BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    LIFEPAK 10 DEFIBRILLATOR/MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690196372·Apex Knee System Common Instruments Pan

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690195078·Apex Knee System Common Instruments Pan Insert

    ArgenZ HT+

    FDA 510(k)
    FDA Class 2 ·Dental

    VIVID, MODELS 40-A0001, 40-A0004, 40-A0006

    FDA 510(k)
    FDA Class 1 ·Dental

    COBE SPECTRA WHITE BLOOD CELL SET

    FDA Adverse Event
    Injury ·CARIDIANBCT·Product code LKN·October 28, 2010

    SPECTRUM INFUSION PUMP

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

    RIATA ST PASSIVE FIXATION

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

    The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management.

    FDA Enforcement
    Class II ·Terminated·Livongo Health·May 11, 2016