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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
    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
    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) :

    Davol Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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    K Number
    K243373
    Device Name
    Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
    Manufacturer
    Vitrolife Sweden AB
    Date Cleared
    2025-07-23

    (266 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vitrolife Sweden AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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    K Number
    K251073
    Device Name
    Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
    Manufacturer
    Innovasis, Inc.
    Date Cleared
    2025-07-23

    (106 days)

    Product Code
    OLO
    Regulation Number
    882.4560
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    Applicant Name (Manufacturer) :

    Innovasis, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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    K Number
    K251213
    Device Name
    Da Vinci Surgical System (IS5000)
    Manufacturer
    Intuitive Surgical, Inc.
    Date Cleared
    2025-07-23

    (96 days)

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

    Intuitive Surgical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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    K Number
    K243756
    Device Name
    0.014” Willow Guidewire
    Manufacturer
    Arbor Endovascular, LLC
    Date Cleared
    2025-07-17

    (223 days)

    Product Code
    MOF
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arbor Endovascular, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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    K Number
    K243412
    Device Name
    ARCHIMEDES Biodegradable Pancreatic Stent
    Manufacturer
    Q3 Medical USA, LLC (c/o Q3 Medical Devices Ltd.)
    Date Cleared
    2025-07-16

    (257 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Q3 Medical USA, LLC (c/o Q3 Medical Devices Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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    K Number
    K243782
    Device Name
    StimTrial Neuromodulation System
    Manufacturer
    Bioventus LLC
    Date Cleared
    2025-07-16

    (219 days)

    Product Code
    GZF
    Regulation Number
    882.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bioventus LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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    K Number
    K251151
    Device Name
    Rapid CTA 360
    Manufacturer
    iSchemaView
    Date Cleared
    2025-07-16

    (93 days)

    Product Code
    QAS
    Regulation Number
    892.2080
    Why did this record match?
    Applicant Name (Manufacturer) :

    iSchemaView

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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