BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Chalgren

    FDA UDI
    CHALGREN ENTERPRISES·00816020020139·Monopolar Needle Electrode, EMG, 37mm x 27g

    Chalgren

    FDA UDI
    CHALGREN ENTERPRISES·00816020020122·Monopolar Needle Electrode, EMG, 37mm x 27g

    Rhythmlink®

    FDA UDI
    RHYTHMLINK INTERNATIONAL, LLC·00816312024722·50 Monopolar Needle Electrodes, EMG, 37mm x 27g

    Rhythmlink®

    FDA UDI
    RHYTHMLINK INTERNATIONAL, LLC·00816312024739·50 Monopolar Needle Electrodes, EMG, 37mm x 27g

    HYDROFIX VASO SHIELD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 13, 2024

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 1, 2017

    DEPTH GAUGE, ADJUSTABLE

    FDA Adverse Event
    Malfunction ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HRS·May 7, 2013

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·MICROTYPING SYSTEMS·Product code KSZ·June 2, 2011

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL·Product code MTA·August 13, 2008

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021