Wellspect AB is one of 59 FDA 510(k) medical device manufacturers from Sweden in the dataset, ranked by real submission volume.
Wellspect AB - FDA 510(k) Cleared Devices
Recent clearances: LoFric Elle Pro, LoFric Origo
2
Total
2
Cleared
0
Denied
Wellspect AB has 2 FDA 510(k) cleared medical devices. Based in M?lndal, SE.
Latest FDA clearance: Apr 2026. Active since 2025. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Wellspect AB Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Wellspect AB
2 devices