BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    LS-8 VISICORDER

    FDA 510(k)
    FDA Class 1 ·Cardiovascular

    SQ IS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Medtronic Model 5392 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 5, 2014

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·October 15, 2012

    EON IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 2010

    Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906

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