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

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    CRESOLPHTHALEIN COMPLEXONE, CALCIUM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FASTIN RC ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Aqueduct 100 Cervical Dilator

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

    SELECTSECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 10, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MED CORP·Product code MKJ·October 26, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    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