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. Gastroenterology & Urology ✕

5 devices

1-5 of 5

Cleared Mar 01, 1991

NEEDLE, DIALYSIS

Gastroenterology & Urology · 263d

Cleared Nov 20, 1990

STOMACH, GASTRO-ENTEROSTOMY

Gastroenterology & Urology · 173d

Cleared Nov 20, 1990

HEMODIALYSIS SYSTEM AND ACCESSORY

Gastroenterology & Urology · 173d

Cleared Jul 16, 1990

Gastroenterology & Urology · 46d

Cleared Apr 20, 1990

HEMODIALYSIS BLOOD LINES

Gastroenterology & Urology · 89d