BEUDAMED
    12 results · 24ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO HRW-127 WRIST ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502778·FIXATION SCREW 75 MM, TITANIUM

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291101574·SS Suture, 3 per sleeve

    MOTORIZED MICRO MULTILEAF COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    DUAL LUMEN MIDLINE CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INCLUSIVE TAPERED IMPLANT 3.7MMD X 8 MML X 3.5 MMP

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 20, 2023

    INCLUSIVE TAPERED IMPLANT 3.2 MMD X 10 MML X 3.0 MMP

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 21, 2023

    ASCENDRA INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·April 8, 2013

    OCTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATINO DIVISION·Product code LGW·February 15, 2011

    VISX 4 EXCISER

    FDA Adverse Event
    Injury ·Product code LZS·May 8, 2008

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018