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510(k) Data Aggregation

    K Number
    K252892

    Validate with FDA (Live)

    Device Name
    SCOUT MD Surgical Guidance System
    Manufacturer
    Merit Medical Systems, Inc.
    Date Cleared
    2025-12-19

    (99 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    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
    K252781

    Validate with FDA (Live)

    Device Name
    MSFX MIKRON PEEK CAGES
    Manufacturer
    Mikron Makina Sanayi VE Tic. Ltd. Sti.
    Date Cleared
    2025-12-19

    (108 days)

    Product Code
    ODP
    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
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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
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    K Number
    K253577

    Validate with FDA (Live)

    Device Name
    IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
    Manufacturer
    Medicrea International S.A.S. (Medtronic)
    Date Cleared
    2025-12-19

    (32 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    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
    K250864

    Validate with FDA (Live)

    Device Name
    MatriDerm pluS+ Bi-Layer
    Manufacturer
    Medskin Solutions Dr. Suwelack AG
    Date Cleared
    2025-12-19

    (273 days)

    Product Code
    KGN
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    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
    K253758

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    Device Name
    Dental Cone; Dental Sponge
    Manufacturer
    Medizin Produkte Neustadt GmbH (Mpn)
    Date Cleared
    2025-12-18

    (23 days)

    Product Code
    OLR
    Regulation Number
    N/A
    Type
    Special
    Panel
    Dental
    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
    K250319

    Validate with FDA (Live)

    Device Name
    MFUSE (MS001)
    Manufacturer
    Machina Medical, Inc.
    Date Cleared
    2025-12-15

    (314 days)

    Product Code
    QSY
    Regulation Number
    N/A
    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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    Device Description
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    K Number
    K252745

    Validate with FDA (Live)

    Device Name
    Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
    Manufacturer
    Micro-Energy Medical Technology Co., Ltd.
    Date Cleared
    2025-12-12

    (105 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
    Intended Use
    Device Description
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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
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    K Number
    K251883

    Validate with FDA (Live)

    Device Name
    MIM – LesionID Pro
    Manufacturer
    Mim Software, Inc.
    Date Cleared
    2025-12-11

    (174 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    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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