BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    CORTRAK* 2 Enteral Access System (20-0950)

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

    MULTIPIEZO PRO, MULTIPIEZO

    FDA 510(k)
    FDA Class 2 ·Dental

    PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FLO-GARD 6301 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 25, 2008

    VENTILATOR, CONTINUOUS, FACILITY USE

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·August 17, 2011

    TRANSTAR WHEELED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FPO·July 17, 2013

    PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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