Data / Medical devices / Canada / Primed Medical Products Inc.
Primed Medical Products Inc.: FDA-registered device maker in Edmonton Alberta, Canada, 9 510(k) clearances
Primed Medical Products Inc. is registered with the FDA (registration 9615270) in Edmonton Alberta, Canada. It lists 15 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 1, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 9615270
- FEI number
- 3002750002
- Address
- 200, 2003 - 91 Street SW, Edmonton Alberta, Canada, T6X0W8
- Owner or operator
- PRIMED Medical Products Inc. (9030179)
- Roles
- Exporter to the US, Specification developer
- First device listed
- December 12, 2000
- Registered through
- 2027
- Brand names listed
- PRIMAGARD, PRIMASOFT, PRIMED Chemo drug Tested gowns, PRIMED Procedure Masks, PRIMED Sterilization Wrap, PRIMED Surgical Masks, PRIMED Surgical Masks and PRIMED Procedure Masks
Devices it lists
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 |
|---|---|---|---|---|---|---|
| September 1, 2026 | K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) | QSO | Substantially Equivalent | PRIMED Medical Products, Inc. | accessdata.fda.gov |
| November 4, 2025 | K252964 | PRIMED Surgical and Procedure Masks | FXX | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| October 7, 2024 | K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | FRG | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| August 26, 2024 | K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | FXX | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| May 24, 2024 | K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | FRG | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| November 22, 2022 | K213427 | PRIMED Pediatric Facemask | OXZ | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| August 17, 2018 | K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | LZA | Substantially Equivalent | Hartalega Sdn Bhd | accessdata.fda.gov |
| November 4, 2016 | K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | FYC | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
| August 11, 2008 | K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | FXX | Substantially Equivalent | Primed Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Gown, Isolation, Surgical
- All makers of Gown, Examination
- All makers of Shield, Protective, Personnel
- All makers of Cap, Surgical
Updated September 1, 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.