Medical Device Manufacturer · US , Eagle , WI

Healthstats International Pte. , Ltd. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2005

Total

Cleared

Denied

Healthstats International Pte. , Ltd. has 7 FDA 510(k) cleared medical devices. Based in Eagle, US.

Historical record: 7 cleared submissions from 2005 to 2018. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Healthstats International Pte. , Ltd. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Imagenix, Inc. as regulatory consultant.

Healthstats International Pte. , Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Healthstats International Pte. , Ltd.

7 devices

1-7 of 7

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Jun 08, 2026