BEUDAMED
    4 results · 14ms · Sources: EU EUDAMED, US FDA

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    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

    FDA Recall
    Completed ·Cook Incorporated·Product code DQY·May 25, 2022

    Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

    FDA Enforcement
    Class II ·Completed·Cook Incorporated·July 20, 2022

    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Enforcement
    Class II ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·October 30, 2024

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    FDA Enforcement
    Class III ·Completed·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·September 21, 2022