Does FDA registration mean a company is FDA approved?
No. FDA explicitly distinguishes establishment registration and device listing from approval, clearance, certification, or endorsement.
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FDA Establishment Registration & Device Listing Search
Find registered medical device establishments, owner/operators, establishment activities, proprietary device names, product codes, and linked premarket submission numbers.
Direct FDA source dataFree, no account requiredOfficial record links
Find registered facilities
Search establishment names, registration numbers, countries, and owner/operator information.
Inspect listed devices
Review proprietary names, product codes, and device types associated with an establishment.
Understand activities
See whether a facility manufactures, sterilizes, develops specifications, imports, repackages, or performs another role.
Search FDA registrations and listings
Search by establishment or owner/operator, device name, registration number, product code, 510(k), or PMA number.
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Important interpretation note
FDA registration or listing does not denote approval, clearance, certification, or endorsement. Confirm the current registration cycle and the separate marketing authorization for the device.
What registration and listing do—and do not—mean
FDA establishment registration identifies facilities involved in producing or distributing medical devices for the United States. Device listing identifies devices associated with those regulated activities.
One establishment can have many listings, and a product can appear in records for manufacturers, contract sterilizers, specification developers, importers, or other facilities.
Registration and listing do not mean FDA approved, cleared, certified, or endorsed the establishment or device. Verify the applicable 510(k), De Novo, PMA, or exemption separately.
Frequently asked questions
Why can the same device appear under several establishments?
Different facilities may manufacture, sterilize, import, relabel, develop specifications for, or otherwise handle the same device.
How often must an establishment register?
Most device establishments subject to registration requirements must register annually and keep their device listing information current.
How current is this search?
FDA states that the openFDA Registration & Listing endpoint is updated monthly. Results show the dataset update date when available.