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.
Every record in this dataset can be traced back to its primary source at https://open.fda.gov/apis/device/510k/. Underlying content is a US federal government work (public domain under 17 USC §105); our derived data is licensed CC0 1.0.