Medical Device Manufacturer · US , San Jose , CA

Boston Scientific Corp - FDA 510(k) Cleared Devices

432 submissions · 411 cleared · Since 1988
432
Total
411
Cleared
0
Denied
162 devices
26-50 of 162
Cleared Aug 27, 2008
BOSTON SCIENTIFIC SURGICAL MESH
K081275 · PAH
Gastroenterology & Urology · 114d
Cleared Feb 27, 2008
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
K073266 · ESW
Gastroenterology & Urology · 99d
Cleared Jun 29, 2007
SPYCATCH STONE RETRIEVAL BASKET
K071066 · LQR
Gastroenterology & Urology · 74d
Cleared Dec 04, 2006
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS...
K062750 · MUM
Gastroenterology & Urology · 81d
Cleared Sep 21, 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · KNQ
Gastroenterology & Urology · 87d
Cleared Sep 15, 2006
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K061877 · MQR
Gastroenterology & Urology · 74d
Cleared Sep 01, 2006
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · FGE
Gastroenterology & Urology · 122d
Cleared Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
K052194 · ODF
Gastroenterology & Urology · 13d
Cleared Jun 16, 2005
EASY CORE DETACHABLE BIOPSY SYSTEM
K051361 · KNW
Gastroenterology & Urology · 22d
Cleared Jun 16, 2005
SPYSCOPE ACCESS AND DELIVERY CATHETER
K051504 · FED
Gastroenterology & Urology · 9d
Cleared Mar 11, 2005
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
K050232 · PID
Gastroenterology & Urology · 38d
Cleared Mar 04, 2005
SPYGLASS DIRECT VISULATION PROBE
K050403 · ODF
Gastroenterology & Urology · 15d
Cleared Feb 08, 2005
EASY CORE BIOPSY SYSTEM II
K050120 · FCG
Gastroenterology & Urology · 21d
Cleared Nov 09, 2004
ENTERYX INJECTION CATHETER
K042882 · FBK
Gastroenterology & Urology · 21d
Cleared Sep 30, 2004
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
K042065 · MQR
Gastroenterology & Urology · 59d
Cleared Jul 07, 2004
EXTRACTOR RX RETRIEVAL BALLOON
K041606 · FGE
Gastroenterology & Urology · 22d
Cleared May 18, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K040736 · MSD
Gastroenterology & Urology · 57d
Cleared May 06, 2004
EASY CORE BIOPSY SYSTEM
K040893 · FCG
Gastroenterology & Urology · 30d
Cleared Mar 16, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
K040492 · MSD
Gastroenterology & Urology · 19d
Cleared Mar 12, 2004
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
K040447 · LQC
Gastroenterology & Urology · 21d
Cleared Oct 23, 2003
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K032930 · ESW
Gastroenterology & Urology · 31d
Cleared Oct 02, 2003
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712 · MSD
Gastroenterology & Urology · 30d
Cleared Sep 25, 2003
SENTINOL NITINOL BILLARY STENT SYSTEM
K032025 · FGE
Gastroenterology & Urology · 87d
Cleared Aug 27, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM...
K032360 · FGE
Gastroenterology & Urology · 27d
Cleared Jul 14, 2003
ULTRAFLEX PRECISION COLONIC STENT
K030769 · MQR
Gastroenterology & Urology · 125d

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