BEUDAMED
    4 results · 16ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Country: Germany × Clear all

    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I

    FDA Enforcement
    Class II ·Terminated·Chromsystems Instruments & Chemicals GmbH·July 13, 2022

    MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II

    FDA Enforcement
    Class II ·Terminated·Chromsystems Instruments & Chemicals GmbH·July 13, 2022

    The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)

    FDA Enforcement
    Class II ·Terminated·Brainlab AG·March 4, 2015

    Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Abbott Gmbh & Co. KG·February 6, 2019