GEMSS HEALTHCARE CO., LTD. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
GEMSS HEALTHCARE CO., LTD. - FDA 510(k) Cleared Devices
Recent clearances: XPLUS 35 Series (XPLUS 35, XPLUS 35FD), XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
2
Total
2
Cleared
0
Denied
GEMSS HEALTHCARE CO., LTD. has 2 FDA 510(k) cleared medical devices. Based in Paju-Si, KR.
Last cleared in 2023. Active since 2023. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by GEMSS HEALTHCARE CO., LTD. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Mtech Group, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - GEMSS HEALTHCARE CO., LTD.
2 devices