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

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    GROMAN PREPMASTER

    FDA 510(k)
    FDA Class 2 ·Dental

    Tornier Latitude

    FDA UDI
    TORNIER, INC.·00846832015320·ULNAR STEM TRIAL

    BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    260 CORVUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    COMPLETE DOUBLE MOIST

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code LPN·October 14, 2014

    ACRYSOF

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·March 28, 2013

    PIC 50

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·March 21, 2011

    HOMECHOICE CYCLER-REFURBISHED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 15, 2008

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016