BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    REP IMMUNOFIX

    FDA 510(k)
    FDA Class 2 ·Immunology

    iNSitu Total Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127025044·Lateralized Liner Trial Size 58/60 x 36mm ID

    STERILIZATION CASES AND TRAYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIOMODULE 3-M1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWERED WHEELCHAIR

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

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 9, 2010

    10.5CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·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