BEUDAMED
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    MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502761·FIXATION SCREW 70 MM, TITANIUM

    B-P TOTAL SHOULDER SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193025425·B-P SHOULDER HUMERAL HEAD W/ ULTRACOAT - 48 MM

    TANTALUM BEADS - RADIOGRAPHIC MARKER

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

    COLORADO MICRODISSECTION NEEDLE

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

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    GRAFTON PLUS¿ DBM

    FDA Adverse Event
    Malfunction ·Product code NUN·August 28, 2020

    STEALTHSTATION IOR SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·February 15, 2011

    LIVEWIRE TC ABLATION CATH, UNIV. TEMP, 7F QUAD, XLS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL·Product code LPB·June 10, 2008

    "PATIENT SPECIFIC SIT TO STAND BELT"

    FDA Adverse Event
    Injury ·MARKETING MANAGEMENT ASSOCIATES, INC.·Product code FSA·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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013