FDADeviceCheck Run a lookup

Independent tool · not affiliated with FDA

Check a medical-device supplier's
FDA establishment registration.

Search by legal name, FEI or registration number. Compare the facility, country, role and U.S. Agent in the latest available openFDA snapshot, then confirm the record in FDA's official database.

Latest openFDA snapshot
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Pending

Enter a legal name, FEI or registration number.

FDADeviceCheck queries the openFDA device registration & listing data. 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.

  • openFDAlatest available public snapshot
  • FEIfacility identity comparison
  • Transparentsource date and limits shown

The free record

A dated lookup record, not an FDA certificate.

Generate a server-revalidated PDF with the query, matched establishment, FEI, registration number, roles, U.S. Agent, source date, records inspected and explicit data limitations.

The server checks the public source again when it generates the record. No payment or subscription starts.

Registration is not approval

What an FDA registration actually tells you.

What registration DOES mean

  • The establishment reported information to FDA. Establishments subject to the applicable rules generally register annually; most also list their devices.
  • The record can help match facility identity. Compare legal name, address, FEI, registration number and roles with the supplier's documents.
  • Foreign establishments generally designate a U.S. Agent. The agent serves as a contact for FDA communications under the applicable registration rules.

What it does NOT mean

  • It is not a quality endorsement. Registration is not the FDA approving, clearing or vouching for any product.
  • It is not 510(k), De Novo or PMA evidence. Device-level authorization and any applicable exemption must be checked separately.
  • A field not shown is not proof of absence. Treat the U.S. Agent or listing detail as not confirmed by this result and verify in FDA's official source.

Where it saves you

A fast supplier check before you import a medical device.

Importers

Compare a foreign manufacturer's identity and U.S. Agent.

Spot registration or listing mismatches that can delay FDA entry review, then confirm the current official record before shipment.

Distributors / buyers

Vet a supplier before placing an order.

See establishment type, registration status and listed proprietary device names in one lookup.

Quality / compliance

Separate “FDA registered” from device authorization.

Use the establishment match as one evidence item, then check the relevant device-level pathway and applicable exemptions.

Source

Built on public FDA open data.

Dataset

openFDA registration & listing

The latest available public snapshot from FDA's registration and listing data. It is not represented as real-time.

Official verification

FDA Registration & Listing database

Use FDA's own search for the final current check. FDADeviceCheck discloses source date, inspected records and truncation.

How it works

Read the methodology

See query logic, status-code interpretation, known data limits, report contents and the distinction from FDA certificates.

Dossier

One free record. Optional pilots by request.

Download a dated PDF at no charge. Monitoring and bulk access are invitation-only pilots; a request never starts service, payment or a subscription.

Dated lookup record

Free

One server-checked PDF with identity, status, FEI, source date, inspected-record count and limitations.

Start free lookup

Watchlist pilot

$19/mo

Proposed pilot for up to 25 facilities. We confirm scope, cadence, first baseline and activation before any charge.

Bulk-file pilot

$49/mo

Proposed file review for up to 250 facilities. API access is scoped separately and is not currently self-serve.

Email this dated PDF

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Lookup guides

Start with the identifier or claim you have.

Each guide explains what the public establishment data can confirm, what it cannot confirm, and the next check to make before importing.

FEI number lookupSearch a 7–10 digit establishment identifier. FDA registration lookupFind a medical-device establishment by company name. Registration number checkReview the number a supplier put on its documents. FDA certification checkSeparate registration, clearance and approval claims.

FAQ

Common questions about FDA device registration.

Does FDA registration mean the device is FDA approved?

No. Establishment registration and device listing do not mean FDA approval, clearance, authorization, certification or endorsement. Check a device-level 510(k), De Novo, PMA or applicable exemption separately.

What is an FEI number and how do I search by it?

The FEI, or FDA Establishment Identifier, identifies a facility in FDA systems. Enter the 7 to 10 digit number here, or search by legal company name, then compare the returned identity and address with the supplier's documents.

What if a U.S. Agent is not shown in this result?

Treat the U.S. Agent as not confirmed by this result, not necessarily missing. Foreign establishments subject to registration generally designate a U.S. Agent, but you should confirm the current record in FDA's official Registration and Listing database.