Gemss Medical Systems Co., Ltd. is one of 18423 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
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
Gemss Medical Systems Co., Ltd. has 4 FDA 510(k) cleared medical devices. Based in Houston, US.
Historical record: 4 cleared submissions from 2014 to 2017. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Gemss Medical Systems Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mtechgroup as regulatory consultant.
FDA 510(k) Regulatory Record - Gemss Medical Systems Co., Ltd.
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