Boston Scientific Corporation - FDA 510(k) Cleared Devices
236
Total
223
Cleared
1
Denied
236 devices
Cleared
Jun 26, 2009
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710,...
Gastroenterology & Urology
35d
Cleared
CT
Apr 07, 2009
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510,...
Gastroenterology & Urology
120d
Cleared
Sep 05, 2008
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280,...
Gastroenterology & Urology
211d
Cleared
Dec 14, 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
Gastroenterology & Urology
101d
Cleared
Sep 20, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
Cardiovascular
19d
Cleared
May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
Gastroenterology & Urology
92d
Cleared
Apr 12, 2006
SYMMETRY BALLOON DILATATION CATHETER
Cardiovascular
5d
Cleared
Apr 12, 2006
BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER
Cardiovascular
5d
Cleared
Mar 15, 2006
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
Cardiovascular
9d
Cleared
Jan 31, 2006
FIBERED IDC OCCLUSION SYSTEM
Cardiovascular
21d
Cleared
Aug 16, 2005
PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
Cardiovascular
19d
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