BEUDAMED
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    CIBA CORNING ACS FOLATE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    OPERATING CYSTOSCOPE-URETHROSCOPE

    FDA Adverse Event
    Death ·KARL STORZ SE & CO. KG·Product code FGB·March 8, 2023

    1.3MM CURVILINEAR DISTRACTOR R70/LEFT

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code MQN·July 27, 2015

    PINNACLE MTL INS NEUT40IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 18, 2014

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 13, 2012

    Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

    FDA Enforcement
    Class II ·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·March 26, 2025