Boston Scientific Corporation - FDA 510(k) Cleared Devices
229
Total
216
Cleared
1
Denied
229 devices
Cleared
Dec 18, 2020
Advanix Biliary Stent with NaviFlex RX Delivery System
Gastroenterology & Urology
56d
Cleared
Dec 03, 2020
ORISE ProKnife
Gastroenterology & Urology
288d
Cleared
Oct 08, 2020
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy...
Gastroenterology & Urology
41d
Cleared
Oct 06, 2020
iSleeve Introducer Set
Cardiovascular
28d
Cleared
Oct 02, 2020
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
Cardiovascular
57d
Cleared
Sep 15, 2020
Athletis PTA Balloon Dilatation Catheter
Cardiovascular
137d
Cleared
Sep 01, 2020
Resolution 360™ ULTRA Clip
Gastroenterology & Urology
266d
Cleared
Aug 28, 2020
SpaceOAR System
Radiology
21d
Cleared
Aug 17, 2020
WallFlex Colonic Stent System with Anchor Lock Delivery System
Gastroenterology & Urology
109d
Cleared
Jul 28, 2020
TRUSELECT Microcatheter
Cardiovascular
28d
Cleared
Jul 23, 2020
AVVIGO Guidance System
Cardiovascular
30d
Cleared
Jun 26, 2020
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx...
Cardiovascular
193d
Cleared
May 21, 2020
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
General & Plastic Surgery
84d
Cleared
Apr 17, 2020
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex...
Gastroenterology & Urology
74d
Cleared
Apr 17, 2020
Opticross 35 15 MHz Peripheral Imaging Catheter
Cardiovascular
28d
Cleared
Feb 19, 2020
Sentinel Cerebral Protection System
Cardiovascular
163d
Cleared
Jan 16, 2020
Resectr Tissue Resection Device
Obstetrics & Gynecology
220d
Cleared
Jan 02, 2020
Ureteral Stent Systems, Biliary Drainage Catheters
Gastroenterology & Urology
216d
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
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