Medical Device Manufacturer · US , Mishawaka , IN

Ascensia Diabetes Care U.S., Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2016

Total

Cleared

Denied

Ascensia Diabetes Care U.S., Inc. has 7 FDA 510(k) cleared medical devices. Based in Mishawaka, US.

Latest FDA clearance: May 2025. Active since 2016. Primary specialty: Chemistry.

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

1 device has linked clinical trial registered on ClinicalTrials.gov.

FDA 510(k) Regulatory Record - Ascensia Diabetes Care U.S., Inc.

7 devices

1-7 of 7

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 30, 2026