Bibliothèque

FDA AI-Enabled Medical Devices List

FDA AI/ML-enabled medical device authorizations (monthly)

Every AI-enabled medical device on the FDA's published AI-Enabled Medical Devices List as of 2026-09-25 (1,614 authorizations). Each row is one device with its FDA submission number, device name, sponsor (raw + canonical entity-resolved key + corporate family), review pathway (510(k) / De Novo / PMA), medical specialty (FDA panel label), FDA product code, decision date, and a per-row accessdata.fda.gov database link. Sponsors are entity-resolved through a documented rule pipeline (casing/punctuation/corporate-suffix variants merged; conservative corporate-family grouping) and ranked by trailing-12-month clearance velocity (family_rank). Columns: as-of date, submission number, device name, company, canonical company key, sponsor family, family rank, family trailing-12m and lifetime counts, decision date/year/month, review pathway, panel, product code, source URL, row hash. Primary key: submission_number. Cadence: monthly; the as-of date is fixed per run so identical input produces an identical content hash. Caveats: the FDA notes the list is not comprehensive (devices are identified via AI terms in authorization summaries); the panel label 'Clinical Toxcicology' is the FDA's own spelling. Source is U.S. federal public domain (17 U.S.C. 105) — commercial_use = yes. Sample use: filter panel = 'Cardiovascular' for AI cardiology clearances, or order by family_rank for the most active AI-device sponsors.

• ai
• health
• technology
• government