FDA medical device databases (PMA, 510(k), De Novo)

The screening tests and receptor staining kits in this round were read from openFDA's device endpoints (pma, 510k and classification) on 4 November 2026, with the accessdata.fda.gov page consulted where the API was silent, for example the withdrawal date of a PMA or the classification name of a De Novo. A PMA approval order statement is the indication in the FDA's words, and the records quote it where it matters.