SpecStreamAI/fda-medical-device-establishments

FDA registered medical device establishments

SpecStream, the live web data engine.

Each row is one medical device establishment with an active registration at the US Food and Drug Administration (FDA). The row gives the establishment, its registration and FEI numbers, its address, its owner or operator, what it does, the devices it lists with their product codes, classes and brand names, its 510(k) clearances and PMA approvals, and its recall events. This sample holds the first 200 rows of the full list file.

Source

FDA establishment registration and device listing files, with FDA 510(k), PMA and recall records joined by establishment. The Source column links to the FDA record each row was read from.

Columns

Column	What it holds
Establishment name	Name of the registered establishment
FDA registration number	FDA registration number
FEI number	FDA Establishment Identifier
Street	Street address
City	City
State	State, for US addresses
Postal code	Postal code
Country	Country
Owner or operator	Company that owns or runs the establishment
Owner or operator number	FDA number of the owner or operator
Establishment types	What the establishment does, such as manufacturer or complaint file establishment
Device types listed	Number of device listings
Product codes	FDA product codes of the listed devices
Device names	FDA names of the listed devices
Device classes	Device classes of the listed devices
Brand names	Brand names of the listed devices
First device listed	Date of the earliest device listing
510(k) clearances	Number of 510(k) clearances
Latest clearance	Date of the latest 510(k) clearance
PMA approvals	Number of PMA approvals
Recall events	Number of recall events
Class I recall events	Number of Class I recall events
Registered through	Year the registration runs through
Source	Link to the FDA record

How often it changes

The FDA exports its registration files each week. The full list gains about 48 rows a month. This sample was read on November 13, 2026 from the list updated November 11, 2026, built from the FDA files exported November 10, 2026.

License

The sample in this repository is under CC BY 4.0. Credit SpecStream and link to the page below.

The full list

The full list, 25,781 establishments with an active FDA registration, is $337.81 as CSV and Excel at https://specstream.ai/data/medical-devices. Payment needs no account.