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.
No other regulator is imported yet. MedTech Signal holds FDA and Health Canada records only, so it never states anything about a device's status in the EU, Australia, Japan 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. | 233,644 | Sep 22, 2026, 2:35 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 | Sep 21, 2026, 9:00 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. | Sep 21, 2026, 4:31 a.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. | 246 | Sep 20, 2026, 7:02 a.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. | 63 | Sep 20, 2026, 7:02 a.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 | Sep 20, 2026, 4:02 a.m. UTC | Published datasetNo machine-readable source published |
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. | 74,001 | Sep 22, 2026, 3:05 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. | 302,012 | Sep 22, 2026, 3:05 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. | 3,146,946 | Sep 22, 2026, 3:05 p.m. UTC | |
MDALL — companies Each company links to its MDALL company record. | One licence holder, with its published name and address. | 7,658 | Sep 22, 2026, 3:05 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. | 8,640 | Sep 21, 2026, 11:04 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. | Sep 20, 2026, 1:02 a.m. UTC | Published datasetNo machine-readable source published |
Check any record yourself
Look up a device without an account and follow its records straight back to the FDA or Health Canada page they came from.
Open the free device lookup