| WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM (K031331) | Abbott Vascular, Inc. | 2003-08-12 |
| PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION (K032206) | Ev3, Inc. | 2003-08-08 |
| MODIFICATION TO COOK ZILVER BILIARY STENT (K031821) | Cook, Inc. | 2003-07-18 |
| DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML (K030638) | Avantec Vascular Corp. | 2003-07-09 |
| MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K031777) | Cordis Corp. | 2003-07-07 |
| EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM (K024303) | Edwards Lifesciences, LLC | 2003-07-03 |
| RUSCH GUIDED CHOLANGIOGRAPHY CATHETER (K023666) | Rusch Intl. | 2003-06-17 |
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K031197) | Cordis Corp. | 2003-06-16 |
| MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) (K030839) | Medtronic Ave, Inc. | 2003-05-30 |
| LUMINEXX ENDOSCOPIC BILIARY STENT (K031186) | C.R. Bard, Inc. | 2003-05-06 |
| PANCREATIC DRAINAGE TUBE (K021672) | Aomori Olympus Co., Ltd. | 2003-04-16 |
| LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS (K023308) | Orbus Medical Technologies | 2003-04-14 |
| JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 (K030053) | Jomed AG | 2003-03-31 |
| BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT (K030645) | Boston Scientific Corp | 2003-03-25 |
| 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM (K030107) | Boston Scientific Corp | 2003-03-21 |
| LIFESTENT BILIARY ENDOPROSTHESIS (K023121) | Orbus Medical Technologies | 2003-03-10 |
| SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM (K030409) | Cordis Corp. | 2003-03-10 |
| LIFESTENT LP SDS BILIARY ENDOPROSTHESIS (K023248) | Orbus Medical Technologies | 2003-02-11 |
| EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 (K010714) | Medi-Globe Corp. | 2003-01-21 |
| MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM (K024048) | Boston Scientific Scimed, Inc. | 2003-01-06 |
| BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM (K021994) | C.R. Bard, Inc. | 2003-01-02 |
| FLEXIMA BILIARY CATHETER (K023870) | Boston Scientific/Medi-Tech | 2002-12-20 |
| VIABIL BILIARY ENDOPROSTHESIS (K014215) | W. L. Gore & Associates, Inc. | 2002-12-19 |
| MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K023243) | Sulzer Intratherapeutics, Inc. | 2002-12-13 |
| BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM (K021630) | Boston Scientific Corp | 2002-10-25 |
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K023217) | Cordis Corp. | 2002-10-25 |
| SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K021898) | Cordis Corp. | 2002-08-14 |
| MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) (K022026) | Medtronic Ave, Inc. | 2002-07-19 |
| DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 (K021824) | Guidant Corp. | 2002-07-02 |
| MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (K021345) | Cordis Corp. | 2002-06-28 |
| MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K021729) | Sulzer Intratherapeutics, Inc. | 2002-06-21 |
| WILSON-COOK ZILVER BILIARY STENT (K020788) | Wilson-Cook Medical, Inc. | 2002-05-08 |
| INTRASTENT LD (LARGE DIAMETER) STENT (K020528) | Sulzer Intratherapeutics, Inc. | 2002-04-16 |
| MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (K020809) | Cordis Corp. | 2002-04-12 |
| BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM (K020682) | C.R. Bard, Inc. | 2002-04-02 |
| MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON (K013737) | Telemed Systems, Inc. | 2002-03-01 |
| SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K020052) | Cordis Corp. | 2002-02-11 |
| BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) (K010549) | Medi-Globe Corp. | 2002-01-18 |
| MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM (K014184) | Guidant Corp. | 2002-01-18 |
| MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K014136) | Sulzer Intratherapeutics, Inc. | 2002-01-17 |
| MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) (K014205) | Medtronic Ave, Inc. | 2002-01-14 |
| DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM (K014007) | Guidant Corp. | 2002-01-07 |
| ULTRA-THIN SDS BALLOON DILATATION CATHETER (K011909) | Boston Scientific Corp | 2001-11-28 |
| FANELLI BILIARY STENT (K010601) | Cook, Inc. | 2001-11-16 |
| WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE (K012752) | Boston Scientific Corp | 2001-11-15 |
| MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX (K012822) | Boston Scientific Scimed, Inc. | 2001-10-24 |
| BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM (K011080) | Medtronic Ave, Inc. | 2001-10-11 |
| MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K012993) | Cordis Corp. | 2001-10-05 |
| PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K011806) | Sulzer Intratherapeutics, Inc. | 2001-09-07 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM (K012590) | Cordis Corp. | 2001-09-07 |
| PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM (K010411) | Cordis Corp. | 2001-08-27 |
| PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K012347) | Sulzer Intratherapeutics, Inc. | 2001-08-23 |
| BRIDGE FX (K011817) | Medtronic Ave, Inc. | 2001-08-22 |
| NIROYAL BILIARY PREMOUNTED STENT SYSTEM (K012216) | Boston Scientific Scimed, Inc. | 2001-08-17 |
| INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS (K011184) | Intratherapeutics, Inc. | 2001-08-13 |
| COOK ZILVER BILIARY STENT (K010242) | Cook, Inc. | 2001-08-13 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (K012090) | Cordis, A Johnson & Johnson Co. | 2001-08-01 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT (K012087) | Cordis Corp. | 2001-08-01 |
| PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K012066) | Sulzer Intratherapeutics, Inc. | 2001-08-01 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (K012056) | Cordis Europa, N.V. | 2001-08-01 |
| R STENT BILIARY ENDOPROSTHESIS (K010107) | Orbus Medical Technologies | 2001-07-31 |
| DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM (K011881) | Guidant Corp. | 2001-07-18 |
| OMNILINK .035 BILIARY STENT SYSTEM (K011506) | Guidant Corp. | 2001-06-15 |
| OMNILINK .018 BILIARY STENT SYSTEM (K011039) | Guidant Corp. | 2001-05-08 |
| RX HERCULINK PLUS BILIARY STENT SYSTEM (K010684) | Guidant Corp. | 2001-04-12 |
| NIROYAL BILIARY PREMOUNTED STENT SYSTEM (K003929) | Boston Scientific Corp | 2001-03-22 |
| PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM (K010445) | Cordis Corp. | 2001-03-16 |
| VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 (K002650) | Bentec Medical, Inc. | 2001-02-16 |
| INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS (K003997) | Intratherapeutics, Inc. | 2001-01-24 |
| HORIZONS ERCP CANNULA (K002235) | Horizons Intl. Corp. | 2001-01-23 |
| BARD MEMOTHERM ENDOSCOPIC BILIARY STENT (K003186) | C.R. Bard, Inc. | 2001-01-09 |
| BARD LUMINEXX BILIARY STENT (K003793) | C.R. Bard, Inc. | 2001-01-05 |
| GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE (K003753) | Uresil Corp. | 2001-01-04 |
| INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY (K003040) | Intratherapeutics, Inc. | 2000-12-28 |
| INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS (K003450) | Intratherapeutics, Inc. | 2000-12-07 |
| MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K003336) | Cordis Corp. | 2000-11-22 |
| S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) (K003365) | Cordis Corp. | 2000-11-22 |
| NIR BILIARY STENT (K002130) | Medinol, Ltd. | 2000-10-30 |
| NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER (K002133) | Boston Scientific Corp | 2000-10-12 |
| DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM (K002143) | Guidant Corp. | 2000-10-12 |
| MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER (K001338) | Boston Scientific Corp | 2000-08-30 |
| INTRASTENT DOUBLESTRUT PARAMOUNT (K001648) | Intratherapeutics, Inc. | 2000-08-28 |
| ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER (K002101) | AngioDynamics, Inc. | 2000-07-31 |
| S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K001843) | Cordis Corp. | 2000-07-18 |
| BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM (K001258) | Cordis Corp. | 2000-06-27 |
| MEDTRONIC AVE BRIDGE X3 STENT (K000744) | Medtronic Ave, Inc. | 2000-06-05 |
| WALLSTENT BILIARY ENDOPROSTHESIS (K000308) | Boston Scientific Corp | 2000-05-19 |
| RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 (K001224) | Guidant Corp. | 2000-05-17 |
| OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 (K001222) | Guidant Corp. | 2000-05-17 |
| INTRASTENT DOUBLESTRUT XS STENT (K000864) | Intratherapeutics, Inc. | 2000-04-14 |
| 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER (K000793) | Guidant Corp. | 2000-04-12 |
| CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY (K000564) | Cordis Corp. | 2000-03-23 |
| SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER (K993303) | Boston Scientific Corp | 2000-03-23 |
| OTW MEGALINK SDS BILIARY STENT SYSTEM (K000550) | Advanced Cardiovascular Systems, Inc. | 2000-03-17 |
| INTRASTENT DOUBLESTRUT LD (K993904) | Intratherapeutics, Inc. | 2000-02-01 |
| MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B (K994156) | Cordis Corp. | 2000-01-07 |
| BARD MEMOTHERM FLEXX BILIARY STENT (K993392) | C.R. Bard, Inc. | 2000-01-06 |
| DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45 (K993892) | C.R. Bard, Inc. | 2000-01-06 |
| WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM (K993232) | Boston Scientific Scimed, Inc. | 1999-12-30 |
| S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K994068) | Cordis Corp. | 1999-12-23 |