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)
Get daily alerts for FGESample briefCSV

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
DateFirm and productCodeLinked 510(k)
Jul 2, 2008Edwards Lifesciences, Llc
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070201CD; 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: EX090203CD; 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: EX100203CD; 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: EX060201CD; 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: EX090201CD; 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: EX090801CD; 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: EX100201CD; 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: EX090303CD; 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: EX090803CD; 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: EX100803CD; 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: EX060301CD; 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: EX100903CD; 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: EX100301CD; 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: EX070301CD; 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: EX090301CD; 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: EX100303CD; 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: EX080203CD; 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: EX070801CD; 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: EX060203CD; 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: EX080801CD; 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: EX090403CD; 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: EX080301CD; 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: EX100801CD; 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: EX070601CD; 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: EX100603CD; 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: EX070203CD; 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: EX060801CD; 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: EX070401CD; 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: EX080303CD; 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: EX060601CD; 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: EX100403CD; 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: EX090601CD; 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: EX060401CD; 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: EX 070303CD; 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: EX090401CD; Edwards Lifesciences LLC, Irvine, CA 92614.v
Terminated		 FGEK053404
Jul 2, 2008Edwards Lifesciences, Llc
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060303CD; 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: EX100601CD; 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: EX070803CD; 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: EX090603CD; 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: EX100401CD; 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: EX080601CD; 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: EX080803CD; 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: EX080401CD; 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: EX080403CD; 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: EX070603CD; 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: EX070403CD; 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: EX060803CD; 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: EX060403CD; 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: EX060603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Terminated		 FGEK053404
May 6, 2008Ev3, Inc
ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-002. ev3 IntraStent LD Max Large Diameter Periphera
Terminated		 FGEK980290

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.