BEUDAMED
    97 results · 30ms · Sources: EU EUDAMED, US FDA

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    BioGlue Spreader Tip, 12mm, Sterile, RX Only. Product Usage: BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code MUQ·June 4, 2018

    Pulmonary Hemi-Artery SG Used in heart surgery

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·February 17, 2011

    Pulmonary Valve & Conduit SG Used in heart surgery

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·February 17, 2011

    CryoValve Pulmonary Valve and Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·December 10, 2003

    CryoValve Pulmonary Valve & Conduct

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·November 4, 2003

    CryoValve, Pulmonary Valve & Conduit SG

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·August 18, 2003

    CryoValve, Aortic Valve & Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·December 17, 2004

    CryoValve Allograft heart valve

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·January 30, 2003

    CryoValve Allograft, Heart valve

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·April 30, 2003

    CryoValve, Pulmonary Valve & Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·July 15, 2004

    Pulmonary Valve & Conduit SG Used in heart surgery

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code MIE·January 7, 2011

    CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135 C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code DXZ·November 10, 2020

    CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.

    FDA Recall
    Terminated ·CryoLife, Inc.·Product code OHA·November 10, 2020

    CryoValve, Pulmonary Valve and Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·December 17, 2004

    CryoValve, Pulmonary Valve & Conduit SG

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·November 19, 2003

    CryoValve, Pulmonary Valve

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·November 19, 2003

    CryoValve, Aortic Valve

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·November 19, 2003

    Aortic Valve & Conduit

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·May 17, 2005

    CryoValve Heart-valve, allograft

    FDA Recall
    Terminated ·Cryolife Inc·Product code LMO·March 19, 2003

    CryoValve Pulmonary Valve & Conduit.

    FDA Recall
    Terminated ·Cryolife Inc·Product code MIE·May 23, 2003