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    K Number
    K251913
    Device Name
    OsteoCentric® UnifiMI® TCS Plating System
    Manufacturer
    OsteoCentric Technologies
    Date Cleared
    2025-08-16

    (54 days)

    Product Code
    HRS
    Regulation Number
    888.3030
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    Applicant Name (Manufacturer) :

    OsteoCentric Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    Device Description
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    K Number
    K243650
    Device Name
    Zio® monitor (DFG0001)
    Manufacturer
    iRhythm Technologies, Inc.
    Date Cleared
    2025-08-15

    (262 days)

    Product Code
    DSH
    Regulation Number
    870.2800
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    Applicant Name (Manufacturer) :

    iRhythm Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K250036
    Device Name
    MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2025-08-15

    (219 days)

    Product Code
    LTTJWYLRGLTW
    Regulation Number
    866.1640
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    Applicant Name (Manufacturer) :

    Beckman Coulter, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K250397
    Device Name
    Helios Dermal Scaffold
    Manufacturer
    Helios Biomedical Inc.
    Date Cleared
    2025-08-15

    (184 days)

    Product Code
    KGN
    Regulation Number
    N/A
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    Applicant Name (Manufacturer) :

    Helios Biomedical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
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    K Number
    K250818
    Device Name
    Nerveblox
    Manufacturer
    Smart Alfa Teknoloji San. Ve Tic. A.S.
    Date Cleared
    2025-08-15

    (150 days)

    Product Code
    QRG
    Regulation Number
    868.1980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Smart Alfa Teknoloji San

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K250867
    Device Name
    Dunamis Screw and Suture Locking System
    Manufacturer
    Dunamis Medical, LLC
    Date Cleared
    2025-08-15

    (144 days)

    Product Code
    HWCGATMBI
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dunamis Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K251243
    Device Name
    OneRF Trigeminal Nerve Radiofrequency Probes
    Manufacturer
    NeuroOne Medical Technologies Corp.
    Date Cleared
    2025-08-15

    (115 days)

    Product Code
    GXI
    Regulation Number
    882.4725
    Why did this record match?
    Applicant Name (Manufacturer) :

    NeuroOne Medical Technologies Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K251747
    Device Name
    VEA Align; spineEOS
    Manufacturer
    EOS imaging
    Date Cleared
    2025-08-15

    (70 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    EOS imaging

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K251834
    Device Name
    Persona Partial Knee
    Manufacturer
    Zimmer Biomet
    Date Cleared
    2025-08-15

    (60 days)

    Product Code
    HSX
    Regulation Number
    888.3520
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    Applicant Name (Manufacturer) :

    Zimmer Biomet

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    K Number
    K251871
    Device Name
    FEATHER 01 02 03 04 (Model:01)
    Manufacturer
    Heat In A Click LLC.
    Date Cleared
    2025-08-15

    (58 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Heat In A Click LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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