BEUDAMED
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    ATS MAYER'S ALBUMIN

    FDA 510(k)
    FDA Class 1 ·Pathology

    Precept

    FDA UDI
    Nuvasive, Inc.·00887517153630·PRECEPT MOD Dilator, Primary

    Trimline

    FDA UDI
    ORMCO CORPORATION·00889989052589·LOWER LEFT SECOND MOLAR TRIMLINE BAND SIZE 22

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690189756·AK3 Femoral Sizing/Alignment Guide

    FORZA

    FDA UDI
    Orthofix US LLC·18257200082360·FORZA - TRIAL TRAY (89-0022)

    N/A

    FDA UDI
    Ulrich GmbH & Co. KG·04052536083633·uCentum tray P2 for distraction and compression...

    SafeBreath Filter Mouthpiece

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PARADIS VASO SHIELD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPINALPAK(R) STIMULATOR ELECTRODES

    FDA Adverse Event
    Injury ·EBI, LLC.·Product code LOF·March 14, 2017

    SPINALPAK(R) STIMULATOR ELECTRODES

    FDA Adverse Event
    Injury ·EBI, LLC.·Product code LOF·March 14, 2017

    SPINALPAK(R) STIMULATOR ELECTRODES

    FDA Adverse Event
    Injury ·EBI, LLC.·Product code LOF·March 14, 2017

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 7, 2014

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·November 3, 2010

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 2012

    3.5MM TI LOCKING SCREW SELF-TAPPING 36MM

    FDA Adverse Event
    Injury ·SYNTHES GRENCHEN·Product code KTT·February 19, 2016

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012