Data / Medical devices / Mask, Surgical / Canada
FDA-registered makers of Mask, Surgical in Canada: 7 establishments
7 establishments in Canada are registered with the FDA to make Mask, Surgical (product code FXX). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Mask, Surgical
- Product code
- FXX
- Country
- Canada
Makers of Mask, Surgical in Canada
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Repackager or relabeler, Specification developer | 3 | November 10, 2022 | 0 | 2 | 0 | api.fda.gov |
| Primed Medical Products Inc. | Edmonton Alberta, Canada | Exporter to the US, Specification developer | 3 | November 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Amd Medicom Inc. | Saint-Laurent Quebec, Canada | Complaint file establishment, Manufacturer | 2 | November 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Supermax Healthcare Canada Inc. | Longueuil Quebec, Canada | Specification developer | 2 | November 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Beyes Dental Inc | Toronto Ontario, Canada | Manufacturer | 1 | March 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Vitacore Industries | Port Coquitlam British Columbia, Canada | Manufacturer | 1 | September 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| PRIMED Medical Products Manufacturing Ltd. | Cambridge Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.