BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    HUMPHREY FIELD ANALYZER MODEL 630

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DR 600

    FDA 510(k)
    FDA Class 2 ·Radiology

    GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO PRO PLUS METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014

    EASYTRAK 3

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NIK·October 4, 2010

    TI PANGEA(TM) LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·November 30, 2012

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 14, 2015

    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