 60-EC0326 Pointe Ecstasy (MDMA) Calibrator (500 ng/mL) Cutoff; 60-EC0328 Pointe Ecstasy (MDMA) Calibrator (750 ng/mL) Intermediate; 60-EC0330 Pointe Ecstasy (MDMA) Calibrator (1000 ng/mL) High; 60-EC0334 Pointe Ecstasy (MDMA) Control (375 ng/mL) Level 1; 60-EC0336 Pointe Ecstasy (MDMA) Control (625 ng/mL) Level 2; 60-FN0620 Pointe Fentanyl (Qualitative) Reagent; 60-H70776 Pointe Hydrocodone 100 Level 2 Control (125 ng/mL); 60-HY0760 Pointe Hydrocodone 100 Reagent; 60-HY0764 Pointe Hydrocodone 100 Calibrator (50 ng/mL); 60-HY0766 Pointe Hydrocodone 100 Calibrator (100 ng/mL); 60-HY0768 Pointe Hydrocodone 100 Calibrator (150 ng/mL); 60-HY0770 Pointe Hydrocodone 100 Calibrator (300 ng/mL); 60-HY0774 Pointe Hydrocodone 100 Level 1 Control (75 ng/mL); 60-HY0780 Pointe Hydrocodone 300 Reagent; 60-HY0784 Pointe Hydrocodone 300 Calibrator (150 ng/mL); 60-HY0786 Pointe Hydrocodone 300 Calibrator (300 ng/mL); 60-HY0788 Pointe Hydrocodone 300 Calibrator (500 ng/mL); 60-HY0790 Pointe Hydrocodone 300 Calibrator (800 ng/mL); 60-HY0794 Pointe Hydrocodone 300 Level 1 Control (225 ng/mL); 60-HY0796 Pointe Hydrocodone 300 Level 2 Control (375 ng/mL); 60-MA1704 Pointe Multi-Analyte Set C Urine Low Calibrator; 60-MA1706 Pointe Multi-Analyte Set C Urine DAU Cutoff Calibrator; 60-MA1708 Pointe Multi-Analyte Set C Urine DAU Intermediate Calibrator; 60-MA1710 Pointe Multi-Analyte Set C Urine DAU High Calibrator; 60-MA1714 Pointe Multi-Analyte Set C Urine DAU Level 1 Control; 60-MA1716 Pointe Multi-Analyte Set C Urine DAU Level 2 Control; 60-MA1742 Pointe Multi-Analyte Set D Urine DAU Negative Calibrator; 60-MA1744 Pointe Multi-Analyte Set D Urine DAU Low Calibrator; 60-MA1746 Pointe Multi-Analyte Set D Urine DAU Cutoff Calibrator; 60-MA1748 Pointe Multi-Analyte Set D Urine DAU Intermediate Calibrator; 60-MA1750 Pointe Multi-Analyte Set D Urine DAU High Calibrator; 60-MA1754 Pointe Multi-Analyte Set D Urine DAU Level 1 Control; 60-MA1756 Pointe Multi-Analyte Set D Urine DAU Level 2 Control; 60-MA1782 Pointe Multi-Analyte Set E DAU Negative Calibrator; 60-MA1784 Pointe Multi-Analyte Set E DAU Low Calibrator; 60-MA1786 Pointe Multi-Analyte Set E DAU Cutoff Calibrator; 60-MA1788 Pointe Multi-Analyte Set E DAU Intermediate Calibrator; 60-MA1790 Pointe Multi-Analyte Set E DAU High Calibrator; 60-MA1794 Pointe Multi-Analyte Set E DAU Level 1 Control; 60-MA1796 Pointe Multi-Analyte Set E DAU Level 2 Control; 60-MB0744 Pointe Carisporodol Metabolite (SOMA) Calibrator (50 ng/mL) Low; 60-MB0746 Pointe Carisporodol Metabolite (SOMA) Calibrator (100 ng/mL) Cutoff; 60-MB0748 Pointe Carisporodol Metabolite (SOMA) (200 ng/mL) Intermediate; 60-MB0750 Pointe Carisporodol Metabolite (SOMA) (400 ng/mL) High; 60-MB0754 Pointe Carisporodol Metabolite (SOMA) Control (75 ng/mL) Level 1; 60-MB0756 Pointe Carisporodol Metabolite (SOMA) Control (125 ng/mL) Level 2; 60-ME0220 Pointe Methadone Reagent; 60-ME0224 Pointe Methadone Calibrator (150 ng/mL); 60-ME0226 Pointe Methadone Calibrator (300 ng/mL); 60-ME0228 Pointe Methadone Calibrator (600 ng/mL); 60-ME0230 Pointe Methadone Calibrator (1000 ng/mL); 60-ME0234 Pointe Methadone Level 1 Control (225 ng/mL); 60-ME0236 Pointe Methadone Level 2 Control (375 ng/mL); 60-MM0380 Pointe Methadone Metabolite (EDDP) Reagent; 60-MM0384 Pointe Methadone Metabolite (EDDP) Calibrator (150 ng/mL) Low; 60-MM0386 Pointe Methadone Metabolite (EDDP) Calibrator (300 ng/mL) Cutoff; 60-MM0388 Pointe Methadone Metabolite (EDDP) Calibrator (600 ng/mL) Intermediate; 60-MM0390 Pointe Methadone Metabolite (EDDP) Calibrator (1000 ng/mL) High; 60-MM0394 Pointe Methadone Metabolite (EDDP) Control (225 ng/mL) Level 1; 60-MM0396 Pointe Methadone Metabolite (EDDP) Control (375 ng/mL) Level 2; 60-MM0404 Pointe Methadone Metabolite (EDDP) Calibrator (50 ng/mL) Low; 60-MM0406 Pointe Methadone Metabolite (EDDP) Calibrator (100 ng/mL) Cutoff; 60-MM0408 Pointe Methadone Metabolite (EDDP) Calibrator (250 ng/mL) Intermediate; 60-MM0410 Pointe Methadone Metabolite (EDDP) Calibrator (500 ng/mL) High; 60-MM0414 Pointe Methadone Metabolite (EDDP) Control (75 ng/mL) Level 1; 60-MM0416 Pointe Methadone Metabolite (EDDP) Control (125 ng/mL) Level 2; 60-MP0700 Pointe Methamphetamine Reagent; 60-MP0704 Pointe Methamphetamine Calibrator (250 ng/mL) Low; 60-MP0706 Pointe Methamphetamine Calibrator (500 ng/mL) Cutoff; 60-MP0708 Pointe Methamphetamine Calibrator (1000 ng/mL) Intermediate; 60-MP0710 Pointe Methamphetamine Calibrator (2000 ng/mL) High; 60-MP0714 Pointe Methamphetamine Control (375 ng/mL) Level 1; 60-MP0716 Pointe Methamphetamine Control (625 ng/mL) Level 2; 60-NB0544 Pointe Norbuprenorphine Level 1 Control (3 ng/mL); 60-NB0546 Pointe Norbuprenorphine Low/Cutoff Calibrator (5 ng/mL); 60-NB0548 Pointe Norbuprenorphine Level 1/Level 2 Control (7 ng/mL); 60-NB0550, Pointe Norbuprenorphine Cutoff Calibrator #2 (10 ng/mL); 60-NB0552 Pointe Norbuprenorphine Level 2 Control (13 ng/mL); 60-NB0554 Pointe Norbuprenorphine Intermediate Calibrator #1 (20 ng/mL); 60-NB0556 Pointe Norbuprenorphine Intermediate Calibrator #2 (40 ng/mL); 60-NB0558 Pointe Norbuprenorphine High Calibrator (75 ng/mL); 60-NF0626 Pointe Norfentanyl Calibrator (5 ng/mL); 60-NF0634 Pointe Norfentanyl Level 1 Control (3.75 ng/mL); 60-NF0636 Pointe Norfentanyl Level 2 Control (6.25 ng/mL); 60-OP0040 Pointe Opiate 300 Reagent; 60-OP0044 Pointe Opiate Calibrator (Morphine 150 ng/mL); 60-OP0046 Pointe Opiate Calibrator (Morphine 300 ng/mL); 60-OP0048 Pointe Opiate Calibrator (Morphine 600 ng/mL); 60-OP0050 Pointe Opiate Calibrator (Morphine 1000 ng/mL); 60-OP0054 Pointe Opiate Level 1 Control (Morphine 225 ng/mL); 60-OP0056 Pointe Opiate Level 2 Control (Morphine 375 ng/mL); 60-OP0660 Pointe Opiate 2000 Reagent; 60-OP0664 Pointe Opiate 2000 Calibrator (Morphine 1000 ng/mL); 60-OP0666 Pointe Opiate 2000 Calibrator (Morphine 2000 ng/mL); 60-OP0668 Pointe Opiate 2000 Calibrator (Morphine 4000 ng/mL); 60-OP0670 Pointe Opiate 2000 Calibrator (Morphine 6000 ng/mL); 60-OP0674 Pointe Opiate 2000 Level 1 Control (Morphine 1500 ng/mL); 60-OP0676 Pointe Opiate 2000 Level 2 Control (Morphine 2500 ng/mL); 60-OX0480 Pointe Oxycodone Reagent; 60-OX0484 Pointe Oxycodone Control (75 ng/mL); 60-OX0486 Pointe Oxycodone Calibrator (100 ng/mL); 60-OX0488 Pointe Oxycodone Control (125 ng/mL); 60-OX0490 Pointe Oxycodone Control (225 ng/mL); 60-OX0492 Pointe Oxycodone Calibrator (300 ng/mL); 60-OX0494 Pointe Oxycodone Control (375 ng/mL); 60-OX0496 Pointe Oxycodone Calibrator (500 ng/mL); 60-OX0498 Pointe Oxycodone Calibrator (800 ng/mL); 60-OX0504 Pointe Oxycodone Calibrator (50 ng/mL); 60-PC0024 Pointe Phencyclidine Calibrator (12.5 ng/mL); 60-PC0026 Pointe Phencyclidine Calibrator (25 ng/mL); 60-PC0028 Pointe Phencyclidine Calibrator (50 ng/mL); 60-PC0030 Pointe Phencyclidine Calibrator (100 ng/mL); 60-PC0034 Pointe Phencyclidine Level 1 Control (18 ng/mL); 60-PC0036 Pointe Phencyclidine Level 2 Control (32 ng/mL); 60-PH0020 Pointe Phencyclidine Reagent; 60-PP0240 Pointe Propoxyphene Reagent; 60-PP0244 Pointe Propoxyphene Calibrator (150 ng/mL) Low; 60-PP0246 Pointe Propoxyphene Calibrator (300 ng/mL) Cutoff; 60-PP0248 Pointe Propoxyphene Calibrator (600 ng/mL) Intermediate; 60-PP0250 Pointe Propoxyphene Calibrator (1000 ng/mL) High; 60-PP0254 Pointe Propoxyphene Control (225 ng/mL) Level 1; 60-PP0256 Pointe Propoxyphene Control (375 ng/mL) Level 2; 60-TH0004 Pointe THC Negative Calibrator (0 ng/mL); 60-TH0012 Pointe THC Control (18.75 ng/mL); 60-TH0014 Pointe THC Calibrator/Control (37.5 ng/mL); 60-TH0016 Pointe THC Control (62.5 ng/mL); 60-TH0018 Pointe THC Control (125 ng/mL); 60-TH0144 Pointe THC Calibrator (12.5 ng/mL); 60-TH0146 Pointe THC Calibrator (25 ng/mL); 60-TH0148 Pointe THC Control (31.25 ng/mL); 60-TH0150 Pointe THC Calibrator (50 ng/mL); 60-TH0152 Pointe THC Calibrator/Control (75 ng/mL); 60-TH0154 Pointe THC Calibrator (100 ng/mL); 60-TH0156 Pointe THC Calibrator (150 ng/mL); 60-TH0158 Pointe THC Calibrator (200 ng/mL); 60-UN0002 Pointe Universal Negative Calibrator; A7502 Pointe Albumin Reagent; A7502-STD Pointe Albumin Standard; A7503 Pointe Acid Phosphatase Reagent; A7504, Pointe Alcohol Reagent; A7504-CTL, Pointe Ammonia / Alcohol Control Set; A7504-STD, Pointe Alcohol Standard; A7505 Pointe Alkaline Phosphatase Reagent; A7516 Pointe Alkaline Phosphatase Reagent; A7526 Pointe Liquid ALT (SGPT) Reagent; A7527 ALT Single Reagent; A7553, Pointe Ammonia Reagent; A7553-STD, Pointe Ammonia Standard; A7561 Pointe Aspartate Aminotransferase (AST) Reagent; A7562 Pointe AST Single Reagent; A7564, Pointe Liquid Amylase (CNPG3) Reagent; A7567 Pointe ASO Calibrator; A7567 Pointe ASO Reagent; ABX Minocal Whole Blood Hematology Calibrator (5300100300); ABX Minotrol 16 Whole Blood Hematology Controls (5300100303, 5300100306, 5300100312) BFTROL; B7538, Pointe Direct Bilirubin Reagent; B7550-STD Pointe BUN Standard; B7551, Pointe Urea Nitrogen (BUN) (Berthelot/Colorimetric); B7552 Pointe Liquid Urea Nitrogen (BUN) Reagent; B7554 Pointe BUN Reagent; B7576 Pointe Total Bilirubin Reagent; C7053-STD Pointe Calcium Standard; C7502 Pointe Carbon Dioxide Reagent; C7502-STD Pointe Carbon Dioxide Standard; C7503, HC902 Pointe Calcium Reagent; C7504-STD, Carbon Dioxide Standard; C7506-CAL Pointe Chemistry Calibrator; C7506-DIL Pointe Chemistry Diluent; C7509-STD, Pointe Cholesterol Standard; C7510, Pointe Cholesterol Reagent; C7513-STD Pointe Creatinine Standard; C7522 Pointe Liquid Creatine Kinase Reagent (CK); C7529 Pointe Calcium Arsenazo III Reagent; C7539 Pointe Creatinine Reagent; C7548, Pointe Creatinine (Enzymatic) Reagent; C7562 Pointe Creatine Kinase-MB (CK-MB) Reagent (Powder); C7562-CTL, Pointe CK-MB Controls; C7563 Pointe Creatine Kinase-MB (CK-MB) Reagent (2pt liquid); C7568, Pointe C-Reactive Protein High Sensitivity CRP (HS); C7568-CAL, Pointe CRP(HS) Wide Range Multi-Calibrator; C7568-CTL, Pointe CRP(HS) Wide Range Controls; C7568-STD, Pointe CRP(HS) Wide Range Multi-Standard; C7585 Cystatin C Reagent; C7585-CAL Cystatin C Calibrator; C7585-CTL Cystatin C Controls; C7590, Pointe Chemistry Control, Level 1; C7591, Pointe Chemistry Control, Level 2; C7592, Pointe Chemistry Controls, Level 1 and Level 2; CM1105, Pointe Troponin I (Human Cardiac Specific) EIA Test Kit; CM1117, Pointe Myoglobin Enzyme Immunoassay (EIA); COC150, Pointe Cocaine Metabolite Reagent; F1027, Pointe Human Chorionic Gonadotropin (hCG) EIA Test Kit; F1029, Pointe Follicle-Stimulation Hormone (FSH) Enzyme Immunoassay; F1031, Pointe Luteinizing Hormone (LH) Enzyme Immunoassay; F1037, Pointe Prolactin Immunoassay; F7505 Pointe Ferritin Reagent; F7505-CAL Pointe Ferritin Calibrators; F7505-CTL Pointe Ferritin Controls; G7517, Pointe Glucose (Hexokinase) Reagent; G7518-STD Pointe Glucose Oxidase Standard; G7521 Pointe Liquid Glucose (Oxidase) Reagent; G7540, Pointe Glycohemoglobin Reagent; G7540-CTL, Pointe Glycohemoglobin Controls; G7540-STD, Pointe Glycohemoglobin Standard; G7571, HG959, Pointe GGT (y-glutamyl transferase) Reagent; G7583, Pointe Glucose-6-Phosphate Dehydrogenase Reagent (G6PD); G7583-CTL, Pointe G6PD Controls; G7583-LYS, Pointe G6PD Lyse; H7504 Pointe Hemoglobin Reagent; H7505-STD, Hemoglobin Standard; H7506-CTL Pointe Hemoglobin Controls; H7506-STD Pointe Hemoglobin Standard; H7507, Pointe HDL Cholesterol Precipitating Reagent (Dextran Sulfate); H7511, Pointe HDL Cholesterol Precipitating Reagent; H7512-STD, Pointe HDL Cholesterol Standard; H7541 Pointe Hemoglobin A1c Reagent; H7541-CAL Pointe Hemoglobin A1c Calibrator; H7541-CTL Pointe Hemoglobin A1c Controls; H7545, Pointe Liquid autoHDL Choldesterol Reagent; H7545-CAL, Pointe autoHDL/LDL Cholesterol Calibrator; H7546 Pointe Hemoglobin A1c Reagent; H7575, Pointe Homocysteine Reagent; H7575-CAL, Pointe Homocysteine Calibrator; H7575-CTL, Pointe Homocysteine Controls; H7587, Pointe B-Hydroxybutyrate Reagent; H7587-CTL, Pointe B-Hydroxybutyrate Controls; H7587-STD, Pointe B-Hydroxybutyrate Standard; H7588 B-Hydroxybutyrate Reagent; H7588-CAL B-Hydroxbutyrate Calibrator; H7588-CTL B-Hydroxybutyrate Controls; H7590, HDL Reagent; HA965, Pointe Amylase (EPS-G7) Reagent; HB936 Pointe Direct Bilirubin Reagent; HB979 Pointe Total Bilirubin Reagent; HM929, Pointe Magnesium Reagent; HU982, U7581, Pointe Uric Acid Reagent; I7504, I7505, HI904, Pointe Total Iron Reagent; I7505-STD, I7513-STD Pointe Iron Standard; I7506, Pointe UIBC Buffer; I7517, Pointe Direct TIBC Reagent; I7517-CAL, Pointe Direct TIBC Calibrator; L7503 Pointe Lipase (Colormetric) Reagent; L7513 Lipase Reagent; L7513-CTL Lipase Controls; L7513-STD Lipase Standard; L7572, HL956, Pointe Lactate Dehydrogenase Reagent (LD); L7574, Pointe autoLDL Cholesterol Reagent; L7580-CTL, Pointe Lipid Controls; L7596, Pointe Lactate Reagent; L7596-STD, Pointe Lactate Standard; L7597, Pointe Lipoprotein (a) Reagent; L7597-CAL, Pointe Lipoprotein (a) Calibrator; L7597-CTL, Pointe Lipoprotein (a) Control; LPA400 Lipoprotein (a); LPA400C Lipoprotein (a) Calibrator; LPA400CR Lipoprotein (a) Calibrator; M7527-STD, Pointe Magnesium Standard; M7562, Pointe Microalbumin Reagent; M7562-CAL, Pointe Microalbumin Multi-Calibrator; M7562-CTL, Pointe Microalbumin Controls; Mindray BA800 Chemistry Analyzer; Mindray BS200 Chemistry Analyzer; Mindray BS480 Chemistry Analyzer; P1025, Pointe Ferritin Enzyme Immunoassy (EIA); P1035, Pointe Immunoglobulin E (IgE) Enzyme Immunoassay (EIA); P7516, HP916, Pointe Inorganic Phosphorus Reagent (UV); P7516-STD, Pointe Phosphorus Standard; P7582, Pointe Microprotein Reagent; P7582-STD, Pointe Microprotein Standard; Pointe 180 II Chemistry Analyzer; Pointe 180 Plus Chemistry Analyzer; Pointe 180 QT Chemistry Analyzer; Pointe C2000 Chemistry Analyzer; Pointe Impulse Chemistry Analyzer; Pointe Lipid Control Set; R7502 Pointe Rheumatoid Factor (RF) Reagent; R7502-CAL Pointe Rheumatoid Factor (RF) Calibrators; RA502-CTL Pointe RF/ASO Controls; S1111, Pointe Estradiol (E2) Enzyme Immunoassay; S1113, Pointe Progesterone Enzyme Immunoassay; S1115, Pointe Testosterone Enzyme Immunoassay; S1887, Pointe Cortisol Enzyme Immunoassay; T1001, Pointe Thyroid Stimulating Hormone (TSH) Enzyme Immunoassay (EIA); T1003, Pointe Ultra-Sensitive Thyroid Stimulating Hormone (U-TSH) EIA; T1005, Pointe Triiodothyronine (T3) Enzyme Immunoassay (EIA); T1006 Pointe Free T3 EIA; T1007, Pointe Total Thyroxine (T4) Enzyme Immunoassay (EIA); T1008, Pointe Free Thyroxine (fT4) Enzyme Immunoassay (EIA); T7528, HT928, Pointe Total Protein (Biuret) Reagent; T7528-STD Pointe Total Protein Standard; T7531, T7532, Pointe Triglyceride (GPO) Reagent; T7531-STD, Pointe Triglyceride Standard; T7535 Pointe Transferrin Reagent; T7535-CAL Pointe Transferrin Calibrators; T7535-CTL Pointe Transferrin Controls; T8001, Pointe Toxoplasma IgG Enzyme Immunoassay; T8002, Pointe Toxoplasma IgM Enzyme Immunoassay; T8003, Pointe Rubella IgG Enzyme Immunoassy; T8004, Pointe Rubella IgM Enzyme Immunoassay; T8005, Pointe CMV IgG Enzyme Immunoassay; T8006, Pointe CMV IgM Enzyme Immunoassay; T8007, Pointe HSV IgG Enzyme Immunoassay; U7580, Pointe Uric Acid Reagent; U7580-STD, Pointe Uric Acid Standard; Yumizen C560 Chemistry Analyzer",2021-11-19,128,2020-08-11,0,32,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221827821%22&limit=1
"Terumo Medical Canada, Inc.",3008307705,3008307705,10911 Keele Street Units 2-4,Vaughan Ontario,,L6A 5A6,Canada,TERUMO MEDICAL CORP.,9003933,Exporter to the US,30,DQO; DQX; DQY; DSY; DTM; DTN; DTZ; DYB; FLL; FMF; FMI; FOZ; FPA; HCG; JKA; KDI; KGZ; KOD; KRA; KRD; KRL; MEG; MGB; MIH; OCY; OPR; OUT; QCA; QEZ; QSK,"Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Filter, Blood, Cardiopulmonary Bypass, Arterial Line; Reservoir, Blood, Cardiopulmonary Bypass; Oxygenator, Cardiopulmonary Bypass; Introducer, Catheter; Continuous Measurement Thermometer; Syringe, Piston; Needle, Hypodermic, Single Lumen; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Device, Neurovascular Embolization; Tubes, Vials, Systems, Serum Separators, Blood Collection; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Accessories, Catheter; Catheter, Urological; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Detector, Bubble, Cardiopulmonary Bypass; Syringe, Antistick; Device, Hemostasis, Vascular; System, Endovascular Graft, Aortic Aneurysm Treatment; Endoscopic Guidewire, Gastroenterology-Urology; Intrasaccular Flow Disruption Device; Intracranial Aneurysm Flow Diverter; Intracranial Coil-Assist Stent; Aspiration Thrombectomy Catheter; Hybrid Stent Graft, Thoracic Aortic Lesion Treatment",1; 2; 3,"27G X 1/2; 29G AND 30G K-PACK II NEEDLE; AZUR CX Coil System-Detachable 18 AZUR CX; AZUR CX Detachable 18 Peripheral Coil System; AZUR CX Peripheral Coil System Detachable 35; AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35; AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35; AZUR Peripheral Hydrocoil Embolization System; AZUR Peripheral Hydrocoil Embolization System (Detachable 18); AZUR Peripheral Hydrocoil Embolization System (Detachable 35); AZUR Peripheral Hydrocoil Endovascular Embolization Coil System; AZUR Pushable 18 & 35 System; Angio-Seal; Angio-Seal VIP Vascular Closure Device; Azur Detachable 35 Platinum Coil System; Azur Peripheral Hydrocoil Embolization System Detachable 35; CAPIOX AF125X ARTERIAL FILTER; CAPIOX ARTERIAL FILTER; CAPIOX CARDIOTOMY RESERVOIR; CAPIOX FLEXIBLE VENOUS RESERVOIR; CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER; CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER; CAPIOX HEMOCONCENTRATOR; CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS; CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR; CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR; CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR; CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR; CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR; CAPIOX(R) BUBBLE TRAP; Chaperon Guiding Catheter,System; Cosmos 10 Advanced; Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath; FRED 21; Finecross M3; Gelsoft Plus Vascular Prostheses; Gelweave; Gelweave Vascular Prostheses; Glidesheath; Glidesheath Slender; Glidesheath Slender Tibial Pedal Kit; Glidewire; Glidewire Advantage Track; Glidewire GT; Glidewire GT,; Glidewire GT-R; Glidewire Gold; Glidewire Gold Neuro; Headliner Hydrophilic Coated Guidewire; Glidewire Gold Neuro; Headway 17 Microcatheter; Headway 21+ Microcatheter; Headway 27 Microcatheter; Heartrail III 5Fr Guiding Catheter; Heartrail III Coronary Guiding Catheter; HydroCoil® Embolic System (HES); HydroFill 10 Advanced; HydroFrame 10 Advanced; HydroFrame 18 Advanced; HydroSoft 3D Advanced; HyperSoft 3D Advanced; HyperSoft Advanced; Hypodermic Needle for Single Use; Hypodermic Syringe Without Needle; K-PACK II; K-PACK II NEEDLE - 27G X 3/4 THIN WALL; K-PACK II NEEDLE - 29G THIN WALL; K-PACK II NEEDLE- 27G & 30G THIN WALL; K-Pack II Needle - 29G x 5/16 Thin Wall; K-Pack II Needle-21G x 2; K-Pack Surshield Needle,; LIPO-PORT; LVIS; MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES); MicroPlex Cosmos; MicroPlex VFC Advanced; MicroPlex® Coil System (MCS); Navicross 018; Neuro Glidewires; Pinnacle Introducer Sheath; Pinnacle Precision Access System; Pinnacle R/O II; Pinnacle R/O II HiFlo; Prevent Safety Winged Infusion Set; Priority One AC; Progreat; Progreat Coaxial Microcatheter System; Progreat Coaxial Microcatheter System,; Progreat Lambda; R2P Destination Slender Guiding Sheath; R2P NaviCross; R2P™ Destination Slender™ Guiding Sheath; Radifocus Glidecath Hydrophilic Coated Catheter; Radifocus Glidecath, Radifocus Glidecath XP; Radifocus Glidewire; Radifocus Glidewire Advantage; Radifocus Glidewire Advantage 014; Radifocus Glidewire,; Radifocus Glidewire® Endoscopic Wire; Radifocus Guide Wire M,; Radifocus Introducer II; Radifocus Introducer II with R/O Marker; Radifocus Optitorque Angiographic Catheter; Radifocus Torque Device; Radifocus® Optitorque™ Angiographic Catheter; RelayPro Thoracic Stent-Graft System; Runthrough NS Extension Wire; Runthrough NS PTCA Guide Wire; SOFIA 6F Catheter; SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD); SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD); Scepter Mini Occlusion Balloon Catheter; Surflash IV Catheter; Surflo Winged Infusion Set; Surguard2 Safety Hypodermic Needle,; Surguard2 Safety Needle,; Surguard2 Safety Syringe,; Surshield Safety Winged Blood Collection Set; Surshield Safety Winged Infusion Set; TERUMO HOLLOW OXYGENATOR CIRCUIT; TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER; TREO Abdominal Stent-Graft System; Terumo NaviCross Support Catheter; Terumo Needle, Terumo Hypodermic Needle, Hypodermic Single Lumen Needle; Terumo Single Use Guidewire; Terumo SurGuard Hypodermic Syringe with Safety Needle; Terumo SurGuard3 Safety Hypodermic Needle; Terumo SurGuard3 Safety Needle; Terumo Surflo I.V. Catheter; Terumo Surguard2 Safety Hypodermic Needle; Terumo Surguard2 Safety Needle,; Terumo Surguard2 Safety Syringe,; Terumo Surguard2 with Safety Hypodermic Needle,; Terumo Syringe / Hypodermic Syringe w/o Needle; Terumo Syringe, Terumo Syringe w Needle; Terumo®SurGuard®3 Safety Needle Terumo®SurGuard®3 Hypodermic Syringe with Safety Needle; Thoraflex Hybrid Plexus; Traxcess; Traxcess Docking Wire; VIA-17 MICROCATHETER,VIA-17-154-01; Venoject Luer Adapter; VisiGlide Single Use Guidewire; WEB Aneurysm Embolization System; X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR",1996-04-15,121,2025-02-27,7,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008307705%22&limit=1
ICU Medical Healthcare Manufacturing S.A. de C.V.,9617604,3002558692,AVENIDA CALIDAD No 14409 Parque Industrial Internacional Tijuana,"Tijuana, B.C. C.P. Baja California",,22424,Mexico,"ICU Medical, Inc.",8020727,Contract manufacturer; Manufacturer; Repackager or relabeler,58,BSB; BSJ; BSN; BSO; BSP; BSR; BSY; BSZ; BTC; BTM; BTO; BTR; BWC; BWF; BYD; BYG; BYP; BZA; BZO; BZT; BZW; CAF; CAH; CAI; CAP; CAZ; CBI; CBN; CBT; CCK; CCO; DTW; DWJ; DWS; DYB; EPE; FLL; FMI; FOZ; FPA; FRN; JAY; JKA; JOH; KDQ; KOD; KZL; LGZ; LHI; LJS; LJT; LLD; LZG; MEA; MIA; NHK; OFP; PWH,"Warmer, Blood, Non-Electromagnetic Radiation; Mask, Gas, Anesthetic; Filter, Conduction, Anesthetic; Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Gas-Machine, Anesthesia; Bag, Reservoir; Ventilator, Emergency, Manual (Resuscitator); Tube, Tracheostomy (W/Wo Connector); Tube, Tracheal (W/Wo Connector); Needle, Emergency Airway; Spirometer, Therapeutic (Incentive); Condenser, Heat And Moisture (Artificial Nose); Mask, Oxygen; Mouthpiece, Breathing; Connector, Airway (Extension); Set, Tubing And Support, Ventilator (W Harness); Stethoscope, Esophageal, With Electrical Conductors; Stethoscope, Esophageal; Nebulizer (Direct Patient Interface); Filter, Bacterial, Breathing-Circuit; Circuit, Breathing (W Connector, Adaptor, Y Piece); Monitor, Airway Pressure (Includes Gauge And/Or Alarm); Anesthesia Conduction Kit; Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector); Apparatus, Gas-Scavenging; Arterial Blood Sampling Kit; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Bed, Rocking, Breathing Assist; Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass; System, Thermal Regulating; Instruments, Surgical, Cardiovascular; Introducer, Catheter; Brush, Cleaning, Tracheal Tube; Continuous Measurement Thermometer; Needle, Hypodermic, Single Lumen; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Pump, Infusion; Support, Breathing Tube; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tube Tracheostomy And Tube Cuff; Bottle, Collection, Vacuum; Catheter, Urological; Device, Warming. Blood And Plasma; Warmer, Thermal, Infusion Fluid; Set, I.V. Fluid Transfer; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Port & Catheter, Implanted, Subcutaneous, Intraperitoneal; Pump, Infusion, Insulin; Pump, Infusion, Pca; Needle, Spinal, Short Term; Resuscitator, Manual, Non Self-Inflating; Anesthesia Breathing Circuit Kit (Adult & Pediatric); Administrations Sets With Neuraxial Connectors",1; 2,"""SNUGGLE WARM"" CONVE; 1st Response Adult Manual Resuscita; 250 ML Reservoir with FFP; ANALYZER; ANESTHESIA BREATHING CIRCUITS; Adapter; Administration Set Male/Male Luer; Anesthesia Breathing Bag; BIVONA; BL Ultra Suctionaid Change Kits; BLU; BLUS; BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit or Tray with BLUselect Tracheostomy Tube with or without; BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray with or without BLUselect Tracheostomy Tube; Bivona; Bivona Adjustable Hyperflex; Bivona Disconnect Wedge; Bivona Hyperflex; Bivona® Aire-Cuf® Neonatal and Pediatric Tracheostomy Tubes; Bivona® Aire-Cuf® Tracheostomy Tubes; Bivona® Cuff Maintenance Device (CMD¿)open; Bivona® Fome-Cuf® Tracheostomy Tubes; Bivona® Mid-Range Aire-Cuf® Adult Tracheostomy Tubes; Bivona® Uncuffed Neonatal and Pediatric FlexTend Plus Silicone Tracheostomy Tubes; Bivona® Uncuffed Neonatal and Pediatric Tracheostomy Tubes; Blue Line; Blue Line Ultra Inner Cannulas; Blue Line Ultra Suctionaid; Blue Line Ultra Tracheostomy Tubes and Kits; Bougie; CADD Administration Set; CADD Extension Set; CADD High Volume Administration Set; CADD High volume Administration Set; CADD Prizm High Vol. Admin. Set; CADD-MS3 Infusion Pump; CADD-Prizm PCS Accessories; CADD-Prizm PCS Infusion Pump; CADD® Filling Adapter with male NRFit™ connector and female Luer; CADD® Infusion Adapter with male NRFit™ connector and female Luer; CADD® Yellow Administration Set with NRFit™ connector; CADD® Yellow Extension Sets with NRFit™ connector; CADD® Yellow Medication Cassette Reservoir with NRFit™ connector; CARBON-DIOXIDE; CIRCUVENT; CLEO Infusion Set; CSEcure® Combined Spinal Epidural; Cartridge, CADD-MS3; Cathmark; Clinicath Sheath Introducer; Connector; Continuous Epidural tray/kit; Cozmonitor Blood Glucose Monitor; D.I.C. Flex Tracheostomy Tubes; D.I.C. Tracheostomy Tubes; DIC LARYNGECTOMY; DIC TRACHEOSTOMY TUBE; DISPOSABLE MANOMETER; Datascope; Deltec Cozmo 3-ml Insulin Cartridge; Deltec Cozmo Insulin Pump Mdl. 1700; Disposable Normothermic IV Administration Sets; Drainage Bag; Duralife; Elbow; EpiFuse; Equator® Convective Warmer; Esophageal Stethoscope; Esophageal Stethoscope w/thermocouple; Exhalation filter; Expandable; Face Mask; FaceTent; Female Yellow Cap with NRFit™ connector; Filtered HME; First Breath; First Response; Flexible Meidication Reservior; Flo2; GAS; GASEOUS-PHASE; GE Datex-Ohmedla Aisys CS' Anesthesia System; GRIPPER; GRIPPER MICRO; GRIPPER PLUS Needle; General Purpose Probe; Gripper Micro 1.25 inch Needle Access Device; Gripper Needle; Gripper PLUS Needle; Gripper Plus; HEPA; HME; HMEF; HYPERINFLATION BAG SYSTEM; Hotline; Hotline 2 Fluid Warmers; Hotline 3; Hyperinflation System; Incentive Spirometer; Industrial - Connectors (IFE); Introducer; Jelco Point-Lok Sharps Safety Device; Jelco Saf-T Holder Device; Jelco Saf-T Wing Blood Collection Set; Jelco Saf-T Wing Blood Collection and Infusion Set; Leval (1) Irrigation Accessories; Level 1 (R) Fast Flow Fluid Warmer; Level 1 Esophageal Stethoscope; Level 1 Esophageal Stethoscope w/thermocouple; Level 1 Esophageal/Recal Temperature Probe; Level 1 Esophageal/Rectal Temperature Probe; Level 1 Hotline 2 Fluid Warming Set; Level 1 Normothermic I.V. Fluid Administration Set; Level 1 Skin Temperature Sensor; Level 1® H-1200 Fast Flow Fluid Warmer; Locator Wand Cover; LockIt Plus; MULTIPLE (STERICATH; MULTIPLE BIVONA; MULTIPLE BIVONA (IFE); Male Yellow Cap with NRFit™ connector; Manual Ventilator Transport Kit; Maxiflo; Medication Cassette Reservoir; Medication Nebulizer; Modified Jackson-Rees; Mount; Myocardial Temperature Sensor; Myocardial Temperature Sensors; NORMOFLO; Natural, Yellow, Blue; Neo-Therm; Neo-vac meconium; No-Pour; Novaplus; O FILTER; Ohmeda; PAC Dual Lumen Port, Low Profile; PAC Dual Lumen Porta Ti/Polysulfone; PAC Dual Lumen Portal Preconnected; PAC II FluroFree LP Dual Lumen Port; PAC II FluroFree Low Profile Port; PAC II FluroFree Port; PAC II Ti/Polysulfone Port Low Prof; PAC II Ti/Polysulfone Port Preatchd; PAC Implantable Power Port; PAC Ti Dual Lumen Portal; PAC Titanium Contoured Port Polyure; PAC Titanium Contoured Port Silicon; PAS Port Elite Infusion Port; PEEP Valve; PERC TRACH KIT with Forceps; PORT-A-CATH; PORT-A-CATH Power P.A.C. Implantable Venous Access Systems; PORTEX GRIGGS PERC TRACH KITS; PORTEX HYPERINFLATION BAG SYSTEM; PORTEX TUOHY EPIDURAL NEEDLE; PORTEX ULTRAPERC; POWER GRIPPER PLUS Needle; POWER PORT-A-CATH II Implantable Venous Access System; POWER PORT-A-CATH Implantable Venous Access System; PVC - Portex Tubes Blue Line Classic; Peel Away Sheath Introducers; Pencil Point Spinal Needle; PeriFuse; Plus; Point-Lok; Polar North; Polar South; Port-a-Cath II Ti/Polysolfone Port; Port-a-Cath Needle (various); Port-a-Cath Peritoneal Port; Port-a-Cath Port; Portex; Portex Adjustable Flange Tracheostomy Tube; Portex Anesthesia Airway Gas Sampling Line; Portex BLUselect Suctionaid Tracheostomy Tube; Portex BLUselect Tracheostomy Inner Cannula; Portex BLUselect Tracheostomy Tube; Portex Blue Line Endobronchial Tube; Portex Blue Line Ultra Paediatric Tracheotomy Tube; Portex Blue Line Ultra Suctionaid Trachostomy Tube Kits; Portex Blue Line Ultra Tracheostomy Kit; Portex Blue Line Ultra Tracheostomy Kit Suctionaid; Portex Blue Line Ultra Tracheostomy Tube; Portex Blue Line Ultra Tracheostomy Tube Inner Cannula; Portex Blue Line Ultra® tracheostomy tubes; Portex Catheters Maxi-Flo (IFE); Portex EchoGlo Continuous Nerve Block Kit; Portex EchoGlo Peripheral Nerve Block Needle: Continuous Catheter; Portex EchoGlo Peripheral Nerve Block Needle: Single Shot; Portex EchoGlo Single Shot Nerve Block Support Kit; Portex Emergency Cricothyroidotomy; Portex Emergency Cricothyroidotomy Kit; Portex Endotracheal Tube (IFE); Portex EpiFuse Catheter with NRFit Connector; Portex Epidural Filter; Portex Epidural Flat Filter with NRFit Connector; Portex Epidural Minipack System; Portex Fibre-Optic Bronchoscope Swivel Connector (IFE); Portex Filter Needle with NRFit Connector; Portex Filter Straw with NRFit Connector; Portex Filters; Portex HEPA filters; Portex HEPA/HME filters; Portex Hyperinflation Bag System; Portex Incentive Spirometer; Portex L.O.R. Syringes with NRFit Connector; Portex Lancet Point Spinal Needles with NRFit Connectors; Portex Manual Ventilator Transport Kit; Portex NRFit Epidural Needles; Portex Oxygen/Aerosol Adapters and Connectors (IFE); Portex Oxygen/Aerosol Tubing (IFE); Portex PDT Trachesotomy kit; Portex Pencil Point Spinal Needles with NRFit Connectors; Portex Percutaneous Dilation Tracheostomy Kit; Portex Percutaneous Dilation Trachesotomy kit; Portex Pulmonary Function Test Filt; Portex Pulmonary Function Test Filter; Portex Regional Anesthesia Catheter Connector; Portex Reinforced Endotracheal Tube; Portex Reinforced Tracheal Tube; Portex Respiratory Stylets (IFE); Portex Small Volume Medication Nebulizer; Portex Small Volume Medication Nebulizer Kit; Portex Suction Adaptor; Portex Tube Securement Other (IFE); Portex ULTRAperc tracheostomy apparatus and instruments; Portex combined Spinal/Epidural Minipack; Portex® Plastic L.O.R. Syringes; Portex®Spinal Needles; Premium; ProPort Plastic Port Poly Cath; ProPort Plastic Port Silicone Cath; ProPort Plastic Preattched Catheter; RESCAL; RESERVOIR BAG; SACETT; SMITHS GS LINES; SUB-Q Infusion Set; SUBCUTANEOUS TUNNELING DEVICE; Saf-T Holder; Saf-T Wing; Saf-T Wing (IFE); Single Limb; Single Shot Epidural tray/kit; Snuggle Warm; Snuggle Warm® Blankets; Snuggle Warm® Convective Warming Blanket; Spinal tray/kit; Steri-Cath; Suction above cuff Tracheal Tube; SuctionPro 72; Super Brush; Swivel; THERMOVENT; THERMOVENT T - 15MM CONNECTOR HEAT & MOISTURE EXCHANGER, 50/CA; Thera-Heat; Thermovent HEPA filters; TrachT; Tracheal tube holders; Tympanic Temperature Sensor; UNI-SET; UNIVERSAL MOUTHPIECE; Ultraset; UniPerc Adjustable Flange Tracheostomy Tube; UniPerc PDT Kit; UniPerc Percutaneous Dilation Tracheostomy Kit; VALVE FILTER ASSEMBLY; VARIOUS W/WO MALE-FEMALE LUERS; VENTILATOR CIRCUITS; Vent filter; W/WO MALE-MALE LUERS; maxillo-facial",1992-07-20,127,2021-11-26,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229617604%22&limit=1
"Ortho-Clinical Diagnostics, Inc.",1319681,1000136573,100 Indigo Creek Dr,Rochester,NY,14626,United States,QuidelOrtho Corporation,2024674,Complaint file establishment; Manufacturer; Manufacturer for export; Specification developer,137,CDD; CDN; CDP; CDT; CDZ; CEC; CEK; CEM; CEO; CEP; CEW; CFJ; CFN; CFT; CGA; CGJ; CGN; CGR; CGZ; CHH; CHI; CHP; CIG; CIT; CIW; CIX; CJE; CJY; CKA; CZW; DAD; DBF; DBI; DCF; DCK; DDG; DDR; DEM; DGR; DHA; DHR; DHX; DIF; DIH; DIO; DIP; DIS; DJG; DJR; DKB; DKJ; DKZ; DLJ; DLZ; DMT; DNN; GIF; GTQ; JFY; JGJ; JGP; JGS; JHS; JHX; JID; JIH; JIS; JIT; JIX; JIY; JJE; JJX; JJY; JKD; JLS; JLW; JMM; JMO; JQB; JRC; JXM; JZJ; KHO; KHP; KHQ; KHS; KLI; KLS; KLT; KNK; KSF; KSG; KSI; KSN; KSZ; LBR; LBS; LCD; LCM; LDJ; LDO; LDP; LEG; LEH; LFM; LFX; LIP; LOJ; LOL; LOM; LPS; LTJ; LTK; LXG; MIU; MJX; MJY; MMI; MOI; MRG; MRR; MSJ; MZA; MZF; MZO; NBC; NIG; NQD; OHQ; PDJ; PMT; PPM; QKO; QKP; QLC; QVP; SEI,"Radioassay, Vitamin B12; Urease, Photometric, Urea Nitrogen; Radioimmunoassay, Total Triiodothyronine; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Method, Nephelometric, Immunoglobulins (G, A, M); Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Radioimmunoassay, Cortisol; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Radioimmunoassay, Estradiol; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Starch-Dye Bound Polymer, Amylase; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Azo Dye, Calcium; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Whole Human Serum, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet; Calibrators, Ethyl Alcohol; Diluent, Blood Cell; Antistreptolysin - Titer/Streptolysin O Reagent; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Lowry (Colorimetric), Total Protein; Electrode, Ion Specific, Sodium; Differential Rate Kinetic Method, Cpk Or Isoenzymes; Fluorometric Method, Cpk Or Isoenzymes; Photometric Method, Ammonia; Flame Photometry, Lithium; Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, C-Peptides Of Proinsulin; Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Column Chromatography & Color Development, Hydroxyproline; Ferrozine (Colorimetric) Iron Binding Capacity; Kinetic Method, Gamma-Glutamyl Transpeptidase; Micro Pipette; Enzyme Immunoassay, Benzodiazepine; Prealbumin, Antigen, Antiserum, Control; Fluorometer, For Clinical Use; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzymatic, Carbon-Dioxide; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Kit, Quality Control For Blood Banking Reagents; Media, Potentiating For In Vitro Diagnostic Use; Lectins And Protectins; Centrifuge, Cell-Washing, Automated For Immuno-Hematology; System, Test, Automated Blood Grouping And Antibody; Ldl & Vldl Precipitation, Hdl; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Enzyme Immunoassay, Cannabinoids; Enzymatic Radiochemical Assay, Tobramycin; Colorimetry, Acetaminophen; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Immunoassay, Digitoxin; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Kit, Test,Alpha-Fetoprotein For Testicular Cancer; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Urinary Homocystine (Nonquantitative) Test System; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Enzyme Linked Immunosorbent Assay, T. Cruzi; Kit, Serological, Positive Control; Kit, Serological, Negative Control; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; System, Test, Vitamin D; System, Test, Low Density, Lipoprotein; Apolipoproteins; Test, Equipment, Automated Bloodborne Pathogen; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Test, Natriuretic Peptide; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Multi-Analyte Controls Unassayed; Hemoglobin A1c Test System; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; General Purpose Reagent; Reagent, Coronavirus Serological; Coronavirus Antigen Detection Test System.; Interleukin 6; Sars-Cov-2 Serology Test; Qualitative And Quantitative Hepatitis B Virus Antibody Assays",1; 2; N; U,"DAT Control, MTS DAT Card; MTS Diluent 2; MTS Diluent 2 PLUS; ORTHO Antibody Enhancement Solution; ORTHO Bovine Albumin Solution Polymerized; ORTHO Bovine Serum Albumin, 22% Protein Concentration; ORTHO Confidence System; ORTHO Optix Reader; ORTHO Summit Processor (OSP); ORTHO T.cruzi ELISA Test System; ORTHO VERSEIA Integrated Processor (VIP); ORTHO VERSEIA Pipettor (VERSEIA); ORTHO VISION Analyzer; ORTHO VISION Analyzer - Certified; ORTHO VISION Max Analyzer; ORTHO Workstation; Ortho 7% BSA; Ortho Anti A1 Lectin; Ortho Coombs Control; Ortho Optix Reader; Ortho Rhhr Control (human & bovine); QuickVue At Home COVID-19; QuickVue COVID-19 Test Control Swab Set; QuickVue SARS Antigen Test; Quidel Molecular Adenovirus Control Set (M110); Quidel Molecular Bordetella Control Set (M117); Quidel Molecular C. difficile Control Set (M108); Quidel Molecular GBS Control Set (M116); Quidel Molecular HSV 1+2 Control Set (M109); Quidel Molecular HSV 1+2/VZV Control Set (M121); Quidel Molecular Influenza A+B Control Set (M106); Quidel Molecular Parainfluenza Virus Control Set (M115); Quidel Molecular RSV+hMPV Control Set (M107); Quidel Molecular Strep A+G Control Set (M111); Quidel Molecular Trichomonas Control Set (M119); Sofia 2 SARS Antigen FIA; Sofia SARS Antigen FIA; Solana HSV 1+2/VZV Control Set (M118); Solana Influenza A+B Control Set (M122); Solana RSV+hMPV Control Set (M123); VITROS 25-OH Vitamin D Total Calibrators; VITROS 25-OH Vitamin D Total Reagent Pack; VITROS 250 Chemistry System; VITROS 250 Chemistry System Refurbished; VITROS 350 Chemistry System; VITROS 3600 Immunodiagnostics System; VITROS 3600 Immunodiagnostics System - Certified; VITROS 3600 Immunodiagnostics System - Refurbished; VITROS 4600 Chemistry System; VITROS 4600 Chemistry System Refurbished; VITROS 5,1 FS Chemistry System; VITROS 5,1 FS Chemistry System Refurbished; VITROS 5600 Integrated System; VITROS 5600 Integrated System Certified; VITROS 5600 Integrated System Refurbished; VITROS 7% BSA; VITROS AAT Reagent; VITROS AAT/HPT Performance Verifiers; VITROS ACET Slides; VITROS AFP Calibrators; VITROS AFP Range Verifier; VITROS AFP Reagent Pack; VITROS ALB Slides; VITROS ALB-TP Slides; VITROS ALC Slides; VITROS ALKP Slides; VITROS ALT Slides; VITROS ALTV Slides; VITROS AMON Slides; VITROS AMPH Reagent; VITROS AMYL Slides; VITROS ASO Reagent; VITROS ASO/RF Performance Verifiers; VITROS AST Slides; VITROS Anemia Controls; VITROS Anti- HCV Reagent Pack; VITROS Anti-HAV IgM Calibrator; VITROS Anti-HAV IgM Controls; VITROS Anti-HAV IgM Reagent Pack; VITROS Anti-HAV Total Calibrators; VITROS Anti-HAV Total Controls; VITROS Anti-HAV Total Reagent Pack; VITROS Anti-HBc Calibrator; VITROS Anti-HBc Controls; VITROS Anti-HBc IgM Calibrator; VITROS Anti-HBc IgM Controls; VITROS Anti-HBc IgM Reagent Pack; VITROS Anti-HBc Reagent Pack; VITROS Anti-HBe Calibrators; VITROS Anti-HBe Reagent Pack; VITROS Anti-HBs Quantitative Calibrators; VITROS Anti-HBs Quantitative Controls; VITROS Anti-HBs Quantitative Reagent Pack; VITROS Anti-HCV Calibrators; VITROS Anti-HCV Controls; VITROS Anti-HIV 1+2 Calibrator; VITROS Anti-HIV 1+2 Controls; VITROS Anti-HIV 1+2 Reagent Pack; VITROS Anti-SARS-CoV-2 IgG Calibrator; VITROS Anti-SARS-CoV-2 IgG Controls; VITROS Anti-SARS-CoV-2 IgG Quantitative Calibrator EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Controls EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack EUA210322; VITROS Anti-SARS-CoV-2 IgG Reagent Pack; VITROS Anti-SARS-CoV-2 Total N Antibody Calibrator EUA210355; VITROS Anti-SARS-CoV-2 Total N Antibody Reagent Pack EUA210355; VITROS Anti-SARS-CoV-2 Total N Controls EUA210355; VITROS ApoA1 Performance Verifiers; VITROS ApoA1 Reagent; VITROS ApoB Performance Verifiers; VITROS ApoB Reagent; VITROS B12 Calibrator; VITROS B12 Range Verifier; VITROS B12/Folate Reagent Pack 1/2; VITROS B12/Folate Reagent Pack 3; VITROS BARB Reagent; VITROS BENZ Reagent; VITROS BRAHMS PCT Calibrators; VITROS BRAHMS PCT Controls; VITROS BRAHMS PCT Range Verifier; VITROS BRAHMS PCT Reagent Pack; VITROS BUN/UREA Slides; VITROS BuBc Slides; VITROS C-Peptide Calibrator; VITROS C-Peptide Reagent Pack; VITROS C3 Reagent; VITROS C4 Reagent; VITROS CA 125 II Calibrator; VITROS CA 125 II Range Verifier; VITROS CA 125 II Reagent Pack; VITROS CA 15-3 Calibrator; VITROS CA 15-3 Range Verifier; VITROS CA 15-3 Reagent Pack; VITROS CA 19-9 Calibrator; VITROS CA 19-9 Range Verifiers; VITROS CA 19-9 Reagent Pack; VITROS CAFFN Reagent Kit; VITROS CEA Calibrators; VITROS CEA Range Verifier; VITROS CEA Reagent Pack; VITROS CHE Slides; VITROS CHOL Slides; VITROS CK Slides; VITROS CK-MB Calibrator; VITROS CK-MB Range Verifier; VITROS CK-MB Reagent Pack; VITROS CKMB Slides; VITROS COCM Reagent; VITROS CRBM Slides; VITROS CREA Slides; VITROS CRP Performance Verifiers; VITROS CRP Slides; VITROS Ca Slides; VITROS Calibrator Kit 1; VITROS Calibrator Kit 10; VITROS Calibrator Kit 11; VITROS Calibrator Kit 12; VITROS Calibrator Kit 13; VITROS Calibrator Kit 14; VITROS Calibrator Kit 16; VITROS Calibrator Kit 17; VITROS Calibrator Kit 19; VITROS Calibrator Kit 2; VITROS Calibrator Kit 20; VITROS Calibrator Kit 21; VITROS Calibrator Kit 22; VITROS Calibrator Kit 23; VITROS Calibrator Kit 24; VITROS Calibrator Kit 25; VITROS Calibrator Kit 26; VITROS Calibrator Kit 27; VITROS Calibrator Kit 28; VITROS Calibrator Kit 29; VITROS Calibrator Kit 3; VITROS Calibrator Kit 30; VITROS Calibrator Kit 31; VITROS Calibrator Kit 32; VITROS Calibrator Kit 4; VITROS Calibrator Kit 5; VITROS Calibrator Kit 6; VITROS Calibrator Kit 7; VITROS Calibrator Kit 8; VITROS Calibrator Kit 9; VITROS Calibrator Kit 99; VITROS Chemistry Products Calibrator Kit 25; VITROS Chemistry Products Performance Verifiers; VITROS Chemistry Products dHDL Slides; VITROS Cl Slides; VITROS Cortisol Calibrator; VITROS Cortisol Range Verifier; VITROS Cortisol Reagent Pack; VITROS DAT Performance Verifiers; VITROS DGXN Slides; VITROS ECO2; VITROS ECi Immunodiagnostic System; VITROS ECi Immunodiagnostic System Refurbished; VITROS ECiQ Immunodiagnostic System; VITROS Estradiol Calibrator; VITROS Estradiol Range Verifier; VITROS Estradiol Reagent Pack; VITROS FS Calibrator 1; VITROS FS Diluent Pack 1, 2, 3 and 4; VITROS FS Micro Tips; VITROS FS Reconstitution Diluent; VITROS FSH Calibrator; VITROS FSH Range Verifier; VITROS FSH Reagent Pack; VITROS Fe Slides; VITROS Ferritin Calibrator; VITROS Ferritin Range Verifier; VITROS Ferritin Reagent Pack; VITROS Folate Calibrator; VITROS Folate Range Verifier; VITROS Folate Reagent Pack 1/2; VITROS Free T3 Calibrator; VITROS Free T3 Range Verifier; VITROS Free T3 Reagent Pack; VITROS Free T4 Range Verifier; VITROS Free T4 Reagent Pack; VITROS Free Thyroid Controls; VITROS GENT Reagent; VITROS GGT Slides; VITROS GLU Slides; VITROS HBeAg Calibrator; VITROS HBeAg Reagent Pack; VITROS HBsAg Calibrator; VITROS HBsAg Confirmatory Kit; VITROS HBsAg Controls; VITROS HBsAg Reagent Pack; VITROS HCY2 Performance Verifiers; VITROS HCY2 Reagent; VITROS HIV Combo Calibrator; VITROS HIV Combo Controls (Anti-HIV-1 group O); VITROS HIV Combo Controls (HIV p24 Antigen); VITROS HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2); VITROS HIV Combo Reagent Pack; VITROS HPT Reagent; VITROS HbA1c Reagent Kit; VITROS High Sample Diluent A and B; VITROS INTACT PTH Calibrators; VITROS INTACT PTH Controls; VITROS INTACT PTH Range Verifier; VITROS INTACT PTH Reagent Pack; VITROS IgA Reagent; VITROS IgG Reagent; VITROS IgM Reagent; VITROS Immuno-Wash Fluid; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack DEN210040; VITROS Immunodiagnostic Products CA 19-9 Calibrator; VITROS Immunodiagnostic Products CA 19-9 Reagent Pack; VITROS Immunodiagnostic Products CEA Calibrators; VITROS Immunodiagnostic Products CEA Reagent Pack; VITROS Immunodiagnostic Products IL-6 Calibrator; VITROS Immunodiagnostic Products IL-6 Controls; VITROS Immunodiagnostic Products IL-6 Reagent Pack; VITROS Immunodiagnostic Products Intact PTH II Calibrators; VITROS Immunodiagnostic Products Intact PTH II Reagent Pack; VITROS Immunodiagnostic Products Progesterone 2 Calibrators; VITROS Immunodiagnostic Products Progesterone 2 Range Verifiers; VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack; VITROS Immunodiagnostic Products Syphilis Calibrator; VITROS Immunodiagnostic Products Syphilis Controls; VITROS Immunodiagnostic Products Syphilis Reagent Pack; VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack; VITROS Immunodiagnostic Products hs Troponin I Calibrator; VITROS Immunodiagnostic Products hs Troponin I Low Control; VITROS Immunodiagnostic Products hs Troponin I Reagent Pack; VITROS Immunodiagnostic Products hsTroponin I Calibrator; VITROS Insulin Calibrator; VITROS Insulin Reagent Pack; VITROS Isoenzyme PVs; VITROS K+ Slides; VITROS LAC Slides; VITROS LDH Slides; VITROS LDHI SLides; VITROS LH Calibrator; VITROS LH Range Verifier; VITROS LH Reagent Pack; VITROS LIPA Slides; VITROS Li Slides; VITROS Liquid Performance Verifiers; VITROS METD Reagent; VITROS Metabolism Controls; VITROS Mg Slides; VITROS Micro Tips; VITROS MicroSensor Check Fluids; VITROS Myoglobin Calibrator; VITROS Myoglobin Range Verifier; VITROS Myoglobin Reagent Pack; VITROS NT pro-BNP Calibrators; VITROS NT pro-BNP Range Verifier; VITROS NT pro-BNP Reagent Pack; VITROS NT-proBNP II Reagent Pack; VITROS NTx Calibrator; VITROS NTx Controls; VITROS NTx Range Verifier; VITROS NTx Reagent Pack; VITROS Na+ Slides; VITROS OP Reagent; VITROS PALB Performance Verifiers; VITROS PALB Reagent; VITROS PCP Reagent; VITROS PHBR Slides; VITROS PHOS Slides; VITROS PHYT Slides; VITROS PROT SLides; VITROS Percent A1c Performance Verifiers; VITROS Performance Verifiers; VITROS Progesterone Calibrator Kit; VITROS Progesterone Range Verifier; VITROS Progesterone Reagent Pack; VITROS Prolactin Calibrator; VITROS Prolactin Range Verifier; VITROS Prolactin Reagent Pack; VITROS Protein Performance Verifiers; VITROS RE Controls; VITROS RF Reagent; VITROS Red Cell Folate Pack; VITROS Reference Fluids; VITROS Rubella IgG Calibrator; VITROS Rubella IgG Reagent Pack; VITROS SALI Slides; VITROS SARS-COV-2 Antigen Calibrator EUA202928; VITROS SARS-COV-2 Antigen Controls EUA202928; VITROS SARS-COV-2 Antigen Reagent Pack EUA202928; VITROS SARS-COV-2 Extraction Buffer EUA202928; VITROS Signal Reagent; VITROS Specialty Diluent; VITROS T3 Uptake II Calibrator; VITROS T3 Uptake II Range Verifier; VITROS T3 Uptake II Reagent Pack; VITROS T4 Calibrator; VITROS TBIL Slides; VITROS TDM Performance Verifiers; VITROS THC Reagent; VITROS THEO Slides; VITROS TIBC Kit; VITROS TOBRA Reagent; VITROS TP Slides; VITROS TRFRN Reagent; VITROS TRIG Slides; VITROS TSH Calibrator; VITROS TSH Range Verifier; VITROS TSH Reagent Pack; VITROS Testosterone Calibrator; VITROS Testosterone Controls; VITROS Testosterone Range Verifier; VITROS Testosterone Reagent Pack; VITROS Total PSA Calibrator; VITROS Total PSA Range Verifier; VITROS Total PSA Reagent Pack; VITROS Total T3 II Calibrator; VITROS Total T3 II Range Verifier; VITROS Total T3 II Reagent Pack; VITROS Total T4 Calibrator; VITROS Total T4 Range Verifier; VITROS Total T4 Reagent Pack; VITROS Total Thyroid Controls; VITROS Total bhCG II Calibrator; VITROS Total bhCG II Range Verifier; VITROS Total bhCG II Reagent Pack; VITROS Troponin I ES Calibrators; VITROS Troponin I ES Range Verifier; VITROS Troponin I ES Reagent Pack; VITROS UDA Empty Packs; VITROS UPRO Performance Verifiers; VITROS UPRO Slides; VITROS URIC Slides; VITROS Universal Wash Reagent; VITROS Urine Electrolyte Diluent; VITROS VALP Reagent; VITROS VANC Reagent; VITROS Versa Tips; VITROS XT 3400 Chemistry System; VITROS XT 7600 Integrated System; VITROS XT 7600 Integrated System Certified; VITROS XT ALTV-AST Slides; VITROS XT GLU-Ca Slides; VITROS XT TBIL-ALKP Slides; VITROS XT TRIG-CHOL Slides; VITROS XT UREA-CREA Slides; VITROS dHDL Slides; VITROS dLDL Reagent; VITROS dTIBC Performance Verifiers; VITROS dTIBC Reagent; VITROS hsCRP Performance Verifiers; VITROS hsCRP Reagent; VITROS mALB Performance Verifiers; VITROS mALB Reagent",2020-11-24,120,2025-10-29,7,135,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221319681%22&limit=1
Siemens Healthcare Diagnostics Products GmbH,9610806,3001644026,76 Emil-Von-Behring Strasse,MARBURG Hesse,,35041,Germany,SIEMENS HEALTHCARE DIAGNOSTICS INC.,9096044,Complaint file establishment; Contract manufacturer; Manufacturer; Specification developer,80,CFN; CFQ; CHN; CZP; CZS; CZW; CZX; DAD; DAP; DAS; DBA; DBF; DBI; DCF; DCH; DCN; DCO; DDB; DDG; DDR; DDX; DEB; DEH; DEM; DEW; DFC; DFH; DFZ; DGC; DHR; GFK; GFO; GFX; GGC; GGM; GGN; GGP; GGW; GHM; GIL; GIR; GIT; GIZ; GJA; GJS; GJT; GKP; GTQ; GTR; JBQ; JBR; JCB; JCC; JCO; JIS; JIT; JIX; JJE; JJQ; JJX; JJY; JMG; JOZ; JPA; JPE; JZG; JZJ; JZW; KFF; KPA; KQJ; LKL; LPS; MIF; MSJ; NAO; NDY; NQD; QLU; QTY,"Method, Nephelometric, Immunoglobulins (G, A, M); Radioimmunoassay, Immunoglobulins (G, A, M); Immunochemical, Ceruloplasmin; Iga, Antigen, Antiserum, Control; Retinol-Binding Protein, Antigen, Antiserum, Control; Complement C3, Antigen, Antiserum, Control; Hemopexin, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control; Igg (Fc Fragment Specific), Antigen, Antiserum, Control; Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; System, Test, C-Reactive Protein, Rhodamine; System, Test, C-Reactive Protein; Alpha-Globulin, Antigen, Antiserum, Control; Ceruloplasmin, Antigen, Antiserum, Control; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Plasminogen, Antigen, Antiserum, Control; Alpha-2-Macroglobulin, Antigen, Antiserum, Control; Lambda, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Igg, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; Kappa, Antigen, Antiserum, Control; Igg (Gamma Chain Specific), Antigen, Antiserum, Control; Ige, Antigen, Antiserum, Control; System, Test, Rheumatoid Factor; Fibrinogen Determination Standards And Controls; Activated Partial Thromboplastin; Fibrinogen Standard; Control, Plasma, Abnormal; Control, Hemoglobin; Plasma, Coagulation Control; Test, Qualitative And Quantitative Factor Deficiency; Test, Time, Partial Thromboplastin; Test, Sickle Cell; Plasma, Fibrinogen Control; Reagent, Russel Viper Venom; Reagent & Control, Partial Thromboplastin Time; Plasma, Control, Normal; Test, Thrombin Time; Test, Time, Prothrombin; Plasma, Coagulation Factor Deficient; Instrument, Coagulation, Automated; Antistreptolysin - Titer/Streptolysin O Reagent; Antideoxyribonuclease, Streptococcus Spp.; Antithrombin Iii Quantitation; Test, Heparin Neutralization; Detergent; Ph Buffer; Bothrops Atrox Reagent; Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Colorimeter, Photometer, Spectrophotometer For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay (Two-Site Solid Phase), Ferritin; System, Automated Platelet Aggregation; System, Multipurpose For In Vitro Coagulation Studies; Antithrombin Iii, Two Stage Clotting Time Assay; System, Test, Beta-2-Microglobulin Immunological; Prealbumin, Antigen, Antiserum, Control; Nephelometer; Assay, Heparin; Slide Stainer, Automated; System, Fibrinogen Determination; Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control; Urinary Homocystine (Nonquantitative) Test System; Prothrombin Fragment 1.2; Apolipoproteins; Test, Carbohydrate Deficient Transferrin; Test, Cystatin C; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Anti-Factor Xa Activity Test System, Apixaban; Von Willebrand Factor Assay",1; 2,"ADVIA 2120 and ADVIA 2120i Aspiration pathway Wash Kit; ADVIA 2120 and ADVIA 2120i Perox Flow cell wash kit; ADVIA 2120 and ADVIA 2120i RBC Flow Cell Wash Kit; ADVIA 2120 and ADVIA 2120i Vent Line Wash Kit; ADVIA Chemistry; ADVIA Chemistry Cystatin C_2 Calibrator; ADVIA Chemistry HAPT; Advanced D-Dimer Control Plasma 1; Advanced D-Dimer Control Plasma 2; Advanced D-Dimer Standard Plasma; Apolipoprotein Control Serum CHD; Atellica CH Alpha-1-Antitrypsin 2 (AAT2); Atellica CH Alpha-1-acid Glycoprotein (AAG); Atellica CH Anti-Streptolysin-O_2 (ASO_2); Atellica CH Anti-Streptolysin-O_3 (ASO_3); Atellica CH Bilirubin Calibrator (BILI CAL); Atellica CH Cystatin C Calibrators (CysC CAL); Atellica CH Haptoglobin_2 (Hapt_2); Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2); Atellica CH Liquid Specific Protein Calibrators (LSP CAL); Atellica CH Microalbumin_2 Calibrator (?ALB_2 CAL); Atellica CH Prealbumin (PALB); Atellica CH Protein 1 Calibrator (PROT1 CAL); Atellica CH Protein 2 Calibrator (PROT2 CAL); Atellica CH Revised C-Reactive Protein Calibrator (RCRP CAL); Atellica CH Special Chem CAL (SPCL CHEM CAL); Atellica CH Toxicology Calibrator (TOX CAL); Atellica CH Urine Albumin (UAlb); BC Thrombin Reagent; BC Validation Kit; BC Vial Kit; BC von Willebrand Reagent; BCS System Cuvette Rotors; BCS XP System; BFT II Analyzer; BFT II Analyzer ""Dispo System""; BN II Additive; BN II Evaporation Stoppers; BN II System; BN ProSpec System; Batroxobin Reagent; Behring Coagulation Cup; Berichrom Antithrombin III (A); Berichrom Heparin; Berichrom Heparin LMW Calibrator; Berichrom Heparin LMW Control 1; Berichrom Heparin LMW Control 2; Berichrom Heparin UF Calibrator; Berichrom Heparin UF Control 1; Berichrom Heparin UF Control 2; Berichrom Plasminogen; Berichrom Protein C; Berichrom a2-Antiplasmin; Blood Gas Systems Buffer; CLEANER SCS; Calcium Chloride Solution; CardioPhase hsCRP; Clotting Factor V Deficient Plasma; Coag Factor II Deficient Plasma; Coag Factor IX Deficient Plasma; Coag Factor VII Deficient Plasma; Coag Factor VIII Deficient Plasma; Coag Factor X Deficient Plasma; Coag Factor XI Deficient Plasma; Coag Factor XII Deficient Plasma; Control Plasma N; Control Plasma P; Cuvettes for BFT II Analyzer; Dade Actin Activated Cephaloplastin Reagent; Dade Actin FS Activated PTT Reagent; Dade Actin FSL Activated PTT Reagent; Dade CA System Buffer; Dade Ci-Trol Coagulation Control Level 1; Dade Ci-Trol Coagulation Control Level 2; Dade Ci-Trol Coagulation Control Level 3; Dade Ci-Trol Heparin Control, High; Dade Ci-Trol Heparin Control, Low; Dade Cluster Platelet Aggregation Reagents; Dade Data-Fi Abnormal Control; Dade Fibrinogen Determination Reagents; Dade Hepzyme; Dade Innovin; Dade PFA Collagen/ADP Test Cartridges; Dade PFA Collagen/EPI Test Cartridges; Dade PFA Priming Cartridges; Dade PFA Trigger Solution; Dade PFA Vacuum Cups; Dade Thrombin Reagent; Dimension BUN Flex; Dimension CA Flex; Dimension CHEM I Cal; Dimension Chemistry Wash; Dimension Cuvette Cartridge; Dimension Enzyme Verifier; Dimension FERR Flex; Dimension IMT Probe Cleaner; Dimension Reaction Vessels; Dimension Reagent Probe Cleaner; Dimension Salt Bridge Solution; Dimension Sample Cups with Lids; Dimension Sample Diluent; Dimension Sample Probe Cleaner; Dimension Vista A1AG Flex; Dimension Vista A1AT Flex; Dimension Vista A1MIC Flex; Dimension Vista A2MAC Flex; Dimension Vista APO Cal; Dimension Vista APO Control; Dimension Vista APOAI Flex; Dimension Vista APOB Flex; Dimension Vista ASL Flex; Dimension Vista C1IN Cal; Dimension Vista C1IN Con; Dimension Vista C1IN Flex; Dimension Vista C3 Flex; Dimension Vista C4 Flex; Dimension Vista CDT CON H; Dimension Vista CDT CON L; Dimension Vista CDT Cal; Dimension Vista CDT Flex; Dimension Vista CER Flex; Dimension Vista CRP Flex; Dimension Vista CYSC Control H; Dimension Vista CYSC Control L; Dimension Vista CYSC Flex; Dimension Vista Chemistry 1 Calibrator; Dimension Vista HAPT Flex; Dimension Vista HCYS Flex; Dimension Vista HPX Flex; Dimension Vista IGA Flex; Dimension Vista IGE Flex; Dimension Vista IGG Flex; Dimension Vista IGG1 Flex; Dimension Vista IGG2 Flex; Dimension Vista IGG3 Flex; Dimension Vista IGG4 Flex; Dimension Vista IGM Flex; Dimension Vista KAPPA Flex; Dimension Vista LAMBDA Flex; Dimension Vista MALB Flex; Dimension Vista PREALB Flex; Dimension Vista PROT1 CON H; Dimension Vista PROT2 Cal; Dimension Vista PROT2 Control H; Dimension Vista PROT2 Control L; Dimension Vista PROT3 Cal; Dimension Vista RBP Flex; Dimension Vista RF Flex; Dimension Vista Thyroxine/Thyronine-Uptake Calibrator; Dimension Vista hsCRP Control H; Dimension Vista hsCRP Control L; Dimension Vista hsCRP Felx; Dimension Vista sALB Flex reagent cartridge (sALB); Dimension Vista sTFR Flex; Dimension® HM; Enzygnost F1+2 monoclonal; Enzygnost TAT micro; Factor V Leiden; Factor VIII Chromogenic Assay; Fibrinogen Calibrator Kit; Hema-Tek Slide Stainer; Hematek; Hematek 3000; IMMULITE 2000 / XPi Probe Cleaning Kit; IMMULITE 2000 / XPi Probe Wash Module; IMMULITE Probe Cleaning Kit; IMMULITE Probe Wash Module; INNOVANCE Anti-Xa; INNOVANCE Antithrombin; INNOVANCE Apixaban Controls; INNOVANCE Apixaban Standards; INNOVANCE D-Dimer; INNOVANCE D-Dimer 2; INNOVANCE D-Dimer 2 Control 1; INNOVANCE D-Dimer 2 Control 2; INNOVANCE D-Dimer 2 Control 3; INNOVANCE D-Dimer 2 Sample Diluent; INNOVANCE D-Dimer Controls; INNOVANCE D-Dimer Sample Diluent; INNOVANCE Free PS Ag; INNOVANCE Heparin; INNOVANCE Heparin Calibrator; INNOVANCE Heparin LMW Control 1; INNOVANCE Heparin LMW Control 2; INNOVANCE Heparin UF Control 1; INNOVANCE Heparin UF Control 2; INNOVANCE VWF Ac; Imidazole Buffer Solution; Kaolin Suspension; LA 1 Screening Reagent; LA 2 Confirmation Reagent; LA Control High; LA Control Low; Multifibren U; N AS IgG1; N AS IgG2; N AS IgG3; N AS IgG4; N Antisera to Human IgA; N Antisera to Human IgG; N Antisera to Human IgG, IgA, IgM; N Antisera to Human IgM; N Antisera to Human Immunoglobulins (IgA); N Antisera to Human Immunoglobulins (IgM); N Antiserum to Human Albumin; N Antiserum to Human Antithrombin III; N Antiserum to Human Apolipoprotein A-I; N Antiserum to Human Apolipoprotein B; N Antiserum to Human C1 Inhibitor; N Antiserum to Human C3c; N Antiserum to Human C4; N Antiserum to Human Ceruloplasmin; N Antiserum to Human Fibrinogen; N Antiserum to Human Haptoglobin; N Antiserum to Human Hemopexin; N Antiserum to Human Plasminogen; N Antiserum to Human Prealbumin; N Antiserum to Human RbP; N Antiserum to Human Transferrin; N Antiserum to Human a1-Antitrypsin; N Antiserum to Human a1-acid Glycoprotein; N Antiserum to Human-Ig/L-chain, &#955; type; N Antiserum to Human-Ig/L-chain, k type; N Antiserum to Human-a2-Macroglobulin; N Apolipoprotein Standard Serum; N Cuvettes Segments for BN II; N Cuvettes Segments for BN ProSpec; N Diluent; N Evaporation Caps for Control Vials (2.5 mL); N FLC Control SL1; N FLC Control SL2; N FLC Standard SL; N FLC Supplementary Reagent; N Latex ADNase B; N Latex ASL; N Latex B2-Microglobulin; N Latex CDT Kit; N Latex Cystatin C; N Latex FLC Kappa; N Latex FLC Lambda; N Latex FLC kappa; N Latex FLC lambda; N Latex Ferritin; N Latex HCY; N Latex IgA; N Latex IgE mono; N Latex IgM; N Latex Lp(a) Reagent; N Latex Myoglobin; N Latex RF Kit; N Latex sTfR; N Lp (a) Control SY; N Lp (a) Standard SY; N Predilution Wells; N Protein Standard PY; N Protein Standard SL; N Protein Standard UY; N Reaction Buffer; N Rheumatology Standard SL; N Supplementary Reagent L; N Supplementary Reagent/Precipitation; N a1-Microglobulin Kit; N/T Protein Control LC; N/T Protein Control PY; N/T Protein Control SL/H; N/T Protein Control SL/L; N/T Protein Control SL/M; N/T Rheumatology Control SL/1; N/T Rheumatology Control SL/2; Neodisher GK; Owren's Veronal Buffer; PFA-100 System; Pathromtin SL; Printer Paper for BFT II; ProC Control Plasma; Protein C Reagent; Protein S Ac; Purified Water Diluent; QuikLYTE IMT Std A; QuikLyte IMT Std B; RapiTex CRP; RapiTex RF; Sickle-Sol Tests; Sickle-Trol Hemoglobin Control; Standard Human Plasma; TRF, PROT3 CON; Test Thrombin Reagent; Thromborel S; Vista B2MIC Flex; Vista PROT1 CON L; Vista PROT1 CON M; Vista PROT1 Cal; Washing Solution for Coagulation Analyzers; Xprecia System PT Controls; vWF Ag",2001-10-26,127,2026-08-11,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229610806%22&limit=1
"Medtronic, Inc.",2182208,2182208,8200 Coral Sea Street NE,Mounds View,MN,55112,United States,"Medtronic, Inc.",2112641,Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,46,DPS; DQK; DQX; DQY; DRA; DRE; DRF; DSA; DSI; DSQ; DTA; DTB; DTC; DTD; DTE; DTF; DTG; DTL; DWS; DXH; DXY; DYB; DYG; FTL; JOQ; KRE; KRG; LDF; LPB; LWP; LWS; MXC; MXD; NIK; NKE; NVN; NVY; NVZ; OAD; OAE; OJX; OSR; OUG; PNJ; QYX; QZI,"Electrocardiograph; Computer, Diagnostic, Programmable; Wire, Guide, Catheter; Catheter, Percutaneous; Catheter, Steerable; Dilator, Vessel, For Percutaneous Catheterization; Catheter, Electrode Recording, Or Probe, Electrode Recording; Cable, Transducer And Electrode, Patient, (Including Connector); Detector And Alarm, Arrhythmia; Ventricular (Assist) Bypass; Tester, Pacemaker Electrode Function; Permanent Pacemaker Electrode; Analyzer, Pacemaker Generator Function; Pacemaker Lead Adaptor; Pulse-Generator, Pacemaker, External; Tools, Pacemaker Service; Magnet, Test, Pacemaker; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Instruments, Surgical, Cardiovascular; Transmitters And Receivers, Electrocardiograph, Telephone; Implantable Pacemaker Pulse-Generator; Introducer, Catheter; Catheter, Flow Directed; Mesh, Surgical, Polymeric; Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only); Analyzer, Pacemaker Generator Function, Indirect; Programmer, Pacemaker; Electrode, Pacemaker, Temporary; Cardiac Ablation Percutaneous Catheter; Implantable Pulse Generator, Pacemaker (Non-Crt); Implantable Cardioverter Defibrillator (Non-Crt); Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection); Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection); Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D); Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P); Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes; Permanent Defibrillator Electrodes; Pulse Generator, Permanent, Implantable; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation; Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode; Pacemaker/Icd/Crt Non-Implanted Components; Medical Device Data System; Leadless Pacemaker; Outpatient Cardiac Telemetry; Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation",1; 2; 3,"10-Lead 2ACHC; AORTIC CUFF; ATAKR; ATRIAL LIFT SYSTEM; AURORA EV-ICD™ MRI SURESCAN™ SW041; Accessory; Accessory Port ATS Medical Thoracic Port System; AccuRhythm AI (Zelda AI); AccuRhythm™ AI AF Algorithm; AccuRhythm™ AI Pause Algorithm; AccuRhythm™ AI Post Processor; Ace Header Emulator; Achieve; Achieve Advance Mapping Catheter; Achieve Advance Mapping Catheter and Catheter Connecting Cable; Actuators; Adapta; Adapta L; Adapta S; Adapter Cable; Adaptor; Adaptor Extender Kit; Adaptor Kit; Adhesive; Adjustable Slitter; Adjustable Valve; Advisa DR; Advisa DR MRI SureScan; Advisa SR MRI SureScan; Affera™ Ablation System; Affera™ Integrated Mapping System; Affera™ Mapping System; Amplia MRI CRT-D SureScan; Amplia MRI Quad CRT-D SureScan; Analyzer Adapter; Analyzer Cable; Arctic Front Advance ProTM; Arctic Front Advance cardiac cryoablation catheter; Attain; Attain 6227DEF; Attain Ability Lead; Attain Ability MRI SureScan Lead; Attain Ability Plus Lead; Attain Ability Plus MRI SureScan Lead; Attain Ability Straight Lead; Attain Ability Straight MRI SureScan Lead; Attain Bipolar OTW Lead; Attain Command + SureValve Guide Catheter for Left-Heart Delivery; Attain Command + SureValve Guide Catheters for Left Heart Delivery; Attain Command + SureValve Left Heart Delivery System; Attain Command + SureValve Left-Heart Delivery System; Attain OTW; Attain Performa Lead; Attain Performa MRI SureScan Lead; Attain Performa S Lead; Attain Performa S MRI SureScan Lead; Attain Performa Straight Lead; Attain Performa Straight MRI SureScan Lead; Attain Prevail 6228 CTH; Attain Select; Attain Select II + SureValve Delivery Catheter System; Attain Stability Quad MRI SureScan Lead; Attesta DR MRI; Attesta L DR MRI; Attesta S DR MRI; Attesta SR MRI; Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator; Azure S DR MRI; Azure S SR MRI; Azure XT DR MRI; Azure XT SR MRI; Brava; Brava Quadripolar CRT-D; C315 Delivery Catheter; C320LBB Delivery System; Cable; Cables; CapSure Lead; CapSure SP Novus; CapSure Sense; CapSure Sense MRI SureScan Leads; CapSure Unipolar Lead; CapSure VDD-2 Lead; CapSure Z Novus; CapSureFix Lead; CapSureFix MRI SureScan Lead; CapSureFix Novus Leads; CapSureFix Novus MRI SureScan Leads; Capsure SP Novus; CardioInsight Cardiac Mapping System; CardioSight Reader; CareLink Encore Programmer; CareLink Encore Programmer RF Head; CareLink Express Mobile System - Android; CareLink Express Mobile System - iOS; CareLink Express Monitor; CareLink Mobile Application; CareLink Network Software; CareLink Programmer RF Head; CareLink SmartSync Azure Astra Application; CareLink SmartSync Base 24970A; CareLink SmartSync Common Application Android; CareLink SmartSync Common Application iOS; CareLink SmartSync Host Application; CareLink SmartSync LINQ II ICM Application; CareLink SmartSync LINQ II Platform Application; CareLink SmartSync PSA Application; CareLink SmartSync Patient Connector 24967; CareLink SmartSync Percepta, Solera, Serena Application; CareLink SmartSync Platform Android; CareLink SmartSync Platform iOS; CareLink SmartSync Power Cord 249705; CareLink SmartSync Power Supply 249701; CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025; CareLink Wireless Network Adapter Card; Claria MRI CRT-D; Claria MRI Quad CRT-D; Coaxial Cable; Cobalt DR MRI Surescan; Cobalt HF CRT-D MRI SureScan; Cobalt HF Quad CRT-D MRI SureScan; Cobalt VR MRI Surescan; Cobalt XT DR MRI Surescan; Cobalt XT HF CRT-D MRI SureScan; Cobalt XT HF Quad CRT-D MRI SureScan; Cobalt XT VR MRI Surescan; Communicator; Compia MRI CRT-D SureScan; Compia MRI Quad CRT-D SureScan; Concerto ICD; Concerto II CRT-D; Consulta CRT-P; Consulta DF4 ICD; Consulta ICD; Cosine-10 Diagnostic Catheter; Crome DR MRI Surescan; Crome HF CRT-D MRI SureScan; Crome HF Quad CRT-D MRI SureScan; Crome VR MRI Surescan; Cryoconsole; DF-1 Port Pin Plug; DiamondTemp Ablation System; DiamondTemp™ Ablation Catheter; DiamondTemp™ Catheter-to-RF Generator Cable; DiamondTemp™ EGM Cable; DiamondTemp™ Foot Switch; DiamondTemp™ GenConnect Cable; DiamondTemp™ Generator Connection Box E; DiamondTemp™ Irrigation Pump; DiamondTemp™ Irrigation Tubing Set; DiamondTemp™ RF Generator; Discovery Link MDDS; DiscoveryLink MDDS; Disposable EPG Cover; Disposable Patient Safety Cable; Disposable Pouch; Disposable patient safety cables; ECG Cable; ECG Output Adapter; ECG Port Plug; ECVUE Cardiac Mapping System; EPG Cover; EXTRA LG BLADE SET TOOL; EnTrust ICD; End Cap; Epicardial Lead Implant Tool; Epicardial Patch Lead; Epsila EV™ MRI SureScan™ extravascular lead; Epsila EV™ Sternal Tunneling Tool; Epsila EV™ Transverse Tunneling Tool; Evera; Evera MRI S DR SureScan; Evera MRI S VR; Evera MRI XT DR SureScan; Evera MRI XT VR SureScan; Evera S DR; Evera S VR; Evera XT DR; Evera XT VR; External Pacemaker Pulse Generator; External Pulse Generator; FlexCath Advance; FlexCath Advance Steerable Sheath and Dilator; FlexCath Contour™ Steerable Sheath; FlexCath Cross™ Transseptal Solution; FlexCath Select; Freezor; Freezor MAX Surgical cryoablation catheter; Freezor MAX cardiac cryoablation catheter; Freezor Xtra; Freezor Xtra Surgical cardiac cryoablation catheter; Freezor Xtra cardiac cryoablation catheter; Freezor cardiac cryoablation catheter; GEM; GEM VR; HeartWare Ventricular Assist System; INTERCOSTAL RETRACTOR SYSTEM; IS-1 Port Pin Plug Kit; Impedance Localization Patch Kit; Implant Tool Kit; Impulse II Lead; InCheck Patient Assistant; Instrument Command Library (ICL)Device Command Library (DCL); Insync; Integrated Diagnostics Data Calculation Module Model 5242; Intrinsic ICD; Kappa 400 DR IPG; Kappa 400 SR IPG; LARGE BLADE SET TOOL; LEAD INTRODUCER; LINQ II Insertable Cardiac Monitor; LINQ II™ Insertable Cardiac Monitor (ICM); LINQ II™ Insertable Cardiac Monitor (LNQ22); LINQ Tool Kit; Lead Accessory Kit; Lead Adaptor; Lead Adaptor Kit; Lead Analyzer; Lead Patch; Lead anchoring Sleeve; Location Reference Patch Kit; MARINR; MEDIUM BLADE SET TOOL; MICRO JEWEL; MICRO JEWEL II; MITRAL COLLAR AND TIE; MRI SureScan™; Magnetic localization Patch Kit; Marinr Steerable Intracardiac Electrode Catheter; Marquis DR ICD; Marquis VR ICD; Maximo DR ICD; Maximo II CRT-D; Maximo II DR; Maximo II VR; Maximo VR ICD; Medtronic; Medtronic CareLink Monitor; Medtronic CareLink Programmer; Medtronic CareLink Website; Medtronic Longevity; Medtronic Temporary External Pacemaker; Micra AV TPS; Micra AV2 TPS; Micra Introducer Sheath with Hydrophilic Coating; Micra TPS; Micra Transcatheter Pacemaker System; Micra VR2 TPS; Mounting Rail; MyCareLink Patient Monitor; MyCareLink Patient Monitor Model 24950; MyCareLink Smart Application Android; MyCareLink Smart Application iOS; N'Vision Report Link; NUVANT Mobile Cardiac Telemetry (MCT) System; Nitron CryoConsole; Nitron Remote; OmniaSecure™; PATIENT PROGRAMMER; PCD; PIN PLUG KIT; PLI Kit; PROGRAM STIMULATOR; Paceart; Paceart Optima; Paceart Optima Clinic Management Component; Paceart Optima Data Transformation Engine Component; Paceart Optima System 1.6 with Analytics; Paceart Optima System 1.7; Paceart Optima System 1.8; Paceart Optima and Mainspring Data Express Version 6; Paceart System Get Connected III, Connected Systems Gateway; Pacemaker Repair Kit; Patient Assistant; Patient Cable; Patient Connector; Patient Data Service App for Intellis; Patient Magnet; Percepta CRT-P MRI SureScan; Percepta Quad CRT-P MRI SureScan; Percutaneous Lead Introducer; Percutaneous Lead Introducers; Percutaneous lead introducer; Primo MRI DR SureScan; Primo MRI VR SureScan; Prodigy IPG; Program Interface Cable; Protecta CRT-D; Protecta DR; Protecta VR; Protecta XT CRT-D; Protecta XT DR; Protecta XT VR; PulseSelect Pulsed Field Ablation (PFA) Loop Catheter; PulseSelect™ Pulsed Field Ablation (PFA); RETRACTOR RACK TOOL; REVEAL LINQ; RF CONDUCTR; RF CONTACTR; RF ENHANCR II; RF MARINR; Relia IPG; Remote Assistant Model 9462; Reveal DX; Reveal LINQ; Reveal LINQ Mobile Manager; Reveal LINQ Mobile Manager Application; Reveal LINQ™ Insertion Tools; Reveal Plus Activator ICM; Reveal XT; Reveal XT Patient Assistant; Revo MRI SureScan; Rotation Tool Kit; SEEQ External Cardiac Monitor (ECM) System; SEEQ Mobile Cardiac Telemetry (MCT) System; SELECTSECURE; SELECTSITE™; SELECTSITE™ C304-HIS Deflectable catheter system; SMALL BLADE SET TOOL; SOLOIST; STERILIZATION TRAY TOOL; SUTURE BELT; Secura DR; Secura VR; SelectSecure MRI SureScan; Sensia DR IPG; Sensia IPG; Serena CRT-P MRI SureScan; Serena Quad CRT-P MRI SureScan; Service Kit; Session Management; Sizing Sleeve; Solara CRT-P MRI SureScan; Solara Quad CRT-P MRI SureScan; Soloist Intracardiac Electrode Catheter; Sphera DR MRI; Sphera L DR MRI; Sphera SR MRI; Sphere 360; Sphere-9™ Catheter; Sprint Quattro Lead; Sprint Quattro MRI SureScan Lead; Sprint Quattro Secure Lead; Sprint Quattro Secure MRI SureScan Lead; Sprint Quattro Secure S Lead; Sprint Quattro Secure S MRI SureScan Lead; StableMapr; StableMapr Steerable Intracardiac Electrode Catheter; Sterile Plastic Sleeve; Subcutaneous Lead; SureFix; Surgical Cable; Surgical cable; Syncra CRT-P; System Cart; TORQR; TYRX Absorbable Antibacterial Envelope; TYRX Neuro Absorbable Antibacterial Envelope; TYRX™ Absorbable Antibacterial Envelope; TYRX™ Neuro Absorbable Antibacterial Envelope; Temporary Pacing Lead System, Model 6416; Torclip; Torqr Intracardiac Electrode Catheter; Transvene Lead; Transvene SVC Lead; Tunneling Tool; Universal II Slitter; Universal Mounting Rail; Upsizing Sleeve; Versa DR IPG; Virtuoso II DR/VR ICD; Visia AF MRI S VR SureScan; Visia AF MRI VR SureScan; Visia AF VR; Vitatron C20 SR IPG; Vitatron Crystalline Lead; Vitatron Excellence PS+ Lead; Viva; Viva CRT-P; Viva Quad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D; patient connector; pinch on tool; stylet kit",1992-12-02,99,2025-12-19,27,95,6,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222182208%22&limit=1
Siemens Healthcare Diagnostics Products Limited,3002806944,3002806944,Glyn Rhonwy,LLANBERIS Wales,,LL55 4EL,United Kingdom,SIEMENS HEALTHCARE DIAGNOSTICS INC.,9096044,Complaint file establishment; Manufacturer; Specification developer,85,CDD; CDP; CDZ; CEC; CEE; CEP; CEW; CFL; CFP; CFT; CGC; CGI; CGJ; CGN; CGR; CGT; CHP; CIZ; CKG; DCN; DDR; DFJ; DGO; DHA; DHB; DHX; DIO; DIP; DKZ; GGT; GIF; JFH; JHR; JHX; JIR; JIT; JJE; JJQ; JJX; JJY; JKC; JKD; JKR; JLS; JLW; JMF; JMG; JMM; JNL; JZG; JZO; KLB; KLI; KLS; KLT; KXT; LAF; LCD; LDJ; LEG; LEH; LFM; LFX; LFZ; LGC; LGD; LIG; LIP; LKQ; LOJ; LOK; LOM; LPS; LTJ; LTK; LYR; MMI; MOI; MSW; MTF; MTG; NGA; NHX; NQD; SEI,"Radioassay, Vitamin B12; Radioimmunoassay, Total Triiodothyronine; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Radioimmunoassay, Thyroxine-Binding Globulin; Radioimmunoassay, Luteinizing Hormone; Radioimmunoassay, Parathyroid Hormone; Radioimmunoassay, Human Growth Hormone; Radioimmunoassay, Immunoreactive Insulin; Radioimmunoassay, Prolactin (Lactogen); Radioimmunoassay, Gastrin; Radioimmunoassay, Estriol; Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Radioimmunoassay, Cortisol; Radioimmunoassay, Cyclic Gmp; Radioimmunoassay, Estradiol; Radioimmunoassay, Androstenedione; Radioimmunoassay, Acth; System, Test, C-Reactive Protein; Myoglobin, Antigen, Antiserum, Control; Albumin, Rhodamine, Antigen, Antiserum, Control; Ige, Peroxidase, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Radioallergosorbent (Rast) Immunological; System, Test, Carcinoembryonic Antigen; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Amphetamine; Assay, Erythropoietin; Diluent, Blood Cell; Acid Phosphatase (Prostatic), Tartrate Inhibited; Radioimmunoassay, Immunoglobulins (D, E); Fluorometric Method, Cpk Or Isoenzymes; Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Calibrator, Secondary; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Colorimeter, Photometer, Spectrophotometer For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate); Radioimmunoassay, C-Peptides Of Proinsulin; Radioimmunoassay, Calcitonin; Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Radioimmunoassay, Human Placental Lactogen; Radioimmunoassay (Two-Site Solid Phase), Ferritin; Column Chromatography & Color Development, Hydroxyproline; Immunochemical, Thyroglobulin Autoantibody; System, Test, Beta-2-Microglobulin Immunological; System, Test, Thyroid Autoantibody; Radioimmunoassay, Tobramycin; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Enzyme Immunoassay, Digoxin; Gas Chromatography, Methamphetamine; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Cannabinoids; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Immunoassay, Digitoxin; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus; Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Radioassay, Intrinsic Factor Blocking Antibody; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Antibody Igm,If, Cytomegalovirus Virus; Kit, Test,Alpha-Fetoprotein For Testicular Cancer; Kit, Test, Alpha-Fetoprotein For Neural Tube Defects; Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Urinary Homocystine (Nonquantitative) Test System; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Helicobacter Pylori; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; System, Test, Thyroglobulin; Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; Test, Follicle Stimulating Hormone (Fsh), Over The Counter; Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp); Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Qualitative And Quantitative Hepatitis B Virus Antibody Assays",1; 2; 3,"3gAllergy Specific Allergens: Basil (F269), Cacao (F93),; 600 Series Blood Gas; A482 (Native Ole e 1); A753 (Native Art v 1); A89 (Native Bet v 1); ACTH Control Module (ACT QC); ADVIA Centaur Anti-Thyroglobulin II (aTgII); ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII); ADVIA Centaur C-peptide (CpS); ADVIA Centaur CMV IgM (CMV IgM); ADVIA Centaur CMV IgM Quality Control (CMV IgM QC); ADVIA Centaur HBc Total 2 (HBcT2); ADVIA Centaur HBc Total 2 Quality Control (HBcT2 QC); ADVIA Centaur Multi-Diluent 1 (M-Dil 1); ADVIA Centaur Multi-Diluent 10 (M-Dil 10); ADVIA Centaur Multi-Diluent 11 (M-Dil 11); ADVIA Centaur Multi-Diluent 15; ADVIA Centaur Multi-Diluent 2 (M-Dil 2); ADVIA Centaur Multi-Diluent 3 (M-Dil 3); ADVIA Centaur aTPOII Diluent (aTPOII DIL); ADVIA Centaur aTPOII Master Curve Material (aTPOII MCM); ADVIA Centaur aTPOII Quality Control (aTPOII QC); ADVIA Centaur aTgII Master Curve Material (aTgII MCM); ADVIA Centaur aTgII Quality Control (aTgII QC); Allergen - F237 Apricot, F261 Asparagus, F288 Blueberry; Anti-thyroglobulin antibody; Aspergillus niger; Atellica CH A-LYTE IMT Cleaner; Atellica HEMA Diluent (HEMA Diluent); Atellica IM Anti-Thyroglobulin II (aTgII); Atellica IM Anti-Thyroid Peroxidase II (aTPOII); Atellica IM C-peptide (CpS); Atellica IM CMV IgM (CMV IgM); Atellica IM CMV IgM Quality Control (CMV IgM QC); Atellica IM HBc Total 2 (HBcT2); Atellica IM HBc Total 2 Quality Control (HBcT2 QC); Atellica IM Multi-Diluent 1 (M-Dil 1); Atellica IM Multi-Diluent 10 (M-Dil 10); Atellica IM Multi-Diluent 11 (M-Dil 11); Atellica IM Multi-Diluent 12 (M-Dil 12); Atellica IM Multi-Diluent 13 (M-Dil 13); Atellica IM Multi-Diluent 15 (M-Dil 15); Atellica IM Multi-Diluent 2 (M-Dil 2); Atellica IM Multi-Diluent 3 (M-Dil 3); Atellica IM Tg Master Curve Material (Tg MCM); Atellica IM Thyroglobulin (Tg); Atellica IM aTPOII Diluent (aTPOII DIL); Atellica IM aTPOII Master Curve Material (aTPOII MCM); Atellica IM aTPOII Quality Control (aTPOII QC); Atellica IM aTgII Master Curve Material (aTgII MCM); Atellica IM aTgII Quality Control (aTgII QC); Blood Gas Systems; Brewer's Yeast (F403L2); Cantaloupe (F102L2);; Careless weed; Cephalosporium acremonium; Cinnamon (F220L2); Flounder (F147L2);; Cortisol Control Module; DOUBLE ANTIBODY ALBUMIN; Dimension T4 Flex; Dimension Vista® Acid Clean Flex® reagent cartridge; E220 (Cat Serum Albumin, Fel d 2); E221 (Dog Serum Albumin, Can f 3); F270 Ginger, F306 Lime, F65 Perch, F236 Whey; F291 Cauliflower, F279 Chili Pepper, F50 Chub Mackerel; Green Bean (F315L2); Green Pepper (F263L2); HCG-Human chorionic gonadotropin; Halibut (F303L2); Mushroom (F212L2); IMMULITE; IMMULITE 1000 Sycamore T11 (T11); IMMULITE 2000 / XPi Probe Cleaning Kit; IMMULITE 2000 / XPi Probe Wash Module; IMMULITE 2000 3gAllergy Specific IgE; IMMULITE 2000 3gAllergy Specific IgE (SPE CVM); IMMULITE 2000 3gAllergy Specific IgE (SPE); IMMULITE 2000 ACTH (ACT); IMMULITE 2000 ACTH Calibrator Verification Material (ACT CVM); IMMULITE 2000 AFP; IMMULITE 2000 AFP (AF); IMMULITE 2000 AFP Calibration Verification Material (AF CVM); IMMULITE 2000 ANTI-TPO; IMMULITE 2000 Albumin (ALB); IMMULITE 2000 Allergens; IMMULITE 2000 American Cockroach I206; IMMULITE 2000 Androstenedione (AND); IMMULITE 2000 Androstenedione Calibration Verification Material (AND CVM); IMMULITE 2000 Anti-CCP Calibration Verification Material (CCP CVM); IMMULITE 2000 Anti-CCP IgG (CCP); IMMULITE 2000 Anti-HBc (aBC); IMMULITE 2000 Anti-HBc IgM (BcM); IMMULITE 2000 Anti-HBs (aBs); IMMULITE 2000 Anti-TG Ab; IMMULITE 2000 Anti-TG Ab Calibration Verification Material (ATG CVM); IMMULITE 2000 Anti-TPO Ab Calibration Verification Material (ATA CVM); IMMULITE 2000 Aureobasidium Pullulans M12, 20 size; IMMULITE 2000 Avocado F96; IMMULITE 2000 BR-MA; IMMULITE 2000 BR-MA Calibration Verification Material (BRM CVM); IMMULITE 2000 Baccharis W67; IMMULITE 2000 Bayberry Sweet Gale T218; IMMULITE 2000 Beta-2 Microglobulin (BMG); IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material (BMG CVM); IMMULITE 2000 Black Pepper F280; IMMULITE 2000 Blomia Tropicalis D20, 20 size; IMMULITE 2000 Brazilian Peppertree T401, 20 size; IMMULITE 2000 Broccoli F260; IMMULITE 2000 Budgerigar Feathers E78, 20 size; IMMULITE 2000 C-Peptide (PEP); IMMULITE 2000 C-Peptide Calibrator Verification Material (CPE CVM); IMMULITE 2000 C-Peptide Sample Diluent (PEP DIL); IMMULITE 2000 CMV IgG; IMMULITE 2000 CMV IgM (CMM); IMMULITE 2000 Cabbage F216; IMMULITE 2000 Calcitonin (CAL); IMMULITE 2000 Canary feather E201, 20 size; IMMULITE 2000 Carbamazepine (CMP); IMMULITE 2000 Carcinoembryonic Antigen (CEA); IMMULITE 2000 Cheese, Mold Type F82; IMMULITE 2000 Chemiluminescent Substrate Module; IMMULITE 2000 Cherry F242; IMMULITE 2000 Chestnut F299; IMMULITE 2000 Chicken Feathers E85, 20 size; IMMULITE 2000 Chocolate F105; IMMULITE 2000 Coffee F221; IMMULITE 2000 Cortisol (COR); IMMULITE 2000 Cucumber F244; IMMULITE 2000 DC1L Specific IgE Positive Control; IMMULITE 2000 DC2L Specific IgE Positive Control; IMMULITE 2000 DHEA-SO4 (DHS); IMMULITE 2000 Digitoxin (DGT); IMMULITE 2000 Digoxin (DGX); IMMULITE 2000 Dog Fennel W46; IMMULITE 2000 Erythropoietin (EPO); IMMULITE 2000 Estradiol (E2); IMMULITE 2000 Estradiol CVM (E2 CVM); IMMULITE 2000 Estradiol Sample Diluent (E2 DIL); IMMULITE 2000 FSH (FSH); IMMULITE 2000 FSH CVM (FSH CVM); IMMULITE 2000 FSH Sample Diluent (FSH DIL); IMMULITE 2000 Ferritin (FER); IMMULITE 2000 Ferritin Calibration Verification Material (FER CVM); IMMULITE 2000 Folic Acid (FOL); IMMULITE 2000 Folic Acid /Vitamin B12 Sample Diluent; IMMULITE 2000 Folic Acid Calibration Verification Material (FOL CVM); IMMULITE 2000 Free PSA (fPS); IMMULITE 2000 Free PSA Calibration Verification Material (Fps CVM); IMMULITE 2000 Free T3 (FT3); IMMULITE 2000 Free T3 Calibration Verification Material (FT3 CVM); IMMULITE 2000 Free T4 (F4); IMMULITE 2000 Free T4 Calibrator Verification Material (FT4 CVM); IMMULITE 2000 GENTAMICIN; IMMULITE 2000 Gastrin (GAS); IMMULITE 2000 Grape F259; IMMULITE 2000 Grapefruit F209; IMMULITE 2000 Growth Hormone (GRH); IMMULITE 2000 H. Pylori IgG (HPG); IMMULITE 2000 HBsAg (HBS); IMMULITE 2000 HBsAg Confirmatory; IMMULITE 2000 HCG; IMMULITE 2000 HCG (HCG); IMMULITE 2000 HCG Sample Diluent; IMMULITE 2000 HCG Sample Diluent (HCG DIL); IMMULITE 2000 Haddock F42; IMMULITE 2000 Herpes I & II IgG (HVG); IMMULITE 2000 High Sensitivity C-Reactive Protein (hsC); IMMULITE 2000 High Sensitivity C-Reactive Protein Sample Diluent (hsC DIL); IMMULITE 2000 High Sensitivity CRP (hsC); IMMULITE 2000 High Sensitivity CRP Calibration Verification Material (hsC CVM); IMMULITE 2000 Homocysteine (HCY); IMMULITE 2000 Homocysteine Sample Diluent (HCY DIL); IMMULITE 2000 Hormodendrum Hordei M45; IMMULITE 2000 IGF-1 (IGF); IMMULITE 2000 IGF-1 Sample Diluent (IGF DIL); IMMULITE 2000 IGF-I (IGF); IMMULITE 2000 IGF-I Calibration Verification Material (IGF CVM); IMMULITE 2000 IGF-I Sample Diluent (IGF DIL); IMMULITE 2000 IGFBP-3 (BP3); IMMULITE 2000 IGFBP-3 Calibration Verification Material (BP3 CVM); IMMULITE 2000 IgG/IgM Sample Diluent; IMMULITE 2000 Immunoassay System; IMMULITE 2000 Insulin (INS); IMMULITE 2000 Insulin Sample Diluent (INS DIL); IMMULITE 2000 Intact PTH (iPT); IMMULITE 2000 Intact PTH Sample Diluent (iPT DIL); IMMULITE 2000 L2SNC Specific IgE Negative Control; IMMULITE 2000 LH (LH); IMMULITE 2000 LH Calibrator Verification Material (LH CVM); IMMULITE 2000 Lamb F88; IMMULITE 2000 Lemon F208; IMMULITE 2000 Lima Bean F182; IMMULITE 2000 Live Oak T103; IMMULITE 2000 Loblolly Pine T43, 20 size; IMMULITE 2000 Locust tree T280; IMMULITE 2000 MC6L Specific IgE Positive Control; IMMULITE 2000 Mixed Allergen Panels; IMMULITE 2000 Multi-Diluent 1; IMMULITE 2000 Multi-Diluent 2; IMMULITE 2000 Myoglobin (MYO); IMMULITE 2000 OM-MA (OV); IMMULITE 2000 OM-MA Calibration Verification Material (OV CVM); IMMULITE 2000 OM-MA Sample Diluent (OV DIL); IMMULITE 2000 PAP; IMMULITE 2000 PAP (PAP); IMMULITE 2000 PSA (PTS); IMMULITE 2000 Parrot Feathers E91, 20 size; IMMULITE 2000 Peach F95; IMMULITE 2000 Pear F94; IMMULITE 2000 Penicillium Brevi-Compactum M305, 20 size; IMMULITE 2000 Phenobarbital (PHE); IMMULITE 2000 Phenytoin (PHN); IMMULITE 2000 Pigeon Droppings E7, 20 size; IMMULITE 2000 Pineapple F210; IMMULITE 2000 Plum F255; IMMULITE 2000 Privet T210; IMMULITE 2000 Progesterone (PRG); IMMULITE 2000 Prolactin (PRL); IMMULITE 2000 Prolactin Calibrator Verification Material (PRL CVM); IMMULITE 2000 Prolactin Sample Diluent (PRL DIL); IMMULITE 2000 Pumpkin F225; IMMULITE 2000 Pyrilinks-D (DPD); IMMULITE 2000 Rabbit Bush W36, 20 size; IMMULITE 2000 Rapid TSH (RTH); IMMULITE 2000 Red Mulberry T71; IMMULITE 2000 Red Snapper F381; IMMULITE 2000 Rubella IgM (RUM); IMMULITE 2000 Rubella Quantitative IgG (RUB); IMMULITE 2000 SHBG (SBG); IMMULITE 2000 SHBG Calibrator Verification Material (SBG CVM); IMMULITE 2000 Sole F337; IMMULITE 2000 Specific Allergens; IMMULITE 2000 Spinach F214; IMMULITE 2000 Stemphylium Solani M88; IMMULITE 2000 Sweet Potato F54; IMMULITE 2000 Syphilis Screen; IMMULITE 2000 Systems Allergen Tube Caps; IMMULITE 2000 Systems Allergen Tube Septum; IMMULITE 2000 Systems Diluent Tube Caps; IMMULITE 2000 Systems Diluent Tubes; IMMULITE 2000 Systems Microsampling Tube Caps; IMMULITE 2000 Systems Reaction Tubes; IMMULITE 2000 Systems Third Generation TSH; IMMULITE 2000 T4 (TT4); IMMULITE 2000 TBG; IMMULITE 2000 TBG (TBG); IMMULITE 2000 TBG CVM (TBG CVM); IMMULITE 2000 TOBRAMYCIN; IMMULITE 2000 TSH Sample Diluent (TSH DIL); IMMULITE 2000 TSIIMMULITE 2000 TSI Calibration Verification Material (TSI CVM); IMMULITE 2000 Theophylline (THE); IMMULITE 2000 Thyroglobulin; IMMULITE 2000 Thyroglobulin (TG); IMMULITE 2000 Thyroglobulin Calibration Verification Material (TG CVM); IMMULITE 2000 Thyroglobulin Sample Diluent (TG DIL); IMMULITE 2000 Thyroid Uptake (TU); IMMULITE 2000 Tobacco O201, 20 size; IMMULITE 2000 Total IgE; IMMULITE 2000 Total IgE (TIE CVM); IMMULITE 2000 Total T3 CVM (T3 CVM); IMMULITE 2000 Total T4 CVM (TT4 CVM); IMMULITE 2000 Total Testosterone (TES); IMMULITE 2000 Total Testosterone Calibrator Verification Material (TES CVM); IMMULITE 2000 Toxoplasma IgM (TXM); IMMULITE 2000 Toxoplasma Quantitative IgG (TXP); IMMULITE 2000 Troponin I (TPI); IMMULITE 2000 Troponin I Calibration Verification Material (TPI CVM); IMMULITE 2000 Trout F204; IMMULITE 2000 Turkey Feathers E89, 20 size; IMMULITE 2000 Turkey Meat F284; IMMULITE 2000 Unconjugated Estriol; IMMULITE 2000 VALPROIC ACID (VAL); IMMULITE 2000 VITAMIN B12; IMMULITE 2000 Vancomycin; IMMULITE 2000 Vancomycin Sample Diluent; IMMULITE 2000 Watermelon F329; IMMULITE 2000 White Bald Cypress T37; IMMULITE 2000 XPi Immunoassay System; IMMULITE 2000 XPi System Sample Cup Nesting; IMMULITE 2000 nAsp r 1 A3050, 20 size; IMMULITE 2000 nCan f 1 A174, 20 size; IMMULITE 2000 nDer  p1 A310, 20 Size; IMMULITE 2000 nDer f 1 A295, 20 size; IMMULITE 2000 nDer f2 A302, 20 size; IMMULITE 2000 nDer p 2 A316, 20 size; IMMULITE 2000 nFel d 1 A345, 20 size; IMMULITE 2000 nPen m 1, F351, 20 size; IMMULITE AFP Control Module; IMMULITE Albumin CVM (ALB CVM); IMMULITE Albumin Control Module (ALB QC); IMMULITE Ascorbic Acid (Ascorbic Acid); IMMULITE Beta-2 Microglobulin Control Module (BMG QC); IMMULITE C- Peptide Control Module (CPE QC); IMMULITE CEA CVM (CEA CVM); IMMULITE CMV IgG; IMMULITE CMV IgG Control Module; IMMULITE CMV IgG Control Module (CVG QC); IMMULITE Calcitonin Calibration Verification Material (CAL CVM); IMMULITE Calcitonin Control Module (CAL QC); IMMULITE Cortisol Calibration Verification Material (COR CVM); IMMULITE DHEA-SO4 CVM (DHS CVM); IMMULITE EPO; IMMULITE EPO Control Module; IMMULITE Estradiol Control Module (E2 QC); IMMULITE Gastrin Calibration Verification Material (GAS CVM); IMMULITE Gastrin Control Module (GAS QC); IMMULITE Growth Hormone CVM (GRH CVM); IMMULITE H. Pylori IgG Control Module (HPG QC); IMMULITE H.Pylori IgG Calibration Verification Material (HPG CVM); IMMULITE HCG CVM (HCG CVM); IMMULITE HCG Control Module; IMMULITE HCG Control Module (HCG QC); IMMULITE High Sensitivity C-Reactive Protein Control Module (hsC QC); IMMULITE Homocysteine CVM (HCY CVM); IMMULITE IgF Control Module (IGF QC); IMMULITE Insulin CVM (INS CVM); IMMULITE Insulin Control Module (INS QC); IMMULITE Intact PTH CVM (iPT CVM); IMMULITE Intact PTH Control Module (iPT QC); IMMULITE Myoglobin CVM (MYO CVM); IMMULITE PAP Control Module; IMMULITE PAP Control Module (PAP QC); IMMULITE PSA Calibration Verification Material (PSA CVM); IMMULITE Probe Cleaning Kit; IMMULITE Probe Wash Module; IMMULITE Prostatic Acid Phosphatase Calibration Verification Material (PAP CVM); IMMULITE Pyrilinks-D Control Module (DPD QC); IMMULITE Rubella IgG Control Module (RUB QC); IMMULITE Rubella IgM Control Module (RUM QC); IMMULITE Rubella Quant IgG; IMMULITE Rubella Quantitative IgG Calibration Verification Material (RUB CVM); IMMULITE SHBG (Sex Hormone Bind Globulin); IMMULITE SHBG Control Module (SBG QC); IMMULITE Serum Drug Control Module; IMMULITE Syphilis Screen Control Module; IMMULITE TBG; IMMULITE TBG Control Module; IMMULITE TBG Control Module (TBG QC); IMMULITE TBG Sample Diluent; IMMULITE TBG Sample Diluent (TBG DIL); IMMULITE Third Generation TSH CVM (TSH CVM); IMMULITE Thyroglobulin; IMMULITE Thyroglobulin Control Module; IMMULITE Thyroglobulin Control Module (TG QC); IMMULITE Thyroglobulin Sample Diluent; IMMULITE Thyroid Control Module; IMMULITE Total IgE Control Module (TIE QC); IMMULITE Toxoplasma Quantitative IgG Calibration Verification Material (TXP CVM); IMMULITE Toxoplasma Quantitative IgG Control Module (TXP QC); IMMULITE Turbo CK-MB; IMMULITE Vitamin B12; IMMULITE Vitamin B12 Calibration Verification Material (VB CVM); IMMULITE/IMMULITE 1000 Erythropoietin (EPO) Sample Diluent; IMMULITE/IMMULITE 1000 Free T4; IMMULITE/IMMULITE 1000 HCG; IMMULITE/IMMULITE 1000 HCG Sample Diluent; IMMULITE® / IMMULITE® 1000 FSH; IMMULITE® 2000 3gAllergyTM Specific IgE Universal Kit; IMMULITE® 2000 FSH; IMMULITE® 2000 FSH Sample Diluent; IMMUUTE 2000 Systems Microsampling Tubes; IRMA Count SHBG (Sex Hormone Bind Globulin); MAGIC LITE INTACT PTH DILUENT; Oregano (F283), Parsley (F86), Pine Nut (F253),; Pinto Beans (F300L2); Red Kidney Bean (F287L2); Poplar; Progesterone Calibration Verification Material (CVM); Saltbush; Sex Hormone Bind Globulin (SHBG); Specific Allergens:; Sugar Cane (F21L2); Yogurt (F360L2); Sunflower; Third Generation TSH Control Module (TSH QC); Total IgE; Total IgE Control Module; Unconjugated Estriol Calibration Verification Material (UE3 CVM); Vancomycin; Vanilla (F234); Vista FSH Flex; n Pru p 3, (A603 Peach, Prunus persica); rBet v 2, (A127 Birch pollen, Betula verrucose); rMal d 1 (A464 Apple, Malus domestica); rMal d 4, (A796 Apple, Malus domestica); rPru av 1, (A597 Cherry, Prunus avium); rPru av 3, (A599 Cherry, Prunus avium); rPru av 4 (A600 Cherry, Prunus avium)",1998-02-12,117,2025-12-04,8,1,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223002806944%22&limit=1
Diamond Diagnostics Inc.,3006198300,3006198300,6 Oradna Street,Budapest,,1044,Hungary,Diamond Diagnostics Inc.,10028706,Contract manufacturer; Exporter to the US,241,CDD; CDM; CDO; CDP; CDQ; CDS; CDT; CDZ; CEC; CEE; CEK; CEM; CEN; CEO; CEP; CET; CEW; CFJ; CFL; CFN; CFP; CFQ; CFR; CFT; CGA; CGI; CGJ; CGL; CGN; CGR; CGS; CGT; CGX; CGZ; CHH; CHJ; CHL; CHN; CHP; CIC; CIG; CIT; CIX; CJE; CJW; CJX; CKA; CKB; CKG; CZP; CZW; DAD; DAO; DAP; DBF; DBI; DCF; DCK; DCN; DDG; DDR; DEF; DEL; DEM; DER; DEW; DFC; DFJ; DGC; DGI; DGO; DHA; DHB; DHR; DHX; DIC; DIF; DIH; DIO; DIP; DIS; DJG; DJR; DKB; DKJ; DKZ; DLB; DLJ; DLZ; DML; DOD; GGF; GGZ; GHH; GHS; GJS; GKF; GKL; GKP; GKR; GKZ; GLK; GLY; JBP; JFH; JFJ; JFL; JFO; JFP; JFY; JGJ; JGQ; JGS; JHI; JHN; JHR; JHS; JHX; JHY; JIF; JIH; JIL; JIN; JIO; JIR; JIS; JIT; JIX; JIY; JJB; JJE; JJF; JJG; JJH; JJO; JJQ; JJS; JJX; JJY; JKC; JKD; JLB; JLS; JLW; JMA; JMF; JMG; JMM; JMO; JMT; JPA; JPD; JPI; JQB; JQX; JRE; JSM; JXM; JXN; JXO; JZG; JZO; JZW; KHG; KHO; KHP; KHQ; KHS; KLB; KLI; KLP; KLS; KLT; KNK; KPA; KQI; KQO; KSZ; KXS; KXT; LAF; LAN; LAR; LAS; LBS; LBZ; LCD; LCM; LCP; LCR; LDJ; LDP; LEG; LEH; LFM; LFX; LFZ; LGC; LGD; LGI; LGQ; LGR; LGS; LJX; LKM; LOJ; LOL; LON; LPS; LPT; LSL; LSR; LTJ; LTK; LYR; MKZ; MMI; MOI; MOJ; MQM; MRR; MSW; MYT; MZA; NBC; NDW; NDY; NJR; NQD; NSU; OAV; OCC; OEM; OEP; OOI; OOU; OTG; OUY; OZX; OZZ; QFS,"Radioassay, Vitamin B12; Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.); Acid, Uric, Uricase (U.V.); Radioimmunoassay, Total Triiodothyronine; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Electrode, Ion Specific, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Radioimmunoassay, Thyroxine-Binding Globulin; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Dye-Indicator, Ph (Urinary, Non-Quantitative); Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Olive Oil Emulsion (Turbidimetric), Lipase; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Radioimmunoassay, Human Growth Hormone; Method, Nephelometric, Immunoglobulins (G, A, M); Radioimmunoassay, Immunoreactive Insulin; Radioimmunoassay, Immunoglobulins (G, A, M); Hexokinase, Glucose; Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Estriol; Radioimmunoassay, Follicle-Stimulating Hormone; Electrode, Ion Based, Enzymatic, Creatinine; Acid, Folic, Radioimmunoassay; Radioimmunoassay, Cortisol; Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes; Radioimmunoassay, Cyclic Gmp; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Mercuric Thiocyanate, Colorimetry, Chloride; Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph; Immunochemical, Ceruloplasmin; Radioimmunoassay, Estradiol; Cresolphthalein Complexone, Calcium; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Bromcresol Purple Dye-Binding, Albumin; Acid Phosphatase, Disodium Phenylphosphate; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Acid Phosphatase, Naphthyl Phosphate; Radioimmunoassay, Acth; Iga, Antigen, Antiserum, Control; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Igm (Mu Chain Specific), Antigen, Antiserum, Control; Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; System, Test, C-Reactive Protein; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control; Lipoprotein X, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Alpha-1-Lipoprotein, Antigen, Antiserum, Control; Igg, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; Albumin, Rhodamine, Antigen, Antiserum, Control; Ige, Antigen, Antiserum, Control; Breast Milk, Rhodamine, Antigen, Antiserum, Control; Ige, Peroxidase, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Radioallergosorbent (Rast) Immunological; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Radioimmunoassay, Lsd (125-I); Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Nad-Nadh, Specific Reagent For Alcohol Enzyme Method; Gas Chromatography, Amphetamine; Acid Hematin; Oxyhemoglobin; Fibrin Split Products; Assay, Carboxyhemoglobin; Test, Time, Prothrombin; Instrument, Hematocrit, Automated; Counter, Cell, Automated (Particle Counter); Instrument, Coagulation, Automated; System, Hemoglobin, Automated; Counter, Differential Cell; Control, Hematocrit; Oximeter To Measure Hemoglobin; Activated Whole Blood Clotting Time; Acid Phosphatase (Prostatic), Tartrate Inhibited; Catalytic Methods, Amylase; Ph Rate Measurement, Carbon-Dioxide; Fluorometric, Calcium; Electrode, Ion Specific, Calcium; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Turbidimetric, Total Protein; Electrode, Ion Specific, Sodium; Visual, Pregnancy Hcg, Prescription Use; Turbidimetric Method, Lipoproteins; Radioimmunoassay, Immunoglobulins (D, E); Differential Rate Kinetic Method, Cpk Or Isoenzymes; Fluorometric Method, Cpk Or Isoenzymes; Colorimetric Method, Cpk Or Isoenzymes; Enzymatic Method, Ammonia; Flame Photometry, Lithium; Method, Enzymatic, Glucose (Urinary, Non-Quantitative); Nitroprusside, Ketones (Urinary, Non-Quant.); Blood, Occult, Colorimetric, In Urine; Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Analyzer, Chemistry, Micro, For Clinical Use; Analyzer, Chemistry, Centrifugal, For Clinical Use; Clinical Sample Concentrator; Flame Emission Photometer For Clinical Use; Colorimeter, Photometer, Spectrophotometer For Clinical Use; Controls For Blood-Gases, (Assayed And Unassayed); Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate); Radioimmunoassay, C-Peptides Of Proinsulin; Atp And Creatine Kinase (Enzymatic), Creatine; Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric); Radioimmunoassay, Human Placental Lactogen; Radioimmunoassay (Two-Site Solid Phase), Ferritin; Column Chromatography & Color Development, Hydroxyproline; Ferrozine (Colorimetric) Iron Binding Capacity; Diazo (Colorimetric), Nitrite (Urinary, Non-Quant); System, Multipurpose For In Vitro Coagulation Studies; Hemoglobin A2 Quantitation; Device, Hematocrit Measuring; Kinetic Method, Gamma-Glutamyl Transpeptidase; Nephelometer, For Clinical Use; Refractometer For Clinical Use; Culture Media, Non-Propagating Transport; Enzyme Immunoassay, Benzodiazepine; Enzyme Immunoassay, Propoxyphene; Enzyme Immunoassay, Cocaine; System, Test, Beta-2-Microglobulin Immunological; System, Test, Thyroid Autoantibody; Nephelometer; Whole Blood Hemoglobin Determination; Fluorometer, For Clinical Use; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzymatic, Carbon-Dioxide; Radioimmunoassay, Tobramycin; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Amikacin Serum Assay; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Slide Stainer, Automated; Assay, Fetal Hemoglobin; Automated Urinalysis System; System, Test, Automated Blood Grouping And Antibody; Radioimmunoassay, Methaqualone; Enzyme Immunoassay, Digoxin; Gas Chromatography, Methamphetamine; Enzyme Immunoassay, N-Acetylprocainamide; Enzyme Immunoassay, Procainamide; Drug Specific Control Materials; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Quinidine; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Assay, Glycosylated Hemoglobin; Fluorescent Immunoassay, Tobramycin; Enzyme Immunoassay, Cannabinoids; Colorimetry, Acetaminophen; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Immunoassay, Digitoxin; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus; Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Fluorescence Polarization Immunoassay, Carbamazepine; Fluorescence Polarization Immunoassay, Phenobarbital; Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total); Fluorescence Polarization Immunoassay, Theophylline; Test, Urine Leukocyte; Counter, Urine Particle; Kit, Test,Alpha-Fetoprotein For Testicular Cancer; Hepatitis A Test (Antibody And Igm Antibody); System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Urinary Homocystine (Nonquantitative) Test System; System, Test, Urinary Methylmalonic Acid; Dna-Reagents, Neisseria; Reagent, Borrelia Serological Reagent; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Helicobacter Pylori; Dna Probe, Nucleic Acid Amplification, Chlamydia; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free); Bilirubin (Total And Unbound) In The Neonate Test System; System, Test, Low Density, Lipoprotein; System, Test, Thyroglobulin; Biosensor, Immunoassay, Cpk Or Isoenzymes; Test, Equipment, Automated Bloodborne Pathogen; Test, Natriuretic Peptide; Assay, Porphyrin, Spectrophotometry, Lithium; Test, Cystatin C; Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Instrumentation For Clinical Multiplex Test Systems; Mycophenolic Acid Test System; Respiratory Virus Panel Nucleic Acid Assay System; Human Metapneumovirus (Hmpv) Rna Assay System; Influenza A Virus Subtype Differentiation Nucleic Acid Assay; Real Time Nucleic Acid Amplification System; Parainfluenza Multiplex Nucleic Acid Assay; Non-Sars Coronavirus Multiplex Nucleic Acid Assay; Trichomonas Vaginalis Nucleic Acid Amplification Test System; Mycoplasma Pneumoniae Dna Assay System; Bordetella Pertussis Dna Assay System; Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment",1; 2; N; U,"ANALYZER, CHEMISTRY; Analyzer; Assay System; Automated Test System; BK BUN; BK Creatinine; BK Glucose; BK ISE; Blood Gas; CALIBRATOR; CD Cal-Packs; CLINCAL CHEMISTRY; CLINICAL SAMPLE CONCENTRATOR; CONTROL; Cal-Packs; Calibrator; Chemistry; Chemistry Analyzer; Clinical Chemistry; Coagulation; Controls; Dade Calibrator; Diamond Calibrators for Atac 8000/Envoy 500 ISE Modules; Diamond Calibrators for Tokyo Boeki ISE Module; Glucose Test System; HEMATOLOGY ANALYZER; Hema; Hematocrit; Hematology; Hematology Analyzer; Hematology Device; Immunoassay Analyzer; Immunodiagnostic System; Immunology; Immunology Analyzer; Linearity; MICROBIOLOGY ANALYZER; Microbiology; Mission Reagents; OY Reagents; PROLTYE® Electrolyte Analyzer; PROLYTE; Packs; Photometric; SMARTLYTE® Electrolyte Analyzer; SmartLyte; SmartLyte Plus Electrolyte Analyzer; Test Systems; Trinity B; URINALYSIS; Urinalysis Analyzer; Urine Analyzer; chemistry",2009-02-26,124,2023-08-04,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006198300%22&limit=1
Stryker Leibinger GMBH & Co. KG,8010177,3002821504,Botzinger Strasse 39-41,FREIBURG Baden-Wurttemberg,,D-79111,Germany,STRYKER CORP.,1811755,Complaint file establishment; Contract manufacturer; Exporter to the US; Manufacturer; Specification developer,77,DMG; DZE; DZI; DZJ; DZL; EHO; ERL; EZX; FSM; FTD; FTL; FTM; FWP; FZO; FZX; GCX; GCY; GDY; GEA; GEI; GEN; GEY; GWO; GXD; GXI; GXP; GXR; HAO; HAW; HBE; HBW; HPZ; HQN; HRS; HRX; HSB; HTJ; HTN; HTT; HTW; HTY; HWC; HWE; HWQ; HWT; HWX; HXD; HXK; HXX; IRQ; JEY; JOF; KCT; KTT; KWS; LFL; LLZ; LRC; LRN; LRP; LWH; LXH; LYA; LYS; LZD; MAI; MNF; MQN; MQU; NDP; NEI; NPK; NQR; OLO; OUG; PGW; QLV,"Papers, Ion; Implant, Endosseous, Root-Form; Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Screw, Fixation, Intraosseous; Bar, Preformed; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Mesh, Surgical, Metal; Tray, Surgical, Instrument; Lamp, Surgical; Mesh, Surgical, Polymeric; Mesh, Surgical; Prosthesis, Chin, Internal; Chisel, Surgical, Manual; Guide, Surgical, Instrument; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Gauze/Sponge, Internal, X-Ray Detectable; Cannula, Surgical, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Motor, Surgical Instrument, Ac-Powered; Plate, Cranioplasty, Preformed, Alterable; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Methyl Methacrylate For Cranioplasty; Cover, Burr Hole; Instrument, Surgical, Non-Powered; Neurological Stereotaxic Instrument; Drills, Burrs, Trephines & Accessories (Simple, Powered); Fastener, Plate, Cranioplasty; Implant, Eye Sphere; Conformer, Ophthalmic; Plate, Fixation, Bone; Arthroscope; Rod, Fixation, Intramedullary And Accessories; Gauge, Depth; Washer, Bolt Nut; Burr, Orthopedic; Bit, Drill; Pin, Fixation, Smooth; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Passer; Template; Tap, Bone; Clamp; Holder, Needle; Orthopedic; Screwdriver; Unit, Heating, Powered; Plate, Bone; Polymer, Ent Synthetic, Porous Polyethylene; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Instrument, Ultrasonic Surgical; System, Image Processing, Radiological; Instrument, Ent Manual Surgical; Wire, Surgical; Tray, Surgical; Counter, Sponge, Surgical; Orthopedic Manual Surgical Instrument; Splint, Intranasal Septal; Bone Mill; Joint, Temporomandibular, Implant; Fastener, Fixation, Biodegradable, Soft Tissue; Implant, Temporal; External Mandibular Fixator And/Or Distractor; Ocular Peg; Accessories, Implant, Dental, Endosseous; Prosthesis, Condyle, Mandibular, Temporary; Barrier, Synthetic, Intraoral; Sealant, Dural; Orthopedic Stereotaxic Instrument; Medical Device Data System; Ear, Nose, And Throat Stereotaxic Instrument; Field Generator Positioning Device",1; 2; 3; U,"0250-070-500 Suction Irrigator 2; 0250-070-520 StrykeFlow 2 With Tip; 045 IN. (1.143mm) K-WIRE W/LENGTH MARKINGS; 1.2X10mm BONE SCREWSCROSSPINSELFT; 1.2X12mm BONE SCREWSCROSSPINSELFT; 1.2X14mm BONE SCREWSCROSSPINSELFT; 1.2X16mm BONE SCREWSCROSSPINSELFT; 1.2X18mm BONE SCREWSCROSSPINSELFT; 1.2X20mm BONE SCREWSCROSSPINSELFT; 1.2X4mm BONE SCREWSCROSSPINSELFT; 1.2X5mm BONE SCREWSCROSSPINSELFT; 1.2X6mm BONE SCREWSCROSSPINSELFT; 1.2X7mm BONE SCREWSCROSSPINSELFT; 1.2X8mm BONE SCREWSCROSSPINSELFT; 1.2X9mm BONE SCREWSCROSSPINSELFT; 1.4X3mm EMERG SCREWSCROSSPINSELFT; 1.4X5mm EMERG SCREWSCROSSPINSELFT; 1.4X7mm EMERG SCREWSCROSSPINSELFT; 1.4X9mm EMERG SCREWSCROSSPINSELFT; 1.7 S PROFYLE HAND LOCK 3-D PLATE,2X2+2H; 1.7 S PROFYLE HAND LOCK 3-D PLATE,2X2H; 1.7 S PROFYLE HAND LOCK 3-D PLATE,3X2H; 1.7 S PROFYLE HAND LOCK 3-D PLATE,4X2H; 1.7 S PROFYLE HAND LOCK 3-D REPL PL,4X2H; 1.7 S PROFYLE HAND LOCK L-PLATE,LE,6H; 1.7 S PROFYLE HAND LOCK L-PLATE,RI,6H; 1.7 S PROFYLE HAND LOCK PLATE,STRAI,16H; 1.7 S PROFYLE HAND LOCK PLATE,STRAI,4H; 1.7 S PROFYLE HAND LOCK ROTATION PLATE,5H; 1.7 S PROFYLE HAND LOCK T-PLATE,NAR,10H; 1.7 S PROFYLE HAND LOCK T-PLATE,NAR,6H; 1.7 S PROFYLE HAND LOCK T-PLATE,REG,7H; 1.7 S PROFYLE HAND LOCK T-PLATE,WIDE,8H; 1.7 S PROFYLE HAND LOCK Z-PLATE,NAR,9H; 1.7 S VARIAX HAND LOCK ROTATION PLATE,5H; 1.7X10MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X10mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X11MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X11mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X12MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X12mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X13MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X13mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X14MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X14mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X15MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X15mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X16MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X16mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X18MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X18mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X20MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X20mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X22MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X22mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X24MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X24mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X5MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X5mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X6MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X6mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X7MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X7mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X8MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X8mm BONE SCREWSCROSSPINSELFTAPPING; 1.7X9MM LOCKING SCREWS,CROSS-PIN,SELF-T; 1.7X9mm BONE SCREWSCROSSPINSELFTAPPING; 1.9X10mm EMERG SCREWSCROSSPINSELFT; 1.9X12mm EMERG SCREWSCROSSPINSELFT; 1.9X5mm EMERG SCREWSCROSSPINSELFT; 1.9X8mm EMERG SCREWSCROSSPINSELFT; 10mm SUBFIX TRIAL; 11.5mm SUBFIX TRIAL; 2 mm  ASNIS MICRO CANNULATED SCREW 10/4 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 11/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 12/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 13/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 14/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 15/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 16/7 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 17/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 17/8 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 18/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 18/8 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 19/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 19/9 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 20/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 20/9 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 22/10 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 22/5 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 24/10 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 24/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 26/12 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 26/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 28/12 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 28/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 30/14 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 30/6 mm STERILE; 2 mm  ASNIS MICRO CANNULATED SCREW 8/4 mm STERILE; 2 mm  ASNIS MICRO WASHER 2mm STERILE; 2 mm  ASNIS MICRO, CANNULATED SCREW, 10/4 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 11/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 12/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 13/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 14/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 15/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 16/7 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 17/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 17/8 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 18/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 18/8 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 19/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 19/9 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 20/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 20/9 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 22/10 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 22/5 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 24/10 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 24/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 26/12 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 26/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 28/12 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 28/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 30/14 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 30/6 mm; 2 mm  ASNIS MICRO, CANNULATED SCREW, 8/4 mm; 2 mm  ASNIS MICRO, WASHER 2mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 16mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 18mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 20mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 22mm; 2 mm TITANIUM LOCKING PEG, CROSS-PIN, 24mm; 2.3 L PROFYLE HAND ROTATION PLATE,5H; 2.3 M PROFYLE HAND LOCK 3-D PLATE,2X2+2H; 2.3 M PROFYLE HAND LOCK 3-D PLATE,2X2H; 2.3 M PROFYLE HAND LOCK 3-D PLATE,3X2H; 2.3 M PROFYLE HAND LOCK 3-D PLATE,4X2H; 2.3 M PROFYLE HAND LOCK 3-D REPL PL,4X2H; 2.3 M PROFYLE HAND LOCK L-PLATE,LE,6H; 2.3 M PROFYLE HAND LOCK L-PLATE,RI,6H; 2.3 M PROFYLE HAND LOCK LE MC V PLATE,5H; 2.3 M PROFYLE HAND LOCK PLATE STRAIGHT BAR 4H; 2.3 M PROFYLE HAND LOCK PLATE,STRAI,16H; 2.3 M PROFYLE HAND LOCK PLATE,STRAI,4H; 2.3 M PROFYLE HAND LOCK RI MC V PLATE,5H; 2.3 M PROFYLE HAND LOCK ROTATION PLATE,5H; 2.3 M PROFYLE HAND LOCK T-PLATE,NAR,6H; 2.3 M PROFYLE HAND LOCK T-PLATE,REG,7H; 2.3 M PROFYLE HAND LOCK T-PLATE,WIDE,8H; 2.3 M PROFYLE HAND LOCK Y-PLATE,NAR,7H; 2.3 M PROFYLE HAND LOCK Z-PLATE,NAR,13H; 2.3 M PROFYLE HAND ROTATION PLATE,5H; 2.3 M VARIAX HAND LOCK ROTATION PLATE,5H; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 10mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 12mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 14mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 28mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 30mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 32mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 34mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 36mm; 2.3 mm TITANIUM BONE SCREW, CROSS-PIN, SELF-TAPPING, 38mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 10mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 12mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 14mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 28mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 30mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 32mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 34mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 36mm; 2.3 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 38mm; 2.3X10MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X10mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X11MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X11mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X12MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X12mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X13mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X13mm LOCKING SCREWSCROSSPINSELFT; 2.3X14MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X14mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X15MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X15mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X16MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X16mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X18MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X18mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X20MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X20mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X22MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X22mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X24MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X24mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X26MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X26mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X6MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X6mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X8MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X8mm BONE SCREWSCROSSPINSELFTAPPING; 2.3X9MM LOCKING SCREWS,CROSS-PIN,SELF-T; 2.3X9mm BONE SCREWSCROSSPINSELFTAPPING; 2.5X10mm EMERG SCREWSCROSSPINSELFT; 2.5X12mm EMERG SCREWSCROSSPINSELFT; 2.5X6mm EMERG SCREWSCROSSPINSELFT; 2.5X8mm EMERG SCREWSCROSSPINSELFT; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 10mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 12mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 14mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.7 mm TITANIUM  BONE SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 16mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 18mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 20mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 22mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 24mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, 26mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 10mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 12mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 14mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.7 mm TITANIUM LOCKING SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 16mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 18mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 20mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 22mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 24mm; 2.7 mm TITANIUM PARTIALLY THREADED BONE SCREW, CROSS-PIN, SELF-TAPPING, 26mm; 206-716 w/2 small sculps/pkg; 3 mm  ASNIS MICRO CANNULATED SCREW 10/4 mm  STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 11/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 12/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 13/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 14/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 14/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 15/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 15/7 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 16/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 16/7 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 17/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 17/8 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 18/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 18/8 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 19/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 19/9 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 20/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 20/9 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 21/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 21/9 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 22/10 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 22/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 23/10 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 23/5 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 24/10 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 24/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 25/10 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 25/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 26/12 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 26/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 27/12 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 27/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 28/12 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 28/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 29/12 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 29/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 30/14 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 30/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 32/14 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 32/6 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 34/16 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 34/7 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 36/16 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 36/7 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 38/18 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 38/8 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 40/18 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 40/8 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 8/4 mm STERILE; 3 mm  ASNIS MICRO CANNULATED SCREW 9/4 mm STERILE; 3 mm  ASNIS MICRO WASHER 3mm STERILE; 3 mm  ASNIS MICRO, CANNULATED SCREW, 10/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 11/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 12/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 13/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 14/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 14/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 15/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 15/7 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 16/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 16/7 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 17/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 17/8 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 18/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 18/8 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 19/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 19/9 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 20/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 20/9 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 21/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 21/9 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 22/10 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 22/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 23/10 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 23/5 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 24/10 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 24/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 25/10 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 25/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 26/12 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 26/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 27/12 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 27/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 28/12 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 28/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 29/12 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 29/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 30/14 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 30/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 32/14 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 32/6 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 34/16 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 34/7 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 36/16 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 36/7 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 38/18 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 38/8 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 40/18 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 40/8 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 8/4 mm; 3 mm  ASNIS MICRO, CANNULATED SCREW, 9/4 mm; 3 mm  ASNIS MICRO, WASHER 3mm; 3-D PLATE LEFT; 3-D PLATE RIGHT; 3.2mmX14mm TWINFIX COMP. SCREW; 3.2mmX16mm TWINFIX COMP. SCREW; 3.2mmX18mm TWINFIX COMP. SCREW; 3.2mmX20mm TWINFIX COMP. SCREW; 3.2mmX21mm TWINFIX COMP. SCREW; 3.2mmX22mm TWINFIX COMP. SCREW; 3.2mmX23mm TWINFIX COMP. SCREW; 3.2mmX24mm TWINFIX COMP. SCREW; 3.2mmX25mm TWINFIX COMP. SCREW; 3.2mmX26mm TWINFIX COMP. SCREW; 3.2mmX27mm TWINFIX COMP. SCREW; 3.2mmX28mm TWINFIX COMP. SCREW; 3.2mmX30mm TWINFIX COMP. SCREW; 3.2mmX32mm TWINFIX COMP. SCREW; 3.2mmX34mm TWINFIX COMP. SCREW; 3.9mm Omega Drill; 3MM DBL SLEEVE 80MM TROC/ASSY; 3mm PREDRILL ASSEMBLY LONG; 3mm PREDRILL ASSEMBLY SHORT; 4.75mm AlphaVent and Omega Drill; 4MM DBL SLVE 180MM TROC/ASSY; 4mm DBL SLEEVE 150mm TROC/ASSY; 4mm PREDRILL ASSEMBLY EXTRA SHORT; 4mm PREDRILL ASSEMBLY LONG; 4mm PREDRILL ASSEMBLY SHORT; 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill; 5mm PREDRILL ASSEMBLY EXTRA SHORT; 5mm PREDRILL ASSEMBLY LONG; 5mm PREDRILL ASSEMBLY SHORT; 5mm SPANNER WRENCH; 6.5mm SUBFIX TRIAL; 6mm PREDRILL ASSEMBLY EXTRA SHORT; 6mm PREDRILL ASSEMBLY LONG; 6mm PREDRILL ASSEMBLY SHORT; 7MM SPANNER WRENCH; 7mm SPANNER WRENCH; 8mm SUBFIX TRIAL; 9mm SUBFIX TRIAL; A 2 DRILL BRACE W/O CHUCK; A 4 4MM CHUCK; A 5 T-WRENCH; A 51 T WRENCH W/35 EXTENSION; ACL Reconstruction Accessories; ACL Workstation; ADAPT for Gamma 3; ADAPT for Gamma3; AEQ FRAC LONG SUP IMP ENS; AEQ FRAC SUPPORT DE BRAS; AEQ FRACT GR AXE LIAISON; AEQ FRACT MESUREUR AMOVIB; AEQ FRACT NM FANT TIG; AEQ IMPACTEUR DE PROTHESE; AEQ TIGE FRA LG FANT; AEQ USA FANT CALO; AEQUALIS; AEQUALIS FRACTURE; AEQUALIS RESURFACING HEAD; AGM 6 6MM CHUCK; ALEUTIAN Interbody Systems Trays; ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS); ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE; ANCHORAGE CP LAPIDUS TEMPLATE; ANCHORAGE CP MTP PIVOTING DRILL GUIDE; ANCHORAGE CP MTP TEMPLATE; ANCHORAGE CP POLYAXIAL DRILL GUIDE; ANCHORAGE CP UTILITY TEMPLATE; ANCHORAGE FIXATION PIN; ANCHORAGE FIXED DRILL GUIDE 2.5MM; ANCHORAGE FIXED DRILL GUIDE 2MM; ANCHORAGE INSTRUMENTS RACK (LEVEL 1); ANCHORAGE INSTRUMENTS RACK (LEVEL 2); ANCHORAGE INSTRUMENTS RACK COVER; ANCHORAGE PLATE BENDER; ANCHORAGE PLATE GRIPPER; ANTEVERSION GUIDE; AO HANDLE - LENGTH 135MM; AO Quick Coupling with Elastosil Handle; AO/JACOBS QUICK RELEASE APEX CHUCK 3mm; AO/JACOBS QUICK RELEASE APEX CHUCK 4mm; AO/JACOBS QUICK RELEASE APEX CHUCK 5mm; AO/JACOBS QUICK RELEASE APEX CHUCK 6mm; APEX DRILL BRACE - 3/4/5/6mm; APEX DRILL GUIDE HANDLE; APEX TRAY BASE; APEX TRAY LID; APEX TRAY LOWER INSERT; APEX TRAY UPPER INSERT; ASNIS MICRO 2mm LENGTH 9mm; ASNIS MICRO 2mm LENGTH 9mm STERILE; ATP Disc Prep; AXSOS ADAPTOR FOR TORQUE TESTER T20; AXSOS ADAPTOR FOR TORQUE TESTER T8/T15; AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK; Accolade II System Instrumentation; Adherus AutoSpray Dural Sealant; Adherus AutoSpray ET Dural Sealant; Aequalis Fracture; Aequalis Reversed Fracture; Aequalis Reversed II; Aequalis"" Fx2; Aequalis"" Instrument; Aequalis"" PerFORM; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; All OrthoHelix Orthopedic Manual Surgical Instruments; All Tornier Orthopeadic Manual Surgical Instruments (exempt); Aluminum Lid - Universal; Anato Hip System Instrumentation; Anatomic Express Tray; Angeld Farabeuf clamp; Archbar; Asnis® III Cannulated Screw System; Asnis® PRO Cannulated Screw System; AxSOS; AxSOS 3; AxSOS 3 AF System and AxSOS 3 Ti System, Plate; AxSOS 3 Ankle Fusion; AxSOS 3 Ti; BARREL REAMER ASSEMBLY STAND; BATTERY POWERED SCREWDRIVER II; BIOCOMPRESSION WRENCH 15mm TUBE; BIOCOMPRESSION WRENCH 20mm TUBE; BIOCOMPRESSION WRENCH 25mm TUBE; BLADES, PROBES; BONE MILL; BONE SCREW T10 3.5X10mm; BONE SCREW T10 3.5X12mm; BONE SCREW T10 3.5X14mm; BONE SCREW T10 3.5X16mm; BONE SCREW T10 3.5X18mm; BONE SCREW T10 3.5X20mm; BONE SCREW T10 3.5X22mm; BONE SCREW T10 3.5X24mm; BONE SCREW T10 3.5X26mm; BONE SCREW T10 3.5X28mm; BONE SCREW T10 3.5X30mm; BONE SCREW T10 3.5X32mm; BONE SCREW T10 3.5X34mm; BONE SCREW T10 3.5X36mm; BONE SCREW T10 3.5X38mm; BONE SCREW T10 3.5X40mm; BONE SCREW T10 3.5X42mm; BONE SCREW T10 3.5X44mm; BONE SCREW T10 3.5X46mm; BONE SCREW T10 3.5X48mm; BONE SCREW T10 3.5X50mm; BONE SCREW T10 3.5X55mm; BONE SCREW T10 3.5X60mm; BONE SCREW T10 3.5X65mm; BONE SCREW T10 3.5X70mm; BONE SCREW T7 2.3X10 MM; BONE SCREW T7 2.3X12 MM; BONE SCREW T7 2.3X14MM; BONE SCREW T7 2.3X16 MM; BONE SCREW T7 2.3X18 MM; BONE SCREW T7 2.3X20 MM; BONE SCREW T7 2.3X22MM; BONE SCREW T7 2.3X24 MM; BONE SCREW T7 2.3X26 MM; BONE SCREW T7 2.3X28 MM; BONE SCREW T7 2.3X30 MM; BONE SCREW T7 2.3X32 MM; BONE SCREW T7 2.3X34 MM; BONE SCREW T7 2.3X36 MM; BONE SCREW T7 2.3X38 MM; BONE SCREW T7 2.7X10 MM; BONE SCREW T7 2.7X10mm; BONE SCREW T7 2.7X12 MM; BONE SCREW T7 2.7X12mm; BONE SCREW T7 2.7X14 MM; BONE SCREW T7 2.7X14mm; BONE SCREW T7 2.7X16 MM; BONE SCREW T7 2.7X16mm; BONE SCREW T7 2.7X18 MM; BONE SCREW T7 2.7X18mm; BONE SCREW T7 2.7X20 MM; BONE SCREW T7 2.7X20mm; BONE SCREW T7 2.7X22 MM; BONE SCREW T7 2.7X22mm; BONE SCREW T7 2.7X24 MM; BONE SCREW T7 2.7X24mm; BONE SCREW T7 2.7X26 MM; BONE SCREW T7 2.7X26mm; BONE SCREW T7 2.7X28mm; BONE SCREW T7 2.7X30mm; BONE SCREW T7 2.7X32mm; BONE SCREW T7 2.7X34mm; BONE SCREW T7 2.7X36mm; BONE SCREW T7 2.7X38mm; BONE SCREW T7 2.7X40mm; BONE SCREW T7 2.7X45mm; BONE SCREW T7 2.7X50mm; BONE SCREW T7 2.7X8mm; BROAD STRAIGHT PLATE LONG; BROAD STRAIGHT PLATE MEDIUM; BROAD STRAIGHT PLATE SHORT; BURR, ORTHOPEDIC - ForeFoot STP; Battery Pack for VariSpeed; Battery Powered ScrewDriver II; BioZip System; Bioabsorable Wedge Interference Screw System; Biosteon IntraLine System; Biosteon Wedge Interference Screw System; Bixcut, IM Reamer; Bone Plug Extractor; Bone Screw Washers; BriteField Depth Gauge; Broach and Inserter Handle; Burr Hole covers; CALCANEUS MESH PLATE LARGE; CALCANEUS MESH PLATE MEDIUM; CALCANEUS MESH PLATE, SMALL; CALCANEUS STANDARD PLATE LARGE; CALCANEUS STANDARD PLATE MEDIUM; CALCANEUS STANDARD PLATE SMALL; CANYON Retractor Systems Trays; CAPRI Corpectomy Cage System Trays; CASPIAN Spinal System Trays; CAYMAN Plate System Trays; CHESAPEAKE Stabilization System Trays; CHISELS; CLAMP; CMF MEDPOR Customize Implants; CURSOR; CURVED PLATE 4 HOLES; CURVED PLATE 5 HOLES LEFT; CURVED PLATE 5 HOLES RIGHT; CURVED PLATE 6 HOLES; CUTTING SCREWDRIVER 4.5; CYLINDRICAL BUSH HOLDER; CalcLock Extreme; CalcLock manual surgical instruments; Cannulated Countersink with AO Fitting; Cannulated Drill with AO Fitting; Cannulated Drill ø 2,7/3.5mm with AO Fitting; Cannulated Screwdriver with AO Fitting; Cannulated Screwdriver with Elastosil Handle; Cannulated Tap with AO Fitting; CapsulePass 45 Up Suture Passer; Cascadia Interbody System; Champion Slingshot; CinchLock; Colored Plugs; Counterbore Drill; Cross-Screw System; Custom Mandible Recon Plate; Cut Guide; DART-FIRE EDGE Cannulated Screws; DENALI Spinal System Trays; DEPTH GAUGE; DEPTH GAUGE (DISTAL RADIUS); DEPTH GAUGE (HAND); DISPOSABLE CEMENT SCULPS; DISSECTORS; DJD II STORAGE CASE; DORSAL SMARTLOCK  PLATE STANDARD LEFT; DORSAL SMARTLOCK  PLATE STANDARD RIGHT; DORSAL SMARTLOCK  PLATE WIDE RIGHT; DORSAL SMARTLOCK DR PLATE STANDARD LEFT X LONG; DORSAL SMARTLOCK DR PLATE STANDARD RIGHT X LONG; DORSAL SMARTLOCK DR PLATE WIDE LEFT X LONG; DORSAL SMARTLOCK DR PLATE WIDE RIGHT X LONG; DORSAL SMARTLOCK PLATE WIDE LEFT; DRILL BIT; DRILL GUIDE; DRILL GUIDE BLOCK COMPACT 4 HOLE; DRILL GUIDE BLOCK COMPACT PERI 4 HOLE; DRILL GUIDE BLOCK HII 10 HOLE; DRILL GUIDE BLOCK HII 5 HOLE; DRILL GUIDE BLOCK MONOTUBE 4 HOLE; DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE; DRILL GUIDE LOCK II 2.5; DRILL SLEEVE; DRIVER; SCREW INSERTER; DRLock Extreme; DRLock Extreme, MaxLock Extreme, MaxTorque, CalcLock, Mini MaxLock Extreme; Delta DualStart; Delta Resorbable Fixation System; Delta System; Delta Water Bath; Delta Water Bath 2; Depth Gauge; Depth Gauge (Foot/Elbow/Distal Fib); Digital Port Connector; Direct Measuring Gauge; DirectInject® Extended Cannula; DirectInject® Standard Cannula; Double Drill Guide ø 2,0/3,5mm; Drill Bit; Drill Bit ø 2,0 x 150mm; Drill Guide Non Sterile; Drill Sleeve; Dual-sided Baseplate Centering Guide; DualStart; EASY CLIP ANGLED DRILL GUIDE SIZE 15; EVEREST Spinal System Trays; Edgelock manual surgical instruments; Eikon LT SL Sterilization Tray; Eikon LT Sterilization Tray; Elastosil T-Handle with AO Coupling; Endoscopy Device; Exeter Hip System Instrumentation; Express Humeral Stem Extractor; Express Insert; Extractor Rod; Extractor for Screws; FASCIA CUTTER; FEMORAL CANAL BRUSH, STANDARD; FIXOS 4 MV DEPTH GAUGE; FLEXIBLE DEPTH GUAGE; FORCEPS; FOREFOOT SET; FUNNEL; Facet Fusion Retractor System; Facial Tissue; Farabeuf clamp; Fibula Straigh Plate Insert; Fixation Pin; Flex Shoulder System; GUIDE FOR HALF-PINS; Gamma4; Gamma4 System; Gauge, Depth; General Instruments; Glenoid pin guide; Graft box body; Graft box compression screw; Graft box locking screw; Graft box washer; Graft box wedge; Graft sizer; Guide Wire; Guide Wire Pusher; Guide Wire Ruler; Guide Wire Targeter; Guide Wire Targeter - Crown; Guide Wire Targeter - Sleeve; Guide Wire, Threaded; H-PLATE LARGE; H-PLATE MEDIUM; H-PLATE SMALL; HENNING; HII 7mm T-WRENCH / 5+6mm SOCKET; HII COMPACT 5mm WRENCH/3&4mm SOCKET; HII COMPACT GUIDE BLOCK W/AO; HII COMPACT MRI STORAGE CASE BASE; HII COMPACT MRI STORAGE CASE LID; HII COMPACT MRI STORAGE CASE UPPER INSERT; HII COMPACT STORAGE CASE BASE; HII COMPACT STORAGE CASE LID; HII COMPACT STORAGE CASE UPPER INSERT; HII MICRO 2mm PIN DRIVER; HII MICRO DRILL GUIDE ASSEMBLY; HII MICRO NUT DRIVER; HII MICRO STORAGE CASE BASE; HII MICRO STORAGE CASE DRILL BIT HOLDER; HII MICRO STORAGE CASE LID; HII MICRO STORAGE CASE LOWER INSERT; HII MICRO STORAGE CASE UPPER INSERT; HII MRI TRAY BASE; HII MRI TRAY LID; HII MRI TRAY LOWER INSERT; HII TRAY BASE; HII TRAY LID; HII TRAY LOWER INSERT; HII TRAY UPPER INSERT; HLS KNEETEC; HLS UNI EVOLUTION; HM MINI 4 SPANNER WRENCH; HOFFMAN II MICRO EXTERNAL FIXATION; HOFFMANN LRF INFO BOARD; HOFFMANN LRF INSTRUMENTS AND IMPLANTS INSERT; HOFFMANN LRF INSTRUMENTS AND IMPLANTS TRAY; HOFFMANN LRF RATCHET WRENCH - HEX 10; HOFFMANN LRF SPANNER WRENCH - 5 mm; HOFFMANN LRF SPANNER WRENCH - 7/10 mm; HOFFMANN LRF TELES. STRUT WRENCH; HOFFMANN LRF THUMBWHEEL - HEX 10; HOFFMANN LRF THUMBWHEEL FOR TELESCOPIC STRUTS; HOFFMANN LRF UNIVERSAL COMPONENTS INSERT; HOFFMANN LRF UNIVERSAL COMPONENTS TRAY; HOFFMANN LRF WIRE BOLT WRENCH; HOFFMANN LRF WIRE TENS. NOSE - LONG; HOFFMANN LRF WIRE TENS. NOSE - SHORT; HOFFMANN LRF WIRE TENSIONER; HOFFMANN XPRESS SILICON MAT; HOFFMANN XPRESS SILICON THUMBWHEEL; HOFFMANN XPRESS SPANNER WRENCH; HOFFMANN XPRESS STORAGE CASE BASE; HOFFMANN XPRESS STORAGE CASE INSERT; HOFFMANN XPRESS STORAGE CASE LID; HOFFMANN XPRESS TORQUE WRENCH; HOFFMANN3 TRAY FOR STANDARD COMPOMENTS; HOLDING SPANNER 4.5; HOWMEDICA MIX KIT I TM 10PK; HeartSine Gateway; HexStar; Hoffmann LRF; Hoffmann LRF System, Insert; Hoffmann LRF System, Instrument; Hoffmann LRF System, Ruler; Hoffmann LRF System, Wire Tensioner; Hoffmann LRF System, Wrench; Holding Sleeve; Humeral Express Tray; Hybrid MMF Spacer; Hybrid Tip Pointer; HydroSet; ICONIX All Suture Anchor System; IMN Instruments Percutaneous guide wire inserter; IMN Instruments Self-Holding Screwdriver T20; INBONE; INCLINED DRILL GUIDE SCREW EZ18; INCLINED DRILLING GUIDE + SCREW EZ20; INFINITY; INSTRUMENT TRAY; INSTRUMENT TRAY BASE 4.5; INSTRUMENT TRAY LID FIXOS; INTERMEDIATE PROSTHESIS HOLDER LEFT; INTERMEDIATE PROSTHESIS HOLDER RIGHT; INTRAMEDULLARY BRUSH STANDARD 14MM OD; Injector; Insertion Sleeve for Guide Wire; Instrument Guides; Inter-Lock System; Intraosseous Fixation System; Intraosseous Fixation system manual surgical instruments; Invuity BriteField Port Access System; Invuity Rotator Cuff Retractor System; JA FANTOME CALOTTE; Jaw Clamp Large Offset Curved; Jaw Clamp Large offset Straight; Jaw Clamp Std Long; Jaw Clamp Std Short; Jaw Clamp offset Overbite; Jaw Clamp offset Underbite; Jaw Clamp, Curved Offs. Counterclockwise; Jaw Clamp, Overbite Counterclockwise; Jaw Clamp, Std Offset Counterclockwise; Jaw Clamp, Std Short Counterclockwise; Jaw Clamp, Std, Long Counterclockwise; Jaw Clamp, Underbite Counterclockwise,; Jungbluth Clamp, Narrow; Jungbluth Clamp, Wide; K-TEK BASIC CLAMP, EU/UK; K-TEK BASIC CLAMP, US; K-TEK SELECT BLADE CLAMP, EU; K-WIRE 1X160mm (PACK OF 10); K-WIRE FULLY THREADED 1.6mm X 200mm; K-WIRE SMOOTH 1.4mm X 100mm; K-WIRE W/ 17mm STOP; K2M General Instruments; KIT; KTEK ROUND POST CLAMP, US; KTEK SELECT BLADE CLAMP, US; KW BENDING IRON ICS; Kit Suture Menisical Henning; Knifelight; Knotilus+ 2.4X11.3mm Drill, Hard Bone; Knotilus+ 2.4x11.3mm Drill; Knotilus+ 2.4x8.9mm Drill, Hard Bone, Hip; Knotilus+ 2.4x8.9mm Drill, Hip; Knotilus+ 2.9x12.5mm Drill; Knotilus+ 2.9x12.5mm Drill, Hard Bone; Knotilus+ 2.9x12.5mm Drill, Hard Bone, Hip; Knotilus+ 2.9x12.5mm Drill, Hip; Knotilus+ 2.9x15.5mm Drill; Knotilus+ 2.9x15.5mm Drill, Hard Bone; Knotilus+ Crown Tip Guide; Knotilus+ Crown Tip Guide, Hip; Knotilus+ Fishmouth Tip Guide; Knotilus+ Fork Tip Guide, Hip; Knotilus+ Offset Tip Guide; L PROFYLE HAND COMP L-PLATE,LE,6H; L PROFYLE HAND COMP L-PLATE,RI,6H; L PROFYLE HAND COMP PLATE,STRAI,BAR,4H; L PROFYLE HAND COMP PLATE,STRAI,BAR,5H; L PROFYLE HAND COMP PLATE,STRAI,BAR,6H; L PROFYLE HAND COMP PLATE,STRAI,BAR,8H; L PROFYLE HAND COMP T-PLATE,6H; L PROFYLE HAND COMP T-PLATE,NAR,10H",1986-06-09,122,2026-07-31,2,8,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228010177%22&limit=1
LBN Medical A/S,3009196578,3009196578,Gugvej 70,Aalborg Nordjylland,,9210,Denmark,LBN Medical ApS,10055731,Exporter to the US,24,DXT; DZE; FCG; ITX; IYN; IYO; IZH; JAA; JAK; KPS; LLZ; LNH; LNI; MOS; MUE; MUH; NHA; OAS; OBJ; OIJ; OTE; OWB; OXO; QIH,"Injector And Syringe, Angiographic; Implant, Endosseous, Root-Form; Biopsy Needle; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Mammographic; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Tomography, Computed; System, Tomography, Computed, Emission; System, Image Processing, Radiological; System, Nuclear Magnetic Resonance Imaging; System, Nuclear Magnetic Resonance Spectroscopic; Coil, Magnetic Resonance, Specialty; Full Field Digital, System, X-Ray, Mammographic; System, X-Ray, Extraoral Source, Digital; Abutment, Implant, Dental, Endosseous; X-Ray, Tomography, Computed, Dental; Catheter, Ultrasound, Intravascular; Biopsy Needle Guide Kit; Digital Breast Tomosynthesis; Interventional Fluoroscopic X-Ray System; Image-Intensified Fluoroscopic X-Ray System, Mobile; Automated Radiological Image Processing Software",2; 3,"Acuson Probe 9L4 S2000/SC2000; Acuson Probe EC9-4 vaginal; Acuson Probe EV8C4; Acuson Probe V5M; Acuson TEE Probe V7M; Acuson probe 4V1C; Aquilion Prime; Arcadis Varic; BK MEDICAL 8818; BK Medical 8809; BK Medical 8823; BK Medical 8870; BK Medical Flex Focus 400; Canon Aplio i700; Canon Aplio i800; Canon Aquilion One; Canon PLT-1202BT; Canon PVI-475BX; Canon PVT-382MV; Canon PVT-712BT; Canon Vantage Elan 1.5T; D2CWC; Esaote G-scan Brio 0.25T; GE 10C-SC; GE 12S-D; GE 3SP-D; GE 6VT-D probe Vivid E9; GE 8C; GE 9L-D; GE Brightspeed 16; GE C1-5-RS; GE C1-6D; GE C16-D probe E9 XD clear; GE C2-7D probe; GE C2-9D; GE C2-9VN-D; GE Discovery 710; GE E8C-RS probe; GE E8C-RS transducer; GE HDXT Signa 1,5T; GE HDxT 1.5T MRI; GE IC5-9D; GE IC9-RS; GE L10-22-RS; GE L2-9D; GE L4-12T-RS; GE L8-18I-D; GE L8-18I-D probe; GE L8-18I-SC; GE LightSpeed 16; GE Logiq S8; GE M5SC-RS; GE ML6-15-D; GE OEC 9800 C-ARM; GE OEC 9900 Elite; GE Optima 660; GE Optima CT580; GE Optima MR450W; GE Probe 12L-RS; GE Probe 3S; GE Probe 4C-RS convex; GE Probe 4C-SC 1.8-5 MHz; GE Probe 4V-D 4D sector; GE Probe 4VC-D; GE Probe 8C; GE Probe 8C-rs; GE Probe BE9CS-D; GE Probe L3-12-D; GE Probe P2D CW Doppler; GE Probe RAB6-RS; GE Probe RIC5-9A-RS; GE Probe RIC5-9D; GE Probe RIC5-9H 4D vaginal; GE RAB4-8L probe; GE RAB6-D; GE RAB6-RS; GE RIC5-9-H probe; GE RIC5-9W-RS probe; GE RIC6-12D; GE Revolution EVO; GE S6S-RS transducer; GE TE 100024 probe; GE Vivid I Portable; GE Vivid IQ; GE Vivid S70; GE probe 4C; GE probe L8-18i-D intraoper; GE probe S1-5; Hitachi 14-6 Probe; Hitachi L441 ultrasound transducer; Hologic 3Dimensions; Hologic Afirm Prone Biopsy Table; Hologic Selenia Dimensions 2D; Hologic Selenia Dimensions 3000 2D; Hologic Selenia Dimensions 3D; Hologic Selenia Dimensions 5000; Hologic Selenia Dimensions 5000 3D; Hologic Selenia Dimensions 8000; Hologic Selenia Dimensions 8000 3D; Hologic Selenia Dimensions 8000 TOMO; Hologic Selenia Dimensions TOMO; Hologic Selenia Dimensions TOMO 3D; L8-3 freesyle; Logiq Fortis; Medrad Stellant Dual Injector; PHILIPS C10-3V; PHILIPS C5-1; PHILIPS EL18-4; PHILIPS L12-3; PHILIPS L12-5; PHILIPS S5-1; PHILIPS X5-1; Philips 3D9-3V for Clearvue; Philips Brightview XCT; Philips CX50; Philips D2cwc; Philips Epiq 7C; Philips Epiq CVx ultrasound; Philips L12-3; Philips Probe 3D9-3V for Epiq; Philips Probe 3D9-3V for IU22; Philips Probe BP10-5EC; Philips Probe C10-4EC; Philips Probe C6-2 for Affinit; Philips Probe C8-5 microconvex; Philips Probe C9-2 for Epiq; Philips Probe L15-7IO for Epiq; Philips Probe L18-5 for Epiq; Philips Probe S12-4 for Epiq; Philips Probe VL13-5; Philips Probe X7-2 for Epiq; Philips S7-3T transducer; Philips X5-1C; Philips X7-2T; Philips XL14-3; Philips probe C10-3V Epiq; Philips probe C5-1 for Epiq 7; Philips probe C8-5 for Epiq; Philips probe L12-3 for Epiq 5; Philips probe L12-3 for Epiq 7; Philips probe L17-5 for IU22; Philips probe V6-2 for Epiq; SAMSUNG V5-9; Samsung CA2-9AD probe; Samsung CA3-10A; Samsung LA4-18B probe; Samsung V8 Ulstrasound; Siemens 10EV3; Siemens 10L4; Siemens 11M3; Siemens 12L3; Siemens 12L4; Siemens 14L5; Siemens 15L4 For Sequoia; Siemens 16L4; Siemens 18H6; Siemens 18L6; Siemens 4C1; Siemens 4V1C; Siemens 5C1; Siemens 5P1; Siemens 6C1 HD; Siemens 6C2; Siemens 8V3; Siemens 9C2; Siemens 9EC4; Siemens 9L4; Siemens Acuson Redwood; Siemens CT Force; Siemens EC9-4; Siemens EC9-4W for X600/X700; Siemens MC9-4; Siemens Magnetom Aera 1.5T; Siemens Magnetom Verio 3T; Siemens Probe VF12-4 for X700; Siemens Somatom Drive; Siemens Somatom Go.Now; Siemens probe 6C1 HD for S2000; Sonosite Convex probe C60; Sonosite M-Turbo Portable; Sonosite MicroMaxx; Sonosite Probe HFL 38; Sonosite Probe L38; Supersonic SL10-2; TEK Medical Systems LLC, DBA All Imaging Systems; Terason 15L4; Toshiba Probe PLT-1204BT; Toshiba Probe PLT-1204BX; Toshiba Probe PLT-805AT; Toshiba Probe PST-25BT; Toshiba Probe PVT-375BT; Toshiba Probe PVT-661VT; Toshiba Probe PVT-781VT; XW8000 Workstation; Ziehm Vision RFD",2017-09-27,121,2025-11-24,2,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009196578%22&limit=1
"Bard Peripheral Vascular, Inc.",2020394,2020394,1625 W 3rd St,Tempe,AZ,85281,United States,"C. R. Bard, Inc.",2212754,Complaint file establishment; Contract manufacturer; Manufacturer; Specification developer,48,DQX; DQY; DSW; DSY; DTK; DWF; DWP; DWS; DXT; DXZ; DYB; DYF; FCG; FGE; FMI; FSH; FZP; GAA; GDF; GDW; GEI; ITX; IWJ; IZD; KCT; KNW; KRD; KXK; LIT; MAV; MCW; MIR; MMX; MSD; MZY; NEU; NIO; NIP; OMZ; OZT; PDU; PFV; PNG; PNO; PQK; PRL; QAN; QEW,"Wire, Guide, Catheter; Catheter, Percutaneous; Bag, Polymeric Mesh, Pacemaker; Prosthesis, Vascular Graft, Of 6mm And Greater Diameter; Filter, Intravascular, Cardiovascular; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Dilator, Vessel, Surgical; Instruments, Surgical, Cardiovascular; Injector And Syringe, Angiographic; Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene; Introducer, Catheter; Prosthesis, Vascular Graft, Of Less Then 6mm Diameter; Biopsy Needle; Stents, Drains And Dilators For The Biliary Ducts; Needle, Hypodermic, Single Lumen; Tray, Surgical, Needle; Clip, Implantable; Needle, Aspiration And Injection, Disposable; Guide, Needle, Surgical; Staple, Implantable; Electrosurgical, Cutting & Coagulation & Accessories; Transducer, Ultrasonic, Diagnostic; System, Applicator, Radionuclide, Manual; Probe, Uptake, Nuclear; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Instrument, Biopsy; Device, Vascular, For Promoting Embolization; Source, Brachytherapy, Radionuclide; Catheter, Angioplasty, Peripheral, Transluminal; Syringe, Balloon Inflation; Catheter, Peripheral, Atherectomy; Shunt, Portosystemic, Endoprosthesis; Device, Percutaneous Retrieval; Catheter, Hemodialysis, Implanted; Graft, Vascular, Stainless Steel Tunneler; Marker, Radiographic, Implantable; Stent, Iliac; Stent, Superficial Femoral Artery; Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter; Balloon Aortic Valvuloplasty; Catheter For Crossing Total Occlusions; System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Catheter, Percutaneous, Cutting/Scoring; Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access; Iliac Covered Stent, Arterial; Stent, Iliac Vein; Peripheral Mechanical Thrombectomy With Aspiration",1; 2; 3,"125 Implant Seeds; Arteriovenous (AV) Sheath Tunneler; Arteriovenous (AV) Sheath Tunneler Sterilization Cassette; Aspirex Thrombectomy System; Atlas Gold PTA Dilatation Catheter; Atlas PTA Balloon Dilatation Catheter; BD EleVation Breast Biopsy System; BD Trek™ Bone Lesion Biopsy System; BD Trek™ Bone Marrow Biopsy System; BD Trek™ Power Driver; BD Trek™ Sterile Sleeve; Bard Brener Carotid Bypass Shunt; Bard Burbank Carotid Bypass Shunt; Bard Carotid Bypass Shunt; Bard Javid Carotid Bypass Shunt; Bard Magnum Reusable Core Biopsy Instrument; Bard Max-Core Disposable Core Biopsy Instrument; Bard Mission Disposable Core Biopsy Instrument; Bard Mission Disposable Core Biopsy Instrument Kit; Bard Monopty Disposable Core Biopsy Instrument; Bard PTFE Braided Tape; Bard PTFE Felt Pledget; Bard PTFE Thick Felt Pledget; Bard Parsonnet Pulse Generator; Bard Sauvage Filamentous Fabric; Bard TruGuide Disposable Coaxial Biopsy Needles; BrachySource Seed Implants; BrachyStar Brachytherapy Needles; BrachyStar Needles; Brachysource Seed Implants with Sourcecap Bioabsorbable Caps; Caterpillar Arterial Embolization Device; Caterpillar Micro Arterial Embolization Device; Chiba Fine Needle Aspiration Device; Conquest 40 PTA Dilatation Catheter; Conquest PTA Dilatation Catheter; Covera Vascular Covered Stent; Crosser CTO Recanalization Catheter; Crosser CTO Recanalization Catheters 14S, S6; Crosser Generator; Crosser iQ CTO Recanalization System; Denali Vena Cava Filter, Femoral Delivery Kit; Denali Vena Cava Filter, Jugular/Subclavian Delivery Kit; Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit; Distaflo Bypass Graft; Dorado PTA Balloon Catheter; Dorado PTA Dilatation Catheter; DuaLok Breast Lesion Localization Wire; Dynaflo Bypass Grafts; E-LUMINEXX Biliary Stent System; E-Luminexx Vascular Stent System; ESU-1 Electrosurgical Generator; Economy Illinois Sternal/lliac Bone Marrow Aspiration Tray; Economy Soft Tissue Biopsy Tray; EnCor Breast Biopsy Probe with Rinse Tube – 10G; EnCor Breast Biopsy Probe with Rinse Tube – 10G Vertical; EnCor Breast Biopsy Probe with Rinse Tube – 12G; EnCor Breast Biopsy Probe with Rinse Tube – 12G Vertical; EnCor Breast Biopsy Probe with Rinse Tube – 7G; EnCor Breast Biopsy Probe with Rinse Tube – 7G Vertical; EnCor Breast Biopsy System; EnCor Breast Biopsy System - EnCor Probes, Drivers, and Accessories; EnCor Breast Biopsy System – Accessories; EnCor EnCompass Breast Biopsy and Tissue Removal System; EnCor Encompass VisiLoc MRI Introducer Set; EnCor Enspire Breast Biopsy System and Accessories; EnCor Probe; EnCor Probe Introducer; EnCor Ultra Breast Biopsy System and Accessories; EnCor Ultrasound Stylet and Coaxial; EnCor VisiLoc MRI Introducer Set; Finesse Ultra Breast Biopsy System Driver; Flair Endovascular Stent Graft; FlowMate Injector; Fluency Plus Endovascular Stent Graft; Franseen FNA Needle; Gamma Finder, Sterile Sleeve; Gel Mark Ultra Biopsy Site Markers; Gel Mark UltraCor Biopsy Site Markers; Ghiatas Beaded Breast Localization Wire; GlidePath 7.5F Long-Term Hemodialysis Catheter; GlidePath Retro Long Term Hemodialysis Catheter; GlidePath™ 10F Long Term Dialysis Catheter; GlidePath™ 13F Long Term Hemodialysis Catheter; GlidePath™ Long Term Hemodialysis Catheter; Handheld Gamma Finder; HemoStar XK™ Long Term Hemodialysis Catheter; HemoStar™ Long Term Hemodialysis Catheter; Highlander 014 PTA Balloon Dilatation Catheter; IMPRA Carboflo ePTFE Vascular Grafts; Illinois Bone Marrow Aspiration Needle; Illinois Bone Marrow Aspiration Tray; Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle; Instrument, biopsy; Jamshidi Bone Marrow Biopsy and Aspiration Tray; Jamshidi Bone Marrow Biopsy/Aspiration Needle; Jamshidi Evolve Bone Marrow Biopsy and Aspiration Trays; Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle; Jamshidi Menghini Soft Tissue Biopsy Needle/Syringe; Jamshidi Menghini Soft Tissue Biopsy Tray; Kelly-Wick AV Access Tunneler; LifeStar Biliary Stent System; LifeStar Vascular Stent System; LifeStent 5F Vascular Stent System; LifeStent Biliary Stent System; LifeStent XL Biliary Stent System; LifeStream Balloon Expandable Vascular Covered Stent; Lifestent Solo Vascular Stent System; Lifestent XL Biliary Stent System; Lifestent and Lifestent XL Vascular Stent System; Liverty TIPS Stent Graft; Liverty™ TIPS Access Set; Low Porosity PTFE Felt; Magnum Core Biopsy Needles; Marker (Ribbon); Marquee™ Disposable Core Biopsy Instrument; Marquee™ Disposable Core Biopsy Instrument Kit; PT Stepper; PTFE Felt; PTFE Felt (Thick); Palladium-103 Seed Implant Kits; Parsonnet Vascular Probe; Peripheral Vascular (PV) Sheath; PeritX™ 2L Drainage Kit; PeritX™ 2L Drainage Starter Pack; PeritX™ 2L Drainage Starter Tote; PeritX™ Peritoneal Catheter System; Pouch (Small, Large, X-Large); Presto Inflation Device; Pristine™ Long Term Hemodialysis Catheter; Prosthesis; QuickLink Delivery System; QuickLink Loader; QuickLink Relay System; ReadyLink Delivery System; Recon Support Catheter; Recovery Cone Removal System; Rotarex Atherectomy System; Rotarex S; Safe-T PLUS Tray; Safe-T PLUS Trays; Safety Soft Tissue Biopsy Tray; Seedlinks; Seeker Crossing Support Catheter; SenoMark Biopsy Site Markers; SenoMark Ultra Breast Tissue Marker; SenoMark UltraCor Breast Tissue Marker; SenoMark UltraCor MRI Biopsy Site Markers; Sidekick Support Catheter; Simon Nitinol Vena Cava Filter; Soft Tissue Biopsy Drug Free Tray; Soft Tissue Biopsy Tray; SourceLink Brachytherapy Seeding; SourceLink Connectors; SourceLink Loader; SourceLink Spacers; Spacer Links; Stabilization System; Starchmark Breast Tissue Marker; Starchmark UltraCor Breast Tissue Marker; Straub Endovascular System; SurePoint Stepping and Stabilization System; SurePoint Tracker Stepping and; Surepoint PT Stepper; T-Handle Illinois Bone Marrow Aspiration Needle; T-Handle Illinois Bone Marrow Aspiration Tray; T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Trays; T-Handle Jamshidi Bone Marrow Biopsy/Aspiration Needle; Tissue Marker (Wing and Coil); TruGuide Coaxial Biopsy Needles; True BAV BAlloon Valvuloplasty Catheter; True Dilatation Balloon Valvuloplasty Catheter; True Flow Valvulplasty Perfusion Catheter; Tunneler; Tunneler Sterilization Cassette; UltraClip Dual Trigger Breast; UltraClip Dual Trigger Tissue; UltraClip II MR Tissue Marker; UltraClip II Tissue Marker; UltraClip II Tissue Marker Coil; UltraClip II Tissue Marker Wing and; UltraClip II US Tissue Marker; UltraCor Biopsy Site Markers; UltraCor Twirl Breast Tissue Marker; UltraScore Focused Force PTA Balloon; Ultraverse 014 and 018 PTA Balloon Dilatation Catheters; Ultraverse 035 PTA Balloon Dilatation Catheter; Ultraverse RX PTA Balloon Dilatation Catheter; Usher Support Catheter; Vaccess PTA Dilatation Catheter; Vacora Vacuum Assisted Biopsy Sys; Valeo Biliary Stent; Vascular Graft of less than 6mm; Vascutrak PTA Dilatation Catheter; Venaflo II Bypass Graft; Venclose EVSRF Catheter; Venclose Foot Pedal; Venclose Maven Catheter; Venclose Maven Perforator Catheter; Venclose Maven Perforator RF Catheter; Venclose Maven System; Venclose Power Cord; Venclose RF Ablation Catheter; Venclose System; Venclose digiRF Generator; Venovo Venous Stent System; Vida BAV Balloon Valvuloplasty Catheter; Vida PTV Dilatation Catheter; WavelinQ EndoAVF System; WavelinQ Generator; brachytherapy seed implant needles; ePTFE Cardiovascular Patch",1998-03-19,115,2026-08-14,7,68,2,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222020394%22&limit=1
Respironics Inc.,2518422,2518422,1001 Murry Ridge Lane,Murrysville,PA,15668,United States,Philips Medical Systems International BV,2518422,Complaint file establishment; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,43,BTI; BTK; BTT; BWF; BYE; BYG; BYH; BYP; BYT; BYX; BZC; BZD; BZE; BZG; BZH; BZO; BZQ; CAE; CAF; CAI; CAW; CBK; CCK; DQA; DRX; FLL; FMP; FOX; GWQ; HCC; LRK; MNR; MNS; MNT; MQM; MYB; NHJ; NOU; NVP; OLV; OLZ; OUG; SDT,"Compressor, Air, Portable; Strap, Head, Gas Mask; Humidifier, Respiratory Gas, (Direct Patient Interface); Spirometer, Therapeutic (Incentive); Attachment, Breathing, Positive End Expiratory Pressure; Mask, Oxygen; Drain, Tee (Water Trap); Mouthpiece, Breathing; Ventilator, External Body, Negative Pressure, Adult (Cuirass); Tubing, Pressure And Accessories; Calculator, Pulmonary Function Data; Ventilator, Non-Continuous (Respirator); Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer; Spirometer, Diagnostic; Meter, Peak Flow, Spirometry; Set, Tubing And Support, Ventilator (W Harness); Monitor, Breathing Frequency; Airway, Oropharyngeal, Anesthesiology; Nebulizer (Direct Patient Interface); Circuit, Breathing (W Connector, Adaptor, Y Piece); Generator, Oxygen, Portable; Ventilator, Continuous, Facility Use; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Oximeter; Electrode, Electrocardiograph; Continuous Measurement Thermometer; Protector, Skin Pressure; Stand, Infusion; Full-Montage Standard Electroencephalograph; Device, Biofeedback; Device, Anti-Snoring; Ventilatory Effort Recorder; Ventilator, Continuous, Non-Life-Supporting; Continuous, Minimal Ventilatory Support, Facility Use Ventilator; Bilirubin (Total And Unbound) In The Neonate Test System; Pillow, Cervical (For Mild Sleep Apnea); Device, Positive Pressure Breathing, Intermittent; Continuous, Ventilator, Home Use; Holding Chambers, Direct Patient Interface; Standard Polysomnograph With Electroencephalograph; Automatic Event Detection Software For Polysomnograph With Electroencephalograph; Medical Device Data System; Intra-Pulmonary Percussive Vibration (Ipv) Devices",1; 2,"12/24V Battery Cable w/terminals or adapter; 920 & 920M Handheld Pulse Oximeter; 920M Plus Pulse Oximeter; A30 Heated Humidifier; A40 Heated Humidifier; AF421 FFM; AF531 FFM; AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask; AF531 Oro-Nasal SE Face Mask; AF531 SE Full Face Mask; AF541 EE Leak 1 Full Face Mask; AF541 EE Leak 2 Full Face Mask; AF541 FFM; AF541 SE Full Face Mask; AF811 FFM; AOM (RIMR); AP111 Nasal Mask; Actiwatch Score; Adam Shell Thermocouple Assembly; Alice 6 Headbox LDE; Alice 6 PSG Base Station LDE; Alice NightOne; Alice PDX; Alice PSG or components; Altis Full Face Mask; Amara View SE FFM; Assess Low Range Peak Flow Meter; Asthma Check; Asthma Mentor; BiPAP A30 Ventilatory Support System; BiPAP A40 Ventilatory Support System; BiPAP AVAPS or S/T C-Series; BiPAP AVAPS ventilatory support system; BiPAP Q-Series; BiPAP Q-Series w/HT; BiPAP S/T ventilatory support system; BiPAP V30 Auto; BiPAP Vision; BiPAP autoSV Advanced; BiliChek; Body Position Sensor; Bronchoscopy Elbow; Bronchoscopy Elbow, Click Style; Bronchoscopy elbow; CPAP VALVES; Cannula Style Thermocouples; Care Orchestrator; Care Orchestrator Essence; Care Orchestrator Essence 4.3 USB Release; Care Orchestrator Essence, Japan; Chest Shell and components; Chin Strap; Comfort Gel Blue Nasal Mask; ComfortGel Blue FFM; ComfortGel Blue SE FFM; Cough Assist T70; CoughAssist; Crystal Trace Piezo Sensor; DirectView Data Management System; Disposable 15 mm non-heated passive and heated active circuits; Disposable 15mm MPV circuit; Disposable 22mm non-heated passive and heated active circuits; Disposable Adult/Ped Heated Active Circuit; Disposable Adult/Ped Heated Passive Circuit; Disposable Angled Mouthpiece; Disposable Swivel Passive Exhalation Port; Disposable/FEP/Invasive Circuits; Dorma CPAP; Drain, Tee (water trap); DreamMapper; DreamStation 2 Roll Stand – RIST; DreamStation BiPAP AVAPS w/ & w/o Humidifier; DreamStation BiPAP Auto w/ & w/o Humidifier; DreamStation BiPAP Pro w/ & w/o Humidifier; DreamStation BiPAP S/T w/ & w/o Humidifier; DreamStation BiPAP autoSV w/ & w/o Humidifier; DreamStation CPAP Assist; DreamStation CPAP w/ & w/o Humidifier; DreamStation Cellular Modem (RIST); DreamStation Go Auto CPAP; DreamStation Go CPAP; DreamStation Link Module (RIST); DreamStation Roll Stand - RIST; DreamStation Wi-Fi Accessory (RIST); DreamWear Full Mask; DreamWear Nasal Mask; DreamWisp Nasal Mask; Dreamstation 2 Advanced System; Dreamstation 2 System; Dreamstation CPAP Auto w/ & w/o Humidifier; Dreamstation CPAP Pro w/ & w/o Humidifier; Dreamstation GO w/ & w/o Humidifier; Dreamwear Silicone Pillows Mask; Dual Limb Active Exhalation Valve; ECG electrode; ECG wireset; EZ-1 System Resp Sensor/ZRIP; Encore Anywhere; Encore/Encore Pro Data Management System; EncoreAnywhere; EverFlo; EverFlo Quiet; Everflo Ultrafill; Everflo/Everflo Q/L4; External Flow Sensor Assembly Adult/Pediatric OR Pediatric/Infant; FFM; Flex Trach Adaptor 15 cm, 22M/15F-15F; Flex Trach Adaptor 15 cm, 22M/15F-22F; FloTrak CO2 Sensor; Flow Sensor; Garbin Plus Ventilator BT; Garbin Ventilator BT; HL7 Interface Utility (RIMR); Headgear; Heated Humidifier - HC100; Heated Humidifier - HC500; Heated Humidifier - MR410; Heated Humidifier - MR850; I-Neb AAD Nebulizer w/Insight SW or Components; I-neb TIM/General Purpose; Innospire Elegance; Innospire Essence; Innospire Mini; LDx; LDxN; LDxS; LiquiCell CPAP Cushions; LiteTouch Mask; Low Range Cabinet Flow Meter; Masimo MS Series; Masimo Oximetry Kit; Millenium M10; Millennium Transfill; Mouthpiece Straight; Mouthpiece, Angled; Multiple - Invasive; NightBalance; Nonin Finger Oximeter; Nonin Handheld; Nonin Oximetry Kit; Nonin Wrist Ox; Nuance and Nuance Pro Nasal Pillow Mask; Nurse Call Adaptor Cable – Alarm Open/Closed; Nurse Call Rj9 Adapter Cable Open; OMNILAB DIRECT; OPI & non-OPI; OPI and non-OPI; Omnilab Advanced/Advanced +; Omnilab Conncect (RIMR); Omnilab Direct; Opti Chamber Valved Holding Chamber; OptiChamber Diamond with Lite Touch mask; Optilife Nasal Mask; Oxygen Manifold Kit; PAM-RL; PC Direct; PLM Sensor; PLV-102 & 102b; PN841 Nasal Mask; PN841 SE Nasal Mask; PR1 Wired/Wireless Modems (RIST); PTAF 2, 3, Lite; PTrak FFM; Passover Humidifier; Patient Circuits; Payer Integration Software (RIMR); Peak Flow Meter; PerforMax Pediatric EE Total FFM - Leak 1 and 2; Performance Tubing; Performance Tubing 6'; Performax FitLife SE Total Face Mask; Performax Pediatric SE Total FFM; Performax, FitLife EE Total Face Mask; Personal Best Low Range Peak Flow Meter; Pico SE Nasal Mask; Pressure Transducer Airflow Sensor (PTAF); Pressure Valve; Pro-Flow and Pro-Flow Plus Cannula Sensors; Pro-flow multi-purpose nasal cannula; ProChamber Valved Holding Chamber; Quantum Respiratory Effort Sensor; REMStar SE CPAP; REMstar Auto A-flex HT (Q-series); REMstar Auto w/C-Flex & Heated Humi; REMstar Heated Humidifier; REMstar Plus CPAP; REMstar Pro w C Flex CPAP System; REMstar Q-Series CPAP; REMstar Q-series CPAP w/HT; REMstar SE CPAP; REMstar/BiPAP Q-Series w/HT; RUSleeping; Remote Alarm; Respironics Disposable Heated Wire Circuits; Reusable Mouthpiece; Roll Stand, BiPAP A-series – RIMR; Roll Stand, OmniLab Advanced + - RIMR; S/M/L/MW Dreamwear Full Med Frm w/HGR; SIDESTREAM TUCKER THE TURTLE MASK, SYSTEM 22 PAEDIATRIC MASK; SM Child  Nasal Mask; SPRS-2 Roll Stand, H-111 cm, EV300 Mount; Shimmer Full Face Mask; Sidestream Disposable Neb and Masks; Sidestream Plus Adult Mask; Sidestream Plus Nebulizer; Sidestream Plus Pediatric Mask; Sidestream Reusable Neb and Masks; Simply Clear; SimplyFlo POC; SimplyGo Mini POC; SimplyGo POC; Sleepmapper (RIMR); Sleepware; Sleepware G3; Sleepware G3, Event Detection Software; SmartSleep, Deep Sleep Headband; SnoreSilencer; Snoring Microphone; Spectrum; Stardust 2; Stardust I, II; System 22 Aerosol Mask; System One BiPAP w/ & w/o Humidifier; Therapy Mask 3100 NC/SP; Thermistor Cannula Style; Threshold IMT; Threshold Pep; Total Face Mask; Transfill; Trilogy 100 BT International; Trilogy 100 Ventilator; Trilogy 100 Ventilator BT, U.S.; Trilogy 200 BT International; Trilogy 200 Ventilator; Trilogy 200 Ventilator BT, U.S.; Trilogy 202 Ventilator; Trilogy EC Ventilator; Trilogy EV300; Trilogy Evo Mounting Bracket - RIMR; Trilogy Evo Roll Stand – RIMR; Trilogy Evo Universal Ventilator; Trilogy Evo Ventilator; Trilogy Evo Wheelchair Mount – RIMR; Trilogy Nurse Call Adaptor Cable; TrueBlue Nasal Mask; Ultrafill Quiet; Universal Battery Pack (UBP2); V60 Ventilator; V60 with PPV and Auto-Trak +; Vitalsense; Whisper Swivel II; WhisperFlow Procedure Packs; Wisp Nasal Mask; Wisp Pediatric Nasal Mask; Wisp Pediatric Nasal Mask SE Elbow Accessory; Wisp SE Nasal Mask; Wisp Youth Nasal Mask",1992-07-08,122,2026-09-25,0,65,30,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222518422%22&limit=1
Straumann Villeret SA,9614404,3002807318,Les Champs Du Clos 2,VILLERET Bern,,CH-2613,Switzerland,INSTITUT STRAUMANN AG,9005052,Manufacturer,15,DZE; DZI; DZL; EHO; EJL; EJX; EME; EMH; EMM; KCT; KCZ; NDP; NHA; OAT; PNP,"Implant, Endosseous, Root-Form; Drill, Bone, Powered; Screw, Fixation, Intraosseous; Bar, Preformed; Bur, Dental; Anchor, Preformed; Punch, Biopsy, Surgical; Forceps, Rongeur, Surgical; Chisel, Osteotome, Surgical; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Prosthesis, Breast, External, Used With Adhesive; Accessories, Implant, Dental, Endosseous; Abutment, Implant, Dental, Endosseous; Implant, Endosseous, Orthodontic; Dental Abutment Design Software For Dental Laboratory",1; 2,"033.530S Standard TL, RN, Ø4.1mm, SLActive 6mm, TiZr; 033.531S Standard TL, RN, Ø4.1mm, SLActive 8mm, TiZr; 033.532S Standard TL, RN, Ø4.1mm, SLActive 10mm, TiZr; 033.533S Standard TL, RN, Ø4.1mm, SLActive 12mm, TiZr; 033.534S Standard TL, RN, Ø4.1mm, SLActive 14mm, TiZr; 033.535S Standard TL, RN, Ø4.1mm, SLActive 16mm, TiZr; 033.560S Standard Plus TL, RN, Ø4.1mm, SLActive 6mm, TiZr; 033.561S Standard Plus TL, RN, Ø4.1mm, SLActive 8mm, TiZr; 033.562S Standard Plus TL, RN, Ø4.1mm, SLActive 10mm, TiZr; 033.563S Standard Plus TL, RN, Ø4.1mm, SLActive 12mm, TiZr; 033.564S Standard Plus TL, RN, Ø4.1mm, SLActive 14mm, TiZr; 033.571S Tapered Effect, TL, RN, Ø4.1mm, SLActive 8mm, TiZr; 033.572S Tapered Effect, TL, RN, Ø4.1mm, SLActive 10mm, TiZr; 033.573S Tapered Effect, TL, RN, Ø4.1mm, SLActive 12mm, TiZr; 033.574S Tapered Effect, TL, Ø4.1mm, SLActive 14mm, TiZr; 033.580S Standard TL, RN, Ø4.8mm, SLActive 6mm, TiZr; 033.581S Standard TL, RN, Ø4.8mm, SLActive 8mm, TiZr; 033.582S Standard TL, RN, Ø4.8mm, SLActive 10mm, TiZr; 033.583S Standard TL, RN, Ø4.8mm, SLActive 12mm, TiZr; 033.584S Standard TL, RN, Ø4.8mm, SLActive 14mm, TiZr; 033.590S Standard Plus TL, RN, Ø4.8mm, SLActive 6mm, TiZr; 033.591S Standard Plus TL, RN, Ø4.8mm, SLActive 8mm, TiZr; 033.592S Standard Plus TL, RN, Ø4.8mm, SLActive 10mm, TiZr; 033.593S Standard Plus TL, RN, Ø4.8mm, SLActive 12mm, TiZr; 033.594S Standard Plus TL, RN, Ø4.8mm, SLActive 14mm, TiZr; 033.600S Standard TL, WN Ø4.8mm, SLActive 6mm, TiZr; 033.601S Standard TL, WN Ø4.8mm, SLActive 8mm, TiZr; 033.602S Standard TL, WN Ø4.8mm, SLActive 10mm, TiZr; 033.603S Standard TL, WN Ø4.8mm, SLActive 12mm, TiZr; 033.610S Standard Plus TL, WN Ø4.8mm, SLActive 6mm, TiZr; 033.611S Standard Plus TL, WN Ø4.8mm, SLActive 8mm, TiZr; 033.612S Standard Plus TL, WN Ø4.8mm, SLActive 10mm, TiZr; 033.613S Standard Plus TL, WN Ø4.8mm, SLActive 12mm, TiZr; 033.614S Standard Plus TL, WN Ø4.8mm, SLActive 14mm, TiZr; 033.622S Tapered Effect, TL, WN, Ø4.1mm, SLActive 10mm, TiZr; 033.623S Tapered Effect, TL, WN, Ø4.1mm, SLActive 12mm, TiZr; 033.624S Tapered Effect, TL, WN, Ø4.1mm, SLActive 14mm, TiZr; BLC Implant 3.75mm RB, SLActive® 18mm, Roxolid®; BLC Implant 3.75mm RB, SLA® 18mm, Roxolid®; BLC Implants; BLT 3.3 NC, SLActive 18mm, TiZr, Loxim; BLT 3.3mm NC, SLA 18mm, TiZr, Loxim; BLT 4.1 RC, SLActive 18mm, TiZr, Loxim; BLT 4.1mm RC, SLA 18mm, TiZr, Loxim; BLT 4.8 RC, SLActive 18mm, TiZr, Loxim; BLT 4.8mm RC, SLA 18mm, TiZr, Loxim; Bone Level Implant TiZr RC 4.1mm L 8,10,12, 14mm; Bone Level Implant TiZr RC 4.8mm L 8, 10, 12, 14mm; Dental Implant Accesories; MEMFIX; NC Closure Cap; NC GOLD ABUTMENT FOR CROWNS; NC Healing Abutment; NC Healing Abutment, bottle; NC Healing Abutment, conical; NC Healing Abutment, customizable; NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type A; NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 2.5mm, Type B; NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type A; NC Screw-retained abutment, TAN, angled 17, D 4.6mm, GH 4mm, Type B; NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type A; NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 2.5mm, Type B; NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type A; NC Screw-retained abutment, TAN, angled 30, D 4.6mm, GH 4mm, Type B; NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 0, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 2mm, MO 1, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 0, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment angled 15, GH 3.5mm, MO 1, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 0, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment straight, GH 2mm, MO 1, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 0, ZrO2; NC Straumann® Anatomic IPS e.max® Abutment straight, GH 3.5mm, MO 1, ZrO2; NC Temporary Abutment, VITA CAD-Temp, PMMA; NC Variobase Abutment with screw, D 3.8mm, H 3.5mm, TAN; NC Variobase™  Abutments, with screw, D 3.8mm, H 3.5mm, TAN; NC Variobase®, for crown, with screw, D 3.8mm, H 5.5mm, TAN; NC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type A; NC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type B; NC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type A; NC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type B; NNC Basel Screw for Cementable Abutments; NNC Cementable Abutment, 15 degree angle Type A; NNC Cementable Abutment, 15 degree angle Type B; NNC Cementable Abutment, straight; NNC Closure Cap; NNC Healing Cap; NNC Protective Cap; NNC Solid Abutment; NNC Temporary Abutment, VITA CAD-Temp, PMMA; NNC Temporary Coping; NNC Variobase Abutment, with screw, D 55mm, H 4mm, TAN; NNC Variobase™ Abutments, with screw, D 3.9mm, H 3.75mm, TAN; NNC Variobase®, for crown, with screw, D 3.9mm, H 5.75mm, TAN; Narrow Neck CrossFit (NNC) Gold Abutment for Bridges; Neodent Titanium Block for Medentika Holder; Pre-milled Abutment Blank for CARES®; RB/WB Screw-retained abutment, angled 17° & 30°, 4.6mm; RC Closure Cap; RC Healing Abutment , bottle; RC Healing Abutment, conical; RC Healing Abutment, customizable; RC Temporary Abutment; RC Temporary Abutment, VITA CAD-Temp, PMMA; RC Variobase Abutment, with screw, D 4.5mm, 3.5mm, TAN; RC Variobase™ Abutments, with screw, D 4.5mm, 3.5mm, TAN; RC Variobase®, for crown, with screw, D 4.5mm, H 5.5mm, TAN; RC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type A; RC abutment, 17, D 4.6 mm, GH 5.5 mm, TAN, Type B; RC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type A; RC abutment, 30, D 4.6 mm, GH 5.5 mm, TAN, Type B; RN Closure Cap; RN Gold Abutment, for Bridge; RN Healing Cap; RN Temporary Abutment, VITA CAD-Temp, PMMA; RN Variobase Abutment, with screw, D 55mm, H 4mm, TAN; RN Variobase™ Abutments, with screw, D 55mm, H 4mm, TAN; RN Variobase®, for crown, with screw, D 55mm, H 6mm, TAN; Roxolid BLX Implants; SRBB Bone Level; STRAUMANN DENTAL IMPLANT SYSTEM; STRAUMANN EXTRAORAL IMPLANT SYSTEM; Screw Retained Abutments; Screw-Retained Abutments; Strauamnn CARES Dolder Bar Titanium; Straumann 4 mm Short Implants; Straumann Anatomic Healing Abutments; Straumann BLC Implants; Straumann BLX 3.5 mm Implants; Straumann BLX Gold Abutment; Straumann BLX Implant System; Straumann Bone Level Tapered Implant; Straumann CARES Abutments; Straumann CARES Screw-Retained Bridges and Bars; Straumann CARES Screw-retained Bridge Titanium; Straumann Dental Implant System; Straumann Immediate Temporary Abutments; Straumann InLab Validated Workflow; Straumann Modular Cassette; Straumann Narrow Neck CrossFit (NNC) Closure Screws; Straumann Narrow Neck CrossFit (NNC) Dental Implant System; Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Crown; Straumann Narrow Neck CrossFit (NNC) Healing Caps; Straumann Narrow Neck CrossFit (NNC) Temporary Abutments; Straumann PURE Ceramic Implants; Straumann PUREloc Abutments; Straumann Pre-Milled Abutment Blank for Medentika Holder; Straumann Roxolid SLA Implants; Straumann Screw Retained Abutments; Straumann TLC Implants; Straumann Variobase Abutments; Straumann Variobase Abutments for Bridge/Bar; Straumann Variobase C; Straumann Variobase for CEREC; Straumann Variobase for Crown AS; Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA; Straumann® Retentive System – Novaloc TiN Abutments; TLC Implants; TLX Implant System; TLX Screw-Retained Abutments; Taper Effect Roxolid; Variobase for CEREC; Variobase® XC for Bridge/Bar, Variobase® XC for Bridge/Bar AS; WN Closure Cap; WN Gold Abutment, for Bridge; WN Healing Cap; WN Temporary Abutment, VITA CAD-Temp, PMMA; WN Variobase Abutment, with screw, D 7mm, H 4.5mm, TAN; WN Variobase™ Abutments, with screw, D 7mm, H 4.5mm, TAN; WN Variobase®, for crown, with screw, D 7mm, H 6.5mm, TAN; synOcta abutment",1999-03-10,122,2026-03-10,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229614404%22&limit=1
"Shenzhen Mindray Bio-Medical Electronics Co., Ltd.",3009156722,3009156722,1203 Nanhuan Avenue Guangming District,Shenzhen Guangdong,,518106,China,"SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD",9058402,Manufacturer; Specification developer,54,BSZ; BZK; CAD; CBK; CBQ; CBR; CBS; CCK; CCL; CDQ; CEM; CFR; CGZ; DPZ; DQA; DRG; DRQ; DRS; DRT; DSB; DSI; DSJ; DSK; DXG; DXN; FLL; GGK; GIF; GKZ; GXY; ITX; IYN; IYO; JCB; JGS; JJE; KDP; KOI; KRC; LLZ; MHX; MLC; MLD; MNT; MSX; MUD; MWI; NHO; NHP; NHQ; OLT; OLW; OMC; ORT,"Gas-Machine, Anesthesia; Spirometer, Monitoring (W/Wo Alarm); Vaporizer, Anesthesia, Non-Heated; Ventilator, Continuous, Facility Use; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Electrode, Ion Specific, Potassium; Hexokinase, Glucose; Electrode, Ion-Specific, Chloride; Oximeter, Ear; Oximeter; Transmitters And Receivers, Physiological Signal, Radiofrequency; Amplifier And Signal Conditioner, Transducer Signal; Transducer, Blood-Pressure, Extravascular; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Plethysmograph, Impedance; Detector And Alarm, Arrhythmia; Alarm, Blood-Pressure; Computer, Blood-Pressure; Computer, Diagnostic, Pre-Programmed, Single-Function; System, Measurement, Blood-Pressure, Non-Invasive; Continuous Measurement Thermometer; Products, Red-Cell Lysing Products; Diluent, Blood Cell; Counter, Differential Cell; Electrode, Cutaneous; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Detergent; Electrode, Ion Specific, Sodium; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Regulator, Vacuum; Stimulator, Nerve, Peripheral, Electric; Tester, Electrode, Surface, Electrocardiographic; System, Image Processing, Radiological; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Monitor, St Segment; Monitor, St Segment With Alarm; Continuous, Minimal Ventilatory Support, Facility Use Ventilator; System, Network And Communication, Physiological Monitors; Oximeter, Tissue Saturation; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration); Non-Normalizing Quantitative Electroencephalograph Software; Index-Generating Electroencephalograph Software; Reduced- Montage Standard Electroencephalograph; Burst Suppression Detection Software For Electroencephalograph",1; 2,"A3 ANESTHESIA DELIVERY SYSTEM; A4 Anesthesia System; A5 ANESTHESIA DELIVERY SYSTEM; A5 Anesthesia System; A7 Anesthesia System; A8, A9 Anesthesia System; ACCUTORR 7,VS-900 VITAL SIGNS MONITOR; ACUSON Bonsai Diagnostic Ultrasound System; Accutorr 3,VS-600 Vital Signs Monitor; Accutorr 7 Vital Signs Monitor; Accutorr 7/VS-900/VS-900c Vital Signs Monitor; Anesthesia System(A5,A7,A4); Anesus I9 Easi/Eagus I9 Diagnostic Ultrasound System; BA-480 Chemistry Analyzer; BC-3200 Auto Hematology Analyzer; BC-3600 Auto Hematology Analyzer; BC-5390 Auto Hematology Analyzer; BS-200 Chemistry Analyzer,Pointe c2000 Chemistry Analyzer; BS-400/CLC 720 Chemistry Analyzer; BS-480 Chemistry Analyzer; BS-490 Chemistry Analyzer; BS-800M,ABS800,BA-800M ISE KIT,BS-800M Chemistry Analyzer,BA-800M Chemistry Analyzer,ABS-800 Chemistry Analyzer; BeneVision Central Monitoring System; BeneVision Central Monitoring System(BeneVision/ TMS-6016/Telepack-608/TMS60/TM80/TM70); BeneVision N Series Patient Monitor (BeneVision N12, BeneVision N15, BeneVision N17 ); BeneVision N Series Patient Monitor (BeneVision N19, BeneVision N22, BeneVision N1); BeneVision N Series Patient Monitor (BeneVision N19, BeneVision N22,BeneVision N1); BeneVision N Series Patient Monitors (Including BeneVision M12 , BeneVision M12C); BeneVision N Series Patient Monitors (Including BeneVision M17C , BeneVision M15 , BeneVision M15C); BeneVision N Series Patient Monitors (Including BeneVision M19 , BeneVision M19C , BeneVision M17); BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17); BeneVision N Series Patient Monitors (Including BeneVision N12C, BeneVision N12 OR, BeneVision N12 Neo); BeneVision N Series Patient Monitors (Including BeneVision N15 ICU, BeneVision N15 OR, BeneVision N15 Neo); BeneVision N Series Patient Monitors (Including BeneVision N17 ICU, BeneVision N17 OR, BeneVision N17 Neo); BeneVision N Series Patient Monitors (Including BeneVision N19 ICU,BeneVision M22 ,BeneVision M22C); BeneVision N Series Patient Monitors (Including BeneVision N19, BeneVision N22, BeneVision N1); BeneVision N Series Patient Monitors (Including BeneVision N22 OR, BeneVision N19 OR, BeneVision N22 ICU); CD 80 Detergent; CLC720i Chemistry Analyzer; Consona AE, Consona AT, Consona N6 Exp, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System; Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S Diagnostic Ultrasound System; Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System; Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR Diagnostic Ultrasound System; Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S Diagnostic Ultrasound System; Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite Diagnostic Ultrasound System; Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite Diagnostic Ultrasound System; Crius R9 CV, Anesus R9 CV, Recho R9 Super, Recho R9 Lumi, Recho R CV, Recho R CVx Diagnostic Ultrasound System; DC-3/DC-3T Diagnostic Ultrasound System; DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System; DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic; DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System; DC-41/DC-42/DC-40T/ DC-33/DC-36/DC-38/DC-39 Diagnostic Ultrasound System; DC-50/DC-50S/DC-51/DC-52/DC-56/DC-65/DC-65S/DC-62/DC-63/DC-65T Diagnostic Ultrasound System; DC-7 Diagonostic Ultrasound System; DC-70; DC-70 Pro; DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System; DC-70/DC-70T/DC-70 PRO/DC-70 EXP DIAGNOSTIC ULTRASOUND SYSTEM; DC-70Exp; DC-70T; DC-8,DC-8 PRO,DC-8 CV,DC-8 EXP,DC-8S Diagnostic Ultrasound System; DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic Ultrasound System; DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System; DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System; DC-90/DC-90S/DC-90Q/DC-95/DC-95S Diagnostic Ultrasound System; DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System; DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM; DC-N3 PRO DIAGNOSTIC ULTRASOUND SYSTEM; DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM; DC-T6 Diagnostic Ultrasound System; DP-10/DP-20/DP-30/DP-25 Digital Ultrasonic Diagnostic Imaging System; DP-20,DP-30 Digital Ultrasonic Diagnostic Imaging System; DP-5, DP-7 Digital Ultrasonic Diagnostic Imaging System; DP-6900 Digital Ultrasonic Diagnostic Imaging System; DP-6900,DP-50 Digital Ultrasonic Diagnostic Imaging System; Diagnostic Ultrasound System (MU7 Pro); Diagnostic Ultrasound System (MU7 Super); Diagnostic Ultrasound System (MU7P); Diagnostic Ultrasound System (MU7A); Diagnostic Ultrasound System (MU7S); Diagnostic Ultrasound System (MU7T); Diagnostic Ultrasound System (MU7 Exp); Diagnostic Ultrasound System (MU9 Exp); Diagnostic Ultrasound System (MU9 Pro); Diagnostic Ultrasound System (MU9 Super); Diagnostic Ultrasound System (MU9); Diagnostic Ultrasound System (MU9S); Diagnostic Ultrasound System (MU9T); Diagnostic Ultrasound System (MU9P); Diagnostic Ultrasound System (MU9A); Diagnostic Ultrasound System (MU7); Diagnostic Ultrasound System Anesus ME7; Diagnostic Ultrasound System Anesus ME7T; Diagnostic Ultrasound System Aquila; Diagnostic Ultrasound System ME7; Diagnostic Ultrasound System ME8; Diagnostic Ultrasound System MX7; Diagnostic Ultrasound System MX7P; Diagnostic Ultrasound System MX7T; Diagnostic Ultrasound System MX7W; Diagnostic Ultrasound System MX8; Diagnostic Ultrasound System MX8T; Diagnostic Ultrasound System Malody; Diagnostic Ultrasound System Nuda; Diagnostic Ultrasound System Vaus7; Diagnostic Ultrasound System Vaus8; Diagnostic Ultrasound System Zeus; Diagnostic Ultrasound System( Resona A MV, Eagus A20W, Eagus A20); Diagnostic Ultrasound System( Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite); Diagnostic Ultrasound System(Consona EI/Consona EF/Consona N5 Elite/Consona N5 Ultra/Consona N3/Consona N3 Exp); Diagnostic Ultrasound System(Consona N5/Consona N5 Pro/Consona N5 Super/Consona N5 Exp/Consona ER/Consona N5S); Diagnostic Ultrasound System(DC-60/DC-60S/DC-60 Exp/DC-55 ); Diagnostic Ultrasound System(Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares); Diagnostic Ultrasound System(Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M); Diagnostic Ultrasound System(Hepatus 6,Hepatus 7T,Hepatus 6S,Hepatus 5S); Diagnostic Ultrasound System(Hepatus 6T,Fibrous 7,Fibrous 5,Fibrous 6,Hepatus 7S,Hepatus 5T,Hepatus 7,Hepatus 5); Diagnostic Ultrasound System(Imagyn A20S); Diagnostic Ultrasound System(Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp); Diagnostic Ultrasound System(MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/AnesusME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8); Diagnostic Ultrasound System(Nuewa A Elite, Nuewa A MS, Nuewa A20 Premium, Nuewa A20 Plus, Nuewa A18W, Nuewa A20 Pro); Diagnostic Ultrasound System(Nuewa A20T, Nuewa A20S, Nuewa A Lumi, Nuewa AR, Imagyn A20 Exp, Imagyn A20, Imagyn A20T); Diagnostic Ultrasound System(Nuewa A20W, Nuewa A20, Nuewa A20 Exp, Nuewa A20 Elite, Nuewa A20Q, Nuewa A MV); Diagnostic Ultrasound System(Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W); Diagnostic Ultrasound System(Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T); Diagnostic Ultrasound System(Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W); Diagnostic Ultrasound System(Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20); Diagnostic Ultrasound System(Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite); Diagnostic Ultrasound System(Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20); Diagnostic Ultrasound System(Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa,Resona IV); Diagnostic Ultrasound System(TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T); Diagnostic Ultrasound System(TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite); Diagnostic Ultrasound System(TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite); Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Nuewa IY Diagnostic Ultrasound System; Emerus MX5,Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp Diagnostic Ultrasound System; Emerus MX6,Emerus MX6 Exp, Anesus MX6,Anesus MX6 Exp, Crius MX6, Crius MX6 Exp Diagnostic Ultrasound System; FUKUDA Vital Signs Monitor; Gas Module 3; Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S Diagnostic Ultrasound System; Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/ Fibrous 5 Diagnostic Ultrasound System; Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp Diagnostic Ultrasound System; Imagyn I9S/Imagyn I9 Easi/Nuewa I9/Nuewa I9S Diagnostic Ultrasound System; M-30 E-Z CLEANSER; M-30CFL LYSE, M-5LEO(I) LYSE, M-5LEO(II) LYSE, M-53LH LYSE; M-30D DILUENT,M-53D DILUENT; M-30P PROBE CLEANSER; M-30R Rinse; M5 Diagnostic Ultrasound System,Various Names and Models; M6/M6T/M6 Exp/M6s/M6 Pro/M5 Exp/M55/M58 Diagnostic Ultrasound System; M7 Diagnostic Ultrasound System; M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM; M9/M9CV/M9T/M8 Elite Diagnostic Ultrasound System; M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/ Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System; M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System; M9/M9T/M9CV Diagnostic Ultrasound System; MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2,MX2 BW Diagnostic Ultrasound System; MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI Diagnostic Ultrasound System; MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG Diagnostic Ultrasound System; MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/ MX8T/Vaus8/ME8 Diagnostic Ultrasound System; MX7P/MX7W Diagnostic Ultrasound System; Mindray SV600 Ventilator, Mindray SV800 Ventilator; Nuewa I9T/Nuewa I9 Exp/Nuewa I9 Easi/Anesus I9 Diagnostic Ultrasound System; Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S Diagnostic Ultrasound System; Nuewa R9/Nuewa R9 Exp/Nuewa R9 Pro/Nuewa R9S Diagnostic Ultrasound System; PROBE CLEANSER; Panorama Patient Monitoring Network; Passport Series Patient Monitors (Passport 12m, Passport 17m); Passport Series Patient Monitors (T1); Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1); Passport Series Patient Monitors(Passport 8 and Passport 12); Patient Monitors cPM 8 and cPM 12; Recho R9W, Recho R9, Recho R9 Pro, Recho R9 Exp, Recho R9S, Recho R9T Diagnostic Ultrasound System; Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System; Resona 7/Resona 7CV/Resona 7EXP/Resona 7S Diagnostic Ultrasound Syste; Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System; Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB/ Resona 8 Diagnostic Ultrasound System; Resona 7OB/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System; Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi Diagnostic Ultrasound System; Resona I9 Easi/Resona I9 Nasa/Resona IV/Imagyn I9 Diagnostic Ultrasound System; Resona I9/Resona I9 Exp/Resona I9S/Resona I9T Diagnostic Ultrasound System; Resona I9W Diagnostic Ultrasound System; Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super Diagnostic Ultrasound System; Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S Diagnostic Ultrasound System; Resona R9/Resona R9 Exp/Resona R9 Pro/Resona R9S Diagnostic Ultrasound System; Resona R9W, Resona R7W, Nuewa R9W, Nuewa R7W Diagnostic Ultrasound System; Rosebud VC; Rosie 4; Rosie 4 Vital Signs Monitor; SV70 Ventilator (SV70); TE Air Diagnostic Ultrasound System; TE7 Diagnostic Ultrasound System,TE5 Diagnostic Ultrasound System,J5 Diagnostic Ultrasound System; TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System, J5 Diagnostic Ultrasound System; TE7/TE5/TE7 Max/ TE5 Max/TE9 Diagnostic Ultrasound System; TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System; TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System; V60 Anesthetic Vaporizer; V80 Anesthetic Vaporizer; VS Series Vital Signs Monitors (Including VS 9/VS 8/VS 8A); VS-900 Vital Signs Monitor; VS-900c Vital Signs Monitor; Ventilator(SV600,SV800,SV700,SV900); ViewMate Multi Ultrasound System (VMM-ICE-01); ViewMate Ultrasound System; ViewMateTM Ultrasound System; ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02); Vital Signs Monitors (specifically Accutorr 3, Rosebud); Vital Signs Monitors(Including VS 9, VS 8, VS 8A); Wash Solution; Yumizen C560 Chemistry Analyzer; Z.ONE PRO; Z5 DIAGNOSTIC ULTRASOUND SYSTEM; Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System; Z6 Diagnostic Ultrasound System; Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System; ZS3 /z.one pro/ ViewMate Ultrasound Systems; ZS3 Ultrasound System; ZS3 and z.one pro Ultrasound Systems; ZS3KP Elite/ ZS3 Elite /ZS4 Ultrasound Systems; ePM 15A,ePM 15C,ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC,ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC; ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C ); ePM Series Patient Monitor(/ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC); ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M ePM 15A,ePM 15C); ePM Series Patient Monitors (Including ePM 10, ePM12, ePM 15, ePM 10M, ePM 12M, ePM 15M); ePM Series Patient Monitors (Including ePM 12A,ePM 12C,ePM 10A,ePM 10C,ePM 15MA,ePM 15MC); ePM Series Patient Monitors (Including ePM 12MA,ePM 12MC,ePM 10MA,ePM 10MC); uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors; uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S); z.onepro Ultrasound System",2008-02-17,121,2026-10-16,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009156722%22&limit=1
Veenak International Limited,3013298431,3013298431,1406 Coventry Road South Yardley,Birmingham,,B25 8AE,United Kingdom,VEENAK INTERNATIONAL LIMITED,10058153,Exporter to the US,162,BSJ; BSP; BSY; BTA; BTO; BXW; BYG; BYX; BYY; BYZ; BZA; BZG; CAE; CAI; CBH; CCK; CCX; DPS; DQA; DRX; DTL; DXN; DXQ; DZI; EFS; ELC; ELZ; EOB; EOQ; ERA; ETY; EXB; EXE; EXH; EYJ; EYQ; EZL; EZQ; EZR; FAM; FCY; FER; FLL; FMA; FMF; FMH; FMI; FMP; FMR; FMW; FNY; FOB; FOD; FON; FOX; FOZ; FPA; FQL; FQM; FRC; FRG; FRN; FRO; FTY; FXP; FXX; FYA; FYF; FZZ; GAA; GAL; GAM; GAP; GAQ; GAR; GAT; GAW; GBX; GDT; GDY; GEI; GEN; GJS; GXB; GXY; GXZ; HBA; HEB; HIB; HKM; HLI; HLJ; HLS; HMF; HMP; HRX; IKT; ILS; IMD; ITG; JIR; JKA; JOH; JOJ; JOK; JOL; JQP; JRS; KDC; KDD; KGO; KGQ; KGX; KGZ; KKX; KME; KMF; KMJ; KMK; KNT; KNX; KOA; KOX; KPE; KXF; KXG; KYW; KYZ; LDE; LFR; LHI; LJH; LRJ; LRO; LWH; LWK; LYU; LZA; LZC; MDA; MDM; MEG; MGQ; MHW; MMK; MVL; MWI; NAB; NAC; NAD; NAE; NBW; NDP; NEW; NNI; OEA; OHY; PIF; PNG; PNR; PUI; QRL,"Mask, Gas, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Catheters, Suction, Tracheobronchial; Pump, Portable, Aspiration (Manual Or Powered); Tube, Tracheostomy (W/Wo Connector); Calibrator, Volume, Gas; Mask, Oxygen; Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Trap, Sterile Specimen; Connector, Airway (Extension); Spirometer, Diagnostic; Airway, Oropharyngeal, Anesthesiology; Circuit, Breathing (W Connector, Adaptor, Y Piece); Device, Fixation, Tracheal Tube; Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Support, Patient Position; Electrocardiograph; Oximeter; Electrode, Electrocardiograph; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; System, Measurement, Blood-Pressure, Non-Invasive; Blood Pressure Cuff; Drill, Bone, Powered; Unit, Oral Irrigation; Scaler, Ultrasonic; Crown, Preformed; Nasopharyngoscope (Flexible Or Rigid); Bronchoscope (Flexible Or Rigid); Otoscope; Tester, Auditory Impedance; Collector, Ostomy; Protector, Ostomy; Bag, Urinary, Ileostomy; Holder, Ureteral Catheter; Garment, Protective, For Incontinence; Catheter, Retention Type, Balloon; Pouch, Colostomy; Cement, Stomal Appliance, Ostomy; Sigmoidoscope And Accessories, Flexible/Rigid; Bulb, Inflation, For Endoscope; Anoscope And Accessories; Continuous Measurement Thermometer; Depressor, Tongue, Non-Surgical; Syringe, Piston; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Protector, Skin Pressure; Device, Transfer, Patient, Manual; Cover, Mattress (Medical Purposes); Basin, Emesis; Bedpan; Device, Occlusion, Umbilical; Bag, Drainage, With Adhesive, Ostomy; Stand, Infusion; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Stocking, Medical Support (For General Medical Purposes); Bandage, Elastic; Indicator, Biological Sterilization Process; Wrap, Sterilization; Pump, Infusion; Dressing, Wound, Drug; Tape, Measuring, Rulers And Calipers; Cover, Shoe, Operating-Room; Mask, Surgical; Gown, Surgical; Cap, Surgical; Marker, Skin; Needle, Aspiration And Injection, Disposable; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Catheter, Irrigation; Staple, Removable (Skin); Gauze/Sponge, Internal, X-Ray Detectable; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Test, Time, Prothrombin; Esthesiometer; Electrode, Cutaneous; Electrode, Needle; Neurosurgical Paddie; Tampon, Menstrual, Unscented; Speculum, Vaginal, Nonmetal; Retinoscope, Battery-Powered; Ophthalmoscope, Ac-Powered; Ophthalmoscope, Battery-Powered; Exophthalmometer; Stand, Instrument, Ac-Powered, Ophthalmic; Pad, Eye; Arthroscope; Electrode, Needle, Diagnostic Electromyograph; Adaptor, Hygiene; Pack, Hot Or Cold, Disposable; Bandage, Cast; Indicator Method, Protein Or Albumin (Urinary, Non-Quant.); Tubes, Vials, Systems, Serum Separators, Blood Collection; Tube Tracheostomy And Tube Cuff; Indicator, Physical/Chemical Sterilization Process; Scissors, Medical, Disposable; Catheter And Tip, Suction; Calculator/Data Processing Module, For Clinical Use; Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis); Instrument, Surgical, Disposable; Kit, Surgical Instrument, Disposable; Surgeon'S Gloves; Cream, Gloving, Surgeon'S; Tape And Bandage, Adhesive; Accessories, Catheter; Drape, Surgical, Antimicrobial; Bedding, Disposable, Medical; Bandage, Liquid; Lubricant, Patient; Device, Intravascular Catheter Securement; Tubes, Gastrointestinal (And Accessories); Collector, Urine, (And Accessories) For Indwelling Catheter; Surgical Instruments, G-U, Manual (And Accessories); Solvent, Adhesive Tape; Container, I.V.; Applicator, Absorbent Tipped, Non-Sterile; Applicator, Absorbent Tipped, Sterile; Container, Liquid Medication, Graduated; Syringe, Irrigating (Non Dental); Stethoscope, Manual; Glucose Dehydrogenase, Glucose; Set, I.V. Fluid Transfer; System, Irrigation, Urological; Disinfectant, Medical Devices; General Surgery Tray; Counter, Sponge, Surgical; Razor, Surgical; Accessory, Surgical Apparel; Polymer Patient Examination Glove; Medical Glove, Specialty; Elastomer, Silicone, For Scar Management; Instrument, Manual, Surgical, General Use; Syringe, Antistick; Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic; Dressing, Compression; Container, Sharps; Cord, Retraction; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Hydrophilic; Dressing, Wound, Occlusive; Dressing, Wound, Hydrogel Without Drug And/Or Biologic; System, Test, Blood Glucose, Over The Counter; Accessories, Implant, Dental, Endosseous; Suture, Surgical, Absorbable, Polydioxanone; Container, Specimen, Non-Sterile; Non-Surgical Gown; Pill Crusher/Cutter; Gastrointestinal Tubes With Enteral Specific Connectors; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Enteral Syringes With Enteral Specific Connectors; Drape, Surgical, Exempt; Multiple Use Blood Lancet For Single Patient Use Only",1; 2; U,"ELASTOMER, SILICONE, FOR SCAR MANAGEMENT",2018-09-10,121,2024-11-01,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013298431%22&limit=1
"bioMerieux, Inc.",3031977134,3031977134,3015 Carrington Mill Blvd,Morrisville,NC,27560,United States,BIOMERIEUX SA,8020790,Complaint file establishment,6,LON; LRG; LTT; LTW; MDB; NGZ,"System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems; Panels, Test, Susceptibility, Antimicrobial; Susceptibility Test Cards, Antimicrobial; System, Blood Culturing; Susceptibility Test Plate, Antifungal",1; 2,"(240),; (<= 0.12 - >= 8 mcg/ml); 3D Combination; AST Cefotaxime; AST Clindamycin; AST Penicillin; AST Streptococcus Vancomycin; AST-GN Imipenem; BACT/ALERT FA PLUS CULTURE BOTTLE; BACT/ALERT FN PLUS; BACT/ALERT MP Reagent System; BACT/ALERT PF PLUS CULTURE BOTTLE; BacT/ALERT 3D with Mycobacterium; BacT/ALERT Blood Culturing System; BacT/ALERT FA (Plastic Bottle); BacT/ALERT FA Plus; BacT/ALERT FN (Plastic Bottles); BacT/ALERT PF (Plastic Bottles); BacT/ALERT PF Plus; BacT/ALERT SA (Plastic Bottles); BacT/ALERT SN (Plastic Bottles); BacT/ALERT VIRTUO Microbial Detection System; DensiCHEK Plus; Indication; Quinupristin / Dalfopristin; S. pneumo; Trimethoprim / Sulfamethoxazole; Trimethoprim/Sulfamethoxazole; VITEK 2 AST - Gram Negative Ertapenem; VITEK 2 AST - Gram Negative Imipenem; VITEK 2 AST Gram Negative Cefotaxime; VITEK 2 AST Streptococcus Ceftriaxone; VITEK 2 AST- Gram Negative Polymyxin B; VITEK 2 AST- Gram Positive Telavancin; VITEK 2 AST- Streptococcus Cefotaxime; VITEK 2 AST-GN Amikacin; VITEK 2 AST-GN Amox/Clav; VITEK 2 AST-GN Amp/Sulbactam; VITEK 2 AST-GN Ampicillin; VITEK 2 AST-GN Aztreonam; VITEK 2 AST-GN Cefalotin; VITEK 2 AST-GN Cefazolin; VITEK 2 AST-GN Cefepime; VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL); VITEK 2 AST-GN Cefotaxime; VITEK 2 AST-GN Cefotetan; VITEK 2 AST-GN Cefoxitin; VITEK 2 AST-GN Cefpodoxime; VITEK 2 AST-GN Ceftazidime; VITEK 2 AST-GN Ceftazidime/Avibactam; VITEK 2 AST-GN Ceftizoxime; VITEK 2 AST-GN Ceftolozane/Tazobactam; VITEK 2 AST-GN Ceftriaxone; VITEK 2 AST-GN Cefuroxime; VITEK 2 AST-GN Ciprofloxacin; VITEK 2 AST-GN Gentamicin; VITEK 2 AST-GN Imipenem; VITEK 2 AST-GN Levofloxacin; VITEK 2 AST-GN Meropenem; VITEK 2 AST-GN Nalidixic Acid; VITEK 2 AST-GN Nitrofurantoin; VITEK 2 AST-GN Norfloxacin; VITEK 2 AST-GN Pip/Tazob.; VITEK 2 AST-GN Piperacillin; VITEK 2 AST-GN Piperacillin/tazobactam; VITEK 2 AST-GN Tetracycline; VITEK 2 AST-GN Ticarcillin; VITEK 2 AST-GN Ticarcillin/ Clavulanic Acid; VITEK 2 AST-GN Tigecycline; VITEK 2 AST-GN Tobramycin; VITEK 2 AST-GN Trimeth./sulfa; VITEK 2 AST-GP Amp/Sulbactam; VITEK 2 AST-GP Ampicillin; VITEK 2 AST-GP Cefazolin; VITEK 2 AST-GP Ceftaroline; VITEK 2 AST-GP Chloramphenicol; VITEK 2 AST-GP Ciprofloxacin; VITEK 2 AST-GP Clindamycin; VITEK 2 AST-GP Erythromycin; VITEK 2 AST-GP Gentamicin; VITEK 2 AST-GP Gentamicin, HL; VITEK 2 AST-GP Levofloxacin; VITEK 2 AST-GP Minocycline; VITEK 2 AST-GP Nitrofurantoin; VITEK 2 AST-GP Norfloxacin; VITEK 2 AST-GP Ofloxacin; VITEK 2 AST-GP Oxacillin; VITEK 2 AST-GP Penicillin G; VITEK 2 AST-GP Rifampin; VITEK 2 AST-GP Sparfloxacin; VITEK 2 AST-GP Streptomycin, HL; VITEK 2 AST-GP Tetracycline; VITEK 2 AST-GP Vancomycin; VITEK 2 AST-GP for S.pn Cefotaxime; VITEK 2 AST-GP for S.pn Ceftriaxone; VITEK 2 AST-GP for S.pn Chloramphenicol; VITEK 2 AST-GP for S.pn Ofloxacin; VITEK 2 AST-GP for S.pn Penicillin G; VITEK 2 AST-GP for S.pn Tetracycline; VITEK 2 AST-GP for S.pn Trimeth./sulfa; VITEK 2 AST-GP for S.pn Vancomycin; VITEK 2 AST-Gram Negative Ceftazidime; VITEK 2 AST-Gram Negative Ciprofloxacin; VITEK 2 AST-Gram Negative Eravacycline; VITEK 2 AST-Gram Negative Fosfomycin; VITEK 2 AST-Gram Negative Imipenem/Relebactam; VITEK 2 AST-Gram Negative Levofloxacin; VITEK 2 AST-Gram Negative Meropenem; VITEK 2 AST-Gram Negative Meropenem/Vaborbactam; VITEK 2 AST-Gram Negative Minocycline; VITEK 2 AST-Gram Negative Omadacycline; VITEK 2 AST-Gram Negative Piperacillin / Tazobactam; VITEK 2 AST-Gram Negative Plazomicin; VITEK 2 AST-Gram Negative Tobramycin; VITEK 2 AST-Gram Positive Cefoxitin Screen; VITEK 2 AST-Gram Positive Dalbavancin; VITEK 2 AST-Gram Positive Daptomycin; VITEK 2 AST-Gram Positive Delafloxacin; VITEK 2 AST-Gram Positive Fosfomycin; VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance; VITEK 2 AST-Gram Positive Lefamulin; VITEK 2 AST-Gram Positive Linezolid; VITEK 2 AST-Gram Positive Moxifloxacin; VITEK 2 AST-ST Ampicillin; VITEK 2 AST-ST Clindamycin; VITEK 2 AST-ST Erythromycin; VITEK 2 AST-ST Inducible Clindamycin Resistance; VITEK 2 AST-ST Levofloxacin; VITEK 2 AST-ST Linezolid; VITEK 2 AST-ST Meropenem; VITEK 2 AST-ST Moxifloxacin; VITEK 2 AST-ST Tigecycline; VITEK 2 AST-Streptococcus Penicillin; VITEK 2 AST-Yeast Anidulafungin; VITEK 2 AST-Yeast Caspofungin; VITEK 2 AST-Yeast Fluconazole; VITEK 2 AST-Yeast Voriconazole; VITEK 2 Antimicrobial Susceptibility Test Device (GN, GP, and GP for S.pn); VITEK 2 Compact; VITEK 2 ESBL Test; VITEK 2 GN Doxycycline; VITEK 2 GP Amoxicillin for S pneumo; VITEK 2 GP Cefoxitin Screen; VITEK 2 GP Ertapenem for S. pneumo; VITEK 2 GP Erythromycin for; VITEK 2 GP Levofloxacin for; VITEK 2 GP Linezolid for S. pneumo; VITEK 2 GP Meropenem for; VITEK 2 GP Moxifloxacin for; VITEK 2 GP Sparfloxacin for S.pn; VITEK 2 GP Telithromycin for; VITEK 2 GP for; VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE; VITEK 2 GRAM POSITIVE DOXCYCLINE; VITEK 2 Gram Negative; VITEK 2 Gram Negative Ceftriaxone; VITEK 2 Gram Negative Doripenem; VITEK 2 Gram Negative Ertapenem; VITEK 2 Gram Negative Gatifloxacin; VITEK 2 Gram Negative Levofloxacin; VITEK 2 Gram Negative Meropenem; VITEK 2 Gram Negative Moxifloxacin; VITEK 2 Gram Negative Piperacillin; VITEK 2 Gram Negative Tigecycline; VITEK 2 Gram Positive; VITEK 2 Gram Positive Daptomycin; VITEK 2 Gram Positive Ertapenem; VITEK 2 Gram Positive Erythromycin; VITEK 2 Gram Positive Gatifloxacin; VITEK 2 Gram Positive Inducible Clindamycin Resistance; VITEK 2 Gram Positive Linezolid; VITEK 2 Gram Positive Meropenem; VITEK 2 Gram Positive Moxifloxacin; VITEK 2 Gram Positive Tigecycline; VITEK 2 Gram Positive VRSA Screen; VITEK 2 Gram Positive Vancomycin; VITEK 2 Streptococcus Penicillin; VITEK 2 Streptococcus Tetracycline; VITEK 2 Streptococcus Trimethoprim/Sulfamethoxazole; VITEK DENSICHEK; VITEK2 AST-Gram Negative Delafloxacin; VITEK® 2 AST-GN Gentamicin; Vitek 2 AST Gram Negative Cefazolin; and BacT/ALERT 3D60 Instrument; for Pipercillin/Tazobactam",2007-12-06,120,2024-06-12,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223031977134%22&limit=1
ABBOTT GmbH,3002809144,3002809144,Max-Planck-Ring 2,Wiesbaden Hesse,,65205,Germany,ABBOTT LABORATORIES,1415939,Exporter to the US; Manufacturer; Specification developer,137,CDD; CDO; CDP; CDZ; CEC; CEK; CEM; CEO; CEP; CEW; CFJ; CFP; CFR; CFT; CGJ; CGN; CGX; CGZ; CHH; CHI; CHP; CIG; CIT; CIX; CJE; CJW; CKA; CZP; CZW; DAD; DBF; DBI; DCK; DDG; DDR; DER; DEW; DFC; DFT; DHA; DHR; DHX; DIF; DIP; DKB; DLJ; DLZ; EQJ; ERL; GGJ; GGK; GIF; GJH; GJL; GKZ; JCB; JCC; JFJ; JFR; JFT; JFY; JGJ; JGS; JHX; JIF; JIQ; JIS; JIT; JIX; JIY; JJE; JJX; JJY; JKC; JKD; JLS; JLW; JPZ; JQF; JQP; JRS; JZJ; JZO; KEW; KHP; KHQ; KLI; KLT; KNK; KQN; KXT; LCD; LCP; LDZ; LEG; LEH; LFX; LFZ; LGD; LGR; LGS; LIP; LOK; LOL; LOM; LPS; LTJ; LTK; MJX; MJY; MMI; MOI; MQM; MRG; MTF; MTG; MZA; MZF; MZO; NBC; NDW; NDY; NHX; NIG; NQD; OHQ; OIU; ONX; OSX; PDJ; PMT; PPM; PRI; PTF; QAT; QCH; SEI,"Radioassay, Vitamin B12; Acid, Uric, Uricase (U.V.); Radioimmunoassay, Total Triiodothyronine; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Radioimmunoassay, Immunoreactive Insulin; Hexokinase, Glucose; Radioimmunoassay, Prolactin (Lactogen); Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Radioimmunoassay, Estradiol; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Bromcresol Purple Dye-Binding, Albumin; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Iga, Antigen, Antiserum, Control; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Alpha-1-Lipoprotein, Antigen, Antiserum, Control; Igg, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; Igm, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Drug Mixture Control Materials; Enzyme Immunoassay, Diphenylhydantoin; Calibrators, Drug Mixture; Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Fluid, Diluting, White-Cell; Products, Red-Cell Lysing Products; Diluent, Blood Cell; Stain, Reticulocyte; Romanowsky Stains; Counter, Differential Cell; Detergent; Ph Buffer; Catalytic Methods, Amylase; Indirect Copper Assay, Ceruloplasmin; Fluorometric, Cortisol; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Electrode, Ion Specific, Sodium; Fluorometric Method, Cpk Or Isoenzymes; Enzymatic Method, Ammonia; Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.); Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate); Radioimmunoassay, C-Peptides Of Proinsulin; Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Colorimetric Method, Gamma-Glutamyl Transpeptidase; Bathophenanthroline, Iron Binding Capacity; Calculator/Data Processing Module, For Clinical Use; Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis); Prealbumin, Antigen, Antiserum, Control; System, Test, Thyroid Autoantibody; Slides, Microscope; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Radioassay, Angiotensin Converting Enzyme; Enzyme Immunoassay, Digoxin; Enzyme Immunoassay, Gentamicin; Assay, Glycosylated Hemoglobin; Fixative, Alcohol Containing; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total); Fluorescence Polarization Immunoassay, Theophylline; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Kit, Test, Alpha-Fetoprotein For Neural Tube Defects; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Urinary Homocystine (Nonquantitative) Test System; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Kit, Serological, Positive Control; Kit, Serological, Negative Control; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; Bilirubin (Total And Unbound) In The Neonate Test System; System, Test, Vitamin D; Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; Test, Equipment, Automated Bloodborne Pathogen; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Test, Natriuretic Peptide; Assay, Porphyrin, Spectrophotometry, Lithium; Test, Cystatin C; Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp); System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Multi-Analyte Controls Unassayed; Test, Epithelial Ovarian Tumor Associated Antigen (He4); Ovarian Adnexal Mass Assessment Score Test System; Galectin-3 In Vitro Diagnostic Assay; Hemoglobin A1c Test System; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; General Purpose Reagent; Procalcitonin Assay; Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission; Brain Trauma Assessment Test; Assayed Quality Control Material For Clinical Microbiology Assays; Qualitative And Quantitative Hepatitis B Virus Antibody Assays",1; 2; 3; N,"20X SSC, 500g; ACE Calibrator (LN 06U8201); ACE Calibrator (LN 06U8601); ACE Control (LN 06U8210); ACE Control (LN 06U8610); ACE Reagent (LN 06U8225); ACE Reagent (LN 06U8625); ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42); ALANINE AMINOTRANSFERASE (ALT) (LN 7D56-21, 7D56-22); AMP Check E GPR; APOLIPOPROTEIN A1 (ApoA) (LN 9D92-21, 9D92-22); APOLIPOPROTEIN B (APOB) (LN 9D93-21, 9D93-22); ARCHITECT 25-OH Vitamin D Calibrators (LN 5P02-02); ARCHITECT 25-OH Vitamin D Controls (LN 5P02-12); ARCHITECT 25-OH Vitamin D Reagent Kit (LN 5P02-25, 5P02-30, 5P02-35); ARCHITECT 2nd Generation Testosterone Calibrators (LN 2P13-01); ARCHITECT 2nd Generation Testosterone Controls (LN 2P13-10); ARCHITECT AFP Calibrators (LN 3P36-01); ARCHITECT AFP Controls (LN 3P36-10); ARCHITECT AFP Reagent Kit (LN 3P36-25, 3P36-35); ARCHITECT ANTI HCV CALIBRATOR (LN 1L79-01); ARCHITECT ANTI-HCV CONTROLS (LN 1L79-10); ARCHITECT ANTI-HCV REAGENT KIT (LN 1L79-25, 1L79-35); ARCHITECT AUSAB Calibrators (LN 1L82-02, 1L82-03); ARCHITECT AUSAB Controls (LN 1L82-12, 1L82-13); ARCHITECT AUSAB Reagent Kit (LN 1L82-25, 1L82-35, 1L82-26, 1L82-27, 1L82-36, 1L82-37); ARCHITECT AUSAB Reagent Kit (LN 1L82-28, 1L82-38); ARCHITECT AUSAB Specimen Diluent (LN 1L82-40); ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (LN 3P24-01); ARCHITECT Active-B12 (Holotranscobalamin) Calibrators (LN 3P24-02); ARCHITECT Active-B12 (Holotranscobalamin) Controls (LN 3P24-10); ARCHITECT Active-B12 (Holotranscobalamin) Controls (LN 3P24-11); ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit (LN 3P24-25); ARCHITECT Active-B12 (Holotranscobalamin) Reagent Kit (LN 3P24-28, 3P24-38); ARCHITECT Anti-CCP Calibrators (LN 1P65-01); ARCHITECT Anti-CCP Controls (LN 1P65-10); ARCHITECT Anti-CCP Reagent Kit (LN 1P65-25); ARCHITECT Anti-TPO Calibrators (LN 2K47-01); ARCHITECT Anti-TPO Controls (LN 2K47-10); ARCHITECT Anti-TPO Reagent Kit (LN 2K47-27); ARCHITECT Anti-Tg Calibrators (LN 2K46-01); ARCHITECT Anti-Tg Controls (LN 2K46-10); ARCHITECT Anti-Tg Reagent Kit (LN 2K46-20, 2K46-25); ARCHITECT B12 Calibrators (LN 7K61-02); ARCHITECT B12 Controls (LN 7K61-12); ARCHITECT B12 Reagent Kit (LN 7K61-27, 7K61-37); ARCHITECT BNP Calibrators - LN 8K28-02, 8K28-03, 8K28-04; ARCHITECT BNP Controls - LN 8K28-11, 8K28-12, 8K28-13; ARCHITECT BNP Reagent Kit - LN 8K28-27 8K28-35 8K28-28 8K28-36; ARCHITECT BRAHMS PCT Calibrators (LN 6P22-01); ARCHITECT BRAHMS PCT Controls (LN 6P22-10); ARCHITECT BRAHMS PCT Reagent Kit (LN 6P22-27, 6P22-37); ARCHITECT C-Peptide Reagent Kit (LN 3L53-27); ARCHITECT CA125 II Calibrators - LN 02K4502; ARCHITECT CA125 II Controls - LN 02K4511; ARCHITECT CA125 II Reagent Kit - LN 02K4524 02K4529 and 02K4539; ARCHITECT CA15-3 Calibrators - LN 02K4402; ARCHITECT CA15-3 Controls - LN 02K4411; ARCHITECT CA15-3 Reagent Kit - LN 02K4421 02K4427 02K4437; ARCHITECT CA19-9XR Calibrators - LN 02K9103; ARCHITECT CA19-9XR Controls - LN 02K9112; ARCHITECT CA19-9XR Reagent Kit - LN 02K9133; ARCHITECT CEA Calibrators (LN 7K68-02); ARCHITECT CEA Controls (LN 7K68-12); ARCHITECT CEA Reagent Kit (LN 7K68-27, 7K68-32, 7K68-35); ARCHITECT CORE Calibrators (LN 6L22-01); ARCHITECT CORE Controls (LN 6L22-10); ARCHITECT CORE Reagent Kit (LN 6L22-25); ARCHITECT CORE-M CALIBRATORS (LN 6L23-01); ARCHITECT CORE-M CONTROLS (LN 6L23-10); ARCHITECT CORE-M REAGENT KIT (LN 6L23-25); ARCHITECT Cortisol Calibrators (LN 8D15-02); ARCHITECT Cortisol Reagent Kit (LN 8D15-25, 8D15-35); ARCHITECT DHEA-S Calibrators (LN 8K27-02); ARCHITECT DHEA-S Controls (LN 8K27-11); ARCHITECT DHEA-S Reagent Kit (LN 8K27-27); ARCHITECT ESTRADIOL CALIBRATORS (LN 7K72-01); ARCHITECT ESTRADIOL CONTROLS (LN 7K72-10); ARCHITECT Estradiol Manual Diluent (LN 7K72-50); ARCHITECT Estradiol Reagent Kit (LN 7K72-25, 7K72-35); ARCHITECT FERRITIN Controls (LN 7K59-10); ARCHITECT FERRITIN Reagent Kit (LN 7K59-25, 7K59-35); ARCHITECT FSH CALBRATORS (LN 7K75-01); ARCHITECT FSH CONTROLS (LN 7K75-10); ARCHITECT FSH Reagent Kit (LN 7K75-25, 7K75-35); ARCHITECT Folate Calibrators (LN 1P74-02); ARCHITECT Folate Controls (LN 1P74-12); ARCHITECT Folate Manual Diluent (LN 1P74-50); ARCHITECT Folate Reagent Kit (LN 1P74-27, 1P74-37); ARCHITECT Free PSA Calibrators (LN 6C07-01); ARCHITECT Free PSA Controls (LN 6C07-10); ARCHITECT Free PSA Reagent Kit (LN 6C07-27); ARCHITECT Free T3 Calibrators (LN 7K63-01); ARCHITECT Free T3 Calibrators (LN 7K63-02); ARCHITECT Free T3 Controls (LN 7K63-10, 7K63-12); ARCHITECT Free T3 Reagent Kit (LN 7K63-25, 7K63-35, 7K63-27, 7K63-32, 7K63-37); ARCHITECT Free T4 Calibrators (LN 7K65-02); ARCHITECT Free T4 Controls (LN 7K65-10); ARCHITECT Free T4 Reagent Kit (LN 7K65-27, 7K65-32, 7K65-35); ARCHITECT Free T4 Reagent Kit (LN 7K65-29, 7K65-34, 7K65-39); ARCHITECT Galectin-3 Calibrators - LN 05P0301; ARCHITECT Galectin-3 Controls - LN 05P0310; ARCHITECT Galectin-3 Reagent Kit - LN 05P0327; ARCHITECT Glucose2 (LN 04T0120, 04T0130); ARCHITECT HAVAB-G Calibrator (LN 6L27-01); ARCHITECT HAVAB-G Controls (LN 6L27-10); ARCHITECT HAVAB-G Reagent Kit (LN 6L27-25); ARCHITECT HAVAB-M Calibrator (LN 6L21-01); ARCHITECT HAVAB-M Controls (LN 6L21-10); ARCHITECT HAVAB-M Reagent Kit (LN 6L21-25); ARCHITECT HBsAg Next Confirmatory Manual Diluent (LN 4P77-42); ARCHITECT HBsAg Next Confirmatory Reagent Kit (LN 4P77-27); ARCHITECT HBsAg Next Qualitative Calibrators (LN 4P76-02); ARCHITECT HBsAg Next Qualitative Controls (LN 4P76-12); ARCHITECT HBsAg Next Qualitative Reagent Kit (LN 4P76-27, 4P76-37, 4P76-32); ARCHITECT HBsAg Qualitative Calibrators (LN 4P53-01); ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent (LN 4P54-40); ARCHITECT HBsAg Qualitative Confirmatory Reagent Kit (LN 4P54-25); ARCHITECT HBsAg Qualitative Controls (LN 4P53-10); ARCHITECT HBsAg Qualitative Reagent Kit (LN 4P53-25, 4P53-35); ARCHITECT HE4 Calibrators - LN 02P5401; ARCHITECT HE4 Controls - LN 02P5410; ARCHITECT HE4 Reagent Kit - LN 02P5427; ARCHITECT HIV Ag/Ab Combo Calibrator (LN 2P36-01); ARCHITECT HIV Ag/Ab Combo Controls (LN 2P36-10); ARCHITECT HIV Ag/Ab Combo Reagent Kit (LN 2P36-25, 2P36-35); ARCHITECT Homocysteine Calibrators (LN 1L71-01); ARCHITECT Homocysteine Controls (LN 1L71-10); ARCHITECT Homocysteine Reagent Kit (LN 1L71-27); ARCHITECT Insulin Calibrators (LN 08K4103); ARCHITECT Insulin Controls (LN 08K4112); ARCHITECT Insulin Reagent Kit (LN 8K41-28); ARCHITECT LH Calibrators (LN 2P40-01); ARCHITECT LH Reagent Kit (LN 2P40-25, 2P40-35); ARCHITECT PROGESTERONE CALIBRATORS (LN 7K77-01); ARCHITECT PROGESTERONE CONTROLS (LN 7K77-10); ARCHITECT PROLACTIN CALIBRATORS (LN 7K76-01); ARCHITECT PROLACTIN CONTROLS (LN 7K76-10); ARCHITECT Phenobarbital Calibrators (LN 1P33-01); ARCHITECT Phenobarbital Reagent Kit (LN 1P33-25); ARCHITECT Progesterone Manual Diluent (LN 7K77-50); ARCHITECT Progesterone Reagent Kit (LN 7K77-25, 7K77-35); ARCHITECT Prolactin Reagent Kit (LN 7K76-25, 7K76-35); ARCHITECT ROMA (LN 6P30-21); ARCHITECT SHBG Calibrators (LN 8K26-02); ARCHITECT SHBG Controls (LN 8K26-11); ARCHITECT SHBG Reagent Kit (LN 8K26-27); ARCHITECT STAT CK-MB Reagent Kit (LN 2K42-25, 2K42-35); ARCHITECT STAT High Sensitivity Troponin-I Calibrators (LN 2R98-01); ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10); ARCHITECT STAT High Sensitivity Troponin-I Reagent Kit (LN 2R98-25, 2R98-35); ARCHITECT STAT Myoglobin Calibrators (LN 2K43-01); ARCHITECT STAT Myoglobin Reagent Kit (LN 2K43-20, 2K43-25); ARCHITECT Syphilis TP Calibrator (LN 8D06-04); ARCHITECT Syphilis TP Controls (LN 8D06-13); ARCHITECT Syphilis TP Reagent Kit (LN 8D06-31, 8D06-41); ARCHITECT System; ARCHITECT System Accessories; ARCHITECT T-Uptake Reagent Kit (LN 02K4820 and 02K4825); ARCHITECT TOTAL B-HCG Calibrators (LN 7K78-01); ARCHITECT TOTAL B-HCG Controls (LN 7K78-10); ARCHITECT TOTAL B-HCG Reagent Kit (LN 7K78-25, 7K78-30, 7K78-35); ARCHITECT TSH Calibrators (LN 7K62-01); ARCHITECT TSH Controls (LN 7K62-10); ARCHITECT TSH Reagent Kit (LN 7K62-25, 7K62-30, 7K62-35); ARCHITECT Total PSA Calibrators (LN 6C06-01); ARCHITECT Total PSA Controls (LN 6C06-10); ARCHITECT Total PSA Reagent Kit (LN 6C06-27, 6C06-35); ARCHITECT Total T3 Calibrators (LN 7K64-01); ARCHITECT Total T3 Calibrators (LN 7K64-02); ARCHITECT Total T3 Manual Diluent (7K64-50); ARCHITECT Total T3 Reagent Kit (LN 7K64-25, 7K64-35, 7K64-27, 7K64-32, 7K64-37); ARCHITECT Total T4 Calibrators (LN 7K66-01); ARCHITECT Total T4 Calibrators (LN 7K66-02); ARCHITECT Total T4 Controls (LN 7K66-10, 7K66-12); ARCHITECT Total T4 Reagent Kit (LN 7K66-25, 7K66-30, 7K66-35, 7K66-27, 7K66-32, 7K66-37); ARCHITECT iCarbamazepine Calibrator A Multi-Pack (LN 1P36-50); ARCHITECT iCarbamazepine Calibrators (LN 1P36-01); ARCHITECT iCarbamazepine Reagent Kit (LN 1P36-27); ARCHITECT iGentamicin (LN 1P31-27); ARCHITECT iGentamicin Calibrators (LN 1P31-01); ARCHITECT iGentamicin Reagent Kit (LN 1P31-25); ARCHITECT iPTH Calibrators (LN 8K25-04); ARCHITECT iPTH Controls (LN 8K25-13); ARCHITECT iPTH Reagent Kit (LN 8K25-29); ARCHITECT iPhenytoin Calibrators (LN 1P34-01); ARCHITECT iPhenytoin Reagent Kit (LN 1P34-25); ARCHITECT iValproic Calibrators (LN 1P35-01); ARCHITECT iValproic Reagent Kit (LN 1P35-25); ARCHITECt STAT CK-MB Calibrators (LN 2K42-01); ARCHTIECT FERRITIN Calibrators (LN 7K59-01); Abbott Bisulfite Modification Kit; Abbott Proteinase K; Abbott mSample Preparation System Bulk mLysis DNA Buffer; Acetaminophen Calibrator (Alinity c, LN 07P5401); Acetaminophen Calibrator (LN 03R7401); Activated Alanine Aminotransferase (A-ALT) (Alinity c, LN 08P1824); Activated Alanine Aminotransferase (ARCHITECT, LN 08L9224, 08L9244); Activated Aspartate Aminotransferase (A-AST) (Alinity c, LN 08P2324); Activated Aspartate Aminotransferase (ARCHITECT, LN 08L9124, 08L9144); Activated Aspartate Aminotransferase (LN 8L91-22, 8L91-42); Alanine Aminotransferase2 (ARCHITECT; LN 04S8820, 04S8830); Alanine Aminotransferase2 (Alinity c; LN 04T8420, 04T8430); Albumin BCG2 (ARCHITECT, LN 04T3420 and 04T3430); Albumin BCG2 (Alinity c, LN 04U3020 and 04U3030); Albumin BCP2 (ARCHITECT, LN 04U4520 and 04U4530); Albumin BCP2 (Alinity c, LN 04T8220 and 04T8230); Alcohol Diluent GPR 60 mL; Alere NT-proBNP for Alinity i Calibrators (LN 04S7902); Alere NT-proBNP for Alinity i Controls (LN 04S7911); Aliniity c Immunoglobulin G Reagent Kit (LN 09P6220); Alinity Alkaline Phosphatase2 (LN 04T8320, 04T8330); Alinity c ASO Calibrator (LN 01R0602); Alinity c ASO Control I (LN 04S0912); Alinity c ASO Control II (LN 04S0913); Alinity c Activated Alanine Aminotransferase Reagent Kit (LN 08P1820); Alinity c Activated Apartate Aminotransferase Reagent Kit (LN 08P2320); Alinity c Alanine Aminotransferase Reagent Kit (LN 07P9820); Alinity c Ammonia Controls (LN 08P2210); Alinity c Ammonia Ultra Reagent Kit (LN 08P2220); Alinity c Apolipoprotein A1 Reagent Kit (LN 09P4620); Alinity c Apolipoprotein B Reagent Kit (LN 09P4720); Alinity c Aspartate Aminotransferase Reagent Kit (LN 08P1720); Alinity c B2-Microglobulin Calibrator (LN 01R0902); Alinity c Bilirubin Calibrator Kit (LN 08P6101); Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (07P5605); Alinity c CRP Vario HS Control Kit (LN 07P5612); Alinity c CRP Vario High Sensitivity Calibrator Kit (07P5604); Alinity c CRP Vario Reagent Kit (LN 07P5621); Alinity c CRP Vario Reagent Kit (LN 07P5624); Alinity c CRP Vario Wide Range Calibrator Kit (LN 07P5603); Alinity c Cannabinoids Control 1 Kit (LN 09P5410); Alinity c Cannabinoids Control 2 Kit (LN 09P5411); Alinity c Carbon Dioxide Calibrator Kit (LN 08P7201); Alinity c Ceruloplasmin Reagent Kit (LN 09P9320); Alinity c Clinical Chemistry Calibrator Kit (LN 08P6503); Alinity c Complement C3 Reagent Kit (LN 09P5620); Alinity c Complement C4 Reagent Kit (LN 09P5720); Alinity c Creatinine (Enzymatic) Reagent Kit (LN 08P0120, 08P0130); Alinity c Gamma-Glutamyl Transferase Reagent Kit (LN 07P7320, 07P7330); Alinity c Glucose Reagent Kit (LN 07P5520, 07P5530); Alinity c Glucose2 (LN 04T9720, 04T9730); Alinity c Haptoglobin Reagent Kit (LN 09P5920); Alinity c Hemoglobin A1c Calibrators (LN 08P4301); Alinity c Hemoglobin A1c Controls (LN 08P4310); Alinity c Hemoglobin A1c Reagent Kit (LN 08P4320, 08P4321); Alinity c ICT Serum Calibrator Kit (LN 08P6901); Alinity c ICT Urine Calibrator Kit (LN 08P7001); Alinity c Immunoglobulin A Reagent Kit (LN 09P6120); Alinity c Immunoglobulin M Reagent Kit (LN 09P6320); Alinity c Iron Calibrator Kit (LN 04U7501); Alinity c Iron Reagent Kit (LN 08P3920); Alinity c Lactate Dehydrogenase Reagent Kit (LN 07P7420, 07P7430); Alinity c Lactic Acid Reagent Kit (LN 08P2120, 08P2121); Alinity c Lipid Multiconstituent Calibrator Kit (LN 09P1403); Alinity c Lithium Reagent Kit (LN 08P5320); Alinity c Lp(a) Calibrators (LN 01R1401); Alinity c Lp(a) Control Kit (LN 01R1410); Alinity c Magnesium Reagent Kit (LN 08P1920, 08P1930); Alinity c Microalbumin Calibrators - LN 08P0401; Alinity c Microalbumin Controls - LN 08P0410; Alinity c Microalbumin Reagent Kit - LN 08P0420; Alinity c Multiconstituent Calibrator Kit (LN 08P6001); Alinity c Phosphorus Reagent Kit (LN 08P4020, 08P4030); Alinity c Plasmaproteins Cal 3x Kit (LN 08P6601); Alinity c Prealbumin Calibrator Kit (LN 04S0101); Alinity c Prealbumin Reagent Kit (LN 09P8620); Alinity c Processing Module (LN 03R6701); Alinity c Proteins Calibrators (LN 08P6702); Alinity c Proteins Control Kit (LN 08P6712); Alinity c Rheumatoid Factor Calibrator Kit (LN 04S0002); Alinity c Rheumatoid Factor Reagent Kit (LN 04R9921); Alinity c Specific Proteins Multiconstituent Calibrator Kit (LN 08P6201); Alinity c System; Alinity c System Accessories; Alinity c Total Protein Reagent Kit (LN 07P5220); Alinity c Transferrin Reagent Kit (LN 08P3820); Alinity c UIBC Calibrator Kit (LN 08P4401); Alinity c UIBC Reagent Kit (LN 08P4420); Alinity c Uric Acid Reagent Kit (LN 08P5620, 08P5630); Alinity c Urine/CSF Protein Calibrator Kit (LN 08P7101); Alinity c-series Reagent Cartridge, Black (Large) (LN 04S1760); Alinity ci-series System Control Module (LN 03R7001); Alinity h-series AutoClean Solution (LN 01R5104); Alinity h-series Diluent (LN 04R2601); Alinity h-series Glass Slides (LN 09P8420); Alinity h-series HGB Reagent (LN 07P8104); Alinity h-series May-Grunwald-Giemsa Stain (LN 08P8101); Alinity h-series Phosphate Buffer (LN 07P8301); Alinity h-series Retic Reagent (LN 07P8004); Alinity h-series Smear Fix (LN 08P7901); Alinity h-series WBC Reagent (LN 07P7904); Alinity h-series Water Purification System (LN 09P7101); Alinity h-series Wright-Giemsa Stain (LN 08P8001); Alinity i 25-OH Vitamin D Calibrators (LN 08P4501); Alinity i 25-OH Vitamin D Controls (LN 08P4512); Alinity i 25-OH Vitamin D Reagent Kit (08P4522, 08P4532); Alinity i 2nd Generation Testosterone Calibrators (LN 07P6801); Alinity i 2nd Generation Testosterone Controls (LN 07P6810); Alinity i AFP Calibrators (LN 07P9001); Alinity i AFP Controls (LN 07P9010); Alinity i AFP Reagent Kit (LN 07P9020, 07P9030); Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2601); Alinity i Active-B12 (Holotranscobalamin) Calibrators (LN 09P2602); Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610); Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2611); Alinity i Active-B12 (Holotranscobalamin) Reagent Kit (LN 09P2620); Alinity i Active-B12 (Holotranscobalamin) Reagent Kit (LN 09P2625, 09P2635); Alinity i Anti-CCP Calibrators (LN 09P2701); Alinity i Anti-CCP Controls (LN 09P2710); Alinity i Anti-CCP Reagent Kit (LN 09P2720); Alinity i Anti-HBc Calibrator (LN 07P8401); Alinity i Anti-HBc Controls (LN 07P8410); Alinity i Anti-HBc IgM Calibrators (LN 07P8602); Alinity i Anti-HBc IgM Controls (LN 07P8612); Alinity i Anti-HBc IgM Reagent Kit (LN 07P8621); Alinity i Anti-HBc Reagent Kit (LN 07P8421, 07P8431); Alinity i Anti-HBs Calibrators (LN 07P8801); Alinity i Anti-HBs Controls (LN 07P8810); Alinity i Anti-HBs Reagent Kit (LN 07P8851, 07P8856); Alinity i Anti-HBs Reagent Kit (LN 07P8852, 07P8857); Alinity i Anti-HBs Specimen Diluent (LN 07P8841); Alinity i Anti-HCV Calibrator (LN 08P0501); Alinity i Anti-HCV Controls (LN 08P0510); Alinity i Anti-HCV Reagent Kit (LN 08P0521); Alinity i Anti-TPO Calibrators (LN 09P3501); Alinity i Anti-TPO Controls (LN 09P3510); Alinity i Anti-TPO Reagent Kit (LN 09P3521); Alinity i Anti-Tg Calibrators (LN 09P3401); Alinity i Anti-Tg Controls (LN 09P3410); Alinity i Anti-Tg Reagent Kit (LN 09P3420); Alinity i B12 Calibrators (LN 07P6702); Alinity i B12 Controls (LN 07P6712); Alinity i B12 Reagent Kit (LN 07P6721, 07P6731); Alinity i BRAHMS PCT Calibrators (LN 01R1801); Alinity i BRAHMS PCT Controls (LN 01R1810); Alinity i BRAHMS PCT Reagent Kit (LN 01R1821); Alinity i C-Peptide Calibrators (LN 09P3601); Alinity i C-Peptide Controls (LN 09P3610); Alinity i C-Peptide Reagent Kit (LN 09P3620); Alinity i CA 125 II Calibrators (LN 08P4901); Alinity i CA 125 II Controls (LN 08P4910); Alinity i CA 125 II Reagent Kit - LN 08P4920 and 08P4930; Alinity i CA 15-3 Calibrators (LN 08P5101); Alinity i CA 15-3 Controls (LN 08P5110); Alinity i CA 15-3 Reagent Kit - LN 08P5120 and 08P5130; Alinity i CA 19-9XR Calibrators (LN 08P3201); Alinity i CA 19-9XR Controls (LN 08P3210); Alinity i CA 19-9XR Reagent Kit - LN 08P3221; Alinity i CEA Calibrators (LN 07P6201); Alinity i CEA Controls (LN 07P6210); Alinity i CEA Reagent Kit (LN 07P6220, 07P6230); Alinity i CMV IgG Calibrators (LN 07P4202); Alinity i CMV IgG Controls (LN 07P4212); Alinity i CMV IgG Reagent Kit (LN 07P4224, 07P4233); Alinity i Cortisol Calibrators (LN 08P3301); Alinity i Cortisol Reagent Kit (LN 08P3320, 08P3330); Alinity i DHEA-S Calibrators (LN 09P3701); Alinity i DHEA-S Controls (LN 09P3710); Alinity i DHEA-S Reagent Kit (LN 09P3720); Alinity i Estradiol Calibrators (LN 07P5001); Alinity i Estradiol Controls (LN 07P5010); Alinity i Estradiol Manual Diluent Kit (LN 07P5040); Alinity i Estradiol Reagent Kit (LN 07P5020, 07P5030); Alinity i FSH Calibrators (LN 07P4901); Alinity i FSH Controls (LN 07P4910); Alinity i FSH Reagent Kit (LN 07P4920, 07P4930); Alinity i Ferritin Calibrators (LN 07P6501); Alinity i Ferritin Controls (LN 07P6510); Alinity i Ferritin Reagent Kit (LN 07P6520, 07P6530); Alinity i Folate Calibrators (LN 08P1402); Alinity i Folate Controls (LN 08P1412); Alinity i Folate Manual Diluent (08P1460); Alinity i Folate Reagent Kit (LN 08P1421, 08P1431); Alinity i Free PSA Calibrators (LN 07P9301); Alinity i Free PSA Controls (LN 07P9310); Alinity i Free PSA Reagent Kit (LN 07P9321, 07P9331); Alinity i Free T3 Calibrators (LN 07P6901); Alinity i Free T3 Controls (LN 07P6910); Alinity i Free T3 Reagent Kit (LN 07P6920, 07P6930); Alinity i Free T4 Calibrators (LN 07P7001); Alinity i Free T4 Controls (LN 7P7010); Alinity i Free T4 Reagent Kit (LN 07P7020, 07P7030); Alinity i HAVAb IgG Calibrator (LN 08P2701); Alinity i HAVAb IgG Controls (LN 08P2710); Alinity i HAVAb IgG Reagent Kit (LN 08P2721); Alinity i HAVAb IgM Calibrator (LN 08P2801); Alinity i HAVAb IgM Controls (LN 08P2810); Alinity i HAVAb IgM Reagent Kit (LN 08P2821, 08P2831); Alinity i HBsAg Next Confirmatory Manual Diluent (LN 01R6542); Alinity i HBsAg Next Confirmatory Reagent Kit (LN 01R6521); Alinity i HBsAg Next Qualitative Calibrators (LN 01R6402); Alinity i HBsAg Next Qualitative Controls (LN 01R6412); Alinity i HBsAg Next Qualitative Reagent Kit (LN 01R6421, 01R6431); Alinity i HBsAg Qualitative II Calibrators (LN 08P1002); Alinity i HBsAg Qualitative II Confirmatory Manual Diluent (LN 08P1141); Alinity i HBsAg Qualitative II Confirmatory Reagent Kit (LN 08P1121); Alinity i HBsAg Qualitative II Controls (LN 08P1012); Alinity i HBsAg Qualitative II Reagent Kit (LN 08P1021, 08P1031); Alinity i HE4 Calibrators (LN 08P5001); Alinity i HE4 Controls (LN 08P5010); Alinity i HE4 Reagent Kit - LN 08P5021; Alinity i HIV Ag/Ab Combo Calibrator (LN 08P0702); Alinity i HIV Ag/Ab Combo Controls (LN 08P0712); Alinity i HIV Ag/Ab Combo Reagent Kit (LN 08P0721, 08P0731); Alinity i Homocysteine Calibrators (LN 09P2801); Alinity i Homocysteine Controls (LN 09P2810); Alinity i Homocysteine Reagent Kit (LN 09P2820); Alinity i Insulin Calibrators (LN 04T7501); Alinity i Insulin Controls (LN 04T7510); Alinity i Insulin Reagent Kit (LN 04T7520); Alinity i Intact PTH Calibrators (LN 08P3102); Alinity i Intact PTH Controls (LN 08P3111); Alinity i Intact PTH Reagent Kit (LN 08P3121); Alinity i LH Calibrators (LN 07P9101); Alinity i LH Reagent Kit (LN 07P9120, 07P9130); Alinity i Progesterone Calibrators (LN 08P3601); Alinity i Progesterone Controls (LN 08P3610); Alinity i Progesterone Manual Diluent Kit (LN 08P3640); Alinity i Progesterone Reagent Kit (LN 08P3620, 08P3630); Alinity i Prolactin Calibrators (LN 07P6601); Alinity i Prolactin Controls (LN 07P6610); Alinity i Prolactin Reagent Kit (LN 07P6620, 07P6630); Alinity i ROMA (LN 03R7521); Alinity i Refurbished Processing Module (LN 03R65-84); Alinity i Rubella IgG Calibrators (LN 04W02-01); Alinity i Rubella IgG Controls (LN 04W02-10); Alinity i Rubella IgG Reagent Kit (LN 04W02-22); Alinity i SHBG Calibrators (LN 09P3801); Alinity i SHBG Controls (LN 09P3810); Alinity i SHBG Reagent Kit (LN 09P3820); Alinity i STAT CK-MB Calibrators (LN 04V3801); Alinity i STAT CK-MB Controls (LN 04V3810); Alinity i STAT CK-MB Reagent Kit (LN 04V3821, 04V3831); Alinity i STAT High Sensitivity Troponin-I (LN 04Z2125, 04Z2135); Alinity i STAT High Sensitivity Troponin-I Calibrators (LN 04Z2101); Alinity i STAT High Sensitivity Troponin-I Controls (LN 04Z2110); Alinity i STAT High Sensitivity Troponin-I Reagent Kit (LN 04Z2125, 04Z2135); Alinity i STAT Myoglobin Calibrators (LN 04V3701); Alinity i STAT Myoglobin Controls (LN 04V3710); Alinity i STAT Myoglobin Reagent Kit (LN 04V3720, 04V3730); Alinity i Sirolimus Calibrators (LN 09P4101); Alinity i Syphilis TP Calibrator (LN 07P6001); Alinity i Syphilis TP Controls (LN 07P6010); Alinity i Syphilis TP Reagent Kit (LN 07P6021, 07P6031); Alinity i System; Alinity i System Accessories; Alinity i T-Uptake Calibrators (LN 08P1201); Alinity i T-Uptake Controls (LN 08P1210); Alinity i T-Uptake Reagent Kit (LN 08P1220); Alinity i TSH Calibrators (LN 07P4801); Alinity i TSH Controls (LN 07P4810); Alinity i TSH Reagent Kit (LN 07P4820, 07P4830); Alinity i Tacrolimus Calibrators (LN 09P4201); Alinity i Total B-HCG Controls (LN 07P5110); Alinity i Total B-hCG Calibrators (LN 07P5101); Alinity i Total B-hCG Reagent Kit (LN 07P5121, 07P5131); Alinity i Total PSA Calibrators (LN 07P9201); Alinity i Total PSA Controls (LN 07P9210); Alinity i Total PSA Reagent Kit (LN 07P9221, 07P9231); Alinity i Total T3 Calibrators (LN 07P9401); Alinity i Total T3 Manual Diluent (LN 07P9440); Alinity i Total T3 Reagent Kit (LN 07P9420, 07P9430); Alinity i Total T4 Calibrators (LN 07P9501); Alinity i Total T4 Controls (LN 07P9510); Alinity i Total T4 Reagent Kit (LN 07P9520, 07P9530); Alinity i Toxo IgG Calibrators (LN 07P4504); Alinity i Toxo IgG Controls (LN 07P4514); Alinity i Toxo IgG Reagent Kit (LN 07P4540, 07P4545); Alinity i Toxo IgM Calibrator (LN 07P47-04); Alinity i Toxo IgM Controls (LN 07P47-14); Alinity i Toxo IgM Reagent Kit (LN 07P47-40 and 07P47-45); Alinity s System; Alinity s System Accessories; Ammonia Controls (LN 6K89-20); Ammonia Ultra (LN 6K89-30); Amylase2 (04S89-20, 04T8520); Anti-HCV Next Calibrator (LN 06T7901); Anti-HCV Next Controls (LN 06T7910); Anti-HCV Next Reagent Kit (LN 06T7921, 06T7931); Anti-HCV Next Reagent Kit (LN 06T7931); Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (100 mL); Antibody Diluent 2.5X DF with 2X NAD and G6P GPR (1000 mL); Antibody Diluent DF 2X NAD and G6P GPR (100 mL); Antibody Diluent DF 2X NAD and G6P GPR (1000 mL); Antibody Diluent DF with Low NAD & G6P 2X NAD & G6P GPR (1000 Ml); Antifade II Solution 60 ?L x 2; Antifade II Solution, 2 x 60 uL, For Laboratory Use; Antifade Solution, 2 x 240 µL For Laboratory Use; Apolipoprotein A1 (ARCHITECT, LN 09D9224); Apolipoprotein A1 (Alinity c, LN 09P4624); Apolipoprotein B (ARCHITECT, LN 09D9324); Apolipoprotein B (Alinity c, LN 09P4724); Aqua dUTP; Architect Alkaline Phosphatase2 (LN 04S8720, 04S8730); Architect C-Peptide Calibrators (LN 3L53-02); Architect C-Peptide Controls (LN 3L53-11); Architect iDigoxin Calibrators (LN 1P32-02); Architect iDigoxin Reagent Kit (LN 1P32-27); Architect iTheophylline Calibrators (LN 1P29-02); Architect iTheophylline Reagent Kit (LN 1P29-27); Architect iVancomycin Calibrators (LN 1P30-02); Aspartate Aminotranserase (LN 7D81-22); Aspartate Aminotransferase2 (ARCHITECT; LN 04S9020, 04S9030); Aspartate Aminotransferase2 (Alinity c; LN 04T8620,04T8630); Bilirubin Calibrator (LN 1E66-05); CELL-DYN CN Free HGB/NOC Lyse (LN 03H80-02); CELL-DYN CN-Free HGB Reagent (LN 01H79-01); CELL-DYN Diluent/Sheath (LN 01H73-01); CELL-DYN EMERALD (LN 09H39-01); CELL-DYN Emerald 22 (LN 09H5901); CELL-DYN Emerald 22 Diluent (LN 09H62-01); CELL-DYN Emerald 22 Easy Cleaner (LN 09H60-03); CELL-DYN Emerald 22 Lyse (LN 09H6101); CELL-DYN Emerald CN-Free Lyse (LN 09H47-02); CELL-DYN Emerald Cleaner (LN 09H46-02); CELL-DYN Emerald Diluent (LN 09H48-02); CELL-DYN Enzymatic Cleaner Concentrate (LN 99644-01); CELL-DYN Reticulocyte Reagent (LN 03H40-01); CELL-DYN Sapphire System Reticulocyte Reagent (LN 01H76-01); CELL-DYN WBC Lyse (LN 08H52-01); CELL-DYN WBC Reagent - Part A (LN 01H77-01/01H77-02); CELL-DYN WBC Reagent - Part B (LN 01H78-01/01H78-02); CEP Hybridization Buffer; CGH Control DNA (MPE 600) Unlabeled; CGH Hybridization Reagent Kit Assembly; CGH NICK TRANSLATION REAGENTSET; CGH NICK Translation Reagent Set; CGH Target Slides; CRP Calibrator HS (LN 6K26-14); CRP Calibrator Set (LN 6K26-10); CRP Calibrator WR (Wide Range) (LN 6K26-12); CRP Control HS (LN 6K26-21); CRP Vario (LN 6K26-30, 6K26-41); CRP Vario (LN 6K26-31 and 6K26-42); CVS Ovulation Predictor Test; Carbon Dioxide Calibrator (LN 1E64-03); Ceruloplasmin (LN 6K91-30); Cholesterol2 (ARCHITECT, LN 04S9230 and 04S9220 ); Cholesterol2 (Alinity c, LN 04T8830); Clinical Chemistry Calibrator (LN 6K30-10); Complement C3 (ARCHITECT, LN 09D9624); Complement C3 (Alinity c, LN 09P5624); Complement C3 (LN 9D96-21, 9D96-22); Complement C4 (ARCHITECT, LN 09D9724); Complement C4 (Alinity c, LN 09P5724); Complement C4 (LN 9D97-21, 9D97-22); Consolidated Chemistry Calibrator (ARCHITECT; LN 04V1501); Consolidated Chemistry Calibrator (Alinity c; LN 04V6201); Creatinine Enzymatic (LN 8L24-31, 8L24-41); Creatinine2 (ARCHITECT, LN 04S9520); Creatinine2 (Alinity c, LN 04T9120); Cystatin C (LN 06T3220, 06T3230); Cystatin C Calibrators (LN 06T3201); Cystatin C Controls (LN 06T3210); DAPI I Counterstain (1000 ng/mL) 500 ?L x 2; DAPI II  Counterstain (125 ng/mL); DAPI III Counterstain (42 ng/mL) 500 ?L x 2; DNA AMP Check; DNA Activation Reagent; Emerald 22 Autoloader Analyzer (LN 04R1301); Enzyme Conjugate Diluent 2.5X DF with Low Sodium Bisulfite GPR (600 mL); Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (40 mL); Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (400 mL); Enzyme Conjugate Diluent 2X DF with Low Sodium Bisulfite GPR (60 mL); Enzyme Conjugate Diluent DF GPR (60 mL); Enzyme Conjugate Diluent DF GPR (600 mL); Enzyme Conjugate Diluent DF GPR (70 mL); Enzyme Conjugate Diluent DF GPR (700 mL); Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (100 mL); Enzyme Conjugate Diluent DF with Sodium Bisulfite GPR (1000 mL); FISH Specimen Pretreatment Reagent Kit; FreeStyle Control Solution; GAMMA-GLUTAMYL TRANSFERASE (GGT) (LN 7D65-21, 7D65-22, 7D65-42); GFAP Calibrators (ARCHITECT, LN 4W16-01); GFAP Calibrators (Alinity i, LN 04W1701); GFAP Controls (ARCHITECT, LN 4W16-10); GFAP Controls (Alinity i, LN 04W1710); GFAP Reagent Kit (ARCHITECT, LN 4W16-27); GFAP Reagent Kit (Alinity i, LN 04W1722); GLP systems Track (LN 04Z96-51); Gamma-Glutamyl Transferase2 (ARCHITECT; LN 04T0020, 04T0030); Gamma-Glutamyl Transferase2 (Alinity c; LN 04T9620, 04T9630); Gold dUTP; Green dUTP; HAVAb IgG II Calibrator (LN 06S9301); HAVAb IgG II Controls (LN 06S9310); HAVAb IgG II Reagent Kit (LN 06S9321); HEIA Enzyme Conjugate Diluent DF GPR (100 mL); HEIA Enzyme Conjugate Diluent DF GPR (100 mL) HEIA Enzyme Conjugate Diluent DF GPR (1000 mL); Haptoglobin (ARCHITECT, LN 09D9124); Haptoglobin (Alinity c, LN 09P5924); Haptoglobin (LN 9D91-21); Hemo-De Solvent; Hemoglobin A1c (LN 4P52-20, 4P52-22); Hemoglobin A1c Calibrators (LN 4P52-01); Hemoglobin A1c Controls (LN 4P52-11); Higher pH Antibody Diluent DF 2X NAD and G6P GPR (100 mL); Higher pH Antibody Diluent DF 2X NAD and G6P GPR (1000 mL); Human Cot-1 DNA, 250 uL For Laboratory Use; ICT Serum Calibrator (LN 1E46-04); ICT Urine Calibrator (LN 1E47-03); Immunoglobulin A (IgA) (ARCHITECT, LN 09D9824); Immunoglobulin A (IgA) (Alinity c, LN 09P6124); Immunoglobulin A (IgA) (LN 9D98-21, 9D98-22); Immunoglobulin G (IgG) (ARCHITECT, LN 09D9924); Immunoglobulin G (IgG) (Alinity c, LN 09P6224); Immunoglobulin G (IgG) (LN 9D99-21, 9D99-22); Immunoglobulin M (IgM) (ARCHITECT, LN 01E0124); Immunoglobulin M (IgM) (Alinity c, LN 09P6324); Immunoglobulin M (IgM) (LN 1E01-21, 1E01-22); Iron (LN 6K95-30, 6K95-41); Iron2 (ARCHITECT, LN 04T0220); Iron2 (ARCHITECT, LN 04T0230); Iron2 (Alinity c, LN 04T9820); LACTATE DEHYDROGENASE (LDH) (LN 2P56-21, 2P56-22, 2P56-42); LIPASE (LN 7D80-31); LIPID MULTICONSTITUENT CALIBRATOR (LN 5P56-01); LSI®/WCP® Hybridization Buffer; LSI®/WCP® Hybridization Buffer 2 x 500 ?L, For Laboratory Use; Lactate Dehydrogenase2 (LN 04T0320, 04T0330, 04T9920, 04T9930); Lactic Acid (LN 09P1821); Lactic Acid2 (ARCHITECT, LN 04T3020); Lactic Acid2 (Alinity c, LN 04U2620); Lipase NG OC Calibrator (LN 04Y8501); Lipase NG OC Control 1 (LN 04Y8510); Lipase NG OC Control 2 (LN 04Y8511); Lipase2 (LN 04T0420, 04U0020); Lipase2 Calibrator (LN 04U0001, 04T0401); Lipid Multiconstituent Calibrator (LN 5P56-02); Lithium (LN 8L25-30); Lower pH Enzyme Conjugate Diluent DF GPR (60 mL); Lower pH Enzyme Conjugate Diluent DF GPR (600 mL)",1977-12-13,111,2026-09-23,9,17,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223002809144%22&limit=1
GE Healthcare Japan Corporation,9612283,3002808529,"7-127, Asahigaoka 4-chome",HINO-SHI Tokyo,,191-8503,Japan,GE HealthCare Technologies Inc.,9912004,Manufacturer; Specification developer,9,ITO; ITX; IYN; IYO; IZZ; JAK; MJG; OBJ; QIH,"Twister, Brace Setting; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Table, Radiographic, Non-Tilting, Powered; System, X-Ray, Tomography, Computed; Device, Percutaneous, Biopsy; Catheter, Ultrasound, Intravascular; Automated Radiological Image Processing Software",1; 2,"10-D; 10L; 10T-D; 11L; 11L-D; 12L; 12L-RS; 12L-SC; 12S-D; 12S-RS; 3.5C; 3CRF; 3S; 3S-D; 3S-SC; 3Sc-RS; 4C; 4C-RS; 4C-SC; 4D ICE catheter; 4D3C-L; 4Sc-RS; 4V-D; 4Vc-D; 5CS; 6S-D; 6S-RS; 6Sc-D; 6Tc; 6Tc-RS; 6VT-D; 6Vc-D; 7S; 8C; 8C-RS; 9L; 9L-D; 9L-RS; 9T; 9T-RS; 9VT-D; ASiR-V; BE9CS; BE9CS-D; BE9CS-RS; C1-5-D; C1-5-RS; C1-5-RS (only for Vivid T9); C1-6-D; C1-6-D Probe; C1-6VN-D; C2-9-D; C2-9-D Probe; C2-9-D Transducer; C2-9-RS; C2-9VN-D; C3-10-D; C4-8-D; CT660 Cj2.5 Upgrade; Console Generation Upgrade; DISCOVERY CT590 RT; Deep Learning Image Reconstruction; Discovery RT; E7C8L-RS; E8C; E8C Reusable Guide Attachment; E8C-RS; E8CS; E8CS-RS; E8CS-SC; E8Cs-RS; E8Cs-RS (only for Vivid T9); ERB; ERB7/ERB Biopsy Attachment; Enhanced Extream Injector Option; Extream Injector Option; G3 RAD Elevation Table; GCTBL-C4; GT1700V (GT1700V N9 ED3, GT1700V); GT1700V(GT1700V N9 ED3, GT1700V); IC5-9-D; IC9-D; IC9-RS; IC9B-RS; Kunlun Table; L10-22-RS; L12n-RS; L12n-SC; L2-9-D; L2-9VN-D; L3-12-D; L3-12-RS; L4-12t-RS; L4-20t-D; L4-20t-RS; L6-12-RS; L6-24-D; L8-18i-D; L8-18i-RS; L8-18i-SC; L8-18t-RS; LK760-RS; LOGIQ E10; LOGIQ E10s; LOGIQ E10s R2 to R3 UPG; LOGIQ E10s R2R3 to R4 HW Upgrade; LOGIQ E10s R2R3 to R4 HW Upgrade W; LOGIQ E10s R2R3 to R4 SW Upgrade; LOGIQ E10s R2R3 to R4 SW Upgrade W; LOGIQ E10s R3R4_R5 UPG SW + GPU; LOGIQ E10s R3R4_R5 UPG SW + GPU + Wifi; LOGIQ E10s R3R4_R5 UPG SW + Wifi; LOGIQ E10s R3R4_R5 UPG SW Only; LOGIQ E9; LOGIQ E9 XDClear 2; LOGIQ F; LOGIQ F6; LOGIQ F8; LOGIQ F8 Expert; LOGIQ Focus; LOGIQ Fortis; LOGIQ Fortis R3 to R4 HW Upgrade; LOGIQ Fortis R3 to R4 HW Upgrade W; LOGIQ Fortis R3 to R4 SW Upgrade; LOGIQ Fortis R3 to R4 SW Upgrade W; LOGIQ Fortis R3-R5 SW & WiFi Upgrade; LOGIQ Fortis R3-R5 SW HW Upgrade; LOGIQ Fortis R3-R5 SW, HW & WiFi Upgrade; LOGIQ Fortis R5 SW Upgrade; LOGIQ P10; LOGIQ P10 R4 to R4.5 UPG; LOGIQ P5; LOGIQ P7; LOGIQ P8; LOGIQ P8 R4 to R4.5 UPG; LOGIQ P9; LOGIQ P9 R4 to R4.5 UPG; LOGIQ S20; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power; LOGIQ S20 Pro; LOGIQ S7 Expert; LOGIQ S8; LOGIQ Totus; LOGIQ V1; LOGIQ V2; LOGIQ V3; LOGIQ V5; LOGIQ V5 Expert; LOGIQ Vita; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ Vita Pro; LOGIQ e; LOGIQ e NextGen; Lite (LITE TABLE N9 ED3, Lite Table); M5Sc-D; M5Sc-RS; M5sc-RS; M6C-D; ML4-20-D; ML4-20VN-D; ML6-15; ML6-15-D; ML6-15-RS; MTZ Biopsy Guide Attachment; NG 2000 Table; NG LITE 1700 (NG1700 ELITE STANDARD TABLE); NG LITE 2000 (NG2000 ELITE HEAVY TABLE); NG1700 ELITE STANDARD TABLE; NG1700 Patient Table; NG1700SV TABLE; NG1700SV Table; NG2000 ELITE HEAVY TABLE; NG2000SV TABLE; NG2000SV Table; NG2000V table; NM/CT Patient Table; NextGen LOGIQ e; OPTIMA CT580; OPTIMA CT580 RT; OPTIMA CT580 W; Optima CT 670; Optima CT660; Optima CT660FREEdom; Optima CT660J; Optima CT660Pro; Optima CT660ProJ; Optima CT660SE; Optima CT660s; Optima CT660sPro; Optima CT680 Expert; Optima CT680 Professional; Optima CT680 Quantum; Optima RT; P2D; P6D; PA6-8-D; Probe; RAB2-5-D; RAB2-5-RS; RAB2-6-RS; RAB4-8-D; RAB4-8-RS; RAB6-D; RAB6-RS; RAB7-D; RAM3-8; RIC10-D; RIC12-D; RIC5-9-D; RIC5-9A-RS; RIC5-9W-RS; RIC6-12-D; RM14L; RM6C; RM7C; RNA5-9-D; RNA5-9-RS; RSM5-14; RSP6-16-D; RT Refresh Package; Radiographic Table (Model: VFTBL-1); Revolution Ascend; Revolution Ascend EL; Revolution Ascend ES; Revolution Ascend EX; Revolution Ascend Elite; Revolution Ascend Plus; Revolution Ascend Select; Revolution EVO; Revolution EVO 33 kW/48 kW; Revolution EVO EL; Revolution EVO ES; Revolution EVO EX; Revolution RT; Revolution UPG 5; S4-10-D; SP10-16-D; SmartMAR; Standard table; Table (Model: GCTBL-C33); Table (Model: GCTBL-C3333); Table (Model: GCTBL-C4); True Definitional DL; True Enhance DL; VT1700 (GT1700 N9 ED3); VT1700V(GT1700V N9 ED3); VT2000 (GT2000 N9 ED3); VT2000X(GT2000x); Venue; Venue 50; Venue Fit; Venue Go; Venue Sprint; Venue Trident; Versana Active; Versana Balance; Versana Essential; Versana Premier; Versana Premier Lotus; Vivid Advanced; Vivid E80; Vivid E90; Vivid E95; Vivid Explorer; Vivid Focus; Vivid Pioneer; Vivid S60; Vivid S60N; Vivid S70; Vivid S70N; Vivid S70N Dimension; Vivid T8; Vivid T8 T9 v204 v205 to v206 UPG; Vivid T8 T9 v204 v205 to v206 UPG SW only; Vivid T8 T9 v206 to v208 SW only UPG; Vivid T9; Vivid iq; Vivid iq v203 to v206 UPG; Vivid iq v204 to v206 UPG; Vivid iq v204 to v206 UPG SW only; Vivid iq v206 to v208 HW+SW UPG; Vivid iq v206 to v208 SW only UPG; Voluson E series; Voluson E series BT15; Voluson E series BT16; Voluson E10; Voluson E10 BT16; Voluson E6; Voluson E6 BT16; Voluson E8; Voluson E8 BT16; Voluson E8 Expert; Voluson Expert 18; Voluson Expert 20; Voluson Expert 22; Voluson P6; Voluson P8; Voluson Performance 16; Voluson Performance 18; Voluson S series; Voluson S series BT16; Voluson S10; Voluson S10 BT16; Voluson S10 Expert; Voluson S6; Voluson S6 BT16; Voluson S8; Voluson S8 BT16; Voluson S8t; Voluson SWIFT; Voluson SWIFT+; Voluson Signature 18; Voluson Signature 20; Voluson e; Voluson i; eM6C; eM6C G2; eM6C G3; eM6CG2; eX7C; iC5-9-D; t739",2004-09-24,120,2026-10-02,0,1,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229612283%22&limit=1
Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi,3014279513,3014279513,Ilkbahar Mahallesi 620 Sokak No 5,Cankaya Ankara,,06550,Turkey,MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI,10057109,Exporter to the US,71,BTR; CEC; DQX; ERL; ETN; EZQ; FBO; FBP; FCG; FCW; FDF; FDP; FEC; FED; FET; FFL; FGA; FGB; FGC; FGE; FIP; FJK; FTL; FTT; FZP; GAG; GAM; GAN; GAT; GAW; GCI; GCJ; GDO; GDW; GEI; GXN; HBB; HBT; HDA; HET; HGI; HIF; HIG; HIH; HWC; ITX; IYN; IYO; JAA; JDS; JIT; JJX; JLW; KDI; KNW; LCJ; LFL; LKF; LMG; MAI; MBI; MCH; MDM; MOV; MRD; MTD; NTN; OCW; OQY; OWB; OXO,"Tube, Tracheal (W/Wo Connector); Radioimmunoassay, Free Thyroxine; Wire, Guide, Catheter; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Stimulator, Nerve; Pouch, Colostomy; Cystourethroscope; Telescope, Rigid, Endoscopic; Biopsy Needle; Light Source, Fiberoptic, Routine; Colonoscope And Accessories, Flexible/Rigid; Apparatus, Pneumoperitoneum, Automatic; Obturator, For Endoscope; Endoscopic Access Overtube, Gastroenterology-Urology; Endoscopic Video Imaging System/Component, Gastroenterology-Urology; Dislodger, Stone, Basket, Ureteral, Metal; Kit, Nephroscope; Ureteroscope And Accessories, Flexible/Rigid; Urethroscope; Stents, Drains And Dilators For The Biliary Ducts; Subsystem, Water Purification; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve; Mesh, Surgical, Polymeric; Camera, Still, Surgical; Clip, Implantable; Stapler, Surgical; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Absorbable, Synthetic; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Implantable; Electrosurgical, Cutting & Coagulation & Accessories; Plate, Cranioplasty, Preformed, Non-Alterable; Motor, Drill, Pneumatic; Applier, Hemostatic Clip; Forceps, Obstetrical; Laparoscope, Gynecologic (And Accessories); Electrocautery, Gynecologic (And Accessories); Insufflator, Laparoscopic; Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Screw, Fixation, Bone; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Fluoroscopic, Image-Intensified; Nail, Fixation, Bone; Calibrator, Secondary; Single (Specified) Analyte Controls (Assayed And Unassayed); Radioimmunoassay, Thyroid-Stimulating Hormone; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Instrument, Biopsy; Tissue Expander And Accessories; Instrument, Ultrasonic Surgical; Cannula, Manipulator/Injector, Uterine; Agent, Absorbable Hemostatic, Non-Collagen Based; Fastener, Fixation, Biodegradable, Soft Tissue; Fastener, Fixation, Nondegradable, Soft Tissue; Clip, Hemostatic; Instrument, Manual, Surgical, General Use; Catheters, Salpingography; Mammary Sizer; Catheter, Intracardiac Mapping, High-Density Array; Led Light Source; Endoscopic Tissue Approximation Device; Intrauterine Tamponade Balloon; Interventional Fluoroscopic X-Ray System; Image-Intensified Fluoroscopic X-Ray System, Mobile",1; 2; 3; U,,2018-02-23,118,2024-06-14,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014279513%22&limit=1
"Beckman Coulter, Inc.",2050012,2050012,250 S Kraemer Blvd,Brea,CA,92821,United States,"BECKMAN COULTER, INC.",2050012,Manufacturer; Specification developer,128,CDQ; CDS; CDT; CEK; CEM; CEO; CFJ; CFN; CFR; CGA; CGN; CGS; CGX; CGZ; CHH; CHI; CHL; CHW; CIG; CIT; CIX; CJE; CJW; CJY; CKA; CZP; CZW; DAD; DBF; DBI; DCF; DCK; DCN; DDB; DDG; DDQ; DDS; DDT; DEB; DEH; DEM; DEW; DFC; DFH; DFT; DGC; DHR; DIF; DIH; DIO; DIP; DIS; DJG; DJR; DKB; DKC; DKJ; DKZ; DLJ; DLZ; DMT; DNN; GKG; GTQ; GTR; IFB; JBQ; JFJ; JFL; JFM; JFP; JFY; JGG; JGJ; JGS; JHI; JHW; JIF; JIQ; JIS; JIT; JIX; JIY; JJE; JJF; JJX; JJY; JLW; JMG; JMO; JOB; JPI; JPZ; JQC; JQX; JXM; JXN; JZG; JZH; JZJ; KHQ; KLI; KLS; KLT; KNK; KRZ; KXS; KXT; LAS; LBS; LCD; LCM; LCP; LCQ; LCR; LDJ; LDP; LEG; LEH; LFN; LFP; LKL; MGA; MRR; MSJ; NQD; PDJ; PPM,"Urease And Glutamic Dehydrogenase, Urea Nitrogen; Electrode, Ion Specific, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Method, Nephelometric, Immunoglobulins (G, A, M); Hexokinase, Glucose; Glucose Oxidase, Glucose; Acid, Folic, Radioimmunoassay; Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph; Titrimetric With Edta And Indicator, Calcium; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Bromcresol Purple Dye-Binding, Albumin; Azo Dye, Calcium; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Iga, Antigen, Antiserum, Control; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Ferritin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; System, Test, C-Reactive Protein; Ceruloplasmin, Antigen, Antiserum, Control; Transferrin, Antigen, Antiserum, Control; Antigen, Antiserum, Control, Antithrombin Iii; Prealbumin, Fitc, Antigen, Antiserum, Control; Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control; Alpha-2-Macroglobulin, Antigen, Antiserum, Control; Lambda, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Igg, Antigen, Antiserum, Control; Lipoprotein, Low-Density, Antigen, Antiserum, Control; Kappa, Antigen, Antiserum, Control; Igm, Antigen, Antiserum, Control; Ige, Antigen, Antiserum, Control; System, Test, Rheumatoid Factor; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Alcohol Control Materials; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet; Calibrators, Ethyl Alcohol; Centrifuge, Hematocrit; Antistreptolysin - Titer/Streptolysin O Reagent; Antideoxyribonuclease, Streptococcus Spp.; Cytocentrifuge; Antithrombin Iii Quantitation; Catalytic Methods, Amylase; Ph Rate Measurement, Carbon-Dioxide; Enzymatic Method, Bilirubin; Electrode, Ion Specific, Calcium; Enzymatic Method, Creatinine; L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase; Photometric Method, Magnesium; Electrode, Ion Specific, Sodium; Visual, Pregnancy Hcg, Prescription Use; U.V. Method, Cpk Isoenzymes; Enzymatic Method, Ammonia; Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.); Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Analyzer, Chemistry, Micro, For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Thyroid-Stimulating Hormone; Radioimmunoassay (Two-Site Solid Phase), Ferritin; Ferrozine (Colorimetric) Iron Binding Capacity; Hexane Extraction, Fluorescence, Vitamin E; Device, Hematocrit Measuring; Colorimetric Method, Gamma-Glutamyl Transpeptidase; Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use; Nephelometer, For Clinical Use; Enzyme Immunoassay, Benzodiazepine; Enzyme Immunoassay, Propoxyphene; System, Test, Beta-2-Microglobulin Immunological; Factor B, Antigen, Antiserum, Control; Prealbumin, Antigen, Antiserum, Control; Radioassay, Triiodothyronine Uptake; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Calibrator For Hemoglobin And Hematocrit Measurement; Radioimmunoassay, Methaqualone; Enzyme Immunoassay, Digoxin; Drug Specific Control Materials; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Assay, Glycosylated Hemoglobin; Fluorescent Immunoassay Gentamicin; Fluorescent Immunoassay, Tobramycin; Enzyme Immunoassay, Cannabinoids; Colorimetry, Acetaminophen; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Nephelometric Inhibition Immunoassay, Phenobarbital; Conductivity Rate, Urea Nitrogen; Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control; Alpha-1 Microglobulin, Antigen, Antiserum, Control; System, Test, Low Density, Lipoprotein; Apolipoproteins; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Hemoglobin A1c Test System; General Purpose Reagent",1; 2; U,"378020 High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200); 378045 SYNCHRON Systems Vancomycin Calibrator; 378194 Salicylate Reagent (SALY 2 x 45); 439715 Direct Bilirubin Reagent (DBIL 2 x 200); 439770 Ammonia Reagent (AMM 2 x 25); 441350 SYNCHRON Systems Enzyme Validator Set Levels 1 & 2; 441470 Immunochemistry Systems UCAL Urine Protein Calibrator; 442600 SYNCHRON Systems SYNCHRON Multi Calibrator; 442620 Alanine Aminotransferase Reagent (ALT 2 x 200); 442635 Creatine Kinase Reagent (CK 2 x 200); 442640 Synchron Glucose 2 x 300 GLU Reagent; 442650 Gamma-Glutamyl Transferase Reagent (?-GT 2 x 200); 442655 Lactate Dehydrogenase Reagent (LD 2 x 200); 442660 Lactate Dehydrogenase Reagent (LD-P 2 x 200); 442665 Aspartate Aminotransferase Reagent (AST 2 x 200); 442670 Alkaline Phosphatase Reagent (ALP 2 x 200); 442745 Total Bilirubin Reagent (TBIL 2 x 300); 442765 Albumin Reagent (ALB 2 x 300); 442772 SYNCHRON Systems FE/IBCT Calibrator Kit; 442785 Uric Acid Reagent (URIC 2 x 300); 442820 Urea Reagent (UREA 2 x 300); 442831 PVT 2,  472055 PVT 5,  442830 PVT 3; 443360 Synchron CX Calibration Standard 1; 443365 Synchron CX Calibration Standard 2; 445360 Magnesium Reagent (MG 2 x 100); 445803 SYNCHRON Systems DAT Negative Urine Calibrator; 445809 SYNCHRON Systems 50 ng/mL THC Urine Calibrator; 445811 SYNCHRON Systems 100 ng/mL THC Urine Calibrator; 445814 SYNCHRON Systems 200 ng/mL THC Urine Calibrator; 445824 Cannabinoid 20 ng Reagent (THC2 1 x 150); 445850 Triglycerides Reagent (TG 2 x 300); 445860 Microprotein Reagent (M-TP 2 x 50); 445865 SYNCHRON Systems Wash Concentrate II; 445915 Synchron CX CRP Calibrator; 445930 SYNCHRON Systems Microprotein Calibrator; 445967 SYNCHRON CX Systems Antifoam; 445990 Cannabinoid 100 ng Reagent (THC 1 x 150); 446400 IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent; 446410 IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent; 446440 IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent; 446450 IMMAGE Immunochemistry Systems C3 Complement C3 Reagent; 446460 IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent; 446470 IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent; 446480 IMMAGE Immunochemistry Systems HPT Haptoglobin Reagent; 446490 IMMAGE Immunochemistry Systems C4 Complement C4 Reagent; 447020 IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent; 447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2; 447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3; 447060 IMMAGE Immunochemistry Systems Wash Solution; 447070 IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent; 447160 IMMAGE Immunochemistry Systems FER Ferritin Reagent; 447280 IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent; 447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4; 447440 IMMAGE Immunochemistry Systems PAB Prealbumin Reagent; 447450 IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent; 447460 IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A; 447470 IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M; 447480 IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent; 447600 IMMAGE Immunochemistry Systems ALB Albumin Reagent; 447610 IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent; 447620 IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent; 447630 IMMAGE Immunochemistry Systems TRF Transferrin Reagent; 447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1; 447650 IMMAGE Immunochemistry Systems BUF 1 Buffer 1; 447660 IMMAGE Immunochemistry Systems DIL 2 Diluent 2; 447690 IMMAGE Immunochemistry Systems MA Microalbumin Reagent; 447700 IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent; 447710 IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent; 447720 IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent; 447730 IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent; 447740 IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent; 447750 IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent; 447760 IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent; 447780 IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent; 447790 IMMAGE Immunochemistry Systems AMG Alpha-2-Macroglobulin Reagent; 449560 Immunochemistry Systems CAL 1 Calibrator 1; 449730 Immunochemistry Systems CAL 3 Calibrator 3; 450120 Vigil Protein Control Level 1; 450125 Vigil Protein Control Level 2; 450130 Vigil Protein Control Level 3; 450162 Vigil Serology Control Level 1; 450163 Vigil Serology Control Level 2; 450164 Vigil Serology Control Level 3; 464390 SYNCHRON Systems 20 ng/mL THC Urine Calibrator; 465131 C-Reactive Protein Reagent (CRP 2 x 200); 465290 Immunochemistry Systems Level 1 Urine Protein Control; 465300 Immunochemistry Systems Level 2 Urine Protein Control; 465365 Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator; 465440 Vigil Serology Control Level C; 465908, Synchron CX Calibrator 1; 465909, Synchron CX Calibrator 2; 465910, Synchron CX Calibrator 3; 465912 SYNCHRON Systems 75 ng/mL THC Urine Control; 465914 SYNCHRON Systems 20 ng/mL THC Urine Control; 465915 SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR; 465939 SYNCHRON Systems 125 ng/mL THC Urine Control; 465970 Total Iron Binding Capacity Reagent (IBCT 2 x 100); 465971 Total Iron Binding Capacity Reagent (IBCT 2 x 100); 465976 SYNCHRON Systems Total Iron Binding Capacity (IBCT) Column Kit; 465980 Vigil Lipid Control Level 2; 465981 Vigil Lipid Control Level 3; 465982 Vigil Lipid Control Level 4; 465990 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 1; 465993 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 2; 465996 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 3; 467826 Sample Diluent 1 DIL1; 467830 Creatine Kinase Reagent (N-Acetyl-L-cysteine) (CK- 2 x 200); 467840 Alanine Aminotransferase Reagent (ALT- 2 x 300); 467845 Aspartate Aminotransferase Reagent (AST- 2 x 300); 467848 Alanine Aminotransferase Reagent (ALT- 2 x 100); 467849 Aspartate Aminotransferase Reagent (AST- 2 x 100); 467858 SYNCHRON Systems Albumin Reagent; 467900 Apolipoprotein A Reagent (ApoA 2 x 100); 467905 Apolipoprotein B Reagent (ApoB 2 x 100); 467910 Iron Reagent (FE 2 x 200); 467920 Immunoglobulin A Reagent (Ig-A 2 x 150); 467925 Immunoglobulin G Reagent (Ig-G 2 x 150); 467930 Immunoglobulin M Reagent (Ig-M 2 x 150); 467942 Transferrin Reagent (TRFN 2 x 150); 467983 Tobramycin Reagent (TOB 2 x 100); 467995 Valproic Acid Reagent (VPA 2 x 100); 468405 SYNCHRON Systems CAL 1 Calibrator 1; 468429 IMMAGE Immunochemistry Systems FER CAL Ferritin Calibrator; 469110 Synchron Systems NO FOAM; 469112 Carbamazepine Reagent (CAR 2 x 100); 469126 Theophylline Reagent (THE 2 x 100); 469137 Gentamicin Reagent (GEN 2 x 100); 469165 Antistreptolysin-O Reagent (ASO- 2 x 100); 469170 SYNCHRON Systems APO Calibrator; 469188 Phenytoin Reagent (PHY 2 x 100); 469283 APO CAL Apolipoprotein Calibrator; 469600 SYNCHRON Systems Drug Calibrator 1; 469630 SYNCHRON Systems Drug Calibrator 2; 469785 Phenobarbital Reagent (PHE 2 x 100); 469905 Vigil Lipid Control Level 1; 469945 SYNCHRON Systems DAT Drug Free Urine Control; 469965 SYNCHRON Systems CAL 5 Plus; 469975 CAL 5 PLUS Calibrator 5 Plus; 471080 SYNCHRON Systems Drug Calibrator 3 Plus; 472107 SYNCHRON Systems 10 ng/mL THC Urine Control; 472110 SYNCHRON Systems 40 ng/mL THC Urine Control; 472137 SYNCHRON and AU Systems Hemolyzing Reagent; 472169 Acetaminophen Reagent (ACTM 100); 472461 Vigil TDM Control level 1; 472467 Vigil TDM Control level 2; 472472 Vigil TDM Control level 3; 474020 IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator; 474620 IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent; 474630 IMMAGE Immunochemistry Systems CRPH High Sensitivity CRP Reagent; 474824 Vancomycin Reagent (VANC 2 x 100); 474947 Alcohol Reagent (ETOH 2 x 150); 474970 SYNCHRON Systems DAT Multi-Drug Low Urine Calibrator; 474973 SYNCHRON System DAT Multi-Drug High Urine Calibrator; 474976 SYNCHRON Systems DAT Multi-Drug Low Urine Control; 474979 SYNCHRON Systems DAT Multi-Drug High Urine Control; 474982 SYNCHRON Systems OP 300 Low Urine Calibrator; 474985 SYNCHRON Systems OP 300 High Urine Calibrator; 474988 SYNCHRON Systems OP 300 Low Urine Control; 474991 SYNCHRON Systems OP 300 High Urine Control; 474994 SYNCHRON Systems ETOH Calibrator; 475000 Amphetamines Reagent (AMPH 1 x 250); 475003 Cocaine Metabolite Reagent (COCM 1 x 250); 475006 Opiate 2000 ng Reagent (OP2 1 x 250); 475009 Phencyclidine Reagent (PCP 1 x 250); 475012 Barbiturates Reagent (BARB 1 x 250); 475018 SYNCHRON Systems Methadone Reagent; 475024 Opiate 300 ng Reagent (OP 1 x 250); 475027 Propoxyphene Reagent (PROX 1 x 250); 475030 Cannabinoid 50 ng Reagent (THC5 1 x 250); 475081 SYNCHRON Systems PAB Calibrator; 475089 SYNCHRON Systems MA Calibrator; 475100 Microalbumin Reagent (MA 2 x 100); 475106 Prealbumin Reagent (PAB 2 x 100); 476821 Alkaline Phosphatase Reagent (ALP 2 x 400); 476826 Alanine Aminotransferase Reagent (ALT 2 x 400); 476831 Aspartate Aminotransferase Reagent (AST 2 x 400); 476836 Creatine Kinase Reagent (CK 2 x 400); 476841 Lactate Dehydrogenase Reagent (LD 2 x 300); 476846 Gamma-Glutamyl Transferase Reagent (?-GT 2 x 400); 476851 Lipase Reagent (LIP 2 x60); 476856 Direct Bilirubin Reagent (DBIL 2 x 300); 476861 Total Bilirubin Reagent (TBIL 2 x 400); 589784 Trace-Klean Concentrated Cleaning Solution; 598190 598190 Trace-Klean Ready to Use Cleaning Solution; 650038 Vigil HbA1c Controls Levels 1 & 2; 650182 Digoxin Reagent (DIGN 2 x 100); 650218 SYNCHRON Systems Lipid Calibrator Levels 1 & 2; 657133 Cartridge Chemistry Wash Solution (CCWA 2 x 300); 657197 Synchron AUTO-GLOSS CTS; 657365 SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum; 66039 Cleaning Solution; 663940 Immunochemistry Systems CAL 2 Calibrator 2; 664090 CLENZ Solution; 667710 Ultimate -D Bilirubin Control Level 1; 667720 Ultimate -D Bilirubin Control Level 2; 667730 Ultimate -D Bilirubin Control Level 3; 667740 Ultimate -D Bilirubin Control Level 4; 683802 Enzymatic Bilirubin Reagent; 969620 C-Reactive Protein Reagent (C-RP 2 x 200); 969650 Pancreatic Amylase Reagent (PAM 2 x 60); 969706 Direct LDL Cholesterol Reagent (LDLD 2 x 100); 988413 Haptoglobin Reagent (HPT 2 x 100); 988462 C3 Reagent (C3 2 x 100); 988471 C4 Reagent (C4 2 x 100); A09426 Phosphorus Reagent (PHS 2 x300); A15445 IMMAGE 800; A15625 HDL Cholesterol Reagent HDL 2 x 200; A18298 Benzodiazepine Reagent (BNZG 1 x 250); A27318 Unicel DxC 600i Synchron Access Clinical System; A28937 SYNCHRON Systems ISE Electrolyte Reference; A28945 SYNCHRON Systems ISE Electrolyte Buffer; A38656 IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent; A40920 Creatinine Reagent (CR-S 2 x 300); A53722 Synchron Cholinesterase (CHEX) Reagent; A59102 Unicel DxC 880i Synchron Access Clinical System; A60298 Enzymatic Creatinine Reagent (CR-E 2 x 300); A64868 Unicel DxC 660i Synchron Access Clinical System; A64869 Unicel DxC 680i Synchron Access Clinical System; A64870 Unicel DxC 860i Synchron Access Clinical System; A64871 UniCel DxC 660i - Full System Domestic; A64872 UniCel DxC 660i - Full System; A64903 UniCel DxC 680i - Full System Domestic; A64904 UniCel DxC 680i - Full System; A64935 UniCel DxC 860i - Full System Domestic; A64936 UniCel DxC 860i - Full System; A71607 Amylase Reagent (AMY7 2 x 200); A87905 Hemoglobin A1c Reagent (HbA1c- 400); A88469 HbDIL DxC; A95550 Lactate Reagent (LACT 2 x 50); Access Sample Diluent A (Onboard Reagent Kit) (P/N: A79783 MN MFG); Access Sample Diluent A (P/N: 81908 MN MFG); Access Substrate (P/N: 81906 MN MFG); Access Wash Buffer II ( P/N: A16972 KY and DE MFG); Allegra, Optima, Avanti, Microfuge; B00389 HbA1c; B23634 UniCel DxC SYNCHRON Systems HDL Calibrator; B24985 Glucose Reagent GLUH 2 x 300; B36415 Hemoglobin A1c Reagent (HbA1c3 250); BECKMAN ENZYMATIC ALT REAGENT KIT; BUN Electrode; CEQ Sample Loading Solution; CO2 Electrode; COULTER U-V ZYME SGPT REAGENT; Calcium Electrode; Chloride Electrode; DNA Sequencing Separation Buffer; DNA Size Standard Kit - 400; DNA Size Standard Kit - 600; DNA Size Standard Kit - 80; DTCS Quick Start Kit; DxFLEX Daily QC Fluorospheres; ENZYMATIC BILIRUBIN REAGENT; Enzymatic Creatinine Reagent (CR-E 2 x 200); FLOW-CHECK; Flow Check Pro Fluorospheres; GenomeLab GeXP Start Kit; Glucose Oxygen Sensor; HbA1c Advanced; IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M  IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator; Immage CAL 5 Plus; Immage CCRP reagent; Iris® Diluent Pack (800-3202); Iris® System Cleanser Pack (800-3203); J6; LumiPhos PRO Substrate (P/N: B96000 MN MFG); NA+ Electrode; ODR2000 5L WASH SOLUTION; OSR0001 WASH SOLUTION; OSR6127 LACTATE DEHYDROGENASE; OSR6165 HAPTOGLOBIN; OSR6194 ASO; OSR62166 LIH; OSR6227 LACTATE DEHYDROGENASE; Part numbers include, but are not limited to; PerFix NC Kit (Fixative Reagent); Potassium Electrode; QUANTIPLATE OR ENDOPLATE TM HA; SEPARATION GEL-LPA I; SYNCHRON Creatinine; SYNCHRON G7 Amylase Reagent; SYNCHRON Lactate; SYNCHRON Magnesium; SYNCHRON Micro Total Protein; SYNCHRON Systems AQUA CAL 1, 2, 3; SYNCHRON Systems Creatinine Reagent; SYNCHRON Systems Glucose Reagent (Glucose Oxidase)  SYNCHRON Systems CO2 Alkaline Buffer; SYNCHRON Systems Phosphorus Reagent  SYNCHRON Systems CO2 Acid Reagent  SYNCHRON Systems Urea Nitrogen (BUN) Reagent; SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2; SYNCHRON Total Bilirubin; SYNCHRON Transferrin; SYNCHRON UniCel DxC 600i, 800i, 660i, 860i; SYNCHRON Uric acid; Sample Loading Solution (SLS); SatSpin CritSpin Digital Reader (P/N X00-003808-001); SatSpin MP (P/N X00-004998-001); Separation Buffer; Separation Gel – LPAI; StatSpin CritSpin Digital Reader; StatSpin Cytofuge 2 (P/N X00-003066-001); StatSpin Express 2; StatSpin Express 2 (P/N X00-003856-002); StatSpin Express 3; StatSpin Express 3 (P/N X00-005222-001); StatSpin Express 4; StatSpin Express 4 (P/N X00-005531-001); StatSpin MP Centrifuge; Synchron AMM reagent and calibrators; Synchron CRPH reagent; Synchron Glucose; Synchron Salicylate test system; Synchron Systems Total Protein Reagent; UniCel DxC 600 PRO, Recon UniCel DxC 600, Recon UniCel DxC 800 PRO, Recon UniCel DxC 800, Recon; UniCel DxI Access Wash Buffer II (P/N: A16973 KY and DE MFG); UniCel DxI Wash Buffer II OnBoard Dilution Kit (A79784 MN MFG); iChem® VELOCITY™ Wash Solution Case of 2 x 7L (800-7217); iQ Body Fluids Conical Tubes (800-3215); iQ Body Fluids Lysing Reagent (800-3213); iQ Lamina 2 x 7L (800-3236)",1977-12-16,118,2019-01-16,0,356,2,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222050012%22&limit=1
Boston Scientific Corporation,2134265,3002095335,Two Scimed Place,Maple Grove,MN,55311,United States,Boston Scientific Corporation,9912058,Manufacturer; Manufacturer for export; Specification developer,46,DQK; DQO; DQX; DQY; DRG; DSK; DXK; DXO; DYB; FGE; FOX; GEH; GEI; HCG; ITX; IWJ; IYO; KPY; KRA; KRD; LIT; LLZ; LOX; MAF; MCW; MCX; NAJ; NAW; NGV; NIM; NIN; NIO; NIP; NIQ; NIU; NJE; NOY; NTE; OBJ; OCL; ONU; OOB; PUM; QEW; QEY; QEZ,"Computer, Diagnostic, Programmable; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Transmitters And Receivers, Physiological Signal, Radiofrequency; Computer, Blood-Pressure; Echocardiograph; Transducer, Pressure, Catheter Tip; Introducer, Catheter; Stents, Drains And Dilators For The Biliary Ducts; Stand, Infusion; Unit, Cryosurgical, Accessories; Electrosurgical, Cutting & Coagulation & Accessories; Device, Neurovascular Embolization; Transducer, Ultrasonic, Diagnostic; System, Applicator, Radionuclide, Manual; System, Imaging, Pulsed Echo, Ultrasonic; Shield, Protective, Personnel; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Catheter, Angioplasty, Peripheral, Transluminal; System, Image Processing, Radiological; Catheters, Transluminal Coronary Angioplasty, Percutaneous; Stent, Coronary; Catheter, Peripheral, Atherectomy; Catheter, Coronary, Atherectomy; Agents, Embolic, For Treatment Of Uterine Fibroids; Microspheres Radionuclide; System, Appendage Closure, Left Atrial; Stent, Carotid; Stent, Renal; Stent, Iliac; Stent, Superficial Femoral Artery; Coronary Drug-Eluting Stent; Stent, Superficial Femoral Artery, Drug-Eluting; Intracranial Neurovascular Stent; Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia; Temporary Carotid Catheter For Embolic Capture; Catheter, Ultrasound, Intravascular; Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue; Drug-Eluting Peripheral Transluminal Angioplasty Catheter; Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter; Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures; Peripheral Mechanical Thrombectomy With Aspiration; Mechanical Thrombolysis Catheter; Aspiration Thrombectomy Catheter",1; 2; 3; f,AGENT Paclitaxel-Coated Balloon Catheter; AngioJet Spiroflex Thrombecotmy Set; AngioJet Spiroflex VG Thrombectomy Set; AngioJet Ultra 5000A Console; AutoElite Thrombectomy System Console; ELUVIA Drug-Eluting Vascular Stent System; ENROUTE Transcarotid Stent System; Emerge PTCA Dilatation Catheter; Emerge Push PTCA Dilatation Catheter; Express SD Renal/Biliary Premounted Stent System; Gateway PTA Dilatation Catheter; Guidezilla II PV Guide Extension Catheter; Innova Vascular Self-Expanding Stent System; NC Emerge PTCA Dilatation Catheter; REBEL Platinum Chromium Coronary Stent System; ROTAPRO Advancer Burr Advancing Device; ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; ROTAPRO Rotational Atherectomy System Console Kit; ROTAWIRE Drive and wireClip Torquer Extra Support; ROTAWIRE Drive and wireClip Torquer Floppy; Ranger Paclitaxel-Coated PTA Balloon Catheter; RotaLink Advancer Catheter Advancing Device; RotaLink Burr Exchangeable Burr Catheter; RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device; RotaWire and wireClip Torquer Extra Support; RotaWire and wireClip Torquer Floppy; Rotablator Dynaglide Foot Pedal; Rotablator Rotational Atherectomy System Console Kit; Rotaglide Lubricant; SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System; TheraSphereY-90 Glass Microspheres; WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; wireClip Torquer,2005-08-01,106,2026-08-21,12,99,12,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222134265%22&limit=1
Ge Medical Systems SCS,9611343,1000284313,283 Rue De La Miniere,Buc,,78530,France,GE HealthCare Technologies Inc.,9912004,Contract manufacturer; Manufacturer; Specification developer,19,FMQ; ITY; IWX; IYO; IZH; IZI; IZO; JAA; JAK; KPQ; KPS; LLZ; LNH; MUE; OEB; OTE; OWB; OXO; QIH,"Restraint, Protective; Assembly, Tube Housing, X-Ray, Diagnostic; Barrier, Control Panel, X-Ray, Movable; System, Imaging, Pulsed Echo, Ultrasonic; System, X-Ray, Mammographic; System, X-Ray, Angiographic; Generator, High-Voltage, X-Ray, Diagnostic; System, X-Ray, Fluoroscopic, Image-Intensified; System, X-Ray, Tomography, Computed; System, Simulation, Radiation Therapy; System, Tomography, Computed, Emission; System, Image Processing, Radiological; System, Nuclear Magnetic Resonance Imaging; Full Field Digital, System, X-Ray, Mammographic; Lung Computed Tomography System, Computer-Aided Detection; Digital Breast Tomosynthesis; Interventional Fluoroscopic X-Ray System; Image-Intensified Fluoroscopic X-Ray System, Mobile; Automated Radiological Image Processing Software",1; 2; 3,"10x23; 19x23; 24x29; 2DLoc; 2DLocP; 3DStent; 3DXR; 40782; 43318; 45645; 5855555; APOLLON; AVA Xpress; AW 4.3; AW 4.4; AW 4.5; AW 4.7; AW Remote Access; AW Server; AW Server 2; AW Server 3; AW Server 3.1; AW Server 3.2; AW Volume Share 2; AW Volume Share 4; AW VolumeShare 5 with AngioViz; AW VolumeShare 7; Advantage 3D XR; Advantage 4D; Advantage CTC Plus; Advantage Paste; AdvantageALA; AdvantageCTC Pro; AdvantageCTC Pro3D; AdvantageCTC Pro3D EC; AdvantageSim MD; AdvantageSim™ MD MR pelvic organ at risk segmentation Option; AdvantageSim¿ MD; AdvantageSim¿ MD with CT Atlas-based Contouring and Re-planning Options; Allia IGS 3; Allia IGS 5; Allia IGS 7; Allia IGS 7 OR; Allia Moveo; AngioCard; AngioViz; Artemis; AutoBone Refresh; AutoBone Xpress; Autolaunch; BONZAI; BVCAR; Body View; Bone VCAR; Brain View; BrainWave; BrainWave Adv DTI Tracking; BrainWave Adv Visualization; BrainWave Fusion Perf; BrainWave Performance; BrainWave Post Acquisition (PA); BrainWave Skull Stripping; BrainWave Struct Reporting; BrainWave Tract Generation; Brainwave PA; Brainwave PA Fusion Performance; Brainwave PA Performance; Brainwave Resting State; BreView; Brivo OEC 2.2A X-ray Generator; CADstream 5.2; CT MINI; CT Perfusion 4 Neuro; CT Perfusion 4D; CT Perfusion 4D Multi-Organ; CT Perfusion 4D Neuro; CT Perfusion 4D Neuro Gen2; CT Perfusion MULTI-ORGAN; CardEP; CardIQ Flow; CardIQ Function Xpress; CardIQ Fusion PET; CardIQ Fusion SPECT; CardIQ Physio; CardIQ Suite; CardIQ Xpress 2; CardIQ Xpress Process; CardIQ Xpress Process 2 with Snapshot Freeze option; CardIQ Xpress Reveal; Cardiac X-ray Analysis; CardiacVX; CardiacVX Flow; CardiacVX StarMap; CleaRecon DL; Console Generation Upgrade; CortexID Suite; DISCOVERY IGS 730; DJINN BEETLE; DMR; DMR+; Dentascan; Discovery CT750 HD; Discovery IGS 7; Discovery IGS 7 OR; Discovery IGS 730; Discovery IGS 740; Djinn Beetle; Djinn Mammo; Djinn Tonix; Dynamic CT Myocardial Perfusion; Dynamic Shuttle; Dynamic VUE; DynamicIQ; EVARVision; Ergo MONOBLOCK; F19x23; F24x29; FastStroke; FlightPlan for EVAR; FlightPlan for Embolization; FlightPlan for Embolization, with AI Segmentation option; FlightPlan for Liver; FlightPlan for Liver with Parenchyma Analysis option; Flow Analysis; GAIA INTERVENTIONAL GENERATOR; GE Delta Software Option for MRI; GSI Fat; GSI Gout; GSI MSI; GSI Materials; GSI PP; GSI Pulmonary Perfusion; GSI Viewer; GSI Viewer with GSI Fat Option; GSI Viewer with VUE Option; GSI Volume Viewer; GenIQ; HAV; Head Auto Views; HeartVision 2; Hepatic VCAR; Hepatic VCAR Gen2; IGS WF BP; IGS WF SP; INNOVA 2100-IQ; INNOVA 2121-IQ; INNOVA 3100-IQ; INNOVA 3131-IQ; INNOVA 4100-IQ; INNOVA EPVISION; INNOVA HEARTVISION; INNOVA IGS 520; INNOVA IGS 530; INNOVA IGS 540; INNOVA IGS 620; INNOVA IGS 630; INNOVA TRACKVISION; INNOVA VISION; INTERACT Discovery RT; Innova 2100 IQ; Innova 2100-IQ; Innova 2121 IQ; Innova 2121-IQ; Innova 3100; Innova 3100-IQ; Innova 3131 IQ; Innova 3131-IQ; Innova 4100; Innova 4100-IQ; Innova CT; Innova EPVision 2; Innova IGS 3; Innova IGS 5; Innova IGS 520; Innova IGS 530; Innova IGS 540; Innova IGS 6; Innova3DXR; Integrated Innova - s5i system option; Integrated Registration; JEDI 100 VASC 1T; JEDI 60 DC; JEDI 60 DC LITE; JEDI 80 RF1T; JEDI HP; JEDI SC FAST kV; JEDI VCT; Jedi; Jedi 100 VASC 1; Jedi 42 CT; Jedi 50 Plus R1T; Jedi 50 R 1T; Jedi 60 CT; Jedi 60 DC; Jedi 60 DC LITE; Jedi 60DC; Jedi 60DC Lite; Jedi 80 R 1T; Jedi 80 RD 1T; Jedi 80 RF 1T; Jedi 80 RF 2T; Jedi NP+V1.5; Jedi42CT; Jedi50R1T; Jedi60CT; Jedi80R1T; Jedi80RF1T; Jedi80RF2T; LU40782; LU43318ST; LU45645; LU45645ST; LU45645STR; LU45649; LU45649ST; LU45649STR; LU50020; LU8548ST; LU8548STR; LU8743ST; LU8743STR; Liver Suite; Lung VCAR; MAGiC; MAGiC DWI for AW; MAGnetic resonance image Compilation; MAXIRAY 100 TH-M1; MPG100; MPG50; MPPU; MR Pasting; MR Touch; MR VesselIQ Xpress; MR pasting 1.1; MR-Touch Option; MX100 FL; MX100 RAD; MX135CT TH1.1; MX165 NP; MX200CT/Performix Ultra; Maxiray CT Ultra; Maxiray CT VCT; Maxiray MX100 FL; Maxiray MX100 RAD; Mirada RTx; Mobile Senographe Essential; Motion VUE; OncoQuant; Optima CL320i; Optima CL323i; Optima CT680 Expert; Optima IGS 320; Optima IGS 330; Optima IGS Mega; Optima IGS Ultra; PET VCAR; PET VCAR DEAUVILLE; PROView; PROView Automatic Segmentation; Patient-Assisted Compression; Performix 160A; Performix 40; Performix 40 Plus; Performix HD; Performix HD Plus; Performix HDw; Performix Plus; Performix Pro VCT 100; Performix Pulsar; Performix VCT Plus; Premium View i; Preprocessing Enabler; Prisme; Pristina Dueta; Pristina Serena; Pristina Serena 3D; Pristina Serena Bright; Prodigy/DPX Series High Voltage Power Supply; Q.Freeze; Q.Freeze 2; Quantib Brain; Quantib Brain 1.3; Quantix 160; READY View; READY View AD/RD; READY View NRR; READY View R2 Error; Radiation Screen; Radiation Screen Extension; Radiation Screen for Control Station; ReportCard 4; Reporting Tool; Revolution Ace; Revolution Maxima; S10x10; S10x20; SB-80-200R; SBM; SCO; SLoc10; SO7.6; SO9.6x20; SSF; SSF2; SYJ; Sample Imaging for Senographe Pristina; Self-Compression; Send by mail; Seno Advantage 2.1; Seno Advantage 2.2; Seno Iris; SenoBright - CESM; SenoBright HD; SenoClaire - GE Breast Tomosynthesis; SenoVision; Senographe 2000D; Senographe 500T; Senographe 600T; Senographe 700T; Senographe 800T; Senographe Care; Senographe DMR; Senographe DS; Senographe DS Stereotaxy; Senographe Essential; Senographe Essential Stereotaxy; Senographe Pristina (Pristina Via); Senographe Pristina 3D; Senographe Pristina paddles; Senographic Stereo; SmartScore; Smartscore 4; SnapShot Freeze; SnapShot Freeze 2; Solarix 350 Brightspeed; Spectral Bone Marrow; Spectral Color Overlay; Spine Auto Views; StarMap; Stereo 3D; Stereo 3D option for Vision Applications; Stereotix; TAVI; TAVI Analysis; TAVI Analysis Gen2; TTH; TTH 8800; TTH HAWKEYE; TTH MAESTRO; TVCAR; Thoracic VCAR; TrackVision 2; VAMP; VMX; Vamana RAD; Vamana Surgery; VersaViewer; VesselIQ Xpress; VessellQ IXray; Vision 2; Volume Illumination; Volume Viewer; Volume Viewer 2; Volume Viewer 3.1; Volume Viewer 4; Volume Viewer 5; Volume Viewer Apps; Volume Viewer Innova; Volume Viewer Innova 3DStent; Volume Viewer Innova Enhanced; Volume Viewer MR; Volume Viewer PET; X-Ray Generator; ZEUS; ZEUS, ZJ/QJ; ZJ/QJ; Zyx; advantage workstation 4.3; cmr42; cvi42; cvi42_Mitral; cvi42_cmr42; eContrast; eContrast NEW",1999-10-06,115,2026-07-21,2,5,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229611343%22&limit=1
Pharmco Medical BV,3030447506,3030447506,Albert Plesmanweg 39 X,ROTTERDAM Zuid-Holland,,90477456,Netherlands,PHARMCO MEDICAL BV,10089125,Exporter to the US,93,BRZ; BTI; BTO; BWC; BWF; BYD; BYY; BZG; DPS; DQA; DQO; DQX; DRC; DRE; DRX; DXN; DXQ; DYB; DZE; EBF; EHL; EMA; ERA; EWO; EYI; FBK; FBQ; FCG; FED; FER; FFL; FGE; FLL; FMF; FMG; FMI; FOZ; FPA; FPB; FYD; FZX; GAA; GAZ; GBW; GBX; GCD; GCJ; GCY; GEI; GES; HFG; HIB; HIF; HLI; HLJ; HLS; HMF; HMX; HNN; HNY; HRX; HWE; JOH; JOL; JYG; KCP; KGX; KNT; KNW; KOD; KPE; KYZ; LHI; LJE; LJH; LKF; LQR; LRJ; LZA; LZC; MED; MJG; MNK; MNL; MPN; MQF; MWI; NHC; OCT; OMD; ONB; OQY; QDO,"Set, Blood Transfusion; Compressor, Air, Portable; Tube, Tracheostomy (W/Wo Connector); Needle, Emergency Airway; Spirometer, Therapeutic (Incentive); Condenser, Heat And Moisture (Artificial Nose); Tube, Aspirating, Flexible, Connecting; Spirometer, Diagnostic; Electrocardiograph; Oximeter; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Electrode, Electrocardiograph; System, Measurement, Blood-Pressure, Non-Invasive; Blood Pressure Cuff; Introducer, Catheter; Implant, Endosseous, Root-Form; Material, Tooth Shade, Resin; Point, Abrasive; Cement, Dental; Otoscope; Audiometer; Adaptor, Ureteral Catheter; Endoscopic Injection Needle, Gastroenterology-Urology; Trocar, Gastro-Urology; Biopsy Needle; Endoscopic Access Overtube, Gastroenterology-Urology; Anoscope And Accessories; Dislodger, Stone, Basket, Ureteral, Metal; Stents, Drains And Dilators For The Biliary Ducts; Continuous Measurement Thermometer; Syringe, Piston; Stopcock, I.V. Set; Needle, Hypodermic, Single Lumen; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Filter, Infusion Line; Apparatus, Exhaust, Surgical; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Tubing, Noninvasive; Catheter, Peritoneal; Catheter, Irrigation; Connector, Catheter; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Electrosurgical, Cutting & Coagulation & Accessories; Blade, Scalpel; Coagulator, Laparoscopic, Unipolar (And Accessories); Speculum, Vaginal, Nonmetal; Insufflator, Laparoscopic; Ophthalmoscope, Ac-Powered; Ophthalmoscope, Battery-Powered; Exophthalmometer; Stand, Instrument, Ac-Powered, Ophthalmic; Cannula, Ophthalmic; Knife, Ophthalmic; Cystotome; Arthroscope; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Tube Tracheostomy And Tube Cuff; Catheter And Tip, Suction; Curette, Ear; Syringe, Ent; Tape And Bandage, Adhesive; Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Catheter, Urological; Container, I.V.; Syringe, Irrigating (Non Dental); Set, I.V. Fluid Transfer; Catheter, Nephrostomy; System, Irrigation, Urological; Cannula, Manipulator/Injector, Uterine; Dislodger, Stone, Biliary; Disinfectant, Medical Devices; Polymer Patient Examination Glove; Medical Glove, Specialty; Sterilant, Medical Devices; Device, Percutaneous, Biopsy; Endoscopic Bite Block; Accessories, Cleaning Brushes, For Endoscope; Tissue Adhesive For The Topical Approximation Of Skin; Catheter, Assisted Reproduction; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents); Anti Fog Solution And Accessories, Endoscopy; Cutaneous Tissue Adhesive With Mesh; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Intrauterine Tamponade Balloon; Fentanyl And Other Opioid  Protection Glove",1; 2; U,"BECTON DICKINSON; BIOPSY INSTRUMENT; BIOPSY NEEDLE; CABLE,RD SET; CANNULA, TRACH; CATHETER, URETERAL OPEN END; Catheter; SENSOR, NEONATE; SENSOR,MASIMO,RED,SET,NEONATAL; STENT, DRAINS, DILATORS; TUBE, TRACH; TUBE, TRACH CUFF; VIROSAFE FLUID TRAP",2023-12-19,117,2024-03-25,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223030447506%22&limit=1
"Medtronic Xomed, Inc.",1045254,1045254,6743 Southpoint DR. North,Jacksonville,FL,32216,United States,"Medtronic, Inc.",2112641,Complaint file establishment; Manufacturer; Repackager or relabeler; Specification developer,81,BSR; BTR; EMX; EOB; EOX; EPP; EPW; EQJ; ERL; ESZ; ETA; ETB; ETD; ETN; FMH; FMI; FOX; FRN; FSM; FST; FSZ; GAA; GAD; GAT; GBX; GEX; GFF; GWE; GWF; GWJ; GWQ; GXY; GXZ; HAW; HBB; HBC; HBE; HRX; HSZ; HWE; IKN; IKT; ITX; IYN; JYM; JZF; KAH; KAM; KAR; KFK; KHJ; KMA; KWF; KWP; KWQ; LBM; LBN; LFB; LLZ; LRC; LRE; LRK; LTB; LXB; LYA; LYS; MDM; MJY; MNH; MNI; NAB; NBH; NKB; NNO; NOK; NQP; ONO; PGW; PNZ; QDF; QPB,"Stylet, Tracheal Tube; Tube, Tracheal (W/Wo Connector); Balloon, Epistaxis; Nasopharyngoscope (Flexible Or Rigid); Esophagoscope (Flexible Or Rigid); Splint, Nasal; Support, Head, Surgical, Ent; Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Tube, Shunt, Endolymphatic; Replacement, Ossicular Prosthesis, Total; Prosthesis, Partial Ossicular Replacement; Tube, Tympanostomy; Stimulator, Nerve; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Stand, Infusion; Pump, Infusion; Tray, Surgical, Instrument; Light, Surgical, Fiberoptic; Light, Surgical, Carrier; Needle, Aspiration And Injection, Disposable; Retractor; Suture, Nonabsorbable, Synthetic, Polyethylene; Catheter, Irrigation; Powered Laser Surgical Instrument; Bur, Surgical, General & Plastic Surgery; Stimulator, Photic, Evoked Response; Stimulator, Electrical, Evoked Response; Stimulator, Auditory, Evoked Response; Full-Montage Standard Electroencephalograph; Electrode, Cutaneous; Electrode, Needle; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Motor, Drill, Electric; Drills, Burrs, Trephines & Accessories (Simple, Powered); Arthroscope; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Electromyograph, Diagnostic; Electrode, Needle, Diagnostic Electromyograph; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; Inserter, Myringotomy Tube; Tube, Ear Suction; Microrule, Ent; Cannula, Sinus; Irrigator, Sinus; Saw, Pneumatically Powered; Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material); Irrigator, Powered Nasal; Prosthesis, Finger, Polymer; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Porous Polyethylene Ossicular Replacement; Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene; Button, Nasal Septal; System, Image Processing, Radiological; Instrument, Ent Manual Surgical; Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile; Device, Anti-Snoring; Cyclosporine Radioimmunoassay; Hearing Aid, Bone Conduction; Splint, Intranasal Septal; Bone Mill; Instrument, Manual, Surgical, General Use; Kit, Serological, Negative Control; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Gauze / Sponge,Nonresorbable For External Use; Accessories, Arthroscopic; Thoracolumbosacral Pedicle Screw System; Jig, Piston Cutting, Ent, Non-Sterile; Material, External Aesthetic Restoration, No Adhesive; Posterior Metal/Polymer Spinal System, Fusion; Neurosurgical Laser With Mr Thermography; Ear, Nose, And Throat Stereotaxic Instrument; Eustachian Tube Balloon Dilation Device; Parathyroid Autofluorescence Detection Device; System, Suction, Lipoplasty For Removal",1; 2; U,", MOTORS; ALAR Nasal Valve Stent; AUSTIN ENDOLYMPH DISPERSMENT SHUNT; AccuGuide Injection Monitor; Airvance; Alinity i HAVAb IgG Controls (LN 08P2710); Anti-snoring device; ApexCut EM Navigated Blades; Aspen; Aspiration Needles; BIOFLEK; BRIDGEMASTER SPLINT; Bard-Parker; Bone Mill; CATHETER, IRRIGATION; CD Engage Cap; CD HORIZON® Spinal System; CONTACT EMG Rotatable Endotracheal Tube; Clearview Surgical Dissecting Tools; Coaxial; Container; Cooling Tubing Sets; Cranial/Ortho/Neuro Elec Drill Sys; DRILLS; Donaldson; ENT Drill & Handpiece, elec & pneu; Endo-Scrub 2 Lens Cleaning System;Endo-Scrub 2 Lens Cleaning Sheaths; Endoscopic Devices; Endoscrub; Endosheath System; Endosheath system; Feathertouch XPS; Fiberoptic; Fisch; Fisch Modified Total; Fisch Spandrel II Total with Shoe; Fitting Software; Foot Control; Goode T-Tube; Helix Drill; Hi-Pro Programming Cable; Hunsake Mon-jet Ventilation Tube; INSTRUMENT, PROSTHESIS; IPC - Integrated Power Console Drill System; Inserter, Myringotomy Tube; Integrated Power Console; Irrigation Tubing Sets; Irrigator, Sinus; Juhn Tym-Tap Middle Ear Fluid Aspirator/Collector; KyphX 11 Gauge Bone Access Needle; KyphX Handle; Introducer; MAST QUADRANT™ Retractor System; MEROCEL PACKINGS, DRESSINGS, ETC.; MEROCEL SPONGE; METRx Endoscope; MICRO-FRANCE Manual Surgical Instr; MIDAS REX LEGEND EHS SYSTEM; MR8 Drill System; MULTIPLE Manual Surgical Instruments; MUTIPLE TYPES OF BURS; McGee; MeroPack; Micro-Craft System; Microsaw Rasps; Midas Rex Curved Burs; Midas Rex Legend Attachments; Midas Rex Legend Drill System; Midas Rex Legend Surgical Dissecting Tools; Midas Rex MR8 ClearView Tools; Moretz Trimming Block; Mortez; NASAL SPLINT; NIM; NIM 3 Nerve Stimulator; NIM CONTACT Reinforced EMG Endotracheal Tube; NIM Eclipse; NIM Essence™ EMG Endotracheal Tube; NIM PRS; NIM SPINE SYSTEM; NIM Standard Reinforced EMG Endotracheal Tube; NIM Vital™; NIM- Spine"" System Instruments; NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip; NIM™ Surgeon Control Probes; Nasal Septal Button; Nasopharyngoscope; Neddle electrode; Needle electrodes; Novapak; NuVent; NuVent EM Sinus Dilation System; NuVent Eustachian Tube Dilation Balloon; ONO; ORO-TRACHEAL INJECTOR NEEDLE; Ossicular Prosthesis; Ossicular Replacement; Otological Metric Scale; Otomag Alpha 2 Sound Processor; Otomag Binural Softband; Otomag Headband; Otomag Monaural Softband; POWEREASE; PTEYE PARATHYROID AUTOFLUORESCENCE DETECTION DEVICE; Paparella; Peek Rod; Powered nasal irrigator; Preset Needles; SURGICAL DRIVE SYSTEM; Saw Blades; Saw Handpieces (Reciprocating, Oscillating, Sagittal); Sensory Testing Endosheath System; Sharpsite ENT Endoscope; Silicone Instrument Spray; Silicone Sheaths; Silicone Sheets; Silverstein Packing Strips; Skeeter; Spinal System; StealthStation ENT Application; Stimulator, evoked response; Stylet; TNE-2000 Esophagoscope; The Big Easy Piston; Roberson Stapes Prostheses; Thoracolumbosacral pedicle screw system; Tray, Surgical, Instrument; Trephine Cannula; TriVantage EMG Tube; Triton Electric High Torque Handpiece And Accessories; Tube, Ear Suction; Tube-Stat Lighted Intubation Stylets, Naso-Tracheal; Oro-Tracheal; Various ENT polymer materials; Various Otology Vent Tubes; Various Partial & Total Prosthesis; Various Polyethylene Ossic Replace; Various XPS; Various partial prosthesis; Various total prosthesis; Varistim III; Ventilation (Tympanostomy) Tubes; Visao High-Speed Otologic Drill; Visualase; Visualase Thermal Therapy System; Visualase™ Cooled Laser Applicator System; VitalFlow ECMO Cart; Wire Nest; XOMED; XPS; XPS 3000; XPS Curved Bur; XPS Nexus; XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole; XPS Nexus"" ENT Power Console System and Components; XPS Straightshot; Xomed Ball-Tip Monopolar Stimulator Probe; and accessories; instrument tray; neurological stereotaxic instrument",1992-07-20,115,2026-09-04,0,25,3,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221045254%22&limit=1
Seaspine Orthopedics Corporation,3012120772,3012120772,5770 Armada Dr,Carlsbad,CA,92008,United States,SeaSpine Orthopedics Corporation,10049589,Complaint file establishment; Manufacturer; Specification developer,51,FZS; FZT; FZX; FZY; GAD; GDG; GFI; HTD; HTF; HTJ; HTR; HTW; HTX; HWA; HWB; HWD; HWJ; HWN; HWT; HWX; HXB; HXC; HXE; HXG; HXP; HXS; HXW; HXX; HXY; HXZ; KWP; KWQ; LXH; MAX; MNH; MNI; MQP; MRW; NKB; NKG; NQW; ODP; OJH; OLO; OSH; OVD; OVE; OWI; PEK; PGM; PHM,"Curette, Surgical, General Use; Cutter, Surgical; Guide, Surgical, Instrument; Hammer, Surgical; Retractor; Hook, Surgical, General & Plastic Surgery; Osteotome, Manual; Forceps; Curette; Gauge, Depth; Rasp; Bit, Drill; Rongeur; Impactor; Extractor; Starter, Bone Screw; Awl; Instrument, Compression; Template; Tap, Bone; Probe; Wrench; Fork; Tamp; Instrument, Bending Or Contouring; Twister, Wire; Bender; Screwdriver; Brace, Drill; Cutter, Wire; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Orthopedic Manual Surgical Instrument; Intervertebral Fusion Device With Bone Graft, Lumbar; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; System, Facet Screw Spinal Device; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Tray; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Bone Fixation Cerclage, Sublaminar; Spinous Process Plate; Growing Rod System; Intervertebral Fusion Device With Bone Graft, Thoracic",1; 2; U,"Admiral ACP System; Anterior Disc Prep; Anterior Disc Prep System; Atoll OCT Spinal System; Balboa; Balboa Anterior Lumbar Buttress System; BodyForm System; Bodyform Thoracic Fixation System; Cambria; Cambria NanoMetalene; Coral Spinal System; Cordant; Daytona Small Stature Growth Rod Conversion Set; Daytona Small Stature Spinal System; Explorer TO System; FORZA XP Expandable Spacer System; Facet Fixation; Facet Fixation System; Fathom Pedicle-Based Retractor; Hollywood; Hollywood NanoMetalene; IsoTis Cervical Facet Prep Instruments; Laminoplasty; Lattus; Malibu; Malibu Spinal System; Malibu Spinal System with Daytona Deformity System; Manta Ray Anterior Cervical Plate System; Manta Ray TDF Spacer; Mariner; Mariner Cap System; Mariner Cortical System and Retractor Set; Mariner Deformity System; Mariner Extension; Mariner MIS Pedicle Screw System; Mariner MIS Wayfinder System; Mariner Outrigger Revision System; Mariner Outrigger System; Mariner Pedicle Screw System; Mariner RDX MIS System; Mariner RDX System; Meridian Anterior Plate System; Meridian Interbody System; Meridian System; Navigation Instruments; NewPort Spinal System; Newport; Newport Spinal System; NorthStar Facet Prep Instruments; NorthStar OCT Spinal System; NorthStar OCT System; Pacifica; Paramount IBF; Posterior Disc Prep; Posterior Disc Prep System; Power Final Tightening Tool; RAPID Graft Delivery; Redondo; Redondo-L; Reef L Interbody System; Reef TA System; Reef TH Interbody System; Reef TH System; Reef TO System; Reef TO/TA System; Regatta Lateral Plate System; Regatta Lateral System; Regatta System; SeaSpine; SeaSpine Beachside System; SeaSpine Cabo ACP (Anterior Cervical Plate) System; SeaSpine Cambria System; SeaSpine Complete Cervical Intervertebral Body Fusion Device; SeaSpine Daytona Small Stature Spinal System; SeaSpine Expandable Intervertebral Body Fusion Device System; SeaSpine Laminoplasty System; SeaSpine Meridian System; SeaSpine Navigation System; SeaSpine NewPort Spinal System; SeaSpine Reef TH System; SeaSpine Reef TO/TA System; SeaSpine Regatta Lateral System; SeaSpine Shoreline ACS - Anterior Cervical System; SeaSpine Spacer System; SeaSpine Spacer System (Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura NanoMetalene); SeaSpine Spacer System NM; SeaSpine Spacer System – Hollywood NanoMetalene, Hollywood VI NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene; SeaSpine Spinous Process System; SeaSpine VBR System; SeaSpine Ventura NanoMetalene System; SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device; SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device; SeaSpine Vu aPod Prime NanoMetalene; SeaSpine Vu ePOD System; SeaSpine Vu ePod System; SeaSpine WaveForm C Interbody System; SeaSpine WaveForm L Interbody System; SeaSpine WaveForm TA Interbody System; SeaSpine WaveForm TO Interbody System; SeaSpine WaveForm™ L, WaveForm™ TO, WaveForm™ TA Systems; SeaSpine® Daytona® Small Stature Spinal System; SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®; SeaSpine® Cambria NanoMetalene®; Shoreline ACS (Anterior Cervical System); Shoreline ACS Interbody System; Shoreline ACS and RT Interbody System; Shoreline Cervical Interbody RT System; Shoreline RT Interbody System; Shoreline TruProfile Threaded Plate; Sierra; Skipjack; Sonoma; Sonoma Anterior Cervical Plate System; Spinous Process System; Stainless Steel Spinal System; Tether; UCR; UCR Spinal System; Ventura; Ventura NanoMetalene; Virata Spinal Fixation System; Vu Mesh; Vu aPOD; Vu aPOD Intervertebral Body Fusion; Vu aPOD Prime NanoMetalene; Vu aPOD-L; Vu aPod L NanoMetalene; Vu cPOD; Vu cPOD IBF; Vu ePOD; VuLPOD; WaveForm A Interbody System; WaveForm A System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody System; Waveform C Interbody System; Zuma; Zuma-C; Zuma-L",2015-06-28,115,2025-06-18,0,9,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012120772%22&limit=1
"Icu Medical, Inc.",3013319212,3013319212,600 N Field Dr,Lake Forest,IL,60045,United States,"ICU MEDICAL, INC.",2025816,Complaint file establishment; Specification developer,32,BSB; BYY; DQA; DQE; DQO; DRG; DRS; DWJ; DXQ; DYG; FOX; FOZ; FPA; FPK; FRN; GBX; GCE; IKX; KPE; KRB; KZL; LGZ; LHI; MEA; MRZ; NEP; ODA; ONB; OUG; PEH; PHC; QBP,"Warmer, Blood, Non-Electromagnetic Radiation; Tube, Aspirating, Flexible, Connecting; Oximeter; Catheter, Oximeter, Fiber-Optic; Catheter, Intravascular, Diagnostic; Transmitters And Receivers, Physiological Signal, Radiofrequency; Transducer, Blood-Pressure, Extravascular; System, Thermal Regulating; Blood Pressure Cuff; Catheter, Flow Directed; Stand, Infusion; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Tubing, Fluid Delivery; Pump, Infusion; Catheter, Irrigation; Adaptor, Catheter; Aid, Transfer; Container, I.V.; Probe, Thermodilution; Device, Warming. Blood And Plasma; Warmer, Thermal, Infusion Fluid; Set, I.V. Fluid Transfer; Pump, Infusion, Pca; Accessories, Pump, Infusion; System/Device, Pharmacy Compounding; Endoscopic Central Control Unit; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System; Medical Device Data System; Hemodialysis Catheter Luer End Cap; Infusion Safety Management Software; Cap, Device Disinfectant",1; 2,"ADAPTOR, CATHETER; Accessories, pump, infusion; Additive Hinge Cap; Administration Set; Administration Sets: Primary Sets, Extension Sets, Burette Sets, Blood Sets; Advanced Sensor Catheter; Blood Set; Burette Set; CLAVE Connector; CVP Polyurethane Catheter W Heparin (No Balloon); Cath Lab Kits; Catheter, Flow Directed; Catheter, oximeter, fiber-optic; ChemoLock; ChemoPort; ClearGuard HD Antimicrobial barrier cap; Cogent Hemodynamic Monitoring System; DEVICE, WARMING. BLOOD AND PLASMA; Decanting Set; Diana; Diana ChemoLock Transfer Set; Diana Compounding Workflow System; Dye Management System; ESP 60™Syringe Pump; Effective Cap; Empty Container and Infusion Set; Extension Set; Flow Directed Thermal-Dilution Infusion; Gemstar Infusion Sets; ICU Medical MedNet Medication Management Suite; Infusion Blood Set; Infusion Pump System with Administration Set; Infusion Set; Infusion System; Infusion safety management software; Irrigation Set; LifeShield™ Infusion Safety Software Suite; Lifecare 5000 Infusion System; Lifecare PCA Infusion System; Lifecare PCA Infusion system; Medical device data system; NovaCath; Nutrimix Empty Container; Omni Flow Infusion System; Opticath; Opticath, Heparin Coated; PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter; PLUM 360 Infusion System; PLUM A+ Infusion System; PLUM XL Infusion System; Plum Duo Precision IV Pump; Plum DuoTM Infusion System; Plum Solo Precision IV Pump; Primary Set; Pump, infusion; Pump, infusion, pca; Rio™ Drug Reconstitution Transfer Device; STAND, INFUSION; Sapphire Set; Sapphire Sets; Set, administration, intravascular; Sterile Empty Container; SwabCap; SwabTip Male Disinfectant Cap; System, thermal regulating; THORACENTESIS SET, 30 Inch; Transpac IT; Two-Way Transfer Device; Vital Signs Wireless Monitoring System; Warmer, blood, non-electromagnetic radiation; Warmer, thermal, infusion fluid; Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432",1999-08-04,114,2026-04-02,0,88,13,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013319212%22&limit=1
Instrumentation Laboratory SPA,3012348571,3012348571,"Via Leonardo da Vinci, 36",Roncello Lombardy,,20877,Italy,Instrumentation Laboratory SpA,10082968,Exporter to the US,43,DAK; DBL; DBM; DDC; DHN; DHR; DQA; FMK; GGN; JIT; JIX; JJX; JPA; KTL; LIG; LJM; LKO; LKP; LLL; LRM; LSW; LYR; MID; MLE; MOB; MQA; MST; MSV; MVJ; MVM; NBS; NBT; NHX; NIY; NJF; NRI; NSU; NUM; NXO; NYO; OBE; OPN; PIV,"Complement C1q, Antigen, Antiserum, Control; Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control; Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control; Thyroglobulin, Antigen, Antiserum, Control; Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control; System, Test, Rheumatoid Factor; Oximeter; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Plasma, Coagulation Control; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Single (Specified) Analyte Controls (Assayed And Unassayed); System, Multipurpose For In Vitro Coagulation Studies; Anti-Dna Indirect Immunofluorescent Solid Phase; Radioassay, Intrinsic Factor Blocking Antibody; Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls; Anti-Rnp Antibody, Antigen And Control; Anti-Sm Antibody, Antigen And Control; Extractable Antinuclear Antibody, Antigen And Control; Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control; Anti-Dna Antibody, Antigen And Control; Helicobacter Pylori; System, Test, Anticardiolipin Immunological; Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control; Test System, Antineutrophil Cytoplasmic Antibodies (Anca); Anti-Ribosomal P Antibodies; Antibodies, Gliadin; System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi); Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm); Autoantibodies, Endomysial(Tissue Transglutaminase); Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1); Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae); Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp); Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis; Antibodies, Anti-Actin, Anti-Smooth Muscle; Autoantibodies, Nuclear Pore Glycoprotein Gp210; Instrumentation For Clinical Multiplex Test Systems; Autoantibodies, Nuclear Body Protein, Sp100; Calprotectin, Fecal; Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody; Anti-Ss-A 52 Autoantibodies; Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex; Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use",1; 2,"(anti-phosphatidylserineand prothombin); AVOX1000E - Whole Blood Oximeter Instrument; Anti-neutrophil Cytoplasmic Autoantibody Reagents; Aptiva APS IgG Reagent; Aptiva APS IgM Reagent; Aptiva CTD Essential Reagent; Aptiva Celiac Disease IgA Reagent; Aptiva Celiac Disease IgG Reagent; Aptiva System Cleaning Solution kit; Aptiva System Rinse; Auto AB Panel; BIO-FLASH System Rinse; Hemochron Signature Elite; HemosIL AcuStar Anti-B2 Glycoprotein-I IgG; HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls; HemosIL AcuStar Anti-B2 Glycoprotein-I IgM; HemosIL AcuStar Anti-Cardiolipin IgG; HemosIL AcuStar Anti-Cardiolipin IgG Controls; HemosIL AcuStar Anti-Cardiolipin IgM; HemosIL AcuStar Anti-Cardiolipin IgM Controls; HemosIL Acustar System Rinse; NOVA Lite ANA KSL; NOVA Lite ANA KSL Kit; NOVA Lite ANA Plus; NOVA Lite ANA Plus Mouse Kidney & Stomach; NOVA Lite ANCA; NOVA Lite ANCA (Ethanol Fixed); NOVA Lite ANCA (Formalin Fixed); NOVA Lite ANCA (Formalin) Kit with DAPI; NOVA Lite ANCA Formalin Kit; NOVA Lite ANCA Kit; NOVA Lite ANCA Substrate Slide Pack; NOVA Lite Auto AB Panel; NOVA Lite Autoantibody Controls; NOVA Lite DAPI ANA Kit; NOVA Lite DAPI ANCA (Ethanol) Kit; NOVA Lite DAPI ANCA (Formalin) Kit; NOVA Lite DAPI dsDNA Crithidia luciliae Kit; NOVA Lite HEp-2 ANA Kit; NOVA Lite Monkey Oesophagus IFA Kit; NOVA Lite Rat Liver, Kidney, Stomach Kit; NOVA Lite Rat Liver,Kidney,Stomach; NOVA Lite dsDNA; NOVA Lite dsDNA Crithidia luciliae; NOVA View; NOVA View 2; NOVA View Automated Fluorescence Microscope; NOVA View Automated Fluorescence Microscope with AUTOLoader; QUANTA Flash B2 GP1 IgA; QUANTA Flash B2 GP1 IgA Controls; QUANTA Flash B2 GP1 IgA Reagents; QUANTA Flash B2GP1 IgG; QUANTA Flash B2GP1 IgG Controls; QUANTA Flash B2GP1 IgG Reagents; QUANTA Flash B2GP1 IgM; QUANTA Flash B2GP1 IgM Controls; QUANTA Flash B2GP1 IgM Reagents; QUANTA Flash B2GP1-Domain1; QUANTA Flash B2GP1-Domain1 Controls; QUANTA Flash B2GP1-Domain1 Reagents; QUANTA Flash CCP3; QUANTA Flash CCP3 Calibrators; QUANTA Flash CCP3 Controls; QUANTA Flash CCP3 Reagents; QUANTA Flash Calprotectin; QUANTA Flash Calprotectin Calibrators; QUANTA Flash Calprotectin Controls; QUANTA Flash Calprotectin Extraction Buffer; QUANTA Flash Calprotectin Reagents; QUANTA Flash Cardiolipin IgA; QUANTA Flash Cardiolipin IgA Controls; QUANTA Flash Cardiolipin IgA Reagents; QUANTA Flash Centromere Calibrators; QUANTA Flash Centromere Controls; QUANTA Flash Centromere Reagents; QUANTA Flash DGP IgA Calibrators; QUANTA Flash DGP IgA Controls; QUANTA Flash DGP IgA Reagents; QUANTA Flash DGP IgG Calibrators; QUANTA Flash DGP IgG Controls; QUANTA Flash DGP IgG Reagents; QUANTA Flash DGP Screen; QUANTA Flash DGP Screen Calibrators; QUANTA Flash DGP Screen Controls; QUANTA Flash DGP Screen Reagents; QUANTA Flash ENA7 Calibrator Kit; QUANTA Flash ENA7 Calibrators; QUANTA Flash ENA7 Control Kit; QUANTA Flash ENA7 Controls; QUANTA Flash ENA7 Reagent Kit; QUANTA Flash ENA7 Reagents; QUANTA Flash GBM; QUANTA Flash GBM Calibrators; QUANTA Flash GBM Controls; QUANTA Flash GBM Reagents; QUANTA Flash HMGCR Reagents; QUANTA Flash Jo-1; QUANTA Flash Jo-1 Calibrators; QUANTA Flash Jo-1 Controls; QUANTA Flash Jo-1 Reagents; QUANTA Flash LKM-1 Calibrators; QUANTA Flash LKM-1 Controls; QUANTA Flash LKM-1 Reagents; QUANTA Flash M2 (MIT3) Calibrators; QUANTA Flash M2 (MIT3) Controls; QUANTA Flash M2 (MIT3) Reagents; QUANTA Flash MPO; QUANTA Flash MPO Calibrators; QUANTA Flash MPO Controls; QUANTA Flash MPO Reagents; QUANTA Flash PR3; QUANTA Flash PR3 Calibrators; QUANTA Flash PR3 Controls; QUANTA Flash PR3 Reagents; QUANTA Flash RF IgA; QUANTA Flash RF IgA Reagents; QUANTA Flash RF IgM; QUANTA Flash RF IgM Reagents; QUANTA Flash RNP Calibrators; QUANTA Flash RNP Controls; QUANTA Flash RNP Reagents; QUANTA Flash Ro52; QUANTA Flash Ro52 Calibrators; QUANTA Flash Ro52 Controls; QUANTA Flash Ro52 Reagents; QUANTA Flash Ro60 Calibrators; QUANTA Flash Ro60 Controls; QUANTA Flash Ro60 Reagents; QUANTA Flash SS-B Controls; QUANTA Flash SSB Calibrators; QUANTA Flash SSB Reagents; QUANTA Flash Scl-70; QUANTA Flash Scl-70 Calibrators; QUANTA Flash Scl-70 Controls; QUANTA Flash Scl-70 Reagents; QUANTA Flash Sm Calibrators; QUANTA Flash Sm Controls; QUANTA Flash Sm Reagents; QUANTA Flash aCL IgA; QUANTA Flash aCL IgA Controls; QUANTA Flash aCL IgA Reagents; QUANTA Flash aCL IgG; QUANTA Flash aCL IgG Controls; QUANTA Flash aCL IgG Reagents; QUANTA Flash aCL IgM; QUANTA Flash aCL IgM Controls; QUANTA Flash aCL IgM Reagents; QUANTA Flash dsDNA; QUANTA Flash dsDNA Calibrators; QUANTA Flash dsDNA Controls; QUANTA Flash dsDNA Reagents; QUANTA Flash h-tTG; QUANTA Flash h-tTG IgA; QUANTA Flash h-tTG IgA Calibrators; QUANTA Flash h-tTG IgA Controls; QUANTA Flash h-tTG IgA Reagents; QUANTA Flash h-tTG IgG Calibrators; QUANTA Flash h-tTG IgG Controls; QUANTA Flash h-tTG IgG Reagents; QUANTA LIte ASCA (S. cerevisiae) IgA; QUANTA LIte GPA (Gastric Parietal Cell Antibody) ELISA; QUANTA LIte Gliadin IgG II ELISA Bulk Pack; QUANTA Lite ACA IgA ELISA Bulk Pack; QUANTA Lite ACA IgA III; QUANTA Lite ACA IgG III; QUANTA Lite ACA IgG III ELISA Bulk Pack; QUANTA Lite ACA IgM III; QUANTA Lite ACA IgM III ELISA Bulk Pack; QUANTA Lite ACA Screen III; QUANTA Lite ANA ELISA; QUANTA Lite ASCA (S.cerevisiae) IgG; QUANTA Lite ASCA IgA ELISA; QUANTA Lite ASCA IgA ELISA (S. cerevisiae); QUANTA Lite ASCA IgG ELISA; QUANTA Lite ASCA IgG ELISA (S. cerevisiae); QUANTA Lite Actin IgG ELISA; QUANTA Lite Actin IgG ELISA Bulk Pack; QUANTA Lite B2 GPI IgA ELISA; QUANTA Lite B2 GPI IgA ELISA Bulk Pack; QUANTA Lite B2 GPI IgM ELISA; QUANTA Lite B2 GPI IgM ELISA Bulk Pack; QUANTA Lite B2 GPI Screening ELISA; QUANTA Lite B2 GPI Screening ELISA Bulk Pack; QUANTA Lite B2GP1 IgG ELISA Bulk Pack; QUANTA Lite B2GPI IgG ELISA; QUANTA Lite C1q CIC ELISA; QUANTA Lite CCP3 IgG ELISA; QUANTA Lite CCP3 IgG ELISA Bulk Pack; QUANTA Lite CCP3.1 IgG/IgA ELISA; QUANTA Lite CCp3.1 IgG/IgA ELISA Bulk Pack; QUANTA Lite Celiac DGP Screen; QUANTA Lite Celiac DGP Screen ELISA; QUANTA Lite Centromere ELISA; QUANTA Lite Chromatin ELISA; QUANTA Lite ENA 4; QUANTA Lite ENA 4 ELISA; QUANTA Lite ENA 4 ELISA Sm,RNP, SS-A and SS-B Screening Test; QUANTA Lite ENA 5 ELISA; QUANTA Lite ENA 6 ELISA; QUANTA Lite F-Actin IgA ELISA; QUANTA Lite GBM ELISA; QUANTA Lite GBM ELISA Bulk Pack; QUANTA Lite GPA ELISA; QUANTA Lite GPA ELISA (Gastric Parietal Cell Antibody); QUANTA Lite Gliadin IgA ELISA; QUANTA Lite Gliadin IgA ELISA Bulk Pack; QUANTA Lite Gliadin IgA II ELISA; QUANTA Lite Gliadin IgA II ELISA Bulk Pack; QUANTA Lite Gliadin IgG ELISA; QUANTA Lite Gliadin IgG ELISA Bulk Pack; QUANTA Lite Gliadin IgG II ELISA; QUANTA Lite H. pylori IgA ELISA; QUANTA Lite H. pylori IgG ELISA; QUANTA Lite HA dsDNA ELISA; QUANTA Lite Histone ELISA; QUANTA Lite IgG II; QUANTA Lite Intrinsic Factor ELISA; QUANTA Lite Jo-1 ELISA; QUANTA Lite LKM-1 ELISA; QUANTA Lite M2 EP (MIT3); QUANTA Lite M2 EP (MIT3) ELISA; QUANTA Lite M2 EP (MIT3) ELISA Bulk Pack; QUANTA Lite MPO IgG ELISA; QUANTA Lite PBC Screen IgG/IgA ELISA; QUANTA Lite PR-3 IgG ELISA; QUANTA Lite PR3 SC ELISA; QUANTA Lite PR3 SC ELISA Bulk Pack; QUANTA Lite Phosphatidylserine IgA ELISA; QUANTA Lite Phosphatidylserine IgG ELISA; QUANTA Lite Phosphatidylserine IgG ELISA Bulk Pack; QUANTA Lite Phosphatidylserine IgM ELISA; QUANTA Lite Phosphatidylserine IgM ELISA Bulk Pack; QUANTA Lite R h-tTG IgA ELISA; QUANTA Lite R h-tTG IgA ELISA Bulk Pack; QUANTA Lite R h-tTG IgG ELISA; QUANTA Lite R h-tTG IgG ELISA Bulk Pack; QUANTA Lite RF IgA ELISA; QUANTA Lite RF IgG ELISA; QUANTA Lite RF IgM ELISA; QUANTA Lite RNA Pol III; QUANTA Lite RNA Pol III ELISA; QUANTA Lite RNP ELISA; QUANTA Lite Ribosome P ELISA; QUANTA Lite SLA; QUANTA Lite SLA ELISA; QUANTA Lite SLA ELISA (Soluble Liver Antigen); QUANTA Lite SS-A 52 ELISA; QUANTA Lite SS-A ELISA; QUANTA Lite SS-B ELISA; QUANTA Lite Scl-70 ELISA; QUANTA Lite Sm ELISA; QUANTA Lite TPO ELISA; QUANTA Lite Thyroid T ELISA; QUANTA Lite aPS/PT IgG ELISA; QUANTA Lite aPS/PT IgM ELISA; QUANTA Lite ds DNA ELISA double stranded DNA ELISA; QUANTA Lite dsDNA ELISA; QUANTA Lite dsDNA SC ELISA; QUANTA Lite gp210; QUANTA Lite gp210 ELISA; QUANTA Lite h-tTG IgA ELISA; QUANTA Lite h-tTG IgA ELISA Bulk Pack; QUANTA Lite h-tTG IgG ELISA; QUANTA Lite h-tTG IgG ELISA (Human Tissue Transglutaminase); QUANTA Lite h-tTG IgG ELISA Bulk Pack; QUANTA Lite h-tTG Screen; QUANTA Lite h-tTG Screen ELISA; QUANTA Lite h-tTG/DGP Screen; QUANTA Lite h-tTG/DGP Screen ELISA; QUANTA Lite sp100 ELISA; QUANTA Lite tTG ELISA; QUANTA Lite tTG ELISA (TissueTransglutaminase); QUATNA Flash SS-B Calibrators; QUATNA Flash SS-B Reagents; QUATNA Flash SSB Controls; QUATNA Lite Phosphatidylserine IgM ELISA Bulk Pack; ROTEM Delta System; ROTROL N; ROTROL P; Sm,RNP,SS-A,SS-B and Scl-70 Screening Test; Sm,RNP,SS-A,SS-B,Scl-70 & Jo-1 Screening Test; TF1000I - Tenderfoot Newborn Heel Incision Device; TF200I - Tenderfoot Newborn Heel Incision Device; TF50I - Tenderfoot Newborn Heel Incision Device; TFM50I - Tenderfoot Micro-Preemie Heel Incision Device; TFP1000I - Tenderfoot Preemie Heel Incision Device; TFP200I - Tenderfoot Preemie Heel Incision Device; TFP50I - Tenderfoot Preemie Heel Incision Device; TFT50I - Tenderfoot Toddler Heel Incision Device; ap-tem; ex-tem; fib-tem; hep-tem; in-tem; star-tem",2021-10-18,114,2024-12-17,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012348571%22&limit=1
"Ortho-Clinical Diagnostics, Inc.",2250051,2250051,1001 US Highway 202,Raritan,NJ,08869,United States,QuidelOrtho Corporation,2024674,Complaint file establishment; Contract manufacturer; Manufacturer; Specification developer,124,CDN; CDP; CDT; CDZ; CEC; CEK; CEM; CEW; CFJ; CFN; CFT; CGA; CGJ; CGN; CGR; CGZ; CHH; CHI; CHP; CIG; CIT; CIW; CIX; CJE; CJY; CKA; CZW; DAD; DBI; DCF; DCK; DDG; DDR; DEM; DGR; DHA; DHR; DHX; DIF; DIH; DIO; DIP; DIS; DJG; DJR; DKB; DKJ; DKZ; DLJ; DMT; DNN; GTQ; JFY; JGJ; JGP; JGS; JHS; JHX; JID; JIH; JIS; JIT; JIX; JIY; JJE; JJX; JJY; JLS; JLW; JMO; JQB; JRC; JXM; JZJ; KHO; KHP; KHQ; KHS; KLI; KLS; KLT; KNK; KSF; KSG; KSI; KSN; KSZ; LBR; LBS; LCD; LCM; LDJ; LDO; LDP; LEG; LEH; LFM; LOL; LOM; LPS; LTJ; LTK; MIU; MJX; MJY; MMI; MOI; MRG; MRR; MSJ; MZA; MZF; MZO; NBC; NIG; NQD; OHQ; PDJ; PMT; PPM; QKO; QKP; QVP; SEI,"Urease, Photometric, Urea Nitrogen; Radioimmunoassay, Total Triiodothyronine; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Method, Nephelometric, Immunoglobulins (G, A, M); Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Radioimmunoassay, Cortisol; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Lipase-Esterase, Enzymatic, Photometric, Lipase; Radioimmunoassay, Estradiol; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Starch-Dye Bound Polymer, Amylase; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Azo Dye, Calcium; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Whole Human Serum, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Calibrators, Drug Specific; Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet; Calibrators, Ethyl Alcohol; Antistreptolysin - Titer/Streptolysin O Reagent; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Lowry (Colorimetric), Total Protein; Electrode, Ion Specific, Sodium; Differential Rate Kinetic Method, Cpk Or Isoenzymes; Fluorometric Method, Cpk Or Isoenzymes; Photometric Method, Ammonia; Flame Photometry, Lithium; Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Ferrozine (Colorimetric) Iron Binding Capacity; Kinetic Method, Gamma-Glutamyl Transpeptidase; Micro Pipette; Enzyme Immunoassay, Benzodiazepine; Prealbumin, Antigen, Antiserum, Control; Fluorometer, For Clinical Use; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzymatic, Carbon-Dioxide; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Kit, Quality Control For Blood Banking Reagents; Media, Potentiating For In Vitro Diagnostic Use; Lectins And Protectins; Centrifuge, Cell-Washing, Automated For Immuno-Hematology; System, Test, Automated Blood Grouping And Antibody; Ldl & Vldl Precipitation, Hdl; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Enzyme Immunoassay, Cannabinoids; Enzymatic Radiochemical Assay, Tobramycin; Colorimetry, Acetaminophen; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Immunoassay, Digitoxin; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Urinary Homocystine (Nonquantitative) Test System; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Enzyme Linked Immunosorbent Assay, T. Cruzi; Kit, Serological, Positive Control; Kit, Serological, Negative Control; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; System, Test, Vitamin D; System, Test, Low Density, Lipoprotein; Apolipoproteins; Test, Equipment, Automated Bloodborne Pathogen; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Test, Natriuretic Peptide; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Multi-Analyte Controls Unassayed; Hemoglobin A1c Test System; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; General Purpose Reagent; Reagent, Coronavirus Serological; Coronavirus Antigen Detection Test System.; Sars-Cov-2 Serology Test; Qualitative And Quantitative Hepatitis B Virus Antibody Assays",1; 2; N; U,"DAT Control, MTS DAT Card; MTS Diluent 2; MTS Diluent 2 PLUS; ORTHO Antibody Enhancement Solution; ORTHO Bovine Albumin Solution Polymerized; ORTHO Bovine Serum Albumin, 22% Protein Concentration; ORTHO Confidence System; ORTHO Optix Reader; ORTHO Summit Processor (OSP); ORTHO T.cruzi ELISA Test System; ORTHO VERSEIA Integrated Processor (VIP); ORTHO VERSEIA Pipettor (VERSEIA); ORTHO VISION Analyzer; ORTHO VISION Analyzer - Certified; ORTHO VISION Max Analyzer; ORTHO Workstation; Ortho 7% BSA; Ortho Anti A1 Lectin; Ortho Coombs Control; Ortho Optix Reader; Ortho Rhhr Control (human & bovine); QuickVue At Home COVID-19; QuickVue COVID-19 Test Control Swab Set; QuickVue SARS Antigen Test; Quidel Molecular Adenovirus Control Set (M110); Quidel Molecular Bordetella Control Set (M117); Quidel Molecular C. difficile Control Set (M108); Quidel Molecular GBS Control Set (M116); Quidel Molecular HSV 1+2 Control Set (M109); Quidel Molecular HSV 1+2/VZV Control Set (M121); Quidel Molecular Influenza A+B Control Set (M106); Quidel Molecular Parainfluenza Virus Control Set (M115); Quidel Molecular RSV+hMPV Control Set (M107); Quidel Molecular Strep A+G Control Set (M111); Quidel Molecular Trichomonas Control Set (M119); Sofia 2 SARS Antigen FIA; Sofia SARS Antigen FIA; Solana HSV 1+2/VZV Control Set (M118); Solana Influenza A+B Control Set (M122); Solana RSV+hMPV Control Set (M123); VITROS 25-OH Vitamin D Total Calibrators; VITROS 25-OH Vitamin D Total Reagent Pack; VITROS 250 Chemistry System; VITROS 250 Chemistry System Refurbished; VITROS 350 Chemistry System; VITROS 3600 Immunodiagnostics System; VITROS 3600 Immunodiagnostics System - Certified; VITROS 3600 Immunodiagnostics System - Refurbished; VITROS 4600 Chemistry System; VITROS 4600 Chemistry System Refurbished; VITROS 5,1 FS Chemistry System; VITROS 5,1 FS Chemistry System Refurbished; VITROS 5600 Integrated System; VITROS 5600 Integrated System Certified; VITROS 5600 Integrated System Refurbished; VITROS 7% BSA; VITROS AAT Reagent; VITROS AAT/HPT Performance Verifiers; VITROS ACET Slides; VITROS AFP Range Verifier; VITROS ALB Slides; VITROS ALB-TP Slides; VITROS ALC Slides; VITROS ALT Slides; VITROS ALTV Slides; VITROS AMON Slides; VITROS AMPH Reagent; VITROS AMYL Slides; VITROS ASO Reagent; VITROS ASO/RF Performance Verifiers; VITROS AST Slides; VITROS Anti- HCV Reagent Pack; VITROS Anti-HAV IgM Calibrator; VITROS Anti-HAV IgM Controls; VITROS Anti-HAV IgM Reagent Pack; VITROS Anti-HAV Total Calibrators; VITROS Anti-HAV Total Controls; VITROS Anti-HAV Total Reagent Pack; VITROS Anti-HBc Calibrator; VITROS Anti-HBc Controls; VITROS Anti-HBc IgM Calibrator; VITROS Anti-HBc IgM Controls; VITROS Anti-HBc IgM Reagent Pack; VITROS Anti-HBc Reagent Pack; VITROS Anti-HBe Calibrators; VITROS Anti-HBe Reagent Pack; VITROS Anti-HBs Quantitative Calibrators; VITROS Anti-HBs Quantitative Controls; VITROS Anti-HBs Quantitative Reagent Pack; VITROS Anti-HCV Calibrators; VITROS Anti-HCV Controls; VITROS Anti-HIV 1+2 Calibrator; VITROS Anti-HIV 1+2 Controls; VITROS Anti-HIV 1+2 Reagent Pack; VITROS Anti-SARS-CoV-2 IgG Calibrator; VITROS Anti-SARS-CoV-2 IgG Controls; VITROS Anti-SARS-CoV-2 IgG Quantitative Calibrator EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Controls EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack EUA210322; VITROS Anti-SARS-CoV-2 IgG Reagent Pack; VITROS Anti-SARS-CoV-2 Total N Antibody Calibrator EUA210355; VITROS Anti-SARS-CoV-2 Total N Antibody Reagent Pack EUA210355; VITROS Anti-SARS-CoV-2 Total N Controls EUA210355; VITROS ApoA1 Performance Verifiers; VITROS ApoA1 Reagent; VITROS ApoB Performance Verifiers; VITROS ApoB Reagent; VITROS B12 Range Verifier; VITROS BARB Reagent; VITROS BENZ Reagent; VITROS BRAHMS PCT Calibrators; VITROS BRAHMS PCT Controls; VITROS BRAHMS PCT Range Verifier; VITROS BRAHMS PCT Reagent Pack; VITROS BUN/UREA Slides; VITROS BuBc Slides; VITROS C3 Reagent; VITROS C4 Reagent; VITROS CA 125 II Calibrator; VITROS CA 125 II Range Verifier; VITROS CA 125 II Reagent Pack; VITROS CA 15-3 Calibrator; VITROS CA 15-3 Range Verifier; VITROS CA 15-3 Reagent Pack; VITROS CA 19-9 Calibrator; VITROS CA 19-9 Range Verifiers; VITROS CA 19-9 Reagent Pack; VITROS CAFFN Reagent Kit; VITROS CEA Calibrators; VITROS CEA Range Verifier; VITROS CEA Reagent Pack; VITROS CHE Slides; VITROS CHOL Slides; VITROS CK Slides; VITROS CK-MB Calibrator; VITROS CK-MB Range Verifier; VITROS CK-MB Reagent Pack; VITROS CKMB Slides; VITROS COCM Reagent; VITROS CRBM Slides; VITROS CREA Slides; VITROS CRP Performance Verifiers; VITROS CRP Slides; VITROS Ca Slides; VITROS Calibrator Kit 1; VITROS Calibrator Kit 10; VITROS Calibrator Kit 11; VITROS Calibrator Kit 12; VITROS Calibrator Kit 13; VITROS Calibrator Kit 14; VITROS Calibrator Kit 16; VITROS Calibrator Kit 17; VITROS Calibrator Kit 19; VITROS Calibrator Kit 2; VITROS Calibrator Kit 20; VITROS Calibrator Kit 21; VITROS Calibrator Kit 22; VITROS Calibrator Kit 23; VITROS Calibrator Kit 24; VITROS Calibrator Kit 25; VITROS Calibrator Kit 26; VITROS Calibrator Kit 27; VITROS Calibrator Kit 28; VITROS Calibrator Kit 29; VITROS Calibrator Kit 3; VITROS Calibrator Kit 30; VITROS Calibrator Kit 31; VITROS Calibrator Kit 32; VITROS Calibrator Kit 4; VITROS Calibrator Kit 5; VITROS Calibrator Kit 6; VITROS Calibrator Kit 7; VITROS Calibrator Kit 8; VITROS Calibrator Kit 9; VITROS Calibrator Kit 99; VITROS Chemistry Products Calibrator Kit 25; VITROS Chemistry Products Performance Verifiers; VITROS Chemistry Products dHDL Slides; VITROS Cl Slides; VITROS Cortisol Calibrator; VITROS Cortisol Range Verifier; VITROS Cortisol Reagent Pack; VITROS DAT Performance Verifiers; VITROS DGXN Slides; VITROS ECO2; VITROS ECi Immunodiagnostic System; VITROS ECi Immunodiagnostic System Refurbished; VITROS ECiQ Immunodiagnostic System; VITROS Estradiol Calibrator; VITROS Estradiol Range Verifier; VITROS Estradiol Reagent Pack; VITROS FS Calibrator 1; VITROS FS Diluent Pack 1, 2, 3 and 4; VITROS FS Micro Tips; VITROS FS Reconstitution Diluent; VITROS FSH Calibrator; VITROS FSH Range Verifier; VITROS FSH Reagent Pack; VITROS Fe Slides; VITROS Ferritin Range Verifier; VITROS Folate Calibrator; VITROS Folate Range Verifier; VITROS Folate Reagent Pack 1/2; VITROS Free T3 Calibrator; VITROS Free T3 Range Verifier; VITROS Free T3 Reagent Pack; VITROS Free T4 Range Verifier; VITROS Free T4 Reagent Pack; VITROS GENT Reagent; VITROS GGT Slides; VITROS GLU Slides; VITROS HBeAg Calibrator; VITROS HBeAg Reagent Pack; VITROS HBsAg Calibrator; VITROS HBsAg Confirmatory Kit; VITROS HBsAg Controls; VITROS HBsAg Reagent Pack; VITROS HCY2 Performance Verifiers; VITROS HCY2 Reagent; VITROS HIV Combo Calibrator; VITROS HIV Combo Controls (Anti-HIV-1 group O); VITROS HIV Combo Controls (HIV p24 Antigen); VITROS HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2); VITROS HIV Combo Reagent Pack; VITROS HPT Reagent; VITROS HbA1c Reagent Kit; VITROS High Sample Diluent A and B; VITROS INTACT PTH Calibrators; VITROS INTACT PTH Controls; VITROS INTACT PTH Range Verifier; VITROS INTACT PTH Reagent Pack; VITROS IgA Reagent; VITROS IgG Reagent; VITROS IgM Reagent; VITROS Immuno-Wash Fluid; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack DEN210040; VITROS Immunodiagnostic Products CA 19-9 Calibrator; VITROS Immunodiagnostic Products CA 19-9 Reagent Pack; VITROS Immunodiagnostic Products CEA Calibrators; VITROS Immunodiagnostic Products CEA Reagent Pack; VITROS Immunodiagnostic Products Intact PTH II Calibrators; VITROS Immunodiagnostic Products Intact PTH II Reagent Pack; VITROS Immunodiagnostic Products Progesterone 2 Calibrators; VITROS Immunodiagnostic Products Progesterone 2 Range Verifiers; VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack; VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack; VITROS Immunodiagnostic Products hs Troponin I Low Control; VITROS Immunodiagnostic Products hsTroponin I Calibrator; VITROS Isoenzyme PVs; VITROS K+ Slides; VITROS LAC Slides; VITROS LDH Slides; VITROS LDHI SLides; VITROS LH Range Verifier; VITROS LIPA Slides; VITROS Li Slides; VITROS Liquid Performance Verifiers; VITROS METD Reagent; VITROS Metabolism Controls; VITROS Mg Slides; VITROS Micro Tips; VITROS MicroSensor Check Fluids; VITROS Myoglobin Calibrator; VITROS Myoglobin Range Verifier; VITROS Myoglobin Reagent Pack; VITROS NT pro-BNP Calibrators; VITROS NT pro-BNP Range Verifier; VITROS NT pro-BNP Reagent Pack; VITROS NT-proBNP II Reagent Pack; VITROS NTx Range Verifier; VITROS Na+ Slides; VITROS OP Reagent; VITROS PALB Performance Verifiers; VITROS PALB Reagent; VITROS PCP Reagent; VITROS PHYT Slides; VITROS PROT SLides; VITROS Percent A1c Performance Verifiers; VITROS Performance Verifiers; VITROS Progesterone Calibrator Kit; VITROS Progesterone Range Verifier; VITROS Progesterone Reagent Pack; VITROS Prolactin Calibrator; VITROS Prolactin Range Verifier; VITROS Prolactin Reagent Pack; VITROS Protein Performance Verifiers; VITROS RF Reagent; VITROS Red Cell Folate Pack; VITROS Reference Fluids; VITROS SALI Slides; VITROS SARS-COV-2 Antigen Calibrator EUA202928; VITROS SARS-COV-2 Antigen Controls EUA202928; VITROS SARS-COV-2 Antigen Reagent Pack EUA202928; VITROS SARS-COV-2 Extraction Buffer EUA202928; VITROS Signal Reagent; VITROS T3 Uptake II Calibrator; VITROS T3 Uptake II Range Verifier; VITROS T3 Uptake II Reagent Pack; VITROS T4 Calibrator; VITROS TBIL Slides; VITROS TDM Performance Verifiers; VITROS THC Reagent; VITROS THEO Slides; VITROS TIBC Kit; VITROS TOBRA Reagent; VITROS TP Slides; VITROS TRFRN Reagent; VITROS TRIG Slides; VITROS TSH Calibrator; VITROS TSH Range Verifier; VITROS TSH Reagent Pack; VITROS Testosterone Calibrator; VITROS Testosterone Range Verifier; VITROS Testosterone Reagent Pack; VITROS Total PSA Calibrator; VITROS Total PSA Range Verifier; VITROS Total PSA Reagent Pack; VITROS Total T3 II Calibrator; VITROS Total T3 II Range Verifier; VITROS Total T3 II Reagent Pack; VITROS Total T4 Calibrator; VITROS Total T4 Range Verifier; VITROS Total T4 Reagent Pack; VITROS Total bhCG II Calibrator; VITROS Total bhCG II Range Verifier; VITROS Total bhCG II Reagent Pack; VITROS Troponin I ES Calibrators; VITROS Troponin I ES Range Verifier; VITROS Troponin I ES Reagent Pack; VITROS UPRO Performance Verifiers; VITROS UPRO Slides; VITROS URIC Slides; VITROS Universal Wash Reagent; VITROS Urine Electrolyte Diluent; VITROS VALP Reagent; VITROS VANC Reagent; VITROS Versa Tips; VITROS XT 3400 Chemistry System; VITROS XT 7600 Integrated System; VITROS XT 7600 Integrated System Certified; VITROS XT ALTV-AST Slides; VITROS XT GLU-Ca Slides; VITROS XT TBIL-ALKP Slides; VITROS XT TRIG-CHOL Slides; VITROS dHDL Slides; VITROS dLDL Reagent; VITROS dTIBC Performance Verifiers; VITROS dTIBC Reagent; VITROS hsCRP Performance Verifiers; VITROS hsCRP Reagent; VITROS mALB Performance Verifiers; VITROS mALB Reagent",2020-11-24,107,2024-05-08,7,16,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222250051%22&limit=1
Zeus Scientific LLC,2242436,2242436,200 Evans Way,Branchburg,NJ,08876,United States,ZEUS SCIENTIFIC LLC,2242436,Contract manufacturer; Manufacturer; Remanufacturer; Repackager or relabeler,61,DAK; DBE; DBJ; DBL; DBM; DDC; DEW; DHC; DHN; DHR; GLZ; GMP; GMQ; GMS; GQC; GQH; GQL; GQW; JMM; JRY; JZO; KIY; KTL; LDZ; LFX; LFY; LFZ; LGC; LGD; LHL; LIP; LJB; LJM; LJN; LJY; LJZ; LKI; LKJ; LKQ; LLL; LLM; LSE; LSQ; LSR; LYR; MCD; MID; MOB; MST; MVJ; MVM; MXJ; MYF; MYL; MYM; OBE; OPM; PET; PIV; PPM; QKO,"Complement C1q, Antigen, Antiserum, Control; Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control; Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control; Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control; Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control; Thyroglobulin, Antigen, Antiserum, Control; Igg, Antigen, Antiserum, Control; System, Test, Systemic Lupus Erythematosus; Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control; System, Test, Rheumatoid Factor; Antigens, If, Toxoplasma Gondii; Antisera, Control For Nontreponemal Tests; Antigens, Nontreponemal, All; Anti-Human Globulin, Fta-Abs Test; Antisera, Cf, Equine Encephalitis Virus, Eee, Wee; Antigen, Cf (Including Cf Control), Cytomegalovirus; Antisera, Fluorescent, Herpesvirus Hominis 1,2; Antigen, Cf, (Including Cf Control), Varicella-Zoster; Column Chromatography & Color Development, Hydroxyproline; Antiserum, Fluorescent, Epstein-Barr Virus; System, Test, Thyroid Autoantibody; Chamber, Slide Culture; Anti-Dna Indirect Immunofluorescent Solid Phase; Fixative, Alcohol Containing; Enzyme Linked Immunoabsorbent Assay, Rubella; Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster; Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus; Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific; Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii; Reagents, Antibody, Legionella, Direct & Indirect Fluorescent; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Enzyme Linked Immunoabsorbent Assay, Rubeola Igg; Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls; Antibody Igm, If, Epstein-Barr Virus; Enzyme Linked Immunoabsorbent Assay, Mumps Virus; Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.; Antisera, Fluorescent, Chlamydia Spp.; Antinuclear Antibody, Antigen, Control; Antibody Igm,If, Cytomegalovirus Virus; Extractable Antinuclear Antibody, Antigen And Control; Test, Antigen, Nuclear, Epstein-Barr Virus; Epstein-Barr Virus, Other; Reagent, Rickettsia Serological; Reagent, Borrelia Serological Reagent; Helicobacter Pylori; Antigen, Ebv, Capsid; System, Test, Anticardiolipin Immunological; Test System, Antineutrophil Cytoplasmic Antibodies (Anca); Antibodies, Gliadin; Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm); Autoantibodies, Endomysial(Tissue Transglutaminase); Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1; Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2; Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg; Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm; Anti-Ss-A 52 Autoantibodies; Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2; Anti-Ss-A Ro60 Autoantibodies; Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use; General Purpose Reagent; Reagent, Coronavirus Serological",1; 2; 3; N,"ANA HEp-2; ANTI-DNA INDIRECT IMMUNOFLUORESCENT SOLID PHASE; ANTIGEN, CF (INCLUDING CF CONTROL), CYTOMEGALOVIRUS; ANTIGENS, NONTREPONEMAL, ALL; ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL; ANTINUCLEAR ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL; ANTIPARIETAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL; ANTISERA, CF, EQUINE ENCEPHALITIS VIRUS, EEE, WEE; ANTISERA, CONTROL FOR NONTREPONEMAL TESTS; ANTISERA, FLUORESCENT, CHLAMYDIA SPP.; ANTISERUM, FLUORESCENT, EPSTEIN-BARR VIRUS; ANTISMOOTH MUSCLE ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL; ASA (Monkey Esophagus); Alegria FLash SSB; Alegria Flash CTD Screen; Alegria Flash ENA Screen; Alegria Flash GBM; Alegria Flash MPO; Alegria Flash PR3; Alegria Flash SSA-52; Alegria Flash SSA-60; Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-fixed); Antisera, fluorescent, herpesvirus hominis 1,2; AtheNA Multi-Lyte® MMRV IgG Plus Test System; AtheNA Multi-Lyte® RF IgM Plus Test System; Autoantibodies, endomysial(tissue transglutaminase); Devices, measure, antibodies to glomerular basement membrane (gbm); EPSTEIN-BARR VIRUS, OTHER; General purpose reagent; MULTIPLE AUTOANTIBODIES, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL; Mouse Kidney/Stomach/Liver Tissue; REAGENT, RICKETTSIA SEROLOGICAL; REAGENTS, ANTIBODY, LEGIONELLA, DIRECT & INDIRECT FLUORESCENT; Rat Kidney/Stomach Tissue; Rat Kidney/Stomach/Liver Tissue; SYSTEM, TEST, SYSTEMIC LUPUS ERYTHEMATOSUS; SYSTEM, TEST, THYROID AUTOANTIBODY; TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA); ZEUS IFA™ ANA HEp-2 Test System; ZEUS dIFine® Digital Scanner and Software",1992-07-14,112,2026-08-21,2,11,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222242436%22&limit=1
ConMed Corporation,3004491689,3004491689,6363 S Fiddlers Green Cir Ste 1400,Greenwood Village,CO,80111,United States,CONMED CORPORATION,1317214,Specification developer,33,BYX; DWG; FBM; FEC; FEH; FHO; FOX; FRN; FWZ; FXX; FYD; FZQ; GAZ; GBW; GCJ; GCX; GEI; GEN; HAM; HBT; HES; HET; HFG; HGI; HIF; JOS; KCT; KDQ; KNF; LKF; NKC; OCT; QQS,"Tubing, Pressure And Accessories; Electrosurgical Device; Cannula And Trocar, Suprapubic, Non-Disposable; Obturator, For Endoscope; Electrode, Flexible Suction Coagulator; Pneumoperitoneum Needle; Stand, Infusion; Pump, Infusion; Operating Room Accessories Table Tray; Mask, Surgical; Apparatus, Exhaust, Surgical; Clip, Removable (Skin); Tubing, Noninvasive; Catheter, Peritoneal; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Operating-Room, Wall Vacuum Powered; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Apparatus, Electrosurgical; Applier, Hemostatic Clip; Insufflator, Carbon-Dioxide, Uterotubal (And Accessories); Laparoscope, Gynecologic (And Accessories); Coagulator, Laparoscopic, Unipolar (And Accessories); Electrocautery, Gynecologic (And Accessories); Insufflator, Laparoscopic; Electrode, Electrosurgical; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Bottle, Collection, Vacuum; Coagulator-Cutter, Endoscopic, Unipolar (And Accessories); Cannula, Manipulator/Injector, Uterine; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Anti Fog Solution And Accessories, Endoscopy; Stapler, Skin",1; 2,"1 Liter Pressure Infusor; 1000 SES; 3 Liter Pressure Infusor; ABC; ABC Flex Probes; ABC Footswitch; ABC Handpieces/Accessories; ABC Laparoscopic Probe; AIR SAFE; AIrseal; Accessory Electrode; Aer Defense; AirSeal; AirSeal Robotic Solution; AirSeal dV Solution; AirSeal iFS System; AirSeal® Bifurcated Filtered Tube Set; AirSeal® Cannula Cap; Altrus; Anchor Tissue Retrieval System; Anchor Tissue Retrieval System by CONMED; AnchorPort; AnchorPort SILK; Arthroscopic Energy System; Ball Electrodes; Bend A Beam; BiCap Superconductor; BiCapIII; Big Yank; Bipolar Coagulating Forceps; Bipolar Cord; Bovie; CONMED Laparoscopic Electrode; CONMED Laparoscopic Scissors; CORE E3; Clearvac; Clearview; ConMed 1000 Smoke Evacuator Sys.; ConMed 1200 Smoke Evacuator Sys.; ConMed Stealth Electrode; Core; Core Dynamics; Core Trumpet; DetachaPort; DetachaTip; DetachaTip Instrument Tray; Detachatip III; Dflex; Dispersive Electrode Adapter; Dual 1 Liter Pressure Infusor; Dual Tank Gauge; EDGE Bi-Polar Arthroscopic RF System; EDGE S.A.F.E.; ESU Footswitch; EZLink; Examine; Excel; Expose Retractor; Extended Blade Electrosurgical Electrode; FIXATION STRAP; FUMOVAC; FloVac; Footcontrol - Bipolar Forceps; Footswitch, Bipolar; Forcep Accessories; GoldVac; GoldVac Slim; Goldline handpieces/Pencils; HOSE ASSEMBLY; HOSE HANDLERS; HP Pin Index Yoke 1m; HP Pin Index Yoke with Gauge 1m; Hand-Trol; Handcontrol - Bipolar Forceps; Harmony AIR; HarmonyAIR; HelixAR; HelixAR ABC System; Holster; HyfreVAC; Infusor Compressor; LEG STABILIZER; LaparoLight; LaparoVue; LaseADAPT; Linvatec; Loop Electrosurgical Electrode; Loop Excision Electrode; Loop Excision Electrodes; MEP-1; Macrolyte; MicroSafe; Monopolar Forceps; NITROGEN HOSE; Needle Electrosurgical Electrode; Neptune; OR-VAC; OSTEON HOSE; OnePort; Optimumm; OrthoVAC; PLUMEPORT; PenAdapt; Phoenix; Pin Index Yoke Mounted Valve; PlumeGuard; PlumePen; PlumePort; PlumeSafe X5 Smoke Management System; PlumeVac; QUIKLINK; Reflex; Reusable Bipolar Forceps; Reusable Grounding Pad Cable; SHE SHA; STABILIZER BALL; STRESS POST; Sabre Genesis; SelectOne; SkyVac; Smoke Evacuator Accessories; Smoke Plume; Smoke Shark; SnapEvac; Stackhouse; Straight Blade Electrosurgical Electrode; StrykeVac; Surefit; Surgical Laser Mask; Switching Valve w/ hoses and mounting bracket; System 2450 ESU and Accessories; System 5000 ESU and accessories; TUR/Endoscopic Cable; TeleVac; Thermogard; TroGard Finesse; UNIVERSAL HOSE; Universal Cart Strap; Universal Modular Base Cart; Universal Modular Cart Cord Wraps; Universal Plus; Universal Plus ES; VARIOUS ENDOSCOPIC PROB; VCARE; VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator); VCARE Plus; VCare Dx; VCare Dx Plus; Vacuum hose holder stand; Valve with Hoses and Mounting Bracket; ViroSafe; ViroVac; VisiClear; VueTip; core; iFS Cart 6"" Bottle with Valve; iFS Cart with Valve; iFS Cart with Valve and two Bottle Racks; iFS House Gas Switching Valve; puddle vac; smokeSTAR",1992-06-27,113,2024-08-05,0,9,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004491689%22&limit=1
Medical Components Inc,2518902,2518902,1499 Delp Drive,Harleysville,PA,19438,United States,Medical Components Inc,2518902,Complaint file establishment; Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler; Reprocessor; Specification developer,34,DQO; DQX; DQY; DRC; DRE; DWS; DXC; DYB; FJS; FMF; FOZ; FPA; GAH; GBS; GBX; GCB; GDF; HXD; JCY; KMK; KNT; KNZ; LFJ; LFK; LJS; LJT; MPB; MSD; MZY; NFK; NGT; NIE; PND; PTI,"Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Instruments, Surgical, Cardiovascular; Clamp, Vascular; Introducer, Catheter; Catheter, Peritoneal, Long-Term Indwelling; Syringe, Piston; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Stylet, Surgical, General & Plastic Surgery; Catheter, Ventricular, General & Plastic Surgery; Catheter, Irrigation; Needle, Catheter; Guide, Needle, Surgical; Clamp; Catheter, Infusion; Device, Intravascular Catheter Securement; Tubes, Gastrointestinal (And Accessories); Accessories, A-V Shunt; Catheter, Subclavian; Catheter, Femoral; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Catheter, Hemodialysis, Non-Implanted; Catheter, Hemodialysis, Implanted; Graft, Vascular, Stainless Steel Tunneler; Kit, Repair, Catheter, Hemodialysis; Saline, Vascular Access Flush; Catheter, Hemodialysis, Triple Lumen, Non-Implanted; Midline Catheter; Non-Coring (Huber) Needle",1; 2,"20G X 3/4"" Pro-Lock Safety Infusion Set; Catheter Extension Repair Clamps; Duralock; Pro-Line XL Power Injectable Central Venous Catheter; Pro-Line XL Tunneler; Pro-PICC(R) CT; Symetrex LTHD Catheter and Symetrex LTHD Catheter with Sideholes",1992-11-17,113,2026-10-09,0,23,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222518902%22&limit=1
Baxter Healthcare Corporation,1416980,1416980,25212 W. Illinois Route 120,Round Lake,IL,60073,United States,BAXTER HEALTHCARE CORPORATION,1417572,Complaint file establishment; Manufacturer; Specification developer,58,BRZ; CAN; DPW; DWP; DXC; DXG; DXZ; ERA; EYI; FMF; FMG; FOX; FPA; FPB; FRN; FTM; FZP; GCJ; GCY; GDO; GXQ; HLJ; HRX; HTD; ITX; IYN; JRG; KCT; KGZ; KHJ; KPE; KSW; KYX; KYZ; LHI; LJH; LMF; LMG; LXG; LYC; LZH; MCN; MDM; MEB; MKY; MQV; MTJ; MVR; NBE; NEP; NOI; OXB; OXE; PAJ; PHC; PMX; PSQ; PWH,"Set, Blood Transfusion; Regulator, Pressure, Gas Cylinder; Flowmeter, Blood, Cardiovascular; Dilator, Vessel, Surgical; Clamp, Vascular; Computer, Diagnostic, Pre-Programmed, Single-Function; Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene; Otoscope; Adaptor, Ureteral Catheter; Syringe, Piston; Stopcock, I.V. Set; Stand, Infusion; Set, Administration, Intravascular; Filter, Infusion Line; Pump, Infusion; Mesh, Surgical; Clip, Implantable; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Applier, Surgical, Clip; Dura Substitute; Ophthalmoscope, Battery-Powered; Arthroscope; Forceps; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; Block, Heating; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Accessories, Catheter; Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material); Container, I.V.; System, Processing For Frozen Blood; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Set, I.V. Fluid Transfer; System, Irrigation, Urological; Agent, Absorbable Hemostatic, Collagen Based; Agent, Absorbable Hemostatic, Non-Collagen Based; Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use; Bone Grafting Material, Synthetic; Pump, Infusion, Enteral; Barrier, Absorbable, Adhesion; Instrument, Manual, Surgical, General Use; Pump, Infusion, Elastomeric; System, Skin Closure; Filler, Bone Void, Calcium Compound; Wax, Bone; Device, Anastomotic, Microvascular; Sealant, Polymerizing; System/Device, Pharmacy Compounding; Stand, Instrument, Ophthalmic, Battery Powered; Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction; Mesh, Surgical, Collagen, Staple Line Reinforcement; Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed; Infusion Safety Management Software; Absorbable Collagen Hemostatic Agent With Thrombin; Intracardiac Patch Or Pledget, Biologically Derived; Administrations Sets With Neuraxial Connectors",1; 2; 3; U,"3 Lead Ext w/2 Interlink Inject Sit; 3 Port Adapter; 719-3 Li-Ion Plus USB Handle for Desk Charger; 719-DSK Welch Allyn Universal Desk Charger; 719-USB USB POWER SUPPLY,5V,1.4A,USB-A; ADAPTACAP; ALTAPORE; ARS-530 Air Regulator System; AUTOMIX 3+3 COMPOUNDER; Abacus; Actifuse; Actifuse ABX; Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS; Actifuse Flow; Actifuse Shape; Additive Cap; Adept; All-In-One Two Chamber Container; Allen; Altapore MIS; Altapore Shape; Anastomotic Instrument; Arthromatic; Arthroscopic Irrigation Set; Automix 3+3/AS Compounder System; Aviva; BLK Pocket LED Otoscope; Bard Epidural Spike Tubing Set; Baxter Pain Mate Pain Mgt System; Baxter Starling Sensor; Blood Administration Set; Blood Administration Sets; Blood Recipient Set; Buretrol; Buretrol Solution Sets; CHEMO-AIDE DISPENSING PIN; Cheetah Sensors; Clearlink; Clearlink Luer Activated Valve; Clearlink System Solution Set; Compacset Portable Dignostic Set, Lumiview w/Various Transformer Sets and Accessories; Continu-Flo; ContinuFlo Solution Set; Control-A-Flo; Coseal Surgical Sealant; Cystoscopy Irrigation Set; DUPLOJECT EASY-PREP SYSTEM; DermaClose Continous External Tissue Expander; DermaClose XL Continuous External Tissue Expander; Digital MacroView, MacroView, 3.5V Diagnostic, Pneumatic, Op77E-Rating, PocketScope, Pocket Jr.; Dispencing Pins; Dose IQ Safety Software; Due Set A; Duo Set; Duo-Vent; Duoset; DuploReach; Duplocath; Duploject; Dura-Guard-Dural Repair Patch; EASYGRIP FLO-41 Precision MIS Delivery System; EM2400 Pharmacy Compounder; EXACTAMED; EXACTAMED Oral Dispenser; EXACTAMIX EVA TPN Bags; EXACTAMIX Valve Sets & Inlets; EasySpray; Electrode; Evacuated Container; ExactaMix Pro 1200 Display Module; ExactaMix Pro 1200 Display Module - Refurbished; ExactaMix Pro 2400 Display Module; ExactaMix Pro 2400 Display Module - Refurbished; Extension Set; FENWAL BLOOD RECIPIENT SET; Fibrinotherm; Flo-Rester; Flo-Rester Vessel Sizer; Flo-Thru; Floseal; Forceps; GEM Biover Clamps; GEM FLOW COUPLER Monitor (GEM2010M-1); GEM Flow COUPLER Monitor Power Cord; GEM Flow Coupler Device and System; GEM ZIPCLIP; Galaxy; Gem Flow Now (GEM2770-FN); Gem FlowCoupler System; Glycerolyte 57 Solution; I.V. Administration Set with Control-A-Flo Regulator; INTELLIFILL I.V.; Infusion Set; Instrument Trays; Interlink; Interlink System; Interlink System T Connector Ext Se; Interlink System T-Connector ExtSet; Interlink Universal Vial Adapter; IntraVia; IntraVia Container Empty; Intravascular Administration Sets; Intravascular Administration Sets with Stopcock and Manifold; Intravascular Extension Set (Light Resistant Extension Set); Intravascular Extension Sets and Accessories; Irrigating (Non-Dental) Syringe - Ear Wash System and accessories; KWIK VIAL; LOGIX; Luer Lock Universal Spike; MICRO-VOLUME Extension Set; MICROMIX BCR COMPOUNDER; MICROMIX COMPOUNDER AN; MINIBAG PLUS CONTAINER; Malleable Applicator Tip; Micro-Volume; Microvascular Anastomotic Device; Mini-Bag Plus; Mini-Infuser; Multirate Infusor LV; Multirate Infusor SV; NEOTHRIVE; NICOM Electrodes; NICOM sensor; Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec; Nitroglycerin Set with DUO-VENT Spike; Non-DEHP IV Fat Emulsion Administration Sets; None; Novum IQ Hub; Novum IQ Large Volume Pump; Novum IQ Syringe Pump; One-Link; Ophthalmoscope, battery-powered; Oral Liquid Bottle Adapter; Oral Liquid Dispenser; Ostene; Otoscope and Accessories; PCA Syringe Sets; PCEA Syringe Set; PERI-GUARD Repair Patch, Supple PERI-GUARD Repair Patch; PERI-GUARD and SUPPLE PERI-GUARD; PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology; PerClot Polysaccharide Hemostatic System; Peri-Guard, Supple Peri-Guard; Peri-Strips Dry with Veritas; Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Techonology (PSDV-SG); Pocket LED Otoscopes (multi-colors) and accessories; Pre-wired NICOM Sensor; PreveLeak; Prewired Electrode of Cheetah Medical; Processing Solution; RAPIDFILL; RAPIDFILL Tube Set; REPEATER PUMP; REPEATER PUMP Tube Sets; REPEATER PUMP Tube Sets and Connectors; Radiation Sterilized Extension Sets; Recothrom; Reusable and Disposable Specula,Dispensers; SIGMA Spectrum Infusion Pump with Master Drug Library; Secondary Medication Set; Seprafilm; SiGMA Spectrum Infusion Pump with Master Drug Library; Solution Administration Sets; Solution Set; Solution Set for Epidural Use; Solution Set w/1.2 Micron Air Eliminating Filter; Solution Sets, Extension Sets; Solutions Administration Sets with 0.2 Micron Filter; Spectrum IQ Infusion System with Dose IQ Safety Software; Spectrum IQ Infusion System with Dose IQ Safety Software (3570009); Spray Set for Tisseel; Starling Sensors; Sterile Luer Lock-to-Catheter Tip Adapter; Sterile Luer Lock-to-Urethral Tip Adapter; Stopcock and I.V. Solution Administration Sets with Stopcocks; TUR Irrigation Set; Tissomat and Spray Set; Transfer Set; Tubing Sets for Pharmacy Compounder; Uromatic; VIAL-MATE Reconstitution Device; Valve Controller & Tube Sets for MICROMACRO Compounder; Vascu-Guard; Vascu-Guard Vascular Repair Patch; Vascular Probe; Veritas Collagen Matrix; Viaflex; Vial-Mate; Welch Allyn LED Otoscope; Welch Allyn LumiView Clear Single-Use Ear Specula; Welch Allyn MacroView Basic Otoscope; Welch Allyn MacroView Plus Oto for iEx; Welch Allyn MacroView Plus iExaminer Kit; Welch Allyn Universal Desk Charger with Lithium-ion Handles",1991-04-01,106,2025-07-28,6,107,2,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221416980%22&limit=1
"Inova Diagnostics, Inc.",2026994,2026994,9900 Old Grove Rd,San Diego,CA,92131,United States,"INOVA DIAGNOSTICS, INC.",2026994,Contract manufacturer; Manufacturer; Manufacturer for export; Repackager or relabeler; Specification developer,46,DAK; DBL; DBM; DDC; DHN; DHR; JIT; JIX; JJE; JJX; JJY; JPA; KTL; LIG; LJM; LKJ; LKO; LKP; LLL; LRM; LSW; LYR; MID; MLE; MOB; MQA; MST; MSV; MVJ; MVM; MVU; NBS; NBT; NHX; NIY; NJF; NRI; NSU; NUM; NXO; NYO; OBE; OHQ; OPN; PIV; PPM,"Complement C1q, Antigen, Antiserum, Control; Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control; Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control; Thyroglobulin, Antigen, Antiserum, Control; Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control; System, Test, Rheumatoid Factor; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); System, Multipurpose For In Vitro Coagulation Studies; Anti-Dna Indirect Immunofluorescent Solid Phase; Radioassay, Intrinsic Factor Blocking Antibody; Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls; Antinuclear Antibody, Antigen, Control; Anti-Rnp Antibody, Antigen And Control; Anti-Sm Antibody, Antigen And Control; Extractable Antinuclear Antibody, Antigen And Control; Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control; Anti-Dna Antibody, Antigen And Control; Helicobacter Pylori; System, Test, Anticardiolipin Immunological; Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control; Test System, Antineutrophil Cytoplasmic Antibodies (Anca); Anti-Ribosomal P Antibodies; Antibodies, Gliadin; System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi); Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm); Autoantibodies, Endomysial(Tissue Transglutaminase); Reagents, Specific, Analyte; Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1); Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae); Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp); Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis; Antibodies, Anti-Actin, Anti-Smooth Muscle; Autoantibodies, Nuclear Pore Glycoprotein Gp210; Instrumentation For Clinical Multiplex Test Systems; Autoantibodies, Nuclear Body Protein, Sp100; Calprotectin, Fecal; Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody; Anti-Ss-A 52 Autoantibodies; Multi-Analyte Controls Unassayed; Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex; Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use; General Purpose Reagent",1; 2,"(anti-phosphatidylserineand prothombin); ANA KSL (Mouse Kidney, Stomach, Liver) Slide; ANA PCNA Pattern; ANCA (Ethanol Fixed Human Neutrophil) Slide; ANCA (Formalin Fixed Human Neutrophil) Slide; Anti-C1q ELISA Plate; Anti-C1q High Positive; Anti-C1q Low Positive; Anti-C1q Sample Diluent; Anti-neutrophil Cytoplasmic Autoantibody Reagents; Aptiva APS IgA Controls; Aptiva APS IgA Reagent; Aptiva APS IgG Calibrators; Aptiva APS IgG Controls; Aptiva APS IgG Reagent; Aptiva APS IgM Calibrators; Aptiva APS IgM Controls; Aptiva APS IgM Reagent; Aptiva CTD Essential Calibrators; Aptiva CTD Essential Controls; Aptiva CTD Essential Reagent; Aptiva Celiac Disease IgA Calibrators; Aptiva Celiac Disease IgA Controls; Aptiva Celiac Disease IgA Reagent; Aptiva Celiac Disease IgG Calibrators; Aptiva Celiac Disease IgG Controls; Aptiva Celiac Disease IgG Reagent; Aptiva Multi-Analyte Instrument; Aptiva Optical Calibrator Kit; Aptiva Optical Cleaning Solution; Aptiva Optical Control Kit; Aptiva System; Aptiva System Cleaning Solution Kit; Aptiva System Rinse; Atypical ANCA Positive; Auto AB Panel; BIO-FLASH; BIO-FLASH Cuvette Waste Bin; BIO-FLASH Cuvettes; BIO-FLASH High Capacity Rinse Accessory; BIO-FLASH Narrow Tube Sample Adaptor; BIO-FLASH Sample Cups; BIO-FLASH Sample Diluent; BIO-FLASH Sample Racks Adapters; BIO-FLASH Screw Caps for Sample Cups; BIO-FLASH System Cleaning Solution; BIO-FLASH System Rinse; BIO-FLASH Triggers; BIO-FLASH Waste Bottle; BIO-Flash Sample Racks; CarP ELISA Plate; Cerebellum (Primate)Slide; DFS-70 ELISA Plate; Endomysial (Celiac) Positive; F-Actin Slide; FITC IgA Conjugate; FITC IgG Conjugate; FITC IgG Conjugate Primate Absorbed; FITC IgG Conjugate with DAPI; FITC IgGAM Conjugate; Fecal Extraction Device; GBM ELISA Calibrator Set; Gastric Parietal Cell (GPA) Pattern; HEp-2 ANA Slide; HMGCR ELISA Plate; Heart (Primate)Slide; HemosIL Acustar Anti-B2GPI-Domain 1; HemosIL Acustar Anti-B2GPI-Domain 1 Controls; HemosIL Acustar Anti-B2GPI-Domain 1 Reagents; Hu (ANNA-1) Positive Control; ICA (Primate Pancreas); Instrument System Cuvettes; Mitochondrial (AMA) Pattern; Monkey Oesophagus Slide; Mounting Medium; Mounting Medium Pack; NOVA Lite ANA KSL; NOVA Lite ANA KSL Kit; NOVA Lite ANA KSL Slide Pack; NOVA Lite ANA Plus; NOVA Lite ANA Plus Mouse Kidney & Stomach; NOVA Lite ANCA; NOVA Lite ANCA (Ethanol Fixed); NOVA Lite ANCA (Formalin Fixed); NOVA Lite ANCA (Formalin) Kit with DAPI; NOVA Lite ANCA Formalin Kit; NOVA Lite ANCA Kit; NOVA Lite ANCA Substrate Slide Pack; NOVA Lite Auto AB Panel; NOVA Lite Autoantibody Controls; NOVA Lite Cerebellum (Primate) Slide Pack; NOVA Lite DAPI ANA Kit; NOVA Lite DAPI ANCA (Ethanol) Kit; NOVA Lite DAPI ANCA (Formalin) Kit; NOVA Lite DAPI EMA Kit; NOVA Lite DAPI dsDNA Crithidia luciliae Kit; NOVA Lite HEp-2 ANA Kit; NOVA Lite HEp-2 ANA Slide Pack; NOVA Lite Heart (Primate)Slide Pack; NOVA Lite ICA (Primate Pancrease) Slide Pack; NOVA Lite IFA Pancreatic Islet Cell Positive Control; NOVA Lite IFA Yo (PCA-1) Positive Control; NOVA Lite IgG F-Actin; NOVA Lite Monkey Oesophagus IFA Kit; NOVA Lite Monkey Oesophagus Slide Pack; NOVA Lite Ovary (Primate) Slide Pack; NOVA Lite Rat Liver, Kidney, Stomach Kit; NOVA Lite Rat Liver,Kidney,Stomach; NOVA Lite Rat Liver/Kidney/Stomach Slide Pack; NOVA Lite dsDNA; NOVA Lite dsDNA (Crithidia luciliae) Slide Pack; NOVA Lite dsDNA Crithidia luciliae; NOVA Lite® IFA Hu (ANNA-1) Positive Control; NOVA View; NOVA View 2; NOVA View Automated Fluorescence Microscope; NOVA View Automated Fluorescence Microscope with AUTOLoader; PBS Concentrate (40x); PBS II Concentrate (40x); Pancreatic Islet Cell Positive Control; Pemphigus Positive; Pemphigus Positive Control; Primate Ovary Slide; QUANTA Flash B2 GP1 IgA; QUANTA Flash B2 GP1 IgA Controls; QUANTA Flash B2 GP1 IgA Reagents; QUANTA Flash B2GP1 IgG; QUANTA Flash B2GP1 IgG Controls; QUANTA Flash B2GP1 IgG Reagents; QUANTA Flash B2GP1 IgM; QUANTA Flash B2GP1 IgM Controls; QUANTA Flash B2GP1 IgM Reagents; QUANTA Flash B2GP1-Domain1; QUANTA Flash B2GP1-Domain1 Controls; QUANTA Flash B2GP1-Domain1 Reagents; QUANTA Flash CCP3; QUANTA Flash CCP3 Calibrators; QUANTA Flash CCP3 Controls; QUANTA Flash CCP3 Reagents; QUANTA Flash CTD Screen Plus Calibrators; QUANTA Flash CTD Screen Plus Controls; QUANTA Flash CTD Screen Plus Reagents; QUANTA Flash Calprotectin; QUANTA Flash Calprotectin Calibrators; QUANTA Flash Calprotectin Controls; QUANTA Flash Calprotectin Extraction Buffer; QUANTA Flash Calprotectin Reagents; QUANTA Flash Cardiolipin IgA; QUANTA Flash Cardiolipin IgA Controls; QUANTA Flash Cardiolipin IgA Reagents; QUANTA Flash Centromere Calibrators; QUANTA Flash Centromere Controls; QUANTA Flash Centromere Reagents; QUANTA Flash DFS70 Calibrators; QUANTA Flash DFS70 Controls; QUANTA Flash DFS70 Reagents; QUANTA Flash DGP IgA Calibrators; QUANTA Flash DGP IgA Controls; QUANTA Flash DGP IgA Reagents; QUANTA Flash DGP IgG Calibrators; QUANTA Flash DGP IgG Controls; QUANTA Flash DGP IgG Reagents; QUANTA Flash DGP Screen; QUANTA Flash DGP Screen Calibrators; QUANTA Flash DGP Screen Controls; QUANTA Flash DGP Screen Reagents; QUANTA Flash ENA7 Calibrator Kit; QUANTA Flash ENA7 Calibrators; QUANTA Flash ENA7 Control Kit; QUANTA Flash ENA7 Controls; QUANTA Flash ENA7 Reagent Kit; QUANTA Flash ENA7 Reagents; QUANTA Flash GBM; QUANTA Flash GBM Calibrators; QUANTA Flash GBM Controls; QUANTA Flash GBM Reagents; QUANTA Flash HMGCR Calibrators; QUANTA Flash HMGCR Controls; QUANTA Flash HMGCR Reagents; QUANTA Flash Intrinsic Factor Calibrators; QUANTA Flash Intrinsic Factor Control; QUANTA Flash Intrinsic Factor Reagents; QUANTA Flash Jo-1; QUANTA Flash Jo-1 Calibrators; QUANTA Flash Jo-1 Controls; QUANTA Flash Jo-1 Reagents; QUANTA Flash LKM-1 Calibrators; QUANTA Flash LKM-1 Controls; QUANTA Flash LKM-1 Reagents; QUANTA Flash M2 (MIT3) Calibrators; QUANTA Flash M2 (MIT3) Controls; QUANTA Flash M2 (MIT3) Reagents; QUANTA Flash MPO; QUANTA Flash MPO Calibrators; QUANTA Flash MPO Controls; QUANTA Flash MPO Reagents; QUANTA Flash PR3; QUANTA Flash PR3 Calibrators; QUANTA Flash PR3 Controls; QUANTA Flash PR3 Reagents; QUANTA Flash RF IgA; QUANTA Flash RF IgA Calibrators; QUANTA Flash RF IgA Controls; QUANTA Flash RF IgA Reagents; QUANTA Flash RF IgM; QUANTA Flash RF IgM Calibrators; QUANTA Flash RF IgM Controls; QUANTA Flash RF IgM Reagents; QUANTA Flash RNP Calibrators; QUANTA Flash RNP Controls; QUANTA Flash RNP Reagents; QUANTA Flash Ribosomal P Calibrators; QUANTA Flash Ribosomal P Controls; QUANTA Flash Ribosomal P Reagents; QUANTA Flash Ro52; QUANTA Flash Ro52 Calibrators; QUANTA Flash Ro52 Controls; QUANTA Flash Ro52 Reagents; QUANTA Flash Ro60 Calibrators; QUANTA Flash Ro60 Controls; QUANTA Flash Ro60 Reagents; QUANTA Flash SS-B Controls; QUANTA Flash SSB Calibrators; QUANTA Flash SSB Reagents; QUANTA Flash Scl-70; QUANTA Flash Scl-70 Calibrators; QUANTA Flash Scl-70 Controls; QUANTA Flash Scl-70 Reagents; QUANTA Flash Sm Calibrators; QUANTA Flash Sm Controls; QUANTA Flash Sm Reagents; QUANTA Flash aCL IgA; QUANTA Flash aCL IgA Controls; QUANTA Flash aCL IgA Reagents; QUANTA Flash aCL IgG; QUANTA Flash aCL IgG Controls; QUANTA Flash aCL IgG Reagents; QUANTA Flash aCL IgM; QUANTA Flash aCL IgM Controls; QUANTA Flash aCL IgM Reagents; QUANTA Flash aPL Multi Controls; QUANTA Flash dsDNA; QUANTA Flash dsDNA Calibrators; QUANTA Flash dsDNA Controls; QUANTA Flash dsDNA Reagents; QUANTA Flash h-tTG; QUANTA Flash h-tTG IgA; QUANTA Flash h-tTG IgA Calibrators; QUANTA Flash h-tTG IgA Controls; QUANTA Flash h-tTG IgA Reagents; QUANTA Flash h-tTG IgG Calibrators; QUANTA Flash h-tTG IgG Controls; QUANTA Flash h-tTG IgG Reagents; QUANTA LIte ASCA (S. cerevisiae) IgA; QUANTA LIte GPA (Gastric Parietal Cell Antibody) ELISA; QUANTA LIte Gliadin IgG II ELISA Bulk Pack; QUANTA Lite ACA IgA ELISA Bulk Pack; QUANTA Lite ACA IgA III; QUANTA Lite ACA IgG III; QUANTA Lite ACA IgG III ELISA Bulk Pack; QUANTA Lite ACA IgM III; QUANTA Lite ACA IgM III ELISA Bulk Pack; QUANTA Lite ACA Screen III; QUANTA Lite ANA ELISA; QUANTA Lite ASCA  IgG ELISA; QUANTA Lite ASCA (S.cerevisiae) IgG; QUANTA Lite ASCA IgA ELISA; QUANTA Lite ASCA IgA ELISA (S. cerevisiae); QUANTA Lite ASCA IgG ELISA (S. cerevisiae); QUANTA Lite Actin IgG ELISA; QUANTA Lite Actin IgG ELISA Bulk Pack; QUANTA Lite Anti-C1q ELISA; QUANTA Lite B2 GPI IgA ELISA; QUANTA Lite B2 GPI IgA ELISA Bulk Pack; QUANTA Lite B2 GPI IgM ELISA; QUANTA Lite B2 GPI IgM ELISA Bulk Pack; QUANTA Lite B2 GPI Screening ELISA; QUANTA Lite B2 GPI Screening ELISA Bulk Pack; QUANTA Lite B2GP1 IgG ELISA Bulk Pack; QUANTA Lite B2GPI IgG ELISA; QUANTA Lite C1q CIC ELISA; QUANTA Lite CCP3 IgG ELISA; QUANTA Lite CCP3 IgG ELISA Bulk Pack; QUANTA Lite CCP3.1 IgG/IgA ELISA; QUANTA Lite CCp3.1 IgG/IgA ELISA Bulk Pack; QUANTA Lite Calprotectin Extended Range; QUANTA Lite Celiac DGP Screen; QUANTA Lite Celiac DGP Screen ELISA; QUANTA Lite Centromere (CENP-A &CENP-B); QUANTA Lite Centromere ELISA; QUANTA Lite Chromatin ELISA; QUANTA Lite ENA 4; QUANTA Lite ENA 4 ELISA; QUANTA Lite ENA 4 ELISA Sm,RNP, SS-A and SS-B Screening Test; QUANTA Lite ENA 5 ELISA; QUANTA Lite ENA 6 ELISA; QUANTA Lite F-Actin IgA ELISA; QUANTA Lite GBM ELISA; QUANTA Lite GBM ELISA Bulk Pack; QUANTA Lite GPA ELISA; QUANTA Lite GPA ELISA (Gastric Parietal Cell Antibody); QUANTA Lite Gliadin IgA ELISA; QUANTA Lite Gliadin IgA ELISA Bulk Pack; QUANTA Lite Gliadin IgA II ELISA; QUANTA Lite Gliadin IgA II ELISA Bulk Pack; QUANTA Lite Gliadin IgG ELISA; QUANTA Lite Gliadin IgG ELISA Bulk Pack; QUANTA Lite Gliadin IgG II ELISA; QUANTA Lite H. pylori IgA ELISA; QUANTA Lite H. pylori IgG ELISA; QUANTA Lite HA dsDNA ELISA; QUANTA Lite HMGCR ELISA; QUANTA Lite Histone ELISA; QUANTA Lite IgG II; QUANTA Lite Intrinsic Factor ELISA; QUANTA Lite Jo-1 ELISA; QUANTA Lite LKM-1 ELISA; QUANTA Lite M2 EP (MIT3); QUANTA Lite M2 EP (MIT3) ELISA; QUANTA Lite M2 EP (MIT3) ELISA Bulk Pack; QUANTA Lite MPO IgG ELISA; QUANTA Lite PBC Screen IgG/IgA ELISA; QUANTA Lite PR-3 IgG ELISA; QUANTA Lite PR3 SC ELISA; QUANTA Lite PR3 SC ELISA Bulk Pack; QUANTA Lite Phosphatidylserine IgA ELISA; QUANTA Lite Phosphatidylserine IgG ELISA; QUANTA Lite Phosphatidylserine IgG ELISA Bulk Pack; QUANTA Lite Phosphatidylserine IgM ELISA; QUANTA Lite Phosphatidylserine IgM ELISA Bulk Pack; QUANTA Lite R h-tTG IgA ELISA; QUANTA Lite R h-tTG IgA ELISA Bulk Pack; QUANTA Lite R h-tTG IgG ELISA; QUANTA Lite R h-tTG IgG ELISA Bulk Pack; QUANTA Lite RF IgA ELISA; QUANTA Lite RF IgG ELISA; QUANTA Lite RF IgM ELISA; QUANTA Lite RNA Pol III; QUANTA Lite RNA Pol III ELISA; QUANTA Lite RNP ELISA; QUANTA Lite Ribosome P ELISA; QUANTA Lite SLA; QUANTA Lite SLA ELISA; QUANTA Lite SLA ELISA (Soluble Liver Antigen); QUANTA Lite SS-A 52 ELISA; QUANTA Lite SS-A ELISA; QUANTA Lite SS-B ELISA; QUANTA Lite Scl-70 ELISA; QUANTA Lite Sm ELISA; QUANTA Lite TPO ELISA; QUANTA Lite Thyroid T ELISA; QUANTA Lite aPS/PT IgG ELISA; QUANTA Lite aPS/PT IgM ELISA; QUANTA Lite ds DNA ELISA double stranded DNA ELISA; QUANTA Lite dsDNA ELISA; QUANTA Lite dsDNA SC ELISA; QUANTA Lite gp210; QUANTA Lite gp210 ELISA; QUANTA Lite h-tTG IgA ELISA; QUANTA Lite h-tTG IgA ELISA (Human Tissue Transglutaminase); QUANTA Lite h-tTG IgA ELISA Bulk Pack; QUANTA Lite h-tTG IgG ELISA; QUANTA Lite h-tTG IgG ELISA (Human Tissue Transglutaminase); QUANTA Lite h-tTG IgG ELISA Bulk Pack; QUANTA Lite h-tTG Screen; QUANTA Lite h-tTG Screen ELISA; QUANTA Lite h-tTG/DGP Screen; QUANTA Lite h-tTG/DGP Screen ELISA; QUANTA Lite sp100 ELISA; QUANTA Lite tTG ELISA; QUANTA Lite tTG ELISA (TissueTransglutaminase); QUANTA-Lyser 160; QUANTA-Lyser 2; QUANTA-Lyser 240; QUANTA-Lyser 3000; QUANTA-Lyser ELISA/IFA; QUANTA-Lyser ELISA/IFA+Incubator; QUANTA-Lyser IFA; QUATNA Flash SS-B Calibrators; QUATNA Flash SS-B Reagents; QUATNA Flash SSB Controls; QUATNA Lite Phosphatidylserine IgM ELISA Bulk Pack; Rat Liver/Kidney/Stomach Slide; Sm,RNP,SS-A,SS-B and Scl-70 Screening Test; Sm,RNP,SS-A,SS-B,Scl-70 & Jo-1 Screening Test; Smooth Muscle (ASMA) Pattern; Yo (Purkinje Cell) Positive Control; dsDNA (Crithidia luciliae) Slide",2005-08-22,112,2026-02-06,0,3,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222026994%22&limit=1
Stryker Spine,3004024955,3004024955,2 Pearl Court,Allendale,NJ,07401,United States,"VB Spine, LLC",10093189,Complaint file establishment; Manufacturer; Specification developer,36,ETN; FMF; FST; FZX; GAD; GDF; GEG; HAO; HAW; HWT; HXI; KNW; KWP; KWQ; LXH; LYC; MAX; MDM; MNH; MNI; MQP; MQV; MRW; NKB; NKG; NQW; ODP; OLO; OSH; OVD; OVE; OWI; PDQ; PEK; PGM; PLR,"Stimulator, Nerve; Syringe, Piston; Light, Surgical, Fiberoptic; Guide, Surgical, Instrument; Retractor; Guide, Needle, Surgical; Elevator, Surgical, General & Plastic Surgery; Instrument, Surgical, Non-Powered; Neurological Stereotaxic Instrument; Template; Passer, Wire, Orthopedic; Instrument, Biopsy; Appliance, Fixation, Spinal Interlaminal; Appliance, Fixation, Spinal Intervertebral Body; Orthopedic Manual Surgical Instrument; Bone Grafting Material, Synthetic; Intervertebral Fusion Device With Bone Graft, Lumbar; Instrument, Manual, Surgical, General Use; Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal Pedicle Fixation; Spinal Vertebral Body Replacement Device; Filler, Bone Void, Calcium Compound; System, Facet Screw Spinal Device; Thoracolumbosacral Pedicle Screw System; Posterior Cervical Screw System; Orthosis, Spine, Plate, Laminoplasty, Metal; Intervertebral Fusion Device With Bone Graft, Cervical; Orthopedic Stereotaxic Instrument; Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis; Intervertebral Fusion Device With Integrated Fixation, Lumbar; Intervertebral Fusion Device With Integrated Fixation, Cervical; Bone Fixation Cerclage, Sublaminar; Neurosurgical Nerve Locator; Spinous Process Plate; Growing Rod System; Spinal Vertebral Body Replacement Device - Cervical",1; 2; U,"AERO-C Cervical Cage System; AVIATOR; AVS AL; AVS ALign; AVS ARIA; AVS ARIA PEEK Spacers; AVS AS; AVS ASL PEEK Spacer System; AVS ASL PEEK Spacers; AVS Anchor-C Cervical Cage; AVS Anchor-L; AVS Navigator; AVS Navigator PEEK Spacers; AVS PL; AVS PL - UNILIF; AVS PL PEEK SPACER SYSTEM; AVS PL PEEK Spacers; AVS TL; AVS TL PEEK Spacers; AVS UniLIF; AVS UniLIF PEEK Spacers; AVS ® PL; AVS® AL; AVS® AL PEEK Spacer; AVS® ALign PEEK Spacers; AVS® ARIA PEEK Spacer; AVS® AS PEEK Spacer; AVS® Anchor-C Cervical Cage System; AVS® Anchor-L Spacer; AVS® Aria PEEK Spacer; AVS® Navigator PEEK Spacer; AVS® PL PEEK Spacer; AVS® TL PEEK Spacer; AVS® UniLIF PEEK Spacer; AVS® UniLIF™ PEEK Spacers; AccuLIF; AccuLIF TL and PL Cages; AccuLIF TL and PL Cages associated instrumentation; Aero-AL; Aero-LL; Aero™-AL Lumbar Cage System; Aero™-LL Lumbar Cage System; Aero®-C Cervical Cage System; Aleutian IBF System; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; Anchor-L; Ascential IBD PEEKc Spacer; Aviator® Anterior Cervical Plate System; BLADES, PROBES; BLUE RIDGE Cervical Plate System; BWM Spine System; CAYMAN Thoracolumbar and Buttress Plate system; CHISELS; Capri Corpectomy Cage System; Cascadia Interbody System; Chesapeake Stabilization System; DISSECTORS; DRILL GUIDE; Diapason® Spinal System; Drill Bit; DynaTran™ Anterior Cervical Plate System; ES2 Neuromonitoring Accessory Instruments; ES2 Spinal System; ES2™ Augmentable Spinal System; ES2™ Spinal System; Escalate Laminoplasty Base (hinge) plate; Escalate Laminoplasty Expandable plate; Escalate Laminoplasty self-drilling screws; Escalate Laminoplasty self-tapping screws; Escalate® Laminoplasty System; FASCIA CUTTER; FORCEPS; General Instruments; IMBIBE BONE MARROW ASPIRATION SYRINGE; Imbibe Needle; K2M General Instruments; LITe BIO Delivery System - Delivery Handle; LITe BIO Delivery System - Delivery Plunger; LITe BIO Delivery System - Loading Funnel; LITe BIO Delivery System - Loading Tool; LITe BIO Delivery System - Sterile Package with Cannula; LITe Decompression; LITe® Plate System Appliance, fixation, spinal intervertebral body; MANTIS; MANTIS REDUX SPINAL SYSTEM; Mantis Redux System; Mantis Spinal System; Mantis® Redux; Mantis® Spinal System; Mesa, Mesa Small Stature, Napa MI, Nile Alternative, Nile, Pyrenees, Santorini; Mojave Expandable Interbody System; Monterey AL Interbody System; Monterey™ AL Interbody System; Multi-Axial Cross (MAC) Connectors; NAPA Access System; Napa Access System; Navigation Enabled (Xia 2, Xia 3, Xia 4.5, ES2, Mantis); Nile® Alternative Fixation Spinal System; Nile® Proximal Fixation Spinal System; Nulock; OASYS; OASYS CC PLATE BLOCKER; OASYS CC PLATE NUT; OASYS CROSS CONNECTOR PLATE; OASYS Saddle Connector; OPUS BONE SCREWS MULTIPLE SIZES; ORTHOPEDIC MANUAL; OSS ROD UNION; OSTEOTOMES; OZARK Cervical Plate System; Oasys; Oasys System; Oasys® Occipito-Cervico-Thoracic System; Opus™ Spinal System; Orthopaedic Manual Instrumentation; PYRENEES Cervical Plate System; Q Interbody Instruments; RADIUS SPINAL SYSTEM; RAYLOR ELEVATOR; Radius Spinal System; Radius Spinal System Line Ext.; Radius Vitallium Rod; Radius® Spinal System; Reflex Hybrid ACP System; Reflex Zero Profile ACP System; Reflex™ Hybrid Anterior Cervical Plate System; Retractor; SAHARA Stabilization System; SPINE OSS DOMINO CONNECTOR; SPINE OSS RODS, BONE SCREWS; STRYKER TUNNELER STRYKER Y-NEEDLE 100 STRYKER Y-NEEDLE 200 STRYKER Y-NEEDLE 300 STRYKER Y-NEEDLE 400; SURGICAL KNIVES; Sahara Stabilization System; Santorini Corpectomy Cage System; Screw Insertion Sleeve; Serrato® Spinal System; Spinal Interlaminal Fixation Orthosis-Oasys Transition Rods; Stryker KWIC Needle; Stryker Spine AVS AS PEEK Spacers; Stryker Spine Power Adaptor; Stryker Spine Power Adaptor Accessory; Stryker Spine VLIFT™ Vertebral Body Replacement System; TRIO SPINAL FIXATION SYSTEM; TRIO TRAUMA SPINAL; TRIO TRAUMA SPINAL SYSTEM; TRIO+ SPINAL FIXATION SYSTEM; Terra Nova, Ravine, Serengeti, VCR, Cricket; Trio® & Trio+ Spinal Fixation System; Tritanium C Anterior Cervical Cage; Tritanium PL Cage; Tritanium TL Curved Posterior Lumbar Cage; Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Tritanium® X PL Expandable Posterior Lumbar Cage; Tritanium® X TL Expandable Curved Posterior Lumbar Cage; UniVise; UniVise™ Spinous Process Fixation Plate Spinous Process Fixation Plate; VITOMATRIX BONE GRAFTING MATERIAL; VITOSS BA2X BIOACTIVE BONE GRAFT SUBSTITUTE; VITOSS BONE GRAFT SUBSTITUTE; VLIFT Vertebral Body Replacement; VLIFT®-s Vertebral Body Replacement System; Vikos Allograft System; Vitoss BA Bioactive Bone Graft Substitute; Vitoss BBTrauma Bioactive Bone Graft Substitute; Vitoss BiModal Bioactive Bone Graft Substitute; Vitoss BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss Bioactive Foam Strip; Vitoss Foam Bone Graft Substitute; Vulcan Spinal System; XIA 3; XIA 3 Spinal System; XIA 3 Uniplanar & Reduction Screws; XIA 4.5 Spinal System; XIA 4.5 XIA CT (Corticol Trajectory); XIA Rod Template; XIA SPINAL SYSTEM; XIA TI AND SS SPINAL SYSTEMS; XIA Ti AND SS SPINAL SYSTEMS; XIA Ti LONG ARM LAM. HOOKS, MULTIPL; XIA Ti LONG ARM MONOAXIAL SCREWS; XIA Ti LONG ARM PEDICLE HOOK, SMALL; XIA Ti LONG ARM POLYAXIAL SCREWS; XIA VITALLIUM, MULTIPLE; XIA® 3 Spinal System; XIA® 4.5 Cortical Trajectory; XIA® 4.5 Spinal System; XIA® Anterior; XIA® Growth Rod Conversion Set; XIA® II Spinal System; XIA® Precision System; Xia; Xia 3; Xia 3 Spinal System; Xia 4.5; Xia 4.5 Spinal System; Xia 4.5 Spinal System - Line Ext.; Xia Blocker Inserter; Xia Spinal System; Xia® 3 Spinal System - Serrato; Y-Wire2 Y-Wire Guidewire; Yukon OCT Spinal System",2025-04-14,112,2024-11-07,0,49,1,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004024955%22&limit=1
Orta Medical Ltd,3013188547,3013188547,Bazelet 14,TZUR YIGAL Central,,44862,Israel,ORTA MEDICAL LTD,10053784,Exporter to the US; Repackager or relabeler,100,BSP; BSR; BSY; BSZ; BTO; BTR; BXJ; BYD; BYX; BYY; BZG; CAT; CBH; CCX; DPS; DPZ; DQA; DRX; DWJ; DXH; ERA; EWL; FCM; FHO; FIQ; FMF; FMG; FMI; FMK; FOK; FOZ; FPA; FRO; FTL; FYD; FZP; GAG; GAM; GAW; GCJ; GCY; GDO; GDT; GDW; GDX; GEI; GJS; GXB; HLI; HRX; HTD; JAY; JKA; JOH; JOK; JOL; JOS; JSM; KAC; KBN; KCM; KCT; KDI; KDJ; KDW; KGX; KKX; KMF; KMK; KNT; KNW; KPE; KQO; KXP; KYW; KYX; KYZ; KZF; KZH; LFL; LHI; LJH; LRJ; LZA; MDB; MDM; MED; MNL; MPN; MWI; NAB; NAY; NLM; OCT; OCW; OEA; OMD; ORQ; PNG; PTM,"Needle, Conduction, Anesthetic (W/Wo Introducer); Stylet, Tracheal Tube; Catheters, Suction, Tracheobronchial; Gas-Machine, Anesthesia; Tube, Tracheostomy (W/Wo Connector); Tube, Tracheal (W/Wo Connector); Clip, Nose; Condenser, Heat And Moisture (Artificial Nose); Tubing, Pressure And Accessories; Tube, Aspirating, Flexible, Connecting; Spirometer, Diagnostic; Cannula, Nasal, Oxygen; Device, Fixation, Tracheal Tube; Support, Patient Position; Electrocardiograph; Oximeter, Ear; Oximeter; Electrode, Electrocardiograph; System, Thermal Regulating; Transmitters And Receivers, Electrocardiograph, Telephone; Otoscope; Prosthesis, Laryngeal (Taub); Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit); Pneumoperitoneum Needle; Cannula, A-V Shunt; Syringe, Piston; Stopcock, I.V. Set; Needle, Hypodermic, Single Lumen; Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature; Pad, Neonatal Eye; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Dressing, Wound, Drug; Mesh, Surgical, Polymeric; Apparatus, Exhaust, Surgical; Clip, Implantable; Stapler, Surgical; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polypropylene; Laparoscope, General & Plastic Surgery; Apparatus, Suction, Single Patient Use, Portable, Nonpowered; Applier, Surgical, Clip; Staple, Removable (Skin); Staple, Implantable; Scalpel, One-Piece; Electrosurgical, Cutting & Coagulation & Accessories; Test, Time, Prothrombin; Esthesiometer; Ophthalmoscope, Ac-Powered; Arthroscope; Forceps; Support, Breathing Tube; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tube Tracheostomy And Tube Cuff; Scissors, Medical, Disposable; Catheter And Tip, Suction; Electrode, Electrosurgical; Culture Media, Non-Propagating Transport; Tube, Laryngectomy; Gag, Mouth; Dropper, Ent; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Set, Administration, For Peritoneal Dialysis, Disposable; Container, Specimen Mailer And Storage, Temperature Controlled, Sterile; Tape And Bandage, Adhesive; Drape, Surgical, Antimicrobial; Bandage, Liquid; Device, Intravascular Catheter Securement; Tubes, Gastrointestinal (And Accessories); Instrument, Biopsy; Container, I.V.; Automated Urinalysis System; Stent, Vaginal; Container, Liquid Medication, Graduated; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); Device, Medical Examination, Ac Powered; Introducer, Syringe Needle; Instrument, Ultrasonic Surgical; Set, I.V. Fluid Transfer; System, Irrigation, Urological; Disinfectant, Medical Devices; Polymer Patient Examination Glove; System, Blood Culturing; Instrument, Manual, Surgical, General Use; Sterilant, Medical Devices; Accessories, Cleaning Brushes, For Endoscope; Tissue Adhesive For The Topical Approximation Of Skin; Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms); Gauze / Sponge,Nonresorbable For External Use; System, Surgical, Computer Controlled Instrument; Laparoscope, General & Plastic Surgery, Reprocessed; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Tissue Approximation Device; Non-Surgical Gown; Cutaneous Tissue Adhesive With Mesh; Mesh, Surgical, Deployer; Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling; Syringe, Balloon Inflation, Exempt",1; 2; U,"Device, medical examination, ac powered; ENDO CATCH GOLD; ERA - OTOSCOPE; Gauze / sponge,nonresorbable for external use; Laparoscope, general & plastic surgery; LigaSure™ Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated; Non-surgical isolation gown; ORTA MEDICAL; Ophthalmoscope, ac-powered; Owen Mumford; SPIROMETER, DIAGNOSTIC DPS - Electrocardiograph; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID; Shiley; Shiley Disposable Cannula Trach. Tube; UNISCAN 10 SGL STRIP 10 S; URISCAN 10 SGL STRIP 774; URISCREEN 6L STRIP 10S; VERASTEP; Verastep; hylard; shiley covidian",2017-01-11,111,2024-08-08,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013188547%22&limit=1
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi,3014479313,3014479313,"NO:4 MIMAR SINAN MAHALLESI NAMIK KEMAL CADDESI AYDIN SOKAK, ATASEHIR 34762, Istanbul (Anatolia) Turkey",Istanbul,,34758,Turkey,SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI,10089530,Exporter to the US; Manufacturer,52,BTO; BTR; CCK; DWF; DZI; DZJ; EIA; EQJ; ERL; ETN; FHO; FMI; FTL; FXY; FYA; FZP; GAB; GAG; GAL; GAM; GAT; GCI; GCJ; GDO; GDT; GDW; GEI; GEY; GFA; GFF; GXZ; HAW; HBB; HBC; HBE; HDA; HRX; HSZ; HWE; IKT; JOH; KDI; KFK; LFL; LQR; MCX; MDM; OCT; OCW; OLO; OXC; OXJ,"Tube, Tracheostomy (W/Wo Connector); Tube, Tracheal (W/Wo Connector); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Drill, Bone, Powered; Driver, Wire, And Bone Drill, Manual; Unit, Operative Dental; Bur, Ear, Nose And Throat; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Stimulator, Nerve; Pneumoperitoneum Needle; Needle, Hypodermic, Single Lumen; Mesh, Surgical, Polymeric; Hood, Surgical; Gown, Surgical; Clip, Implantable; Needle, Suturing, Disposable; Stapler, Surgical; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Synthetic, Polyethylene; Laryngoscope, Endoscope; Laparoscope, General & Plastic Surgery; Applier, Surgical, Clip; Staple, Removable (Skin); Staple, Implantable; Electrosurgical, Cutting & Coagulation & Accessories; Motor, Surgical Instrument, Ac-Powered; Blade, Saw, General & Plastic Surgery, Surgical; Bur, Surgical, General & Plastic Surgery; Electrode, Needle; Neurological Stereotaxic Instrument; Motor, Drill, Pneumatic; Motor, Drill, Electric; Drills, Burrs, Trephines & Accessories (Simple, Powered); Forceps, Obstetrical; Arthroscope; Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Electrode, Needle, Diagnostic Electromyograph; Tube Tracheostomy And Tube Cuff; Dialyzer, High Permeability With Or Without Sealed Dialysate System; Saw, Pneumatically Powered; Instrument, Ultrasonic Surgical; Dislodger, Stone, Biliary; Catheter, Coronary, Atherectomy; Instrument, Manual, Surgical, General Use; Anti Fog Solution And Accessories, Endoscopy; Endoscopic Tissue Approximation Device; Orthopedic Stereotaxic Instrument; Mesh, Surgical, Absorbable, Staple Line Reinforcement; Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects",1; 2; 3; U,"ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE; ABSORBATACK FIXATION DEVICES; ADT FLEX TRACH W TG CUFF; AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH; AUTO SUTURE SURGICAL STAPLES; AUTO SUTUREMENDOSCOPIC CLAMP; AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE; AUTOSUTURE PROTACK; TACKER SYSTEM; Appose Skin Staplers; ConcordeMultifire Premium skin stapler;; BLADE, SAW, GENERAL PLASTIC SUGERY, SURGICAL; BURR; Blade; Bur, Ear, Nose And Throat MEDTRONIC; CATHETER, CORONARY, ATHERECTOMY BS; CLOSUREFAST RADIOFREQUENCY CATHETER; Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass; Covidien Endo GIA Ultra Universal stapler; Covidien Optical Bladeless 12MM Standard Tricor; DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP); DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DST SERIES(TM) TA(TM) STAPLERS; Dislodger, Stone, Biliary; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece MDT; Drills, Burrs, Trephines & Accessories (Simple, Powered); EEA Stapler; ENDO CLIP III 5MM CLIP APPLIER; ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS; ENDOBAG; ENT Blades & Burs; Easycap II; Electrode; Electrosurgical, Cutting & Coagulation & Accessories; Electrosurgical, Cutting & Coagulation & Accessories MDT; Electrosurgical, Cutting & Coagulation & Accessories MEDTRONIC; Endo GIA Tm Reinforced Reload with Tn-Staple Tm Technology; Endoscopic Tissue Approximation Device; Endoscopic Tissue Approximation Device MDT; FAST-FIX 360; FLYTE HOOD; HOODS AND TOGAS; INSTRUMENT TRACKER; Instrument, Manual,Surgical,General Use; LF1823; LigaSure™ Blunt Tip, Laparoscopic Sealer/Divider Nano-coated; LF1837 and LF1844; LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS; LIGATING LOOP; LPG1510AL LAPAROSCOPIC SELF-FIXATING MESH; LPG1510AR LAPAROSCOPIC SELF-FIXATING MESH; Laparoscope, General & Plastic Surgery COVIDIEN; Laparoscope, General & Plastic Surgery MDT; Laparoscope, General & Plastic Surgery MEDTRONIC; Laryngoscope, endoscope MDT; LigaSure Atlas™ Tissue Fusion Laparoscopic Instrument, LS1037; LigaSure Atlas™ Tissue Fusion Open Instrument, LS1020; LigaSure Exact Dissector, Nano-coated; LigaSure Impact Curved, Large Jaw; LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing; LigaSure Retractable L-Hook Laparoscopic Sealer/Divider; LigaSure TMCurved, Snmall Jaw, Open Sealer / Divider (LFI 212); LigaSure™ Blunt Tip Open Sealer/Divider Nano-coated; LigaSure™ Maryland Jaw Laparoscopic Sealer/Divider One-step Sealing, Nano-coated, LF1937 and LF1944; LigaSure™ XP Maryland Jaw Sealer/Divider; Ligasure Blunt Tip Sealer/Divider; Ligasure Blunt Tip, Sealer/Divider, Nano-coated; Ligasure Small Jaw Tissue Fusion Instrument; McKesson Skin Staplers 35 REGULAR; McKesson Skin Staplers 35 WIDE; Mesh, Surgical, Polymeric; Mesh, Surgical, Polymeric MDT; Mesh, Surgical, Polymeric MEDTRONIC; Midas Rex; Motor, drill, pneumatic; NERVE INTEGRITY MONITOR-2 (NIM-2 XL); Nano-coated; ORIGIN BLUNT TIP SURGICAL TROCAR; Open Sealer/Divider, Nano-coated; Orthopedic Stereotaxic Instrument MEDTRONIC; POLYHESIVE PATIENT RETURN ELECTRODE; PREPERITONEAL DISTENTION BALLOON SYSTEM; PROTACK; Parietene Macroporous Mesh; Parietex Composite Mesh (PCO and PCO-OS references); Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references); Parietex Plug and Patch (new name : Parietex Plug and Patch System); Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh); Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh); Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh),; Peak Surgical Plasma Blade; PlasmaBlade X 3S, PlasmaBlade X 4; Pneumoperitoneum Needle; Precision Thin; Premium Surgiclip; Endo Clip; AcuClip; Prisma flex; Probe; Progrip Laparoscopic Self-Fixating Mesh; RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS; SFS Stapler; Signet; SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE; LONG CUFFED; SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T; SILS STITCH ENDOSCOPIC SUTURING DEVICE; SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT; STRYKER CROSSFIRE SYSTEM; STRYKER SAGITTAL SAW ATTACHMENT; STRYKER STRI-SHIELD FLYTE TOGAS; STRYKER TOTAL PERFORMANCE (TPS) SYSTEM; SYMBOTEX(TM) COMPOSITE MESH; Shiley; Shiley Adult; Signia; Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device; Sonicision Battery Charger, Sonicision Battery Insertion Guide; Sonicision Curved Jaw Dissectors (multiple lengths); Sonicision Reusable Generator, Sonicision Reusable Battery Pack; Spacemaker Pro Access and Dissector System; Staple, Implantable; Stapler, Surgical Covidien Stapler; Stimulator, Nerve MDT; Tri-Staple 2 Reinforced Reload; Tube Tracheostomy And Tube Cuff; Tube, Tracheal (W/Wo Connector) MDT; V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE; V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE; VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR; VLOC9ABSORBABLE; VersaOne; VersaOne Bladed Trocar,; VersaOne Optical Trocar with Fixation Balloon Cannula; VersaOne Universal Fixation Balloon Cannula; VersaOne™ Bladeless Trocar; XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC); iBur hubs and cutting accessories; shiley",2023-12-14,108,2023-08-30,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014479313%22&limit=1
STRYKER EMEA Supply Chain Services,3008837339,3008837339,Frans Maasweg 2,Venlo Limburg,,5928 SB,Netherlands,STRYKER CORP.,1811755,Exporter to the US,75,BTA; DQX; DQY; EOB; ERL; FAJ; FAS; FCS; FCW; FED; FFS; FMF; FSM; FXY; FYA; FZX; GAT; GCJ; GEI; GEN; GWG; GXD; GXI; GZT; HAW; HCG; HDB; HET; HIF; HIG; HIH; HRX; HSB; HTO; HTR; HTS; HTW; HTZ; HWB; HWC; HWE; HWJ; HWQ; HXB; HXI; HXX; HXZ; JDR; KCT; KQT; KRA; KRD; KWS; LFL; LLZ; LXH; MBI; MJN; MOF; NAY; NBH; NDN; NJE; NKC; NRY; OCZ; OLO; OSV; OUT; OWN; PGW; QCA; QIH; QJP; QPB,"Pump, Portable, Aspiration (Manual Or Powered); Wire, Guide, Catheter; Catheter, Percutaneous; Nasopharyngoscope (Flexible Or Rigid); Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Cystoscope And Accessories, Flexible/Rigid; Electrode, Electrosurgical, Active, Urological; Light, Catheter, Fiberoptic, Glass, Ureteral; Light Source, Fiberoptic, Routine; Endoscopic Access Overtube, Gastroenterology-Urology; Image, Illumination, Fiberoptic, For Endoscope ; Syringe, Piston; Tray, Surgical, Instrument; Hood, Surgical; Gown, Surgical; Guide, Surgical, Instrument; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, General & Plastic Surgery; Endoscope, Neurological; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Retractor, Self-Retaining, For Neurosurgery; Neurological Stereotaxic Instrument; Device, Neurovascular Embolization; Extractor, Vacuum, Fetal; Laparoscope, Gynecologic (And Accessories); Insufflator, Laparoscopic; Insufflator, Hysteroscopic; Hysteroscope (And Accessories); Arthroscope; Rod, Fixation, Intramedullary And Accessories; Reamer; Rasp; Knife, Orthopedic; Bit, Drill; Instrument, Cutting, Orthopedic; Extractor; Screw, Fixation, Bone; Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment; Awl; Passer; Probe; Passer, Wire, Orthopedic; Screwdriver; Cutter, Wire; Staple, Fixation, Bone; Sterilization Wrap Containers, Trays, Cassettes & Other Accessories; Evacuator, Gastro-Urology; Catheter, Continuous Flush; Device, Vascular, For Promoting Embolization; Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented; Instrument, Ultrasonic Surgical; System, Image Processing, Radiological; Orthopedic Manual Surgical Instrument; Fastener, Fixation, Nondegradable, Soft Tissue; Catheter, Intravascular Occluding, Temporary; Guide, Wire, Catheter, Neurovasculature; System, Surgical, Computer Controlled Instrument; Accessories, Arthroscopic; Cement, Bone, Vertebroplasty; Intracranial Neurovascular Stent; Tubing/Tubing With Filter, Insufflation, Laparoscopic; Catheter, Thrombus Retriever; Endoscopic Grasping/Cutting Instrument, Non-Powered; Orthopedic Stereotaxic Instrument; Insufflator, Endoscopic Vessel Harvesting; Intracranial Aneurysm Flow Diverter; Confocal Optical Imaging; Ear, Nose, And Throat Stereotaxic Instrument; Intracranial Coil-Assist Stent; Automated Radiological Image Processing Software; Catheter, Percutaneous, Neurovasculature; System, Suction, Lipoplasty For Removal",1; 2; 3; U; f,"01030100 HipCheck; 01030300 HipCheck Software; 1.3MM X 35.6CM NITINOL GUIDE WIRE; 1.9MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK, C-MOUNT; 1.9MM OBTURATOR; 1.9MM SPEEDLOCK PENCIL TIP OBTURATOR; 1.9MM TROCAR; 1.9MM X 30º C-MOUNT, A/C; 1.9mm Speedlock Pencil Tip Obturator; 10 X 28mm Biosteon Screw; 10 X 35mm Biosteon Screw; 100MM DRAIN CANNULA; 10MM 0° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM; 10MM 0° BARIATRIC LAPAROSCOPE, AC; 10MM 0° LAPAROSCOPE, AC; 10MM 0° OPERATIVE LAPAROSCOPE WITH 45° EYEPIECE; 10MM 30° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM; 10MM 30° AUTOCLAVABLE LAPAROSCOPE; 10MM 30° BARIATRIC LAPAROSCOPE, AC; 10MM 30° LAPAROSCOPE, AC; 10MM 45° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM; 10MM 45° AUTOCLAVABLE LAPAROSCOPE; 10MM 45° BARIATRIC LAPAROSCOPE, AC; 10MM 45° LAPAROSCOPE, AC; 10MM 90° OPERATING LAPAROSCOPE; 10MM CLIP-APPLYING FORCEPS, ETHICON ML( LC300 OR LT300 COMP); 10MM DRAIN CANNULA; 10MM MONO, BABCOCK,PADDLE; 10MM MYOMA DRILL; 10MM PADDLE BABCOCK GRASPER; 10MM, 33CM BIOPSY SPOON; 10MM, 33CM BIPOLAR ALLIS FORCEPS; 10MM, 33CM DOUBLE ACTION CLAW; 10MM, 33CM MARYLAND DISSECTOR; 10MM, 33CM MIXTER FORCEPS; 10MM, 33CM MONOPOLAR HANDLE; 10MM, 33CM OPERATING SCISSORS, SERRATED; 10MM, 33CM PEEK MONOPOLAR HANDLE; 10MM, 33CM PEEK MULTI-FUNCTION HANDLE; 10MM, 33CM RATCHETING HANDLE; 10MM, 33CM SINGLE ACTION CLAW; 10X23mm Biosteon Screw; 10mm Articulating Laparoscope; 10mm SUBFIX TRIAL; 11 X 35mm Biosteon Screw; 11.5mm SUBFIX TRIAL; 11MM 90° OPERATING LAPAROSCOPE; 11MM CANNULA, AUTOMATIC VALVE, STOPCOCK WITHOUT TROCAR; 11MM FIXABLE CONE FOR HASSON CANNULA; 11MM HASSON CANNULA, AUTOMATIC VALVE, STOPCOCK; 11MM OBTURATOR FOR HASSON CANNULA; 11X28mm Biosteon Screw; 12 X 35mm Biosteon Screw; 120MM VERESS NEEDLE; 12X28mm Biosteon Screw; 16-L INSUFFLATOR TUBING; 1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER; 1688 AIM 4K CAMERA HEAD, C-MOUNT; 1688 AIM 4K INLINE CAMERA HEAD, C-MOUNT; 1688 Camera Control Unit; 1688 Pendulum Camera Head with Coupler; 17FR CYSTO STANDARD OBTURATOR; 17FR CYSTO VISUAL OBTURATOR; 17FR CYSTOSCOPE SHEATH; 19FR CYSTO STANDARD OBTURATOR; 19FR CYSTO VISUAL OBTURATOR; 19FR CYSTOSCOPE SHEATH; 2-0 Knot Pusher/Suture Cutter; 2.1MM BLUNT NOSE DOWN ASSY; 2.1MM BLUNT NOSE LEFT ASSY; 2.1MM BLUNT NOSE RIGHT ASSY; 2.1MM BLUNT NOSE STRAIGHT ASSY; 2.1MM BLUNT NOSE UP ASSY; 2.3MM  OBTURATOR; 2.3MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK,C-MOUNT; 2.3MM AUTOCLAVABLE BLUNT TIP OBTURATOR WITH SPEED-LOCK; 2.3MM AUTOCLAVABLE PENCIL TIP OBTURATOR WITH SPEED-LOCK; 2.3MM AUTOCLAVABLE TROCAR FOR 2.9MM CANNULA WITH SPEED-LOCK; 2.3MM TROCAR; 2.3MM X 0 DEG, A/C; 2.3MM X 0 DEG, C-,MOUNT, A/C; 2.3MM X 30 DEG, A/C; 2.3MM X 30 DEG, C-,MOUNT, A/C; 2.3MM X 30 DEG, C-,MOUNT, REVERSE CANT, A/C; 2.3MM X 70 DEG, C-,MOUNT, A/C; 2.5MM GRASPER ASSY; 2.5MM SCISSORS ASSY; 2.7MM 0 DEG AUTOCLAVABLE ARTHROSCOPE; 2.7MM 0° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT; 2.7MM 0° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM; 2.7MM 0° C-MOUNT, ARTHROSCOPE; 2.7MM 0° C-MOUNT, STUBBY; 2.7MM 0° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT; 2.7MM 30 DEG AUTOCLAVABLE ARTHROSCOPE; 2.7MM 30° A/C STUBBY REVERSE CANT SCOPE W/ SPEEDLOCK,C-MOUNT; 2.7MM 30° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT; 2.7MM 30° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM; 2.7MM 30° C-MOUNT, STUBBY; 2.7MM 30° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT; 2.7MM 30°C-MOUNT, ARTHROSCOPE; 2.7MM 70 DEG AUTOCLAVABLE ARTHROSCOPE; 2.7MM 70° A/C STUBBY ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT; 2.7MM 70° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT; 2.7MM BLUNT NOSE STRAIGHT ASSY; 2.7MM BLUNT NOSE UP ASSY; 2.7MM HYSTERSCOPE OPERATIVE SHEATH (6MM DIAMETER); 2.7MM NORROW PUNCH; 2.7MM OBTURATOR; 2.7MM SCOPE BRIDGE; 2.7MM SPEEDLOCK PENCIL TIP OBTURATOR; 2.7MM STUBBY SCOPE AUTOCLAVABLE; 2.7MM TROCAR; 2.7MM X 0 DEG, C-MOUNT, A/C; 2.7MM X 30 DEG, C-MOUNT, A/C; 2.7MM X 30° STUBBY AUTOCLAVABLE STUBBY SCOPE REVERSE CANT; 2.7MM X 70DEG STUBBY, A/C; 2.8MM  TWO ROTATING STOPCOCKS; 2.8MM CANNULA WITH 1 FIXED STOPCOCK; 2.8MM CANNULA WITH 1 ROTATING STOPCOCK; 2.8MM CANNULA WITH 2 FIXED STOPCOCKS; 2.8MM CANNULA WITH 2 ROTATING STOPCOCKS; 2.9MM AUTOCLAVABLE CANNULA, 1 ROTATING STOPCOCK W/SPEEDLOCK; 2.9MM CANNULA WITH 1 ROTATING STOPCOCK; 2.9MM IDEAL EYES PRECISION HD AUTOCLAVABLE 200MM C-MOUNT ARTHROSCOPE - 30 DEG. WITH MODIFIED SPEEDLOCK; 206-716 w/2 small sculps/pkg; 21FR CYSTO STANDARD OBTURATOR; 21FR CYSTO VISUAL OBTURATOR; 21FR CYSTOSCOPE SHEATH; 21FR URETHROTOME STANDARD OBTURATOR; 21FR URETHROTOME VISUAL OBTURATOR; 21FR VISUAL URETHROTOME OPTICAL BRIDGE; 21FR VISUAL URETHROTOME SHEATH; 22 FR, 0 DEGREE (STRAIGHT) CUTTING LOOP ELECTRODE, 14; 22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, 14; 22 FR, COLLINGS KNIFE ELECTRODE; 22 FR, DIMPLED VAPORIZING ROLLER BALL ELECTRODE; 22 FR, GOLD COAGULATING ELECTRODE; 22 FR, ROLLING BALL ELECTRODE; 22FR., 30° (STRAIGHT) CUTTING LOOP ELECTRODE, 14; 22FR., 30° CUTTING LOOP ELECTRODE, 14; 22FR., COLLINGS KNIFE ELECTRODE; 22FR., ROLLER BALL ELECTRODE, 303MM; 22FR., ROLLER ELECTRODE, 3MM; 22FR., VAPORIZATION ELECTRODE; 23FR CYSTO STANDARD OBTURATOR; 23FR CYSTO VISUAL OBTURATOR; 23FR CYSTOSCOPE SHEATH; 24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH; 24/26FR RESECTOSCOPE STANDARD OBTURATOR; 24/26FR RESECTOSCOPE TIMBERLAKE OBTURATOR; 24/26FR RESECTOSCOPE VISUAL OBTURATOR; 24FR STANDARD FLOW RESECTOSCOPE SHEATH; 24FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER; 24FR., 0° (STRAIGHT) CUTTING LOOP ELECTRODE, 14; 24FR., 30° CUTTING LOOP ELECTRODE, 14; 24FR., 90° CUTTING LOOP ELECTRODE, 14; 24FR., COLLINGS KNIFE ELECTRODE; 24FR., ROLLER BALL ELECTRODE, 3.3MM; 24FR., ROLLER ELECTRODE, 3MM; 24FR., SPIKE ELECTRODE; 24FR., VAPORIZATION ELECTRODE; 25FR BALLOON CATHETER SHEATH; 25FR CYSTO STANDARD OBTURATOR; 25FR CYSTO VISUAL OBTURATOR; 25FR CYSTOSCOPE SHEATH; 25FR VISUAL URETHROTOME OUTER SHEATH; 266-719-000 PKG, WESSINGER ROD (SMALL); 266-720-000 PKG, WISSINGER ROD (LARGE); 266-721-000 PKG. WISSINGER HANDLE, SE3; 27/28FR CONTINUOUS FLOW INNER/OUTER SHEATH; 27/28FR RESECTOSCOPE STANDARD OBTURATOR; 27/28FR RESECTOSCOPE TIMBERLAKE OBTURATOR; 27/28FR RESECTOSCOPE VISUAL OBTURATOR; 27FR STANDARD FLOW RESECTOSCOPE SHEATH; 27FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER; 27FR., 0 DEG (STRAIGHT) CUTTING LOOP ELECTRODE, 14; 27FR., 30° CUTTING LOOP ELECTRODE, 14; 27FR., 90° CUTTING LOOP ELECTRIC, 14; 27FR., COLLINGS KNIFE ELECTRODE; 27FR., ROLLER BALL ELECTRODE, 3.3MM; 27FR., ROLLER ELECTRODE, 3MM; 27FR., SPIKE ELECTRODE; 27FR., VAPORIZATION ELECTRODE; 2FR LONG TIP ELECTRODE, 115CM (3BX); 2FR SHORT TIP ELECTRODE, 115CM (3BX); 3.2MM CANNULA WITH 1 FIXED STOPCOCK; 3.2MM CANNULA WITH 1 ROTATING STOPCOCK; 3.2MM CANNULA WITH 2 FIXED STOPCOCKS; 3.2MM SPEEDLOCK PENCIL TIP OBTURATOR; 3.4MM 30 LEFT MENISCAL PUNCH; 3.4MM 30 RIGHT MENISCAL PUNCH; 3.4MM HIP GRASPER; 3.4MM HIP PUNCH - STRAIGHT; 3.4MM LOOSEBODY GRASPER W/ RATCHET; 3.4MM NARROW PUNCH-15° UP; 3.4MM NORROW PUNCH; 3.5MM CANNULA, AUTOMATIC VALVE, STOPCOCK, W/OUT TROCAR(55MM); 3.5MM FORMULA SERIES, SMALL JOINT CUTTER CANNULA; 3.5MM SWITCHING STICK; 3.9mm Omega Drill; 3.9mm Omega Tap; 3.9mm Omega and 4.75mm AlphaVent Awl; 3105001000 HipMap Femoroacetabular Impingement Analysis; 3910-500-582, ICONIX DC Guide for 2.3mm anchor; 3910-500-583, ICONIX DC Obturator for 2.3mm anchor; 3FR 3-WIRE GRASPING FORCEP, 70CM; 3FR 3-WIRE GRASPING FORCEP, 90CM; 3FR FLEXIBLE BIOPSY CUP FORCEP 60CM; 3FR FLEXIBLE GRASPING FORCEP, 60CM; 3FR FLEXIBLE RAT TOOTH FORCEP, 60CM; 3FR LONG TIP ELECTRODE, 115CM (3BX); 3FR SHORT TIP ELECTRODE, 115CM (3BX); 3M Split Ground Pad; 3MM BABCOCK GRASPER 29CM; 3MM BIOPSY PUNCH 20CM; 3MM BLUNT INSERT, WITH SPOON; 3MM DBL SLEEVE 80MM TROC/ASSY; 3MM DISSECTING FORCEPS 29CM; 3MM DOUBLE ACTION ATRAUMATIC GRASPER, 20CM; 3MM DOUBLE ACTION ATRAUMATIC GRASPER, 29CM; 3MM FENESTRATED SCHERTL GRASPER INSERT, 29CM; 3MM HOOK SCISSORS; 3MM HOOK SCISSORS INSERT 29CM; 3MM INSERT ALLIGATOR GRASPER 20CM; 3MM INSERT ALLIGATOR GRASPER 29CM; 3MM INSERT BIOPSY FORCEPS 20CM; 3MM INSERT BIOPSY FORCEPS 29CM; 3MM INSERT BIOPSY PUNCH 29CM; 3MM INSERT BLUNT GRASPER 20CM; 3MM INSERT BLUNT GRASPER 29CM; 3MM INSERT BLUNT SPOON GRASPER; 3MM INSERT COBRA GRASPER 20CM; 3MM INSERT CURVED METZENBAUM SCISSORS 20CM; 3MM INSERT DORSEY GRASPER 20CM; 3MM INSERT DORSEY GRASPER 29CM; 3MM INSERT FENESTRATED SCHERTEL GRASPER 20CM; 3MM INSERT FUNDUS GRASPER 29CM; 3MM INSERT MARYLAND DISSECTORS 20CM; 3MM INSERT MARYLAND DISSECTORS 29CM; 3MM INSERT NEEDLE NOSE DISSECTORS 20CM; 3MM INSERT NEEDLE NOSE DISSECTORS 29CM; 3MM INSERT RIGHT ANGLE DISSECTORS 29CM; 3MM INSERT RIGHT ANGLE DISSECTORS, 20CM; 3MM INSERT STRAIGHT NEEDLEHOLDER 20CM; 3MM INSERT STRAIGHT NEEDLEHOLDER 29CM; 3MM INSERT TAPERED BULLET 20CM; 3MM INSERT TAPERED BULLET 29CM; 3MM INSERT, CURVED METZENBAUM SCISSORS 29CM; 3MM INSERT, FUNDUS GRASPER 20CM; 3MM INSERT, PERITONEAL SCISSORS 29CM; 3MM PEEK MONOPOLAR HANDLE; 3MM SINGLE ACTION ATRAUMATIC GRASPER, 29CM; 3mm PREDRILL ASSEMBLY LONG; 3mm PREDRILL ASSEMBLY SHORT; 4.4MM HIP OBTURATOR CANNULATED; 4.4MM HIP TROCAR CANNULATED; 4.6 X 200 MM CANNULA, 1 FIXED STOPCOCK; 4.6 X 200 MM CANNULA, 1 FIXED STOPCOCK, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK; 4.6 X 200 MM CANNULA, 1 ROTATING STOPCOCK, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS AT 95°; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS AT 95°, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 FIXED STOPCOCKS, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS AT 95°; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS AT 95°, NO DISTAL HOLES; 4.6 X 200 MM CANNULA, 2 ROTATING STOPCOCKS, NO DISTAL HOLES; 4.75mm AlphaVent Punch Tap; 4.75mm AlphaVent Tap; 4.75mm AlphaVent and Omega Awl; 4.75mm AlphaVent and Omega Drill; 4.75mm Omega Tap; 4MM  0° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT; 4MM  0° C-MOUNT STYLE A ARTHROSCOPE; 4MM 0DEG C-MOUNT; 4MM 0° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM; 4MM 30° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT; 4MM 30° AUTOCLAVABLE HIP ARTHROSCOPE; 4MM 30° AUTOCLAVABLE REVERSE CANT ARTHROSCOPE, C-MOUNT; 4MM 30° C-MOUNT STYLE A ARTHROSCOPE; 4MM 30° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM; 4MM 70° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT; 4MM 70° C-MOUNT STYLE A ARTHROSCOPE; 4MM 70° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5 CM; 4MM 70° REV. CANT, STORZ; 4MM A/C ARTHROSCOPE; 4MM AUTOCLAVABLE ARTHROSCOPE; 4MM CANNULA WITH 1 FIXED STOPCOCK; 4MM CANNULA WITH 1 ROTATING STOPCOCK; 4MM CANNULA WITH 2 FIXED STOPCOCKS; 4MM CANNULA WITH 2 ROTATING STOPCOCKS; 4MM CANNULATED SWITCHING STICK; 4MM CYSTOSCOPE, KS SERIES 0DEG; 4MM CYSTOSCOPE, KS SERIES 12DEG; 4MM CYSTOSCOPE, KS SERIES 30DEG; 4MM CYSTOSCOPE, KS SERIES 70DEG; 4MM DBL SLVE 180MM TROC/ASSY; 4MM HYSTERSCOPE DIAGNOSTIC SHEATH (6MM DIAMETER); 4MM HYSTERSCOPE OPERATIVE SHEATH (7MM DIAMETER); 4MM X 0° LONG ARTHROSCOPE SPEEDLOCK A/C; 4MM X 24 SWITCHING STICK; 4MM X 30° LONG ARTHROSCOPE SPEEDLOCK A/C; 4MM X 70° LONG ARTHROSCOPE SPEEDLOCK A/C; 4MM, 30 HIP ARTHOSCOPE (HIPSCOPE); 4mm DBL SLEEVE 150mm TROC/ASSY; 4mm PREDRILL ASSEMBLY EXTRA SHORT; 4mm PREDRILL ASSEMBLY LONG; 4mm PREDRILL ASSEMBLY SHORT; 5 MM BIPOLAR FORCEPS, SPRING HANDLE, MICRO TIP, 45 CM; 5 MM MICRO SCISSORS, CURVED INSERT; 5.5MM CANNULA, AUTOMATIC VALVE, STOPCOCK WITHOUT TROCAR; 5.5MM CANNULATED SWITCHING STICK; 5.5MM HASSON CANNULA, AUTOMATIC VALVE, STOPCOCK; 5.5MM OBTURATOR FOR HASSON CANNULA; 5.5MM SLOTTED CANNULA; 5.5mm AlphaVent Tap; 5.5mm AlphaVent and 4.75mm Hard Bone Omega Drill; 5.8 CANNULA, 2 ROTATING STOPCOCKS FOR 4MM LONG ARTHROSCOPE; 5.8MM CANNULA, 1 FIXED STOPCOCK; 5.8MM CANNULA, 2 FIXED STOPCOCKS; 5.8MM CANNULA, 2 ROTATING STOPCOCKS; 5.8MM HIPSCOPE CANNULA, 2 ROTATING STOPCOCKS; 5FR BALL ELECTRODE, 65CM (3BX); 5FR BUGBEE ELECTRODE, 65CM (3BX); 5FR DOMED ELECTRODE, 65CM (3BX); 5FR FLEXIBLE BIOPSY CUP FORCEP, 60CM; 5FR FLEXIBLE GRASPING FORCEP, 60CM; 5FR FLEXIBLE RAT TOOTH FORCEP, 60CM; 5FR FLEXIBLE SCISSOR, 60CM; 5MM 0° AUTOCLAVABLE LAPAROSCOPE; 5MM 0° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE; 5MM 0° LAPAROSCOPE, AC; 5MM 30° AUTOCLAVABLE LAPAROSCOPE; 5MM 30° BARIATRIC LAPAROSCOPE, AC; 5MM 30° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE; 5MM 30° LAPAROSCOPE, AC; 5MM 45CM METZENBAUM MINI SCISSORS INSERT; 5MM 45° AUTOCLAVABLE LAPAROSCOPE; 5MM 45° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE; 5MM 45° LAPAROSCOPE, AC; 5MM ASPIRATION NEEDLE, 33CM LONG, 17 GAUGE NEEDLE; 5MM ASPIRATION NEEDLE, 45CM LONG, 17 GAUGE NEEDLE; 5MM CANNULA 1 ROT SPEEDLOCK; 5MM CANNULA 2 ROT STCK (SPEEDLOCK); 5MM CUFF ANCHOR; 5MM ENDOLOOP APPLICATOR; 5MM MONOPOLAR HANDLE 33CM; 5MM MYOMA DRILL; 5MM PALPATION PROBE, 33CM LONG; 5MM PALPATION PROBE, 45CM LONG; 5MM PEEK 45CM MARYLAND FORCEPS; 5MM PEEK MULTIFUNCTION HANDLE; 5MM RATCHETED HANDLE 33CM; 5MM X 45CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW; 5MM, 33CM ALLIGATOR GRASPER; 5MM, 33CM ALLIS GRASPER (DOUBLE ROW OF TEETH); 5MM, 33CM ALLIS GRASPER (SINGLE ROW OF TEETH); 5MM, 33CM BABCOCK GRASPER; 5MM, 33CM BIOPSY PUNCH; 5MM, 33CM BIPOLAR BABCOCK FORCEPS; 5MM, 33CM BIPOLAR FENESTRATED FORCEPS (INSERT); 5MM, 33CM BIPOLAR FENESTRATED FORCEPS WITH RING HANDLE; 5MM, 33CM BIPOLAR FENESTRATED FORCEPS WITH SPRING HANDLE; 5MM, 33CM BIPOLAR MICRO TIP FORCEPS (INSERT); 5MM, 33CM BIPOLAR PADDLE FORCEPS (INSERT); 5MM, 33CM BIPOLAR PADDLE FORCEPS WITH RING HANDLE; 5MM, 33CM BIPOLAR PADDLE FORCEPS WITH SPRING HANDLE; 5MM, 33CM BIPOLAR PENNINGTON FORCEPS; 5MM, 33CM BIPOLAR RING HANDLE; 5MM, 33CM BIPOLAR SHAFT; 5MM, 33CM BIPOLAR SPRING HANDLE; 5MM, 33CM BLAKESLY BIOPSY; 5MM, 33CM BLUNT GRASPER WITH SPOON; 5MM, 33CM COBRA GRASPER; 5MM, 33CM CURVED KELLY DISSECTOR; 5MM, 33CM CURVED LEFT NEEDLEHOLDER; 5MM, 33CM CURVED METZENBAUM SCISSORS (LONG JAWS); 5MM, 33CM CURVED RIGHT NEEDLEHOLDER; 5MM, 33CM DEBAKEY GRASPER; 5MM, 33CM DOLPHIN WITH SPOON DISSECTOR; 5MM, 33CM DORSEY GRASPER; 5MM, 33CM DOUBLE ACTION ATRAUMATIC GRASPER; 5MM, 33CM DOUBLE ACTION BIOPSY SPOON WITH PIN; 5MM, 33CM ENDO METZENBAUM SCISSORS (CURVED); 5MM, 33CM FENESTRATED GRASPER; 5MM, 33CM FENESTRATED SCHERTL GRASPER; 5MM, 33CM FUNDUS GRASPER; 5MM, 33CM GRASPER, DELICATE, FENESTRATED; 5MM, 33CM HOOK SCISSORS; 5MM, 33CM JOHANN FORCEPS; 5MM, 33CM MARYLAND DISSECTOR; 5MM, 33CM MESO-OVARIAN FORCEPS; 5MM, 33CM MICRO GRASPER; 5MM, 33CM MICRO SCISSORS (STRAIGHT); 5MM, 33CM MINI METZENBAUM SCISSORS (CURVED); 5MM, 33CM MIXTER DISSECTOR; 5MM, 33CM NARROW JAW GRASPER; 5MM, 33CM NEEDLE NOSE DISSECTOR; 5MM, 33CM NEEDLEHOLDER HANDLE; 5MM, 33CM OVIDUCT FORCEPS; 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM; 5MM, 33CM PERITONEAL SCISSORS; 5MM, 33CM RIGHT ANGLE DISSECTOR; 5MM, 33CM SERRATED FENESTRATED GRASPER; 5MM, 33CM SERRATED GRASPER; 5MM, 33CM SINGLE ACTION ATRAUMATIC GRASPER; 5MM, 33CM SINGLE ACTION BIOPSY SPOON WITH PIN; 5MM, 33CM STRAIGHT METZENBAUM SCISSORS; 5MM, 33CM STRAIGHT METZENBAUM SCISSORS (LONG JAWS); 5MM, 33CM STRAIGHT NEEDLEHOLDER; 5MM, 33CM STRONG GRASPER (FENESTRATED); 5MM, 33CM TAPERED BULLET DISSECTOR; 5MM, 33CM TISSUE GRASPER DISSECTOR (45°); 5MM, 33CM, ENDO GRASPER; 5MM, 33CM, PADDLE BABCOCK GRASPER; 5MM, 33CM, PARK FORCEPS; 5MM, 33CM, RETENTION GRASPER; 5MM, 33CM, TENACULUM FORCEPS; 5MM, 45CM ALLIS GRASPER (DOUBLE ROW OF TEETH); 5MM, 45CM BABCOCK GRASPER; 5MM, 45CM BIOPSY PUNCH; 5MM, 45CM BIPOLAR FENESTRATED FORCEPS (INSERT); 5MM, 45CM BIPOLAR PADDLE FORCEPS (INSERT); 5MM, 45CM BIPOLAR SHAFT; 5MM, 45CM CURVED KELLY DISSECTOR; 5MM, 45CM CURVED LEFT NEEDLEHOLDER; 5MM, 45CM CURVED METZENBAUM (LONG JAWS) SCISSORS; 5MM, 45CM CURVED RIGHT NEEDLEHOLDER; 5MM, 45CM DEBAKEY GRASPER; 5MM, 45CM DISSECTING FORCEPS; 5MM, 45CM DOUBLE ACTION ATRAUMATIC GRASPER; 5MM, 45CM DOUBLE ACTION BIOPSY SPOON WITH PIN; 5MM, 45CM ENDO METZENBAUM SCISSORS CURVED; 5MM, 45CM HOOK SCISSORS; 5MM, 45CM MARYLAND DISSECTOR; 5MM, 45CM MONOPOLAR HANDLE; 5MM, 45CM OVIDUCT FORCEPS; 5MM, 45CM PARK FORCEPS; 5MM, 45CM PEEK MONOPOLAR HANDLE; 5MM, 45CM PEEK MULTI-FUNCTION HANDLE; 5MM, 45CM PERITONEAL SCISSORS; 5MM, 45CM RATCHETING HANDLE; 5MM, 45CM SERRATED GRASPER; 5MM, 45CM SINGLE ACTION ATRAUMATIC GRASPER; 5MM, 45CM STRAIGHT NEEDLEHOLDER; 5MM, 45CM, DORSEY GRASPER; 5MM, 45CM, ENDO GRASPER; 5MM, 45CM, FENESTRATED GRASPER; 5MM, 45CM, FUNDUS GRASPER; 5MM, 45CM, PADDLE BABCOCK GRASPER; 5MM, 45CM, RETENTION GRASPER; 5MM, 45CM, RIGHT ANGLE DISSECTOR; 5MM,33CM DISSECTING FORCEPS; 5MM,33CM RIGHT ANGLE (LONG JAW); 5mm Articulating Laparoscope; 5mm Bariatric Articulating Laparoscope; 5mm PREDRILL ASSEMBLY EXTRA SHORT; 5mm PREDRILL ASSEMBLY LONG; 5mm PREDRILL ASSEMBLY SHORT; 5mm SPANNER WRENCH; 6.5MM CANNULATED SWITCHING STICK; 6.5MM SLOTTED CANNULA; 6.5MM X 75MM CANNULATED OBTURATOR ASSY.; 6.5MM X 90MM CANNULATED OBTURATOR ASSY.; 6.5mm SUBFIX TRIAL; 6X23mm Biosteon Screw; 6X28mm Biosteon Screw; 6mm PREDRILL ASSEMBLY EXTRA SHORT; 6mm PREDRILL ASSEMBLY LONG; 6mm PREDRILL ASSEMBLY SHORT; 7 X 23mm Biosteon Screw; 7 X 28mm Biosteon Screw; 7FR BALL ELECTRODE, 40CM (3BX); 7FR BUGBEE ELECTRODE, 40CM (3BX); 7FR DOMED ELECTRODE, 40CM (3BX); 7MM SPANNER WRENCH; 7mm SPANNER WRENCH; 8 X 23mm Biosteon Screw; 8 X 28mm Biosteon Screw; 8MM X 75MM CANNULATED OBTURATOR ASSY.; 8MM X 90MM CANNULATED OBTURATOR ASSY.; 8mm SUBFIX TRIAL; 9 X 23mm Biosteon Screw; 9 X 28mm Biosteon Screw; 9 X 35mm Biosteon Screw; 9mm SUBFIX TRIAL; A 2 DRILL BRACE W/O CHUCK; A 4 4MM CHUCK; A 5 T-WRENCH; A 51 T WRENCH W/35 EXTENSION; ACL Reconstruction Accessories; ACL Workstation; ADAPT for Gamma 3; ADAPT for Gamma3; ADAPTOR SPEED LOCK SYRINGE; AEQ FRAC LONG SUP IMP ENS; AEQ FRAC SUPPORT DE BRAS; AEQ FRACT GR AXE LIAISON; AEQ FRACT MESUREUR AMOVIB; AEQ FRACT NM FANT TIG; AEQ IMPACTEUR DE PROTHESE; AEQ TIGE FRA LG FANT; AEQ USA FANT CALO; AGM 6 6MM CHUCK; AIM 4K Coupler, 20mm, C-Mount; AIM SAFELIGHT FIBER OPTIC CABLE, 5MM X 10FT / 35M; ALBARRAN BRIDGE, DOUBLE HORN; ALBARRAN BRIDGE, SINGLE HORN; ANCHORAGE CP INSTRUMENTS SILICONE SUPPORT (WITHOUT INSTRUMENTS); ANCHORAGE CP LAPIDUS PIVOTING DRILL GUIDE; ANCHORAGE CP LAPIDUS TEMPLATE; ANCHORAGE CP MTP PIVOTING DRILL GUIDE; ANCHORAGE CP MTP TEMPLATE; ANCHORAGE CP POLYAXIAL DRILL GUIDE; ANCHORAGE CP UTILITY TEMPLATE; ANCHORAGE FIXATION PIN; ANCHORAGE FIXED DRILL GUIDE 2.5MM; ANCHORAGE FIXED DRILL GUIDE 2MM; ANCHORAGE INSTRUMENTS RACK (LEVEL 1); ANCHORAGE INSTRUMENTS RACK (LEVEL 2); ANCHORAGE INSTRUMENTS RACK COVER; ANCHORAGE PLATE BENDER; ANCHORAGE PLATE GRIPPER; ANTEVERSION GUIDE; AO HANDLE - LENGTH 135MM; AO Quick Coupling with Elastosil Handle; AO/JACOBS QUICK RELEASE APEX CHUCK 3mm; AO/JACOBS QUICK RELEASE APEX CHUCK 4mm; AO/JACOBS QUICK RELEASE APEX CHUCK 5mm; AO/JACOBS QUICK RELEASE APEX CHUCK 6mm; APEX DRILL BRACE - 3/4/5/6mm; APEX DRILL GUIDE HANDLE; APEX TRAY BASE; APEX TRAY LID; APEX TRAY LOWER INSERT; APEX TRAY UPPER INSERT; ARTHROSCOPE; ATP Disc Prep; AWL; AXS Catalyst 5; AXS Catalyst 6; AXS Catalyst Distal Access Catheter; AXS Catalyst Distal Access Catheter (AXS Catalyst 7); AXS Offset Delivery Assist Catheter; AXS Universal Aspiration System (AXS Catalyst 7 Distal Access Catheter); AXSOS ADAPTOR FOR TORQUE TESTER T20; AXSOS ADAPTOR FOR TORQUE TESTER T8/T15; AXSOS SPARE SET SCREW/FEMUR AIMING BLOCK; Accolade II System Instrumentation; Adaptor 1 SOLOASSIST II; Adaptor 2 SOLOASSIST II; Aequalis"" Ascend"" Flex; Aequalis"" Instrument; Aleutian, Ari, Blue Ridge, Canyon, Capri, Cascadia, Caspian, Chesapeake, Cayman, Cayman MI, Denali MI, Denali, Everest; All OrthoHelix Orthopedic Manual Surgical Instruments; All Tornier Instruments, Cutting, Orthopeadic; All Tornier Orthopeadic Manual Surgical Instruments (exempt); Anato Hip System Instrumentation; Anatomic Express Tray; Arthroscope and Camera Sterilization Tray; Asnis® III Cannulated Screw System; Asnis® PRO Cannulated Screw System; AxSOS; AxSOS 3; AxSOS 3 AF System and AxSOS 3 Ti System, Plate; AxSOS 3 Ankle Fusion; AxSOS 3 Ti; BARREL REAMER ASSEMBLY STAND; BIOCOMPRESSION WRENCH 15mm TUBE; BIOCOMPRESSION WRENCH 20mm TUBE; BIOCOMPRESSION WRENCH 25mm TUBE; BIOPSY CUP 5FR SEMI FLEX; BIOPSY CUP 7FR SEMI FLEX; BIOPSY PUNCH 5FR SEMI FLE; BIOPSY PUNCH, 7FR. SEMI-FLEXIBLE; BLADDER SYRINGE ADAPTER CYSTO SHEATH; BLADDER SYRINGE ADAPTER, INNER SHEATH; BLADDER SYRINGE ADAPTER, OUTER SHEATH; BLUNT TIP OBTURATOR; BLUNT TIP OBTURATOR FOR 2.8MM CANNULA; BLUNT TIP OBTURATOR FOR 2.9MM CANNULA; BLUNT TIP OBTURATOR FOR 3.2 CANNULA; BLUNT TIP OBTURATOR FOR 4MM CANNULA; BLUNT TIP OBTURATOR FOR 4MM LONG ARTHROSCOPE; BUR CANNULA 5MM; Bariatric Articulating Laparoscope Sterilization Tray; Bariatric Laparoscope; Battery Light Source for Fiber Cystoscope; Big Dog Suture Center; BioZip System; Bioabsorable Wedge Interference Screw System; Biosteon Wedge Interference Screw System; Bixcut, IM Reamer; Bone Plug Extractor; Box Sterile Drape 10 SOLOASSIST II; BriteField Depth Gauge; Broach and Inserter Handle; CANNULA 4MM; CANNULA 4MM W/2 ROTATING STOPCOCKS; CANNULA 6.5 1 FXD STCK (SPEED-LOCK); CANNULA 6.5MM 1 ROT STCK (SPEED-LOCK); CANNULA 6.5MM 2 FXD STCKS (SPEED-LOCK); CANNULA 6.5MM 2 ROT STCKS (SPEED-LOCK); CANNULA PLUG; CANNULA, 2.8MM; CANNULA, 2.8MM  ONE FIXED STOPCOCK; CANNULA, 2.8MM  ONE ROTATING STOPCOCK; CANNULA, 2.8MM  TWO FIXED STOPCOCKS; CANNULA, 3.2MM  ONE FIXED STOPCOCK; CANNULA, 3.2MM  ONE ROTATING STOPCOCK; CANNULA, 3.2MM  TWO FIXED STOPCOCKS; CANNULA, 3.2MM  TWO ROTATING STOPCOCKS; CANNULA, 4MM ONE FIXED STOPCOCK; CANNULA, 4MM SPEEDLOCK TWO FIXED STOPCOCKS; CANNULATED OBTROCAR FOR 4.6 X 200 MM CANNULA; CANNULATED OBTURATOR FOR 4.6 X 200 MM CANNULA; CANNULATED PENCIL TIP OBTURATOR FOR LONG 5.8MM SCOPE SHEATH; CANNULATED TROCAR FOR 4.6 X 200 MM CANNULA; CMI; CMI Delivery Clamp; CMI Mesuring Cannula; COHEN INTRAUTERINE CANNULA COMPLETE; COHEN INTRAUTERINE CANNULA ONLY; COLD KNIFE, HALF MOON; COLD KNIFE, HOOK; COLD KNIFE, LOOP; COLD KNIFE, SERRATED; COLD KNIFE, STRAIGHT; CROSSFLOW; CURSOR; CURVED HIP BLADE, SHARP TIP; CURVED HIP PROBE; CUTTER & BUR TRAY; CUTTER CANNULA 4.5MM; CUTTER CANNULA W/ HOLE 5MM; CUTTER CANNULA W/HOLE 4.5MM; CUTTER/ BUR CANNULA 5.6MM; CUTTER/BUR CANNULA (W/HOLE) 5.6MM; CUTTING SCREWDRIVER 4.5; CYLINDRICAL BUSH HOLDER; CYSTOSCOPE, 4MM 0 DEG AUTOCLAVABLE; CYSTOSCOPE, 4MM 12 DEG AUTOCLAVABLE; CYSTOSCOPE, 4MM 30 DEG AUTOCLAVABLE; CYSTOSCOPE, 4MM 30 DEG WITH GREEN LIGHT FILTER AUTOCLAVABLE; CYSTOSCOPE, 4MM 70 DEG AUTOCLAVABLE; CalcLock Extreme; CalcLock manual surgical instruments; Cannulated Countersink with AO Fitting; Cannulated Drill with AO Fitting; Cannulated Drill ø 2,7/3.5mm with AO Fitting; Cannulated Screwdriver with AO Fitting; Cannulated Screwdriver with Elastosil Handle; Cannulated Tap with AO Fitting; Capsule Punch; CapsulePass 45 Up Suture Passer; Cascadia Interbody System; Champion Shoulder Instrumentation; Champion Slingshot; CinchLock; Cobra Suture Passer, Capture; Cobra Suture Passer, Hook; Colored Plugs; Cone Adapter SOLOASSIST II; Counterbore Drill; Cross-Screw System; Crosscut; Cut Guide; DEPTH GAUGE; DEPTH GAUGE (DISTAL RADIUS); DEPTH GAUGE (HAND); DISPOSABLE BIOPSY NEEDLE, SEDAN 2.5MM/210MM; DISPOSABLE CEMENT SCULPS; DISPOSABLE SHEATH FOR FIBER CYSTOSCOPE-1.5M; DISS ADAPTOR FOR UNIVERSAL GAS CONNECTION; DJD II STORAGE CASE; DOUBLE HORN BRIDGE; DRAIN CANNULA 70MM; DRAIN CNLA 70MM W/ 2ND; DRILL BIT; DRILL GUIDE; DRILL GUIDE BLOCK COMPACT 4 HOLE; DRILL GUIDE BLOCK COMPACT PERI 4 HOLE; DRILL GUIDE BLOCK HII 10 HOLE; DRILL GUIDE BLOCK HII 5 HOLE; DRILL GUIDE BLOCK MONOTUBE 4 HOLE; DRILL GUIDE BLOCK YLW MONOTUBE 2 HOLE; DRILL GUIDE LOCK II 2.5; DRILL SLEEVE; DRIVER; SCREW INSERTER; DRLock Extreme; Depth Gauge (Foot/Elbow/Distal Fib); Digital Cystoscope; Digital Cystoscope Disposal Sheaths 1.5mm; Digital Cystoscope Disposal Sheaths 2.1mm; Direct Measuring Gauge; Double Drill Guide ø 2,0/3,5mm; Drill Bit; Drill Bit ø 2,0 x 150mm; Drill Guide Non Sterile; Drill Sleeve; Dual-sided Baseplate Centering Guide; EASY CLIP ANGLED DRILL GUIDE SIZE 15; EDINTRAK II; ELLIK ADAPTER CYSTO SHEATH; ELLIK ADAPTER INNER SHEATH; ELLIK ADAPTER OUTER SHEATH; ELLIK EVACUATOR; ENDOTRAC ECTR; ENDOTRAC EPF/ EGR; EVALUATION BRIDGE; EXTRACTOR; Edgelock manual surgical instruments; Elastosil T-Handle with AO Coupling; EndoSheath for Digital Cystoscope; EndoSheath for Fiber Cystoscope; Endoscope Clamp SOLOASSIST II; Endoscopy Device; Endotrac; Excelsior 1018 Microcatheter; Excelsior 1018 Pre-Shaped Microcatheter; Excelsior SL-10 Microcatheter; Excelsior SL-10 Pre-Shaped Microcatheter; Excelsior XT-17 Flex Microcatheter; Excelsior XT-17 Microcatheter; Excelsior XT-27 Microcatheter; Excelsior® XT-27® Microcatheters; Exeter Hip System Instrumentation; Express Humeral Stem Extractor; Express Insert; Extractor; Extractor Rod; Extractor for Screws; FEELER; PROBE; FEMALE LUER-LOCK FOR 6MM TUBING; FEMORAL CANAL BRUSH, STANDARD; FIXATION CLAMP 5MM WITH RATCHET; FIXOS 4 MV DEPTH GAUGE; FLEXIBLE BIOPSY FORCEP, CUP, 5FR; FLEXIBLE BIOPSY FORCEP, CUP, 7FR; FLEXIBLE BIOPSY FORCEP, CUP, 9FR; FLEXIBLE GRASPING FORCEP, 5FR; FLEXIBLE GRASPING FORCEP, 7FR; FLEXIBLE GRASPING FORCEP, 9FR; FLEXIBLE SCISSOR, 5FR; FLEXIBLE SCISSOR, 7FR; FLEXIBLE SCISSOR, 9FR; FLOCONTROL - ARTHROSCOPY PUMP MODEL 200; FLOCONTROL ARTHROSCOPY PUMP MODEL 150; FLOSTEADY - DISPOSABLE TUBE SET; FLOSTEADY MODEL 200 - ARTHROSCOPY POLE PUMP; FLUID SAFE PUMP VERSION EU 1; FLUID SAFE PUMP VERSION EU 2; FLUID SAFE PUMP VERSION EU 3; FLYTE HOODS; FLYTE TOGAS; FORMULA 180 SHAVER (HAND CONTROL); FORMULA SHAVER (HAND CONTROL); FUNNEL; Fiber Cystoscope; Fiber Cystoscope Disposable Sheaths 2.1mm; FlexStick Passer; Flexible Control Unit; FlowPort II; Fluid Safe; Flyte SurgiCool Hoods; Flyte SurgiCool Togas; GLENOID PLANER; GLICK HIP KIT TRAY; GRASPER 5 FR SEMI FLX DBLACTION; GRASPER, 5FR SEMI FLEX; GRASPER, 7FR SEMI FL DOUBLE; GRSPR, 7FR SEMI-FLX SINGLACTION; GUIDE FOR HALF-PINS; Gateway PTA Balloon Catheter; General Instruments; Glenoid pin guide; Graft box body; Graft box compression screw; Graft box locking screw; Graft box washer; Graft box wedge; Graft container; Graft extractor; Graft sizer; Guide Wire; Guide Wire Pusher; Guide Wire Ruler; Guide Wire Targeter; Guide Wire Targeter - Crown; Guide Wire Targeter - Sleeve; Guide Wire, Threaded; HD 0 DEG., ARTHROSCOPE, 4MM X 140MM,C-MOUNT, SPEEDLOCK, A/C; HD 1.9 X 0 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 1.9MM X 0° ARTHROSCOPE J-LOCK A/C; HD 1.9MM X 30 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 1.9MM X 30° ARTHROSCOPE J-LOCK A/C; HD 10MM 0 DEGREES BARIATRIC IR LAPARSCOPE, AC; HD 10MM 0 DEGREES IR LAPARSCOPE, AC; HD 10MM 30 DEGREES BARIATRIC IR LAPARSCOPE, AC; HD 10MM 30 DEGREES IR LAPARSCOPE, AC; HD 10MM 45 DEGREES BARIATRIC IR LAPARSCOPE, AC; HD 10MM 45 DEGREES IR LAPARSCOPE, AC; HD 2.3MM X 0 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 2.3MM X 0° ARTHROSCOPE J-LOCK A/C; HD 2.3MM X 30 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 2.3MM X 30 DEGREE REVERSE CANT ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 2.3MM X 30° ARTHROSCOPE J-LOCK A/C; HD 2.3MM X 30° REVERSE CANT ARTHROSCOPE J-LOCK A/C; HD 2.3MM X 70 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 2.3MM X 70° ARTHROSCOPE J-LOCK A/C; HD 2.7MM X 0 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C; HD 2.7MM X 0 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 2.7MM X 0° ARTHROSCOPE SPEEDLOCK A/C; HD 2.7MM X 0° STUBBY ARTHROSCOPE J-LOCK A/C; HD 2.7MM X 30 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C; HD 2.7MM X 30 DEGREE REVERSE CANT STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 2.7MM X 30 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 2.7MM X 30° ARTHROSCOPE SPEEDLOCK A/C; HD 2.7MM X 30° STUBBY ARTHROSCOPE J-LOCK A/C; HD 2.7MM X 70 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C; HD 2.7MM X 70 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C; HD 2.7MM X 70° ARTHROSCOPE SPEEDLOCK A/C; HD 2.7MM X 70° STUBBY ARTHROSCOPE J-LOCK A/C; HD 30 DEG, ARTHROSCOPE, 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C, REVERSE CANT; HD 30 DEG., 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C; HD 30 DEG., ARTHROSCOPE, 2.9MM X 200MM, C-MOUNT, SPEEDLOCK, A/C; HD 30 DEG., ARTHROSCOPE, 4MM X 140MM, C-MOUNT, SPEEDLOCK, A/C; HD 30 DEG., ARTHROSCOPE, 4MM X 140MM,C-MOUNT, SPEEDLOCK, REVERSE CANT, A/C; HD 4MM X 0° ARTHROSCOPE SPEEDLOCK A/C; HD 4MM X 0° ARTHROSCOPE, SPEEDLOCK, C-MOUNT; HD 4MM X 30° ARTHROSCOPE SPEEDLOCK A/C; HD 4MM X 30° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C; HD 4MM X 30° LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C; HD 4MM X 30° REVERSE CANT ARTHROSCOPE SPEEDLOCK A/C; HD 4MM X 30° REVERSE CANT ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C; HD 4MM X 30° REVERSE CANT LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C; HD 4MM X 45° ARTHROSCOPE, SPEEDLOCK, A/C; HD 4MM X 70 DEG LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C; HD 4MM X 70° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C; HD 4MM X 70° ARTHROSCOPES, SPEEDLOCK, A/C; HD 5MM 0 DEGREE BARIATRIC IR LAPARASCOPE, AC; HD 5MM 0 DEGREES IR LAPARSCOPE, AC; HD 5MM 0° BARIATRIC LAPAROSCOPE, AC; HD 5MM 30 DEGREES BARIATRIC IR LAPARSCOPE, AC; HD 5MM 30 DEGREES IR LAPARSCOPE, AC; HD 5MM 45 DEGREES BARIATRIC IR LAPARSCOPE, AC; HD 5MM 45 DEGREES IR LAPARSCOPE, AC; HD 5MM 45° BARIATRIC LAPAROSCOPE, AC; HD 70 DEG., ARTHROSCOPE, 4MM X 140MM,C-MOUNT, SPEEDLOCK, A/C; HD 70 DEG., ARTHROSCOPE, 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C; HIGH FLOW INSUFFLATOR TUBING; HII 7mm T-WRENCH / 5+6mm SOCKET; HII COMPACT 5mm WRENCH/3&4mm SOCKET; HII COMPACT GUIDE BLOCK W/AO; HII COMPACT MRI STORAGE CASE BASE; HII COMPACT MRI STORAGE CASE LID; HII COMPACT MRI STORAGE CASE UPPER INSERT; HII COMPACT STORAGE CASE BASE; HII COMPACT STORAGE CASE LID; HII COMPACT STORAGE CASE UPPER INSERT; HII MICRO 2mm PIN DRIVER; HII MICRO DRILL GUIDE ASSEMBLY; HII MICRO NUT DRIVER; HII MICRO STORAGE CASE BASE; HII MICRO STORAGE CASE DRILL BIT HOLDER; HII MICRO STORAGE CASE LID; HII MICRO STORAGE CASE LOWER INSERT; HII MICRO STORAGE CASE UPPER INSERT; HII MRI TRAY BASE; HII MRI TRAY LID; HII MRI TRAY LOWER INSERT; HII TRAY BASE; HII TRAY LID; HII TRAY LOWER INSERT; HII TRAY UPPER INSERT; HIP  SUTURE GRASPER; HIP 4MM CANNULA; HIP 4MM CANNULA, WITH DISTAL HOLES; HIP 5.5MM CANNULA; HIP 5.5MM CANNULA, WITH DISTAL HOLES; HIP 5MM CANNULA",1986-06-09,107,2026-07-22,2,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008837339%22&limit=1
Argon Medical Devices Inc.,1625425,1625425,1445 Flat Creek RD.,Athens,TX,75751,United States,"ARGON MEDICAL DEVICES, INC",9059795,Contract manufacturer; Manufacturer; Repackager or relabeler; Specification developer,76,BSP; DOX; DQO; DQX; DQY; DRC; DRE; DRS; DTK; DTL; DWO; DWZ; DXC; DXT; DYB; DYG; EXF; FCG; FGE; FMG; FMH; FMI; FNY; FOZ; FPA; FPK; FZX; GAA; GBO; GBQ; GCB; GCC; GDF; GDJ; GDM; GDY; GEA; GES; HIO; HXD; IWJ; IZI; KGC; KGX; KGZ; KKX; KNW; KNY; KOC; KOE; KRA; KRB; LJE; LJS; LKF; LYA; LYV; MAV; MCW; MDG; MMP; MMX; MSD; NEU; OEQ; OEZ; OFB; OFL; OGJ; OJA; OJT; OWL; PPI; PTL; QEW; QSY,"Needle, Conduction, Anesthetic (W/Wo Introducer); Fluorometer, Lead (Dedicated Instruments); Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Trocar; Dilator, Vessel, For Percutaneous Catheterization; Transducer, Blood-Pressure, Extravascular; Filter, Intravascular, Cardiovascular; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Needle, Biopsy, Cardiovascular; Device, Biopsy, Endomyocardial; Clamp, Vascular; Injector And Syringe, Angiographic; Introducer, Catheter; Catheter, Flow Directed; Bag, Bile Collecting; Biopsy Needle; Stents, Drains And Dilators For The Biliary Ducts; Stopcock, I.V. Set; Container, Specimen, Sterile; Needle, Hypodermic, Single Lumen; Basin, Emesis; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Tubing, Fluid Delivery; Guide, Surgical, Instrument; Needle, Aspiration And Injection, Disposable; Catheter, Nephrostomy, General & Plastic Surgery; Catheter, Continuous Irrigation; Needle, Catheter; Dilator, Catheter; Guide, Needle, Surgical; Clamp, Surgical, General & Plastic Surgery; Needle, Aspiration And Injection, Reusable; Gauze/Sponge, Internal, X-Ray Detectable; Cannula, Surgical, General & Plastic Surgery; Blade, Scalpel; Sampler, Amniotic Fluid (Amniocentesis Tray); Clamp; System, Applicator, Radionuclide, Manual; System, X-Ray, Angiographic; Tube, Gastro-Enterostomy; Tape And Bandage, Adhesive; Accessories, Catheter; Drape, Surgical, Antimicrobial; Instrument, Biopsy; Accessories, Catheter, G-U; Accessories, Blood Circuit, Hemodialysis; Dilator, Urethral; Catheter, Continuous Flush; Probe, Thermodilution; Catheter, Nephrostomy; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Cannula, Manipulator/Injector, Uterine; Splint, Intranasal Septal; Label Or Tag, Sterile; Syringe, Balloon Inflation; Catheter, Peripheral, Atherectomy; System, Intrafallopian Cannula; Cover, Barrier, Protective; Device, Percutaneous Retrieval; Catheter, Hemodialysis, Implanted; Marker, Radiographic, Implantable; Angiography/Angioplasty Kit; Cardiovascular Procedure Kit; Catheter Guide Wire Kit; Percutaneous Sheath Introducer Kit; Nerve Block Tray; Intravenous Extension Tubing Set; Aspiration Tray; Peripheral Catheter Insertion Kit; Hemodialysis Tray (Not A Start/Stop Kit); Wire, Guide, Catheter, Exempt; Peripheral Mechanical Thrombectomy With Aspiration; Hemostatic Wound Dressing Without Thrombin Or Other Biologics",1; 2; U,"11 guage Bone Access Needles; ACN, SACN, Biopsy Needle; ARGON ANGIO FLUSHING SET; AVI Dual Lumen HydroPICC; AVI HydroMID; AVI HydroPICC; Abrivo Introducer; Access needles; Accessories to Drainage Catheter; Accura Breast Localization Needles; Accura II Breast Localization Needles (Sadowsky Style); Amniocentesis needle and accessories; ArgoBags; ArgoTrans; Argon Angiography Drape; Argon Arterial Catheter Kit; Argon Arterial Needle; Argon Bone Marrow Tray; Argon Central Venous Catheter Tray; Argon Continuous Flush Device; Argon Control & Med Syringes; Argon Cournand Needle; Argon EKM Inflation Device; Argon Fluid Management System; Argon Guidewires; Argon Hemostasis Introducer; Argon Heparin Coated Guidewires; Argon High Pressure Lines; Argon High Pressure Stopcock; Argon Introducer for Guiding Cath; Argon Medical IV Lines; Argon Medical Scalpels; Argon Modified Disposable Stopcock; Argon Obturator; Argon One-Piece Introducer; Argon PTFE Coated Stainless Steel Guidewires; Argon Percutaneous Needle; Argon Pressure Monitoring Lines; Argon Septishield; Argon Sheath/Dilator; Argon Soft Tissue Biopsy Tray; Argon Stainless Steel Guidewires; Argon Stopcock; Argon Towel Clamp; Argon Tuohy-Borst Introducer; Argon Vessel Dilator; Arthrogram Tray; Atrieve Vascular Snare Kit; BioPince Full Core Biopsy Instrument; BioPince Ultra Full Core Biopsy Instrument; Biopsy Needles; Bone Marrow Aspiration Needles; Bone Marrow Biopsy Trays; Bone Marrow Harvest Needles; Bracco Arthrogram Tray; Bracco Basic Biopsy Tray; Bracco Local Anesthesia Tray; Bulldog; Catheter securement device; Central Catheter Tray; Cleaner Plus 18F; Cleaner Plus™ Thrombectomy System; CleanerVac Thrombectomy System; Co-Axial Introducer Needle; Co-axial Introducer Needles; Coaxial Access System Hard Introducer (6 & 11cm); Coaxial Access System Soft Introducer (10, 13 & 23cm); Connecting tubes for drainage catheters; D Wire Breast Localization Needles; D-Bag Drainage Bag; Device, Biopsy, Endomyocardial; Drainage Catheter; Drakon and Sequre Microcatheters; Drakon® and Sequre® Microcatheters; EKM Inflation Device; F/F Luer Adaptor; Fine Needle Aspiration (FNA) Biopsy Needles Chiba; First Midcath; First Midcath SL Kit; First PICC; First PICC DL Kit; First PICC SL Kit; Franseen; Galactography Kits; Green; Guidewire Bowl; Guidewire Introducer Needle; Guidewire Introducer Needle/ Winged Base Plate; Guidewire Torque Handle; Guidewires; HBO Pass Through; HSG Catheters, HSG Procedure Tray; Halo; Halo Single-Loop Microsnare; Hawkins Blunt Needles; Hawkins I Breast Localization Needles; Hawkins II Breast Localization Needle w/ Hardware; Hawkins II Breast Localization Needles w/ Flexstrand; Hawkins III Breas Localization Needle w/ Flexstrand; Hawkins III Breast Localization Needle w/ Echogenic Tip and Hardwire; Hawkins III Breast Localization Needle w/ Hardware; Homer Breast Localization Needles; Hystero-Access Catheter Set (a.k.a. PBN Fallopian Tube Catheter System); IMC Drapes; IntraCath; Introducer Cannula / Needle; JAWZ; Kits; Kodiak Dual Port Coaxial Introducer Kit; L-Cath™ Midline Catheters; L-Cath™ Single and Dual Lumen Catheters; Locking Syringe; Lumbar Puncture Tray; M/M Luer Adaptor; MANAN SPINAL AND EPIDURAL NEEDLES; MLK Identification Labels; Manan Spinal Needles; Mandrel Guidewire; MaxiCELL; MicroStic; Microlite Disposable Suction Needle; Mini Bulldog; Myelogram Tray; Needle Guide; OSTY-CORE BONE BIOPSY NEEDLES; OneStic; Pediatric Bone Marrow Access Needles; Peritoneal Lavage drainage needle/catheter; Pointer Nitinol Guidewire; Potts/Cournand Needle; Pro-Cut; Pro-Mag Ultra 2.2 Automatic Biopsy Instrument; Pro-Mag Ultra Biopsy Needles, Pro-Mag Ultra Automatic Biopsy Instrument; Prostate Seeding Sets; Prostate Stablization Needles; SABD; SKATER Fix; Safety MST Kit; Safewedge Relief Valve Device; Scorpion; Scorpion X; Screw Dilator; Seldinger Needle; Short/Long Handles; Single-Loop Snare Retrieval Kit; Skater All Purpose Drainage Catheter; Skater All Purpose and Nephrostomy Drainage Catheter; Skater Billiary Drainage Catheter; Skater Centesis Catheter; Skater Drainage Catheter; Skater Introducer Sets; Skater Mini-Loop; Skater Nephrostomy Drainage Catheter w/ Locking Pigtail; Skater Single Step Drainage Catheter; Skin Fix; Specimen Container; Spinal; Splittable Needle Introducer; Steriflo II; Stopcock 3 Way; Super Core II Biopsy Instruments; SuperCore Advance; T-Lab; T-Lok Bone Marrow Biopsy Needles; TLAB® Transvenous Liver Biopsy System; Techna-Cut Biopsy Needle; Thermodilution Catheter; Traveler16 Portal Vein Access Set; Traveler21 Portal Vein Access Set; Traveler38 Portal Vein Access Set; Triple-Loop Snare Retieval Kit; Trocar; Tru-Core Auto Biopsy Needles; Tru-Core I EURO Biopsy Needles; Tru-Core II URO Automatic Biopsy Instruments; Tru-Core III Semi-Automatic Biopsy Instruments; Tubing; Turner; Ultra-Core Biopsy Needles; Ultrastream; Uterine Cornual Access Set (Tungsten); V-Mark Breast Biopsy Marker; V-Pad; V-Stick; V-Stick Vacular Access Set; V-Stick Vacular Access Set with Talwire; VascuClamps; Vessel Clude; Vessel Loops; Vessel Paw; Vessel Paws; Westcott Soft Tissue Biosy Needles; Worker Guidewire; Worker Guidewire Amplatz; Worker Guidewire Standard; Zero Port; convenience kit",1993-01-09,108,2025-12-15,0,30,2,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221625425%22&limit=1
"Avanos Medical, Inc.",3011270181,3011270181,5405 Windward Parkway,Alpharetta,GA,30004,United States,"Avanos Medical, Inc.",2022573,Complaint file establishment; Repackager or relabeler; Specification developer,61,BSO; BSP; BSS; BSY; BTR; BWN; BYD; BYI; CAC; CAZ; EFW; EXE; EZD; FBK; FDI; FDX; FED; FFD; FFN; FME; FMF; FPA; FPD; FRN; FTY; GBM; GCJ; GEI; GXD; GXI; HXD; ILC; ILO; IRP; JOL; KDH; KGC; KGE; KGX; KME; KNT; KOI; KPE; KXF; KYX; KYZ; LRO; LYR; MEA; MEB; MMO; MNL; MOZ; NSB; OCZ; OFQ; OYI; PIF; PLI; PNR; PYO,"Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Tube, Nasogastric; Catheters, Suction, Tracheobronchial; Tube, Tracheal (W/Wo Connector); Table And Attachments, Operating-Room; Condenser, Heat And Moisture (Artificial Nose); Percussor, Powered-Electric; Apparatus, Autotransfusion; Anesthesia Conduction Kit; Toothbrush, Manual; Protector, Ostomy; Catheter, Straight; Endoscopic Injection Needle, Gastroenterology-Urology; Snare, Flexible; Endoscopic Cytology Brush; Endoscopic Access Overtube, Gastroenterology-Urology; Evacuator, Bladder, Manually Operated; Clamp, Non-Electrical; Gown, Examination; Syringe, Piston; Set, Administration, Intravascular; Tube, Feeding; Pump, Infusion; Tape, Measuring, Rulers And Calipers; Catheter, Urethral; Laparoscope, General & Plastic Surgery; Electrosurgical, Cutting & Coagulation & Accessories; Generator, Lesion, Radiofrequency; Probe, Radiofrequency Lesion; Clamp; Utensil, Eating; Pack, Hot Or Cold, Water Circulating; Massager, Powered Inflatable Tube; Catheter And Tip, Suction; Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration; Tube, Gastro-Enterostomy; Forceps, Biopsy, Electric; Tape And Bandage, Adhesive; Bedding, Disposable, Medical; Tubes, Gastrointestinal (And Accessories); Stimulator, Nerve, Peripheral, Electric; Container, I.V.; Applicator, Absorbent Tipped, Non-Sterile; Dispenser, Liquid Medication; Syringe, Irrigating (Non Dental); General Surgery Tray; Helicobacter Pylori; Pump, Infusion, Pca; Pump, Infusion, Elastomeric; Tray, Surgical, Ent; Accessories, Cleaning Brushes, For Endoscope; Acid, Hyaluronic, Intraarticular; Patient Personal Hygiene Kit; Endoscopic Grasping/Cutting Instrument, Non-Powered; Anesthesia Kit; Non-Bronchoscopic Bronchoalveolar Lavage Catheter; Gastrointestinal Tubes With Enteral Specific Connectors; Gastrointestional Tube Holder; Enteral Syringes With Enteral Specific Connectors; Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use",1; 2; 3,"220266MIL; 220316; 220342; 220343; 220344; 220404; 220405; 220451; 220462; 220463; 220466; 220471; 220471NR; 220472; 220472NR; 220473; 220473NR; 220477; 220481ANR; 220481AUS; 220481NZ; 220481ZNR; 220489NR; 220490NR; 220491NR; 220493; 220507; 220507NR; 220508; 220508NR; 220509; 220509NR; 220513; 220513NR; 220528; 220532; 220537; 220539; 220541; 220542; 220560; 220561; 220562; 220563; 220568; 220573; 220574; 220575; 220576; 220577; ANTI-FOG KIT; AVANOS* Universal Block Trays; Ace Stopper; Ameritus Entral Feeding Tube; BALLARD; BALLARD* Mini-BAL Prep Pack with Specimen Trap; Ballard Metered Dose Inhaler (MDI) Adapter; Ballard Single Dose Vials, 0.9% Sodium Chloride Solution; Baxter Enteral Syringe with ENFit Connector; Baxter Pharmacy Bottle Caps; Baxter Tip Caps; CLOtest; COOLIEF Radiofrequency Ablation System; COOLIEF* Cooled Radiofrequency Fluid Delivery Introducer; COOLIEF* Cooled Radiofrequency Kit; COOLIEF* Cooled Radiofrequency Kit Advanced; COOLIEF* Cooled Radiofrequency Probe Advanced; COOLIEF* Fluid Delivery Introducer; COOLIEF* Multi-Cooled Radiofrequency Kit; COOLIEF* Multi-Cooled Radiofrequency Kit Advanced; COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced; COOLIEF* SInergy* Cooled Radiofrequency Kit; CORFLO* PEG Fixation Device Base and Cover; CORFLO* PEG Kit; CORFLO* PEG Pinch Clamps; CORFLO* PEG Silicone Fixation Device; CORGRIP* SR NG/NI Tube Retention System; CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELIEF; CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE; CORTRAK* 2 ENTERAL ACCESS SYSTEM; CORTRAK* 2 Equilateral Enteral Access System; Container, IV; Coolief Radiofrequency Generator (CRG) System; Cytology Brush; DENTASWAB; Dentaswab; EASI-LAV; ECHOBRIGHT; ENTERAL DRAINAGE BAG; ENTRAL FEEDING TUBES AND ACCESSORIES; EZstim*; EchoBright Echogenic PNB Needle; EchoBright Echogenic Regional Block Needle with Injection Set; EchoLong Needle/Catheter Set; Endoscope Cleaning Brush; Endoscopic Accessories; Fenestrated Infusion Catheter; Fenestrated NeoDrape (Sterling Medical product); Game Ready Therapy System; Game Ready system; Gastropexy Kit and Dilator; HOMEPUMP ECLIPSE*; Halyard; I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP); I-Flow Elastomeric Pump; KIDS PIB; KimVent Closed Suction System; KimVent Microcuff; KimVent Oral Care; Kimberly-Clark Microcuff; Liberator/Restore; LumbarCool; MIC LOW PROFILE GASTROSTOMY TUBE; MIC PEG Kit; MIC PEG TUBE; MIC and MIC-KEY G-Tube and Extension Sets; MIC-KEY; MIC-KEY ""G"" LOW PROFILE G; MIC-KEY and MIC Transgastric Jejunal feeding tubes; MIC-KEY*; Med4 Elite; Minibore extension set; NERVE BLOCK INFUSION KIT; NeoConnect DoseMate DL Oral Administration Tip; NeoConnect DoseMate Oral Administration Tip; NeoConnect Enteral Extension Set with ENFit connector; NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connectors (0.5mL to 6mL); NeoConnect NeoSecure Syringe Tip Caps (for use with NeoConnect Oral/Enteral Syringes with ENFit Connector); NeoConnect Oral/Enteral Syringes with ENFit connectors (12ml to 100ml); NeoConnect PVC Enteral Feeding Tubes with ENFit Connector; NeoConnect Pharmacy Bottle Caps; NeoConnect Polyurethane Enteral Feeding Tubes with ENFit connector; NeoConnect Sampling Straw with ENFit Connector; NeoConnect Silicone Enteral Feeding Tubes with ENFit Connector (Footprint Medical); NeoConnect Syringe-to-Syringe Coupler; NeoConnect at Home Oral/Enteral Syringes with ENFit Connector; NeoDrape; NeoMed Colostrum and Breastmilk Container with Transfer Lid; NeoMed Enteral Only Extension Set; NeoMed Fill Cap Coupler; NeoMed GravityPro Oral/Enteral Syringes; NeoMed NeoBottle; NeoMed Oral Syringe-to-syringe Coupler; NeoMed PVC Enteral Feeding Tubes; NeoMed Polyurethane Feeding Tubes; NeoMed Sampling Straw; NeoMed Silicone Enteral Feeding Tubes; NeoMed Sterile Oral/Enteral Syringes; NeoMed Transfer Lid; NeoMed Urinary Catheter; ON-Q CATHETER, ON-Q ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER; ON-Q Pain Relief System with Bolus; ON-Q Tunnelers and Sheaths; ON-Q*; ON-Q* ANTIMICROBIAL EXPANSION-Q KITS WITH SILVERSOAKER* ANTIMICROBIAL CATHETER AND NRFit"" CONNECTOR; ON-Q* Antimicrobial Expansion Kits with SILVERSOAKER* Catheter; ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC NERVE BLOCK WITH NRFit™ CONNECTOR; ON-Q* PAIN RELIEF SYSTEM T-BLOC* CONTINUOUS ECHOGENIC STIMULATING NERVE BLOCK TRAY WITH NRFit™ CONNECTOR; ON-Q* PAIN RELIEF SYSTEM T-BLOC* ECHOGENIC STIMULATING NEEDLE/CATHETER SET WITH NRFit™ CONNECTOR; ON-Q* PAIN RELIEF SYSTEM T-BLOC* ULTRASOUND NERVE BLOCK PREP TRAY WITH NRFit™ CONNECTOR; ON-Q* Pain Relief System T-Bloc* Continuous Echogenic Stimulating Nerve Block Tray; ON-Q* Pain Relief System T-Bloc* Echogenic Needle/Catheter Set; ON-Q* Pain Relief System T-Bloc* Echogenic Stimulating Needle/Catheter Set; ON-Q* Pain Relief System T-Bloc* Needle/Catheter Set; ON-Q* Pain Relief System T-Bloc* Ultrasound Nerve Block Prep Tray; ON-Q* Pain Relief System with SELECT-A-FLOW* Variable Rate Controller; ON-Q* Pump; ON-Q* Tunneler Introducer Sheaths; ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP; PCA Pump Remote Bolus Button Switch; PERIPHERAL NERVE BLOCK SUPPORT TRAY; PIB IL; PMP Kits and Catheters; PROLONG, MODELS PL50, PL100, PL150; PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS; Pharmacy Pack Oral Syringes; Plaster; PreSet PCA; PreSet v1.5; ProBloc, HN Series and Prolong, PL Series; Prolong; RF Cannula; Radiofrequency Bipolar Adapter; Radiofrequency Generator Connector Cable; Radiofrequency Probe; Radiofrequency Probe Kit-Curved; Radiofrequency Probe Kit-Straight; Radiofrequency Probe-Curved; Radiopaque RF Cannula; SELECT-A-FLOW*; SOAKER CATHETER; SOFSWAB; Silicone/non DEHP Pump; Sinergy; Single Shot Tray Products or Continuous Tray Products; Split Dispersive Electrode Grounding Pad; Superlock Syringes; Syringe; TRACH CARE TRACHEAL SUCTION SYSTEM; ThoraCool; Toothbrush; Transdiscal; TriVisc; Yankauer; ambIT Continuous infusion pump; ambIT Introducer; ambIT PCA Pump; ambIT PCA*PIB; ambIT PIB; ambIT PIB*PCA; ambIT PIB/PCA v 1.5; ambIT PIEB; ambIT PreSet Pump; ambIT Programmable Intermittent Pump; anesthesia conduction kit - ON-Q* Pain Relief System T-Bloc* Continuous Echogenic Nerve Block Tray; cleaning, non-sterile; enteral feeding tubes; lavage catheter",1995-01-23,107,2025-01-31,1,48,5,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011270181%22&limit=1
Bio-Rad Laboratories Inc.,3010127294,3010127294,9 Holland,Irvine,CA,92618,United States,"Bio-Rad Laboratories, Inc.",9929003,Contract manufacturer; Manufacturer; Specification developer,19,DAK; DHN; DHR; DIE; DIF; GGM; GGN; JCM; JCN; JIX; JJS; JJT; JJW; JJX; JJY; JPK; KSF; MYZ; PMN,"Complement C1q, Antigen, Antiserum, Control; Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control; System, Test, Rheumatoid Factor; Heavy Metals Control Materials; Drug Mixture Control Materials; Control, Hemoglobin; Plasma, Coagulation Control; Control, Hemoglobin, Abnormal; Control, Cell Counter, Normal And Abnormal; Calibrator, Multi-Analyte Mixture; Controls For Blood-Gases, (Assayed And Unassayed); Enzyme Controls (Assayed And Unassayed); Urinalysis Controls (Assayed And Unassayed); Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Mixture, Hematology Quality Control; Kit, Quality Control For Blood Banking Reagents; Kit, Test (Donors), For Bloodborne Pathogen; Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays",1; 2,"Amplichek II; Beckman Coulter Lyophilized Chemistry Calibrator 1 and 2; InteliQ Assayed Muliqual Control; InteliQ Cardiac Advance Control; InteliQ Cardiac Markers Plus Control LT; InteliQ Diabetes Control (12008309, 12008310, 12008311, 12008312); InteliQ Ethanol/Ammonia Control; InteliQ Homocysteine Control; InteliQ Immunoassay Plus Control; InteliQ Immunology Control; InteliQ Specialty Immunoassay Control; InteliQ Specialty Immunoassay Plus Control; InteliQ Tumor Marker Control,; InteliQ Urine Chemistry Control; Liquichek AMH Control; Liquichek ANA Control, Homogeneous Positive; Liquichek ANA Controls Set, Positive: Homogenous, Speckled, Centromere and Nucleolar Patterns; Liquichek Autoimmune Control, Anti-Mitochondrial; Liquichek Autoimmune Control, Anti-Smooth Muscle; Liquichek Autoimmune Control, Anti-nDNA; Liquichek Autoimmune Negative Control; Liquichek Blood Gas CO-Oximeter Control (Radiometer); Liquichek Blood Gas Control; Liquichek Blood Gas Plus CO-Oximeter (IL Synthesis Series); Liquichek Blood Gas Plus CO-Oximeter Control; Liquichek Blood Gas Plus E Control; Liquichek Blood Gas Plus EGL Control; Liquichek CK/LD Isoenzyme Control; Liquichek Cardiac Advance Control; Liquichek Cardiac Markers LT Control (1, 2, 3, Low ); Liquichek Cardiac Markers Plus; Liquichek Cardiac Markers Plus Control; Liquichek Cardiac Markers Plus Control LT (Vista); Liquichek Cardiac Markers Plus Control LT 1, 2, 3 and Low; Liquichek Cardiac Troponins Control; Liquichek D-dimer Control; Liquichek Diabetes Control (12011308, 12011309,12011310, 12011331); Liquichek Diabetes Control (12011343, 12011344,12011345, 12011334); Liquichek Diabetes Control (171, 172, 173, 172X); Liquichek Elevated CRP Control; Liquichek Ethanol/Ammonia Control; Liquichek Ethanol/Ammonia Control (Vista); Liquichek Hematology Control (A); Liquichek Hematology Control (C); Liquichek Hematology Control (S); Liquichek Hematology Control (X); Liquichek Hematology-16 Control; Liquichek Hematology-16T Control; Liquichek Homocysteine Control; Liquichek Immunoassay Plus Control; Liquichek Immunoassay Plus Control (Vista); Liquichek Immunoassay Premium Control; Liquichek Immunology Control; Liquichek Immunology Control (Vista); Liquichek Lipids Control; Liquichek Maternal Serum First Trimester Control; Liquichek Maternal Serum II Control; Liquichek Microalbumin Control; Liquichek Opiate Control; Liquichek Pediatric Control; Liquichek Pediatric Control (Vista); Liquichek Qualitative Urine Toxicology Control; Liquichek Reticulocyte Control (A); Liquichek Reticulocyte Control (A-1); Liquichek Reticulocyte Control (C); Liquichek Reticulocyte Control (S); Liquichek Reticulocyte Control (X); Liquichek Rheumatoid Factor Control; Liquichek Serum Volatiles Control; Liquichek Specialty Immunoassay Control; Liquichek Specialty Immunoassay Plus Control; Liquichek Spinal Fluid Control; Liquichek Spinal Fluid Control (Vista); Liquichek Therapeutic Drug Monitoring Control (TDM); Liquichek ToRCH Plus IgM Control; Liquichek Tumor Marker Control; Liquichek Tumor Marker Control (Vista); Liquichek Urinalysis Control; Liquichek Urine Chemistry Control; Liquichek Urine Chemistry Control (2.5 mL vials) and Liquichek Urine Chemistry Control (Tubes); Liquichek Urine Toxicology Control Screen S1, S2, S3; Liquichek Urine Toxicology Control, Confirmatory C1; Liquichek Urine Toxicology Control, Confirmatory, C2, C2 Low Opiate, C3, C3 Low Opiate, C4; Liquichek Urine Toxicology Control, S1O, S2O, S1O Low Opiate, S2O Low Opiate; Liquichek Urine Toxicology Control, Screen - S1S and S2S; Liquichek Urine Toxicology Control, Screen EIA S1E and S2E Low Opiate and S1E and S2E; Liquichek Urine Toxicology Negative Control; Liquichek Whole Blood Immunosuppressant Control; Liquid Assayed Multiqual (Vista); Liquid Assayed Multiqual Premium; Liquid Assayed Multiqual,; Lyphochek Allergen sIgE Control, Negative; Lyphochek Allergen sIgE Control, Panel A; Lyphochek Anemia Control; Lyphochek Assayed Chemistry Control; Lyphochek Benzo/TCA Control Set B; Lyphochek Coagulation Control; Lyphochek Diabetes Control; Lyphochek Drug Free Serum; Lyphochek Fertility Control Serum; Lyphochek Hemoglobin A1C Linearity Set; Lyphochek Hemoglobin A2 Control; Lyphochek Hemostasis Control; Lyphochek Hypertension Markers Control; Lyphochek Immunoassay Plus Control; Lyphochek Immunolgy Plus Control; Lyphochek Maternal Serum Control; Lyphochek Quantitative Urine Control, Abnormal; Lyphochek Quantitative Urine Control, Normal; Lyphochek Specialty Immunoassay Control; Lyphochek Therapeutic Drug Monitoring Control; Lyphochek Tumor Marker Control; Lyphochek Tumor Marker Plus Control; Lyphochek Urine Bone Markers Control; Lyphochek Urine Metals Control; Lyphochek Urine Toxicology Control; Lyphochek Whole Blood Control; Lyphochek Whole Blood Immunosuppressant Control; Lyphochek Whole Blood Metals Control; Meter Trax Control; Quantify Advance Control; Quest Diagnostics Immunoassay/TDM Control; Quest Diagnostics Serum Chemistry Control; Quest Diagnostics Tumor Marker; VIROCLEAR; VIROTROL HIV-1 Ag; VIROTROL HIV-2; VIROTROL I; VIROTROL II; VIROTROL III; VIROTROL IV; VIROTROL TORCH; Virotrol III; qUAntify Control; qUAntify Plus Control",2008-01-17,108,2017-01-10,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010127294%22&limit=1
Ortho-Clinical Diagnostics Singapore Pte Ltd,3002642396,3002642396,27 International Business Park #07-01,Singapore South West,,S609924,Singapore,QuidelOrtho Corporation,2024674,Complaint file establishment,114,CDN; CDP; CDT; CDZ; CEC; CEM; CEW; CFJ; CFN; CFT; CGA; CGJ; CGN; CGR; CHH; CHP; CIG; CIT; CIW; CIX; CJE; CJY; CZW; DAD; DBI; DCF; DCK; DDG; DDR; DEM; DGR; DHA; DHR; DHX; DIF; DIH; DIO; DIP; DIS; DJG; DJR; DKB; DKJ; DKZ; DLJ; DLZ; DMT; GTQ; JFY; JGJ; JGP; JGS; JHX; JID; JIH; JIS; JIT; JIX; JIY; JJE; JJX; JJY; JLW; JMO; JRC; JXM; JZJ; KHO; KHP; KHQ; KLI; KLS; KLT; KNK; KSF; KSG; KSI; KSN; KSZ; LBR; LBS; LCD; LCM; LDJ; LDO; LDP; LEG; LEH; LFM; LOL; LOM; LPS; LTJ; LTK; MJX; MJY; MMI; MOI; MRG; MRR; MSJ; MZF; MZO; NBC; NIG; NQD; OHQ; PDJ; PMT; PPM; QKO; QKP; QVP; SEI,"Urease, Photometric, Urea Nitrogen; Radioimmunoassay, Total Triiodothyronine; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Electrode, Ion Specific, Potassium; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Method, Nephelometric, Immunoglobulins (G, A, M); Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Radioimmunoassay, Cortisol; Enzymatic Esterase--Oxidase, Cholesterol; Radioimmunoassay, Estradiol; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Starch-Dye Bound Polymer, Amylase; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Azo Dye, Calcium; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Whole Human Serum, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet; Antistreptolysin - Titer/Streptolysin O Reagent; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Lowry (Colorimetric), Total Protein; Electrode, Ion Specific, Sodium; Fluorometric Method, Cpk Or Isoenzymes; Photometric Method, Ammonia; Flame Photometry, Lithium; Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Thyroid-Stimulating Hormone; Ferrozine (Colorimetric) Iron Binding Capacity; Micro Pipette; Enzyme Immunoassay, Benzodiazepine; Prealbumin, Antigen, Antiserum, Control; Fluorometer, For Clinical Use; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Kit, Quality Control For Blood Banking Reagents; Media, Potentiating For In Vitro Diagnostic Use; Lectins And Protectins; Centrifuge, Cell-Washing, Automated For Immuno-Hematology; System, Test, Automated Blood Grouping And Antibody; Ldl & Vldl Precipitation, Hdl; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Enzyme Immunoassay, Cannabinoids; Enzymatic Radiochemical Assay, Tobramycin; Colorimetry, Acetaminophen; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Immunoassay, Digitoxin; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Urinary Homocystine (Nonquantitative) Test System; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Kit, Serological, Positive Control; Kit, Serological, Negative Control; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; System, Test, Vitamin D; System, Test, Low Density, Lipoprotein; Apolipoproteins; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Test, Natriuretic Peptide; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Multi-Analyte Controls Unassayed; Hemoglobin A1c Test System; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; General Purpose Reagent; Reagent, Coronavirus Serological; Coronavirus Antigen Detection Test System.; Sars-Cov-2 Serology Test; Qualitative And Quantitative Hepatitis B Virus Antibody Assays",1; 2; N; U,"DAT Control, MTS DAT Card; MTS Diluent 2; MTS Diluent 2 PLUS; ORTHO Antibody Enhancement Solution; ORTHO Bovine Albumin Solution Polymerized; ORTHO Bovine Serum Albumin, 22% Protein Concentration; ORTHO Confidence System; ORTHO Optix Reader; ORTHO VISION Analyzer; ORTHO VISION Analyzer - Certified; ORTHO VISION Max Analyzer; ORTHO Workstation; Ortho 7% BSA; Ortho Anti A1 Lectin; Ortho Coombs Control; Ortho Optix Reader; Ortho Rhhr Control (human & bovine); QuickVue At Home COVID-19; QuickVue COVID-19 Test Control Swab Set; QuickVue SARS Antigen Test; Quidel Molecular Adenovirus Control Set (M110); Quidel Molecular Bordetella Control Set (M117); Quidel Molecular C. difficile Control Set (M108); Quidel Molecular GBS Control Set (M116); Quidel Molecular HSV 1+2 Control Set (M109); Quidel Molecular HSV 1+2/VZV Control Set (M121); Quidel Molecular Influenza A+B Control Set (M106); Quidel Molecular Parainfluenza Virus Control Set (M115); Quidel Molecular RSV+hMPV Control Set (M107); Quidel Molecular Strep A+G Control Set (M111); Quidel Molecular Trichomonas Control Set (M119); Sofia 2 SARS Antigen FIA; Sofia SARS Antigen FIA; Solana HSV 1+2/VZV Control Set (M118); Solana Influenza A+B Control Set (M122); Solana RSV+hMPV Control Set (M123); VITROS 25-OH Vitamin D Total Calibrators; VITROS 25-OH Vitamin D Total Reagent Pack; VITROS 250 Chemistry System; VITROS 250 Chemistry System Refurbished; VITROS 350 Chemistry System; VITROS 3600 Immunodiagnostics System; VITROS 3600 Immunodiagnostics System - Certified; VITROS 3600 Immunodiagnostics System - Refurbished; VITROS 4600 Chemistry System; VITROS 4600 Chemistry System Refurbished; VITROS 5,1 FS Chemistry System; VITROS 5,1 FS Chemistry System Refurbished; VITROS 5600 Integrated System; VITROS 5600 Integrated System Certified; VITROS 5600 Integrated System Refurbished; VITROS 7% BSA; VITROS AAT Reagent; VITROS AAT/HPT Performance Verifiers; VITROS ACET Slides; VITROS AFP Range Verifier; VITROS ALB-TP Slides; VITROS ALC Slides; VITROS AMON Slides; VITROS AMPH Reagent; VITROS AMYL Slides; VITROS ASO Reagent; VITROS ASO/RF Performance Verifiers; VITROS AST Slides; VITROS Anti- HCV Reagent Pack; VITROS Anti-HAV IgM Calibrator; VITROS Anti-HAV IgM Controls; VITROS Anti-HAV IgM Reagent Pack; VITROS Anti-HAV Total Calibrators; VITROS Anti-HAV Total Controls; VITROS Anti-HAV Total Reagent Pack; VITROS Anti-HBc Calibrator; VITROS Anti-HBc Controls; VITROS Anti-HBc IgM Calibrator; VITROS Anti-HBc IgM Controls; VITROS Anti-HBc IgM Reagent Pack; VITROS Anti-HBc Reagent Pack; VITROS Anti-HBe Calibrators; VITROS Anti-HBe Reagent Pack; VITROS Anti-HBs Quantitative Calibrators; VITROS Anti-HBs Quantitative Controls; VITROS Anti-HBs Quantitative Reagent Pack; VITROS Anti-HCV Calibrators; VITROS Anti-HCV Controls; VITROS Anti-HIV 1+2 Calibrator; VITROS Anti-HIV 1+2 Controls; VITROS Anti-HIV 1+2 Reagent Pack; VITROS Anti-SARS-CoV-2 IgG Calibrator; VITROS Anti-SARS-CoV-2 IgG Controls; VITROS Anti-SARS-CoV-2 IgG Quantitative Calibrator EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Controls EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack EUA210322; VITROS Anti-SARS-CoV-2 IgG Reagent Pack; VITROS Anti-SARS-CoV-2 Total N Antibody Calibrator EUA210355; VITROS Anti-SARS-CoV-2 Total N Antibody Reagent Pack EUA210355; VITROS Anti-SARS-CoV-2 Total N Controls EUA210355; VITROS ApoA1 Performance Verifiers; VITROS ApoA1 Reagent; VITROS ApoB Performance Verifiers; VITROS ApoB Reagent; VITROS B12 Range Verifier; VITROS BARB Reagent; VITROS BENZ Reagent; VITROS BRAHMS PCT Calibrators; VITROS BRAHMS PCT Controls; VITROS BRAHMS PCT Range Verifier; VITROS BRAHMS PCT Reagent Pack; VITROS BuBc Slides; VITROS C3 Reagent; VITROS C4 Reagent; VITROS CA 125 II Calibrator; VITROS CA 125 II Range Verifier; VITROS CA 125 II Reagent Pack; VITROS CA 15-3 Calibrator; VITROS CA 15-3 Range Verifier; VITROS CA 15-3 Reagent Pack; VITROS CA 19-9 Calibrator; VITROS CA 19-9 Range Verifiers; VITROS CA 19-9 Reagent Pack; VITROS CAFFN Reagent Kit; VITROS CEA Calibrators; VITROS CEA Range Verifier; VITROS CEA Reagent Pack; VITROS CHE Slides; VITROS CK-MB Calibrator; VITROS CK-MB Range Verifier; VITROS CK-MB Reagent Pack; VITROS COCM Reagent; VITROS CRBM Slides; VITROS CREA Slides; VITROS CRP Performance Verifiers; VITROS Ca Slides; VITROS Calibrator Kit 1; VITROS Calibrator Kit 10; VITROS Calibrator Kit 11; VITROS Calibrator Kit 12; VITROS Calibrator Kit 13; VITROS Calibrator Kit 14; VITROS Calibrator Kit 16; VITROS Calibrator Kit 17; VITROS Calibrator Kit 19; VITROS Calibrator Kit 2; VITROS Calibrator Kit 20; VITROS Calibrator Kit 21; VITROS Calibrator Kit 22; VITROS Calibrator Kit 23; VITROS Calibrator Kit 24; VITROS Calibrator Kit 25; VITROS Calibrator Kit 26; VITROS Calibrator Kit 27; VITROS Calibrator Kit 28; VITROS Calibrator Kit 29; VITROS Calibrator Kit 3; VITROS Calibrator Kit 30; VITROS Calibrator Kit 31; VITROS Calibrator Kit 32; VITROS Calibrator Kit 4; VITROS Calibrator Kit 5; VITROS Calibrator Kit 8; VITROS Calibrator Kit 9; VITROS Calibrator Kit 99; VITROS Chemistry Products Calibrator Kit 25; VITROS Chemistry Products Performance Verifiers; VITROS Chemistry Products dHDL Slides; VITROS Cortisol Calibrator; VITROS Cortisol Range Verifier; VITROS Cortisol Reagent Pack; VITROS DAT Performance Verifiers; VITROS DGXN Slides; VITROS ECi Immunodiagnostic System; VITROS ECi Immunodiagnostic System Refurbished; VITROS ECiQ Immunodiagnostic System; VITROS Estradiol Calibrator; VITROS Estradiol Range Verifier; VITROS Estradiol Reagent Pack; VITROS FS Calibrator 1; VITROS FS Diluent Pack 1, 2, 3 and 4; VITROS FS Micro Tips; VITROS FS Reconstitution Diluent; VITROS FSH Calibrator; VITROS FSH Range Verifier; VITROS FSH Reagent Pack; VITROS Fe Slides; VITROS Ferritin Range Verifier; VITROS Folate Calibrator; VITROS Folate Range Verifier; VITROS Folate Reagent Pack 1/2; VITROS Free T3 Range Verifier; VITROS Free T4 Range Verifier; VITROS Free T4 Reagent Pack; VITROS GENT Reagent; VITROS HBeAg Calibrator; VITROS HBeAg Reagent Pack; VITROS HBsAg Calibrator; VITROS HBsAg Confirmatory Kit; VITROS HBsAg Controls; VITROS HBsAg Reagent Pack; VITROS HCY2 Performance Verifiers; VITROS HCY2 Reagent; VITROS HIV Combo Calibrator; VITROS HIV Combo Controls (Anti-HIV-1 group O); VITROS HIV Combo Controls (HIV p24 Antigen); VITROS HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2); VITROS HIV Combo Reagent Pack; VITROS HPT Reagent; VITROS HbA1c Reagent Kit; VITROS High Sample Diluent A and B; VITROS INTACT PTH Calibrators; VITROS INTACT PTH Controls; VITROS INTACT PTH Range Verifier; VITROS INTACT PTH Reagent Pack; VITROS IgA Reagent; VITROS IgG Reagent; VITROS IgM Reagent; VITROS Immuno-Wash Fluid; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack DEN210040; VITROS Immunodiagnostic Products CA 19-9 Calibrator; VITROS Immunodiagnostic Products CA 19-9 Reagent Pack; VITROS Immunodiagnostic Products CEA Calibrators; VITROS Immunodiagnostic Products CEA Reagent Pack; VITROS Immunodiagnostic Products Intact PTH II Calibrators; VITROS Immunodiagnostic Products Intact PTH II Reagent Pack; VITROS Immunodiagnostic Products Progesterone 2 Calibrators; VITROS Immunodiagnostic Products Progesterone 2 Range Verifiers; VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack; VITROS Immunodiagnostic Products hs Troponin I Low Control; VITROS Immunodiagnostic Products hsTroponin I Calibrator; VITROS K+ Slides; VITROS LAC Slides; VITROS LDH Slides; VITROS LDHI SLides; VITROS LH Range Verifier; VITROS Li Slides; VITROS Liquid Performance Verifiers; VITROS METD Reagent; VITROS Metabolism Controls; VITROS Mg Slides; VITROS Micro Tips; VITROS MicroSensor Check Fluids; VITROS Myoglobin Calibrator; VITROS Myoglobin Range Verifier; VITROS Myoglobin Reagent Pack; VITROS NT pro-BNP Calibrators; VITROS NT pro-BNP Range Verifier; VITROS NT pro-BNP Reagent Pack; VITROS NT-proBNP II Reagent Pack; VITROS NTx Range Verifier; VITROS Na+ Slides; VITROS OP Reagent; VITROS PALB Performance Verifiers; VITROS PALB Reagent; VITROS PCP Reagent; VITROS PHBR Slides; VITROS PHYT Slides; VITROS Percent A1c Performance Verifiers; VITROS Performance Verifiers; VITROS Progesterone Calibrator Kit; VITROS Progesterone Range Verifier; VITROS Progesterone Reagent Pack; VITROS Prolactin Calibrator; VITROS Prolactin Range Verifier; VITROS Prolactin Reagent Pack; VITROS Protein Performance Verifiers; VITROS RF Reagent; VITROS Red Cell Folate Pack; VITROS Reference Fluids; VITROS SALI Slides; VITROS SARS-COV-2 Antigen Calibrator EUA202928; VITROS SARS-COV-2 Antigen Controls EUA202928; VITROS SARS-COV-2 Antigen Reagent Pack EUA202928; VITROS SARS-COV-2 Extraction Buffer EUA202928; VITROS Signal Reagent; VITROS T3 Uptake II Calibrator; VITROS T3 Uptake II Range Verifier; VITROS T3 Uptake II Reagent Pack; VITROS T4 Calibrator; VITROS TBIL Slides; VITROS TDM Performance Verifiers; VITROS THC Reagent; VITROS THEO Slides; VITROS TIBC Kit; VITROS TOBRA Reagent; VITROS TRFRN Reagent; VITROS TRIG Slides; VITROS TSH Calibrator; VITROS TSH Range Verifier; VITROS TSH Reagent Pack; VITROS Testosterone Calibrator; VITROS Testosterone Range Verifier; VITROS Testosterone Reagent Pack; VITROS Total PSA Calibrator; VITROS Total PSA Range Verifier; VITROS Total PSA Reagent Pack; VITROS Total T3 II Calibrator; VITROS Total T3 II Range Verifier; VITROS Total T3 II Reagent Pack; VITROS Total T4 Calibrator; VITROS Total T4 Range Verifier; VITROS Total T4 Reagent Pack; VITROS Total bhCG II Calibrator; VITROS Total bhCG II Range Verifier; VITROS Total bhCG II Reagent Pack; VITROS Troponin I ES Calibrators; VITROS Troponin I ES Range Verifier; VITROS Troponin I ES Reagent Pack; VITROS UPRO Performance Verifiers; VITROS UPRO Slides; VITROS URIC Slides; VITROS Universal Wash Reagent; VITROS Urine Electrolyte Diluent; VITROS VALP Reagent; VITROS VANC Reagent; VITROS Versa Tips; VITROS XT 3400 Chemistry System; VITROS XT 7600 Integrated System; VITROS XT 7600 Integrated System Certified; VITROS XT GLU-Ca Slides; VITROS XT TBIL-ALKP Slides; VITROS XT TRIG-CHOL Slides; VITROS XT UREA-CREA Slides; VITROS dHDL Slides; VITROS dLDL Reagent; VITROS dTIBC Performance Verifiers; VITROS dTIBC Reagent; VITROS hsCRP Performance Verifiers; VITROS hsCRP Reagent; VITROS mALB Performance Verifiers; VITROS mALB Reagent",2020-11-24,101,2024-05-08,7,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223002642396%22&limit=1
Bio-Rad Laboratories Inc.,2016706,2016706,9500 Jeronimo Rd,Irvine,CA,92618,United States,"Bio-Rad Laboratories, Inc.",9929003,Contract manufacturer; Manufacturer; Specification developer,18,DHN; DHR; DIE; DIF; GGM; GGN; JCM; JCN; JIX; JJS; JJT; JJW; JJX; JJY; JPK; KSF; MYZ; PMN,"Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control; System, Test, Rheumatoid Factor; Heavy Metals Control Materials; Drug Mixture Control Materials; Control, Hemoglobin; Plasma, Coagulation Control; Control, Hemoglobin, Abnormal; Control, Cell Counter, Normal And Abnormal; Calibrator, Multi-Analyte Mixture; Controls For Blood-Gases, (Assayed And Unassayed); Enzyme Controls (Assayed And Unassayed); Urinalysis Controls (Assayed And Unassayed); Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Mixture, Hematology Quality Control; Kit, Quality Control For Blood Banking Reagents; Kit, Test (Donors), For Bloodborne Pathogen; Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays",1; 2,"Amplichek II; Beckman Coulter Lyophilized Chemistry Calibrator 1 and 2; InteliQ Assayed Muliqual Control; InteliQ Cardiac Advance Control; InteliQ Cardiac Markers Plus Control LT; InteliQ Diabetes Control (12008309, 12008310, 12008311, 12008312); InteliQ Ethanol/Ammonia Control; InteliQ Homocysteine Control; InteliQ Immunoassay Plus Control; InteliQ Immunology Control; InteliQ Specialty Immunoassay Control; InteliQ Specialty Immunoassay Plus Control; InteliQ Tumor Marker Control,; InteliQ Urine Chemistry Control; Liquichek AMH Control; Liquichek ANA Control, Homogeneous Positive; Liquichek ANA Controls Set, Positive: Homogenous, Speckled, Centromere and Nucleolar Patterns; Liquichek Autoimmune Control, Anti-Mitochondrial; Liquichek Autoimmune Control, Anti-Smooth Muscle; Liquichek Autoimmune Control, Anti-nDNA; Liquichek Autoimmune Negative Control; Liquichek Blood Gas CO-Oximeter Control (Radiometer); Liquichek Blood Gas Control; Liquichek Blood Gas Plus CO-Oximeter (IL Synthesis Series); Liquichek Blood Gas Plus CO-Oximeter Control; Liquichek Blood Gas Plus E Control; Liquichek Blood Gas Plus EGL Control; Liquichek CK/LD Isoenzyme Control; Liquichek Cardiac Advance Control; Liquichek Cardiac Markers LT Control (1, 2, 3, Low ); Liquichek Cardiac Markers Plus; Liquichek Cardiac Markers Plus Control; Liquichek Cardiac Markers Plus Control LT (Vista); Liquichek Cardiac Markers Plus Control LT 1, 2, 3 and Low; Liquichek Cardiac Troponins Control; Liquichek D-dimer Control; Liquichek Diabetes Control (12011308, 12011309,12011310, 12011331); Liquichek Diabetes Control (12011343, 12011344,12011345, 12011334); Liquichek Diabetes Control (171, 172, 173, 172X); Liquichek Elevated CRP Control; Liquichek Ethanol/Ammonia Control; Liquichek Ethanol/Ammonia Control (Vista); Liquichek Hematology Control (A); Liquichek Hematology Control (C); Liquichek Hematology Control (S); Liquichek Hematology Control (X); Liquichek Hematology-16 Control; Liquichek Hematology-16T Control; Liquichek Homocysteine Control; Liquichek Immunoassay Plus Control; Liquichek Immunoassay Plus Control (Vista); Liquichek Immunoassay Premium Control; Liquichek Immunology Control; Liquichek Immunology Control (Vista); Liquichek Lipids Control; Liquichek Maternal Serum First Trimester Control; Liquichek Maternal Serum II Control; Liquichek Microalbumin Control; Liquichek Opiate Control; Liquichek Pediatric Control; Liquichek Pediatric Control (Vista); Liquichek Qualitative Urine Toxicology Control; Liquichek Reticulocyte Control (A); Liquichek Reticulocyte Control (A-1); Liquichek Reticulocyte Control (C); Liquichek Reticulocyte Control (S); Liquichek Reticulocyte Control (X); Liquichek Rheumatoid Factor Control; Liquichek Serum Volatiles Control; Liquichek Specialty Immunoassay Control; Liquichek Specialty Immunoassay Plus Control; Liquichek Spinal Fluid Control; Liquichek Spinal Fluid Control (Vista); Liquichek Therapeutic Drug Monitoring Control (TDM); Liquichek ToRCH Plus IgM Control; Liquichek Tumor Marker Control; Liquichek Tumor Marker Control (Vista); Liquichek Urinalysis Control; Liquichek Urine Chemistry Control; Liquichek Urine Chemistry Control (2.5 mL vials) and Liquichek Urine Chemistry Control (Tubes); Liquichek Urine Toxicology Control Screen S1, S2, S3; Liquichek Urine Toxicology Control, Confirmatory C1; Liquichek Urine Toxicology Control, Confirmatory, C2, C2 Low Opiate, C3, C3 Low Opiate, C4; Liquichek Urine Toxicology Control, S1O, S2O, S1O Low Opiate, S2O Low Opiate; Liquichek Urine Toxicology Control, Screen - S1S and S2S; Liquichek Urine Toxicology Control, Screen EIA S1E and S2E Low Opiate and S1E and S2E; Liquichek Urine Toxicology Negative Control; Liquichek Whole Blood Immunosuppressant Control; Liquid Assayed Multiqual (Vista); Liquid Assayed Multiqual Premium; Liquid Assayed Multiqual,; Lyphochek Allergen sIgE Control, Negative; Lyphochek Allergen sIgE Control, Panel A; Lyphochek Anemia Control; Lyphochek Assayed Chemistry Control; Lyphochek Benzo/TCA Control Set B; Lyphochek Coagulation Control; Lyphochek Diabetes Control; Lyphochek Drug Free Serum; Lyphochek Fertility Control Serum; Lyphochek Hemoglobin A1C Linearity Set; Lyphochek Hemoglobin A2 Control; Lyphochek Hemostasis Control; Lyphochek Hypertension Markers Control; Lyphochek Immunoassay Plus Control; Lyphochek Maternal Serum Control; Lyphochek Quantitative Urine Control, Abnormal; Lyphochek Quantitative Urine Control, Normal; Lyphochek Specialty Immunoassay Control; Lyphochek Therapeutic Drug Monitoring Control; Lyphochek Tumor Marker Control; Lyphochek Tumor Marker Plus Control; Lyphochek Urine Bone Markers Control; Lyphochek Urine Metals Control; Lyphochek Urine Toxicology Control; Lyphochek Whole Blood Control; Lyphochek Whole Blood Immunosuppressant Control; Lyphochek Whole Blood Metals Control; Meter Trax Control; Quantify Advance Control; Quest Diagnostics Immunoassay/TDM Control; Quest Diagnostics Serum Chemistry Control; Quest Diagnostics Tumor Marker; VIROCLEAR; VIROTROL HIV-1 Ag; VIROTROL HIV-2; VIROTROL I; VIROTROL II; VIROTROL III; VIROTROL IV; VIROTROL TORCH; Virotrol III; qUAntify Control; qUAntify Plus Control",2008-01-17,107,2017-01-10,0,1,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222016706%22&limit=1
"Ortho Clinical Diagnostics, K.K.",3012963943,3012963943,"Harumi Prime Square 15F, 2-1-40 Experience Center","Harumi, Chuo-ku Tokyo",,104-0053,Japan,QuidelOrtho Corporation,2024674,Complaint file establishment,113,CDN; CDP; CDT; CDZ; CEC; CEM; CEW; CFJ; CFN; CFT; CGA; CGJ; CGN; CGR; CHH; CIG; CIT; CIW; CIX; CJE; CJY; CZW; DAD; DBI; DCF; DCK; DDG; DDR; DEM; DGR; DHA; DHR; DHX; DIF; DIH; DIO; DIP; DIS; DJG; DJR; DKB; DKJ; DKZ; DLJ; DLZ; DMT; GTQ; JFY; JGJ; JGP; JGS; JHX; JID; JIH; JIS; JIT; JIX; JIY; JJE; JJX; JJY; JLW; JMO; JRC; JXM; JZJ; KHO; KHP; KHQ; KLI; KLS; KLT; KNK; KSF; KSG; KSI; KSN; KSZ; LBR; LBS; LCD; LCM; LDJ; LDO; LDP; LEG; LEH; LFM; LOL; LOM; LPS; LTJ; LTK; MJX; MJY; MMI; MOI; MRG; MRR; MSJ; MZF; MZO; NBC; NIG; NQD; OHQ; PDJ; PMT; PPM; QKO; QKP; QVP; SEI,"Urease, Photometric, Urea Nitrogen; Radioimmunoassay, Total Triiodothyronine; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Electrode, Ion Specific, Potassium; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Method, Nephelometric, Immunoglobulins (G, A, M); Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Radioimmunoassay, Cortisol; Enzymatic Esterase--Oxidase, Cholesterol; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Starch-Dye Bound Polymer, Amylase; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Azo Dye, Calcium; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Whole Human Serum, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet; Antistreptolysin - Titer/Streptolysin O Reagent; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Lowry (Colorimetric), Total Protein; Electrode, Ion Specific, Sodium; Fluorometric Method, Cpk Or Isoenzymes; Photometric Method, Ammonia; Flame Photometry, Lithium; Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Thyroid-Stimulating Hormone; Ferrozine (Colorimetric) Iron Binding Capacity; Micro Pipette; Enzyme Immunoassay, Benzodiazepine; Prealbumin, Antigen, Antiserum, Control; Fluorometer, For Clinical Use; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Kit, Quality Control For Blood Banking Reagents; Media, Potentiating For In Vitro Diagnostic Use; Lectins And Protectins; Centrifuge, Cell-Washing, Automated For Immuno-Hematology; System, Test, Automated Blood Grouping And Antibody; Ldl & Vldl Precipitation, Hdl; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Enzyme Immunoassay, Cannabinoids; Enzymatic Radiochemical Assay, Tobramycin; Colorimetry, Acetaminophen; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Immunoassay, Digitoxin; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Urinary Homocystine (Nonquantitative) Test System; Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Kit, Serological, Positive Control; Kit, Serological, Negative Control; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; System, Test, Vitamin D; System, Test, Low Density, Lipoprotein; Apolipoproteins; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Test, Natriuretic Peptide; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Multi-Analyte Controls Unassayed; Hemoglobin A1c Test System; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; General Purpose Reagent; Reagent, Coronavirus Serological; Coronavirus Antigen Detection Test System.; Sars-Cov-2 Serology Test; Qualitative And Quantitative Hepatitis B Virus Antibody Assays",1; 2; N; U,"DAT Control, MTS DAT Card; MTS Diluent 2; MTS Diluent 2 PLUS; ORTHO Antibody Enhancement Solution; ORTHO Bovine Albumin Solution Polymerized; ORTHO Bovine Serum Albumin, 22% Protein Concentration; ORTHO Confidence System; ORTHO Optix Reader; ORTHO VISION Analyzer; ORTHO VISION Analyzer - Certified; ORTHO VISION Max Analyzer; ORTHO Workstation; Ortho 7% BSA; Ortho Anti A1 Lectin; Ortho Coombs Control; Ortho Optix Reader; Ortho Rhhr Control (human & bovine); QuickVue At Home COVID-19; QuickVue COVID-19 Test Control Swab Set; QuickVue SARS Antigen Test; Quidel Molecular Adenovirus Control Set (M110); Quidel Molecular Bordetella Control Set (M117); Quidel Molecular C. difficile Control Set (M108); Quidel Molecular GBS Control Set (M116); Quidel Molecular HSV 1+2 Control Set (M109); Quidel Molecular HSV 1+2/VZV Control Set (M121); Quidel Molecular Influenza A+B Control Set (M106); Quidel Molecular Parainfluenza Virus Control Set (M115); Quidel Molecular RSV+hMPV Control Set (M107); Quidel Molecular Strep A+G Control Set (M111); Quidel Molecular Trichomonas Control Set (M119); Sofia 2 SARS Antigen FIA; Sofia SARS Antigen FIA; Solana HSV 1+2/VZV Control Set (M118); Solana Influenza A+B Control Set (M122); Solana RSV+hMPV Control Set (M123); VITROS 25-OH Vitamin D Total Calibrators; VITROS 25-OH Vitamin D Total Reagent Pack; VITROS 250 Chemistry System; VITROS 250 Chemistry System Refurbished; VITROS 350 Chemistry System; VITROS 3600 Immunodiagnostics System; VITROS 3600 Immunodiagnostics System - Certified; VITROS 3600 Immunodiagnostics System - Refurbished; VITROS 4600 Chemistry System; VITROS 4600 Chemistry System Refurbished; VITROS 5,1 FS Chemistry System; VITROS 5,1 FS Chemistry System Refurbished; VITROS 5600 Integrated System; VITROS 5600 Integrated System Certified; VITROS 5600 Integrated System Refurbished; VITROS 7% BSA; VITROS AAT Reagent; VITROS AAT/HPT Performance Verifiers; VITROS ACET Slides; VITROS AFP Range Verifier; VITROS ALB-TP Slides; VITROS ALC Slides; VITROS AMON Slides; VITROS AMPH Reagent; VITROS AMYL Slides; VITROS ASO Reagent; VITROS ASO/RF Performance Verifiers; VITROS AST Slides; VITROS Anti- HCV Reagent Pack; VITROS Anti-HAV IgM Calibrator; VITROS Anti-HAV IgM Controls; VITROS Anti-HAV IgM Reagent Pack; VITROS Anti-HAV Total Calibrators; VITROS Anti-HAV Total Controls; VITROS Anti-HAV Total Reagent Pack; VITROS Anti-HBc Calibrator; VITROS Anti-HBc Controls; VITROS Anti-HBc IgM Calibrator; VITROS Anti-HBc IgM Controls; VITROS Anti-HBc IgM Reagent Pack; VITROS Anti-HBc Reagent Pack; VITROS Anti-HBe Calibrators; VITROS Anti-HBe Reagent Pack; VITROS Anti-HBs Quantitative Calibrators; VITROS Anti-HBs Quantitative Controls; VITROS Anti-HBs Quantitative Reagent Pack; VITROS Anti-HCV Calibrators; VITROS Anti-HCV Controls; VITROS Anti-HIV 1+2 Calibrator; VITROS Anti-HIV 1+2 Controls; VITROS Anti-HIV 1+2 Reagent Pack; VITROS Anti-SARS-CoV-2 IgG Calibrator; VITROS Anti-SARS-CoV-2 IgG Controls; VITROS Anti-SARS-CoV-2 IgG Quantitative Calibrator EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Controls EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack EUA210322; VITROS Anti-SARS-CoV-2 IgG Reagent Pack; VITROS Anti-SARS-CoV-2 Total N Antibody Calibrator EUA210355; VITROS Anti-SARS-CoV-2 Total N Antibody Reagent Pack EUA210355; VITROS Anti-SARS-CoV-2 Total N Controls EUA210355; VITROS ApoA1 Performance Verifiers; VITROS ApoA1 Reagent; VITROS ApoB Performance Verifiers; VITROS ApoB Reagent; VITROS B12 Range Verifier; VITROS BARB Reagent; VITROS BENZ Reagent; VITROS BRAHMS PCT Calibrators; VITROS BRAHMS PCT Controls; VITROS BRAHMS PCT Range Verifier; VITROS BRAHMS PCT Reagent Pack; VITROS BuBc Slides; VITROS C3 Reagent; VITROS C4 Reagent; VITROS CA 125 II Calibrator; VITROS CA 125 II Range Verifier; VITROS CA 125 II Reagent Pack; VITROS CA 15-3 Calibrator; VITROS CA 15-3 Range Verifier; VITROS CA 15-3 Reagent Pack; VITROS CA 19-9 Calibrator; VITROS CA 19-9 Range Verifiers; VITROS CA 19-9 Reagent Pack; VITROS CAFFN Reagent Kit; VITROS CHE Slides; VITROS CK-MB Calibrator; VITROS CK-MB Range Verifier; VITROS CK-MB Reagent Pack; VITROS COCM Reagent; VITROS CRBM Slides; VITROS CREA Slides; VITROS CRP Performance Verifiers; VITROS Ca Slides; VITROS Calibrator Kit 1; VITROS Calibrator Kit 10; VITROS Calibrator Kit 11; VITROS Calibrator Kit 12; VITROS Calibrator Kit 13; VITROS Calibrator Kit 14; VITROS Calibrator Kit 16; VITROS Calibrator Kit 17; VITROS Calibrator Kit 19; VITROS Calibrator Kit 2; VITROS Calibrator Kit 20; VITROS Calibrator Kit 21; VITROS Calibrator Kit 22; VITROS Calibrator Kit 23; VITROS Calibrator Kit 24; VITROS Calibrator Kit 25; VITROS Calibrator Kit 26; VITROS Calibrator Kit 27; VITROS Calibrator Kit 28; VITROS Calibrator Kit 29; VITROS Calibrator Kit 3; VITROS Calibrator Kit 30; VITROS Calibrator Kit 31; VITROS Calibrator Kit 32; VITROS Calibrator Kit 4; VITROS Calibrator Kit 5; VITROS Calibrator Kit 8; VITROS Calibrator Kit 9; VITROS Calibrator Kit 99; VITROS Chemistry Products Calibrator Kit 25; VITROS Chemistry Products Performance Verifiers; VITROS Chemistry Products dHDL Slides; VITROS Cortisol Calibrator; VITROS Cortisol Range Verifier; VITROS Cortisol Reagent Pack; VITROS DAT Performance Verifiers; VITROS DGXN Slides; VITROS ECi Immunodiagnostic System; VITROS ECi Immunodiagnostic System Refurbished; VITROS ECiQ Immunodiagnostic System; VITROS Estradiol Range Verifier; VITROS FS Calibrator 1; VITROS FS Diluent Pack 1, 2, 3 and 4; VITROS FS Micro Tips; VITROS FS Reconstitution Diluent; VITROS FSH Calibrator; VITROS FSH Range Verifier; VITROS FSH Reagent Pack; VITROS Fe Slides; VITROS Ferritin Range Verifier; VITROS Folate Calibrator; VITROS Folate Range Verifier; VITROS Folate Reagent Pack 1/2; VITROS Free T3 Calibrator; VITROS Free T3 Range Verifier; VITROS Free T3 Reagent Pack; VITROS Free T4 Range Verifier; VITROS Free T4 Reagent Pack; VITROS GENT Reagent; VITROS HBeAg Calibrator; VITROS HBeAg Reagent Pack; VITROS HBsAg Calibrator; VITROS HBsAg Confirmatory Kit; VITROS HBsAg Controls; VITROS HBsAg Reagent Pack; VITROS HCY2 Performance Verifiers; VITROS HCY2 Reagent; VITROS HIV Combo Calibrator; VITROS HIV Combo Controls (Anti-HIV-1 group O); VITROS HIV Combo Controls (HIV p24 Antigen); VITROS HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2); VITROS HIV Combo Reagent Pack; VITROS HPT Reagent; VITROS HbA1c Reagent Kit; VITROS High Sample Diluent A and B; VITROS INTACT PTH Calibrators; VITROS INTACT PTH Controls; VITROS INTACT PTH Range Verifier; VITROS INTACT PTH Reagent Pack; VITROS IgA Reagent; VITROS IgG Reagent; VITROS IgM Reagent; VITROS Immuno-Wash Fluid; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack DEN210040; VITROS Immunodiagnostic Products CA 19-9 Calibrator; VITROS Immunodiagnostic Products CA 19-9 Reagent Pack; VITROS Immunodiagnostic Products CEA Calibrators; VITROS Immunodiagnostic Products CEA Reagent Pack; VITROS Immunodiagnostic Products Intact PTH II Calibrators; VITROS Immunodiagnostic Products Intact PTH II Reagent Pack; VITROS Immunodiagnostic Products Progesterone 2 Calibrators; VITROS Immunodiagnostic Products Progesterone 2 Range Verifiers; VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack; VITROS Immunodiagnostic Products hs Troponin I Low Control; VITROS Immunodiagnostic Products hsTroponin I Calibrator; VITROS K+ Slides; VITROS LAC Slides; VITROS LDH Slides; VITROS LDHI SLides; VITROS LH Range Verifier; VITROS Li Slides; VITROS Liquid Performance Verifiers; VITROS METD Reagent; VITROS Metabolism Controls; VITROS Mg Slides; VITROS Micro Tips; VITROS MicroSensor Check Fluids; VITROS Myoglobin Calibrator; VITROS Myoglobin Range Verifier; VITROS Myoglobin Reagent Pack; VITROS NT pro-BNP Calibrators; VITROS NT pro-BNP Range Verifier; VITROS NT pro-BNP Reagent Pack; VITROS NT-proBNP II Reagent Pack; VITROS NTx Range Verifier; VITROS Na+ Slides; VITROS OP Reagent; VITROS PALB Performance Verifiers; VITROS PALB Reagent; VITROS PCP Reagent; VITROS PHBR Slides; VITROS PHYT Slides; VITROS Percent A1c Performance Verifiers; VITROS Performance Verifiers; VITROS Progesterone Calibrator Kit; VITROS Progesterone Range Verifier; VITROS Progesterone Reagent Pack; VITROS Prolactin Calibrator; VITROS Prolactin Range Verifier; VITROS Prolactin Reagent Pack; VITROS Protein Performance Verifiers; VITROS RF Reagent; VITROS Red Cell Folate Pack; VITROS Reference Fluids; VITROS SALI Slides; VITROS SARS-COV-2 Antigen Calibrator EUA202928; VITROS SARS-COV-2 Antigen Controls EUA202928; VITROS SARS-COV-2 Antigen Reagent Pack EUA202928; VITROS SARS-COV-2 Extraction Buffer EUA202928; VITROS Signal Reagent; VITROS T3 Uptake II Calibrator; VITROS T3 Uptake II Range Verifier; VITROS T3 Uptake II Reagent Pack; VITROS T4 Calibrator; VITROS TBIL Slides; VITROS TDM Performance Verifiers; VITROS THC Reagent; VITROS THEO Slides; VITROS TIBC Kit; VITROS TOBRA Reagent; VITROS TRFRN Reagent; VITROS TRIG Slides; VITROS TSH Calibrator; VITROS TSH Range Verifier; VITROS TSH Reagent Pack; VITROS Testosterone Calibrator; VITROS Testosterone Range Verifier; VITROS Testosterone Reagent Pack; VITROS Total PSA Calibrator; VITROS Total PSA Range Verifier; VITROS Total PSA Reagent Pack; VITROS Total T3 II Calibrator; VITROS Total T3 II Range Verifier; VITROS Total T3 II Reagent Pack; VITROS Total T4 Calibrator; VITROS Total T4 Range Verifier; VITROS Total T4 Reagent Pack; VITROS Total bhCG II Calibrator; VITROS Total bhCG II Range Verifier; VITROS Total bhCG II Reagent Pack; VITROS Troponin I ES Calibrators; VITROS Troponin I ES Range Verifier; VITROS Troponin I ES Reagent Pack; VITROS UPRO Performance Verifiers; VITROS UPRO Slides; VITROS URIC Slides; VITROS Universal Wash Reagent; VITROS Urine Electrolyte Diluent; VITROS VALP Reagent; VITROS VANC Reagent; VITROS Versa Tips; VITROS XT 3400 Chemistry System; VITROS XT 7600 Integrated System; VITROS XT 7600 Integrated System Certified; VITROS XT GLU-Ca Slides; VITROS XT TBIL-ALKP Slides; VITROS XT TRIG-CHOL Slides; VITROS XT UREA-CREA Slides; VITROS dHDL Slides; VITROS dLDL Reagent; VITROS dTIBC Performance Verifiers; VITROS dTIBC Reagent; VITROS hsCRP Performance Verifiers; VITROS hsCRP Reagent; VITROS mALB Performance Verifiers; VITROS mALB Reagent",2020-11-24,100,2024-05-08,7,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012963943%22&limit=1
"Beckman Coulter, Inc.",2919016,2919016,1584 Enterprise Blvd,West Sacramento,CA,95691,United States,"BECKMAN COULTER, INC.",2050012,Contract manufacturer; Manufacturer; Manufacturer for export; Specification developer,17,JJQ; JSG; JSP; JTC; JTZ; JWY; JXB; LIB; LIE; LON; LQL; LQM; LRG; LTT; LTW; OUG; SAN,"Colorimeter, Photometer, Spectrophotometer For Clinical Use; Culture Media, Non-Selective And Non-Differential; Kit, Anaerobic Identification; Device, Microtiter Diluting/Dispensing; Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth; Manual Antimicrobial Susceptibility Test Systems; Kit, Identification, Yeast; Device, General Purpose, Microbiology, Diagnostic; Reagent/Device, Inoculum Calibration; System, Test, Automated, Antimicrobial Susceptibility, Short Incubation; Gram Positive Identification Panel; Gram Negative Identification Panel; Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems; Panels, Test, Susceptibility, Antimicrobial; Susceptibility Test Cards, Antimicrobial; Medical Device Data System; Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples",1; 2,"B1018-340R MicroScan WA 40 Plus Reconditioned; B1018-396R MicroScan WA 96 Plus Reconditioned; C24164 MicroScan LabPro V5 System DVD Kit (JP); C24165 MicroScan LabPro Connect V5 System DVD Kit (JP); C24166 MicroScan LabPro V5 System DVD Kit (MR); C24167 MicroScan LabPro Connect V5 System DVD Kit (MR); C38721 MicroScan LabPro V5 System DVD Kit (FMR); C38722 MicroScan LabPro Connect V5 System DVD Kit (FMR); C54389 MicroScan HighFlexX Software v2.9, Electronic; C66901 MicroScan LabPro V5 Panel Update - 07 DVD Kit (Japan); C66902 MicroScan LabPro V5 Update - 07 DVD System Kit (Japan); C79969 MicroScan LabPro V4.43/4.44 Panel Update-08 DVD Kit (MR); C82964 MicroScan LabPro V5 Maintenance Update 1 W/ Panel Update 09 DVD Kit (MR); C82964 MicroScan LabPro v5 Maintenance Update 1 W/Panel Update 09 DVD Kit (MR); C90384 MicroScan LabPro V5 Maintenance Update 1 W/ Panel Update 09 (MR), Electronic; C90384 MicroScan LabPro V5 Maintenance Update 1 W/Panel Update 09 (MR), Electronic; C90683 LabPro V5 Panel Update 10 (FMR), Electronic; C90683 MicroScan LabPro V5 Panel Update 10 (FMR), Electronic; C90685 MicroScan LabPro V5 Panel Update 10 DVD Kit (FMR); D03455 MicroScan LabPro v5 EU SMU Predictive Susceptibility (MR), Electronic; D05946 MicroScan LabPro v50 Data Delivery-03, Electronic; D11478 MicroScan LabPro V4.45/V5 Data Delivery 4 (JP); D11977 MicroScan LabPro v50 Data Delivery-05, MR, Electronic; D12427 MicroScan LabPro V4_V5 Maintenance Update 05 (US), Electronic; D12429 MicroScan LabPro V4_V5 Maintenance Update 05 DVD Kit (US, FMR, MR); D12596 MicroScan LabPro V4_V5 Maintenance Update 05 (MR, FMR), Electronic; D14981 MicroScan LabPro v52 System (JP), Electronic; D15062 MicroScan LabPro Connect v52 System (JP), Electronic; D19723 MicroScan LabPro v50 Data Delivery-06 (FMR), Electronic; D23352 MicroScan LabPro V53 Panel Update 11 (US), Electronic; D23354 MicroScan LabPro V53 Panel Update 11 DVD Kit (US); D23504 MicroScan HighFlexX Software x2.9.2, Electronic; D23824 MicroScan LabPro V53 System (US), Electronic; D23825, MicroScan LabPro Connect V53 System (US), Electronic; D23828 MicroScan LabPro V53 System DVD Kit (US); D23829 MicroScan LabPro Connect V53 System DVD Kit (US); D31041 MicroScan LabPro V54 System (JP), Electronic; D31042 MicroScan LabPro Connect V54 System (JP), Electronic; D31045 MicroScan LabPro V54 System (MR), Electronic; D31046 MicroScan LabPro Connect V54 System (MR), Electronic; D31049 MicroScan LabPro V54 System, Electronic; D31050 MicroScan LabPro Connect V54 System, Electronic; D31060 MicroScan LabPro V54 System DVD Kit (JP); D31061 MicroScan LabPro Connect V54 System DVD Kit (JP); D31062 MicroScan LabPro V54 System DVD Kit (MR); D31063 MicroScan LabPro Connect V54 System DVD Kit (MR); D31064 MicroScan LabPro V54 System DVD Kit; D31065 MicroScan LabPro Connect V54 System DVD Kit; D33604 MicroScan LabPro V53 Data Delivery 07 (US), Electronic; D37099 MicroScan LabPro V54 Panel Update 10 (MR), Electronic; D41475 MicroScan LabPro V53 Data Delivery 08 (US), Electronic; D41479 MicroScan LabPro V54 Data Delivery 08, Electronic; D41482 MicroScan LabPro V54 Data Delivery 08 DVD Kit; D43975 MicroScan LabPro V53 MBT Maintenance Update 01 (US), Electronic; D43977 MicroScan LabPro V53 MBT Maintenance Update 01 DVD Kit (US); D43984 MicroScan LabPro V54 MBT Maintenance Update 01 DVD Kit; DxM 1040 MicroScan WalkAway Instrument (PN B1018-440); DxM 1096 MicroScan WalkAway Instrument (PN B1018-496); MH BROTH with 3% LHB; MICroSTREP Plus Panel Type 3; MICroSTREP Plus Panel Type 5; MicroScan 0.4% Saline with PLURONIC; MicroScan 0.5% N,N-Dimethylalphanaphthylamine 250ml; MicroScan 0.5% N,N-Dimethylalphanaphthylamine 30ml; MicroScan 0.8% Sulfanilic Acid 250ml; MicroScan 0.8% Sulfanilic Acid 30ml; MicroScan 05N Sodium Hydroxide 250ml; MicroScan 05N Sodium Hydroxide 30ml; MicroScan 10% Ferric Chloride 250ml; MicroScan 10% Ferric Chloride 30ml; MicroScan 3ml Inoculum Saline; MicroScan 40% Potassium Hydroxide 250ml; MicroScan 40% Potassium Hydroxide 30ml; MicroScan 96 Well Tray Lids; MicroScan Alpha Naphthol 1.5g; MicroScan Cover Trays; MicroScan Dried Gram Negative BP Combo Panel Type 46; MicroScan Dried Gram Negative Breakpoint Combo Panel Type 42; MicroScan Dried Gram Negative Combo Panel Type 53; MicroScan Dried Gram Negative Combo Panel Type 54; MicroScan Dried Gram Negative Combo Panel Type 58; MicroScan Dried Gram Negative Combo Panels; MicroScan Dried Gram Negative ESBL Confirmation Panel; MicroScan Dried Gram Negative ESBL Confirmation Panel - Cefepime; MicroScan Dried Gram Negative ESBL Confirmation Panel - Cefotetan; MicroScan Dried Gram Negative ESBL Confirmation Panel - Imipenem; MicroScan Dried Gram Negative MIC Panel Type 40; MicroScan Dried Gram Negative MIC/Combo Panels; MicroScan Dried Gram Negative MIC/Combo Panels - Amoxicillin/K Clavulanate; MicroScan Dried Gram Negative MIC/Combo Panels - Ampicillin; MicroScan Dried Gram Negative MIC/Combo Panels - Aztreonam; MicroScan Dried Gram Negative MIC/Combo Panels - Cefepime; MicroScan Dried Gram Negative MIC/Combo Panels - Cefixime; MicroScan Dried Gram Negative MIC/Combo Panels - Cefotaxime; MicroScan Dried Gram Negative MIC/Combo Panels - Cefotaxime / Clavulanic acid; MicroScan Dried Gram Negative MIC/Combo Panels - Cefotetan; MicroScan Dried Gram Negative MIC/Combo Panels - Cefpodoxime; MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime; MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime / Clavulanic acid; MicroScan Dried Gram Negative MIC/Combo Panels - Ceftazidime/Avibactam; MicroScan Dried Gram Negative MIC/Combo Panels - Ceftolozane/Tazobactam; MicroScan Dried Gram Negative MIC/Combo Panels - Ceftriaxone; MicroScan Dried Gram Negative MIC/Combo Panels - Cefuroxime; MicroScan Dried Gram Negative MIC/Combo Panels - Ciprofloxacin; MicroScan Dried Gram Negative MIC/Combo Panels - Ciprofloxacin-S; MicroScan Dried Gram Negative MIC/Combo Panels - Doripenem; MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Cefotaxime; MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Cefpodoxime; MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Ceftazidime; MicroScan Dried Gram Negative MIC/Combo Panels - ESBL Screen - Ceftriaxome; MicroScan Dried Gram Negative MIC/Combo Panels - Eravacycline; MicroScan Dried Gram Negative MIC/Combo Panels - Ertapenem; MicroScan Dried Gram Negative MIC/Combo Panels - Imipenem; MicroScan Dried Gram Negative MIC/Combo Panels - Levofloxacin; MicroScan Dried Gram Negative MIC/Combo Panels - Meropenem; MicroScan Dried Gram Negative MIC/Combo Panels - Meropenem/Vaborbactam; MicroScan Dried Gram Negative MIC/Combo Panels - Moxifloxacin; MicroScan Dried Gram Negative MIC/Combo Panels - Norfloxacin; MicroScan Dried Gram Negative MIC/Combo Panels - Piperacillin/Tazobactam; MicroScan Dried Gram Negative MIC/Combo Panels - Ticarcillin/K. Clavulanate; MicroScan Dried Gram Negative MIC/Combo Panels - Tigecycline; MicroScan Dried Gram Negative MIC/Combo Panels- Minocycline; MicroScan Dried Gram Negative Urine Combo Panel Type 52; MicroScan Dried Gram Negative Urine Combo Panel Type 57; MicroScan Dried Gram Negative Urine Combo Panel Type 59; MicroScan Dried Gram Pos BP Combo 3.2J; MicroScan Dried Gram Pos BPCombo 3.2J (M); MicroScan Dried Gram Pos Combo Panel Type 3.1C; MicroScan Dried Gram Pos Combo Panel Type 3.1J; MicroScan Dried Gram Positive BP Combo Panel Type 28; MicroScan Dried Gram Positive BP Combo Panel Type 32; MicroScan Dried Gram Positive Combo Panel Type 31; MicroScan Dried Gram Positive Combo Panel Type 32; MicroScan Dried Gram Positive Combo Panel Type 37; MicroScan Dried Gram Positive Combo Panel Type 38; MicroScan Dried Gram Positive Combo Panels; MicroScan Dried Gram Positive MIC Panel Type 32; MicroScan Dried Gram Positive MIC/Combo Panels; MicroScan Dried Gram Positive MIC/Combo Panels - Ampicillin; MicroScan Dried Gram Positive MIC/Combo Panels - Azithromycin; MicroScan Dried Gram Positive MIC/Combo Panels - Cefepime; MicroScan Dried Gram Positive MIC/Combo Panels - Cefoxitin Screen Well; MicroScan Dried Gram Positive MIC/Combo Panels - Ceftriaxone; MicroScan Dried Gram Positive MIC/Combo Panels - Ciprofloxacin; MicroScan Dried Gram Positive MIC/Combo Panels - Daptomycin; MicroScan Dried Gram Positive MIC/Combo Panels - Erythromycin; MicroScan Dried Gram Positive MIC/Combo Panels - Gentamicin; MicroScan Dried Gram Positive MIC/Combo Panels - Inducible Clindamycin Test; MicroScan Dried Gram Positive MIC/Combo Panels - Levofloxacin; MicroScan Dried Gram Positive MIC/Combo Panels - Linezolid; MicroScan Dried Gram Positive MIC/Combo Panels - Meropenem; MicroScan Dried Gram Positive MIC/Combo Panels - Moxifloxacin; MicroScan Dried Gram Positive MIC/Combo Panels - Norfloxacin; MicroScan Dried Gram Positive MIC/Combo Panels - Penicillin; MicroScan Dried Gram Positive MIC/Combo Panels - Piperacillin/ Tazobactam; MicroScan Dried Gram Positive MIC/Combo Panels - Streptomycin; MicroScan Dried Gram Positive MIC/Combo Panels - Synercid; MicroScan Dried Gram Positive MIC/Combo Panels - Tigecycline; MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin; MicroScan Dried Gram Positive MIC/Combo Panels- Amoxicillin/K Clavulanate; MicroScan Dried Gram Positive MIC/Combo Panels- Azithromycin; MicroScan Dried Gram Positive MIC/Combo Panels- Cefazolin; MicroScan Dried Gram Positive MIC/Combo Panels- Cefuroxime; MicroScan Dried Gram Positive MIC/Combo Panels- Imipenem; MicroScan Dried Gram Positive MIC/Combo Panels- Rifampin; MicroScan Dried Gram-Negative MIC/Combo Panels - Aztreonam; MicroScan Dried Gram-Negative MIC/Combo Panels - Ceftazidime; MicroScan Dried Gram-Negative MIC/Combo Panels - Ciprofloxacin; MicroScan Dried Gram-Negative MIC/Combo Panels - Levofloxacin; MicroScan Dried Gram-Negative MIC/Combo Panels - Meropenem; MicroScan Dried Gram-Positive MIC/Combo Panels - Daptomycin; MicroScan Dried Gram-Positive MIC/Combo Panels with Ceftaroline; MicroScan ESBL Plus ESBL Confirmation - Aztreonam; MicroScan ESBL Plus ESBL Confirmation - Ceftazidime; MicroScan ESBL Plus ESBL Confirmation - Ceftriaxone; MicroScan ESBL plus ESBL Confirmation Panel - Cefotaxime; MicroScan ESBL plus ESBL Confirmation Panel - Cefotaxime / Calvulanic acid; MicroScan ESBL plus ESBL Confirmation Panel - Ceftazidime; MicroScan ESBL plus ESBL Confirmation Panel - Ceftazidime / Clavulanic acid; MicroScan ESBL plus ESBL Confirmation Panel - Meropenem; MicroScan Ehrlichs Reagent 30ml; MicroScan HNID Indole Reagent 30ml; MicroScan HNID Inoculum Broth; MicroScan HNID Panel; MicroScan HTM BROTH; MicroScan Inoculum Water; MicroScan Inoculum Water with PLURONIC; MicroScan Kovacs Reagent 250ml; MicroScan Kovacs Reagent 30ml; MicroScan LabPro Connect; MicroScan LabPro Data Management System; MicroScan LabPro MBT; MicroScan MICroFAST 7J; MicroScan MICroFAST Panel Type 6J; MicroScan MICroSTREP plus; MicroScan MICroSTREP plus Panel - Clarithromycin; MicroScan MICroSTREP plus Panel Type 6; MicroScan MICroSTREP plus Panels - Amoxicillin/Clavulanic acid; MicroScan MICroSTREP plus Panels - Ampicillin; MicroScan MICroSTREP plus Panels - Azithromycin; MicroScan MICroSTREP plus Panels - Cefaclor; MicroScan MICroSTREP plus Panels - Cefepime; MicroScan MICroSTREP plus Panels - Cefotaxime; MicroScan MICroSTREP plus Panels - Ceftriaxone; MicroScan MICroSTREP plus Panels - Cefuroxime; MicroScan MICroSTREP plus Panels - Chloramphenicol; MicroScan MICroSTREP plus Panels - Clarithromycin; MicroScan MICroSTREP plus Panels - Clindamycin; MicroScan MICroSTREP plus Panels - Daptomycin; MicroScan MICroSTREP plus Panels - Erythromycin; MicroScan MICroSTREP plus Panels - Levofloxacin; MicroScan MICroSTREP plus Panels - Linezolid; MicroScan MICroSTREP plus Panels - Meropenem; MicroScan MICroSTREP plus Panels - Moxifloxacin; MicroScan MICroSTREP plus Panels - Penicillin; MicroScan MICroSTREP plus Panels - Tetracycline; MicroScan MICroSTREP plus Panels - Trimethoprim/Sulfamethoxazole; MicroScan MICroSTREP plus Panels - Vancomycin; MicroScan MICroSTREP plus Panels -Cefotaxime; MicroScan MICroSTREP plus Panels with Tetracycline; MicroScan MSF FAST MIC Panel Type 2; MicroScan MSF NEG MIC Panel Type 2; MicroScan MSF Neg MIC Panel Type 2; MicroScan MSF Neg/Pos ID Panel Type 2; MicroScan MSF Neg/Pos ID Type 2 Panel; MicroScan MSF POS MIC Panel Type 2; MicroScan Mineral Oil 250ml; MicroScan Mineral Oil 60ml; MicroScan Neg BP Combo 1J(M); MicroScan Neg BP Combo 54; MicroScan Neg BP Combo Panel Type 49; MicroScan Neg Bkpt Combo Panel Type 48; MicroScan Neg Breakpoint Combo 2J; MicroScan Neg Breakpoint Combo 4J; MicroScan Neg Breakpoint Combo 50; MicroScan Neg Breakpoint Combo 53; MicroScan Neg Breakpoint Combo Panel Type 42; MicroScan Neg Combo 108; MicroScan Neg Combo 82; MicroScan Neg Combo 83; MicroScan Neg Combo 94; MicroScan Neg Combo 96; MicroScan Neg Combo 97; MicroScan Neg Combo 99; MicroScan Neg Combo EN 2C; MicroScan Neg Combo EN 2J; MicroScan Neg Combo EN 2T; MicroScan Neg Combo EN 3J; MicroScan Neg Combo EN 4J; MicroScan Neg Combo EN 4J (M); MicroScan Neg Combo IN 2J; MicroScan Neg Combo NF 2J; MicroScan Neg Combo NF 3J; MicroScan Neg Combo NF 3J (M); MicroScan Neg Combo NF 3T; MicroScan Neg Combo OUT 2J; MicroScan Neg Combo Panel Type 63; MicroScan Neg Combo Panel Type 66; MicroScan Neg Combo Panel Type 72; MicroScan Neg Entero Combo Panel Type 70; MicroScan Neg ID Panel Type 2; MicroScan Neg MDR Combo 100; MicroScan Neg MIC 2J; MicroScan Neg MIC 57; MicroScan Neg MIC 61; MicroScan Neg MIC 66; MicroScan Neg MIC EN 2J; MicroScan Neg MIC EN 3J; MicroScan Neg MIC EN 51; MicroScan Neg MIC EN 52; MicroScan Neg MIC NF 1J; MicroScan Neg MIC Panel Type 43; MicroScan Neg MIC Panel Type 44; MicroScan Neg MIC Panel Type 62; MicroScan Neg MIC Panel Type 63; MicroScan Neg Multidrug Resistant MIC 1; MicroScan Neg Mutidrug Resistant MIC 2; MicroScan Neg Non Entero Combo Panel Type 71; MicroScan Neg Uriine Combo 95; MicroScan Neg Urine Combo 107; MicroScan Neg Urine Combo 109; MicroScan Neg Urine Combo 81; MicroScan Neg Urine Combo Panel Type 69; MicroScan Neg Urine Combo Panel Type 98; MicroScan Negative MIC EN 47; MicroScan Negative MIC NF 50; MicroScan Negative MIC NF 64; MicroScan Peptidase 250ml; MicroScan Peptidase 30ml; MicroScan Pos Breakpoint Combo 1J; MicroScan Pos Breakpoint Combo Panel Type 28; MicroScan Pos Breakpoint Combo Panel Type 33; MicroScan Pos Combo 1J; MicroScan Pos Combo 2T; MicroScan Pos Combo 48; MicroScan Pos Combo 49; MicroScan Pos Combo 51; MicroScan Pos Combo Panel Type 39; MicroScan Pos Combo Panel Type 41; MicroScan Pos Combo Panel Type 42; MicroScan Pos Combo Panel Type 48; MicroScan Pos Combo Panel Type 49; MicroScan Pos ID Panel Type 3; MicroScan Pos MIC 1J; MicroScan Pos MIC 2J; MicroScan Pos MIC 40; MicroScan Pos MIC 42; MicroScan Pos MIC E 37; MicroScan Pos MIC Panel Type 28; MicroScan Pos MIC Panel Type 33; MicroScan Pos MIC STA 35; MicroScan Pos MIC STA 36; MicroScan Prompt Inoculation System-D; MicroScan RENOK Disposable D-Inoculator Sets; MicroScan RENOK Disposable R-Inoculator Sets; MicroScan RENOK Rehydrator / Inoculator System (PN B1018-14); MicroScan Rapid Anaerobe ID Panel; MicroScan Rapid Indole Reagent-F 30ml; MicroScan Rapid Neg ID Panel Type 3; MicroScan Rapid Neg ID Panel Type 4; MicroScan Rapid Pos ID Panel Type 2; MicroScan Rapid Yeast ID Panel; MicroScan Seal Strip; MicroScan Turbidity Meter; MicroScan WalkAway-40 plus (PN B1018-283); MicroScan WalkAway-96 plus (PN B1018-284); MicroScan Xylene - 30ml; MicroScan Yeast Turbidity Standard 3ml; MicroScan autoSCAN-4; Panels - Gatifloxacin; VITEK REVEAL 96Well Blank Plates; VITEK REVEAL BC GN01-AST; VITEK REVEAL BC GN02-AST; VITEK REVEAL Inoculator; VITEK REVEAL Inoculator Trays; VITEK REVEAL Inoculum Water w Pluronic",1992-12-03,106,2025-08-20,0,16,2,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222919016%22&limit=1
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti,3011989923,3011989923,Oruc Reis Mahallesi Giyimkent 3 Sokak No 21A-23A Esenler,Istanbul,,34235,Turkey,Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti,10060275,Exporter to the US; Specification developer,87,CDD; CDP; CDQ; CDT; CDZ; CEC; CEK; CEM; CEO; CEP; CEW; CFJ; CFN; CFP; CFR; CFT; CGA; CGJ; CGN; CGR; CGX; CGZ; CHH; CHP; CIG; CIT; CIW; CIX; CJE; CJW; CJY; CKA; DAD; DCF; DCK; DHR; DHX; DLZ; FHO; FTL; FZP; GAG; GAT; GCJ; GDW; GEI; HDA; HGI; HRX; HTN; HWC; JFL; JFP; JGJ; JGS; JIS; JIT; JIX; JIY; JJE; JJX; JKC; JLS; JLW; JMG; JMO; JXM; JZO; KNK; LBS; LFL; LFP; LIP; LOK; LOM; LPL; LTK; MBI; MOI; MRG; MVN; MZO; NBC; NBH; NQD; OCY; PPM,"Radioassay, Vitamin B12; Radioimmunoassay, Total Triiodothyronine; Urease And Glutamic Dehydrogenase, Urea Nitrogen; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Biuret (Colorimetric), Total Protein; Electrode, Ion Specific, Potassium; Phosphomolybdate (Colorimetric), Inorganic Phosphorus; Radioimmunoassay, Luteinizing Hormone; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Method, Nephelometric, Immunoglobulins (G, A, M); Radioimmunoassay, Immunoreactive Insulin; Hexokinase, Glucose; Radioimmunoassay, Prolactin (Lactogen); Glucose Oxidase, Glucose; Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Radioimmunoassay, Cortisol; Alkaline Picrate, Colorimetry, Creatinine; Electrode, Ion-Specific, Chloride; Enzymatic Esterase--Oxidase, Cholesterol; Radioimmunoassay, Estradiol; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Starch-Dye Bound Polymer, Amylase; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Bromcresol Purple Dye-Binding, Albumin; Azo Dye, Calcium; Nadh Oxidation/Nad Reduction, Alt/Sgpt; Haptoglobin, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Enzyme Immunoassay, Phenobarbital; Pneumoperitoneum Needle; Mesh, Surgical, Polymeric; Clip, Implantable; Stapler, Surgical; Suture, Nonabsorbable, Synthetic, Polyethylene; Laparoscope, General & Plastic Surgery; Staple, Implantable; Electrosurgical, Cutting & Coagulation & Accessories; Forceps, Obstetrical; Electrocautery, Gynecologic (And Accessories); Arthroscope; Washer, Bolt Nut; Screw, Fixation, Bone; Ph Rate Measurement, Carbon-Dioxide; Electrode, Ion Specific, Calcium; Photometric Method, Magnesium; Electrode, Ion Specific, Sodium; Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate); Radioimmunoassay, Progesterone; Radioimmunoassay, Thyroid-Stimulating Hormone; Radioimmunoassay (Two-Site Solid Phase), Ferritin; Ferrozine (Colorimetric) Iron Binding Capacity; Enzyme Immunoassay, Benzodiazepine; System, Test, Thyroid Autoantibody; Acid, Uric, Uricase (Colorimetric); Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Instrument, Ultrasonic Surgical; Conductivity Rate, Urea Nitrogen; Enzyme Linked Immunoabsorption Assay, Treponema Pallidum; Kit, Test, Alpha-Fetoprotein For Neural Tube Defects; Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Lenses, Soft Contact, Daily Wear; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Fastener, Fixation, Nondegradable, Soft Tissue; System, Test, Immunological, Antigen, Tumor; System, Test, Vitamin D; Lens, Contact, (Disposable); Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Test, Natriuretic Peptide; Accessories, Arthroscopic; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Endoscopic Guidewire, Gastroenterology-Urology; General Purpose Reagent",1; 2; 3; U,"ACCESS AFP REAGENTS; ACCESS DHEA-S REAGENT ASSAY; ACCESS ESTRADIOL REAGENTS; ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY; ACCESS HYBRITECH P2PSA; ACCESS INTACT PTH AND CALIBRATORS; ACCESS PROGESTERONE ASSAY; ACCESS PROLACTIN ASSAY; ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS; ACCESS ULTRASENSITIVE INSULIN ASSAY; ACS FRT4 IMMUNOASSAY; ACS: 180 AND ADVIA CENTAUR ANTITHYROGLOBULIN IMMUNOASSAY; ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY; ADVIA CENTAUR ANTI THYROGLOBULIN IMMUNOASSAYS; ADVIA CENTAUR HCV QUALITY CONTROL MATERIALS; ALANINE AMINOTRANSFERASE REAGENT; ALBUMIN REAGENT; AMYLASE REAGENT; ASPARTATE AMINOTRANSFERASE REAGENT; AUTOSUTURE CLOSURE DEVICE; Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immunoassay System. (P/N: B24839 MN MFG); Access 25(O; Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use; Access BR Monitor; Access CEA; Access Cortisol; Access Ferritin; Access Folate Assay; Access Free T4; Access Substrate; Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems; Access Testosterone; Access Thyroglobulin Antibody; Access Vitamin B12; Auto suture stapler; BLADELESS TROCAR; BNP TEST IMMUNOASSAY SYSTEMS; BUN REAGENT; Biuret (colorimetric), Total Protein; CALCIUM ARSENAZO REAGENT; CHIRON DIAGNOSTICS ACS: 180 FT3; CIBA CORNING ACS T3 IMMUNOASSAY; CIBA CORNING ACS TSH IMMUNOASSAY; COBLATION WAND SUPER TURBOVAC; DIRECT BILIRUBIN REAGENT; Dyonics 25 Tube Set; ENDOBUTTON CL ULTRA FIXATION; Endo clinch; Enzymatic Esterase--oxidase, Cholesterol; FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT; FIRSTPASS NEEDLE; FREE T3 CALIBRATORS; Fastener, Fixation, Nondegradable, Soft Tissue; GLUCOSE REAGENT; HDL CHOLESTEROL (HDLX) ASSAY; HLH HUMAN LUTENIZING HORMONE; IGA REAGENT; IGG REAGENT; IGM REAGENT; IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT; ISE Reagent, Glucose, CRP Latex; Instrument, Ultrasonic Surgical (HARMONIC ACE + LAPAROSCOPIC SHEARS); Jagwire; OLYMPUS ALKALINE PHOSPHATASE REAGENT; OLYMPUS CREATININE REAGENT; OLYMPUS LIPASE REAGENT; OLYMPUS MAGNESIUM REAGENT; OLYMPUS TOTAL BILIRUBIN REAGENT; OLYMPUS TRIGLYCERIDE TEST SYSTEM; PROGRIP RIGHT ANATOMICAL; PROXIMATE CURVED AND STRAIGHT INTRALUMINAL STAPLERS; Q-FIX ALL-SUTURE ANCHOR; RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT; Radioassay, vitamin b12; Radioimmunoassay, Free Thyroxine; SUTUREFIX ULTRA ANCHOR; SYMBOTEX COMPOSITE MESH; Screw, fixation, bone; Suture Anchor;; TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS; Twinfix Ti Suture Anchor; ULTRABRAID SUTURE; ULTRABUTTON Adjustable Fixation Device; UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS TOTAL PROTEIN; UNSATURATED IRON BINDING CAPCITY REAGENT; URIC ACID REAGENT; Urine/CSF Albumin, Urine/CSF Albumin Calibrator; VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS; VERSAPORT; VERSAPORT TROCAR; VIDAS PRG; VersaOne Bladed Trocar; Washer, Bolt Nut; lenses, soft contact, daily wear",2019-04-23,103,2024-05-09,3,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011989923%22&limit=1
Arrow International C.R. a.s.,3006425876,3006425876,Jamska 2359/47,ZDAR NAD SAZAVOU Vysocina,,591 01,Czechia,Arrow International LLC (subsidiary of Teleflex Incorporated,2518433,Contract manufacturer; Exporter to the US; Manufacturer; Repackager or relabeler,50,BSO; BSP; CAZ; CBI; DQO; DQX; DQY; DTL; DYB; DYG; FMF; FMG; FMI; FOZ; FPA; FPB; FRG; FXX; FYA; GAA; GAL; GAM; GAP; GAQ; GAR; GAT; GAW; GAX; GCC; GDX; GEN; HTD; JKA; KGX; KGY; KGZ; KKX; KMJ; KMK; KXF; LFJ; LJS; LJT; MDM; MPB; NAB; NAD; OGE; OWL; PPO,"Catheter, Conduction, Anesthetic; Needle, Conduction, Anesthetic (W/Wo Introducer); Anesthesia Conduction Kit; Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector); Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Introducer, Catheter; Catheter, Flow Directed; Syringe, Piston; Stopcock, I.V. Set; Needle, Hypodermic, Single Lumen; Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days; Set, Administration, Intravascular; Filter, Infusion Line; Wrap, Sterilization; Mask, Surgical; Gown, Surgical; Needle, Aspiration And Injection, Disposable; Suture, Absorbable, Natural; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Nonabsorbable, Silk; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Nonabsorbable, Synthetic, Polypropylene; Tourniquet, Nonpneumatic; Dilator, Catheter; Scalpel, One-Piece; Forceps, General & Plastic Surgery; Forceps; Tubes, Vials, Systems, Serum Separators, Blood Collection; Tape And Bandage, Adhesive; Bag, Intestine; Accessories, Catheter; Drape, Surgical, Antimicrobial; Lubricant, Patient; Device, Intravascular Catheter Securement; Applicator, Absorbent Tipped, Non-Sterile; Catheter, Subclavian; Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days; Port & Catheter, Implanted, Subcutaneous, Intravascular; Instrument, Manual, Surgical, General Use; Catheter, Hemodialysis, Non-Implanted; Gauze / Sponge,Nonresorbable For External Use; Dressing, Wound, Occlusive; Epidural Anesthesia Kit; Peripheral Catheter Insertion Kit; Multi-Lumen Hemodialysis Catheterization Kit",1; 2,"14 Fr 2-L Hemodialysis Catheters; 2- Lumen PICC Products w/ Blue Flex; 2-Lumen Central Venous Access (MAC); 3-WAY STOPCOCK; 3M™ Tegaderm™ +Pad Film Dressing with Non-Adherent Pad – Sterile; ACCESS KIT; ACCESS TRAY; AGB+ Multi-Lumen CVC Kit; AGB+ Quad Lumen CVC Kit; AGB+ Two-Lumen CVC Kit; AGBA PI MIDLINE; AGBA PI PICC KIT; AGBA PICC; AHDC AGB CURVED KIT; AHDC AGB KIT; AHDC AGB U-BEND KIT; AHDC KIT; AM PICC SET; AM/AT PI MIDLINE; ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS; ARROW Radial Artery Catheterization Set with Integral Needle Protection; ARROW(R) VPS(R) ACCESS KIT; ARROWg+ard 2-L Access (MAC); ARROWg+ard Blue Plus Multi-Lumen CVC Extreme Kit; ARROWg+ard Blue Plus Multi-Lumen CVC Kit; ARROWg+ard Blue Plus Multi-Lumen CVC Set; ARROWg+ard Blue Plus Multi-Lumen CVC Super Kit; ARROWg+ard Blue Plus Quad-Lumen CVC; ARROWg+ard Blue Plus Quad-Lumen CVC Set; ARROWg+ard Blue Plus Quad-Lumen CVC Super Kit; ARROWg+ard Blue Plus Two-Lumen CVC; ARROWg+ard Blue Plus Two-Lumen CVC Kit; ARROWg+ard Blue Plus Two-Lumen CVC Set; ARROWg+ard Blue Plus Two-Lumen CVC Super Kit; ARROWg+ard CVCs; ARROWg+ard Hemodialysis Catheters; ARROW® FlexBlock Continuous Peripheral Nerve Block Catheter; ARROW® FlexBlock Continuous Peripheral Nerve Block Kits; ARROW® FlexBlock Continuous Peripheral Nerve Block Sets; Ag+ & Ag+BP Pressure Injectable CVC; Ag+ Blue Plus ML CVCs; Ag+ Quad Lumen CVCs; Ag+ Super ArrowFlex PSIs; Anesthesia Conduct Kit; Arrow ""No Leak"" Sheath Adapter with Side Port; Arrow Access Tray; Arrow Central Venous Catheter Catheterization Kit with Blue FlexTip(R) Catheter; Arrow Central Venous Catheterization Kit; Arrow Continuous Nerve Block Needle; Arrow Continuous Peripheral Nerve Block Kit; Arrow Epidural Anesthesia Kit; Arrow Epidural Catheterization Kit; Arrow Epidural Catheterization Kit with FlexTip Plus® Catheter; Arrow Epidural Catheterization Kit with TheraCath®; Arrow Epidural Catheterization Kit with TheraCath® Catheter; Arrow Epidural Catheterization Kit/Set with FlexTip Plus® Catheter; Arrow Epidural Catheterization Set with FlexTip Plus® Closed Tip Multi-Port Catheter; Arrow Epidural Needle; Arrow Epidural Needle Kit; Arrow FlexBlock Continous Peripheral Nerve Block Kits; Arrow Jugular Puncture Kit; Arrow Large Bore Multi-lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter; Arrow MAC(TM) Two-Lumen Central Venous Access Kit; Arrow MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue Plus(R) Catheter; Arrow Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Nerve Block Prep Tray; Arrow Non-Absorbable Silk Suture; Arrow PICC; Arrow PSI; Arrow Peripherally Inserted Central Catheter; Arrow Prep Tray; Arrow Pressure Injectable Central Venous Catheterization Kit; Arrow Quad-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) ARROWg+ard Blue(R) Catheter; Arrow Radial Artery; Arrow Raulerson Syringe; Arrow Seldinger Arterial Catheterization Device; Arrow Select Kits; Arrow SharpsAwayII¿ Locking Disposal Cup; Arrow Single Shot Epidural Anesthesia Kit; Arrow SnapLock¿ Clamp Fastener (Bulk Non-Sterile); Arrow StimuCath® Continuous Nerve Block Set; Arrow Stimulator Adapter Cable; Arrow TheraCath® Epidural Catheter; Arrow UserGard(R) Needle-Free Injection Hub; Arrow-Clark™ VectorFlow™ Antegrade Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Hemodialysis Catheterization Set; Arrow-Clark™ VectorFlow™ Retrograde Replacement Hub Set; Arrow-Johans ECG Adapter; Arrow-Johans¿ ECG Adapter for Right Atrial Electrocardiography; ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC); Arrowg+ard Blue Advance ™ PICC Kit; Arrowg+ard Blue Advance™ PICC; Arrowg+ard Blue Advance™ PICC pre-loaded with ARROW® VPS® Stylet; Arrowg+ard Blue Advance™ PICC pre-loaded with Arrow® TipTracker™ Stylet; Arrowg+ard Blue Advance™ PICC pre-loaded with Arrow® VPS Precision™ Stylet; Arrowg+ard Blue Advance™ PICC with 130 cm Hydrophilic-Coated Nitinol Guidewire; Arrowg+ard Blue Advance™ PICC with 80 cm Hydrophilic-Coated Nitinol Guidewire; Arrow® 10 mL Luer-Slip Loss of Resistance Syringe; Arrow® 5 mL Luer-Slip Loss of Resistance Syringe; Arrow® Access Tray; Arrow® Arterial Catheterization Set; Arrow® Continuous Epidural Needle; Arrow® Continuous Nerve Block Kit; Arrow® Continuous Nerve Block Set; Arrow® Epidural Catheterization Kit with FlexTip Plus® Catheter; Arrow® Epidural Needle; Arrow® Percutaneous Sheath Introducer Kit with ARROWg+ard Blue® Sheath; Arrow® SnapLock™ Catheter/Syringe Adapter; Arrow® Thermodilution Catheters; Arterial Catheter; BD ECLIPSE HYPODERMIC NEEDLE; BD Eclipse Hypodermic Needle; BD Piston Syringes; Becton Dickinson Syringe; CG+ PICC SET; CVC KIT; CVC SET; Cannon Hemodialysis Catheter; Cannon II Plus Replacement Hub Set; Cannon II Plus; Edge; Catheter Dilator; Catheter Hemodialysis; Drape surgical; Drape, Surgical; Drape, surgical; Dressing commercial; EF-05510N: FILTER COMPONENT NRFit GVS; EZ-BLOCKER; Elcam Stopcock; Epidural Catheterization Kit; Epidural Catheterization Kit with TheraCath(R) and Needle Disposal Feature; Epidural Needle; Filter Needle; FlexTip Plus & Accessories; FlexTip Plus Combined Spinal Epidural Catheterization Kit; FlexTip Plus Epidural Catheter; FlexTip Plus Epidural Catheterization Kit; FlexTip Plus(R) Epidural Catheterization Kit for Lumbar Placement; FlexTip Plus® Combined Spinal Epidural Catheterizaiton Kit; FlexTip Plus® Epidural Catheterization Kit; FlexTip Plus® Epidural Catheterization Kit for Caudal Placement; Foosin Silk Suture; Forceps; GAUZE PADS; Gertie Marx; Guide Wire - Lake Region; HEMODIALYSIS KIT; HEMODIALYSIS SET; Hands-off Thermodilution Catheters; Hemodialysis (Acute) Products; Heparin Coated Thermodilution Ballo; Hypodermic Needle and Syringe; Hypodermic single lumen needle; INSYTE INTRODUCER CATHETER; INTERLINK(TM) INJECTION SITE; INTRAVENOUS SET; INTRODUCER & INJECTION NEEDLES; Infusion Port Thermodilution; Internal Jugular Kit; Intravascular catheter securement; Introducer Dilator; Introducer, Catheter; LBCVC AGB KIT; LBCVC KIT; Large Bore Multi-Lumen CVCs; M-L CVC w/BlueFlex Tip; MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD; MIDLINE CATHETER KIT; MIDLINE CATHETERS; MULTI LUMEN CVC KIT; MULTILUMEN PI CVC KIT; Mandrel Guidewires; Marked Spring-Wire Guide with Arrow Advancer; Multi-Lumen CVC; Multiple; Multiple General Use; NEW HYDROPHILIC COATING FOR WIRE GUIDES; NextStep Antegrade; NextStep Retrograde; NextStep Retrograde (femoral lengths); NextStep Retrograde Replacement Hub Set; Oxygenator, Cardiopulmonary Bypass; PERCUTANEOUS SHEATH INTRODUCER; PI AGBA PICC KIT; PI CATHETER; PI CG+ PICC SET; PI CVC KIT; PI CVC SET; PI JACC KIT; PI MIDLINE; PI MULTI LUMEN CVC; PI PICC; PICC; PICC KIT; PICC SET; PREP KIT; PREP TRAY; Pediatric 2-L Hemodialysis Catheter; Pediatric Two-Lumen Hemodialysis Catheterization Set/Kit with Blue FlexTip Catheter; Peripherally Inserted Central Catheter; Peripherally Inserted central catheter (PICC) with Blue; Peripherally inserted central catheter (PICC) Product with Blue Flex Tip and integral needle protection; Preox LOR Syringe; Pressure Injectable PICC; Pressure Injectable Peripherally Inserted Catheter; Puncture Kit, Disposable Vein; QUAD LUMEN PI CVC KIT; RA Catheter w/Integral Ndl Protect; Raulerson Syringe; Rusch Silko Spray; S-02200-010: FILTER COMM: .2 MICRON FLAT, GVS; S-02200-010N: FILTER COMM: 0.2. MICRON FLAT NRFit, GVS; STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES; STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK; SUR Betha Sheet Holder; SWG; SharpsAway Needle Disposal Cups; Silk Suture; Single Lumen CVCs; Single Shot Epidural; Single Shot Epidural Anesthesia Kit; SnapLock™ Clamp Fastener; Sponge; Spring Wire Guide; Sprotte; StimuCath (19 Ga); StimuCath PNB Catheter; Stopcock i.v. set; Super Arrow-Flex® Percutaneous Sheath Introducer Set; Super ArrowFlex PSIs; Surgical Gown SMS with PE Layer; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, non absorbable-silk; Syringe; TERUMO® SURFLO®0 IX. Catheter; TOURNIQUET COMMERCIAL; Tissue Dilator; Two-Lumen Hemodialysis Catheter with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter; Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter,; USER-GARD NEEDLESS INJECTION HUB; UltraCath Continuous Nerve Block Catheter; UltraCath Continuous Nerve Block Kit; VASCUPUNCTURE PICC GUIDEWIRE; VESSEL CATH KIT; VectorFlow Antegrade Chronic Hemodialysis Catheter; VectorFlow Retrograde Chronic Hemodialysis Catheter; VectorFlow Retrograde Replacement Hub Set; Vessel catheterization Kit/Set; WECK; You-Bend Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip, ARROWg+ard Blue Catheter; You-Bend Two-Lumen Hemodialysis Catheterization Kit/Set with Blue FlexTip Catheter; instrument forceps; none; wrap, sterilization; wrap, sterilzation",1995-02-02,105,2023-02-13,0,0,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006425876%22&limit=1
"Djo, LLC",3017264244,3017264244,5919 Sea Otter Place Suite 200,Carlsbad,CA,92010,United States,"DJO, LLC",9015378,Complaint file establishment; Contract manufacturer; Manufacturer; Repackager or relabeler; Specification developer,106,BTX; BXB; DWL; EGJ; EYZ; FMP; FMQ; FNG; FQJ; FQL; FQM; FSA; FSD; GAX; GEX; GXY; GZI; GZJ; HCC; HRW; HSQ; HST; HWA; IKD; IKK; IKX; ILD; ILE; ILH; ILI; ILO; ILY; ILZ; IMA; IMD; IME; IMF; IMG; IMI; IMJ; IMP; INP; INQ; INT; INW; IOD; IOE; IOY; IOZ; IPF; IPG; IPM; IPR; IPW; IPX; IPY; IQE; IQF; IQI; IQJ; IQK; IRO; IRQ; IRS; IRT; ISA; ISY; ITC; ITG; ITH; ITJ; ITM; ITQ; ITS; ITW; JFC; JOW; KGX; KGZ; KIA; KMN; KNO; KNP; KPI; KQX; KQZ; KTB; KTD; KTZ; KYR; KYS; LGF; LIH; LKY; LLK; LOF; LSB; LWG; LXH; NAD; NDA; NGX; NOC; NUH; NYN; PDZ,"Board, Arm (With Cover), Sterile; Exerciser, Powered; Stocking, Medical Support (To Prevent Pooling Of Blood In Legs); Device, Iontophoresis, Other Uses; System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile; Protector, Skin Pressure; Restraint, Protective; Lift, Patient, Ac-Powered; Support, Scrotal, Therapeutic; Stocking, Medical Support (For General Medical Purposes); Bandage, Elastic; Lift, Patient, Non-Ac-Powered; Binder, Abdominal; Tourniquet, Nonpneumatic; Powered Laser Surgical Instrument; Electrode, Cutaneous; Stimulator, Neuromuscular, External Functional; Stimulator, Nerve, Transcutaneous, For Pain Relief; Device, Biofeedback; Dynamometer, Nonpowered; Belt, Pelvic, Traction; Apparatus, Traction, Non-Powered; Impactor; Cable, Electrode; System, Isokinetic Testing And Evaluation; Aid, Transfer; Adaptor, Dressing; Sling, Arm, Overhead Supported; Splint, Hand, And Components; Sling, Arm; Pack, Hot Or Cold, Water Circulating; Lamp, Infrared, Therapeutic Heating; Accessories, Traction; Pack, Heat, Moist; Pack, Hot Or Cold, Disposable; Pack, Hot Or Cold, Reusable; Unit, Chilling; Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat; Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat; Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat; Cushion, Wheelchair; Tips And Pads, Cane, Crutch And Walker; Table, Powered; Plinth; Table, Mechanical; Components, Exercise; Bars, Parallel, Exercise; Support, Arm; Splint, Abduction, Congenital Hip Dislocation; Stimulator, Muscle, Powered; Shoe, Cast; Cover, Limb; Crutch; Orthosis, Sacroiliac, Soft; Orthosis, Rib Fracture, Soft; Orthosis, Lumbo-Sacral; Orthosis, Lumbar; Orthosis, Cervical-Thoracic, Rigid; Orthosis, Limb Brace; Splint, Clavicle; Orthosis, Cervical; Vibrator, Therapeutic; Unit, Heating, Powered; Head Halter, Traction; Pad, Heating, Powered; Massager, Therapeutic, Electric; Joint, Knee, External Limb Component; Stirrup, External Brace Component; Bandage, Cast; Equipment, Traction, Powered; Walker, Mechanical; Cage, Knee; Joint, Knee, External Brace; Joint, Hip, External Brace; Joint, Ankle, External Brace; System, Pressure Measurement, Intermittent; Sleeve, Limb, Compressible; Tape And Bandage, Adhesive; Accessories, Catheter; Cover, Cast; Chair And Table, Medical; Accessories, Wheelchair; Orthosis, Corrective Shoe; Stimulator, Electrical, Non-Implantable, For Incontinence; Goniometer, Ac-Powered; Component, Traction, Non-Invasive; Device, Iontophoresis, Specific Uses; Orthosis, Abdominal; Caliper; Bag, Ice; Insoles, Medical; Component, Cast; Interferential Current Therapy; Device, External Penile Rigidity; Legging, Compression, Non-Inflatable; Stimulator, Bone Growth, Non-Invasive; Unit, Fluidotherapy; Surgical Table Cushion; Orthopedic Manual Surgical Instrument; Dressing, Wound, Occlusive; Helmet, Cranial, For Protective Use; Stimulator, Muscle, Powered, For Muscle Conditioning; Splint, Extremity, Non-Inflatable, External, Non-Sterile; Stimulator, Nerve, Transcutaneous, Over-The-Counter; Stimulator, Electrical, Transcutaneous, For Arthritis; Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis",1; 2,", BAG HOLDERS; 300PV; 3D ActiveTrac; 6400, 7400, 8600 Low Back Electrode; A2 WRIST BRACE; A60 ANKLE BRACE; ABDOMINAL; ABDOMINAL SUPPORTS; ABDUCTED THUMB SPICA; AC SPORT BRACE; ACROMIOCLAVICULAR BRACE-UNIV; ACTIVE ANKLE T1 ORTHOSIS; ACTYTOE FOOT BRACE; ACTYTOE LIFT; ACTYTOE NIGHT SPLINT; ADVANTAGE STABILIZING ELASTIC WRIST; AIR STIRRUP II ANKLE BRACE; AIR-STIRRUP; AIR-STIRRUP™ ANKLE BRACE; AIRGO; AIRHEEL; AIRLIFT PTTD ANKLE BRACE; AIRSPORT BRACE; AK SUSPENSION WRAP; ALP II; ANAFORM ARM SLEEVE; ANAFORM CALF SLEEVE; ANAFORM SHIN SPLINT SLEEVE; ANAFORM WRIST WRAP; ANKLE BRACES; ANKLET; ARM ELEVATOR SLING; ARM ELEVATOR STING; ARM IMMOBILIZER SLING; ARTHRITIS GLOVES; ARTROMOT® ACTIVE-K; ARTROMOT®-E2; ARTROMOT®-E2 Compact; ARTROMOT®-S4; ARTROMOT®-SP3 Comfort; ARTROMOT®-SP3 Comfort Chip; ARTROMOT®-SP3 Standard; ARTROMOT®-SP3 Standard Chip; ATHLETIC TAPE; Action Patch; Active; Active Back Brace; Adapta; Advanced Dynamic ROM Orthosis; AirSport+; BINDER; BIONIC ELBOW BRACE; BIONIC REEL-ADJUST WRIST BRACE; BOOMERANG WRIST SUPPORT; BUCKS TRACTION; BURNHAM THUMB; Bionic Ankle Brace; Body Holder; CALF SLEEVE; CARPAFORM WRIST BRACE; CAST COMPONENT; CATHETER STRAP; CERVICAL COLLARS; CERVICAL#PHYSICAL MEDICINE; CLAVICLE SUPPORTS; CLINIC TENNIS ELBOW; COLD THERAPY DEVICE; COLLES SPLINT; COMFORT FORM WRIST; CONDILAX ELBOW SUPPORT; CONTOURED ELASTI-WRAP; CORRECTIVE SHOE; CPM PADS; CRYOKNEE W/ COLD PAD; CRYOKNEE W/ COLD UNIT; CTS WRIST SUPPORT; CUSTOM ADJUSTABLE OA DEFIANCE; Cane, Crutch, & Walker Tips & Pads; Champion (Hybresis) Iontophoretic Drug Delivery Device; Chattanooga Continuum; Chattanooga Continuum KIT; Chattanooga Deluxe Exerciser; Chattanooga Heating Unit; Chattanooga Standard Exerciser; Chattanooga Std Exerciser Retail Pk; Compex Fitness Trainer; Compex RX; Compex SP4; Compex Sport; Compex Sport 4; Compex Sport Elite; Compex Strive; Compex Wireless USA; Compression Knee Dressing; CryoKnee Brace; Cybertech Chairback Frame; Cybertech Premium Plus; DEFIANCE; DEFIANCE III; DEFIANCE III FEMALE FOURCE; DEFIANCE III, CCMI; DEFIANCE PINCH GUARD; DELUX ANKLE; DELUXE ROM ELBOW; DIGIFORM FINGER SPLINT; DIGIFORM WRIST-FINGER BRACE; DONJOY ELBOW GUARD; DONJOY Lite; DONJOY Low Profile; DONJOY SI BELT; DONJOY SPORTS ANKLE; DONJOY SPORTS THIGH WRAP; DONJOY VISTA REHABI; DOUBLE STRAP ANKLE WRAP; DR. KOOL HYPOTHERMIC SYSTEM; DRYTEX,ROCKETSOC; DUOFORM WRIST BRACE ADULT; DUOFORM WRIST BRACE PEDIATRIC; Donjoy ACHILLOFORCE AIR; Dupel; Dura Stick; Dura-Stick; Dura-Stick +; Dura-Stick + Snap; Dura-Stick BG; Dura-Stick Premium; ECONOSOC; ELASTIC ELBOW SUPPORT; ELASTIC SHOULDER IMMOBILIZER; ELASTIC WRIST BRACE; ELBOW IMMOBILIZER; ELBOW PROTECTORS; ELBOW RANGER; ELBOW SLEEVE; ELBOW SPIDER PAD; ENHANCED HYBRID ELS BRACE; EPIFORCE; ERGOFORM THUMB BRACE; EXCELERATOR ANKLE STIRRUP; EXCYABIR SHORT W/ COLD UNIT; EXCYABIR W/ COLD UNIT; EXOS FORM II; EXOS® FREE MOTION ANKLE; Electrode SIL/CARBON 6x8CM BLK; Empi Elite; Excyabir Hip Brace; Exos FreeMotion Ankle; FORTILAX ELASTIC ANKLE; FUNCTIONAL KNEE BRACE; Galaxy 3; Galaxy 5; HEAD HALTER; HEEL; HIP ABDUCTION KIT; HIP BRACE; HIP BRACE II; HOT OR COLD PACK; Hybresis; I-Bresis; I-ROM ELBOW; IMAK ELBOW WRAP; IMAK SMART GLOVE W/THUMB; IONTOPHORESIS; Innova® Reusable Comfortpulse Electrodes; Intelect RPW; Intelect RPW 2; Intelect Transport 2 Combo (Neurostimulator and Ultrasound); Intelect Transport 2 Ultrasound; Iomed; Iontophoresis Device, Modification (TQ1 Modified RH-801); JUMP BRACE; KALLASSY ANKLE SUPPORT; KALLASSY LACE-UP ANKLE; KNEE AND OTHER STINGS; KNEE SLING; KODEL CLAVICLE; KODEL SHOULDER IMMOB; LACE-UP WRIST SUPPORT; LERMAN SHOULDER ORTHOSIS; LIMB#PHYSICAL MEDICINE; LITES ELBOW VISCO; LITES VISCO ANKLE; LOAD SENSOR KIT; LONG THUMB SPICA II; LSO Low Profile; Limb Holder Quick Release; MALLEOFORCE; MALOLAX ELASTIC ANKLE; MANUFORCE WRIST BRACE; MAYO CLINIC ELBOW BRACE; MODEL 1100 COLD THERAPY DEVICE; MW-1000 Iontophoretic Electrode; ManaFuse; MaxTrax Air 2; MaxTrax Standard 2; Maxima; Minnova; Montane Andes 7; Multiple Sizes of Steam Packs; NEO TENNIS ELBOW; NM III; NXT GEN Cervical Collar; New Life; Nylatex, wrap to hold cold pad, Accessories; OA Go; ON TRACK TAPE PATCHES; OptiFlex®-K1 Classic; OptiFlex®-K1 Comfort Chip; OptiFlex®-K1 Standard; OptiFlex®-S; OrthoDx Neuromuscular Stimulator; PADDED FINGER COT; PALM MET; PERFORMANCE WRIST WRAP; PERFORMER ELBOW SUPPORT; PLANTAR FASCIITIS STRETCH; PLAYMAKER XPERT SLEEVE; PNEUMATIC ARMBAND; PODALIB NOIR PEDIATRIC; POSTERIOR ELBOW BRACE; POSTURE CLAVICLE SUPPORT; PROTECTOR; Performance Snap; Personal Limb Holder; Phoresor II Auto, Mode PM800 Modification; Phoresor II, Model PM900; Phoresor Model PM2000; Protective Restraint; Protective Restraint - Belts; QUICK RELOAD ECONOMY SHOULDER IMMOBILIZER; QUICK-FIT WRIST BRACE; Quantum Adaptable; Quick Release Limb Holder; REGION 3D TABLE 120V; REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S; REPLACEMENT WRAPS; RH-801, Ag/AgCl, Model TransQ; RH-801/GS Model TransQ®1; RH-900 Electrode; RH-950 Electrode; RHIZOFORM THUMB BRACE; RIB BELT; ROAM OA KNEE BRACE; ROCKETSOC; RX Fit; SACRO-LUMBAR SUPPORTS; SAFETY WRIST BRACE; SAMMONS PRESTON, ARMBAND; SCOI SHOULDER BRACE; SHOULDER CRADLE; SHOULDER IMMOBILIZER; SI BELT; SKIN PRESSURE#GENERAL HOSPITAL; SOFTOES; SPECIALTY SHOULDER IMMOBILIZER; SPORT WRAP KIT; SPORT-STIRRUP; STABILIZING ANKLE; STABILIZING SPEED PRO ANKLE WRAP; STIRRUP ANKLE SPRT; STRAPILAX ELASTIC ANKLE; SULLY SHOULDER; SUPER-LITE A.F.O; SUPPORT EVEREST ICE II SLEEVE; SURROUND FLOAM ANKLE; SURROUND FLOAM ELBOW; SURROUND GEL ANKLE; Saunders Electronic Inclinometer; Saunders Pelvic Traction Belt; Saunders Sacroiliac Belt; Secure All Finger Control Mitt; Secure All One Piece Body Holder; Secure All Pelvic Holder; Select; Small Vaginal/Rectal Electrode; Standard Chairback; Staodyn MaxPreset Model 4470; Steam Pack to Chattanooga Heating Unit; Stimulator, muscle, powered; Strive; Surgical Table Cushion; System 2 Zippered Body Holder; TENNIS ELBOW BRACE; TL7; TL7 Chattanooga Leadwires; TRACTION ACCESSORIES; TRIZONE CALF SLEEVE; TRIZONE ELBOW BRACE; TTFT; Tape Patches; Theratherm; TransQ Electrode, Phoresor II; TransQ1 Iontophoresis Electrode RH 800; TransQ2, Electrode RH-805; TransQ3 Electrode; Trizone Ankle Brace; ULTRASLING IV; ULTRASLING PRO; UNIVERSAL ANKLE BRACE; UNIVERSAL WRIST SUPPORT; Ultra Care Vest Body Holder; Ultra Care Vest with Safety Sleeve; VARIOUS TYPES; VCOMFORT FORM WRIST THUMB; VDELUXE WRIST FOREARM; VELOCITY LITE ANKLE BRACE; VELOCITY LS; VENAFLOW AND ARTERIA; VENAFLOW ELITE; VQ ABDUCTED THUMB SPICA; VQ, UNIVERSAL ANKLE BRACE; Vascular System; Velocity Extension Cuff; VenaFlow Elite System & Accessories; VenaFlow Sterile Cuff; VenaFlow System; VenaGo; VenaPro; WALKERS; WEEKENDER; WESTERN WRIST SLEEVE; WHEELCHAIR PADS; WHEELCHAIR#PHYSICAL MEDICINE; WRIST MANAGEMENT; WRIST-O-PRENE SUPPORT; Wraparound Limb Holder; X-ACT ROM ELBOW BRACE; ZYNEX CERVICAL TRACTION DEVICE; ZYNEX LUMBAR TRACTION DEVICE",1998-04-15,103,2026-09-29,2,4,1,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223017264244%22&limit=1
GC America Inc.,1410097,1410097,3737 W 127th St,Alsip,IL,60803,United States,GC America Inc.,8030268,Complaint file establishment; Contract manufacturer; Manufacturer; Remanufacturer; Repackager or relabeler,38,DYH; DYT; DZE; DZN; EBC; EBD; EBF; EBG; EBH; EBI; EBZ; EFD; EFX; EGD; EHM; EHY; EID; EIE; EIH; EJB; EJH; EJQ; EJR; ELR; ELW; EMA; FLG; KIF; KLE; LBH; LFD; LRJ; LYC; MED; NFS; NHA; NOF; NXC,"Adhesive, Bracket And Tooth Conditioner, Resin; Maintainer, Space Preformed, Orthodontic; Implant, Endosseous, Root-Form; Instruments, Dental Hand; Sealant, Pit And Fissure, And Conditioner; Coating, Filling Material, Resin; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Material, Impression Tray, Resin; Resin, Denture, Relining, Repairing, Rebasing; Activator, Ultraviolet, For Polymerization; Amalgamator, Dental, Ac-Powered; Protector, Silicate; Wax, Dental, Intraoral; Strip, Polishing Agent; Tray, Impression, Preformed; Syringe, Restorative And Impression Material; Dam, Rubber; Powder, Porcelain; Handle, Instrument, Dental; Alloy, Metal, Base; Wheel, Polishing Agent; Agent, Polishing, Abrasive, Oral Cavity; Post, Root Canal; Material, Impression; Cement, Dental; Cleaner, Ultrasonic, Medical Instrument; Resin, Root Canal Filling; Agent, Tooth Bonding, Resin; Varnish, Cavity; Saliva, Artificial; Disinfectant, Medical Devices; Bone Grafting Material, Synthetic; Sterilant, Medical Devices; Device, Jaw Tracking, For Monitoring Jaw Positions; Abutment, Implant, Dental, Endosseous; System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations; Aligner, Sequential",1; 2; U,"AIM2; APPLIER III; Aadva Lab Scanner 2; Aadva Lab Scanner 3; Aadva Ti Coloring Service; Alike; Applicator Holder; Applier IV; Aroma Fine; Aroma Fine Plus; BZF-29; COE TEMP ADVANTAGE; COE-PAK AUTOMIX NDS; Capsule Mixer CM-II; Ceramic Primer; Ceramic Primer II; Ceramic Primer II Unit Dose; Cerasmart; Cerasmart 270; Cerasmart Universal; Check Bite Tray; Coe Alginate; Coe Cal; Coe Cide IX Plus; Coe Cide XL; Coe Comfort; Coe Hydrophilic Gel (GHG); Coe Lubricant; Coe Ortho Alginate; Coe Sideless Impression Tray; Coe Soft; Coe Soft Print; Coe Syringe; Coe Tray Adhesive; Coe Tray Plastic; Coe-Cal; Coe-Flex; Coe-Pak Hard & Fast Set Standard Pak; Coe-Pak Standard Pkg; Coe-Rect; CoeFect Minute Spray; CoeFect Minute Wipes; Coezyme; Creation; Creation CC; Creation LS; Creation Magic Colour; Creation ZI-CT, ZI-F; Cytrans Granules; Dental Prescale II; Depressed Anterior Tray; Diapolisher Paste; Dispensing Guns Plunger for Universal Dispenser; EPITEX; EPITEX FINISHING; EQUIA; EQUIA Coat; EQUIA Fil; EQUIA Forte; EQUIA Forte Coat; EQUIA Forte Fil; EQUIA Forte HT Fil; EXA Advanced; EXA'Lence; EXAFAST NDS; EXAFAST PUTTY; EXAFLEX IMPRESSION MATERIAL; EXAMIX NDS; Eon Aligner; Essentia; Essentia Universal; Exa Advance; Exa'Lence Fast; Exa'Lence Putty; ExaClear; Exabite II NDS; Exaflex; Exajet; Exalence 370; FIT CHECKER; FIT CHECKER II; Fixpeed; Foundation; Fuji Duet; Fuji Filling LC; Fuji Filling LC Self Conditioner; Fuji IX; Fuji IX ART; Fuji Lining LC Paste Pak; Fuji Ortho LC; Fuji Plus; Fuji Spatula; Fuji Triage; Fuji Varnish; FujiRock; Fujivest II; Fusion Fast; Fusion Putty; G-2 Bond Universal Kit; G-Bond; G-Bond Plus; G-CEM Automix; G-CEM CAPSULE; G-CEM ONE; G-CEM Try-in Paste; G-CEM Veneer; G-COAT; G-Cem; G-Cem LinkForce; G-Cem LinkForce Try-In Paste; G-Cera Orbit Color; G-Cera Orbit LC; G-Coat Plus; G-Fix; G-Multi Primer; G-Premio Bond; G-Premio Bond DCA; G-aenial A-Chord; G-aenial Bond; G-aenial Bond Unit Dose; G-aenial Bulk Injectable; G-aenial Flo; G-aenial Flo X; G-aenial Injection Matrix Kit; G-aenial Sculpt; G-aenial Universal Flo; G-aenial Universal Injectable NMF004A; G2-Bond Universal; GC Aadva IOS; GC Aadva IOS 100P; GC Aadva IOS 200; GC Aadva Implant System; GC Aadva Scanner; GC Aadva Zr Disk; GC Acrylic Primer; GC BITE COMPOUND; GC Baseline; GC Capsule Applier V; GC Cartridge Dispenser; GC Cartridge Dispenser II Plunger; GC Dry Mouth Gel; GC Dual Cure Activator; GC Fiber Post; GC Fuji Automix LC; GC Fuji Capsule Applier; GC Fuji Direct; GC Fuji Filling LC; GC Fuji Filling LC Self Conditioner; GC Fuji Lining LC Paste Pak; GC Fuji ORTHO BAND LC PASTE PAK; GC Fuji ORTHO BAND PASTE PAK; GC Fuji ORTHO LC; GC Fuji Ortho Band LC Automix; GC Fuji Ortho LC; GC Fuji Ortho LC Paste Pak Automix; GC Fuji PLUS; GC Fuji PLUS CAPSULE; GC Fuji PLUS CONDITIONER; GC Fuji Triage; GC Fuji Triage EP; GC FujiCEM 2 (Improved); GC FujiCEM Evolve; GC FujiVest; GC Fujii Plus No Etch; GC GAM-100; GC Gel Conditioner; GC Gold Label 9 HS Post. Rest.; GC Gold Label Hybrid; GC Gradia Diamond Polisher; GC Initial Brush; GC Initial ZR Disk HT; GC Initial ZR Disk ML Elite; GC Initial Zirconia Disk HT; GC Initial Zirconia Disk ST; GC Kalore; GC Lisi Press Vest; GC Metal Strips; GC Mixing Tips for Ortho; GC OPA-100; GC OPB-100; GC Occlusal Matrix; GC Optiglaze; GC Oral Moisturizing Gel; GC Ortho Connect Flow; GC Pas/Cion; GC Pattern Resin; GC Reline; GC Reline (Primer, Modifier, Bondin; GC Reline Bonding Agent; GC Reline II; GC Reline Modifier; GC Reline Powder, Liquid; GC Reline Primer M; GC Reline Primer R; GC TEMP ADVANTAGE; GC Temp PRINT; GC TiON Gingival Protector; GC Tooth Mousse; GC Tooth Mousse Plus; GDLS-200; Gradia; Gradia Brush Tips; Gradia Composite Resin; Gradia Diapolisher Paste; Gradia Direct; Gradia Direct Flo; Gradia Plus; HTFX-222; ISO Functional; Impreceed; Impression Syringes; Initial; Initial Brush; Initial IQ; Initial IQ SQIN; Initial LiSi; Initial LiSi Block; Initial LiSi Press; Initial Lustre Paste One; Initial Lustre Pastes NF; Initial One; Initial PC; Initial Spectrum Stains; Initial TI; Intraoral Tips Universal/NDS; JC-50; Kooliner; LD-1 Milling Machiine; Lisi PressVest; MFP-051; MI Fil; MI Flow; MI PASTE; MI Paste; MI Paste Plus; MI Prophy Polish; MI Varnish; MSCB-001; MSN-006; McGowan -Winkler Impression Tray; Microtip Applicator; Mixing Tips; Multi Primer; Nanocoat Color; Nature Cryl HI Plus; Nature Cryl HI-20ET; Nature-Cryl MC; Nature-Cryl Pour; Nature-Cryl Super HI Impact; New Plastone; Nogenol Root Canal Sealer; Nogenol Temporary Cement; ORTHO CONDITIONER; ORTHO GEL CONDITIONER; Omniflex; Optiglaza Color; Optiglaze; Optiglaze Tips; POLISHING STRIPS; Paste Pak Dispenser; Paste Pak Dispenser II; Pattern Resin LS; Perforated Tray; Regular and Partial Tray; Revotek LC; SALIVA CHECK; SOLARE; SOLARE BULK; SOLARE P; Silverlight; Solare Universal Bond; Spacer Tray; Stainless Steel Tray; Stick; StickCARRIER; StickNET; StickREFIX; StickSTEPPER; Sto-K Tray; Super-Soft; Sympress 120; TEMPSMART; Temp Advantage; The Light; The Light 405; Ultimate F&P Kit; Ultimate Finishing & Polishing Kit; Unifast III; Unifast LC; Unifast Trad; Unitip Applier II; Universal VPS Adhesive; everStickC&B; everStickNET; everStickORTHO; everStickPERIO; everX Flow; everX Posterior; fibreNet; fibreStick",2003-05-13,105,2020-11-24,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221410097%22&limit=1
"Ge Parallel Design, Inc.",2032350,3003309342,4313 E Cotton Center BLVD Ste 100,Phoenix,AZ,85040,United States,GE HealthCare Technologies Inc.,9912004,Manufacturer,8,ITO; ITX; IYN; IYO; LLZ; OBJ; PAA; QIH,"Twister, Brace Setting; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; System, Image Processing, Radiological; Catheter, Ultrasound, Intravascular; Automated Breast Ultrasound; Automated Radiological Image Processing Software",1; 2; 3,"10-D; 10L; 10S-RS; 10T-D; 11L; 11L-D; 12L; 12L-RS; 12S-D; 12S-RS; 3.5C; 3CRF; 3S; 3S-D; 3Sc-RS; 4C; 4C-RS; 4D ICE catheter; 4D3C-L; 4Sc-RS; 4V-D; 4Vc-D; 5CS; 6S; 6S-D; 6S-RS; 6Sc-D; 6Tc; 6Tc-RS; 6VT-D; 6Vc-D; 7S; 7S-RS; 8C; 8C-RS; 8L-RS; 9L; 9L-D; 9L-RS; 9T; 9T-RS; 9VT-D; ABUS Single-Use Stabilization Membrane - non Sterile; BE9CS; BE9CS-D; BE9CS-RS; C1-5-D; C1-5-RS; C1-5-RS (only for Vivid T9); C1-6-D; C1-6VN-D; C2-9-D; C2-9-RS; C2-9VN-D; C3-10-D; C4-8-D; E7C8L-RS; E8C; E8C-RS; E8CS; E8CS-RS; E8Cs-RS; E8Cs-RS (only for Vivid T9); ERB; IC5-9-D; IC9-D; IC9-RS; IC9B-RS; Invenia ABUS; Invenia ABUS 2; Invenia ABUS Premium; Invenia ABUS Prime; Invenia ABUS Review Software; Invenia ABUS Scan Station; Invenia ABUS Viewer; Invenia ABUS Workstation; L10-22-RS; L12n-RS; L2-9-D; L2-9VN-D; L3-12-D; L3-12-RS; L4-12t-RS; L4-20t-D; L4-20t-RS; L6-12-RS; L6-24-D; L8-18i-D; L8-18i-RS; L8-18t-RS; LK760-RS; LOGIQ E10; LOGIQ E10s; LOGIQ E10s R2 to R3 UPG; LOGIQ E10s R2R3 to R4 HW Upgrade; LOGIQ E10s R2R3 to R4 HW Upgrade W; LOGIQ E10s R2R3 to R4 SW Upgrade; LOGIQ E10s R2R3 to R4 SW Upgrade W; LOGIQ E10s R3R4_R5 UPG SW + GPU; LOGIQ E10s R3R4_R5 UPG SW + GPU + Wifi; LOGIQ E10s R3R4_R5 UPG SW + Wifi; LOGIQ E10s R3R4_R5 UPG SW Only; LOGIQ E9; LOGIQ E9 XDClear 2; LOGIQ F; LOGIQ F6; LOGIQ F8; LOGIQ F8 Expert; LOGIQ Focus; LOGIQ Fortis; LOGIQ Fortis R3 to R4 HW Upgrade; LOGIQ Fortis R3 to R4 HW Upgrade W; LOGIQ Fortis R3 to R4 SW Upgrade; LOGIQ Fortis R3 to R4 SW Upgrade W; LOGIQ Fortis R3-R5 SW & WiFi Upgrade; LOGIQ Fortis R3-R5 SW HW Upgrade; LOGIQ Fortis R3-R5 SW, HW & WiFi Upgrade; LOGIQ Fortis R5 SW Upgrade; LOGIQ P10; LOGIQ P10 R4 to R4.5 UPG; LOGIQ P5; LOGIQ P7; LOGIQ P8; LOGIQ P8 R4 to R4.5 UPG; LOGIQ P9; LOGIQ P9 R4 to R4.5 UPG; LOGIQ S20; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power; LOGIQ S20 Pro; LOGIQ S7 Expert; LOGIQ S8; LOGIQ Totus; LOGIQ V1; LOGIQ V2; LOGIQ V3; LOGIQ V5; LOGIQ V5 Expert; LOGIQ Vita; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ Vita Pro; LOGIQ e; LOGIQ e NextGen; M5Sc-D; M5Sc-RS; M5sc-RS; M6C-D; ML4-20-D; ML4-20VN-D; ML6-15; ML6-15-D; ML6-15-RS; NextGen LOGIQ e; P2D; P6D; P6D-RS; PA6-8-D; Probe; RAB2-5-D; RAB2-5-RS; RAB2-6-RS; RAB4-8-D; RAB4-8-RS; RAB6-D; RAB6-RS; RAB7-D; RAM3-8; RIC10-D; RIC12-D; RIC5-9-D; RIC5-9A-RS; RIC5-9W-RS; RIC6-12-D; RM14L; RM6C; RM7C; RNA5-9-D; RNA5-9-RS; RSM5-14; RSP6-16-D; S4-10-D; SP10-16-D; Venue; Venue Fit; Venue Go; Venue Sprint; Venue Trident; Versana Active; Versana Balance; Versana Essential; Versana Premier; Versana Premier Lotus; Vivid Advanced; Vivid E80; Vivid E90; Vivid E95; Vivid Explorer; Vivid Focus; Vivid Pioneer; Vivid S60; Vivid S60N; Vivid S70; Vivid S70N; Vivid S70N Dimension; Vivid T8; Vivid T8 T9 v204 v205 to v206 UPG; Vivid T8 T9 v204 v205 to v206 UPG SW only; Vivid T8 T9 v206 to v208 SW only UPG; Vivid T9; Vivid iq; Vivid iq v203 to v206 UPG; Vivid iq v204 to v206 UPG; Vivid iq v204 to v206 UPG SW only; Vivid iq v206 to v208 HW+SW UPG; Vivid iq v206 to v208 SW only UPG; Voluson E series; Voluson E series BT15; Voluson E series BT16; Voluson E10; Voluson E10 BT16; Voluson E6; Voluson E6 BT16; Voluson E8; Voluson E8 BT16; Voluson E8 Expert; Voluson Expert 18; Voluson Expert 20; Voluson Expert 22; Voluson P6; Voluson P8; Voluson Performance 16; Voluson Performance 18; Voluson S series; Voluson S series BT16; Voluson S10; Voluson S10 BT16; Voluson S10 Expert; Voluson S6; Voluson S6 BT16; Voluson S8; Voluson S8 BT16; Voluson S8t; Voluson SWIFT; Voluson SWIFT+; Voluson e; Voluson i; eM6C; eM6C G2; eM6C G3; eM6CG2; eX7C; iC5-9-D; t739",2007-11-07,104,2026-10-02,1,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222032350%22&limit=1
Ortho-Clinical Diagnostics European Support Center,3000308930,3000308930,1500 Boulevard Sebastien Brant B.P. 30335,"Illkirch, CEDEX Bas-Rhin",,67411,France,QuidelOrtho Corporation,2024674,Complaint file establishment,112,CDN; CDP; CDT; CDZ; CEC; CEM; CEW; CFJ; CFN; CFT; CGJ; CGN; CGR; CHH; CHP; CIG; CIT; CIW; CIX; CJE; CJY; CZW; DAD; DBI; DCF; DCK; DDG; DDR; DEM; DGR; DHA; DHR; DHX; DIF; DIH; DIO; DIP; DIS; DJG; DJR; DKB; DKJ; DKZ; DLJ; DLZ; DMT; GTQ; JFY; JGJ; JGP; JGS; JHX; JID; JIH; JIS; JIT; JIX; JIY; JJE; JJX; JJY; JLW; JMO; JRC; JXM; JZJ; KHO; KHP; KHQ; KLI; KLS; KLT; KNK; KSF; KSG; KSI; KSN; KSZ; LBR; LBS; LCD; LCM; LDJ; LDO; LDP; LEG; LEH; LFM; LOL; LOM; LPS; LTK; MJX; MJY; MMI; MOI; MRG; MRR; MSJ; MZF; MZO; NBC; NIG; NQD; OHQ; PDJ; PMT; PPM; QKO; QKP; QVP; SEI,"Urease, Photometric, Urea Nitrogen; Radioimmunoassay, Total Triiodothyronine; Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides; Radioimmunoassay, Testosterones And Dihydrotestosterone; Radioimmunoassay, Free Thyroxine; Electrode, Ion Specific, Potassium; Radioimmunoassay, Parathyroid Hormone; Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase; Method, Nephelometric, Immunoglobulins (G, A, M); Radioimmunoassay, Prolactin (Lactogen); Radioimmunoassay, Follicle-Stimulating Hormone; Acid, Folic, Radioimmunoassay; Radioimmunoassay, Cortisol; Enzymatic Esterase--Oxidase, Cholesterol; Radioimmunoassay, Estradiol; Diazo Colorimetry, Bilirubin; Nadh Oxidation/Nad Reduction, Ast/Sgot; Starch-Dye Bound Polymer, Amylase; Bromcresol Green Dye-Binding, Albumin; Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes; Azo Dye, Calcium; Complement C3, Antigen, Antiserum, Control; Haptoglobin, Antigen, Antiserum, Control; Complement C4, Antigen, Antiserum, Control; Albumin, Antigen, Antiserum, Control; C-Reactive Protein, Antigen, Antiserum, And Control; Transferrin, Antigen, Antiserum, Control; Myoglobin, Antigen, Antiserum, Control; Alpha-1-Antitrypsin, Antigen, Antiserum, Control; Whole Human Serum, Antigen, Antiserum, Control; System, Test, Human Chorionic Gonadotropin; System, Test, Rheumatoid Factor; System, Test, Carcinoembryonic Antigen; Drug Mixture Control Materials; Colorimetry, Cholinesterase; Enzyme Immunoassay, Cocaine And Cocaine Metabolites; Enzyme Immunoassay, Diphenylhydantoin; Enzyme Immunoassay, Barbiturate; Enzyme Immunoassay, Opiates; Enzyme Immunoassay, Methadone; Calibrators, Drug Mixture; Colorimetry, Salicylate; Enzyme Immunoassay, Amphetamine; Calibrators, Drug Specific; Enzyme Immunoassay, Phenobarbital; Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet; Antistreptolysin - Titer/Streptolysin O Reagent; Enzymatic Method, Creatinine; Photometric Method, Magnesium; Lowry (Colorimetric), Total Protein; Electrode, Ion Specific, Sodium; Fluorometric Method, Cpk Or Isoenzymes; Photometric Method, Ammonia; Flame Photometry, Lithium; Calibrator, Primary; Calibrator, Secondary; Calibrator, Multi-Analyte Mixture; Photometric Method, Iron (Non-Heme); Analyzer, Chemistry (Photometric, Discrete), For Clinical Use; Single (Specified) Analyte Controls (Assayed And Unassayed); Multi-Analyte Controls, All Kinds (Assayed); Radioimmunoassay, Thyroid-Stimulating Hormone; Ferrozine (Colorimetric) Iron Binding Capacity; Micro Pipette; Enzyme Immunoassay, Benzodiazepine; Prealbumin, Antigen, Antiserum, Control; Fluorometer, For Clinical Use; Acid, Lactic, Enzymatic Method; Radioassay, Triiodothyronine Uptake; Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine; Enzyme Immunoassay, Theophylline; Enzyme Immunoassay, Carbamazepine; Acid, Uric, Uricase (Colorimetric); Kit, Quality Control For Blood Banking Reagents; Media, Potentiating For In Vitro Diagnostic Use; Lectins And Protectins; Centrifuge, Cell-Washing, Automated For Immuno-Hematology; System, Test, Automated Blood Grouping And Antibody; Ldl & Vldl Precipitation, Hdl; Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl; Enzyme Immunoassay, Gentamicin; Enzyme Immunoassay, Phencyclidine; Enzyme Immunoassay, Cannabinoids; Enzymatic Radiochemical Assay, Tobramycin; Colorimetry, Acetaminophen; Enzyme Immunoassay, Valproic Acid; Radioimmunoassay, Vancomycin; Enzyme Immunoassay, Digitoxin; Hepatitis A Test (Antibody And Igm Antibody); Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen); Urinary Homocystine (Nonquantitative) Test System; Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); Kit, Serological, Positive Control; Kit, Serological, Negative Control; Immunoassay Method, Troponin Subunit; System, Test, Immunological, Antigen, Tumor; System, Test, Vitamin D; System, Test, Low Density, Lipoprotein; Apolipoproteins; Test, Hiv Detection; Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus; Test, Natriuretic Peptide; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Cardiac C-Reactive Protein, Antigen, Antiserum, And Control; Multi-Analyte Controls Unassayed; Hemoglobin A1c Test System; Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens; General Purpose Reagent; Reagent, Coronavirus Serological; Coronavirus Antigen Detection Test System.; Sars-Cov-2 Serology Test; Qualitative And Quantitative Hepatitis B Virus Antibody Assays",1; 2; N; U,"DAT Control, MTS DAT Card; MTS Diluent 2; MTS Diluent 2 PLUS; ORTHO Antibody Enhancement Solution; ORTHO Bovine Albumin Solution Polymerized; ORTHO Bovine Serum Albumin, 22% Protein Concentration; ORTHO Confidence System; ORTHO Optix Reader; ORTHO VISION Analyzer; ORTHO VISION Analyzer - Certified; ORTHO VISION Max Analyzer; ORTHO Workstation; Ortho 7% BSA; Ortho Anti A1 Lectin; Ortho Coombs Control; Ortho Optix Reader; Ortho Rhhr Control (human & bovine); QuickVue At Home COVID-19; QuickVue COVID-19 Test Control Swab Set; QuickVue SARS Antigen Test; Quidel Molecular Adenovirus Control Set (M110); Quidel Molecular Bordetella Control Set (M117); Quidel Molecular C. difficile Control Set (M108); Quidel Molecular GBS Control Set (M116); Quidel Molecular HSV 1+2 Control Set (M109); Quidel Molecular HSV 1+2/VZV Control Set (M121); Quidel Molecular Influenza A+B Control Set (M106); Quidel Molecular Parainfluenza Virus Control Set (M115); Quidel Molecular RSV+hMPV Control Set (M107); Quidel Molecular Strep A+G Control Set (M111); Quidel Molecular Trichomonas Control Set (M119); Sofia 2 SARS Antigen FIA; Sofia SARS Antigen FIA; Solana HSV 1+2/VZV Control Set (M118); Solana Influenza A+B Control Set (M122); Solana RSV+hMPV Control Set (M123); VITROS 25-OH Vitamin D Total Calibrators; VITROS 25-OH Vitamin D Total Reagent Pack; VITROS 250 Chemistry System; VITROS 250 Chemistry System Refurbished; VITROS 350 Chemistry System; VITROS 3600 Immunodiagnostics System; VITROS 3600 Immunodiagnostics System - Certified; VITROS 3600 Immunodiagnostics System - Refurbished; VITROS 4600 Chemistry System; VITROS 4600 Chemistry System Refurbished; VITROS 5,1 FS Chemistry System; VITROS 5,1 FS Chemistry System Refurbished; VITROS 5600 Integrated System; VITROS 5600 Integrated System Certified; VITROS 5600 Integrated System Refurbished; VITROS 7% BSA; VITROS AAT Reagent; VITROS AAT/HPT Performance Verifiers; VITROS ACET Slides; VITROS AFP Range Verifier; VITROS ALB-TP Slides; VITROS ALC Slides; VITROS AMON Slides; VITROS AMPH Reagent; VITROS AMYL Slides; VITROS ASO Reagent; VITROS ASO/RF Performance Verifiers; VITROS AST Slides; VITROS Anti- HCV Reagent Pack; VITROS Anti-HAV IgM Calibrator; VITROS Anti-HAV IgM Controls; VITROS Anti-HAV IgM Reagent Pack; VITROS Anti-HAV Total Calibrators; VITROS Anti-HAV Total Controls; VITROS Anti-HAV Total Reagent Pack; VITROS Anti-HBc Calibrator; VITROS Anti-HBc Controls; VITROS Anti-HBc IgM Calibrator; VITROS Anti-HBc IgM Controls; VITROS Anti-HBc IgM Reagent Pack; VITROS Anti-HBc Reagent Pack; VITROS Anti-HBe Calibrators; VITROS Anti-HBe Reagent Pack; VITROS Anti-HBs Quantitative Calibrators; VITROS Anti-HBs Quantitative Controls; VITROS Anti-HBs Quantitative Reagent Pack; VITROS Anti-HCV Calibrators; VITROS Anti-HCV Controls; VITROS Anti-HIV 1+2 Calibrator; VITROS Anti-HIV 1+2 Controls; VITROS Anti-HIV 1+2 Reagent Pack; VITROS Anti-SARS-CoV-2 IgG Calibrator; VITROS Anti-SARS-CoV-2 IgG Controls; VITROS Anti-SARS-CoV-2 IgG Quantitative Calibrator EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Controls EUA210322; VITROS Anti-SARS-CoV-2 IgG Quantitative Reagent Pack EUA210322; VITROS Anti-SARS-CoV-2 IgG Reagent Pack; VITROS Anti-SARS-CoV-2 Total N Antibody Calibrator EUA210355; VITROS Anti-SARS-CoV-2 Total N Antibody Reagent Pack EUA210355; VITROS Anti-SARS-CoV-2 Total N Controls EUA210355; VITROS ApoA1 Performance Verifiers; VITROS ApoA1 Reagent; VITROS ApoB Performance Verifiers; VITROS ApoB Reagent; VITROS B12 Range Verifier; VITROS BARB Reagent; VITROS BENZ Reagent; VITROS BRAHMS PCT Calibrators; VITROS BRAHMS PCT Controls; VITROS BRAHMS PCT Range Verifier; VITROS BRAHMS PCT Reagent Pack; VITROS BuBc Slides; VITROS C3 Reagent; VITROS C4 Reagent; VITROS CA 125 II Calibrator; VITROS CA 125 II Range Verifier; VITROS CA 125 II Reagent Pack; VITROS CA 15-3 Calibrator; VITROS CA 15-3 Range Verifier; VITROS CA 15-3 Reagent Pack; VITROS CA 19-9 Calibrator; VITROS CA 19-9 Range Verifiers; VITROS CA 19-9 Reagent Pack; VITROS CAFFN Reagent Kit; VITROS CEA Calibrators; VITROS CEA Range Verifier; VITROS CEA Reagent Pack; VITROS CHE Slides; VITROS CK-MB Calibrator; VITROS CK-MB Range Verifier; VITROS CK-MB Reagent Pack; VITROS COCM Reagent; VITROS CRBM Slides; VITROS CREA Slides; VITROS CRP Performance Verifiers; VITROS Ca Slides; VITROS Calibrator Kit 1; VITROS Calibrator Kit 10; VITROS Calibrator Kit 11; VITROS Calibrator Kit 12; VITROS Calibrator Kit 13; VITROS Calibrator Kit 14; VITROS Calibrator Kit 16; VITROS Calibrator Kit 17; VITROS Calibrator Kit 19; VITROS Calibrator Kit 2; VITROS Calibrator Kit 20; VITROS Calibrator Kit 21; VITROS Calibrator Kit 22; VITROS Calibrator Kit 23; VITROS Calibrator Kit 24; VITROS Calibrator Kit 25; VITROS Calibrator Kit 26; VITROS Calibrator Kit 27; VITROS Calibrator Kit 28; VITROS Calibrator Kit 29; VITROS Calibrator Kit 3; VITROS Calibrator Kit 30; VITROS Calibrator Kit 31; VITROS Calibrator Kit 32; VITROS Calibrator Kit 4; VITROS Calibrator Kit 5; VITROS Calibrator Kit 8; VITROS Calibrator Kit 9; VITROS Calibrator Kit 99; VITROS Chemistry Products Calibrator Kit 25; VITROS Chemistry Products Performance Verifiers; VITROS Chemistry Products dHDL Slides; VITROS Cortisol Calibrator; VITROS Cortisol Range Verifier; VITROS Cortisol Reagent Pack; VITROS DAT Performance Verifiers; VITROS DGXN Slides; VITROS ECi Immunodiagnostic System; VITROS ECi Immunodiagnostic System Refurbished; VITROS ECiQ Immunodiagnostic System; VITROS Estradiol Calibrator; VITROS Estradiol Range Verifier; VITROS Estradiol Reagent Pack; VITROS FS Calibrator 1; VITROS FS Diluent Pack 1, 2, 3 and 4; VITROS FS Micro Tips; VITROS FS Reconstitution Diluent; VITROS FSH Calibrator; VITROS FSH Range Verifier; VITROS FSH Reagent Pack; VITROS Fe Slides; VITROS Ferritin Range Verifier; VITROS Folate Calibrator; VITROS Folate Range Verifier; VITROS Folate Reagent Pack 1/2; VITROS Free T3 Calibrator; VITROS Free T3 Range Verifier; VITROS Free T3 Reagent Pack; VITROS Free T4 Range Verifier; VITROS Free T4 Reagent Pack; VITROS GENT Reagent; VITROS HBeAg Calibrator; VITROS HBeAg Reagent Pack; VITROS HBsAg Calibrator; VITROS HBsAg Confirmatory Kit; VITROS HBsAg Controls; VITROS HBsAg Reagent Pack; VITROS HCY2 Performance Verifiers; VITROS HCY2 Reagent; VITROS HIV Combo Calibrator; VITROS HIV Combo Controls (Anti-HIV-1 group O); VITROS HIV Combo Controls (HIV p24 Antigen); VITROS HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2); VITROS HIV Combo Reagent Pack; VITROS HPT Reagent; VITROS HbA1c Reagent Kit; VITROS High Sample Diluent A and B; VITROS INTACT PTH Calibrators; VITROS INTACT PTH Controls; VITROS INTACT PTH Range Verifier; VITROS INTACT PTH Reagent Pack; VITROS IgA Reagent; VITROS IgG Reagent; VITROS IgM Reagent; VITROS Immuno-Wash Fluid; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls DEN210040; VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack DEN210040; VITROS Immunodiagnostic Products CA 19-9 Calibrator; VITROS Immunodiagnostic Products CA 19-9 Reagent Pack; VITROS Immunodiagnostic Products Progesterone 2 Calibrators; VITROS Immunodiagnostic Products Progesterone 2 Range Verifiers; VITROS Immunodiagnostic Products Total beta-hCG II Reagent Pack; VITROS Immunodiagnostic Products hs Troponin I Low Control; VITROS Immunodiagnostic Products hsTroponin I Calibrator; VITROS K+ Slides; VITROS LAC Slides; VITROS LDH Slides; VITROS LDHI SLides; VITROS LH Range Verifier; VITROS Li Slides; VITROS Liquid Performance Verifiers; VITROS METD Reagent; VITROS Metabolism Controls; VITROS Mg Slides; VITROS Micro Tips; VITROS MicroSensor Check Fluids; VITROS Myoglobin Calibrator; VITROS Myoglobin Range Verifier; VITROS Myoglobin Reagent Pack; VITROS NT pro-BNP Calibrators; VITROS NT pro-BNP Range Verifier; VITROS NT pro-BNP Reagent Pack; VITROS NT-proBNP II Reagent Pack; VITROS NTx Range Verifier; VITROS Na+ Slides; VITROS OP Reagent; VITROS PALB Performance Verifiers; VITROS PALB Reagent; VITROS PCP Reagent; VITROS PHBR Slides; VITROS PHYT Slides; VITROS Percent A1c Performance Verifiers; VITROS Performance Verifiers; VITROS Progesterone Calibrator Kit; VITROS Progesterone Range Verifier; VITROS Progesterone Reagent Pack; VITROS Prolactin Calibrator; VITROS Prolactin Range Verifier; VITROS Prolactin Reagent Pack; VITROS Protein Performance Verifiers; VITROS RF Reagent; VITROS Red Cell Folate Pack; VITROS Reference Fluids; VITROS SALI Slides; VITROS SARS-COV-2 Antigen Calibrator EUA202928; VITROS SARS-COV-2 Antigen Controls EUA202928; VITROS SARS-COV-2 Antigen Reagent Pack EUA202928; VITROS SARS-COV-2 Extraction Buffer EUA202928; VITROS Signal Reagent; VITROS T3 Uptake II Calibrator; VITROS T3 Uptake II Range Verifier; VITROS T3 Uptake II Reagent Pack; VITROS T4 Calibrator; VITROS TBIL Slides; VITROS TDM Performance Verifiers; VITROS THC Reagent; VITROS THEO Slides; VITROS TIBC Kit; VITROS TOBRA Reagent; VITROS TRFRN Reagent; VITROS TRIG Slides; VITROS TSH Calibrator; VITROS TSH Range Verifier; VITROS TSH Reagent Pack; VITROS Testosterone Calibrator; VITROS Testosterone Range Verifier; VITROS Testosterone Reagent Pack; VITROS Total PSA Range Verifier; VITROS Total T3 II Calibrator; VITROS Total T3 II Range Verifier; VITROS Total T3 II Reagent Pack; VITROS Total T4 Calibrator; VITROS Total T4 Range Verifier; VITROS Total T4 Reagent Pack; VITROS Total bhCG II Calibrator; VITROS Total bhCG II Range Verifier; VITROS Total bhCG II Reagent Pack; VITROS Troponin I ES Calibrators; VITROS Troponin I ES Range Verifier; VITROS Troponin I ES Reagent Pack; VITROS UPRO Performance Verifiers; VITROS UPRO Slides; VITROS URIC Slides; VITROS Universal Wash Reagent; VITROS Urine Electrolyte Diluent; VITROS VALP Reagent; VITROS VANC Reagent; VITROS Versa Tips; VITROS XT 3400 Chemistry System; VITROS XT 7600 Integrated System; VITROS XT 7600 Integrated System Certified; VITROS XT TBIL-ALKP Slides; VITROS XT TRIG-CHOL Slides; VITROS XT UREA-CREA Slides; VITROS dHDL Slides; VITROS dLDL Reagent; VITROS dTIBC Performance Verifiers; VITROS dTIBC Reagent; VITROS hsCRP Performance Verifiers; VITROS hsCRP Reagent; VITROS mALB Performance Verifiers; VITROS mALB Reagent",2020-11-24,98,2024-05-08,7,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223000308930%22&limit=1
Wipro Ge Medical Device Manufacturing Private Limited,3032109181,3032109181,"No. 4 Kadugodi Industrial Area Sadarmangala, Whitefield",Bangalore Karnataka,,560067,India,GE HealthCare Technologies Inc.,9912004,Manufacturer,39,BZQ; CBQ; CBR; CBS; CCK; CCL; DPS; DPZ; DQA; DQK; DRT; DSI; DSJ; DSK; DXH; DXN; FLL; GWQ; ITO; ITX; IYN; IYO; IZZ; JAK; KOI; KRB; LNH; LNI; MHX; MLD; NHO; NHP; NHQ; OBJ; OLT; OLW; OMC; ORT; QIH,"Monitor, Breathing Frequency; Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.); Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.); Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase; Analyzer, Gas, Oxygen, Gaseous-Phase; Electrocardiograph; Oximeter, Ear; Oximeter; Computer, Diagnostic, Programmable; Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm); Detector And Alarm, Arrhythmia; Alarm, Blood-Pressure; Computer, Blood-Pressure; Transmitters And Receivers, Electrocardiograph, Telephone; System, Measurement, Blood-Pressure, Non-Invasive; Continuous Measurement Thermometer; Full-Montage Standard Electroencephalograph; Twister, Brace Setting; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic; Table, Radiographic, Non-Tilting, Powered; System, X-Ray, Tomography, Computed; Stimulator, Nerve, Peripheral, Electric; Probe, Thermodilution; System, Nuclear Magnetic Resonance Imaging; System, Nuclear Magnetic Resonance Spectroscopic; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms); Monitor, St Segment With Alarm; Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration); Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration); Catheter, Ultrasound, Intravascular; Non-Normalizing Quantitative Electroencephalograph Software; Index-Generating Electroencephalograph Software; Reduced- Montage Standard Electroencephalograph; Burst Suppression Detection Software For Electroencephalograph; Automated Radiological Image Processing Software",1; 2,"10-D; 10T-D; 11L-D; 12L-RS; 12S-D; 12S-RS; 3CRF; 3Sc-RS; 4C-RS; 4D ICE catheter; 4Sc-RS; 4V-D; 4Vc-D; 6S-D; 6S-RS; 6Sc-D; 6Tc; 6Tc-RS; 6VT-D; 6Vc-D; 8C; 8C-RS; 9L-D; 9L-RS; 9T; 9T-RS; 9VT-D; Auto Positioning; B105M Patient Monitor; B105P Patient Monitor; B125M Patient Monitor; B125P Patient Monitor; B155M Patient Monitor; B1X5-F2, Second Frame; BE9CS; BE9CS-D; BE9CS-RS; C1-5-D; C1-5-RS; C1-5-RS (only for Vivid T9); C1-6-D; C1-6VN-D; C2-9-D; C2-9-RS; C2-9VN-D; C3-10-D; C4-8-D; Console Generation Upgrade; E7C8L-RS; E8C-RS; E8CS-RS; E8Cs-RS; E8Cs-RS (only for Vivid T9); G3 RAD Elevation Table; GCTBL-C4; GT1700V (GT1700V N9 ED3, GT1700V); GT1700V(GT1700V N9 ED3, GT1700V); IC5-9-D; IC9-D; IC9-RS; IC9B-RS; Kunlun Table; L10-22-RS; L12n-RS; L2-9-D; L2-9VN-D; L3-12-D; L3-12-RS; L4-12t-RS; L4-20t-D; L4-20t-RS; L6-12-RS; L6-24-D; L8-18i-D; L8-18i-RS; L8-18t-RS; LK760-RS; LOGIQ E10; LOGIQ E10s; LOGIQ E10s R2 to R3 UPG; LOGIQ E10s R2R3 to R4 HW Upgrade; LOGIQ E10s R2R3 to R4 HW Upgrade W; LOGIQ E10s R2R3 to R4 SW Upgrade; LOGIQ E10s R2R3 to R4 SW Upgrade W; LOGIQ E10s R3R4_R5 UPG SW + GPU; LOGIQ E10s R3R4_R5 UPG SW + GPU + Wifi; LOGIQ E10s R3R4_R5 UPG SW + Wifi; LOGIQ E10s R3R4_R5 UPG SW Only; LOGIQ E9; LOGIQ E9 XDClear 2; LOGIQ F; LOGIQ F6; LOGIQ F8; LOGIQ F8 Expert; LOGIQ Focus; LOGIQ Fortis; LOGIQ Fortis R3 to R4 HW Upgrade; LOGIQ Fortis R3 to R4 HW Upgrade W; LOGIQ Fortis R3 to R4 SW Upgrade; LOGIQ Fortis R3 to R4 SW Upgrade W; LOGIQ Fortis R3-R5 SW & WiFi Upgrade; LOGIQ Fortis R3-R5 SW HW Upgrade; LOGIQ Fortis R3-R5 SW, HW & WiFi Upgrade; LOGIQ Fortis R5 SW Upgrade; LOGIQ P10; LOGIQ P10 R4 to R4.5 UPG; LOGIQ P7; LOGIQ P8; LOGIQ P8 R4 to R4.5 UPG; LOGIQ P9; LOGIQ P9 R4 to R4.5 UPG; LOGIQ S20; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power; LOGIQ S20 Pro; LOGIQ S7 Expert; LOGIQ S8; LOGIQ Totus; LOGIQ V1; LOGIQ V2; LOGIQ V3; LOGIQ V5; LOGIQ V5 Expert; LOGIQ Vita; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ Vita Pro; LOGIQ e; LOGIQ e NextGen; Lite (LITE TABLE N9 ED3, Lite Table); M5Sc-D; M5Sc-RS; M5sc-RS; M6C-D; MAC 5 A4; MAC 5 A4 Resting ECG Analysis System; MAC 5 A5; MAC 5 A5 Resting ECG Analysis System; MAC 5 Lite; MAC 5 Lite Resting ECG Analysis System; ML4-20-D; ML4-20VN-D; ML6-15; ML6-15-D; ML6-15-RS; Monitor B105M; Monitor B105P; Monitor B125M; Monitor B125P; Monitor B155M; NG 2000 Table; NG LITE 1700 (NG1700 ELITE STANDARD TABLE); NG LITE 2000 (NG2000 ELITE HEAVY TABLE); NG1700 ELITE STANDARD TABLE; NG1700 Patient Table; NG1700SV TABLE; NG1700SV Table; NG2000 ELITE HEAVY TABLE; NG2000SV TABLE; NG2000SV Table; NG2000V table; NM/CT Patient Table; NextGen LOGIQ e; Optima CT680 Expert; P2D; P6D; RAB2-5-D; RAB2-5-RS; RAB2-6-RS; RAB4-8-D; RAB4-8-RS; RAB6-D; RAB6-RS; RAB7-D; RIC10-D; RIC12-D; RIC5-9-D; RIC5-9A-RS; RIC5-9W-RS; RIC6-12-D; RM6C; RM7C; RNA5-9-D; RNA5-9-RS; RSP6-16-D; Radiographic Table (Model: VFTBL-1); Revolution ACT; Revolution Ace; Revolution Maxima; S4-10-D; SIGNA Prime Elite; Standard table; Table (Model: GCTBL-C33); Table (Model: GCTBL-C3333); Table (Model: GCTBL-C4); VT1700 (GT1700 N9 ED3); VT1700V(GT1700V N9 ED3); VT2000 (GT2000 N9 ED3); VT2000X(GT2000x); Venue; Venue Fit; Venue Go; Venue Sprint; Venue Trident; Versana Active; Versana Balance; Versana Essential; Versana Premier; Versana Premier Lotus; Vivid Advanced; Vivid E80; Vivid E90; Vivid E95; Vivid Explorer; Vivid Focus; Vivid Pioneer; Vivid S60; Vivid S60N; Vivid S70; Vivid S70N; Vivid S70N Dimension; Vivid T8; Vivid T8 T9 v204 v205 to v206 UPG; Vivid T8 T9 v204 v205 to v206 UPG SW only; Vivid T8 T9 v206 to v208 SW only UPG; Vivid T9; Vivid iq; Vivid iq v203 to v206 UPG; Vivid iq v204 to v206 UPG; Vivid iq v204 to v206 UPG SW only; Vivid iq v206 to v208 HW+SW UPG; Vivid iq v206 to v208 SW only UPG; Voluson E series; Voluson E series BT15; Voluson E series BT16; Voluson E10; Voluson E10 BT16; Voluson E6; Voluson E6 BT16; Voluson E8; Voluson E8 BT16; Voluson Expert 18; Voluson Expert 20; Voluson Expert 22; Voluson P6; Voluson P8; Voluson Performance 16; Voluson Performance 18; Voluson S series; Voluson S series BT16; Voluson S10; Voluson S10 BT16; Voluson S10 Expert; Voluson S6; Voluson S6 BT16; Voluson S8; Voluson S8 BT16; Voluson S8t; Voluson SWIFT; Voluson SWIFT+; Voluson Signature 18; Voluson Signature 20; Voluson e; Voluson i; eM6C; eM6C G2; eM6C G3; eM6CG2; eX7C; iC5-9-D",2004-09-24,105,2026-10-02,0,0,0,2027,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223032109181%22&limit=1
WRP Asia Pacific Sdn. Bhd.,8041005,3002808507,"Lot 1, Jalan 3 Kawasan Perusahaan Bandar Baru","SALAK TINGGI, SEPANG Selangor",,43900,Malaysia,WRP ASIA PACIFIC SDN. BHD.,8041005,Complaint file establishment; Contract manufacturer; Manufacturer,12,BTR; EZL; FMC; GBA; GBX; IWP; KGO; LYY; LZA; LZC; OPJ; QDO,"Tube, Tracheal (W/Wo Connector); Catheter, Retention Type, Balloon; Patient Examination Glove; Catheter, Balloon Type; Catheter, Irrigation; Radiographic Protective Glove; Surgeon'S Gloves; Latex Patient Examination Glove; Polymer Patient Examination Glove; Medical Glove, Specialty; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Fentanyl And Other Opioid  Protection Glove",1; 2,IRONTON DISPOSABLE PF NTR GLOVES,1989-03-15,105,2024-03-28,0,1,0,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228041005%22&limit=1
Abbott Vascular,2024168,2024168,26531 Ynez RD.,Temecula,CA,92591,United States,ABBOTT LABORATORIES,1415939,Complaint file establishment; Manufacturer; Manufacturer for export; Specification developer,32,DQK; DQO; DQX; DQY; DRG; DSA; DSK; DTL; DXO; DYB; DYG; FGE; FOX; IYO; KDQ; LDF; LIT; LOX; MAF; MAV; MGB; NIM; NIN; NIO; NIP; NIQ; NIV; NQQ; NTE; NXW; OUG; QEZ,"Computer, Diagnostic, Programmable; Catheter, Intravascular, Diagnostic; Wire, Guide, Catheter; Catheter, Percutaneous; Transmitters And Receivers, Physiological Signal, Radiofrequency; Cable, Transducer And Electrode, Patient, (Including Connector); Computer, Blood-Pressure; Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass; Transducer, Pressure, Catheter Tip; Introducer, Catheter; Catheter, Flow Directed; Stents, Drains And Dilators For The Biliary Ducts; Stand, Infusion; System, Imaging, Pulsed Echo, Ultrasonic; Bottle, Collection, Vacuum; Electrode, Pacemaker, Temporary; Catheter, Angioplasty, Peripheral, Transluminal; Catheters, Transluminal Coronary Angioplasty, Percutaneous; Stent, Coronary; Syringe, Balloon Inflation; Device, Hemostasis, Vascular; Stent, Carotid; Stent, Renal; Stent, Iliac; Stent, Superficial Femoral Artery; Coronary Drug-Eluting Stent; Coronary Covered Stent; System, Imaging, Optical Coherence Tomography (Oct); Temporary Carotid Catheter For Embolic Capture; Scaffold, Infrapopliteal, Absorbable; Medical Device Data System; Aspiration Thrombectomy Catheter",1; 2; 3; f,"20/30 Indeflator; 20/30 PPAK w/COPILOT; 20/30 PPAK with Bleedback Control Valve; AMPLATZER Guidewires; Abbott Medical Epicardial Cable; Abbott Medical Patient Cable; Abbott Medical Threshold Cable; Absolute Pro 35 Biliary Self-Expanding Stent System; Absolute Pro LL Self-Expanding Stent System; Absolute Pro Self-Expanding Stent System; Absolute Pro Vascular Self-Expanding Stent System; Accessory Kit with Bleedback Control Valve; AptiVue™ Imaging Software version E.6; Armada 14 NC PTA Catheter; Armada 14 PTA Catheter; Armada 18 PTA Catheter; Armada 35 and 35LL Dilatation Catheters; Armada14 XT Dilatation Catheter; Barewire Filter Delivery Wire; COPILOT BBC Valve; Cable Connectors; CoroFlow Cardiovascular System; DOC Guide Wire Extension; Disposable Patient Cables; Dragonfly OPTIS Imaging Catheter; Dragonfly OPTIS Imaging Catheter Kit; Dragonfly OpStar™ Imaging Catheter.; E.4 Metallis Stent Optimization E.4 SW; ECG Adapter; Emboshield NAV6 Embolic Protection System; Esprit BTK Everolimus Eluting Resorbable Scaffold System; Flexi-Wire; Graftmaster; Graftmaster RX; Guide Wire Accessory Kit; Guide Wire Accessory Kit with Copilot; Guide Wire Accessory Kit with RHV; Guide Wire Introducer; GuideRight GuideWires; H-Torque Balance Middleweight Guide Wire; HI-TORQUE CROSS-IT 400XT GUIDE WIRE; HI-TORQUE Steelcore Bare Guide Wire; HT Command 14 MT; HT Command 14 ST; HT SPARTACORE; HT STEELCORE; HT SUPRA CORE; Hi-Torque All Star Guide Wire; Hi-Torque BMW Elite Guide Wire; Hi-Torque BMW Universal II; Hi-Torque BMW Universal II Guide Wire; Hi-Torque Balance Guide Wire; Hi-Torque Balance HeavyWeight Guide Wire; Hi-Torque Balance Meddleweight Universal II Guide Wire; Hi-Torque Balance Middleweight Elite Guide Wire; Hi-Torque Balance Middleweight Guide Wire; Hi-Torque Balance Middleweight Guide Wire with Microglide Coating; Hi-Torque Balance Middleweight Universal Guide Wire; Hi-Torque Balance Middleweight with Hydrophilic Coating; Hi-Torque Balance Trek Guide Wire; Hi-Torque Command 18; Hi-Torque Command Guide Wire; Hi-Torque Connect; Hi-Torque Connect Guide Wire; Hi-Torque Cross-It XT; Hi-Torque Extra S'Port Guide Wire; Hi-Torque Extra S'port; Hi-Torque Flex-T Guide Wire; Hi-Torque Flexi-Wire Guide Wire; Hi-Torque Floppy 18; Hi-Torque Floppy II Extra Support; Hi-Torque Floppy II Extra Support w/ Hydrocoat; Hi-Torque Floppy II Guide Wire; Hi-Torque Floppy II w/ Hydrocoat; Hi-Torque Infiltrac Guide Wire; Hi-Torque Iron Man; Hi-Torque Iron Man Guide Wire W/Mic; Hi-Torque JET Guide Wire; Hi-Torque Pilot Guide Wire; Hi-Torque Powerturn Guide Wires; Hi-Torque Proceed Guide Wire; Hi-Torque Progress Guide Wire; Hi-Torque Steelcore 18 Guide Wire; Hi-Torque Steelcore Guide Wire; Hi-Torque Supra Core Guide Wire; Hi-Torque Traverse Guide Wire; Hi-Torque TurnTrac Guide Wires; Hi-Torque VersaTurn Flex Guide Wire; Hi-Torque VersaTurn Guide Wire; Hi-Torque VersaTurn Ultraflex Guide Wire; Hi-Torque Versacore Floppy Guide Wire; Hi-Torque Versacore Guide Wire; Hi-Torque Versacore Modified J Guide Wire; Hi-Torque Versacore Standard Guide Wire; Hi-Torque Whisper Guide Wires; Hi-Torque Wiggle Guide Wire; Hi-Torque Winn; ILUMIEN Guided Therapy System; ILUMIEN OPTIS Mobile System; ILUMIEN OPTIS Mobile System Accessories; ILUMIEN OPTIS System and Accessories; ILUMIEN OPTIS, OPTIS Integrated, OPTIS Mobile with AptiVue Software version E.5.2; ILUMIEN System; ILUMIEN System and Accessories with Dragonfly OPTIS Imaging Catheter; ILUMIEN Systems with AptiVue Software Version D.3; ILUMIEN Therapy Guidance System; ILUMIEN™ OPTIS™ System; JETi Accessory Cart; JETi Hydrodynamic Thrombectomy System; JETi Non-sterile Canister Set; LOC Guidewire Extension; MULTI-LINK 8 Stent System; Mini Trek II OTW; Mini Trek II OTW (1.20 LTD IND; Mini Trek II OTW (1.50-20); Mini Trek II OTW Coronary Dilatation Catheter; Mini Trek OTW; Mini Trek OTW Dilatation Catheters; Mini Trek RX; Mini Trek RX (1.20 LTD IND);; Multi-Link 8-; Multi-Link Mini Vision; Multi-Link Vision-; NC TREK NEO; NC TREK OTW CORONARY DILATATION CATHETER; NC TREK RX CORONARY DILATATION CATHETER; NC TREK RX Coronary Dilatation Catheter; OPTIS Integrated Next Imaging System; OPTIS Integrated System and Accessories; OPTIS Mobile Next; OPTIS Mobile Next Imaging System; OPTIS Mobile System and Accessories; OPTIS™ Integrated System; OPTIS™ Mobile System; Omnilink 35 Biliary Stent System; Omnilink Elite; Optis Integrated Next; Optis Integrated Pre-Install Kit; Optis Mobile Next Direct Upgrade Accessory Kit; Optis Mobile Next Imaging System; Optis Next Upgrade Kit; Optis Tableside Controller Next; PPAK 20/30 w/.115 RHV; PPAK 20/30 w/96 RHV; Pacel Bipolar Pacing Catheter; Pacel Flow Directed Pacing Catheter; Pacel Flow Directed Pacing Catheter 401761, 401762, 401763, 401764; Pacel™ Bipolar Pacing Catheter 401765, 401775, 401766, 401776, 401767, 401768, 401769, 401770, 401771, 401772, 401773; Perclose AT; Perclose ProStyle Suture-Mediated Closue and Repair System; PressureWire X; ProGlide; Prostar XL 10 F; RX ACCULINK CAROTID STENT SYSTEM; RX Herculink Elite Biliary Stent Sy; RX Herculink Elite Renal Stent System; RX Viatrac 14 Plus Peripheral; RX Viatrac 14 Plus Peripheral Dilat; Rotating Hemostatic Valve; Rotating Hemostatic Valve (.115); SJM Adapter; SJM™ Epicardial Cable 401777, 401778; SJM™ Patient Cable 401758,401759,401760; SJM™ Threshold Cable 401748; Spartacore Guide Wire; StarClose SE Vascular Closure System; Supera; TAD Guide Wire; TAD II Guide Wire; Torque Device; Torque Device (10 Pack); Torque Device PTA 25-38; Torque Device; Guide Wire Introducer; Guide Wire Accessory Kit; Guide Wire Accessory Kit with RHV; Trek OTW; Trek RX; Trek RX; Mini Trek RX (1.50-20 Global);; Ultiri Measurement System; Ultra RX; Ultreon 2 Software Upgrade Kit; Ultreon 3 Software Upgrade Kit; Viatrac 14 Plus; X.act Carotid Stent System; XACT Transcarotid Stent System; XIENCE Alpine Everolimus Eluting Stent System; XIENCE PRIME Everolimus Eluting Stent System; XIENCE ProS Everolimus Eluting Stent System; XIENCE Sierra Everolimus Eluting Stent System; XIENCE Skypoint Everolimus Eluting Stent System; XIENCE V Everolimus Eluting Coronar; XIENCE V, OTW Drug Eluting Stent System; XIENCE V, RX Drug Eluting Stent System; XIENCE Xpedition Everolimus Eluting Stent System; XPERT PRO; Xact Carotid Stent System; Xience Nano; Xience V",1988-12-01,91,2026-04-24,13,31,5,2026,https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222024168%22&limit=1