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

DateFirm and productCodeLinked 510(k)
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100203CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100201CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090803CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090801CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090603CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090601CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090403CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090401CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090303CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090301CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090203CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090201CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080803CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080801CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080603CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080601CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080403CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080401CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080303CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080301CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080203CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080201CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070803CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070801CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070603CD
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070601CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070403CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070401CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070303CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070203CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070201CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060803CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060801CD. The LifeStent FlexStar self-expanding biliary stent system is
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060603CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060601CD
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060403CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060401CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060303CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Oct 10, 2008Bard Peripheral Vascular Inc
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system i
Terminated
FGEK053404
Sep 26, 2008Ev3, Inc
ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System. Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-1
Terminated
FGEK061566
Sep 26, 2008Ev3, Inc
ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35
Terminated
FGEK061566
Sep 23, 2008Cook Endoscopy
Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Used
Terminated
FGEK851962
Sep 23, 2008Cook Endoscopy
Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC
Terminated
FGEK851962
Sep 11, 2008Boston Scientific Corp
Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210. System is used for delivery of the stent to the biliary
Terminated
FGEK965147
Aug 26, 2008Ev3, Inc
Ev3 Primus GPS Biliary Stent System 8 mm, 37 mm, B7, .40 mm, 5Fr, REF BXB35-08-37-75 Use before 2009-02 Sterile EO Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 Intended as a palliative treatm
Terminated
FGEK043243
Aug 26, 2008Ev3, Inc
Ev3 Protege GPS Biliary Stent Systems 6 mm, 60 mm, 120cm, .35, 6Fr, OTW Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 REF SERB65-06-60-120 Lot 2675311 Use before 2009-01-01 Sterile EO Intended
Terminated
FGEK032580
Jul 2, 2008Edwards Lifesciences, Llc
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Terminated
FGEK053404
Jul 2, 2008Edwards Lifesciences, Llc
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100901CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Terminated
FGEK053404

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