Guides

How to check if a medical device has been recalled by the FDA
A practical guide to finding FDA medical-device recalls — by device, manufacturer, or product code — and understanding recall classes (Class I, II, III).

Understanding FDA MAUDE adverse event reports (and their limits)
What the FDA MAUDE database contains, how to read adverse-event reports (death, injury, malfunction), and the caveats every analyst should know before drawing conclusions.

UDI-DI, GUDID, and product codes: FDA device identifiers explained
A plain-English guide to the identifiers that connect FDA device data — UDI-DI, GUDID, product codes, and 510(k)/PMA numbers — and how they link registration, recalls, and adverse events.

510(k) vs PMA: how medical devices get cleared by the FDA
The difference between FDA 510(k) clearance and PMA approval — which pathway applies, what each means for device risk, and how to find a device’s clearance history.

FDA device classes explained: Class I, II, and III
How the FDA classifies medical devices by risk — Class I, II, and III — what each class means for regulation and market pathway, and where to find a device’s class.

How to build a medical device safety dashboard with the FDA API
A developer’s guide to building a device safety dashboard on FDA data — linking recalls, adverse events, and clearances by device without wrangling six separate databases.