Establishment name string | FDA registration number int64 | FEI number int64 | Street string | City string | State string | Postal code string | Country string | Owner or operator string | Owner or operator number int64 | Establishment types string | Device types listed int64 | Product codes string | Device names string | Device classes string | Brand names string | First device listed string | 510(k) clearances int64 | Latest clearance string | PMA approvals int64 | Recall events int64 | Class I recall events int64 | Registered through int64 | Source string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Medtronic Engineering and Innovation Center (MEIC) | 3,018,094,310 | 3,018,094,310 | BSR Tech Park Survey No.135, 138, 141 & 142 Nanakramguda Main Road | Hyderabad Telangana | null | 500032 | India | Medtronic, Inc. | 2,112,641 | 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; ... | 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); Humidif... | 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 Intermedi... | 1978-02-15 | 1,316 | 2026-04-21 | 30 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223018094310%22&limit=1 |
Exel Inc. Dba DHL Supply Chain (usa) | 3,008,868,758 | 3,008,868,758 | 9440 South State Road 39 Suite 200 | Mooresville | IN | 46158 | United States | Exel Inc. dba DHL Supply Chain (USA) | 10,026,656 | 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; ... | 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, S... | 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... | 2021-11-15 | 823 | 2021-04-08 | 1 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008868758%22&limit=1 |
Zimmer Biomet Taiwan Co., Ltd. | 3,011,683,674 | 3,011,683,674 | 7F., No. 35, Ln. 11, Guangfu N. Rd.,Songshan Dist. | Taipei | null | 105410 | Taiwan | Zimmer Biomet APAC DFE | 10,056,128 | 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; ... | 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, Ge... | 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 CO... | 2018-04-05 | 634 | 2022-10-04 | 2 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011683674%22&limit=1 |
Zimmer (Shanghai) Medical International Trading Co., Ltd. | 3,015,207,155 | 3,015,207,155 | Ground Floor 129 North Fu Te Road Pilot Free Trade Zone Pudong District | Shanghai | null | 200131 | China | Zimmer Biomet APAC DFE | 10,056,128 | 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; ... | 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, Gene... | 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 CO... | 2018-04-05 | 632 | 2022-10-04 | 2 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015207155%22&limit=1 |
Zimmer Biomet Korea Ltd. | 3,015,542,154 | 3,015,542,154 | 5F, Ilshin Building, 98 Hannamdae-ro, Yongsan-gu | Seoul | null | 04418 | South Korea | Zimmer Biomet APAC DFE | 10,056,128 | 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; ... | 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, Ge... | 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 CO... | 2018-04-05 | 629 | 2022-10-04 | 2 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015542154%22&limit=1 |
Biomet, Inc. | 1,825,034 | 1,825,034 | 56 E Bell Dr Po Box 587 | Warsaw | IN | 46581 | United States | Zimmer Inc | 1,825,034 | 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; ... | 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; Cutt... | 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 ... | 1977-12-28 | 613 | 2026-09-23 | 1 | 254 | 1 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221825034%22&limit=1 |
Synthes (USA) Products LLC | 3,008,812,560 | 3,008,812,560 | 1301 Goshen Pkwy | West Chester | PA | 19380 | United States | SYNTHES (USA) Products LLC | 2,520,274 | 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; ... | 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, M... | 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.... | 1978-03-16 | 597 | 2026-06-11 | 2 | 74 | 1 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008812560%22&limit=1 |
Sanicure BV | 3,012,494,290 | 3,012,494,290 | Evert van de Beekstraat 104 | SCHIPHOL Noord-Holland | null | 11118 CN | Netherlands | Sanicure BV | 10,052,769 | 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; ... | 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); Humidif... | 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;... | 2017-01-03 | 590 | 2026-03-11 | 2 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012494290%22&limit=1 |
Zimmer Biomet Pty Ltd | 3,035,366,890 | 3,035,366,890 | Level 4, 12 Narabang Way, Belrose, NSW | Sydney New South Wales | null | 2085 | Australia | Zimmer Biomet APAC DFE | 10,056,128 | 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; ... | 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, Ge... | 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 Sy... | 2018-04-05 | 560 | 2017-07-28 | 1 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223035366890%22&limit=1 |
CBR Enterprise Limited | 3,013,557,562 | 3,013,557,562 | 300 Des Voeux Road Central Suite A, 9/F., Wah Kit Commercial Centre | Hong Kong | null | Hong Kong | Hong Kong | CBR Enterprise Limited | 10,054,430 | 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; ... | 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... | 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, ... | 2017-03-22 | 548 | 2026-04-10 | 4 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013557562%22&limit=1 |
Mainline Medical Dental Supply | 3,012,421,607 | 3,012,421,607 | Rossdean Dr | North York Ontario | null | M9L 2S1 | Canada | Mainline Medical Dental Supply | 10,052,656 | 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; ... | 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, No... | 1; 2; 3; U | null | 2016-09-02 | 546 | 2026-04-10 | 2 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012421607%22&limit=1 |
Synthes GMBH | 3,009,417,901 | 3,009,417,901 | Luzernstrasse 21 | Zuchwil Solothurn | null | CH-4528 | Switzerland | SYNTHES GMBH / Synthes Produktions GmbH | 9,071,542 | 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; ... | 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, Su... | 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 CANNULATE... | 1981-02-24 | 538 | 2026-06-11 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009417901%22&limit=1 |
Zimmer Pte. Ltd. | 3,013,176,080 | 3,013,176,080 | 401 Commonwealth Drive #06-03 How Par Techno Centre | Singapore South East | null | 149598 | Singapore | Zimmer Biomet APAC DFE | 10,056,128 | 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; ... | 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; Neur... | 1; 2; 3; U | Biomet Knee Joint Replacement Prostheses; THE NATURAL-KNEE REVISION | 2018-08-14 | 538 | 2017-07-28 | 1 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013176080%22&limit=1 |
Philips Electronics Ltd | 3,000,126,629 | 3,000,126,629 | 1875 Buckhorn Gate, 5th Floor | Mississauga Ontario | null | L4W 5P1 | Canada | Philips Medical Systems International BV | 1,217,116 | 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; ... | 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 ... | 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;... | 1992-11-19 | 522 | 2025-05-15 | 5 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223000126629%22&limit=1 |
Oketz Logistics LLC | 3,038,718,579 | 3,038,718,579 | 50 Minorca Ave | Coral Gables | FL | 33134 | United States | Oketz Logistics LLC | 10,093,578 | 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; ... | 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; Capsul... | 1; 2; U | null | 2008-06-17 | 486 | 2025-01-31 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223038718579%22&limit=1 |
Karl Storz Endoscopy-America, Inc. | 3,010,202,439 | 3,007,475,226 | 2151 E. Grand Avenue | El Segundo | CA | 90245 | United States | KARL STORZ SE & CO KG | 8,010,119 | 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; ... | 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); L... | 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... | 1978-06-20 | 465 | 2026-10-14 | 1 | 27 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010202439%22&limit=1 |
Medtronic Sofamor Danek Usa, Inc. | 1,030,489 | 1,000,477,302 | 1800 Pyramid Place | Memphis | TN | 38132 | United States | Medtronic, Inc. | 2,112,641 | 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; ... | 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, Inst... | 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;... | 1978-02-15 | 455 | 2026-07-17 | 9 | 43 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221030489%22&limit=1 |
Karl Storz Endoscopy-America, Inc. | 2,020,550 | 2,020,550 | 28 Millbury Street | Auburn | MA | 01501 | United States | KARL STORZ SE & CO KG | 8,010,119 | 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; ... | 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); L... | 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 Syst... | 1978-06-20 | 437 | 2026-09-25 | 1 | 7 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222020550%22&limit=1 |
Teleflex Medical LLC | 3,011,137,372 | 3,005,747,797 | 3015 Carrington Mill Blvd | Morrisville | NC | 27560 | United States | Teleflex | 9,062,981 | 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; ... | 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, Nasophar... | 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 ... | 1985-04-29 | 421 | 2026-07-09 | 5 | 135 | 14 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011137372%22&limit=1 |
Arthrex, Inc. | 1,220,246 | 1,220,246 | 1370 Creekside Blvd | Naples | FL | 34108 | United States | ARTHREX, INC. | 1,220,287 | 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; ... | 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 So... | 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 COMPONE... | 1994-01-27 | 380 | 2026-10-29 | 0 | 18 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221220246%22&limit=1 |
Siemens Healthcare Diagnostics Inc. | 2,432,235 | 2,432,235 | 511 Benedict Ave | Tarrytown | NY | 10591 | United States | SIEMENS HEALTHCARE DIAGNOSTICS INC. | 9,096,044 | 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; ... | 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; Radioimm... | 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 G... | 1977-12-20 | 354 | 2026-08-10 | 17 | 129 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222432235%22&limit=1 |
Boston Scientific Corporation | 2,124,215 | 2,124,215 | 4100 Hamline Ave N | Saint Paul | MN | 55112 | United States | Boston Scientific Corporation | 9,912,058 | 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; ... | 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... | 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; AM... | 1983-09-09 | 318 | 2026-09-11 | 47 | 86 | 9 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222124215%22&limit=1 |
Smith & Nephew, Inc. | 1,020,279 | 1,020,279 | 1450 Brooks RD. | Memphis | TN | 38116 | United States | Smith & Nephew, Inc. | 1,020,279 | 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; ... | 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-Power... | 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 DRIL... | 1978-02-22 | 362 | 2026-09-08 | 1 | 105 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221020279%22&limit=1 |
MEDLINE INDUSTRIES, LP - Northfield | 1,417,592 | 1,417,592 | Three Lakes Drive | Northfield | IL | 60093 | United States | Medline Industries, LP | 1,417,592 | 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; ... | 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; Humidifi... | 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 SCR... | 1977-12-29 | 357 | 2026-03-25 | 0 | 249 | 29 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221417592%22&limit=1 |
Deroyal Industries, Inc. | 1,043,214 | 1,043,214 | 200 Debusk LN. | Powell | TN | 37849 | United States | DEROYAL INDUSTRIES, INC. | 1,044,833 | 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; ... | 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; Tra... | 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, Surgica... | 1991-04-03 | 351 | 2025-11-21 | 0 | 51 | 2 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221043214%22&limit=1 |
Synthes GMBH | 3,000,270,450 | 3,000,270,450 | Industriestrasse 28 | Selzach Solothurn | null | 2545 Selz. | Switzerland | SYNTHES GMBH / Synthes Produktions GmbH | 9,071,542 | 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; ... | 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, Genera... | 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/ Expand... | 1981-02-24 | 350 | 2026-06-11 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223000270450%22&limit=1 |
Karl Storz Se & Co KG | 3,014,342,096 | 3,014,342,096 | Dr.-Karl-Storz-Str. 34 | TUTTLINGEN Baden-Wurttemberg | null | 78532 | Germany | KARL STORZ SE & CO KG | 8,010,119 | 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; ... | 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... | 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; AR... | 1978-06-20 | 343 | 2026-10-14 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014342096%22&limit=1 |
Cook Incorporated | 1,820,334 | 1,820,334 | 750 Daniels Way | Bloomington | IN | 47404 | United States | COOK, INC. | 1,820,334 | 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; ... | 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; Connecto... | 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 Adapte... | 1977-12-31 | 334 | 2024-03-25 | 4 | 95 | 14 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221820334%22&limit=1 |
Zimmer, Inc. | 1,822,565 | 1,000,220,733 | 1800 W. Center Street | Warsaw | IN | 46580 | United States | ZIMMER, INC. | 1,822,565 | 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; ... | 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 Surger... | 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; ... | 1978-01-06 | 330 | 2026-09-24 | 1 | 267 | 3 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221822565%22&limit=1 |
Roche Diagnostics GMBH | 9,610,126 | 3,002,806,559 | Sandhofer Strasse 116 | MANNHEIM Baden-Wurttemberg | null | D-68305 | Germany | Roche Diagnostics Operations Inc. | 9,039,767 | 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; ... | 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, ... | 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,... | 1983-06-01 | 307 | 2026-10-20 | 22 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229610126%22&limit=1 |
Medos International Sarl | 3,008,114,965 | 3,008,114,965 | Chemin-Blanc 38 | Le Locle Neuchatel | null | 2400 | Switzerland | Medos International SARL | 10,031,083 | 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; ... | 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 (... | 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 SYS... | 2009-12-16 | 323 | 2026-05-26 | 1 | 2 | 1 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008114965%22&limit=1 |
Integra LifeSciences Corporation | 3,003,418,325 | 3,003,418,325 | 1100 Campus Road | Princeton | NJ | 08540 | United States | Integra LifeSciences Corporation | 9,004,007 | 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; ... | 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, ... | 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... | 1981-02-24 | 317 | 2026-06-23 | 5 | 124 | 7 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003418325%22&limit=1 |
Warsaw Orthopedic, Inc. | 1,824,199 | 1,824,199 | 2500 Silveus Xing | Warsaw | IN | 46582 | United States | Medtronic, Inc. | 2,112,641 | 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; ... | 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, Ge... | 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 Ce... | 1978-02-15 | 313 | 2026-07-17 | 6 | 6 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221824199%22&limit=1 |
Siemens Healthcare Diagnostics Inc. | 2,517,506 | 2,517,506 | 500 GBC DR, PO Box 6101 | Newark | DE | 19714 | United States | SIEMENS HEALTHCARE DIAGNOSTICS INC. | 9,096,044 | 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; ... | 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 Sp... | 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... | 1995-04-18 | 303 | 2026-07-24 | 3 | 180 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222517506%22&limit=1 |
Smith & Nephew, Inc. | 3,007,366,790 | 3,007,282,753 | 3303 E Holmes Rd | Memphis | TN | 38118 | United States | Smith & Nephew, Inc. | 1,020,279 | 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; ... | 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-Power... | 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 M... | 1978-02-22 | 302 | 2026-09-08 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223007366790%22&limit=1 |
Depuy Orthopaedics, Inc. | 1,818,910 | 1,818,910 | 700 Orthopaedic DR. | Warsaw | IN | 46582 | United States | DePuy Synthes, Inc. | 1,818,910 | 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; ... | 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; Ret... | 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 F... | 1977-12-22 | 295 | 2026-06-25 | 5 | 86 | 2 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221818910%22&limit=1 |
Boston Scientific Corporation | 1,000,121,056 | 1,000,121,056 | 8 Industrial Dr | Coventry | RI | 02816 | United States | Boston Scientific Corporation | 9,912,058 | 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; ... | 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 Connecto... | 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; Bla... | 1983-09-09 | 270 | 2026-09-03 | 21 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221000121056%22&limit=1 |
Siemens Healthineers AG | 3,004,977,335 | 3,004,977,335 | SIEMENSSTRASSE 1 -OR- Rittigfeld 1 | FORCHHEIM Bavaria | null | 91301 | Germany | Siemens Healthineers AG | 8,010,024 | 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, N... | 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 INTERFAC... | 2003-03-26 | 290 | 2026-09-25 | 1 | 1 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004977335%22&limit=1 |
Cardinal Health 200, LLC | 1,423,537 | 3,001,236,905 | 3651 Birchwood Drive | Waukegan | IL | 60085 | United States | Cardinal Health 200, LLC | 9,028,292 | 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; ... | 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, Trac... | 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 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221423537%22&limit=1 |
DePuy Synthes Sales | 3,034,676,720 | 3,034,676,720 | 75 Fruit St | Bridgewater | MA | 02324 | United States | SYNTHES (USA) Products LLC | 2,520,274 | 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; ... | 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; Tra... | 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 C... | 1978-03-16 | 274 | 2025-10-14 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223034676720%22&limit=1 |
Highridge Medical, LLC | 3,012,447,612 | 3,012,447,612 | 10225 Westmoor Dr | Westminster | CO | 80021 | United States | Highridge Medical, LLC | 9,061,535 | 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; ... | 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, Instru... | 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 Na... | 2004-02-27 | 260 | 2025-05-21 | 10 | 18 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012447612%22&limit=1 |
Globus Medical, Inc. | 3,030,412,764 | 3,030,412,764 | 4670 E. Shelby DR | Memphis | TN | 38118 | United States | GLOBUS MEDICAL, INC. | 9,056,090 | 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; ... | 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 & P... | 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; Em... | 2003-08-19 | 262 | 2026-08-04 | 3 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223030412764%22&limit=1 |
Medacta International SA | 3,005,180,920 | 3,005,180,920 | Strada Regina | Castel San Pietro Ticino | null | 6874 | Switzerland | Medacta International SA | 10,024,526 | 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; ... | 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, ... | 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 ... | 2008-02-11 | 264 | 2026-09-17 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223005180920%22&limit=1 |
Medacta International SA | 3,008,110,533 | 3,008,110,533 | Via Alla Rossa 6 | Rancate Ticino | null | 6862 | Switzerland | Medacta International SA | 10,024,526 | 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; ... | 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, ... | 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 ... | 2008-02-11 | 264 | 2026-09-17 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223008110533%22&limit=1 |
Conmed Corporation | 1,320,894 | 3,001,451,571 | 525 French Rd | Utica | NY | 13502 | United States | CONMED CORPORATION | 1,317,214 | 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; ... | 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... | 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 Sup... | 1992-06-27 | 258 | 2026-05-30 | 1 | 37 | 1 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221320894%22&limit=1 |
Depuy Spine, Inc. | 1,526,439 | 1,526,439 | 325 Paramount Drive | Raynham | MA | 02767 | United States | DePuy Spine, Inc. | 1,526,439 | 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; ... | 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, Instr... | 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... | 1987-05-17 | 258 | 2026-05-26 | 1 | 15 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221526439%22&limit=1 |
Arthrex Distribution Hub EMEA B.V. | 3,016,851,379 | 3,016,851,379 | Amperestraat 9 | Venlo Limburg | null | 5928 PE | Netherlands | ARTHREX, INC. | 1,220,287 | 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; ... | 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 Au... | 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; Appara... | 1994-01-27 | 255 | 2024-07-25 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223016851379%22&limit=1 |
Boston Scientific Limited | 9,681,260 | 3,002,806,565 | Ballybrit Business Park | GALWAY Galway(County) | null | '-- | Ireland | Boston Scientific Corporation | 9,912,058 | 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; ... | 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, Cardiopul... | 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; Bl... | 1983-09-09 | 231 | 2026-09-03 | 22 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229681260%22&limit=1 |
Teleflex LLC (NADC) | 3,010,041,511 | 3,010,041,511 | 11245 N Distribution Cove | Olive Branch | MS | 38654 | United States | Teleflex | 9,062,981 | 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; ... | 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-Rigi... | 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... | 1992-08-03 | 253 | 2025-07-03 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010041511%22&limit=1 |
Covidien | 1,219,930 | 1,219,930 | 60 Middletown Ave | North Haven | CT | 06473 | United States | Covidien llc | 1,282,497 | 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; ... | 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, P... | 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 ... | 1992-06-29 | 251 | 2026-07-01 | 1 | 74 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221219930%22&limit=1 |
Howmedica Osteonics Corp | 2,249,697 | 3,003,070,421 | 325 Corporate DR. | Mahwah | NJ | 07430 | United States | STRYKER CORP. | 1,811,755 | 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; P... | 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 Push... | 1992-11-23 | 240 | 2026-08-06 | 2 | 226 | 1 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222249697%22&limit=1 |
Medtronic Sofamor Danek Usa, Inc. | 3,003,120,897 | 3,003,120,897 | 4340 Swinnea Road | Memphis | TN | 38118 | United States | Medtronic, Inc. | 2,112,641 | 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; ... | 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; Chise... | 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... | 1978-02-15 | 219 | 2026-02-12 | 21 | 3 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223003120897%22&limit=1 |
Becton, Dickinson & Co. | 1,119,779 | 1,119,779 | 7 Loveton Cir. | Sparks | MD | 21152 | United States | Becton Dickinson and Company | 9,922,032 | 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; ... | 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 C... | 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 P... | 1977-12-29 | 236 | 2026-05-28 | 3 | 117 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221119779%22&limit=1 |
Arvato Usa LLC | 3,021,008,900 | 3,021,008,900 | 3303 E Holmes Rd | Memphis | TN | 38118 | United States | Arvato USA LLC | 10,082,727 | 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, Meta... | 1; 2; 3 | Smith and Nephew | 2021-09-23 | 228 | 2021-03-25 | 3 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223021008900%22&limit=1 |
Aesculap AG | 9,610,612 | 3,002,806,315 | Am Aesculap Platz | TUTTLINGEN, DONAU Baden-Wurttemberg | null | D-78532 | Germany | Aesculap AG | 8,010,193 | 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; ... | 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; Inst... | 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 INSTR... | 1977-11-07 | 229 | 2023-06-29 | 1 | 1 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229610612%22&limit=1 |
Abbott Laboratories | 3,005,333,358 | 3,005,333,358 | Conway Park 675 North Field Drive | Lake Forest | IL | 60045 | United States | ABBOTT LABORATORIES | 1,415,939 | 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; ... | 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), Tota... | 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 AMINOT... | 1977-12-13 | 218 | 2026-09-23 | 9 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223005333358%22&limit=1 |
Titanlinks Logistics LLC | 3,044,819,802 | 3,044,819,802 | 73 Omega Dr Suite 280 | Newark | DE | 19713 | United States | TitanLinks Logistics LLC | 10,095,876 | 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; ... | 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, Too... | 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; Cotto... | 2026-05-18 | 227 | 2025-08-27 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223044819802%22&limit=1 |
Arrow Internacional de Chihuahua S.A. de C.V. | 9,680,794 | 3,003,737,899 | Ave. Washington 3701, Interior Circuito Industrial Alta Tecnologia Edificios 2, 4, 36 and 40, Colonia Panamericana | Chihuahua | null | CP 31200 | Mexico | Arrow International LLC (subsidiary of Teleflex Incorporated | 2,518,433 | 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; ... | 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, Balloo... | 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 LO... | 1995-02-02 | 226 | 2025-03-14 | 0 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229680794%22&limit=1 |
Medtronic Puerto Rico Operations Co., Humacao | 2,647,346 | 2,647,346 | Road 909, KM. 0.4. Barrio Mariana | Humacao | PR | 00792 | United States | Medtronic, Inc. | 2,112,641 | 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,... | 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; ... | 1992-12-12 | 224 | 2026-04-21 | 2 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222647346%22&limit=1 |
STRYKER GmbH | 8,031,020 | 3,002,807,830 | Bohnackerweg 1 | SELZACH Solothurn | null | 2545 | Switzerland | STRYKER CORP. | 1,811,755 | 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, Fi... | 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... | 1977-12-29 | 224 | 2026-06-29 | 1 | 21 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228031020%22&limit=1 |
Gyrus ACMI, Inc. | 3,011,050,570 | 3,011,050,570 | 9600 Louisiana Ave North | Brooklyn Park | MN | 55445 | United States | OLYMPUS CORPORATION | 9,067,818 | 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; ... | 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; ... | 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; 70... | 1995-01-20 | 222 | 2026-07-01 | 1 | 6 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011050570%22&limit=1 |
Olympus Medical Systems Corp. | 8,010,047 | 3,002,807,795 | 2951 Ishikawa-Cho | HACHIOJI-SHI Tokyo | null | 192-8507 | Japan | OLYMPUS CORPORATION | 9,067,818 | 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; ... | 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, Gastroen... | 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-VC4... | 1995-01-20 | 217 | 2026-09-10 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%228010047%22&limit=1 |
Zapalign LLC | 3,043,226,252 | 3,043,226,252 | 2281 Griffin Rd | Fort Lauderdale | FL | 33312 | United States | Zapalign LLC | 10,095,225 | 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; ... | 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); Humidif... | 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; Cannu... | 2026-02-08 | 213 | 2026-03-11 | 0 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223043226252%22&limit=1 |
DePuy Mitek, Inc. | 1,221,934 | 1,221,934 | 325 Paramount Dr | Raynham | MA | 02767 | United States | DEPUY MITEK, A JOHNSON & JOHNSON COMPANY | 1,221,934 | 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; ... | 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, ... | 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 BRAND... | 1992-07-22 | 212 | 2026-02-26 | 0 | 26 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221221934%22&limit=1 |
Canon Inc. | 9,614,698 | 3,002,808,382 | 1385, Shimoishigami | OTAWARA-SHI Tochigi | null | 324-8550 | Japan | CANON INC. | 8,030,410 | 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,... | 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-0... | 2023-07-12 | 211 | 2026-05-20 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229614698%22&limit=1 |
Canon Inc. | 3,012,761,544 | 3,012,761,544 | 30-2 Shimomaruko, 3-Chome -- | OHTA-KU Tokyo | null | 146-8501 | Japan | CANON INC. | 8,030,410 | 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, Emissi... | 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-0... | 2023-07-12 | 211 | 2026-05-20 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012761544%22&limit=1 |
Coopersurgical, Inc. | 1,216,677 | 1,216,677 | 95 Corporate Drive | Trumbull | CT | 06611 | United States | COOPERSURGICAL, INC. | 9,002,384 | 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; ... | 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, U... | 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, 1031506... | 1977-12-09 | 211 | 2026-08-19 | 0 | 71 | 1 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221216677%22&limit=1 |
Icu Medical, Inc. | 2,025,816 | 2,025,816 | 951 Calle Amanecer | San Clemente | CA | 92673 | United States | ICU MEDICAL, INC. | 2,025,816 | 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; ... | 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); T... | 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 ... | 1999-08-04 | 211 | 2025-06-05 | 0 | 45 | 4 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222025816%22&limit=1 |
Wright Medical Technology, Inc. | 3,010,667,733 | 3,010,667,733 | 11500 Memphis Arlington Road | Arlington | TN | 38002 | United States | STRYKER CORP. | 1,811,755 | 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; ... | 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; ... | 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 Versi... | 1978-01-10 | 209 | 2026-06-16 | 1 | 20 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010667733%22&limit=1 |
Cardinal Health | 1,921,846 | 1,921,846 | 444 James South Mcdonnell BLVD. | Hazelwood | MO | 63042 | United States | Cardinal Health 200, LLC | 9,028,292 | 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; ... | 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 (... | 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 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221921846%22&limit=1 |
Nuvasive, Inc. | 2,031,966 | 3,002,980,729 | 7475 Lusk Blvd | San Diego | CA | 92121 | United States | NUVASIVE, INC. | 9,036,345 | 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; Neur... | 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 S... | 2006-10-17 | 205 | 2024-08-02 | 2 | 6 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222031966%22&limit=1 |
O&M Halyard, Inc. | 3,014,421,917 | 3,014,421,917 | 1220 Old Alpharetta Rd Ste 320 | Alpharetta | GA | 30005 | United States | O&M Halyard, Inc. | 10,057,479 | 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; ... | 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; Elec... | 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 Gow... | 2018-04-20 | 207 | 2026-07-21 | 0 | 3 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014421917%22&limit=1 |
Soher Med Limited | 3,045,857,207 | 3,045,857,207 | Suite C, Level 7, Word Trust Tower, 50 Stanley Sueet | Hong Kong | null | 999077 | Hong Kong | Soher Med Limited | 10,095,823 | 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; ... | 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 B... | 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;... | 2026-05-05 | 205 | 2021-12-09 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223045857207%22&limit=1 |
Smith & Nephew, Inc. | 3,038,503,932 | 3,038,503,932 | 4340 Swinnea Rd | Memphis | TN | 38118 | United States | Smith & Nephew, Inc. | 1,020,279 | 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; ... | 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-Pow... | 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 GR... | 1978-02-22 | 205 | 2022-09-29 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223038503932%22&limit=1 |
Globus Medical, Inc. | 3,004,142,400 | 3,004,142,400 | 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER | Audubon | PA | 19403 | United States | GLOBUS MEDICAL, INC. | 9,056,090 | 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; ... | 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, Intramed... | 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;... | 2003-08-19 | 202 | 2026-10-23 | 1 | 15 | 1 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004142400%22&limit=1 |
Merit Medical Canada Ltd. | 3,012,536,737 | 3,012,536,737 | 1 Valleywood Drive, units 4&5 | Markham Ontario | null | L3R 5L9 | Canada | Merit Medical Systems, Inc. | 1,721,504 | 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; ... | 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; ... | 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; Act... | 1992-07-14 | 197 | 2026-02-13 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012536737%22&limit=1 |
Merit Medical UK Limited | 3,015,309,643 | 3,015,309,643 | Unit 27, Suttons Business Park Sutton Park Avenue | Earley Reading | null | RG6 1AW | United Kingdom | Merit Medical Systems, Inc. | 1,721,504 | 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; ... | 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... | 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; Act... | 1992-07-14 | 197 | 2026-02-13 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015309643%22&limit=1 |
Medtronic Distribution Center | 3,009,380,063 | 3,009,380,063 | 5300 Airways Blvd | Memphis | TN | 38116 | United States | Medtronic, Inc. | 2,112,641 | 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; ... | 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 Pacema... | 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 Neuros... | 1992-12-12 | 164 | 2026-07-14 | 33 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009380063%22&limit=1 |
Merit Medical Australia Pty Ltd. | 3,033,589,330 | 3,033,589,330 | 53 Canterbury Road | Braiside Victoria | null | 3195 | Australia | Merit Medical Systems, Inc. | 1,721,504 | 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; ... | 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... | 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; Act... | 1992-07-14 | 196 | 2026-02-13 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223033589330%22&limit=1 |
Jersey Dental Supplies | 3,012,187,973 | 3,012,187,973 | 1095 Towbin Ave | Lakewood | NJ | 08701 | United States | Jersey Dental Supplies | 10,050,503 | 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, Resi... | 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; BURBUT... | 2016-07-21 | 195 | 2026-04-10 | 1 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223012187973%22&limit=1 |
Depuy Orthopaedics | 3,004,464,325 | 3,004,464,325 | 50 Scotland BLVD. | Bridgewater | MA | 02324 | United States | DePuy Synthes, Inc. | 1,818,910 | 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; ... | 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, Fib... | 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 FEM... | 1977-12-22 | 194 | 2026-03-02 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223004464325%22&limit=1 |
Merit Medical Nederland BV | 3,006,950,086 | 3,006,950,086 | Amerikalaan 42 | Maastricht Airport Limburg | null | 6199 AE | Netherlands | Merit Medical Systems, Inc. | 1,721,504 | 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; ... | 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... | 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; Act... | 1992-07-14 | 194 | 2026-02-13 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006950086%22&limit=1 |
Medtronic Mexico S. de R.L. de CV | 9,617,601 | 3,002,534,070 | Av. Paseo Cucapah 10510 El Lago | Tijuana Baja California | null | C.P. 22210 | Mexico | Medtronic, Inc. | 2,112,641 | 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, Pa... | 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 Ball... | 1992-07-30 | 184 | 2026-08-14 | 9 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%229617601%22&limit=1 |
Tribe Medical Group | 3,010,400,367 | 3,010,400,367 | 595 Industrial Road | London Ontario | null | N5V 1V2 | Canada | Tribe Medical Group | 10,082,587 | 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; ... | 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, S... | 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-... | 2021-08-19 | 193 | 2024-01-18 | 0 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010400367%22&limit=1 |
Intuitive Surgical, Inc. | 3,015,612,252 | 3,015,612,252 | 3410 Central Expressway -- | Santa Clara | CA | 95051 | United States | Intuitive Surgical, Inc. | 9,028,901 | 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; ... | 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, Balloo... | 1998-01-06 | 190 | 2026-10-14 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015612252%22&limit=1 |
Merit Medical Systems, Inc. | 1,721,504 | 1,721,504 | 1600 West Merit Pkwy. | South Jordan | UT | 84095 | United States | Merit Medical Systems, Inc. | 1,721,504 | 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; ... | 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, Bloo... | 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; AccessPLU... | 1992-07-14 | 188 | 2026-07-27 | 1 | 89 | 2 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221721504%22&limit=1 |
Worldwide Supplies Limited | 3,014,579,161 | 3,014,579,161 | 50 Bonham Strand NO.5, 17/F Bonham Trade Centre | Hong Kong | null | none | Hong Kong | Worldwide Supplies Limited | 10,057,941 | 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; ... | 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 N... | 1; 2; 3; U | null | 2018-06-14 | 188 | 2026-01-26 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014579161%22&limit=1 |
Wright Medical Technology, Inc. | 1,043,534 | 1,043,534 | 11576 Memphis-Arlington Rd | Arlington | TN | 38002 | United States | STRYKER CORP. | 1,811,755 | 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; ... | 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; Appli... | 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 Versi... | 1978-01-10 | 187 | 2026-06-16 | 0 | 29 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221043534%22&limit=1 |
Bio Analitica Argentina S.A. | 3,011,063,460 | 3,011,063,460 | OSVALDO CRUZ 3201 y AGUSTIN MAGALDI 1765 NAVE 03 DEPOSITO N 04, (Verotin SA) | Ciudad Autonoma de Buenos Aires | null | CP 1286 | Argentina | Intuitive Surgical, Inc. | 9,028,901 | 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; L... | 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, Balloo... | 1998-01-06 | 185 | 2026-07-14 | 0 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223011063460%22&limit=1 |
DSV Solutions LTD. | 3,013,868,968 | 3,013,868,968 | Units 3/4 Stratus Park Brudenell Drive | Brinklow Milton Keynes | null | MK10 0DE | United Kingdom | Intuitive Surgical, Inc. | 9,028,901 | 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; L... | 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, Balloo... | 1998-01-06 | 185 | 2026-07-14 | 0 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223013868968%22&limit=1 |
Device Technologies Australia | 3,010,885,402 | 3,010,885,402 | 158 Hollinsworth Road | Marsden Park New South Wales | null | 2765 | Australia | Intuitive Surgical, Inc. | 9,028,901 | 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; L... | 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, Balloo... | 1998-01-06 | 185 | 2026-07-14 | 0 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223010885402%22&limit=1 |
Arthrex Singapore Pte Ltd. | 3,014,004,349 | 3,014,004,349 | 21 Biopolis Road Nucleos North Tower Unit 03-08 | Singapore Central Singapore | null | 138567 | Singapore | ARTHREX, INC. | 1,220,287 | 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; ... | 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; Operat... | 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 ... | 1994-01-27 | 182 | 2024-07-25 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223014004349%22&limit=1 |
Intuitive Surgical, Inc. | 3,001,675,293 | 3,001,675,293 | 1266 Kifer Road | Sunnyvale | CA | 94086 | United States | Intuitive Surgical, Inc. | 9,028,901 | 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 & Pla... | 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, Balloo... | 1998-01-06 | 182 | 2026-10-14 | 0 | 122 | 1 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223001675293%22&limit=1 |
Medtronic Perfusion Systems | 2,184,009 | 1,000,116,158 | 7611 Northland Dr | Minneapolis | MN | 55428 | United States | Medtronic, Inc. | 2,112,641 | 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 Bypas... | 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; Affi... | 1992-12-02 | 181 | 2026-01-20 | 0 | 55 | 4 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%222184009%22&limit=1 |
Expeditors International BV | 3,016,832,577 | 3,016,832,577 | Conakryweg 1 | Amsterdam Noord-Holland | null | 1047 HS | Netherlands | Intuitive Surgical, Inc. | 9,028,901 | 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; L... | 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, Balloo... | 1998-01-06 | 180 | 2026-07-14 | 0 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223016832577%22&limit=1 |
Merit Medical Asia Company Limited | 3,015,225,571 | 3,015,225,571 | Rm 614 6/F Tsim Sha Tsui Center 66 Mody Road | Tsim Sha Tsui | null | 0000 | Hong Kong | Merit Medical Systems, Inc. | 1,721,504 | 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; ... | 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, Bloo... | 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; Act... | 1992-07-14 | 179 | 2026-01-09 | 1 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223015225571%22&limit=1 |
Arthrex Australia Pty Ltd. | 3,019,269,298 | 3,019,269,298 | Suite 501, 20 Rodborough Road | Frenchs Forest New South Wales | null | 2086 | Australia | ARTHREX, INC. | 1,220,287 | 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, Surgica... | 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 Pla... | 1994-01-27 | 173 | 2024-07-25 | 0 | 0 | 0 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223019269298%22&limit=1 |
Bausch & Lomb Incorporated | 1,313,525 | 1,317,628 | 1400 North Goodman Street | Rochester | NY | 14609 | United States | Bausch & Lomb Incorporated | 9,913,003 | 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; ... | 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, S... | 1; 2; 3; U | CX9626 25GA SYST -6/box | 1989-02-22 | 144 | 2026-03-25 | 29 | 25 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%221313525%22&limit=1 |
Bard Access Systems, Inc. | 3,006,260,740 | 3,006,260,740 | 605 North 5600 West | Salt Lake City | UT | 84116 | United States | C. R. Bard, Inc. | 2,212,754 | 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; Cathet... | 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 Acc... | 1992-07-22 | 172 | 2025-09-05 | 0 | 40 | 4 | 2,027 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223006260740%22&limit=1 |
DHL Supply Chain (netherlands) B.V. | 3,009,077,524 | 3,009,077,524 | Zwenkgras 9 | Beringe Limburg | null | 5986 PM | Netherlands | DHL Supply Chain (Netherlands) B.V. | 10,085,309 | 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; ... | 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.)... | 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 PANORA... | 2022-06-02 | 172 | 2021-12-23 | 0 | 0 | 0 | 2,026 | https://api.fda.gov/device/registrationlisting.json?search=registration.registration_number:%223009077524%22&limit=1 |
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