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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 Ultrasoun**d and **Primary care Diagnostics,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251455
    Device Name
    EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
    Manufacturer
    Philips Ultrasound LLC
    Date Cleared
    2025-07-24

    (73 days)

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

    Philips Ultrasoun**d **LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250716
    Device Name
    IMAGE ONE
    Manufacturer
    Infomed Software, S.L.
    Date Cleared
    2025-07-23

    (135 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Infome**d **Software, S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243547
    Device Name
    uMR Ultra
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2025-07-17

    (244 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Unite**d **Imaging Healthcare Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251839
    Device Name
    uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2025-07-17

    (31 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Unite**d **Imaging Healthcare Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K243397
    Device Name
    uMR 680
    Manufacturer
    Shanghai United Imaging Healthcare Co., Ltd.
    Date Cleared
    2025-07-16

    (258 days)

    Product Code
    LNH, MOS, QIH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Unite**d **Imaging Healthcare Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251342
    Device Name
    EchoPAC Software Only / EchoPAC Plug-in
    Manufacturer
    GE Medical Systems Ultrasound and Primary Care Diagnostics
    Date Cleared
    2025-07-16

    (77 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems Ultrasoun**d and **Primary Care Diagnostics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K250181
    Device Name
    AV Viewer
    Manufacturer
    Philips Medical Systems Nederland B.V.
    Date Cleared
    2025-07-15

    (174 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philips Medical Systems Nederlan**d **B

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251045
    Device Name
    Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)
    Manufacturer
    Unimed Medical Supplies, Inc.
    Date Cleared
    2025-07-15

    (103 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Unime**d **Medical Supplies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251132
    Device Name
    The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws
    Manufacturer
    Acumed LLC
    Date Cleared
    2025-07-14

    (94 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    Acume**d **LLC

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

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