Search Filters

Search Results

Found 96980 results

510(k) Data Aggregation

    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K243403
    Device Name
    BD Nexiva™ Closed IV Catheter System
    Manufacturer
    Becton Dickinson Infusion Therapy Systems Inc.
    Date Cleared
    2025-07-25

    (267 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K250970
    Device Name
    Marie
    Manufacturer
    Leo Cancer Care
    Date Cleared
    2025-07-25

    (116 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K250989
    Device Name
    Stryker and Serf hip devices
    Manufacturer
    Howmedica Osteonics Corp (dba Stryker Orthopaedics)
    Date Cleared
    2025-07-25

    (116 days)

    Product Code
    LPH, HWC, KWZ, LZO, MAY, MBL, MEH
    Regulation Number
    888.3358
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 9698