BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    GAMBRO BICART SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Pakter Curved Needle Set

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TECNIS CL

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code HQL·June 13, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·December 13, 2012

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JGS·October 18, 2010

    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    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