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

    Becton Dickinson Infusion Therapy Systems Inc

    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) :

    Ab****bott 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
    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Howmedica Osteonics Corp (dba Stryker Orthopaedics)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251620
    Device Name
    A.L.P.S. Proximal Humerus Plating System
    Manufacturer
    Zimmer Biomet
    Date Cleared
    2025-07-25

    (59 days)

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

    Zimmer Biomet

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251665
    Device Name
    Triathlon® Hinge Knee System
    Manufacturer
    Howmedica Osteonics Corp. dba Stryker Orthopaedics
    Date Cleared
    2025-07-25

    (56 days)

    Product Code
    KRO
    Regulation Number
    888.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    dba Stryker Orthopaedics

    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 Medical 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) :

    B

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250284
    Device Name
    TSK SELECT™ Needle
    Manufacturer
    TSK Laboratory, Japan
    Date Cleared
    2025-07-24

    (174 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TSK Laboratory, Japan

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