Primed Medical Products, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PRIMED Surgical and Procedure Masks, PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600), PRIMED Surgical Masks and PRIMED Procedure Masks
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Primed Medical Products, Inc. General Hospital ✕
8 devices
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