inforMED

About inforMED

inforMED lets you look up any FDA medical device product code or device name and see its adverse event reports (MDRs), recalls, 510(k) clearance history, and the firms registered to make it — sourced live from openFDA.

It's built for two kinds of people: teams developing a new device who want to understand the risk and competitive landscape for their product code before they file, and companies vetting or monitoring the manufacturers they buy from.

FDA inspection classifications, Form 483s, warning letters, and import refusals aren't available as a live API from the FDA, so those sections are populated from periodic data loads rather than in real time.

Data is unvalidated and may be incomplete — this is a research tool, not a substitute for your own regulatory diligence.