BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA

    FDA 510(k)
    FDA Class 1 ·Hematology

    BIVONA CUSTOM HYPERFLEX TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INC.·Product code JOH·June 23, 2014

    TENDRIL DX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·February 28, 2013

    SYMPHONY

    FDA Adverse Event
    Injury ·SORIN CRM·Product code NVZ·February 4, 2011

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015