Medical Device Manufacturer · US , Willow Creek , MT

Gme (German Medical Engineering) GmbH - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2014
6
Total
6
Cleared
0
Denied

FDA 510(k) cleared devices by Gme (German Medical Engineering) GmbH General & Plastic Surgery ✕

6 devices
1-6 of 6
Cleared Mar 10, 2023
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
K221623 · GEX
General & Plastic Surgery · 277d
Cleared Mar 05, 2021
FlexSys
K203054 · GEX
General & Plastic Surgery · 149d
Cleared Nov 19, 2019
TwinScan 808/755 Laser System
K192269 · GEX
General & Plastic Surgery · 90d
Cleared Jul 23, 2018
GME LinScan Lite 808 Laser System
K180518 · GEX
General & Plastic Surgery · 146d
Cleared Jul 31, 2015
GME ExSys 308
K150752 · FTC
General & Plastic Surgery · 130d
Cleared Jul 15, 2014
LINSCAN 808, LINSCAN 980
K141063 · GEX
General & Plastic Surgery · 82d
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