Boston Scientific Corporation - FDA 510(k) Cleared Devices
229
Total
216
Cleared
1
Denied
229 devices
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
Cleared
Aug 09, 2021
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use...
Ear, Nose, Throat
125d
Cleared
Jul 21, 2021
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Gastroenterology & Urology
89d
Cleared
Jun 25, 2021
iLab Polaris Multi-Modality Guidance System
Cardiovascular
92d
Cleared
May 26, 2021
SpyGlass Discover Retrieval Basket
Gastroenterology & Urology
195d
Cleared
May 25, 2021
LUX-Dx Insertable Cardiac Monitor
Cardiovascular
85d
Cleared
May 06, 2021
AutoCap RX
Gastroenterology & Urology
87d
Cleared
Apr 27, 2021
Safety Trocar Cannula
Gastroenterology & Urology
15d
Cleared
Apr 26, 2021
Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit,...
Gastroenterology & Urology
448d
Cleared
Apr 15, 2021
AXIOS Stent and Electrocautery Enhanced Delivery System
Gastroenterology & Urology
178d
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