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

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    LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification

    FDA Enforcement
    Class III ·Terminated·LumiraDx·November 2, 2022

    Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument

    FDA Enforcement
    Class III ·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017