BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    SER Pen Carain MicroSystem (MP1209SP)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    X-OMAT MX Fixer and Replenisher

    FDA UDI
    CARESTREAM HEALTH, INC.·60889971241351·X-OMAT MX Fixer and Repl 10GL

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517076486·

    VOLUMETRIC INCENTIVE SPIROMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HUMERAL STAPLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    FDA Adverse Event
    Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·July 16, 2024

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·November 10, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·September 2, 2011

    COMPR SRS MOD STEM - 8X75MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·July 22, 2013

    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