Boston Scientific Corporation - FDA 510(k) Cleared Devices
Recent clearances: OBSIDIO Conformable Embolic, FARADRIVE™ Steerable Sheath (M004PF21M402), TheraSphere 360™ Y-90 Management Platform
236
Total
223
Cleared
1
Denied
FDA 510(k) Regulatory Record - Boston Scientific Corporation General & Plastic Surgery ✕
7 devices
Cleared
Oct 30, 2025
Moses™ 200 D/F/L Laser Fiber (M0068130100)
General & Plastic Surgery
80d
Cleared
May 21, 2020
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
General & Plastic Surgery
84d
Cleared
May 19, 2016
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS...
General & Plastic Surgery
233d
Cleared
Oct 16, 2014
ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM
General & Plastic Surgery
125d
Cleared
Apr 11, 2013
SHORT PORT BLUNT TIP TROCAR
General & Plastic Surgery
84d
Cleared
Mar 15, 2012
LEVEEN SUPERSLIM NEEDLE ELECTRODE
General & Plastic Surgery
148d
Cleared
Nov 06, 2009
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260,...
General & Plastic Surgery
123d