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.

Ascensia Diabetes Care U.S., Inc. 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 - Ascensia Diabetes Care U.S., Inc.

7 devices

1-7 of 7