FDA DEVICE INTELLIGENCE
FDA Device Product Codes
FDA groups every regulated device under a three-letter product code — its classification regulation, device class, and review panel. Each code here carries its regulatory facts plus live market activity (510(k) clearances and PMA approvals) and recall history. All FDA data.
7,096 product codes · 2,403 Class I · 3,645 Class II · 528 Class III · 520 other
Most active product codes
Ranked by 510(k)/PMA clearance activity, with recall counts. Filter by class, specialty or recall history; search by code or device type.
How to use this library
A product code is FDA’s classification handle for a device type — it decides the regulation, the class and the review path. Compare clearances and recalls side by side, narrow by class or specialty, and open a code for its regulation number, clearance history and recall record.
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
COMPLETE INDEX — ALL 200 PRODUCT CODE
Every count on this page is aggregated from FDA clearance and recall records at render — none is a literal. Follow each code for its underlying FDA records.