BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    NEEDLELESS INJECTION CANNULA

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FORCEPS CEV405 FENESTRATED 350MM JOHANN [MXI/XOM]

    FDA Adverse Event
    Injury ·XOMED MICROFRANCE MFG·Product code GEI·March 19, 2014

    SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)

    FDA 510(k)
    FDA Class 2 ·Dental

    MAXONE IV FLUID/BLOOD WARMER, MODEL 102

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·January 22, 2013

    HARMONIC ACE 36CM W ERG HANDLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 14, 2010

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 9, 2014

    5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·October 28, 2015

    5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·August 21, 2013