BEUDAMED
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    SCD EXPRESS PORTABLE COMPRESSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827899·ACHIMED ACHILLES SUPP BLACK I

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526827837·***DISC*LEVAMED ANKLE SUPPORT BLACK I

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690191384·Patella Resection Cover Size 29

    MODIFICATION TO ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROWANDS AND SPINE WANDS

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

    MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VKMO 70000 #QUAD-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VKMO 70000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    BE-VEMO 7000 #QUADR-I HMO70000+VHK7100

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·January 5, 2015

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 9, 2013

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 6, 2011

    INDURA CATHETER

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·May 9, 2008

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    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