BEUDAMED
    10,000 results · 62ms · 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.
    Filters Regulation: Us FDA ×

    Amplatzer™

    FDA UDI
    ST. JUDE MEDICAL, INC.·00811806011271·

    Amplatzer™

    FDA UDI
    ST. JUDE MEDICAL, INC.·00811806011301·

    Amplatzer™

    FDA UDI
    ST. JUDE MEDICAL, INC.·00811806011288·

    PFO (plantar fascia orthosis)

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357641468·

    PFO (plantar fascia orthosis)

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357641444·

    Amplatzer™ Talisman™

    FDA UDI
    ST. JUDE MEDICAL, INC.·05415067033345·PFO Occluder

    Amplatzer™ Talisman™

    FDA UDI
    ST. JUDE MEDICAL, INC.·05415067033314·PFO Occluder

    Amplatzer™ Talisman™

    FDA UDI
    ST. JUDE MEDICAL, INC.·05415067033307·PFO Occluder

    Amplatzer™ Talisman™

    FDA UDI
    ST. JUDE MEDICAL, INC.·05415067033321·PFO Occluder

    AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MLV·June 1, 2006

    AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.

    FDA Recall
    Terminated ·AGA Medical Corporation·Product code MLV·June 1, 2006

    AMPLATZER PFO OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·January 17, 2017

    AMPLATZER PFO OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·October 25, 2017

    GORE CARDIOFORM SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·W. L. GORE ASSOCIATES, INC.·Product code MLV·March 22, 2022

    AMPLATZER PFO OCCLUDER

    FDA Adverse Event
    Malfunction ·AGA MEDICAL CORPORATION·Product code MLV·February 20, 2020

    AMPLATZER PFO OCCLUDER

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code MLV·August 4, 2021

    AMPLATZER PFO OCCLUDER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL CATD·Product code MLV·October 23, 2019

    AMPLATZER PFO OCCLUDER

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL CATD·Product code MLV·October 23, 2019

    AMPLATZER PFO OCCLUDER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code MLV·December 9, 2021

    AMPLATZER TALISMAN PFO OCCLUDER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code MLV·August 24, 2022