Every facility globally that manufactures / processes / specifies / repackages / relabels medical devices destined for the US market. **324,554 active registrations** with FDA Establishment Identifier (FEI), firm legal name, address, owner/operator (corporate parent), establishment type (Manufacturer, Contract Manufacturer, Specification Developer, Initial Importer, Foreign Exporter, Repackager/Relabeler, Reprocessor, Remanufacturer), registered product codes (3-letter FDA codes joining to /device-classification/{code}), regulation numbers (21 CFR §), 510(k) numbers, PMA numbers, proprietary names, status, registration expiry year. For foreign facilities: mandatory US agent business name + email. Source: openFDA `device/registrationlisting.json` (no auth, monthly refresh, CC0). Country distribution: US ~154k, CN ~50k, DE ~12k, JP ~8k, GB, FR, IT, MX, KR, TW.
The listed URL identifies a referenced source; it does not by itself document the ingestion endpoint. Referenced source URL: https://open.fda.gov/apis/device/registrationlisting/. Source-specific terms apply. US federal employee-authored works are generally public domain under 17 USC 105; non-federal and third-party material retains source terms. Free or keyless access does not alter source terms. Metadata and normalization authored by MORVS (AI Analytics LLC) are CC0 only where expressly stated.