BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    MedtFine Safety Lancet

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

    POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IOGYN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    CONSERVE(R) PLUS HA CUP

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code KWA·November 10, 2014

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    FDA Adverse Event
    EMG TECHNOLOGY CO. LTD·Product code BTI·July 22, 2013

    1.5MM TI CORTEX SCREW SELF-TAPPING 10MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HWC·April 25, 2013

    1.5MM TI CORTEX SCREW SELF-TAPPING 9MM

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code MQN·April 25, 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