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510(k) Data Aggregation

    K Number
    K252191

    Validate with FDA (Live)

    Device Name
    BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
    Manufacturer
    Bonebridge AG
    Date Cleared
    2025-12-17

    (156 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251745

    Validate with FDA (Live)

    Device Name
    Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
    Manufacturer
    Baxter Healthcare Corporation
    Date Cleared
    2025-12-16

    (193 days)

    Product Code
    DXQ
    Regulation Number
    870.1120
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252681

    Validate with FDA (Live)

    Device Name
    EnCor EnCompass™ Breast Biopsy and Tissue Removal System
    Manufacturer
    Bard Peripheral Vascular, Inc.
    Date Cleared
    2025-12-12

    (109 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252391

    Validate with FDA (Live)

    Device Name
    Revi System
    Manufacturer
    Bluewind Medical , Ltd.
    Date Cleared
    2025-12-12

    (134 days)

    Product Code
    QXM
    Regulation Number
    876.5305
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K242817

    Validate with FDA (Live)

    Device Name
    Jason membrane
    Manufacturer
    Botiss Biomaterials GmbH
    Date Cleared
    2025-12-12

    (450 days)

    Product Code
    NPL
    Regulation Number
    872.3930
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
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    K Number
    K251989

    Validate with FDA (Live)

    Device Name
    VizMark Preloaded Tissue Marker Device (VM-0001)
    Manufacturer
    Breast-Med, Inc.
    Date Cleared
    2025-12-12

    (168 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K250974

    Validate with FDA (Live)

    Device Name
    Bio Arterial Deluxe (IC-BAP-DX)
    Manufacturer
    Bio Compression Systems, Inc.
    Date Cleared
    2025-12-12

    (256 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251598

    Validate with FDA (Live)

    Device Name
    Intellidrop
    Manufacturer
    Brainspace, Inc.
    Date Cleared
    2025-12-10

    (197 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252294

    Validate with FDA (Live)

    Device Name
    Fetal EchoScan (v1.2)
    Manufacturer
    Brightheart
    Date Cleared
    2025-12-08

    (138 days)

    Product Code
    POK
    Regulation Number
    892.2060
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K252841

    Validate with FDA (Live)

    Device Name
    REAL INTELLIGENCE™ CORI™ XT (CORI XT)
    Manufacturer
    Blue Belt Technologies, Inc.
    Date Cleared
    2025-12-05

    (88 days)

    Product Code
    OLO,HSX,JWH,KWS,MBH
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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