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510(k) Data Aggregation

    K Number
    K252767

    Validate with FDA (Live)

    Device Name
    actiTENS mini
    Manufacturer
    Sublimed
    Date Cleared
    2026-01-16

    (140 days)

    Product Code
    GZJ,IPF,NGX,NUH,NYN
    Regulation Number
    882.5890
    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
    K254186

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    Device Name
    Azurion R3.1
    Manufacturer
    Philips Medical Systems B.V.
    Date Cleared
    2026-01-16

    (24 days)

    Product Code
    OWB
    Regulation Number
    892.1650
    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
    K251744

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    Device Name
    Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter
    Manufacturer
    Medtronic
    Date Cleared
    2026-01-16

    (224 days)

    Product Code
    DTM
    Regulation Number
    870.4260
    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
    K253925

    Validate with FDA (Live)

    Device Name
    Aventus Thrombectomy System
    Manufacturer
    Inquis Medical
    Date Cleared
    2026-01-15

    (38 days)

    Product Code
    QEZ,CAC,KRA
    Regulation Number
    870.5150
    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
    K252567

    Validate with FDA (Live)

    Device Name
    AltiVate Reverse® ADLC Glenosphere
    Manufacturer
    Encore Medical, L.P.
    Date Cleared
    2026-01-15

    (154 days)

    Product Code
    PHX
    Regulation Number
    888.3660
    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
    K253167

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    Device Name
    Any-Paste
    Manufacturer
    Mediclus Co., Ltd.
    Date Cleared
    2026-01-12

    (108 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    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
    K252807

    Validate with FDA (Live)

    Device Name
    Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2026-01-12

    (131 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    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
    K253142

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    Device Name
    Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
    Manufacturer
    Ningbo Ranor Medical Technology Co., Ltd.
    Date Cleared
    2026-01-09

    (106 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    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
    K252711

    Validate with FDA (Live)

    Device Name
    Advantage-C™ Ti3D Cervical Interbody Fusion Device
    Manufacturer
    Intelivation Technologies
    Date Cleared
    2026-01-08

    (134 days)

    Product Code
    ODP
    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
    K252894

    Validate with FDA (Live)

    Device Name
    aprevo® cervical interbody system
    Manufacturer
    Carlsmed, Inc.
    Date Cleared
    2026-01-06

    (117 days)

    Product Code
    ODP
    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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