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

Dataset · US Food and Drug Administration · primary 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 agency
US Food and Drug Administration
License
CC0 / US public domain
Coverage
7,058 device classifications
API endpoint

Keywords

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

Provenance

Every record in this dataset can be traced back to its primary source at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm. Underlying content is a US federal government work (public domain under 17 USC §105); our derived data is licensed CC0 1.0.

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