BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    MARQUIS PROBE/EXPLORER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896052734·MARQUIS PROBE/EXPLORER #23

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973530·

    SYNCHRON BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CIG·December 20, 2011

    NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STEALTHSTATION® S7¿ PLANNING STATION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 9, 2013

    MECHANICAL CHAIR/TRANSPORT CHAIR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·September 19, 2014

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·May 17, 2011

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017