BEUDAMED
    111 results · 29ms · 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

    On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·July 19, 2017

    BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (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 of large vessels (such as aorta, femoral, and carotid arteries).

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·June 11, 2014

    Pulmonary Hemi-Artery SG Used in heart surgery

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·January 29, 2014

    BioGlue Surgical Adhesive, Model BG3510-5-G

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·December 22, 2021

    BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·July 5, 2017

    Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·June 27, 2018

    On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·September 13, 2017

    Cryopatch SG Pulmonary Human Cardiac Branch, Catalog Number SGP020

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·June 27, 2018

    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 Enforcement
    Class II ·Terminated·CryoLife, Inc.·August 1, 2018

    CryoPatch SG Pulmonary Hemi-Artery, 1 graft

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·October 24, 2018

    On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The On-X¿ Prosthetic Heart Valve is available in 3 aortic configurations. All aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. Aortic valves, size 19 mm through 25 mm, are designed for intrasupra-annular sewing ring position, while the valve size 27/29 mm is designed for intra-annular sewing ring position. All mitral valve sizes are designed for the supra-annular sewing ring position.

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·April 3, 2019

    CryoPatch SG Pulmonary Hemi-Artery Patch

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·May 1, 2019

    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 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·December 30, 2020

    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 Enforcement
    Class II ·Terminated·CryoLife, Inc.·December 30, 2020

    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