FDADeviceCheck Run lookup

Independent public-data guide · not affiliated with FDA

FDA registration lookup for medical-device manufacturers.

Use an FDA registration lookup to 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.

Search a manufacturerOpen official sources
Latest openFDA snapshot
Pending

Enter a legal name, FEI or registration number.

FDADeviceCheck queries the openFDA device registration & listing data, and after a miss the other public FDA datasets and the drug establishment file. Registration status is informational, not an FDA approval.

Establishment registration only. This does not verify device clearance, approval, authorization, quality or import admissibility. Verify in FDA's official database.

Quick answer

FDA registration lookup: match the legal entity, facility and role.

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

Is this the same legal entity?

A marketplace brand or storefront can differ from the legal establishment that appears in FDA data.

Is this the same facility and role?

Compare country, location and activities such as manufacturer, specification developer, contract manufacturer or relabeler.

What device evidence is still needed?

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

  1. Copy the legal establishment name from the invoice, label or supplier regulatory file rather than relying only on a brand name.
  2. Run the name lookup. If several establishments appear, compare location, FEI and every displayed role.
  3. If the name search is inconclusive, ask the supplier for its FEI or registration number and search that identifier.
  4. Confirm the establishment in FDA's official Registration & Listing database and verify device-specific evidence separately.

Related FDA checks

FEI number lookupUse a known facility identifier instead of a name. Registration number checkReconcile the exact number on supplier documents. FDA certification checkTranslate a marketing claim into specific evidence. Import Alert RadarCheck whether an FDA import alert may affect the supplier or product. Run the public-data lookupSearch the latest available openFDA snapshot.

Manufacturer lookup questions

How do I use an FDA registration lookup?

Search the manufacturer's legal establishment name, FEI or registration number, then compare the returned facility, country and role with the supplier's documents. Confirm the current result in FDA's official Registration & Listing database.

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.