BEUDAMED
    19 results · 33ms · Sources: EU EUDAMED, US FDA

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    GUARDIAN II NC HEMOSTASIS VALVE

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II NC HEMOSTASIS VALVE

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II NC HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·February 3, 2012

    GUARDIAN II NC HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II NC HEMOSTASIS VALVE

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 6, 2013

    GUARDIAN II NC HEMOSTASIS VALVE

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 6, 2013

    GUARDIAN II HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II HEMOSTASIS VALVE

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·February 28, 2013

    GUARDIAN II NC HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II HEMOSTASIS VALVE

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·March 8, 2013

    GUARDIAN II NC HV WITH GUIDEWAIRE INTRODUCER

    FDA Adverse Event
    Malfunction ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·September 13, 2012

    GUARDIAN II HEMOSTASIS VALVE NO-CLICK

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·August 20, 2013

    GUARDIAN HEMOSTASIS VALVE NO-CLICK

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS ZERUSA LIMITED·Product code DTL·August 20, 2013

    Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.

    FDA Recall
    Terminated ·Vascular Solutions, Inc.·Product code DTL·February 27, 2013

    Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.

    FDA Enforcement
    Class I ·Terminated·Vascular Solutions, Inc.·March 27, 2013