Bluewind Medical , Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Bluewind Medical , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Revi System, Revi™ System
3
Total
2
Cleared
1
Denied
Bluewind Medical , Ltd. has 2 FDA 510(k) cleared medical devices. Based in Herzliya, IL.
Latest FDA clearance: Dec 2025. Active since 2023. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Bluewind Medical , Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by BioVision , Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Bluewind Medical , Ltd.
3 devices