510k.fyi
Reveal new insights about medical devices
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William Edmisten

510k.fyi - Reveal new insights about medical devices

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A free website to enhance the FDA's 510(k) medical device database by including predicate device data. The 510(k) process requires new devices be equivalent to a "predicate" device, but the FDA does not publish this data directly. Explore it at 510k.fyi

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William Edmisten
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Hi everyone! About a year ago I realized that the FDA's 510(k) medical device database was missing some key information that would be useful to find relationships between cleared devices. So I spent the last year scraping the FDA's summary PDFs in order to provide this data in a structured format. I built 510k.fyi so that consumers, device manufacturers, and regulators can have more transparency into the 510(k) clearance process.
levene
Thanks for sharing project 510k.fyi