Every FDA-cleared medical device since 1976 via the 510(k) substantial-equivalence pathway. ~175k clearances. Each carries: K-number, device name, applicant (mfr/sponsor), 3-letter FDA product code (joins to device classifications), decision code (SE = substantially equivalent, SN = not substantially equivalent, SI = section in), clearance type (Traditional / Special / Abbreviated), advisory committee, decision date, expedited-review flag. The bulk of US-cleared medical devices come through 510(k) rather than full PMA.
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/510k/. 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.