BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    DORIPENEM 10UG BBL SENSI-DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 3, 2024

    LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2011

    ORTHO PROVUE

    FDA Adverse Event
    Other ·MICRO TYPING SYSTEMS, INC.·Product code KSZ·July 23, 2008

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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