Medical Device Manufacturer · CN , Suzhou

Kossel Medtech (Suzhou) Co., Ltd. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2018

Total

Cleared

Denied

Kossel Medtech (Suzhou) Co., Ltd. has 6 FDA 510(k) cleared medical devices. Based in Suzhou, CN.

Latest FDA clearance: Sep 2026. Active since 2018. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Kossel Medtech (Suzhou) Co., Ltd. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by North American Science Associates (Namsa) as regulatory consultant.

Kossel Medtech (Suzhou) Co., Ltd. is one of 2116 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Kossel Medtech (Suzhou) Co., Ltd.

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Oct 05, 2026