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510(k) Data Aggregation

    K Number
    K260561

    Validate with FDA (Live)

    Device Name
    Arthrex FiberTak Suture Anchor
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-03-20

    (29 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260585

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    Device Name
    Noxturnal Web
    Manufacturer
    Nox Medical Ehf
    Date Cleared
    2026-03-20

    (28 days)

    Product Code
    OLV
    Regulation Number
    882.1400
    Type
    Special
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K260519

    Validate with FDA (Live)

    Device Name
    Smart Fit TorsoCardiac 1.5T
    Manufacturer
    Philips Healthcare (Suzhou) Co., Ltd.
    Date Cleared
    2026-03-20

    (31 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260437

    Validate with FDA (Live)

    Device Name
    Valvuloplasty Balloon Catheter (ValvuloPro)
    Manufacturer
    Dongguan TT Medical, Inc.
    Date Cleared
    2026-03-20

    (37 days)

    Product Code
    OZT
    Regulation Number
    870.1255
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260551

    Validate with FDA (Live)

    Device Name
    HemosIL Factor V Leiden (APC Resistance V)
    Manufacturer
    Instrumentation Laboratory (IL) Co.
    Date Cleared
    2026-03-20

    (30 days)

    Product Code
    GGW
    Regulation Number
    864.7925
    Type
    Special
    Panel
    Hematology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K254208

    Validate with FDA (Live)

    Device Name
    FLOWRUNNER Aspiration System
    Manufacturer
    Expanse Medical, Inc.
    Date Cleared
    2026-03-20

    (81 days)

    Product Code
    QEZ
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260544

    Validate with FDA (Live)

    Device Name
    FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
    Manufacturer
    FMD Co., Ltd.
    Date Cleared
    2026-03-20

    (30 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260509

    Validate with FDA (Live)

    Device Name
    AutoContour (RADAC V5)
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2026-03-19

    (30 days)

    Product Code
    QKB
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253746

    Validate with FDA (Live)

    Device Name
    Enroute 0.014'' Transcarotid Guidewire
    Manufacturer
    Lake Region Medical
    Date Cleared
    2026-03-19

    (114 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K260533

    Validate with FDA (Live)

    Device Name
    ELISIO™-H
    Manufacturer
    Nipro Medical Corporation
    Date Cleared
    2026-03-19

    (30 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Type
    Special
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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