Data / Medical devices / Canada / Amd Medicom Inc.
Amd Medicom Inc.: FDA-registered device maker in Saint-Laurent Quebec, Canada, 3 510(k) clearances
Amd Medicom Inc. is registered with the FDA (registration 3017425988) in Saint-Laurent Quebec, Canada. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 10, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017425988
- Address
- 400, Rue Stinson, Saint-Laurent Quebec, Canada, H4N 2E9
- Owner or operator
- AMD Medicom Inc (8020405)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 10, 2007
- Registered through
- 2027
- Brand names listed
- AMD-Ritmed Mask, Medicom AssureMask, Medicom Pediatric Mask, Medicom SafeBasics, Medicom SafeMask, Medicom Surgical/N95 Respirator, Ritmed Pediatric Mask, SafeMask(R) Architect Pro(TM) Surgical/N95 Respirator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Pediatric/Child Facemask | OXZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 10, 2022 | K222551 | Humask Pro Vision, Humask Pro Vision 3000 | FXX | Substantially Equivalent | Entreprise Premont, Inc. | accessdata.fda.gov |
| September 17, 2019 | K190308 | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) | OXZ | Substantially Equivalent | Amd Medicom, Inc. | accessdata.fda.gov |
| September 20, 2005 | K051291 | NON-STERILE SURGICAL MASK | FXX | Substantially Equivalent | A.R. Medicom, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Pediatric/Child Facemask
- All makers of Respirator, Surgical
- All makers of Mask, Surgical
Updated November 10, 2022. 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.