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)
Top companies in FGE
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific | 56 | 81 |
| Ev3 Corporation | 12 | 71 |
| Bard Peripheral Vascular, Inc. | 2 | 69 |
| Edwards Lifesciences, LLC | 7 | 52 |
| Cordis Corp. | 38 | 14 |
| Cook Medical Incorporated | 0 | 39 |
| Cook Incorporated | 22 | 13 |
| Wilson-Cook Medical, Inc. | 20 | 15 |
| Hobbs Medical, Inc. | 3 | 21 |
| Guidant Corp. | 20 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 20, 2005 | K050534 | XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM Abbott Laboratories | FGE |
| Apr 22, 2005 | K050777 | PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 Conmedcorp | FGE |
| Apr 20, 2005 | K050725 | PROTEGE GPS SELF-EXPANDING NITINOL STENT Ev3 Corporation | FGE |
| Mar 30, 2005 | K050698 | MODIFICATION TO:ZILVER 518 BILIARY STENT Cook, Inc. | FGE |
| Mar 22, 2005 | K050627 | LIFESTENT TURBO BILIARY STENT SYSTEMS Edwards Lifesciences, LLC | FGE |
| Mar 14, 2005 | K050501 | MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM Abbott Vascular Devices | FGE |
| Feb 16, 2005 | K050103 | XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM Abbott Laboratories | FGE |
| Feb 14, 2005 | K033862 | BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK Bioteque Corp., TW | FGE |
| Dec 29, 2004 | K043481 | MODIFICATION TO: ZILVER 635 BILIARY STENT Cook, Inc. | FGE |
| Dec 23, 2004 | K042985 | LIFESTENT NT35 BILIARY STENT SYSTEM Edwards Lifesciences, LLC | FGE |
| Dec 9, 2004 | K043243 | PRIMUS STENT AND DELIVERY SYSTEM Ev3, Inc. | FGE |
| Nov 8, 2004 | K042969 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Oct 1, 2004 | K042518 | ZILVER 518 BILIARY STENT Cook, Inc. | FGE |
| Oct 1, 2004 | K041962 | XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 Abbott Laboratories | FGE |
| Aug 23, 2004 | K042204 | MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT Ev3, Inc. | FGE |
| Aug 3, 2004 | K041796 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corporation | FGE |
| Jul 21, 2004 | K041423 | VIABIL BILIARY ENDOPROSTHESIS W. L. Gore & Associates, Inc. | FGE |
| Jul 7, 2004 | K041606 | EXTRACTOR RX RETRIEVAL BALLOON Boston Scientific Corp | FGE |
| Jul 2, 2004 | K040930 | ZILVER BILIARY STENT SYSTEM USW Wilson-Cook Medical, Inc. | FGE |
| Jun 25, 2004 | K040800 | WILOSN-COOK BILIARY DILATION BALLOON Wilson-Cook Medical, Inc. | FGE |
| Jun 24, 2004 | K041370 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Jun 21, 2004 | K040413 | CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM Cordis Europa, N.V. | FGE |
| May 10, 2004 | K041032 | MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Apr 28, 2004 | K040653 | PARAMOUNT MINI GPS BILIARY STENT SYSTEM Ev3, Inc. | FGE |
| Apr 7, 2004 | K040667 | XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 Abbott Laboratories | FGE |
| Mar 30, 2004 | K040027 | BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM Boston Scientific | FGE |
| Mar 16, 2004 | K040550 | LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Mar 16, 2004 | K040505 | ZILVER 635 BILIARY STENT Cook, Inc. | FGE |
| Feb 20, 2004 | K040151 | OASIS BILIARY STENT INTRODUCTION SYSTEM Wilson-Cook Medical, Inc. | FGE |
| Feb 17, 2004 | K033909 | WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM Abbott Laboratories | FGE |
| Feb 4, 2004 | K033497 | BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM C.R. Bard, Inc. | FGE |
| Feb 4, 2004 | K032436 | DURAMAX .018 BILIARY STENT SYSTEM Avantec Vascular Corp. | FGE |
| Jan 2, 2004 | K033834 | OMNILINK .018 BILIARY STENT SYSTEM Guidant Corp. | FGE |
| Dec 22, 2003 | K033394 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM Cordis Corp. | FGE |
| Dec 15, 2003 | K033348 | ZILVER 518 BILIARY STENT Cook, Inc. | FGE |
| Dec 10, 2003 | K033537 | SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 Abbott Laboratories | FGE |
| Nov 21, 2003 | K033314 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM Ev3, Inc. | FGE |
| Nov 17, 2003 | K033134 | MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM Ev3, Inc. | FGE |
| Nov 17, 2003 | K011261 | STONE EXTRACTOR BALLOON CATHETER Medi-Globe Corp. | FGE |
| Nov 14, 2003 | K033333 | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B Aomori Olympus Co., Ltd. | FGE |
| Nov 10, 2003 | K033393 | ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM Guidant Corp. | FGE |
| Oct 30, 2003 | K033212 | LIFESTENT SDS BILIARY ENDOPROSTHESIS Orbus Medical Technologies | FGE |
| Oct 23, 2003 | K032530 | MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM Guidant Corporation | FGE |
| Oct 22, 2003 | K032929 | MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 Abbott Vascular, Inc. | FGE |
| Oct 22, 2003 | K032580 | PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM Ev3, Inc. | FGE |
| Oct 9, 2003 | K032768 | MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) Medtronic Ave, Inc. | FGE |
| Sep 25, 2003 | K032025 | SENTINOL NITINOL BILLARY STENT SYSTEM Boston Scientific Corp | FGE |
| Sep 24, 2003 | K031360 | GI SUPPLY BILIARY STENT Gi Supply | FGE |
| Sep 17, 2003 | K032137 | PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
| Sep 4, 2003 | K032457 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM Cordis Corp. | FGE |
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