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510(k) Data Aggregation

    K Number
    K250689
    Device Name
    CloudTMS Edge
    Manufacturer
    TeleEMG, LLC
    Date Cleared
    2025-09-14

    (192 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
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    K Number
    K251449
    Device Name
    BrainsWay Deep TMS System
    Manufacturer
    BrainsWay Ltd.
    Date Cleared
    2025-09-13

    (127 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250059
    Device Name
    BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O)
    Manufacturer
    Becton, Dickinson and Company
    Date Cleared
    2025-09-12

    (245 days)

    Product Code
    ONB
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251843
    Device Name
    Erchonia EVRL
    Manufacturer
    Erchonia Corporation
    Date Cleared
    2025-09-12

    (88 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252027
    Device Name
    Vertex(TM) Catheter
    Manufacturer
    Jupiter Endovascular
    Date Cleared
    2025-09-12

    (74 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252189
    Device Name
    LED Light Therapy Mask (2311, 2344, 2457, 2458)
    Manufacturer
    Dongguan Yanxi Technology Co., Ltd.
    Date Cleared
    2025-09-12

    (60 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251368
    Device Name
    FETOLY
    Manufacturer
    Diagnoly
    Date Cleared
    2025-09-12

    (134 days)

    Product Code
    IYN,IYO,QIH
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252225
    Device Name
    PowerKnot High Strength Sutures
    Manufacturer
    Medacta International S.A.
    Date Cleared
    2025-09-12

    (58 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251820
    Device Name
    ViewMateTM Ultrasound System
    Manufacturer
    Shenzhen Mindray Bio-medical Electronics Co., Ltd.
    Date Cleared
    2025-09-12

    (91 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250986
    Device Name
    S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
    Manufacturer
    Mevion Medical Systems, Inc.
    Date Cleared
    2025-09-12

    (165 days)

    Product Code
    LHN
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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