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 & Plastic Surgery ✕

4 devices

1-4 of 4

Cleared Oct 15, 1993

CARELET SAFETY LANCET

General & Plastic Surgery · 190d

Cleared Sep 13, 1993

CLEANLET, CLEANLET XL & KIDS

General & Plastic Surgery · 158d

Cleared Aug 10, 1993

SURESEAL BANDAGE

General & Plastic Surgery · 445d

Cleared Aug 01, 1990

SURELITE AND SURELITE XL BLOOD LANCET

General & Plastic Surgery · 62d