Boston Scientific Corporation - FDA 510(k) Cleared Devices
229
Total
216
Cleared
1
Denied
229 devices
Cleared
Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
Cardiovascular
87d
Cleared
Nov 03, 2017
Capio SLIM Suture Capturing Device
Obstetrics & Gynecology
119d
Cleared
Nov 03, 2017
Fixed Patient Leads ECG Cable (Model 3153)
Cardiovascular
66d
Cleared
Oct 04, 2017
CRE RX Biliary Balloon Dilatation Catheter
Gastroenterology & Urology
44d
Cleared
Aug 21, 2017
MAMBA and MAMBA FLEX Microcatheters
Cardiovascular
96d
Cleared
Aug 09, 2017
Epic Biliary Endoscopic Stent System
Gastroenterology & Urology
51d
Cleared
Jul 25, 2017
Rubicon 14, 18 and 35 Support Catheters
Cardiovascular
29d
Cleared
Jul 07, 2017
Interject Injection Therapy Needle Catheter
Gastroenterology & Urology
51d
Cleared
Jul 06, 2017
PSA Cable
Cardiovascular
111d
Cleared
Jun 30, 2017
ACUITY Pro Lead Delivery System
Cardiovascular
29d
Cleared
Jun 23, 2017
CRE Pulmonary Balloon Dilatation Catheter
Ear, Nose, Throat
102d
Cleared
Jun 22, 2017
Tria Firm Ureteral Stent
Gastroenterology & Urology
199d
Cleared
May 16, 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
Cardiovascular
138d
Cleared
Mar 27, 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
Ear, Nose, Throat
129d
Cleared
Mar 24, 2017
FFR Link, FFR Signal Processing Module
Cardiovascular
60d
Cleared
Mar 23, 2017
Guidezilla II Guide Extension Catheter
Cardiovascular
120d
Cleared
Mar 22, 2017
Fathom-16 Steerable Guidewires
Cardiovascular
20d
Cleared
Mar 10, 2017
RHYTHMIA HDx Mapping System
Cardiovascular
157d
Cleared
Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
Gastroenterology & Urology
89d
Cleared
Dec 14, 2016
Emerge PTCA Dilatation Catheter
Cardiovascular
30d
Cleared
Dec 14, 2016
Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail...
Cardiovascular
29d
Cleared
Nov 04, 2016
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation...
Cardiovascular
73d
Cleared
Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
Gastroenterology & Urology
44d
Cleared
Jun 23, 2016
NC Quantum Apex PTCA Dilatation Catheter
Cardiovascular
90d
Cleared
Jun 22, 2016
OptiCross 18, 30 MHz Peripheral Imaging Catheter
Cardiovascular
119d
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