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510(k) Data Aggregation

    K Number
    K254085

    Validate with FDA (Live)

    Device Name
    CARTO™ 3 EP Navigation System V9.0 with PIU Plus
    Manufacturer
    Biosense Webster, Inc.
    Date Cleared
    2026-01-18

    (31 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    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
    K253408

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    Device Name
    CoolTone
    Manufacturer
    Zimmer Medizinsysteme GmbH
    Date Cleared
    2026-01-16

    (108 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    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
    K252205

    Validate with FDA (Live)

    Device Name
    Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System
    Manufacturer
    Curiteva, Inc.
    Date Cleared
    2026-01-16

    (186 days)

    Product Code
    ODP,MAX,NQW,OVD,PHM
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K254061

    Validate with FDA (Live)

    Device Name
    Curiteva Porous PEEK Cervical Interbody Fusion System
    Manufacturer
    Curiteva, Inc.
    Date Cleared
    2026-01-15

    (29 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    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
    K252313

    Validate with FDA (Live)

    Device Name
    Cardinal Health Nitrile Examination Gloves Extended Cuff
    Manufacturer
    Cardinalhealth
    Date Cleared
    2026-01-14

    (173 days)

    Product Code
    LZC,LZA,OPJ,QDO
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    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
    K253511

    Validate with FDA (Live)

    Device Name
    Concerto Versa™ Detachable Coil
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2026-01-14

    (70 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    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
    K252219

    Validate with FDA (Live)

    Device Name
    Cervical Interbody and VBR Fusion System
    Manufacturer
    Sync Surgical
    Date Cleared
    2026-01-14

    (183 days)

    Product Code
    ODP,MQP,PLR
    Regulation Number
    888.3080
    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
    K254014

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    Device Name
    Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    2026-01-13

    (29 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Special
    Panel
    General & Plastic Surgery
    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
    K251307

    Validate with FDA (Live)

    Device Name
    Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
    Manufacturer
    Shenzhen Hingmed Medical Instrument Co., Ltd.
    Date Cleared
    2026-01-12

    (259 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
    K251157

    Validate with FDA (Live)

    Device Name
    Core Metabolic
    Manufacturer
    Truvian Health
    Date Cleared
    2026-01-09

    (269 days)

    Product Code
    CIX,CEK,CFR
    Regulation Number
    862.1035
    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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