Gemss Medical Systems Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System, GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System, TITAN 11
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Gemss Medical Systems Co., Ltd. Radiology ✕
4 devices
Cleared
May 26, 2017
SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System
Radiology
198d
Cleared
May 20, 2016
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
Radiology
128d
Cleared
Aug 07, 2014
TITAN 11
Radiology
247d
Cleared
Jun 16, 2014
GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
Radiology
328d