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

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    SKIN PRESSURE PROTECTORS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    G-LIX TISSUE GRASPER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ELECTROCARDIOGRAPH EK-6 W/OPTIONAL CIRC.

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWS·April 21, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 26, 2012

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO, JUNCOS·Product code LGW·July 15, 2010

    CADD CASSETTE RESERVOIR

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·November 14, 2019

    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