BEUDAMED
    5 results · 28ms · Sources: EU EUDAMED, US FDA

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    Hydrophilic Guidewire, Catalog Number: VM18352, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. VisioMed International Group Inc., 14555 South Robert Trail - #208, Rosemount, MN 55068, www.visiomedical.com.

    FDA Recall
    Terminated ·Argon Medical Devices, Inc·Product code DQX·February 26, 2009

    SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA

    FDA Enforcement
    Class II ·Terminated·Sorin Group USA, Inc.·August 9, 2017

    SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DWE·June 29, 2017

    Light Source 300 Watt Xenon Lamp used in the following models: Viking EndoSite Xenon, Model 8050-1 and Boston Scientific Spyglass 300W Light Source (M00546190)

    FDA Recall
    Terminated ·Vision Systems Group, A Div of Viking Systems·Product code KOG·April 5, 2007

    SoftPerm (synergicon A) Daily Wear Contact Lenses, Rx Only, Sterile. Contents: One sterile contact lens, rigid center/soft hydrophilic skirt (25% water), in normal saline solution buffered with sodium bicarbonate. Ciba Vision Group, Duluth GA 30097 USA SoftPerm contact lenses are indicted for daily wear (class II device) for correction of visual accuracy for keratoconus and in non-aphakic persons with non-diseased eyes that are myopic or hyperopic

    FDA Recall
    Terminated ·CIBA Vision Puerto Rico, Inc. El Jibaro·Product code LPL·February 1, 2011