Primed Medical Products, Inc. is one of 500 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Primed Medical Products, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PRIMED AAMI Level 3 Open Back Gowns, PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2, PRIMED Surgical and Procedure Masks
10
Total
10
Cleared
0
Denied
Primed Medical Products, Inc. has 10 FDA 510(k) cleared general hospital devices. Based in Edmonton, Alberta, CA.
Latest FDA clearance: Sep 2026. Active since 2008.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Primed Medical Products, Inc.
10 devices
Cleared
Sep 11, 2026
PRIMED AAMI Level 3 Open Back Gowns
General Hospital
88d
Cleared
Sep 01, 2026
PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug...
General Hospital
92d
Cleared
Nov 04, 2025
PRIMED Surgical and Procedure Masks
General Hospital
48d
Cleared
Oct 07, 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
General Hospital
70d
Cleared
Aug 26, 2024
PRIMED Surgical Masks and PRIMED Procedure Masks
General Hospital
207d
Cleared
May 24, 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
General Hospital
182d
Cleared
Nov 22, 2022
PRIMED Pediatric Facemask
General Hospital
397d
Cleared
Nov 04, 2016
PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
General Hospital
269d
Cleared
Sep 25, 2009
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE)...
General Hospital
81d
Cleared
Aug 11, 2008
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
General Hospital
61d