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

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    Filters Classification: Class Iii ×

    BiomarC EX Fiducial Marker System, Catalog Number 040165

    FDA Enforcement
    Class III ·Ongoing·Carbon Medical Technologies, Inc.·September 25, 2024

    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

    FDA Enforcement
    Class III ·Terminated·Iris Diagnostics·August 8, 2012