BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    TBG RIA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MEDENTIKA ABUTMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO: CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 31, 2014

    E500 VENTILATOR

    FDA Adverse Event
    Injury ·NEWPORT MEDICAL INSTRUMENTS·Product code CBK·November 15, 2012

    TERUMO ADVANCED PERFUSION SYSTEM I

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·August 31, 2010

    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