Every company that makes or imports medical devices for the U.S. must register its establishment with the FDA and list its devices. Here is how to look up an FDA establishment registration, what the record tells you about a manufacturer, and what it does not.
FDA establishment registration is the record of who makes, repacks, relabels, imports or otherwise handles medical devices sold in the United States. Each establishment has a registration number and an FEI number, and its owner/operator lists the devices made or handled there, by product code and proprietary name.
Registration is annual: establishments must renew between October 1 and December 31 each year, through the FDA's Unified Registration and Listing System (FURLS), and pay the annual establishment user fee, whose amount the FDA sets for each fiscal year. Foreign establishments also name a U.S. agent.
The FDA is explicit that registering an establishment or listing a device "does not in any way denote approval of the establishment or its products by FDA." A listing shows a device is on the market from that site; whether it was cleared or approved is a separate question answered by its 510(k) or PMA.
The FDA's Establishment Registration & Device Listing database is free and needs no account. openFDA publishes the same records as an API.
On the FDA search page, enter an establishment or trade name, an owner/operator name, a proprietary (brand) name, or a registration or FEI number. Searching the owner/operator finds every site a company operates.
Add a product code or classification device name to see who makes a kind of device, an establishment type (for example manufacturer, contract manufacturer or relabeler), or a state or country to see where they are.
A result shows the establishment's address, owner/operator, registration status and expiry year, and its device listings with product codes and, where given, the 510(k) or PMA number each device is marketed under.
Use the 510(k) or PMA number on a listing to open that clearance or approval in the FDA premarket databases — that is where you confirm the device was authorized, not in the registration itself.
openFDA's device/registrationlisting endpoint returns the same records as JSON, one per establishment listing, with registration, owner/operator, U.S. agent and product details. Count queries answer questions like how many registered establishments list a given product code.
Where a listing carries a 510(k) or PMA number, ClinicaLister ties the establishment to that submission, so you can move from a manufacturer to its cleared devices and back.
Registrations are matched, through their 510(k) and PMA numbers, to the same device records that carry GUDID identifiers, recalls and linked clinical trials.
Through the ClinicaLister MCP server, an AI assistant can look up a company's registered establishments and listed product codes without you writing openFDA queries.
~24,500
establishments held — a partial copy
Monthly
refresh from openFDA
336,000+
listing records in openFDA, for comparison
ClinicaLister holds a partial copy of the registration file: about 24,500 establishments, one row each with its listings merged, measured September 2026. To confirm whether a specific company is registered, use the FDA database, which is the authoritative record.
Search the FDA's Establishment Registration & Device Listing database by establishment, owner/operator or brand name, or by registration or FEI number. A current registration shows its expiry year and the devices listed at that site.
No. The FDA states that registration and listing do not denote approval of the establishment or its products. Clearance or approval is shown by the device's 510(k), PMA or De Novo record.
Every year between October 1 and December 31, through FURLS, even if nothing has changed, together with the annual establishment user fee for that fiscal year.
Both identify the establishment. The registration number is assigned through device registration; the FEI (FDA Establishment Identifier) is the FDA's identifier for a facility across its programs, used in inspections. The database can be searched by either.
No. It holds a partial copy of about 24,500 establishments, linked to their 510(k) and PMA records where the listing gives one. For a definitive answer on a specific company, use the FDA database.
See a manufacturer's registrations, clearances and recalls together
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