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

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    MONORAIL

    FDA 510(k)
    FDA Class 2 ·Dental

    BiomarC ®

    FDA UDI
    Carbon Medical Technologies, Inc.·00858015005646·Coaxial Needle

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450148969·

    MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VASOVIEW 5 HARVESTING CANNULA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IMPLANT, ENDOSSEOUS, ROOT-FORM

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 28, 2025

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 19, 2025

    IOLMASTER 500

    FDA Adverse Event
    Injury ·CARL ZEISS MEDITEC AG (JENA SITE)·Product code HJO·April 3, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 5, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code LFR·May 2, 2008

    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