BEUDAMED
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    TECH-CAL(TM)/MULTIPLE

    FDA 510(k)
    FDA Class 2 ·Hematology

    SURGISTAR

    FDA UDI
    SURGISTAR, INC.·00878799009296·

    RESPIRATOR, BANTAM MODEL

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

    FDA 510(k)
    FDA Class 2 ·Immunology

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·October 1, 2010

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·November 16, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020