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 7, 2001K012590CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
Cordis Corp.
FGE
Sep 7, 2001K011806PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Sulzer Intratherapeutics, Inc.
FGE
Aug 27, 2001K010411PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
Cordis Corp.
FGE
Aug 23, 2001K012347PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Sulzer Intratherapeutics, Inc.
FGE
Aug 22, 2001K011817BRIDGE FX
Medtronic Ave, Inc.
FGE
Aug 17, 2001K012216NIROYAL BILIARY PREMOUNTED STENT SYSTEM
Boston Scientific Scimed, Inc.
FGE
Aug 13, 2001K011184INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
Intratherapeutics, Inc.
FGE
Aug 13, 2001K010242COOK ZILVER BILIARY STENT
Cook, Inc.
FGE
Aug 1, 2001K012090CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
Cordis, A Johnson & Johnson Co.
FGE
Aug 1, 2001K012087CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
Cordis Corp.
FGE
Aug 1, 2001K012066PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Sulzer Intratherapeutics, Inc.
FGE
Aug 1, 2001K012056CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
Cordis Europa, N.V.
FGE
Jul 31, 2001K010107R STENT BILIARY ENDOPROSTHESIS
Orbus Medical Technologies
FGE
Jul 18, 2001K011881DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
Guidant Corp.
FGE
Jun 15, 2001K011506OMNILINK .035 BILIARY STENT SYSTEM
Guidant Corp.
FGE
May 8, 2001K011039OMNILINK .018 BILIARY STENT SYSTEM
Guidant Corp.
FGE
Apr 12, 2001K010684RX HERCULINK PLUS BILIARY STENT SYSTEM
Guidant Corp.
FGE
Mar 22, 2001K003929NIROYAL BILIARY PREMOUNTED STENT SYSTEM
Boston Scientific Corp
FGE
Mar 16, 2001K010445PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
Cordis Corp.
FGE
Feb 16, 2001K002650VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
Bentec Medical, Inc.
FGE
Jan 24, 2001K003997INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
Intratherapeutics, Inc.
FGE
Jan 23, 2001K002235HORIZONS ERCP CANNULA
Horizons Intl. Corp.
FGE
Jan 9, 2001K003186BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
C.R. Bard, Inc.
FGE
Jan 5, 2001K003793BARD LUMINEXX BILIARY STENT
C.R. Bard, Inc.
FGE
Jan 4, 2001K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
Uresil Corp.
FGE
Dec 28, 2000K003040INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Intratherapeutics, Inc.
FGE
Dec 7, 2000K003450INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
Intratherapeutics, Inc.
FGE
Nov 22, 2000K003365S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
Cordis Corp.
FGE
Nov 22, 2000K003336MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE
Oct 30, 2000K002130NIR BILIARY STENT
Medinol, Ltd., IL
FGE
Oct 12, 2000K002143DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
Guidant Corp.
FGE
Oct 12, 2000K002133NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER
Boston Scientific Corp
FGE
Aug 30, 2000K001338MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
Boston Scientific Corp
FGE
Aug 28, 2000K001648INTRASTENT DOUBLESTRUT PARAMOUNT
Intratherapeutics, Inc.
FGE
Jul 31, 2000K002101ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
AngioDynamics, Inc.
FGE
Jul 18, 2000K001843S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE
Jun 27, 2000K001258BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
Cordis Corp.
FGE
Jun 5, 2000K000744MEDTRONIC AVE BRIDGE X3 STENT
Medtronic Ave, Inc.
FGE
May 19, 2000K000308WALLSTENT BILIARY ENDOPROSTHESIS
Boston Scientific Corp
FGE
May 17, 2000K001224RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
Guidant Corp.
FGE
May 17, 2000K001222OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
Guidant Corp.
FGE
Apr 14, 2000K000864INTRASTENT DOUBLESTRUT XS STENT
Intratherapeutics, Inc.
FGE
Apr 12, 2000K0007931 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
Guidant Corp.
FGE
Mar 23, 2000K993303SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
Boston Scientific Corp
FGE
Mar 23, 2000K000564CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
Cordis Corp.
FGE
Mar 17, 2000K000550OTW MEGALINK SDS BILIARY STENT SYSTEM
Advanced Cardiovascular Systems, Inc.
FGE
Feb 1, 2000K993904INTRASTENT DOUBLESTRUT LD
Intratherapeutics, Inc.
FGE
Jan 7, 2000K994156MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
Cordis Corp.
FGE
Jan 6, 2000K993892DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
C.R. Bard, Inc.
FGE
Jan 6, 2000K993392BARD MEMOTHERM FLEXX BILIARY STENT
C.R. Bard, Inc.
FGE

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