Boston Scientific Corporation - FDA 510(k) Cleared Devices
236
Total
223
Cleared
1
Denied
236 devices
Cleared
Apr 10, 2018
Imager II Urology Torque Catheter
Gastroenterology & Urology
41d
Cleared
Jan 17, 2018
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD,...
Cardiovascular
30d
Cleared
Jan 10, 2018
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal...
Gastroenterology & Urology
107d
Cleared
Dec 20, 2017
Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx...
Gastroenterology & Urology
117d
Cleared
Dec 19, 2017
LumiCoil Platinum Fiducial Marker
Radiology
70d
Cleared
Dec 15, 2017
Polyform Synthetic Mesh
Obstetrics & Gynecology
228d
Cleared
Nov 16, 2017
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)
Cardiovascular
31d
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
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