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

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    TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LumFix Spinal Fixation Sytem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVOLVE MODULAR RADIAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    CENTURY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·October 29, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 22, 2015

    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

    FDA Enforcement
    Class II ·Ongoing·MED-EL Elektromedizinische Gereate, Gmbh·July 24, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 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