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

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    CUP OUT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Nexxis OR

    FDA UDI
    Barco NV·05415334033030·NEXXIS SYSTEM X670 CM V3

    MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    AUTOMATED EIA MICROPLATE READER MODELS EL312/312I

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·May 27, 2014

    ACCENT DR RF

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·January 9, 2013

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA·Product code NIM·November 22, 2010

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024