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

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    BLAISE-RATHAEL VOICE PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PEEK CAGE FOR THE VERTEBRAL SPINE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INOMAX DSIR (DELIVERY SYSTEM)

    FDA Adverse Event
    Malfunction ·IKARIA·Product code MRP·March 17, 2014

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code FSA·November 14, 2012

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·September 13, 2010

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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