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

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    GAMBRO FLUID CONTROL MONITOR FCM 10-1

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AUSTIN ENDOLYMPH DISPERSMENT SHUNT

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

    PRUITT IRRIGATION AND OCCLUSION CATHETER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·October 11, 2010

    ATLAS DR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·December 10, 2012

    MISC ORTHO SURGICAL INSTR

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code KWQ·June 10, 2014

    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·June 8, 2016