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
    Company names, addresses, device names and identifiers are cleaned into comparable forms. The original regulator text is kept and shown next to the cleaned version.
    Link typeConfirmedProbablePossibleRejected
    FDA ↔ Health Canada companies2,5334,5877,4690
    FDA ↔ Health Canada devices2041,0595,0430
    Canadian recalls ↔ Canadian devices1,55495940
    Canadian ↔ FDA recalls33800
    EU ↔ FDA / Health Canada companies404,4862

    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.

    MedTech Signal organizes published regulator records for information only. Confirm anything you rely on against the linked regulator record.