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    K Number
    K250851
    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
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    K Number
    K252681
    Device Name
    EnCor EnCompass™ Breast Biopsy and Tissue Removal System
    Manufacturer
    Bard Peripheral Vascular, Inc.
    Date Cleared
    2025-12-12

    (109 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252120
    Device Name
    Fundus On Phone Non Mydriatic (FOP NM-10)
    Manufacturer
    Remidio Innovative Solutions Private Limited
    Date Cleared
    2025-12-12

    (158 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253749
    Device Name
    Affixus® Natural Nail® Proximal Humeral System
    Manufacturer
    Zimmer Switzerland Manufacturing GmbH
    Date Cleared
    2025-12-12

    (17 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252273
    Device Name
    Therapy US
    Manufacturer
    Dmc Importação E Exportação DE Equipamentos Ltda
    Date Cleared
    2025-12-12

    (143 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251085
    Device Name
    iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
    Manufacturer
    Ihealth Labs, Inc.
    Date Cleared
    2025-12-12

    (247 days)

    Product Code
    SCA
    Regulation Number
    866.3987
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251092
    Device Name
    iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
    Manufacturer
    Ihealth Labs, Inc.
    Date Cleared
    2025-12-12

    (246 days)

    Product Code
    SCA
    Regulation Number
    866.3987
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253609
    Device Name
    TRAUMAGEL® 2.0 Hemostatic Gel
    Manufacturer
    Cresilon, Inc.
    Date Cleared
    2025-12-12

    (24 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Type
    Special
    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
    K250863
    Device Name
    FUJIFILM Ultrasonic Endoscope EB-710US
    Manufacturer
    FUJIFILM Corporation
    Date Cleared
    2025-12-12

    (266 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252785
    Device Name
    TopCEM Vigor SA Self-Adhesive Resin Cement
    Manufacturer
    Rizhao Huge Biomaterials Company, Ltd.
    Date Cleared
    2025-12-12

    (101 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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