BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    OTOMAG BONE CONDUCATION HEARING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NexxZr™ T / D-100-12-NT-OM20-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271113993·

    THERMO PAL INFRARED EAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code LWS·October 1, 2014

    SITTER ELITE

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code KMI·May 1, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 17, 2011

    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·October 3, 2018

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014