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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) :

    GuangDong ED**A **Technology Co

    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) :

    Howmedic**a Osteonics Corp (dba **Stryker Orthopaedics)

    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) :

    Howmedic**a **Osteonics Corp

    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) :

    Inbell**a **Medical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251297
    Device Name
    MIS LYNX Conical Connection Implant System
    Manufacturer
    Dentsply Sirona Inc.
    Date Cleared
    2025-07-24

    (87 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dentsply Siron**a **Inc

    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) :

    Medact**a **International S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243681
    Device Name
    Neuro Insight V1.0
    Manufacturer
    Olea Medical S.A.S.
    Date Cleared
    2025-07-23

    (236 days)

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

    Ole**a **Medical S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243367
    Device Name
    Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
    Manufacturer
    Minnesota Medical Technologies
    Date Cleared
    2025-07-22

    (265 days)

    Product Code
    PBP
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Minnesot**a **Medical Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243404
    Device Name
    HyHub™ and HyHub™ Duo Vial Access Devices
    Manufacturer
    Takeda Pharmaceuticals
    Date Cleared
    2025-07-18

    (259 days)

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

    Taked**a **Pharmaceuticals

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243775
    Device Name
    True Non-Surgical Spinal Decompression System (DRX9000-SL)
    Manufacturer
    Excite Medical of Tampa Bay, LLC
    Date Cleared
    2025-07-18

    (221 days)

    Product Code
    ITH
    Regulation Number
    890.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Excite Medical of Tamp**a **Bay, LLC

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