Medical Device Manufacturer · US , Mishawaka , IN

Ascensia Diabetes Care - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2016

Total

Cleared

Denied

Ascensia Diabetes Care has 6 FDA 510(k) cleared medical devices. Based in Mishawaka, US.

Latest FDA clearance: Aug 2026. Active since 2016. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Ascensia Diabetes Care Filter by specialty or product code using the sidebar.

2 devices have linked clinical trials registered on ClinicalTrials.gov.

Ascensia Diabetes Care is one of 16269 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Ascensia Diabetes Care

6 devices

1-6 of 6

Data Source

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

Last updated: Sep 05, 2026