LogoFDA 510(k) Search
Search Filters

Search Results

Found 98269 results

510(k) Data Aggregation

    K Number
    K253054

    Validate with FDA (Live)

    Device Name
    LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
    Manufacturer
    Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
    Date Cleared
    2025-12-19

    (88 days)

    Product Code
    OHS
    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
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    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
    Ask a Question

    Ask a specific question about this device

    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
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K251143

    Validate with FDA (Live)

    Device Name
    Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
    Manufacturer
    Ningbo Ranor Medical Science & Technology Co., Ltd.
    Date Cleared
    2025-12-19

    (249 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    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
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K250976

    Validate with FDA (Live)

    Device Name
    Airbile-100
    Manufacturer
    Poskom Co., Ltd.
    Date Cleared
    2025-12-19

    (263 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    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
    Ask a Question

    Ask a specific question about this device

    K Number
    K253613

    Validate with FDA (Live)

    Device Name
    Monkey Rings External Ring Fixation System
    Manufacturer
    Paragon 28, Inc.
    Date Cleared
    2025-12-19

    (31 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Special
    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
    Ask a Question

    Ask a specific question about this device

    K Number
    K252877

    Validate with FDA (Live)

    Device Name
    SANDRO Dual
    Manufacturer
    Wontech Co., Ltd.
    Date Cleared
    2025-12-19

    (100 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
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K251469

    Validate with FDA (Live)

    Device Name
    Endura™ Ureteral Stent and Stent Set
    Manufacturer
    Cathegenix (Xiamen) Co., Ltd.
    Date Cleared
    2025-12-19

    (220 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    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
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K253202

    Validate with FDA (Live)

    Device Name
    Hoffmann LRF System
    Manufacturer
    Stryker GmbH
    Date Cleared
    2025-12-19

    (84 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    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
    Ask a Question

    Ask a specific question about this device

    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
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    Page 1 of 9827