Medical Device Manufacturer · CA , Edmonton, Alberta

Primed Medical Products, Inc.

8 submissions · 8 cleared · Since 2008
8
Total
8
Cleared
0
Denied

Primed Medical Products, Inc. — FDA 510(k) Submissions

Primed Medical Products, Inc. has submitted 8 FDA 510(k) premarket notifications since 2008, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mask, Surgical, Wrap, Sterilization, Gown, Isolation, Surgical, Pediatric/child Facemask . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
PRIMED Surgical and Procedure Masks
K252964 · FXX Mask, Surgical · General Hospital
Nov 2025 48d
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K242208 · FRG Wrap, Sterilization · General Hospital
Oct 2024 70d
PRIMED Surgical Masks and PRIMED Procedure Masks
K240286 · FXX Mask, Surgical · General Hospital
Aug 2024 207d
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K233777 · FRG Wrap, Sterilization · General Hospital
May 2024 182d
PRIMED Pediatric Facemask
K213427 · OXZ Pediatric/child Facemask · General Hospital
Nov 2022 397d
PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
K160361 · FYC Gown, Isolation, Surgical · General Hospital
Nov 2016 269d
PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70
K092012 · FXX Mask, Surgical · General Hospital
Sep 2009 81d
PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS
K081633 · FXX Mask, Surgical · General Hospital
Aug 2008 61d
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