Match a legal establishment, location, FEI and role instead of relying on a marketplace brand or supplier-created certificate.
Independent · public-data based · not affiliated with FDA
About FDADeviceCheck.
FDADeviceCheck helps importers, distributors and supplier-quality teams review a medical-device establishment record before they rely on a supplier claim.
Identity
An independent Covo Capital project led by Amaury Covo.
FDADeviceCheck is not part of, affiliated with, sponsored by or endorsed by the U.S. Food and Drug Administration. The FDA name is used only to describe the public agency data and regulatory records the tool helps users review.
Why the tool exists
Separate establishment registration from device listing, classification, clearance, authorization and approval.
Direct users to the official FDA database for the final, time-sensitive verification.
Record directory
Choose the record that answers your question.
A facility, a product and a recall are different units of evidence. Keep their identifiers and source dates separate when you check a supplier claim.
Which establishment is this?
Compare: legal name, location, FEI and activity.
Source: FDA Registration & Listing. FDA lists a weekly update schedule; the openFDA copy lists monthly updates.
An establishment entry does not establish device approval.
Which device is listed?
Compare: the device and activity linked to the establishment, with the product information in the listing.
Source: FDA Registration & Listing. Confirm the exact record rather than treating a company name as a product match.
Listing is not clearance, authorization or approval.
What product decision is claimed?
Compare: the device, applicant, decision number and scope of the claim.
Source: Devices@FDA for 510(k)/PMA; use the FDA directory for other pathways such as De Novo.
A decision for another device does not resolve this device’s claim.
Does a recall notice concern this item?
Compare: the product description and affected model, lot or serial information in the notice.
Source: the FDA recall database and the current FDA notice.
No match in one search is not proof that an item has no recall.
Directory checked October 30, 2026 against the FDA database directory and FDA’s explanation of registration. Published update schedules are not a guarantee of the freshness of an individual record.
What FDADeviceCheck does—and does not do
The lookup queries the openFDA Device Registrations & Listings endpoint by legal name, FEI or registration number.
Any printable record is informational and is not an FDA document, compliance determination or proof of device approval.
The service is not legal, regulatory, customs or medical advice and cannot determine import admissibility.
Editorial rule: when a public-data field is absent, delayed or ambiguous, FDADeviceCheck treats it as “not confirmed in this result” rather than asserting noncompliance.
How the service is supported
The public lookup is available without charge. FDADeviceCheck may invite users to request a dated record, monitoring pilot or bulk service. Submitting a request does not itself start a payment, monitoring schedule or subscription; any scope, price and activation must be confirmed separately.