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    K Number
    K243244
    Device Name
    Heated Breathing Tube
    Manufacturer
    GuangDong EDA Technology Co., Ltd
    Date Cleared
    2025-07-25

    (287 days)

    Product Code
    BZE
    Regulation Number
    868.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    GuangDong EDA Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250232
    Device Name
    Vathin® Video Bronchoscope System
    Manufacturer
    Hunan Vathin Medical Instrument Co., Ltd.
    Date Cleared
    2025-07-25

    (179 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hunan Vathin Medical Instrument Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250244
    Device Name
    Compression Therapy Device (LGT-2210DS)
    Manufacturer
    Guangzhou Longest Medical Technology Co., Ltd.
    Date Cleared
    2025-07-25

    (179 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou Longest MedicaL TechnoLogy Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250334
    Device Name
    Fusion Craniofacial Implant; Fusion Skull Implant
    Manufacturer
    Kelyniam Global Inc.
    Date Cleared
    2025-07-25

    (170 days)

    Product Code
    GWO
    Regulation Number
    882.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kelyniam Global Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250552
    Device Name
    Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
    Manufacturer
    Abbott Medical
    Date Cleared
    2025-07-25

    (150 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abbott Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250859
    Device Name
    TransForm McCarthy Mitral Annuloplasty Ring (TF)
    Manufacturer
    Genesee Biomedical Inc
    Date Cleared
    2025-07-25

    (126 days)

    Product Code
    KRH
    Regulation Number
    870.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genesee Biomedical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250970
    Device Name
    Marie
    Manufacturer
    Leo Cancer Care
    Date Cleared
    2025-07-25

    (116 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Leo Cancer Care

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251322
    Device Name
    Venue; Venue Go; Venue Fit; Venue Sprint
    Manufacturer
    GE Medical Systems Ultrasound and Primary care Diagnostics,
    Date Cleared
    2025-07-25

    (87 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems Ultrasound and Primary care Diagnostics,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251339
    Device Name
    Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
    Manufacturer
    Zhengzhou PZ Laser Slim Technology Co., Ltd.
    Date Cleared
    2025-07-25

    (86 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhengzhou PZ Laser SLim TechnoLogy Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K252033
    Device Name
    Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
    Manufacturer
    CMT HEALTH PTE. LTD.
    Date Cleared
    2025-07-25

    (25 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMT HEALTH PTE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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