| ADVANIX DOUBLE PIGTAIL BILIARY STENT (K101786) | Boston Scientific Corp | 2010-07-23 |
| DIRECT PERORAL CHOLANGIOSCOPY BALLOON (K101095) | Wilson-Cook Medical, Inc. | 2010-07-19 |
| BONASTENT BILIARY (K093003) | Endochoice, Inc. | 2010-03-24 |
| SCUBA BILIARY STENT SYSTEM (K092352) | Invatec S.P.A. | 2010-03-16 |
| ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC (K093947) | Merit Medical Systems, Inc. | 2010-01-21 |
| MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS (K093392) | Navilyst Medical, Inc. | 2009-12-31 |
| FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM (K081996) | Flexible Stenting Solutions, Inc. | 2009-09-15 |
| BULLSEYE BILIARY STENT SYSTEM (K082093) | Squareone | 2009-07-29 |
| WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM (K083374) | Boston Scientific Corp | 2009-04-22 |
| WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 (K083627) | Boston Scientific Corporation | 2009-04-07 |
| CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS (K090133) | Cook, Inc. | 2009-02-20 |
| MEDINOL X-SUIT NIR BILIARY METALLIC STENT (K081956) | Medinol, Ltd. | 2009-01-09 |
| NITI-S BILIARY STENT (K073667) | Taewoong Medical Co., Ltd. | 2008-11-19 |
| 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 (K081733) | Boston Scientific Corp | 2008-10-27 |
| ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM (K072708) | Abbott Vascular-Vascular Solutions | 2008-08-18 |
| MODIFICATION TO ZILVER 635 BILIARY STENT (K080037) | Cook, Inc. | 2008-08-01 |
| GORE VIABIL BILILARY ENDOPROSTHESIS (K081184) | W.L. Gore & Associates, Inc. Medical Products Div. | 2008-07-22 |
| BARD E LUMINEXX BILIARY STENT (K063532) | Bard Peripheral Vascular, Inc. | 2008-05-30 |
| ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM (K072720) | Alveolus, Inc. | 2008-04-11 |
| 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 (K072301) | Ev3, Inc. | 2008-03-18 |
| SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB (K062798) | Cordis Corp. | 2008-02-06 |
| SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 (K071646) | Idev Technologies, Inc. | 2008-01-31 |
| SKATER BILIARY CATHETER (K073672) | Angiotech | 2008-01-24 |
| RESOLVE BILIARY DRAINAGE CATHETER (K063733) | Merit Medical Systems, Inc. | 2007-11-14 |
| COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM (K062264) | Medtronic Vascular | 2007-11-08 |
| MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM (K063481) | Abbott Vascular, Inc. | 2007-09-14 |
| SKATER BILIARY CATHETER (K070610) | Angiotech | 2007-06-21 |
| WELLFLEX BILIARY RX STENT SYSTEM (K061231) | Boston Scientific Corp | 2006-09-01 |
| PRIMUS GPS BILIARY STENT SYSTEM (K061566) | Ev3, Inc. | 2006-08-31 |
| SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060 (K060557) | Idev Technologies, Inc. | 2006-08-15 |
| MARATHON STENT WITH FUSION TECHNOLOGY (K060624) | Cook Ireland, Ltd. | 2006-08-04 |
| OMNILINK. 018 BILIARY STENT SYSTEM (K060817) | Guidant Endovascular Solutions, Inc. | 2006-06-15 |
| LIFESTENT TURBO BILIARY STENT SYSTEM (K061235) | Edwards Lifesciences, LLC | 2006-06-05 |
| PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX (K060877) | Cordis Corp. | 2006-04-27 |
| OMNILINK .035 BILIARY STENT SYSTEM (K053459) | Guidant Corporation | 2006-04-12 |
| LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM (K060487) | Edwards Lifesciences, LLC | 2006-03-23 |
| ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER (K060023) | AngioDynamics, Inc. | 2006-03-09 |
| PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM (K060057) | Ev3, Inc. | 2006-03-08 |
| RX HERCULINK ELITE BILIARY STENT SYSTEM (K053454) | Guidant Corporation | 2006-03-06 |
| LIFESTENT FLEXSTART BILIARY STENT SYSTEM (K053404) | Edwards Lifesciences, LLC | 2005-12-21 |
| GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER (K053245) | Uresil, LLC | 2005-12-20 |
| COOK FORMULA 418 BILIARY STENT SYSTEM (K052539) | Cook, Inc. | 2005-12-09 |
| BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP (K052114) | Bard Peripheral Vascular, Inc. | 2005-08-25 |
| MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM (K052132) | Edwards Lifesciences, LLC | 2005-08-24 |
| FORMULA 418 BILIARY STENT (K051785) | Cook, Inc. | 2005-08-23 |
| ZILVER 635 BILIARY STENT (K051124) | Cook, Inc. | 2005-07-12 |
| SINGLE USE BALLOON DILATOR MAXPASSTM (K050502) | Olympus Winter & Ibe GmbH | 2005-07-08 |
| PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT (K051379) | Ev3 Corporation | 2005-06-17 |
| XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050534) | Abbott Laboratories | 2005-05-20 |
| PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 (K050777) | Conmedcorp | 2005-04-22 |
| PROTEGE GPS SELF-EXPANDING NITINOL STENT (K050725) | Ev3 Corporation | 2005-04-20 |
| MODIFICATION TO:ZILVER 518 BILIARY STENT (K050698) | Cook, Inc. | 2005-03-30 |
| LIFESTENT TURBO BILIARY STENT SYSTEMS (K050627) | Edwards Lifesciences, LLC | 2005-03-22 |
| MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050501) | Abbott Vascular Devices | 2005-03-14 |
| XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050103) | Abbott Laboratories | 2005-02-16 |
| BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK (K033862) | Bioteque Corp. | 2005-02-14 |
| MODIFICATION TO: ZILVER 635 BILIARY STENT (K043481) | Cook, Inc. | 2004-12-29 |
| LIFESTENT NT35 BILIARY STENT SYSTEM (K042985) | Edwards Lifesciences, LLC | 2004-12-23 |
| PRIMUS STENT AND DELIVERY SYSTEM (K043243) | Ev3, Inc. | 2004-12-09 |
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K042969) | Cordis Corp. | 2004-11-08 |
| ZILVER 518 BILIARY STENT (K042518) | Cook, Inc. | 2004-10-01 |
| XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 (K041962) | Abbott Laboratories | 2004-10-01 |
| MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT (K042204) | Ev3, Inc. | 2004-08-23 |
| PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K041796) | Cordis Corporation | 2004-08-03 |
| VIABIL BILIARY ENDOPROSTHESIS (K041423) | W. L. Gore & Associates, Inc. | 2004-07-21 |
| EXTRACTOR RX RETRIEVAL BALLOON (K041606) | Boston Scientific Corp | 2004-07-07 |
| ZILVER BILIARY STENT SYSTEM USW (K040930) | Wilson-Cook Medical, Inc. | 2004-07-02 |
| WILOSN-COOK BILIARY DILATION BALLOON (K040800) | Wilson-Cook Medical, Inc. | 2004-06-25 |
| LIFESTENT LP SDS BILIARY ENDOPROSTHESIS (K041370) | Orbus Medical Technologies | 2004-06-24 |
| CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM (K040413) | Cordis Europa, N.V. | 2004-06-21 |
| MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS (K041032) | Orbus Medical Technologies | 2004-05-10 |
| PARAMOUNT MINI GPS BILIARY STENT SYSTEM (K040653) | Ev3, Inc. | 2004-04-28 |
| XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 (K040667) | Abbott Laboratories | 2004-04-07 |
| BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM (K040027) | Boston Scientific | 2004-03-30 |
| LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS (K040550) | Orbus Medical Technologies | 2004-03-16 |
| ZILVER 635 BILIARY STENT (K040505) | Cook, Inc. | 2004-03-16 |
| OASIS BILIARY STENT INTRODUCTION SYSTEM (K040151) | Wilson-Cook Medical, Inc. | 2004-02-20 |
| WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM (K033909) | Abbott Laboratories | 2004-02-17 |
| BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM (K033497) | C.R. Bard, Inc. | 2004-02-04 |
| DURAMAX .018 BILIARY STENT SYSTEM (K032436) | Avantec Vascular Corp. | 2004-02-04 |
| OMNILINK .018 BILIARY STENT SYSTEM (K033834) | Guidant Corp. | 2004-01-02 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM (K033394) | Cordis Corp. | 2003-12-22 |
| ZILVER 518 BILIARY STENT (K033348) | Cook, Inc. | 2003-12-15 |
| SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 (K033537) | Abbott Laboratories | 2003-12-10 |
| PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K033314) | Ev3, Inc. | 2003-11-21 |
| MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM (K033134) | Ev3, Inc. | 2003-11-17 |
| STONE EXTRACTOR BALLOON CATHETER (K011261) | Medi-Globe Corp. | 2003-11-17 |
| SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B (K033333) | Aomori Olympus Co., Ltd. | 2003-11-14 |
| ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM (K033393) | Guidant Corp. | 2003-11-10 |
| LIFESTENT SDS BILIARY ENDOPROSTHESIS (K033212) | Orbus Medical Technologies | 2003-10-30 |
| MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM (K032530) | Guidant Corporation | 2003-10-23 |
| MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 (K032929) | Abbott Vascular, Inc. | 2003-10-22 |
| PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K032580) | Ev3, Inc. | 2003-10-22 |
| MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) (K032768) | Medtronic Ave, Inc. | 2003-10-09 |
| SENTINOL NITINOL BILLARY STENT SYSTEM (K032025) | Boston Scientific Corp | 2003-09-25 |
| GI SUPPLY BILIARY STENT (K031360) | Gi Supply | 2003-09-24 |
| PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K032137) | Cordis Corp. | 2003-09-17 |
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K032457) | Cordis Corp. | 2003-09-04 |
| MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT (K030633) | Medtronic Ave, Inc. | 2003-09-02 |
| MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT (K032360) | Boston Scientific Corp | 2003-08-27 |