Every FDA-cleared AI device, indexed. Facts only.

510(k) clearances under product codes whose official FDA descriptions denote automated or algorithmic function — cleared name, applicant, date, pathway, with the government source linked on every entry. Refreshes automatically from openFDA each week.

Last refreshed 2026-08-30 (0 new entries added) · subscribe to new clearances

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The registry is open data. Download the full dataset — CSV · JSON — or subscribe to growth via the sitemap. Reuse is welcome with attribution.

A note on coverage: FDA clearance applies to regulated device software — largely imaging and diagnostics. Categories such as ambient documentation and revenue-cycle AI typically fall outside device clearance; for those, see the evidence landscapes.

Methodology, in full

Source: the openFDA device 510(k) API, queried weekly for each tracked product code. Fields are stored verbatim from the public record. Entries are never edited by hand except to correct a demonstrated discrepancy with the underlying FDA record, and corrections are noted. Vendors may submit public evidence for the disclosure rows at any time via the Vendor Governance Dossier program; submission is free for the basic listing update, and dossier participation is disclosed on the entry. The registry is produced independently: no vendor sponsorship, no paid placement, no fee to be listed or de-listed.