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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.

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Search by establishment or owner/operator, device name, registration number, product code, 510(k), or PMA number.

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About the data

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.

Read the official FDA dataset documentation

Does FDA registration mean a company is FDA approved?
No. FDA explicitly distinguishes establishment registration and device listing from approval, clearance, certification, or endorsement.
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.

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