BEUDAMED
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    RTE SNAPCONE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·July 7, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·February 18, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·February 18, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·February 18, 2014

    INFLATABLE PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·Product code FHW·February 19, 2020

    AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·May 22, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·September 3, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·May 30, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·September 9, 2014

    AMS HYDROFLEX PENILE PROSTHESIS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS·Product code FHW·April 19, 2016

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·July 10, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·November 3, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·June 13, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Death ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·November 3, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·September 3, 2014

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code JCW·June 14, 2016

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code FHW·February 18, 2016

    Device, Impotence, Mechanical/Hydraulic

    FDA classification
    FDA Class 3 ·Device, Impotence, Mechanical/Hydraulic

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Recall
    Terminated ·Coloplast Manufacturing US, LLC·Product code FHW·October 23, 2020