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510(k) Data Aggregation

    K Number
    K253627

    Validate with FDA (Live)

    Device Name
    Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
    Manufacturer
    Surgify Medical OY
    Date Cleared
    2026-03-26

    (127 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    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
    K253379

    Validate with FDA (Live)

    Device Name
    Stealth AXiS Cranial clinical application
    Manufacturer
    Medtronic Navigation, Inc.
    Date Cleared
    2026-03-26

    (177 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    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
    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
    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
    K252358

    Validate with FDA (Live)

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

    (234 days)

    Product Code
    OBP,GWF,IKN,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
    K260537

    Validate with FDA (Live)

    Device Name
    Willow 24 Guidewire
    Manufacturer
    Arbor Endovascular, LLC
    Date Cleared
    2026-03-19

    (30 days)

    Product Code
    MOF
    Regulation Number
    870.1330
    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
    K253587

    Validate with FDA (Live)

    Device Name
    Cala kIQ Plus
    Manufacturer
    Cala Health, Inc.
    Date Cleared
    2026-03-17

    (120 days)

    Product Code
    QBC
    Regulation Number
    882.5897
    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
    K253447

    Validate with FDA (Live)

    Device Name
    Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2026-03-16

    (165 days)

    Product Code
    GXR
    Regulation Number
    882.5250
    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
    Intended Use
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    K Number
    K253590

    Validate with FDA (Live)

    Device Name
    Millipede System
    Manufacturer
    Perfuze, Ltd.
    Date Cleared
    2026-03-16

    (119 days)

    Product Code
    NRY
    Regulation Number
    870.1250
    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
    K252122

    Validate with FDA (Live)

    Device Name
    DCwire Micro-guidewire
    Manufacturer
    Shanghai Achieva Medical Suzhou Co., Ltd.
    Date Cleared
    2026-03-16

    (252 days)

    Product Code
    MOF
    Regulation Number
    870.1330
    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
    Intended Use
    Device Description
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