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510(k) Data Aggregation

    K Number
    K250203
    Device Name
    SureAx-Guide™
    Manufacturer
    SureAx Medical, LLC
    Date Cleared
    2025-10-17

    (266 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K251778
    Device Name
    Remi Custom Night Guard
    Manufacturer
    Remi
    Date Cleared
    2025-10-17

    (129 days)

    Product Code
    OBR
    Regulation Number
    N/A
    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
    K251146
    Device Name
    IntelliVue Patient monitors MX400, MX450, MX500, MX550
    Manufacturer
    Philips Medizin Systeme Boeblingen GmbH
    Date Cleared
    2025-10-17

    (186 days)

    Product Code
    MHX,BZC,BZQ,CBQ,CBR,CBS,CCK,CCL,DPS,DQA,DQK,DRT,DSF,DSJ,DSK,DXN,FLL,GWQ,GWS,KLK,KOI,LKD,MLD,MSX,NHO,NHP,NHQ
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
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    K Number
    K250945
    Device Name
    Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2025-10-17

    (203 days)

    Product Code
    KNS
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250911
    Device Name
    MOSkin Radiation Measurement System
    Manufacturer
    Electrogenics Labs, Ltd
    Date Cleared
    2025-10-17

    (205 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250178
    Device Name
    Adin Customized Abutments
    Manufacturer
    Adin Dental Implant Systems Ltd.
    Date Cleared
    2025-10-17

    (268 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    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
    K252266
    Device Name
    S.I.N. Dental Implant System
    Manufacturer
    S.I.N. Implant System LTDA.
    Date Cleared
    2025-10-17

    (88 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    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
    K250227
    Device Name
    JOVS Electric Stimulation Beauty Device (JE2)
    Manufacturer
    Shenzhen Qianyu Technology Co., Ltd.
    Date Cleared
    2025-10-17

    (263 days)

    Product Code
    NFO
    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
    K250250
    Device Name
    ADVIA Centaur Anti-Thyroid Peroxidase II
    Manufacturer
    Siemens Healthcare Diagnostics, Inc.
    Date Cleared
    2025-10-17

    (262 days)

    Product Code
    JZO,JIT,JJX
    Regulation Number
    866.5870
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251355
    Device Name
    X1-FFR
    Manufacturer
    SpectraWAVE, Inc.
    Date Cleared
    2025-10-17

    (170 days)

    Product Code
    QHA
    Regulation Number
    892.1600
    Type
    Traditional
    Panel
    Radiology
    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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