Data sources & methodology

Data comes from openFDA bulk downloads (device 510(k), PMA, classification, recall and enforcement endpoints), which are in the public domain, updated 2026-09-25. Recall classes (I, II, III) come from the FDA enforcement reports, matched by recall number.

Manufacturers are grouped by name, ignoring legal suffixes such as "Inc." or "GmbH"; different legal entities of the same group may appear separately. Only original PMA approvals get a page; their supplements are counted. We do not publish the contact persons or phone numbers listed in the source files.