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    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 EDA Technology Co

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

    Howmedica Osteonics Corp (dba Stryker OrtHopaedics)

    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
    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 Medical TecHnologies Co

    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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