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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) :

    Genese**e **Biomedical Inc

    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) :

    G**E 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
    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) :

    Responsiv**e **Respiratory

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251984
    Device Name
    Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co.,Ltd.
    Date Cleared
    2025-07-24

    (27 days)

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

    Shenzhen Ulik**e **Smart Electronics Co

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

    Vitrolif**e **Sweden AB

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

    Intuitiv**e **Surgical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250211
    Device Name
    Yushan X-Ray Flat Panel Detector
    Manufacturer
    InnoCare Optoelectronics Corp.
    Date Cleared
    2025-07-22

    (179 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    InnoCar**e **Optoelectronics Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251564
    Device Name
    microINR System
    Manufacturer
    iLine Microsystems S.L.
    Date Cleared
    2025-07-21

    (60 days)

    Product Code
    GJS
    Regulation Number
    864.7750
    Why did this record match?
    Applicant Name (Manufacturer) :

    iLin**e **Microsystems S

    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) :

    Excit**e **Medical of Tampa Bay, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K242505
    Device Name
    Elecsys Cortisol III
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2025-07-17

    (329 days)

    Product Code
    JFT
    Regulation Number
    862.1205
    Why did this record match?
    Applicant Name (Manufacturer) :

    Roch**e **Diagnostics

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