Medical Device Manufacturer · CA , Edmonton, Alberta

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

9 submissions · 9 cleared · Since 1997

Recent clearances: PRIMED SHOE COVERS, PRIMED HEAD COVERS, PRIMED PRIME-PLUS COTTON GAUZE SPONGES

9

Total

9

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Nov 08, 2002

PRIMAGARD SURGICAL EQUIPMENT DRAPES

General Hospital · 71d

Cleared Nov 08, 2002

PRIMAGARD SURGICAL GOWNS

General Hospital · 58d

Cleared Nov 08, 2002

PRIMAGARD SURGICAL GOWNS

General Hospital · 39d

Cleared Sep 23, 2002

PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119,...

General Hospital · 109d

Cleared Apr 16, 2002

PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307

General Hospital · 13d

Cleared Jun 22, 2001

PROCEDURE MASKS: PM4-301 AND PM4-304

General Hospital · 14d

Cleared Sep 08, 2000

PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP,...

General Hospital · 73d

Cleared Jan 13, 1998

PRIMED SHOE COVERS, PRIMED HEAD COVERS

General Hospital · 295d