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510(k) Data Aggregation

    K Number
    K253202

    Validate with FDA (Live)

    Device Name
    Hoffmann LRF System
    Manufacturer
    Stryker GmbH
    Date Cleared
    2025-12-19

    (84 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    Device Description
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    K Number
    K252956

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    Device Name
    Helo Thrombectomy System
    Manufacturer
    Endovascular Engineering, Inc.
    Date Cleared
    2025-12-18

    (93 days)

    Product Code
    QEW
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252533

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    Device Name
    HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
    Manufacturer
    Edwards Lifesciences
    Date Cleared
    2025-12-18

    (128 days)

    Product Code
    DQK,DQE,DSB,DXN,FLL,MUD,QAQ,QEM,QMS,QNL
    Regulation Number
    870.1425
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252935

    Validate with FDA (Live)

    Device Name
    Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)
    Manufacturer
    Foshan Pingchuang Medical Technology Co., Ltd.
    Date Cleared
    2025-12-15

    (91 days)

    Product Code
    NUC
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    Device Description
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    K Number
    K253101

    Validate with FDA (Live)

    Device Name
    HyperVue™ Imaging System - Integrated
    Manufacturer
    Spectrawave, Inc.
    Date Cleared
    2025-12-15

    (82 days)

    Product Code
    NQQ
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K250851

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    Device Name
    Hypnos (369054-200)
    Manufacturer
    Cadwell Industries, Inc.
    Date Cleared
    2025-12-14

    (268 days)

    Product Code
    OLZ
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252745

    Validate with FDA (Live)

    Device Name
    Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
    Manufacturer
    Micro-Energy Medical Technology Co., Ltd.
    Date Cleared
    2025-12-12

    (105 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250821

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    Device Name
    Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
    Manufacturer
    Eurosets Srl
    Date Cleared
    2025-12-12

    (269 days)

    Product Code
    DTZ,DTM,DTN,DTR
    Regulation Number
    870.4350
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252941

    Validate with FDA (Live)

    Device Name
    HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
    Manufacturer
    O&M Halyard, Inc.
    Date Cleared
    2025-12-11

    (87 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252997

    Validate with FDA (Live)

    Device Name
    HyperFlex® Bunion Correction System
    Manufacturer
    Hyperflex Medical
    Date Cleared
    2025-12-11

    (84 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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