Medical Device Manufacturer · US , Walker , MI

Omega-Med Intl., Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1981

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omega-Med Intl., Inc. General & Plastic Surgery ✕

7 devices

1-7 of 7

Cleared Sep 05, 1984

OMED DISPOS. INSTRUMENT GUARDS

General & Plastic Surgery · 62d

Cleared Mar 05, 1984

SUTURE-AID BOOTIES

General & Plastic Surgery · 224d

Cleared Mar 24, 1983

OMED IDENT-I-BAND

General & Plastic Surgery · 37d

Cleared May 24, 1982

OMED FABRIC INSTRUMENT COVERS-RADIOPAQ

General & Plastic Surgery · 19d

Cleared Apr 23, 1981

OMED SILICONE INSTRUMENT COVERS

General & Plastic Surgery · 22d

Cleared Feb 26, 1981

OMED SILICONE LOOPS

General & Plastic Surgery · 27d

Cleared Feb 26, 1981

OMED FABRIC INSTRUMENT COVERS

General & Plastic Surgery · 24d