Answer first: FDA registered does not mean FDA approved. For this check, separate facility registration, device listing, product clearance, approval, authorization, and marketing claims before trusting a label, supplier page, or sales pitch.
Last checked: June 4, 2026. Registry Check Guide is not a government agency, regulator, certification body, law firm, or official registry. Use this page as a practical guide to read official records before you rely on them.
Official sources to start with
| Official source | Use it for |
|---|---|
| FDA: Are There FDA Registered or FDA Certified Medical Devices? | FDA guidance explaining that registration, certification wording, and registration certificates do not mean FDA approval. |
| FDA Search Registration and Listing | FDA guidance for searching releasable medical device establishment registration and listing information. |
| FDA Establishment Registration and Device Listing database | Official database for medical device establishment and listing records. |
What to check first
- Read the seller's exact claim: registered, certified, approved, cleared, authorized, or listed.
- Search the FDA registration and listing database by company, device, or registration details.
- Check whether the result is an establishment record, a device listing, a 510(k), PMA, De Novo, EUA, or another record type.
- Compare the company name, device name, product category, and update date.
- Do not treat a registration certificate or FDA logo as proof of FDA approval.
How to read the record
| Field or claim | How to interpret it |
|---|---|
| Establishment registration | Shows a facility or establishment record; by itself, it does not prove product approval. |
| Device listing | Can show a listed device, but the listing type still needs to be checked against clearance or approval records. |
| FDA certified | FDA warns that this wording can be misleading for medical devices. |
| FDA logo on a certificate | A private certificate using an FDA logo is a red flag unless the claim is backed by the official FDA source. |
What this record does not prove
- It does not prove that a product is safe for every use.
- It does not prove FDA approval, clearance, or authorization unless the matching FDA record says so.
- It does not prove the seller is the manufacturer or official distributor.
Red flags
- The seller shows a certificate but no official FDA database link.
- The claim says FDA certified without explaining the actual FDA record type.
- The company name in the database does not match the seller or product packaging.
Related checks
FDA registration lookup guide Registry Check Guide home
FAQ
Is FDA registered the same as FDA approved?
No. Registration and listing are separate from approval, clearance, or authorization.
Can a medical device company receive an FDA registration certificate?
FDA says it does not issue device registration certificates to medical device facilities.
What should I check after finding a registration record?
Check the product category and whether a matching clearance, approval, authorization, or listing record exists for the specific product claim.