BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    ASTHMA MONITOR MODEL, AM1

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036082727·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450214008·

    POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ABC CERVICAL PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES LTD·Product code MKJ·September 21, 2015

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 2, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 15, 2014

    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