Registration & Listing
This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and listings of medical devices in commercial distribution by both domestic and foreign manufacturers. Generally, owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires a premarket submission before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE). Note: This database is updated weekly.
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Registration & Listing
FILENo link available
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View Parent Record: Devicereglist API
Complete Metadata
| @type | Dataset |
|---|---|
| accessRights | public |
| contactPoint |
[ { "fn": "FDA Governance Team", "@type": "Kind", "hasEmail": "mailto:uig@fda.hhs.gov" } ] |
| description | This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and listings of medical devices in commercial distribution by both domestic and foreign manufacturers. Generally, owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. Generally, establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires a premarket submission before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE). Note: This database is updated weekly. |
| distribution |
[ { "@type": "Distribution", "title": "Registration & Listing", "accessService": [ { "@type": "DataService", "title": "Devicereglist API", "publisher": { "name": "FDA", "@type": "Organization" }, "endpointURL": [ "https://api.fda.gov/device/registrationlisting" ], "contactPoint": [ { "fn": "open FDA", "@type": "Kind", "hasEmail": "mailto:open@fda.hhs.gov" } ], "endpointDescription": [ "https://api.fda.gov/device/registrationlisting.json" ] } ], "useRestriction": [ { "@type": "UseRestriction", "restrictionStatus": "unrestricted" } ] } ] |
| identifier | 000R-FDA-CDRH-PB-I-202608 |
| inventoried | 2026-09-27 |
| isPartOf | devicereglist-api |
| keyword |
[ "Devices/ Facility Registration/ Listings" ] |
| publisher |
{ "name": "Center for Devices and Radiological Health (CDRH)", "@type": "Organization", "subOrganizationOf": [ { "name": "Food and Drug Administration (FDA)", "@type": "Organization", "subOrganizationOf": [ { "name": "U.S. Department of Health and Human Services", "@type": "Organization" } ] } ] } |
| status | Candidate |
| theme |
[ { "@type": "Concept", "prefLabel": "Devices" } ] |
| title | Registration & Listing |
