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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 Medica**l **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 Medica**l **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 Globa**l **Inc

    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 Biomedica**l **Inc

    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 Medica**l **Systems Ultrasound and Primary care Diagnostics,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K252215
    Device Name
    InbellaMAX System
    Manufacturer
    Inbella Medical Ltd.
    Date Cleared
    2025-07-25

    (10 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Inbella Medica**l **Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243392
    Device Name
    Infusomat® Space Volumetric Infusion Pump Administration Sets
    Manufacturer
    B. Braun Medical Inc
    Date Cleared
    2025-07-24

    (266 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Braun Medica**l **Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243711
    Device Name
    Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
    Manufacturer
    Wuxi Hisky Medical Technologies Co., Ltd.
    Date Cleared
    2025-07-24

    (234 days)

    Product Code
    OWN
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Hisky Medica**l **Technologies Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251618
    Device Name
    MOTO Partial Knee System Extension
    Manufacturer
    Medacta International S.A.
    Date Cleared
    2025-07-24

    (58 days)

    Product Code
    HSX
    Regulation Number
    888.3520
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medacta Internationa**l **S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251955
    Device Name
    Onflex™ Mesh
    Manufacturer
    Davol Inc., Subsidiary of C. R. Bard, Inc.
    Date Cleared
    2025-07-24

    (29 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Davo**l **Inc

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