Boston Scientific Corporation - FDA 510(k) Cleared Devices
236
Total
223
Cleared
1
Denied
236 devices
Cleared
Dec 23, 2019
Comet II Pressure Guidewire
Cardiovascular
26d
Cleared
Dec 13, 2019
EXALT Model D Single-Use Duodenoscope, EXALT Controller
Gastroenterology & Urology
23d
Cleared
Nov 27, 2019
Rhythmia HDxTM Mapping System
Cardiovascular
82d
Cleared
Oct 25, 2019
IntellaMap Orion High Resolution Mapping Catheter
Cardiovascular
56d
Cleared
Aug 26, 2019
AXIOS Stent and Electrocautery Enhanced Delivery System
Gastroenterology & Urology
26d
Cleared
Aug 16, 2019
Tria Soft Ureteral Stent
Gastroenterology & Urology
60d
Cleared
Aug 07, 2019
15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set
Cardiovascular
26d
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
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