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
Dec 30, 1999K993232WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
Boston Scientific Scimed, Inc.
FGE
Dec 23, 1999K994068S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE
Nov 28, 1999K993646S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Cordis Corp.
FGE
Nov 26, 1999K990808PBN DILATORS
Medical Device Technologies, Inc.
FGE
Nov 17, 1999K993588MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
Guidant Corp.
FGE
Oct 29, 1999K993091PALMAZ XL TANSHEPATIC BILIARY STENTS
Cordis Corp.
FGE
Oct 21, 1999K993145MEDTRONIC AVE BRIDGE STENT
Medtronic Ave, Inc.
FGE
Oct 15, 1999K992816MODIFICATION TO INTRASTENT
Intratherapeutics, Inc.
FGE
Oct 8, 1999K992319RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
Guidant Corp.
FGE
Sep 15, 1999K992755CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE
Cordis, A Johnson & Johnson Co.
FGE
Sep 2, 1999K990867RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
Advanced Cardiovascular Systems, Inc.
FGE
Sep 1, 1999K990592INTRASTENT II
Intratherapeutics, Inc.
FGE
Aug 31, 1999K992569MEDTRONIC AVE BRIDGE STENT
Medtronic Ave, Inc.
FGE
Aug 12, 1999K991674CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
Cordis Corp.
FGE
Aug 4, 1999K991929INTRASTENT
Intratherapeutics, Inc.
FGE
Aug 4, 1999K991028CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
Cordis Corp.
FGE
Aug 2, 1999K992318MEDTRONIC AVE BRIDGE STENT
Medtronic Ave, Inc.
FGE
Aug 2, 1999K990854INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
Innerdyne, Inc.
FGE
Jul 29, 1999K991533MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
Peripheral Ave
FGE
Jun 25, 1999K991793ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
AngioDynamics, Inc.
FGE
May 5, 1999K983154CYSTIC DUCT BALLOON DILATING CATHETER
Applied Medical Resources
FGE
Apr 30, 1999K991032GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
Guidant Corp.
FGE
Apr 30, 1999K990631CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
Cordis Corp.
FGE
Mar 3, 1999K983075GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
Guidant Corp.
FGE
Feb 12, 1999K990130WILSON-COOK PANCREATIC WEDGE STENT
Wilson-Cook Medical, Inc.
FGE
Jan 29, 1999K982346ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
AngioDynamics, Inc.
FGE
Dec 18, 1998K980823CORDIS NITINOL STENT AND DELIVERY SYSTEM
Cordis Corp.
FGE
Nov 25, 1998K983008PERIPHERAL AVE STENT SYSTEM
Peripheral Ave
FGE
Nov 13, 1998K973171NIR BILIARY STENT
Medinol, Ltd., IL
FGE
Oct 16, 1998K982508FLEXIMA
Boston Scientific Corp
FGE
Sep 2, 1998K982005WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
Boston Scientific Scimed, Inc.
FGE
Jul 21, 1998K980290ITI STENT
Intratherapeutics, Inc.
FGE
Jun 9, 1998K980653PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
Cordis Corp.
FGE
Apr 27, 1998K980372MANAN VS ACCESS NEEDLE/SET
Medical Device Technologies, Inc.
FGE
Feb 9, 1998K980191MANAN BILIARY DRAINAGE CATHETER
Medical Device Technologies, Inc.
FGE
Jan 9, 1998K974815MANAN(TM) INTRODUCER SHEATH/NEEDLE
Medical Device Technologies, Inc.
FGE
Dec 15, 1997K973008COURIER ST BALLOON DILATATION CATHETER
Boston Scientific Corp
FGE
Nov 21, 1997K972582URESIL GUIDEWIRE
Uresil Corp.
FGE
Nov 10, 1997K973113MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
Boston Scientific Corp
FGE
Nov 5, 1997K971295AVE BRIDGE STENT SYSTEM
Arterial Vascular Engineering, Inc.
FGE
Oct 7, 1997K972825OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
Cordis Corp.
FGE
Sep 19, 1997K973114SILICONE BILIARY STENT/BILIARY CATHETER
Specialty Surgical Products, Inc.
FGE
Aug 29, 1997K972583URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
Uresil Corp.
FGE
Jun 30, 1997K965147BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
Boston Scientific Corp
FGE
Jun 20, 1997K964688LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
Cordis Corp.
FGE
May 21, 1997K963254SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Boston Scientific Corp
FGE
May 20, 1997K962899ULTRAFLEX DIAMOND
Boston Scientific Corp
FGE
May 16, 1997K963767MANAN V.S. ACCESS NEEDLE/SET
Manan Medical Products, Inc.
FGE
May 2, 1997K963782BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
C.R. Bard, Inc.
FGE
Apr 28, 1997K964119WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
Boston Scientific Scimed, Inc.
FGE

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