SmartWise Sweden AB is one of 119 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
SmartWise Sweden AB - FDA 510(k) Cleared Devices
Recent clearances: Extroducer Infusion Catheter System, Extroducer Infusion Catheter System
2
Total
2
Cleared
0
Denied
SmartWise Sweden AB has 2 FDA 510(k) cleared medical devices. Based in Tullinge, SE.
Latest FDA clearance: Sep 2026. Active since 2022. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by SmartWise Sweden AB Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - SmartWise Sweden AB
2 devices