FDA data

Public FDA device records, normalised, cross-linked and kept current.

MDM ingests the openFDA device datasets and rebuilds them as pages a person can use. Every record keeps a link to the FDA source, every number on a page is computed from ingested rows, and nothing is asserted that the pipeline does not hold.

Data as of 2026-10-05, the newest FDA export date across the ingested datasets. openFDA device APIs

510(k) clearances176,299recordsPremarket notifications with the device, the applicant, the product code, the decision date and the time FDA took to decide.Product codes7,094codesThe FDA device classification tree, with the definition, the regulation, clearance volume by year and the companies that list each code.Recalls59,336recordsDevice recalls joined to the enforcement reports that carry the Class I, II or III classification, with a root cause tag derived from FDA's own text.

Latest clearances

Newest decision date

Latest recalls

Newest initiation date

Sources

510(k) premarket notifications, device classification and product codes, device recalls, enforcement reports, and establishment registration and listing, all from openFDA. PMA records are ingested too, and are used to resolve companies and to count the PMA records on each company page.

openFDA data is published under the openFDA licence. FDA does not endorse this site or its analysis.