Provenance
Every regulator record set, with a link to the source
MedTech Signal holds no records of its own. Everything it shows comes from one of the published datasets below, and every record keeps a link back to the regulator that published it. Counts are read from stored holdings, and each refresh time is the last one that completed successfully.
MedTech Signal holds FDA, Health Canada, EU EUDAMED and UK MHRA records. EUDAMED is incomplete while registration is phased in, so a missing EU record is never read as "not on the EU market"; likewise a missing UK record is never read as "not registered in the UK". Japan PMDA approvals are also imported, but only from the published approved new medical devices list and matched by applicant name — Japanese approvals are often held by a local distributor, so a missing Japan record is never read as "not sold in Japan". No other regulator (TGA and others) is imported, so nothing here states a device's status in Australia or any other market.
FDA
| Dataset | What one record is | Records held | Last refreshed | Source |
|---|---|---|---|---|
Device premarket authorizations — 510(k), PMA and De Novo (openFDA) Each authorization links to its FDA 510(k), PMA or De Novo database record by submission number. | One premarket authorization, with applicant, product code and decision. | 234,378 | Nov 6, 2026, 2:33 p.m. UTC | |
FDA decision documents — 510(k) summaries, De Novo and PMA summaries Each document links to the PDF the FDA publishes; where no public document exists, the record says so. | One decision document published alongside an authorization. | Not counted separately | Nov 6, 2026, 4:30 p.m. UTC | Published datasetNo machine-readable source published |
Recognized Consensus Standards database Each recognition links to its FDA standard detail page. | One standard recognition, with its recognition number and extent of recognition. | 2,069 FDA and Health Canada recognitions are counted together. | Nov 3, 2026, 6:40 p.m. UTC | Published datasetNo machine-readable source published |
Warning Letters Each letter links to the FDA's published letter. | One warning letter issued to a device establishment. | 256 | Nov 6, 2026, 8:34 p.m. UTC | Published datasetNo machine-readable source published |
Inspection Classification Database and inspection observations Each inspection links to the FDA inspection dashboard for that establishment. | One inspection classification, or one cited observation from an inspection. | 93 | Nov 6, 2026, 8:34 p.m. UTC | |
Artificial Intelligence and Machine Learning enabled medical devices list Each entry links to the device's FDA authorization record. | One AI or machine-learning enabled device the FDA has authorized. | 1,614 | Oct 31, 2026, 11:32 p.m. UTC | Published datasetNo machine-readable source published |
MAUDE medical device adverse event reports (openFDA device/event) Each report links to its FDA MAUDE record. | Monthly report counts over 5 years (deaths, injuries, malfunctions) and top reported problems for one device type or manufacturer. Individual reports are fetched live, not stored. | 1,997 | Nov 6, 2026, 8:31 p.m. UTC | |
GUDID device identifiers (openFDA device/udi) Each device links to its AccessGUDID record. | Per labeling company: number of device identifiers, how many are in commercial distribution, top brands and FDA product codes. Individual identifiers are looked up live, not stored. | 4,608,022 | Nov 6, 2026, 9:02 p.m. UTC |
Health Canada
| Dataset | What one record is | Records held | Last refreshed | Source |
|---|---|---|---|---|
Medical Devices Active Licence Listing (MDALL) — licences Each licence links to its MDALL licence record (active or archived listing). | One medical device licence, with its holder, status and risk class. | 74,315 | Nov 6, 2026, 10:03 p.m. UTC | |
MDALL — licensed devices Each device links to the MDALL record of the licence it appears on. | One device named on a licence, with its model or catalogue name. | 303,457 | Nov 6, 2026, 10:03 p.m. UTC | |
MDALL — device identifiers Identifiers link to the MDALL record of their licence. | One catalogue, model or package identifier published for a licensed device. | 3,172,459 | Nov 6, 2026, 10:03 p.m. UTC | |
MDALL — companies Each company links to its MDALL company record. | One licence holder, with its published name and address. | 7,700 | Nov 6, 2026, 10:03 p.m. UTC | |
Recalls and Safety Alerts — medical devices Each recall links to its published recall notice. | One recall or safety alert, with hazard class, dates and affected products. | 8,709 | Nov 6, 2026, 9:32 p.m. UTC | |
Standards recognized under the Medical Devices Regulations Each recognition links to Health Canada's published standards list. | One standard recognized by Health Canada, with its recognition status. | 2,069 FDA and Health Canada recognitions are counted together. | Oct 31, 2026, 11:36 p.m. UTC | Published datasetNo machine-readable source published |
EU EUDAMED
| Dataset | What one record is | Records held | Last refreshed | Source |
|---|---|---|---|---|
EUDAMED — UDI/device registrations Each device links to its EUDAMED device record. | One registered device (UDI-DI), with trade name, risk class, market status and manufacturer SRN. | Not counted separately | Nov 6, 2026, 3:31 p.m. UTC | |
EUDAMED — notified body certificates Each certificate links to its EUDAMED certificate record. | One MDR/IVDR certificate, with holder, notified body, status and validity dates. | Not counted separately | Nov 6, 2026, 3:31 p.m. UTC |
UK MHRA
| Dataset | What one record is | Records held | Last refreshed | Source |
|---|---|---|---|---|
Public Access Registration Database (PARD) Each manufacturer links to its PARD record. | One manufacturer registered with the MHRA, with its UK Responsible Person and registered devices (GMDN term and class). | 13,177 | Nov 6, 2026, 9:01 p.m. UTC | Published datasetNo machine-readable source published |
Alerts, recalls and safety information: medical devices (GOV.UK) Each alert links to its GOV.UK notice. | One field safety notice, device safety information notice or national patient safety alert. | 848 | Nov 6, 2026, 9:01 p.m. UTC |
ClinicalTrials.gov
| Dataset | What one record is | Records held | Last refreshed | Source |
|---|---|---|---|---|
ClinicalTrials.gov registered studies with a device intervention (API v2) Each trial links to its ClinicalTrials.gov record. | One registered study: title, status, phase, lead sponsor, conditions, device interventions and dates. Results are not imported. | 77,039 | Nov 6, 2026, 9:33 p.m. UTC |
Check any record yourself
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