Nuwellis, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Nuwellis, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
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