BEUDAMED
    10 results · 29ms · Sources: EU EUDAMED, US FDA

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    AMERICAN MONITOR MAGNESIUM #'S 1036&4021

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACUMED

    FDA UDI
    Acumed LLC·10806378099946·General Hexalobe Instrument Tray

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450047613·

    TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00

    FDA 510(k)
    FDA Class 2 ·Hematology

    COMBISON 100-MODEL 100 & 110

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASR ACETABULAR IMPLANT 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 30, 2013

    ESSURE

    FDA Adverse Event
    Malfunction ·BAYER PHARMA AG·Product code HHS·May 28, 2015

    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

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

    smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

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