BEUDAMED
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    ARICULATED TENSION DEVICE SYNTHES TEN

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    SonicEye Dual-Array Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO FMRI HARDWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 13, 2014

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 10, 2012

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 10, 2010

    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