282 results
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Sources: EU EUDAMED, US FDA
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Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V. Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·April 8, 2015
Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code DYB·May 11, 2009
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060601CD
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070603CD
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008
Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA
FDA Recall
Terminated
·Edwards Lifesciences Corporation of Puerto Rico·Product code FOZ·October 8, 2003
Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences Llc·Product code DTL·October 19, 2010
Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614
FDA Recall
Terminated
·Edwards Lifesciences Llc·Product code DTL·October 19, 2010
Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards Lifesciences, LLC., Irvine, CA 92614
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·March 19, 2007
Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA. Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters.
FDA Recall
Terminated
·Edwards Lifesciences, LLC·Product code DWF·June 15, 2011
Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. This product is indicated for use in patients undergoing cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
FDA Recall
Terminated
·Edwards Lifesciences Research Medical, Inc.·Product code DXC·November 26, 2008
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100901CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070301CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070401CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100801CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060203CD; Edwards Lifesciences LLC, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences, Llc·Product code FGE·December 5, 2007