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

Dataset · US Food and Drug Administration · ingestion source ↗

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
API endpoint

Keywords

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

Provenance

This dataset was ingested from the listed source URL. Ingestion source: 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.

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