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

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    'APNEA-ELECTRODE'

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Stick

    FDA UDI
    Gc America Inc.·J0229008261·StickCARRIER 1 Narrow-ended hand instrument

    KONG-TL VBR, End Plate, round, S and Screw, 8° x 26 mm

    FDA UDI
    icotec AG·07640164847559·KONG-TL VBR, End Plate, round, S and Screw, 8° ...

    PRODIGY LATERAL VIEW SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONOBOND PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 27, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 17, 2010

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 12, 2012

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code HAW·November 27, 2023

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·October 1, 2014