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510(k) Data Aggregation

    K Number
    K253098

    Validate with FDA (Live)

    Device Name
    Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)
    Manufacturer
    Nexstim Oyj
    Date Cleared
    2026-03-20

    (178 days)

    Product Code
    OBP,GWF,IKN,QCI,QFF
    Regulation Number
    882.5805
    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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    Device Description
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    K Number
    K252606

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    Device Name
    Bifix Veneer LC, Bifix Veneer Try-In
    Manufacturer
    Voco GmbH
    Date Cleared
    2026-03-20

    (214 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    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
    K253574

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    Device Name
    SOMATOM X.cite; SOMATOM X.ceed
    Manufacturer
    Siemens Medical Solutions USA, Inc.
    Date Cleared
    2026-03-20

    (123 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Type
    Traditional
    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
    K253864

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    Device Name
    NOMAD Pro 3
    Manufacturer
    Dental Imaging Technologies Corporation
    Date Cleared
    2026-03-20

    (107 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    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
    K253604

    Validate with FDA (Live)

    Device Name
    TiLink-L Navigation Instruments
    Manufacturer
    SurGenTec, LLC
    Date Cleared
    2026-03-20

    (122 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    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
    K252050

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    Device Name
    Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2026-03-20

    (262 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    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
    K252005

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    Device Name
    Livi Device
    Manufacturer
    Liviwell, Inc.
    Date Cleared
    2026-03-20

    (266 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    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
    K253849

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    Device Name
    Electric wheelchair (JJW-7002, JJW-7003)
    Manufacturer
    ZheJiang J&J Mobility Co., Ltd.
    Date Cleared
    2026-03-20

    (108 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    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
    K254170

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    Device Name
    Percutaneous Endoscopic Gastrostomy (PEG) Kit
    Manufacturer
    Degania Silicone , Ltd.
    Date Cleared
    2026-03-20

    (87 days)

    Product Code
    PIF
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    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
    K251980

    Validate with FDA (Live)

    Device Name
    ClaveQS™ Bag
    Manufacturer
    Icu Medical, Inc.
    Date Cleared
    2026-03-20

    (266 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Type
    Traditional
    Panel
    General Hospital
    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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