Boston Scientific Corporation - FDA 510(k) Cleared Devices
228
Total
215
Cleared
1
Denied
Boston Scientific Corporation has 215 FDA 510(k) cleared medical devices. Based in Marlborough, US.
Latest FDA clearance: Mar 2026. Active since 2005. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Boston Scientific Corporation Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Boston Scientific Corporation
228 devices
Cleared
Mar 13, 2026
TheraSphere 360™ Y-90 Management Platform
Radiology
28d
Cleared
Feb 10, 2026
SpaceOAR Vue System (SV-2101)
Radiology
27d
Cleared
Oct 30, 2025
Moses™ 200 D/F/L Laser Fiber (M0068130100)
General & Plastic Surgery
80d
Cleared
Oct 30, 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
Cardiovascular
30d
Cleared
Oct 28, 2025
TheraSphere 360™ Y-90 Management Platform
Radiology
77d
Cleared
Sep 26, 2025
Radial Jaw 4 Pulmonary Biopsy Forceps
Anesthesiology
14d
Cleared
Sep 24, 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with...
Gastroenterology & Urology
28d
Cleared
Sep 12, 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
Cardiovascular
28d
Cleared
Jul 09, 2025
Flexiva Pulse Laser Fiber
Gastroenterology & Urology
30d
Cleared
Jun 27, 2025
VIKING™ Fixed Curve Diagnostic Catheter
Cardiovascular
144d
Cleared
Jun 11, 2025
Rezum System
Gastroenterology & Urology
104d
Cleared
May 28, 2025
OptiMap™ System
Cardiovascular
28d
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