BEUDAMED
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    IMMUNODOT AUTOIMMUNE SCREENING PANEL 1

    FDA 510(k)
    FDA Class 2 ·Immunology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756670814·HIP PACK A & B

    MAGNILINK SYSTEM 101

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    REID ENDOCERVICAL SPREADER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TOTALCARE BARIATRIC BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·May 20, 2014

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 5, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014