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

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    MICROSCOPE MITTS SUPPORT TRAY COVER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VEGA

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

    KOBRA GPS FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ROTAWIRE? AND WIRECLIP? TORQUER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)·Product code MCX·June 2, 2014

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 21, 2012

    J-VAC RESERVOIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GCY·September 17, 2010

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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