Medical Device Manufacturer · US , Mcdonough , GA

Gainor Medical Europe, Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1990

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gainor Medical Europe, Ltd. General Hospital ✕

3 devices

1-3 of 3

Cleared May 02, 1994

I.V. ADMINISTRATION SET

General Hospital · 495d

Cleared Oct 23, 1991

I.V. PRIMING SET

General Hospital · 89d

Cleared Jun 06, 1991

NEEDLE, ASPIRATION & INJECTION, DISPOSABLE

General Hospital · 371d