Medical Device Manufacturer · US , Houston , TX

Gemss Medical Systems Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2014

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gemss Medical Systems Co., Ltd. Radiology ✕

4 devices

1-4 of 4

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

Radiology · 247d

Cleared Jun 16, 2014

GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM

Radiology · 328d