Medical Device Manufacturer · CA , Edmonton, Alberta

Primed Medical Products, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2008

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

FDA 510(k) Regulatory Record - Primed Medical Products, Inc. General Hospital ✕

10 devices

1-10 of 10

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