BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    TARGET MICROALBUMINURIA TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Exofin Precision Pen

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Biowy PICC Catheter S Kit

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 11, 2013

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JGS·December 2, 2010

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 3, 2014

    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