BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    ARIA II INSULIN RIA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CANDELA GENTLELASE FAMILY OF LASERS

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

    LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 24, 2014

    REVO MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWP·October 31, 2012

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·August 13, 2010

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

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