Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
863
results for "Boston Scientific"
Cleared
Mar 13, 2026
TheraSphere 360™ Y-90 Management Platform
Boston Scientific Corporation
Radiology
28d
Cleared
Feb 10, 2026
SpaceOAR Vue System (SV-2101)
Boston Scientific Corporation
Radiology
27d
Cleared
Jan 23, 2026
BodyGuardian Remote Monitoring System (BGRMS v3.0)
Boston Scientific Cardiac Diagnostic...
Cardiovascular
452d
Cleared
Nov 26, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional...
Surgical Instrument Service and...
Cardiovascular
118d
Cleared
Oct 30, 2025
OBSIDIO™ Conformable Embolic (M0013972101010)
Boston Scientific Corporation
Cardiovascular
30d
Cleared
Oct 30, 2025
Moses™ 200 D/F/L Laser Fiber (M0068130100)
Boston Scientific Corporation
General & Plastic Surgery
80d
Cleared
Oct 28, 2025
TheraSphere 360™ Y-90 Management Platform
Boston Scientific Corporation
Radiology
77d
Cleared
Oct 09, 2025
Orca Air/Water and Suction Valves
Boston Scientific
Gastroenterology & Urology
27d
Cleared
Sep 26, 2025
Radial Jaw 4 Pulmonary Biopsy Forceps
Boston Scientific Corporation
Anesthesiology
14d
Cleared
Sep 24, 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with...
Boston Scientific Corporation
Gastroenterology & Urology
28d
Cleared
Sep 12, 2025
LUX-Dx II Insertable Cardiac Monitor (M302)
Boston Scientific Corporation
Cardiovascular
28d
Cleared
Aug 07, 2025
GX1 Radiofrequency Generator Kit (RFG-X1-120V)
Boston Scientific Neuromodulation...
Neurology
106d
Cleared
Jul 11, 2025
Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional...
Surgical Instrument Service and...
Cardiovascular
120d
Cleared
Jul 09, 2025
Flexiva Pulse Laser Fiber
Boston Scientific Corporation
Gastroenterology & Urology
30d
Cleared
Jul 03, 2025
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
Boston Scientific
Gastroenterology & Urology
69d
Cleared
Jun 27, 2025
VIKING™ Fixed Curve Diagnostic Catheter
Boston Scientific Corporation
Cardiovascular
144d
Cleared
Jun 11, 2025
Rezum System
Boston Scientific Corporation
Gastroenterology & Urology
104d
Cleared
May 28, 2025
OptiMap™ System
Boston Scientific Corporation
Cardiovascular
28d
Cleared
Apr 15, 2025
Percuflex Ureteral Stent
Boston Scientific Corporation
Gastroenterology & Urology
28d
Cleared
Mar 21, 2025
Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210)
Boston Scientific Corporation
Gastroenterology & Urology
28d
Cleared
Mar 20, 2025
iSLEEVE Introducer Set
Boston Scientific
Cardiovascular
30d
Cleared
Feb 06, 2025
Resolution Clip (M00522600)
Boston Scientific Corporation
Gastroenterology & Urology
27d
Cleared
Dec 06, 2024
WallFlex Biliary PLUS RX Stent System
Boston Scientific
Gastroenterology & Urology
74d
Cleared
Nov 15, 2024
AdVance™ XP Male Sling System (720163-03)
Boston Scientific Corporation
Gastroenterology & Urology
51d