BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    MIYA SPECULUM

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    ZAVATION PISTOL GRIP REDUCER

    FDA UDI
    Zavation LLC·00197157014674·TIGER 2 PISTOL GRIP REDUCER

    Orthodontic Fixation Screw [Smart Anchor Miniscrew]

    FDA 510(k)
    FDA Class 2 ·Dental

    RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2014

    INFUSION/FLUSH ADMINISTRATION SET

    FDA Adverse Event
    Other ·ICU MEDICAL INC.·Product code FPA·June 29, 2010

    ALARIS PCA MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·November 14, 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