BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    INTERWORKS

    FDA 510(k)
    FDA Class 2 ·Radiology

    RHIGENE MESACUP2 TEST- SM

    FDA 510(k)
    FDA Class 2 ·Immunology

    BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 4, 2022

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 22, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 14, 2011

    CORFLO CORLOCK CORPORT (PEG KIT 12 FR)

    FDA Adverse Event
    Other ·VIASYS MEDSYSTEMS·Product code KNT·July 1, 2008

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016