How this site works, and who runs it

DeviceClearance indexes FDA medical device clearances, recalls, and adverse events. No editorializing on the facts, no fabricated data — every record traces back to its source.

Andrew Weston

Installation Systems Engineer

My day job is deploying software inside hospitals and imaging centers — a computer-vision AI radiology suite today, HIPAA-regulated clinical IT before that. Earlier in my career I wrote the work instructions that earned a device-repair shop its ISO 13485 certification. This site applies that same documentation-and-source discipline to public FDA data: every clearance, recall, and adverse-event record here traces back to openFDA, not a secondhand summary of it.

How it works

DeviceClearance is a static index built from a single dataset: one page per 510(k) clearance, company, and product code, generated straight from the underlying records. There's no manual curation of individual devices and no editorial ranking — the facts on each page are the facts openFDA published.

The index refreshes on a schedule so newly published clearances and recalls show up without a manual re-publish step, and each page carries the date it was last checked.

Data & sources

Data comes from the openFDA API, with FDA's periodic bulk data downloads as a fallback when the API is incomplete or lagging. We don't fabricate or estimate figures — if the FDA hasn't published a field, the page says so rather than guessing.

Spot something wrong or out of date? Tell us.

Independent & unofficial

DeviceClearance is operated by Press Pause Garage LLC, a Florida limited liability company.

DeviceClearance is not affiliated with, endorsed by, or operated by the U.S. Food and Drug Administration. We don't use FDA logos or imply government endorsement anywhere on the site. Nothing here is medical or regulatory advice — it's a public-record reference, not a substitute for consulting a qualified professional or the FDA's own systems.

DeviceClearance is unofficial and independent of the FDA. We surface public-record data fromopenFDA — nothing we send is medical or regulatory advice.