Wuxi Hisky Medical Technologies Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Wuxi Hisky Medical Technologies Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000), Confocal Microprobe Imaging System (BrightP980), Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
5
Total
5
Cleared
0
Denied
Wuxi Hisky Medical Technologies Co., Ltd. has 5 FDA 510(k) cleared medical devices. Based in Wuxi, CN.
Latest FDA clearance: Oct 2025. Active since 2018. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Wuxi Hisky Medical Technologies Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Beijing Believe-Med Technology Service Co., Ltd., Pureid Medical Technology Co., Ltd. and Shenzhen Joyantech Consulting Co., Ltd..
FDA 510(k) Regulatory Record - Wuxi Hisky Medical Technologies Co., Ltd.
5 devices
Cleared
Oct 01, 2025
Shear Wave Quantificational Ultrasound Diagnostic System...
Radiology
268d
Cleared
Jul 24, 2025
Confocal Microprobe Imaging System (BrightP980)
General & Plastic Surgery
234d
Cleared
Jun 17, 2025
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990,...
Radiology
181d
Cleared
Mar 17, 2020
Shear Wave Quantificational Ultrasound Diagnostic System
Radiology
56d
Cleared
Jun 22, 2018
Shear Wave Quantificational Ultrasound Diagnostic System
Radiology
213d