Written and maintained by CASRAI Editorial Board
Last updated
General information about a public FDA database, not legal or regulatory advice. Information checked against the FDA pages listed under Sources on 2026-10-30.
Short answer
The FDA Establishment Registration and Device Listing database is a public search of medical device establishments registered with FDA and the devices listed with FDA. You can search it by firm name, registration or FEI number, product code or brand name, or download the data in bulk. A record shows who registered, in what role and which products they listed. FDA states that registration and listing do not denote approval of the establishment or its products.
Definition and scope
FDA describes the database as including medical device manufacturers registered with FDA and medical devices listed with FDA (FDA, Establishment Registration & Device Listing). The public search holds releasable registration and listing information under the Freedom of Information Act (FDA, Search Registration and Listing).
This page covers reading the record. The legal duty to register and list is set out in 21 CFR Part 807 and is a separate subject. For the establishment concept itself, see FDA-registered establishment.
Search fields and what each answers
The advanced search offers ten fields. The table pairs each label with the question it helps answer (the pairing is editorial; the labels are FDA’s).
| Advanced search field | Question it helps answer |
|---|---|
| Establishment or Trade Name | Is this firm in the database under the name on the paperwork? |
| Owner/Operator Name and Owner/Operator Number | Which owner or operator is behind the establishment? |
| Registration or FEI Number | Which exact establishment is this? Useful when two firms have similar names. |
| Proprietary Name | Is this brand name listed, and by whom? |
| Product Code and Classification Device Name | What kind of device is listed? |
| Establishment Type | What role does the establishment hold, for example Manufacturer, Contract Sterilizer, Repackager/Relabeler or Initial Distributor/Importer? |
| Establishment State (U.S.) and Establishment Country | Where is the establishment located? |
A quick search is also available with only Company Name and Device Name fields, with a link to the advanced search (FDA quick search).
Registration number lookup
To look up a registration number, enter it in the Registration or FEI Number field. To go the other way, from a firm to its number, search by Establishment or Trade Name.
Device listing search and establishment registration search
A device listing search starts from Proprietary Name, Product Code or Classification Device Name. An establishment registration search starts from the firm, its number, state or country. Both use the same advanced form. FDA says you can return up to 100 different establishments from any search, and if a search returns nothing you can try entering only a portion of the word (FDA, Search Registration and Listing).
Web search or bulk files
The web search and the bulk download answer different needs. FDA states the web database is updated weekly, usually every Monday, with a delay between upload and public display. The download files are, in FDA’s words, updated every Sunday night.
| Feature | Web search | Bulk download |
|---|---|---|
| Result form | Up to 100 different establishments per search | Compressed pipe-separated text files |
| Update timing stated by FDA | Usually every Monday | Every Sunday night |
The download page lists files such as Registration, Listing PCD (product code), Registration Listing, Owner Operator, US Agent, Official Correspondent, Listing Proprietary Name and Establishment Types, plus three importer files: Non-Registered Importers Identified by Manufacturers, Manufacturers Identified by Importers and Registered Importers Identified by Manufacturers (FDA, files download). The Registration file carries the registration key and number, status, initial importer flag, expiry year, address and name. The Registration Listing file links a registration to a listing file and a premarket submission number.
What a record does and does not show
A record shows that an establishment registered, which role it declared, and which product codes and proprietary names it listed. FDA states that registration, registration numbers and listing do not in any way denote approval of the establishment or its products. Under 21 CFR 807.39, registration or assignment of a registration number does not denote approval, and any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding (21 CFR Part 807).
- A listing is not a clearance. A premarket submission number may be linked to a listing, but clearance status is checked in the premarket databases; see FDA 510(k) data.
- A listing is not a device identifier record. Unique Device Identification data sits in a different database; see UDI labeling and GUDID submission.
- Display lags. Changes appear only after the database update completes, and FDA says existing listings may not be fully viewable until an update finishes. Firms make changes through their FURLS account.
Checklist for reading a record
- Search by the legal entity name or registration number from the supplier’s paperwork, not only the brand.
- Confirm the Establishment Type matches the role you expect (manufacturer, repackager, importer).
- Check that the listed Product Code and Classification Device Name match the device type in question.
- Look for the proprietary name if a brand is being relied on.
- Note the date you searched, because the data updates weekly.
- If premarket status matters, move to the 510(k) or other premarket database instead of treating the listing as proof.
This checklist is an editorial reading aid built from the fields above. Wider vendor paperwork is covered in the vendor onboarding documentation checklist.
Common misunderstandings
“FDA registered” means FDA approved
It does not. FDA’s database pages and 21 CFR 807.39 both say registration does not denote approval.
No result means no registration
Not necessarily. A search returns up to 100 different establishments, a partial word can work better than a full name, and new changes may not yet be displayed.
One number covers everything
The data separates the establishment (registration number) from the owner/operator (owner/operator number).
FAQ
How do I search FDA device listings?
Use the advanced search and enter a Proprietary Name, Product Code or Classification Device Name, or use the quick search with a company or device name.
Is there a registration number lookup?
Yes. The advanced search has a Registration or FEI Number field.
Does being listed mean FDA approved the device?
No. FDA states that registration and listing do not denote approval of the establishment or its products.
How often does the database update?
FDA says the web search is updated weekly, usually every Monday, and the download files every Sunday night.
Sources
- FDA, Establishment Registration & Device Listing, checked 2026-10-30.
- FDA, quick search, checked 2026-10-30.
- FDA, Search Registration and Listing, checked 2026-10-30.
- FDA, Establishment Registration and Medical Device Listing Files for Download, checked 2026-10-30.
- eCFR, 21 CFR Part 807 (section 807.39), checked 2026-10-30.
