ClearanceBrief
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
Sep 2, 2003K030633MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
Medtronic Ave, Inc.
FGE
Aug 27, 2003K032360MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
Boston Scientific Corp
FGE
Aug 12, 2003K031331WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
Abbott Vascular, Inc.
FGE
Aug 8, 2003K032206PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
Ev3, Inc.
FGE
Jul 18, 2003K031821MODIFICATION TO COOK ZILVER BILIARY STENT
Cook, Inc.
FGE
Jul 9, 2003K030638DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
Avantec Vascular Corp.
FGE
Jul 7, 2003K031777MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE
Jul 3, 2003K024303EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
Edwards Lifesciences, LLC
FGE
Jun 17, 2003K023666RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
Rusch Intl.
FGE
Jun 16, 2003K031197MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE
May 30, 2003K030839MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
Medtronic Ave, Inc.
FGE
May 6, 2003K031186LUMINEXX ENDOSCOPIC BILIARY STENT
C.R. Bard, Inc.
FGE
Apr 16, 2003K021672PANCREATIC DRAINAGE TUBE
Aomori Olympus Co., Ltd.
FGE
Apr 14, 2003K023308LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
Orbus Medical Technologies
FGE
Mar 31, 2003K030053JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
Jomed AG
FGE
Mar 25, 2003K030645BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
Boston Scientific Corp
FGE
Mar 21, 2003K030107100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
Boston Scientific Corp
FGE
Mar 10, 2003K030409SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
Cordis Corp.
FGE
Mar 10, 2003K023121LIFESTENT BILIARY ENDOPROSTHESIS
Orbus Medical Technologies
FGE
Feb 11, 2003K023248LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
Orbus Medical Technologies
FGE
Jan 21, 2003K010714EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
Medi-Globe Corp., DE
FGE
Jan 6, 2003K024048MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
Boston Scientific Scimed, Inc.
FGE
Jan 2, 2003K021994BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
C.R. Bard, Inc.
FGE
Dec 20, 2002K023870FLEXIMA BILIARY CATHETER
Boston Scientific/Medi-Tech
FGE
Dec 19, 2002K014215VIABIL BILIARY ENDOPROSTHESIS
W. L. Gore & Associates, Inc.
FGE
Dec 13, 2002K023243MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Sulzer Intratherapeutics, Inc.
FGE
Oct 25, 2002K023217MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE
Oct 25, 2002K021630BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
Boston Scientific Corp
FGE
Aug 14, 2002K021898SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE
Jul 19, 2002K022026MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
Medtronic Ave, Inc.
FGE
Jul 2, 2002K021824DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
Guidant Corp.
FGE
Jun 28, 2002K021345MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
Cordis Corp.
FGE
Jun 21, 2002K021729MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Sulzer Intratherapeutics, Inc.
FGE
May 8, 2002K020788WILSON-COOK ZILVER BILIARY STENT
Wilson-Cook Medical, Inc.
FGE
Apr 16, 2002K020528INTRASTENT LD (LARGE DIAMETER) STENT
Sulzer Intratherapeutics, Inc.
FGE
Apr 12, 2002K020809MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
Cordis Corp.
FGE
Apr 2, 2002K020682BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
C.R. Bard, Inc.
FGE
Mar 1, 2002K013737MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
Telemed Systems, Inc.
FGE
Feb 11, 2002K020052SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE
Jan 18, 2002K014184MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
Guidant Corp.
FGE
Jan 18, 2002K010549BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
Medi-Globe Corp.
FGE
Jan 17, 2002K014136MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Sulzer Intratherapeutics, Inc.
FGE
Jan 14, 2002K014205MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
Medtronic Ave, Inc.
FGE
Jan 7, 2002K014007DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
Guidant Corp.
FGE
Nov 28, 2001K011909ULTRA-THIN SDS BALLOON DILATATION CATHETER
Boston Scientific Corp
FGE
Nov 16, 2001K010601FANELLI BILIARY STENT
Cook, Inc.
FGE
Nov 15, 2001K012752WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
Boston Scientific Corp
FGE
Oct 24, 2001K012822MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
Boston Scientific Scimed, Inc.
FGE
Oct 11, 2001K011080BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
Medtronic Ave, Inc.
FGE
Oct 5, 2001K012993MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE

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