FDA Medical Device Classifications (7,058 product codes — the device taxonomy)

Dataset · US Food and Drug Administration · source URL ↗

Every FDA-classified medical device type. The foundational regulatory taxonomy of the entire US medical device industry — every device sold in the US falls under one of 7,058 product codes. Each entry has the 3-letter product code (OWW for surgical drills, DXP for X-ray systems, KNT for orthopedic implants), device name, regulatory definition, device class (Class I low-risk / Class II 510(k) / Class III PMA high-risk), 21 CFR regulation number, review panel, medical specialty, submission type, and counts of cleared 510(k) submissions + registered establishments. schema.org/MedicalDevice JSON-LD with FDA Product Code identifier, 21 CFR reference, and clearance route. Source: api.fda.gov/device/classification.json (openFDA).

Source organization
US Food and Drug Administration
License / terms
Coverage
7,058 device classifications
Latest local indexed-row date
2026-05-17
API endpoint

Keywords

FDA device classificationproduct codeClass IClass IIClass III510(k)PMAmedical devicedevice taxonomy21 CFR

Provenance

The listed URL identifies a referenced source; it does not by itself document the ingestion endpoint. Referenced source URL: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm. Source-specific terms apply. US federal employee-authored works are generally public domain under 17 USC 105; non-federal and third-party material retains source terms. Free or keyless access does not alter source terms. Metadata and normalization authored by MORVS (AI Analytics LLC) are CC0 only where expressly stated.

For agents