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

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    ENZYMATIC AMYLASE REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110621·COAXIAL VISCOELASTIC ASPIRAT-IRRIGAT TIP

    The Orthodontic Store

    FDA UDI
    Young Innovations, Inc.·00843471179604·Anatomical Molar Bands, Lower Right 1St Molars,...

    MODIFICATION TO: SATELLITE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 3 ·Unknown

    GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

    FDA 510(k)
    FDA Class 2 ·Hematology

    SATELLITE SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code NVR·May 5, 2011

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 21, 2014

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·September 26, 2012

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 13, 2010

    GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 25, 2014