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510(k) Data Aggregation

    K Number
    K252195

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    Device Name
    ARTICOR planner
    Manufacturer
    Artiness S.R.L
    Date Cleared
    2026-03-27

    (256 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    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
    K260255

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    Device Name
    AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
    Manufacturer
    Aventix Medical, Inc.
    Date Cleared
    2026-03-27

    (58 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K251273

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    Device Name
    Asurys Fluid Management System
    Manufacturer
    Boston Scientific Corporation
    Date Cleared
    2026-03-27

    (337 days)

    Product Code
    HIG
    Regulation Number
    884.1700
    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
    K254161

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    Device Name
    Automated Aortic Stenosis Software (AutoAS)
    Manufacturer
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
    Date Cleared
    2026-03-27

    (95 days)

    Product Code
    POK
    Regulation Number
    892.2060
    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
    K260273

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    Device Name
    Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
    Manufacturer
    Shenzhen Urion Technology Co., Ltd.
    Date Cleared
    2026-03-26

    (56 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Type
    Traditional
    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
    K260274

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    Device Name
    Airlock® Ankle Plating System
    Manufacturer
    Novastep SAS
    Date Cleared
    2026-03-25

    (55 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Abbreviated
    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
    K254278

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    Device Name
    Arterial Pressure Monitoring Set/Tray
    Manufacturer
    Spectrum Vascular
    Date Cleared
    2026-03-25

    (85 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    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
    K252169

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    Device Name
    Access BNP II
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2026-03-24

    (257 days)

    Product Code
    NBC
    Regulation Number
    862.1117
    Type
    Traditional
    Panel
    Clinical Chemistry
    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
    K252031

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    Device Name
    Adin Long Dental Implant System
    Manufacturer
    Adin Dental Implant Systems , Ltd.
    Date Cleared
    2026-03-23

    (266 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    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

    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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