A marketplace brand or storefront can differ from the legal establishment that appears in FDA data.
Independent public-data guide · not affiliated with FDA
FDA registration lookup by manufacturer name.
Match a supplier's legal establishment identity to public FDA device registration and listing data before you place an order, wire a deposit or prepare an import.
Quick answer
Match the legal entity, facility and role—not only the brand.
Search the exact establishment name when possible. Compare the returned FEI, registration number, location and establishment roles with the supplier's invoice, label and onboarding documents. A name match alone does not prove that the seller controls the facility or that a particular device is cleared or approved.
Three questions the record should help answer
Compare country, location and activities such as manufacturer, specification developer, contract manufacturer or relabeler.
Request the exact product code, device listing context and applicable premarket reference for the model being purchased.
Source limit: FDADeviceCheck queries the latest available openFDA registration-and-listing snapshot, which is updated monthly. The official FDA public database may reflect a newer weekly update; use it for final verification.
How to run a useful manufacturer lookup
- Copy the legal establishment name from the invoice, label or supplier regulatory file rather than relying only on a brand name.
- Run the name lookup. If several establishments appear, compare location, FEI and every displayed role.
- If the name search is inconclusive, ask the supplier for its FEI or registration number and search that identifier.
- Confirm the establishment in FDA's official Registration & Listing database and verify device-specific evidence separately.
Manufacturer lookup questions
What if the manufacturer uses a trade name?
Ask for the legal establishment name and FEI shown in the supplier's regulatory documents. Search the legal name first, then compare any trade name, address and country with the official FDA record.
Does an active establishment result clear every device?
No. An active establishment record concerns the facility as reported by the source. A specific device may require separate listing, classification, 510(k), De Novo, PMA or exemption evidence.
Is a no-match result proof that the manufacturer is unregistered?
No. A spelling difference, legal-name mismatch, source delay or query limitation can produce no match. Retry with the FEI or registration number and confirm the final status in FDA's official database.