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510(k) Data Aggregation

    K Number
    K253098

    Validate with FDA (Live)

    Device Name
    Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
    Manufacturer
    Nexstim Oyj
    Date Cleared
    2026-03-20

    (178 days)

    Product Code
    OBP,GWF,IKN,QCI,QFF
    Regulation Number
    882.5805
    Type
    Traditional
    Panel
    Neurology
    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
    K252606

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    Device Name
    Bifix Veneer LC, Bifix Veneer Try-In
    Manufacturer
    Voco GmbH
    Date Cleared
    2026-03-20

    (214 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    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
    K260561

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    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
    K253574

    Validate with FDA (Live)

    Device Name
    SOMATOM X.cite; SOMATOM X.ceed
    Manufacturer
    Siemens Medical Solutions USA, Inc.
    Date Cleared
    2026-03-20

    (123 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    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
    K253864

    Validate with FDA (Live)

    Device Name
    NOMAD Pro 3
    Manufacturer
    Dental Imaging Technologies Corporation
    Date Cleared
    2026-03-20

    (107 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    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
    K253604

    Validate with FDA (Live)

    Device Name
    TiLink-L Navigation Instruments
    Manufacturer
    SurGenTec, LLC
    Date Cleared
    2026-03-20

    (122 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    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

    Validate with FDA (Live)

    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252050

    Validate with FDA (Live)

    Device Name
    Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2026-03-20

    (262 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    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
    K252005

    Validate with FDA (Live)

    Device Name
    Livi Device
    Manufacturer
    Liviwell, Inc.
    Date Cleared
    2026-03-20

    (266 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    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
    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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    Device Description
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