Boston Scientific Corporation - FDA 510(k) Cleared Devices
229
Total
216
Cleared
1
Denied
229 devices
Cleared
Jul 25, 2019
Stonetome Stone Removal Device
Gastroenterology & Urology
22d
Cleared
Jul 02, 2019
iLab Polaris Multi-Modality Guidance System
Cardiovascular
77d
Cleared
May 24, 2019
Tria Firm Ureteral Stent
Gastroenterology & Urology
77d
Cleared
May 21, 2019
MAKO 7
Obstetrics & Gynecology
208d
Cleared
Apr 16, 2019
Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm...
Gastroenterology & Urology
111d
Cleared
Mar 25, 2019
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced...
Gastroenterology & Urology
252d
Cleared
Mar 15, 2019
MAMBA and MAMBA Flex Microcatheters
Cardiovascular
24d
Cleared
Mar 08, 2019
CoreDx™ Pulmonary Mini-Forceps
Anesthesiology
122d
Cleared
Mar 08, 2019
Nitinol Thermocouple (TCN) Electrode
Neurology
112d
Cleared
Jan 22, 2019
SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery...
Gastroenterology & Urology
27d
Cleared
Nov 27, 2018
AdVance XP Male Sling
Gastroenterology & Urology
109d
Cleared
Sep 26, 2018
Magic Torque DLVR Guidewire
Cardiovascular
30d
Cleared
Sep 21, 2018
Agile Esophageal Stent System
Gastroenterology & Urology
246d
Cleared
Sep 13, 2018
Seal Single Use Biopsy Valve
Gastroenterology & Urology
22d
Cleared
Aug 23, 2018
SpyGlass DS and DS II Direct Visualization System
Gastroenterology & Urology
83d
Cleared
Jul 25, 2018
RHYTHMIA HDx Mapping System (with software Version 2.0)
Cardiovascular
219d
Cleared
Jun 22, 2018
iSLEEVE Introducer Set
Cardiovascular
88d
Cleared
May 17, 2018
Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
Cardiovascular
28d
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
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