Data map
Where the data comes from, and what still needs a human
Three regulators feed the platform. Every record keeps a link to its original regulator page. Records are cleaned, then matched across borders. Only confirmed matches are stated as the same company or device — everything else stays a "possible match" until someone reviews it. Figures below are live.
1 · Load from regulators
USA
FDA (openFDA)
- 510(k), PMA & De Novo authorizations234,492
- Applicant companies35,030
- Recalls0
- AI-enabled devices1,614
- Warning letters256
- Form 483 inspections99
- Form 483 observations2,099
- Recognized standards1,586
- FDA device authorizationsweekly · last Nov 13, 19:32 UTC
- FDA device recallsdaily · last Nov 13, 19:01 UTC
- FDA AI-enabled device listweekly · last Nov 8, 00:01 UTC
- FDA source documentsdaily · last Nov 13, 20:00 UTC
- FDA recognized consensus standardsweekly · last Nov 13, 07:36 UTC
- FDA QMSR / enforcement dataweekly · last Nov 13, 20:31 UTC
- FDA adverse event reports (MAUDE) — summariesevery 1 h · last Nov 13, 20:01 UTC
- FDA device identifiers (GUDID) — company summariesevery 1 h · last Nov 13, 20:32 UTC
CANADA
Health Canada (MDALL, Recalls)
- Device licences74,374
- Licensed devices303,723
- Device identifiers3,173,328
- Manufacturers7,702
- Recalls8,717
- Health Canada MDALL licencesdaily · last Nov 13, 19:03 UTC
- Health Canada recallsdaily · last Nov 13, 03:31 UTC
- Health Canada recognized standardsweekly · last Nov 8, 00:05 UTC
EU
European Commission (EUDAMED)
- Devices (UDI-DI) — loading class by class323,138
- Notified body certificates7,341
- Manufacturers (by SRN)5,271
- EU EUDAMED devices and certificatesevery 30 min · last Nov 13, 18:31 UTC
UK
UK MHRA (PARD, GOV.UK alerts)
- Registered manufacturers13,228
- Registered devices141,459
- Safety alerts849
- UK MHRA registrations and safety alertsevery 1 h · last Nov 13, 21:31 UTC
US adverse events
FDA MAUDE (openFDA, summaries only)
- Device types and companies summarised1,997
- FDA adverse event reports (MAUDE) — summariesevery 1 h · last Nov 13, 20:01 UTC
Japan approvals
PMDA (approved new medical devices list)
- New device approvals and changes1,423
- Japan PMDA approved new medical devicesevery 1 h · last Nov 13, 21:01 UTC
US device identifiers
FDA GUDID (openFDA, company summaries)
- Device identifiers (top companies)4,609,888
- FDA device identifiers (GUDID) — company summariesevery 1 h · last Nov 13, 20:32 UTC
Device clinical trials
ClinicalTrials.gov (registered studies)
- Registered device trials77,183
| Link type | Confirmed | Probable | Possible | Rejected |
|---|---|---|---|---|
| FDA ↔ Health Canada companies | 2,533 | 4,587 | 7,469 | 0 |
| FDA ↔ Health Canada devices | 204 | 1,059 | 5,043 | 0 |
| Canadian recalls ↔ Canadian devices | 1,554 | 95 | 94 | 0 |
| Canadian ↔ FDA recalls | 3 | 38 | 0 | 0 |
| EU ↔ FDA / Health Canada companies | 4 | 0 | 4,486 | 2 |
Confirmed
Exact identifier match, or reviewed and confirmed by a person. Shown as a match.
Probable / Possible
Found automatically from cleaned names and addresses. Shown as a possible match only — needs manual review.
No apparent match
Nothing found. Never read as 'not licensed' or 'not on the market' — registries are incomplete.