Medical Device Manufacturer · US , Eden Prairie , MN

Nuwellis, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023

Total

Cleared

Denied

Nuwellis, Inc. has 2 FDA 510(k) cleared medical devices. Based in Eden Prairie, US.

Latest FDA clearance: Aug 2025. Active since 2023. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Nuwellis, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Nuwellis, Inc.

2 devices

1-2 of 2