Boston Scientific Corporation - FDA 510(k) Cleared Devices
238
Total
225
Cleared
1
Denied
238 devices
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
Cleared
Feb 03, 2023
14F iSLEEVE™ Introducer Set
Cardiovascular
28d
Cleared
Feb 02, 2023
StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible...
Gastroenterology & Urology
253d
Cleared
Dec 30, 2022
Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Gastroenterology & Urology
25d
Cleared
Dec 29, 2022
Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic...
Gastroenterology & Urology
28d
Cleared
Nov 10, 2022
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima...
Gastroenterology & Urology
506d
Cleared
Sep 23, 2022
OptiCross™ 18 Peripheral Imaging Catheter
Cardiovascular
30d
Cleared
Sep 14, 2022
Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
Gastroenterology & Urology
27d
Cleared
Sep 07, 2022
AXIOS Stent and Electrocautery-Enhanced Delivery System
Gastroenterology & Urology
237d
Cleared
Sep 06, 2022
ROTAPRO Rotational Atherectomy System
Cardiovascular
158d
Cleared
Aug 04, 2022
MANTIS Clip
Gastroenterology & Urology
108d
Cleared
Jul 28, 2022
EXALT Model B Single-Use Bronchoscope
Ear, Nose, Throat
20d
Cleared
Jun 10, 2022
IntellaMap Orion High Resolution Mapping Catheter
Cardiovascular
84d
Cleared
May 06, 2022
SpyGlass Discover Balloon Dilation Catheter
Gastroenterology & Urology
263d
Cleared
Apr 12, 2022
EMBOLD Fibered Detachable Coil System
Cardiovascular
176d
Cleared
Feb 21, 2022
EndoArmor™ + Surgical Gown
General Hospital
444d
Cleared
Jan 14, 2022
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
Cardiovascular
63d
Cleared
Dec 20, 2021
AdVance XP Male Sling System
Gastroenterology & Urology
188d
Cleared
Dec 14, 2021
EkoSonic Endovascular Device, EKOS+ Endovascular Device
Cardiovascular
55d
Cleared
Nov 22, 2021
Agile Esophageal OTW Stent System
Gastroenterology & Urology
151d
Cleared
Oct 20, 2021
AVVIGO Guidance System II
Cardiovascular
72d
Cleared
Sep 14, 2021
Polaris X Unidirectional Steerable Diagnostic Catheter
Cardiovascular
124d
Cleared
Sep 10, 2021
Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
Cardiovascular
129d
Cleared
Aug 13, 2021
WATCHMAN FXD Curve Access System
Cardiovascular
28d
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