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

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    HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HARDY DISK CLARITHROMYCIN, 15MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021

    MAXIFLO ULTRATHIN WITH UNITY CONTRUCTION

    FDA Adverse Event
    Injury ·VASCUTEK LTD.·Product code DSY·August 27, 2012

    CE INFUSOR LV 2, 12 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 8, 2013

    LIVIAN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 6, 2011

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    CE INFUSOR SV 2, 12 PACK

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026