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Panels › Gastroenterology, Urology › Product code FGE · Class 2

Stents, Drains And Dilators For The Biliary Ducts

Regulation 876.5010

10510(k)s in 12 months (478 all time)
12recalls in 12 months (452 all time)
439recalls that name a 510(k)
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Top companies in FGE

Company510(k)sRecalls
Boston Scientific5681
Ev3 Corporation1271
Bard Peripheral Vascular, Inc.269
Edwards Lifesciences, LLC752
Cordis Corp.3814
Cook Medical Incorporated039
Cook Incorporated2213
Wilson-Cook Medical, Inc.2015
Hobbs Medical, Inc.321
Guidant Corp.200
Decided510(k)Device and applicantCode
Aug 23, 2010K102082EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
Boston Scientific Corp
FGE
Jul 23, 2010K101786ADVANIX DOUBLE PIGTAIL BILIARY STENT
Boston Scientific Corp
FGE
Jul 23, 2010K101314ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
Boston Scientific Corp
FGE
Jul 19, 2010K101095DIRECT PERORAL CHOLANGIOSCOPY BALLOON
Wilson-Cook Medical, Inc.
FGE
Mar 24, 2010K093003BONASTENT BILIARY
Endochoice, Inc.
FGE
Mar 16, 2010K092352SCUBA BILIARY STENT SYSTEM
Invatec S.P.A.
FGE
Jan 21, 2010K093947ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
Merit Medical Systems, Inc.
FGE
Dec 31, 2009K093392MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
Navilyst Medical, Inc.
FGE
Sep 15, 2009K081996FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
Flexible Stenting Solutions, Inc.
FGE
Jul 29, 2009K082093BULLSEYE BILIARY STENT SYSTEM
Squareone
FGE
Apr 22, 2009K083374WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
Boston Scientific Corp
FGE
Apr 7, 2009K083627WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
Boston Scientific Corporation
FGE
Feb 20, 2009K090133CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
Cook, Inc.
FGE
Jan 9, 2009K081956MEDINOL X-SUIT NIR BILIARY METALLIC STENT
Medinol, Ltd.
FGE
Nov 19, 2008K073667NITI-S BILIARY STENT
Taewoong Medical Co., Ltd.
FGE
Oct 27, 2008K08173310MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
Boston Scientific Corp
FGE
Aug 18, 2008K072708ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
Abbott Vascular-Vascular Solutions
FGE
Aug 1, 2008K080037MODIFICATION TO ZILVER 635 BILIARY STENT
Cook, Inc.
FGE
Jul 22, 2008K081184GORE VIABIL BILILARY ENDOPROSTHESIS
W.L. Gore & Associates, Inc. Medical Products Div.
FGE
May 30, 2008K063532BARD E LUMINEXX BILIARY STENT
Bard Peripheral Vascular, Inc.
FGE
Apr 11, 2008K072720ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
Alveolus, Inc.
FGE
Mar 18, 2008K0723015MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
Ev3, Inc.
FGE
Feb 6, 2008K062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
Cordis Corp.
FGE
Jan 31, 2008K071646SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
Idev Technologies, Inc.
FGE
Jan 24, 2008K073672SKATER BILIARY CATHETER
Angiotech
FGE
Nov 14, 2007K063733RESOLVE BILIARY DRAINAGE CATHETER
Merit Medical Systems, Inc.
FGE
Nov 8, 2007K062264COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
Medtronic Vascular
FGE
Sep 14, 2007K063481MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
Abbott Vascular, Inc.
FGE
Jun 21, 2007K070610SKATER BILIARY CATHETER
Angiotech
FGE
Sep 1, 2006K061231WELLFLEX BILIARY RX STENT SYSTEM
Boston Scientific Corp
FGE
Aug 31, 2006K061566PRIMUS GPS BILIARY STENT SYSTEM
Ev3, Inc.
FGE
Aug 15, 2006K060557SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
Idev Technologies, Inc.
FGE
Aug 4, 2006K060624MARATHON STENT WITH FUSION TECHNOLOGY
Cook Ireland, Ltd., IE
FGE
Jun 15, 2006K060817OMNILINK. 018 BILIARY STENT SYSTEM
Guidant Endovascular Solutions, Inc.
FGE
Jun 5, 2006K061235LIFESTENT TURBO BILIARY STENT SYSTEM
Edwards Lifesciences, LLC
FGE
Apr 27, 2006K060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
Cordis Corp.
FGE
Apr 12, 2006K053459OMNILINK .035 BILIARY STENT SYSTEM
Guidant Corporation
FGE
Mar 23, 2006K060487LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
Edwards Lifesciences, LLC
FGE
Mar 9, 2006K060023ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
AngioDynamics, Inc.
FGE
Mar 8, 2006K060057PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
Ev3, Inc.
FGE
Mar 6, 2006K053454RX HERCULINK ELITE BILIARY STENT SYSTEM
Guidant Corporation
FGE
Dec 21, 2005K053404LIFESTENT FLEXSTART BILIARY STENT SYSTEM
Edwards Lifesciences, LLC
FGE
Dec 20, 2005K053245GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
Uresil, LLC
FGE
Dec 9, 2005K052539COOK FORMULA 418 BILIARY STENT SYSTEM
Cook, Inc.
FGE
Aug 25, 2005K052114BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
Bard Peripheral Vascular, Inc.
FGE
Aug 24, 2005K052132MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
Edwards Lifesciences, LLC
FGE
Aug 23, 2005K051785FORMULA 418 BILIARY STENT
Cook, Inc.
FGE
Jul 12, 2005K051124ZILVER 635 BILIARY STENT
Cook, Inc.
FGE
Jul 8, 2005K050502SINGLE USE BALLOON DILATOR MAXPASSTM
Olympus Winter & Ibe GmbH
FGE
Jun 17, 2005K051379PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
Ev3 Corporation
FGE

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