Written and maintained by CASRAI Editorial Board
Last updated
General information about public FDA databases, not legal, regulatory or medical advice. Checked against the FDA and openFDA pages listed under Sources on 2026-11-01.
Short answer
To run an FDA registration lookup, search (an FDA registration search or registration number search both work the same way) the FDA Establishment Registration and Device Listing database by company name or by registration or FEI number. That answers one question only: is this establishment registered, and which devices does it list. FDA states that registration does not denote approval of the establishment or its products, so whether a device was approved, cleared or authorized is checked separately, in Devices@FDA, the De Novo database or the Emergency Use Authorization list.
Which question, which FDA database
Most failed checks come from asking one database a question it does not answer. This table pairs each question with the FDA source that answers it. The pairing is editorial; the database descriptions are FDA’s.
| Question you are asking | Where to look | What FDA says it holds |
|---|---|---|
| Is this company or facility registered, and what does it list? | Establishment Registration & Device Listing database | Registration and listing records; FDA states these do not denote approval of the establishment or its products |
| Was this device approved or cleared? | Devices@FDA | “A catalog of approved and cleared medical device information from the FDA”; search by device name or company name |
| Was this device authorized through the De Novo pathway? | De Novo database (Device Classification under Section 513(f)(2)) | Devices reviewed through De Novo, a pathway for low- to moderate-risk devices of a new type; search by device name or requester name |
| Was this device authorized for use in a declared public health emergency? | Emergency Use Authorization list | Devices FDA authorized under an EUA |
How to look up an FDA registration (search by company or facility)
The registration database offers these search fields: Establishment or Trade Name, Owner/Operator Name, Proprietary Name, Product Code, Establishment State (U.S.), Registration or FEI Number, Owner/Operator Number, Classification Device Name, Establishment Type and Establishment Country. For a facility registration lookup, start with the establishment or trade name exactly as it appears on the supplier’s paperwork, then narrow by state or country. The full field-by-field walk-through is in how to read a registration and listing record.
How to find an FDA registration number
Search by establishment or trade name, open the matching record and read the registration number from it. The Registration or FEI Number field also works the other way: enter a number you were given and see which establishment it belongs to. A registration number and an FEI number are different identifiers; see what the FEI number is and the definition of an FDA-registered establishment.
How to verify an FDA registration number a supplier gave you
Do not rely on a document the supplier sends. FDA states it does not issue any type of device registration certificate to medical device facilities and does not “certify” registration information. A certificate bearing the FDA logo is therefore not evidence of registration. Instead, enter the number in the database yourself and compare the establishment name, address and role with what the supplier told you.
How to check if a company is FDA registered
- Find the registration. Search the Establishment Registration & Device Listing database by company name or registration number, as above.
- Read the record. Confirm the name, location and establishment type match the supplier you are dealing with.
- Check the product separately. Ask for the 510(k), PMA, De Novo or EUA identifier for the specific device and look it up in the matching database. See the 510(k) data guide and the PMA database guide.
- Record what you found. Note the date you searched, because the data changes (see below).
Documentation requests that belong in a vendor file are covered in vendor onboarding for medical supply purchases.
How up to date is the data? FDA versus openFDA
FDA says updates to its registration and listing database are generally completed weekly by Monday evening, and that there is a delay between data upload and the data appearing. The openFDA device registration and listing endpoint, which serves data from the same FDA database converted to JSON, lists a monthly update frequency. A newly registered supplier may therefore not appear yet, and the openFDA copy can trail the FDA site. openFDA itself says not to rely on it to make decisions regarding medical care.
Common misunderstandings
“FDA registered” means FDA approved
It does not. FDA’s consumer page answers the question of whether registered or certified is the same as approved, cleared or authorized with a plain “No”. A registration entry does not denote approval, clearance or authorization of the facility or its devices.
There is a registration certificate to ask for
FDA does not issue one. FDA also says firms that display misleading certificates next to a device for sale to imply FDA review or approval misbrand the device.
One database covers everything
Registration, product search and authorization lists are separate FDA resources, as the table above shows. FDA’s consumer page describes Devices@FDA as covering approved and cleared devices; De Novo and EUA products have their own lists.
FAQ
How do you find an FDA registration number?
Search the registration and listing database by establishment or trade name and read the number from the matching record. FDA’s page for the database lists Registration or FEI Number as a search field.
How does an FDA product search work?
For approved or cleared devices, FDA’s consumer page directs you to Devices@FDA, where you type a device name or company name. A generic name such as the example FDA gives, pacemaker, also works.
What does an FDA database search show about a company?
The registration and listing database shows establishments and the devices they list. It does not show approval, and FDA says it does not certify the registration information.
How do you know if the FDA approved, cleared or authorized a medical device?
Check Devices@FDA for approved and cleared devices, the De Novo database for De Novo devices, and the Emergency Use Authorization list for emergency authorizations. Registration alone does not answer this.
Sources
- FDA, Establishment Registration & Device Listing database, accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm, page updated 10/26/2026, checked 2026-11-01.
- FDA, Are there FDA registered or FDA certified medical devices? How do I know what FDA approved? (content dated 03/03/2021), fda.gov consumer page, checked 2026-11-01.
- openFDA, Device registration and listing, open.fda.gov/apis/device/registrationlisting, checked 2026-11-01.
