LogoFDA 510(k) Search
Search Filters

Search Results

Found 8617 results

510(k) Data Aggregation

    K Number
    K252360

    Validate with FDA (Live)

    Device Name
    ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
    Manufacturer
    Anumana, Inc.
    Date Cleared
    2026-03-28

    (242 days)

    Product Code
    SAT
    Regulation Number
    870.2380
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K252195

    Validate with FDA (Live)

    Device Name
    ARTICOR planner
    Manufacturer
    Artiness S.R.L
    Date Cleared
    2026-03-27

    (256 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K260271

    Validate with FDA (Live)

    Device Name
    Strauss Surgical cystoscope, hysteroscope and accessories Instruments
    Manufacturer
    American Medical Endoscopy, Inc.
    Date Cleared
    2026-03-27

    (58 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K260255

    Validate with FDA (Live)

    Device Name
    AVENTIX PFX System (PFX01); NOVOCLEAR Device (CLR001)
    Manufacturer
    Aventix Medical, Inc.
    Date Cleared
    2026-03-27

    (58 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K252893

    Validate with FDA (Live)

    Device Name
    ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
    Manufacturer
    Aneuvo
    Date Cleared
    2026-03-27

    (197 days)

    Product Code
    SDO
    Regulation Number
    890.5851
    Type
    Traditional
    Panel
    Physical Medicine
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K253775

    Validate with FDA (Live)

    Device Name
    SwiftMR
    Manufacturer
    Airs Medical, Inc.
    Date Cleared
    2026-03-26

    (120 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K253615

    Validate with FDA (Live)

    Device Name
    Invictus Bands System
    Manufacturer
    Alphatec Spine, Inc.
    Date Cleared
    2026-03-25

    (127 days)

    Product Code
    OWI
    Regulation Number
    888.3010
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K253680

    Validate with FDA (Live)

    Device Name
    LYNX COBLATION Laryngeal Wand (72290254)
    Manufacturer
    ArthroCare Corporation
    Date Cleared
    2026-03-25

    (124 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K254253

    Validate with FDA (Live)

    Device Name
    LOQTEQ® VA Proximal Humerus Plate 3.5
    Manufacturer
    Aap Implantate AG
    Date Cleared
    2026-03-24

    (85 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K253198

    Validate with FDA (Live)

    Device Name
    NanoKnife Generator (H78720300351US0)
    Manufacturer
    Angiodynamics
    Date Cleared
    2026-03-24

    (179 days)

    Product Code
    OAB
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    Page 1 of 862