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

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    GE TARGET SERIES 2

    FDA 510(k)
    FDA Class 2 ·Radiology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756670791·CYSTO HYDRO II PACK

    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SMDS460 SURGICAL MONITOR DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SELENIA DIMENSION MAMMOGRAPHY SYSTEM 3D

    FDA Adverse Event
    Malfunction ·HOLOGIC INC·Product code OTE·May 20, 2014

    OPTISENSE

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

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·December 31, 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