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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
    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
    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 Ultrasound and Primary care Diagnostics,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251339
    Device Name
    Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
    Manufacturer
    Zhengzhou PZ Laser Slim Technology Co., Ltd.
    Date Cleared
    2025-07-25

    (86 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhengzhou PZ Laser Slim Technology Co

    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) :

    Howmedica Osteonics Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K252033
    Device Name
    Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
    Manufacturer
    CMT HEALTH PTE. LTD.
    Date Cleared
    2025-07-25

    (25 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMT HEALTH PTE

    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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    K Number
    K250322
    Device Name
    Respond OC Conserving Regulator (130-0800)
    Manufacturer
    Responsive Respiratory
    Date Cleared
    2025-07-24

    (170 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    Responsive Respiratory

    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 Sirona Inc

    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 Ultrasound LLC

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