BEUDAMED
    15 results · 36ms · Sources: EU EUDAMED, US FDA

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    Life Saving Tourniquet

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Mirror Suction - Handle (Green)

    FDA UDI
    HAGER WORLDWIDE, INC.·D2482540600·mouth mirror evacuation tip handle only

    Mirror Suction - Handle (Green)

    FDA UDI
    HAGER WORLDWIDE, INC.·00014081540607·mouth mirror evacuation tip handle only

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111825·Modular Tibia Augment Size 6 x 4mm

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690131120·High Performance Revision Tibia Augment, Size 6...

    LANDMARK REBOA Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KIDNEYvault Portable Renal Perfusion System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NA

    FDA UDI
    Exactech, Inc.·10885862525482·TRIAL, TIBIAL ADAPTOR, PLATE, SIZE 6

    VITALITY DS

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·September 19, 2011

    UNKNOWN ZIMMER KNEE COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·July 26, 2013

    BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JSO·July 15, 2022

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Enforcement
    Class II ·Terminated·Omni Life Science·September 19, 2012

    Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.

    FDA Recall
    Terminated ·Omni Life Science·Product code JWH·August 9, 2012

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014