LogoFDA 510(k) Search
Search Filters

Search Results

Found 4121 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
    Why did this record match?
    Applicant Name (Manufacturer) :

    GuangDon**g **EDA Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K244018
    Device Name
    Disposable Biopsy Needle
    Manufacturer
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Date Cleared
    2025-07-22

    (207 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejian**g **CuraWay Medical Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251638
    Device Name
    Mobility Scooter (MS160C)
    Manufacturer
    Suzhou Master Machinery Manufacturing Co., Ltd.
    Date Cleared
    2025-07-22

    (54 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Master Machinery Manufacturin**g **Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K250999
    Device Name
    V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
    Manufacturer
    Samsung Medison Co., Ltd.
    Date Cleared
    2025-07-18

    (108 days)

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

    Samsun**g **Medison Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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 United Imagin**g **Healthcare Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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 United Imagin**g **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 United Imagin**g **Healthcare Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K243227
    Device Name
    B-Scan
    Manufacturer
    ACCUTOME, INC. Doing Business As Keeler USA
    Date Cleared
    2025-07-11

    (276 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Doin**g **Business As Keeler USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251863
    Device Name
    CustomSurg OrthoPlanner
    Manufacturer
    CustomSurg AG
    Date Cleared
    2025-07-07

    (20 days)

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

    CustomSur**g **AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251285
    Device Name
    Electric Wheelchair (HG-630)
    Manufacturer
    Zhejiang Automwheel Tech Co., Ltd.
    Date Cleared
    2025-07-02

    (68 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejian**g **Automwheel Tech Co

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

    Page 1 of 413