The directory
Pick an area of care, search by name or condition, and open any tool for the details.
How we verify
Certification claims on websites and app stores are often vague or out of date. Every entry goes through the same four checks.
- Collect the claimWhat the company says: FDA clearance, CE marking or a German DiGA listing.
- Check the registerWe search the FDA 510(k), De Novo and PMA databases for the product and its legal manufacturer.
- Record the evidencePro members see the FDA reference numbers and dates, plus a note when a listing was wrong or incomplete.
- Re-check monthlyNew clearances move up. Claims we cannot confirm move to the watchlist.
FDA verifiedFound in the FDA register under this product or its manufacturer.
EU DiGAListed as a German digital health application (CE marked). EU register check in progress.
WatchlistClaimed to be certified, but not found in the FDA register. Not a judgement on quality.
Free to browse.
Pro when you need the proof.
Pro gives you the evidence behind every entry, for when you need to justify a choice to a patient, a colleague or a payer.
Free
€0Always
- Search all verified tools
- Certification status and FDA route
- Filter by area of care
Founding member price
Pro
€19per month, or €190 per year
- FDA reference numbers and decision dates
- Verification notes: wrong company, renamed or outdated listings
- The reason behind every watchlist entry
- Copy any list as CSV for your own files
- Monthly update: what was cleared and what moved
Team
Let's talkFor organisations
- Licences for hospitals, insurers and employers
- Full data export and custom shortlists
- Briefing with Prof. Koen Kas