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510(k) Data Aggregation

    K Number
    K252863

    Validate with FDA (Live)

    Device Name
    ClearCalc Model RADCA V2.6
    Manufacturer
    Radformation, Inc.
    Date Cleared
    2025-12-19

    (101 days)

    Product Code
    MUJ
    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
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K251011

    Validate with FDA (Live)

    Device Name
    Chiavaye Personal Moisturizer
    Manufacturer
    Unipack, LLC
    Date Cleared
    2025-12-19

    (262 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
    K252480

    Validate with FDA (Live)

    Device Name
    CE Deliver (DLV)
    Manufacturer
    Capsovision, Inc.
    Date Cleared
    2025-12-19

    (134 days)

    Product Code
    NEZ
    Regulation Number
    876.1300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    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
    K250998

    Validate with FDA (Live)

    Device Name
    CO2 Laser Therapy System (Model: LFS-D9U)
    Manufacturer
    Sanhe Lefis Electronics Co., Ltd.
    Date Cleared
    2025-12-19

    (262 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
    K253409

    Validate with FDA (Live)

    Device Name
    C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
    Manufacturer
    Medtronic, Inc.
    Date Cleared
    2025-12-19

    (80 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    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
    K251771

    Validate with FDA (Live)

    Device Name
    Cambridge Partial Knee
    Manufacturer
    Signature Orthopaedics Pty, Ltd.
    Date Cleared
    2025-12-16

    (189 days)

    Product Code
    HSX
    Regulation Number
    888.3520
    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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    K Number
    K253118

    Validate with FDA (Live)

    Device Name
    Companion Spine DIAM™ Instrumentation
    Manufacturer
    Companion Spine France
    Date Cleared
    2025-12-16

    (83 days)

    Product Code
    QLR
    Regulation Number
    888.4520
    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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    K Number
    K250488

    Validate with FDA (Live)

    Device Name
    Cerynë Intimate Care
    Manufacturer
    Ansella Therapeutics
    Date Cleared
    2025-12-12

    (296 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
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K252482

    Validate with FDA (Live)

    Device Name
    CogNet AI-MT+
    Manufacturer
    Medcognetics, Inc.
    Date Cleared
    2025-12-11

    (126 days)

    Product Code
    QFM
    Regulation Number
    892.2080
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K253200

    Validate with FDA (Live)

    Device Name
    Cervical Spine Truss System - Stand Alone (CSTS-SA)
    Manufacturer
    4Web Medical, Inc.
    Date Cleared
    2025-12-11

    (76 days)

    Product Code
    OVE
    Regulation Number
    888.3080
    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
    AI/ML Overview
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