Medical Device Manufacturer · US , Eden Prairie , MN

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

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
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.

510(k) submissions have been managed by Avio Medtech Consulting as regulatory consultant.

FDA 510(k) Regulatory Record - Nuwellis, Inc.
2 devices
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