BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET

    FDA 510(k)
    FDA Class 2 ·Immunology

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142130·Trial, TLIF, 32L OB CRV 7Deg, 13mm

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033578162·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033578179·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033578186·

    VASCULAR SOLUTIONS DUETT FLOWABLE HEMOSTAT

    FDA 510(k)
    FDA Unclassified ·Unknown

    POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NIM® EMG

    FDA Adverse Event
    Injury ·MEDTRONICXOMED, INC.·Product code ETN·November 24, 2015

    CONQUEST PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·February 20, 2013

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code LWS·March 10, 2011

    6600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·March 12, 2008

    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

    FDA Enforcement
    Class III ·Terminated·DeVilbiss Healthcare LLC·July 9, 2014

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    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