BEUDAMED
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    MICRO-ID

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BREAS, MODEL HA01

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Acclarix LX8 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 7, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 8, 2015

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025