BEUDAMED
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    VISTA INTERFACE SYSSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SILKLINE SOFT RELINING KIT, MODEL 28-100100

    FDA 510(k)
    FDA Class 2 ·Dental

    ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREEPI

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code NVN·June 10, 2014

    ASR UNI FEMORAL IMPL SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·December 6, 2012

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 22, 2015

    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