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

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    DECOMAT 228

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110997·DOUBLE PLASTIC STERILIZATION CASE

    COOLSCULPTING ELITE SYSTEM

    FDA Adverse Event
    Malfunction ·ALLERGAN PLEASANTON·Product code OOK·September 1, 2021

    ZOLL FULLY AUTOMATIC AED PLUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TMO INTEGRATED CIRCUIT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    ASR UNI FEMORAL IMPL SIZE 41

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 17, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 10, 2010

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·July 8, 2014

    KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway

    FDA Enforcement
    Class II ·Terminated·King Systems Corp.·November 28, 2012