BEUDAMED
    9 results · 66ms · Sources: EU EUDAMED, US FDA

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    DULBECCO'S PHOSPHATE BUFFERED SALINE

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

    iNSitu Total Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127025020·Lateralized Liner Trial Size 52 x 36mm ID

    REMECURE MODEL CL 15E

    FDA 510(k)
    FDA Class 2 ·Dental

    SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASR UNI FEMORAL IMPL SIZE 46

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

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013

    PROFEMUR(R) TAPERED HIP STEM

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDL·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