BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    ATA HCM MONOPLACE HYPERBARIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 145mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665009934·

    Toilet Support Arms

    FDA UDI
    Ropox A/S·05707581000300·

    Bullfrog Micro-Infusion Device

    FDA UDI
    MERCATOR MEDSYSTEMS, INC.·M973BF102S1·The Mercator MedSystems Bullfrog Micro-Infusion...

    Bullfrog Micro-Infusion Device

    FDA UDI
    MERCATOR MEDSYSTEMS, INC.·M973BF101S1·The Mercator MedSystems Bullfrog Micro-Infusion...

    ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    C & B FORMULA

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI400401450·C & B FORMULA 1 OZ FORMULA SHADE 45

    Bullfrog Micro-Infusion Device

    FDA UDI
    MERCATOR MEDSYSTEMS, INC.·M973BF102R1·The Mercator MedSystems Bullfrog Micro-Infusion...

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 3, 2013

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 5, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·May 9, 2008

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    VITEK® 2 AST-N350

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 17, 2018

    ULTRA 2 CUTTING BALLOON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010

    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·March 19, 2014

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    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