BEUDAMED
    296 results · 86ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    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

    LEFT ARTERIAL PRESSURE MONITORING CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DRS·October 2, 2007

    AORTIC PERFUSION CANNULA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, RESEARCH MEDICAL·Product code DWF·October 2, 2007

    EMBOL-X SLIM INTRA AORTIC FILTER

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DTM·June 26, 2006

    VESSEL CANNULAE BULK

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWF·August 21, 2007

    AORTIC PERFUSION CANNULA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWF·August 29, 2007

    EMBOL-X GLIDE PROTECTION DEVICE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWF·August 21, 2007

    VASCULAR TOURNIQUET KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWE·September 5, 2007

    AORTIC PERFUSION CANNULA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWF·August 29, 2007

    LEFT ARTERIAL PRESSURE MONITORING CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code GWM·August 21, 2007

    LEFT ARTERIAL PRESSURE MONITORING CATHETER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code GWM·August 21, 2007

    ANTECARDIOPLEGIA KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWF·September 6, 2007

    VENUOUS RETURN CANNULA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWF·August 21, 2007

    THIN FLEX VENUOUS RETURN CANNULA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWF·August 21, 2007

    EMBOL-X SLIM ACCESS DEVICE/AORTIC CANNULA

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWF·December 7, 2004

    CARDIOPLEGIA DELIVERY SET

    FDA Adverse Event
    Other ·EDWARDS LIFESCIENCES RESEARCH MEDICAL·Product code DWF·March 25, 2008

    CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. 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

    EPIC STENTED TISSUE VALVE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, BRASIL LTDA.·Product code LWR·March 24, 2021