BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    SICKLE CELL REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Hematology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482554·INSTRUMENT 6860420 DUAL GUIDE TEMP PIN

    UniTip Catheter

    FDA UDI
    Unisensor AG·07640172971833·

    SpeqT

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    HT70 VENTILATOR

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·December 4, 2012

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 27, 2010

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

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