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    K Number
    K251596
    Device Name
    Lunderquist Extra Stiff Wire Guide
    Manufacturer
    William Cook Europe ApS
    Date Cleared
    2025-11-09

    (166 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K252519
    Device Name
    CO2 Laser Therapy System (K106)
    Manufacturer
    HEBEI KEYLASER SCI-TECH Co.,Ltd
    Date Cleared
    2025-11-07

    (88 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K250739
    Device Name
    Primeprint Direct Aligner
    Manufacturer
    Dreve Dentamid GmbH
    Date Cleared
    2025-11-07

    (241 days)

    Product Code
    NXC
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K253039
    Device Name
    AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
    Manufacturer
    Topcon Corporation
    Date Cleared
    2025-11-07

    (46 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    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
    K251391
    Device Name
    BrainsWay Deep TMS System
    Manufacturer
    BrainsWay Ltd.
    Date Cleared
    2025-11-07

    (186 days)

    Product Code
    OBP
    Regulation Number
    882.5805
    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
    K243131
    Device Name
    Triathlon Pro
    Manufacturer
    Sigma Biomedical
    Date Cleared
    2025-11-07

    (403 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    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
    K251441
    Device Name
    Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
    Manufacturer
    Inion Oy
    Date Cleared
    2025-11-07

    (182 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    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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    K Number
    K251853
    Device Name
    Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System
    Manufacturer
    Shenzhen Mindray Bio-medical Electronics Co., LTD.
    Date Cleared
    2025-11-07

    (143 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K253513
    Device Name
    MultiMatch Flow Chameleon AntiMicrobial Composite
    Manufacturer
    Premier Dental Products Company
    Date Cleared
    2025-11-07

    (1 days)

    Product Code
    EBF,DYH,EBC
    Regulation Number
    872.3690
    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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    K Number
    K250819
    Device Name
    Electric Wheelchair (Rollz Motion Electric 2M)
    Manufacturer
    Rollz International bv
    Date Cleared
    2025-11-07

    (234 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    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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