Medical Device Manufacturer · SE , M?lndal

Wellspect AB - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2025

Total

Cleared

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

1-2 of 2