Boston Scientific Corporation - FDA 510(k) Cleared Devices
236
Total
223
Cleared
1
Denied
236 devices
Cleared
Aug 29, 2024
RHYTHMIA HDx™ Mapping System
Cardiovascular
119d
Cleared
Jul 10, 2024
Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 )
Cardiovascular
29d
Cleared
Jul 01, 2024
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with...
Gastroenterology & Urology
27d
Cleared
Apr 04, 2024
Agile Esophageal Stent System
Gastroenterology & Urology
122d
Cleared
Mar 08, 2024
WallFlex Colonic Stent System with Anchor Lock Delivery System
Gastroenterology & Urology
78d
Cleared
Feb 01, 2024
WATCHMAN TruSteer Access System (M635TU90050)
Cardiovascular
30d
Cleared
Dec 12, 2023
StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue...
Gastroenterology & Urology
28d
Cleared
Dec 11, 2023
FARADRIVE™ Steerable Sheath
Cardiovascular
74d
Cleared
Nov 30, 2023
14F iSLEEVE Introducer Set
Cardiovascular
30d
Cleared
Oct 27, 2023
Polaris X™ Unidirectional Steerable Diagnostic Catheter
Cardiovascular
29d
Cleared
Oct 27, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm)
Gastroenterology & Urology
28d
Cleared
Sep 29, 2023
BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
Cardiovascular
29d
Cleared
Sep 26, 2023
AVVIGO'+ Multi-Modality Guidance System
Cardiovascular
180d
Not Cleared
Aug 18, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent)
Gastroenterology & Urology
144d
Cleared
Aug 14, 2023
Autotome Pro RX 39 Sphincterotome
Gastroenterology & Urology
24d
Cleared
Aug 08, 2023
Rubicon™ Control Support Catheter (H749394323506A1)
Cardiovascular
246d
Cleared
CT
Aug 08, 2023
Visual-ICE Cryoablation System
Orthopedic
161d
Cleared
Jul 14, 2023
Ultraflex™ Tracheobronchial Stent System
Anesthesiology
164d
Cleared
Jun 29, 2023
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Gastroenterology & Urology
30d
Cleared
Jun 27, 2023
EMBOLD™ Soft Detachable Coil System
Cardiovascular
105d
Cleared
Jun 21, 2023
Habib EndoHPB
Gastroenterology & Urology
26d
Cleared
Jun 15, 2023
WallFlex™ Biliary RX Stent System
Gastroenterology & Urology
210d
Cleared
May 18, 2023
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging...
Cardiovascular
86d
Cleared
Mar 22, 2023
POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular...
Cardiovascular
91d
Cleared
Mar 02, 2023
iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound...
Anesthesiology
297d
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