Search Filters

Search Results

Found 98353 results

510(k) Data Aggregation

    K Number
    K253867

    Validate with FDA (Live)

    Date Cleared
    2026-01-02

    (30 days)

    Product Code
    Regulation Number
    N/A
    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
    K253854

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-01-02

    (30 days)

    Product Code
    Regulation Number
    882.5300
    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
    K252817

    Validate with FDA (Live)

    Date Cleared
    2026-01-02

    (120 days)

    Product Code
    Regulation Number
    890.3800
    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
    K251178

    Validate with FDA (Live)

    Date Cleared
    2026-01-02

    (261 days)

    Product Code
    Regulation Number
    876.5130
    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
    K243627

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-31

    (401 days)

    Product Code
    Regulation Number
    870.4450
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The L-ARC is indicated for use in the battlefield to control difficult bleeds inguinal area. The L-ARC is also indicated for use in the battlefield as a last resort for life threatening bleeds of the carotid artery.

    Device Description

    The Laryngoscope-Arterial Restriction Clamp is designed to be used by military medical personnel in the battlefield. The device is designed to control bleeding in the neck and inguinal areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries or soldiers. The Laryngoscope-Arterial Restriction Clamp is use to control areas of difficult bleeding for up to 4 hours until the injured soldier can be transferred to evacuation personnel for further treatment or until the device can be converted to conventional dressings. The device can be used to directly visualize the oropharynx to assist with intubation in the soldier with a compromised airway.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K253888

    Validate with FDA (Live)

    Device Name
    MOLLI 2 System
    Manufacturer
    Date Cleared
    2025-12-31

    (27 days)

    Product Code
    Regulation Number
    878.4300
    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
    K252901

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-31

    (111 days)

    Product Code
    Regulation Number
    N/A
    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
    K252951

    Validate with FDA (Live)

    Device Name
    Genesis Sleep
    Manufacturer
    Date Cleared
    2025-12-31

    (106 days)

    Product Code
    Regulation Number
    882.5800
    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
    K253305

    Validate with FDA (Live)

    Date Cleared
    2025-12-31

    (93 days)

    Product Code
    Regulation Number
    882.5890
    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
    K253532

    Validate with FDA (Live)

    Date Cleared
    2025-12-30

    (47 days)

    Product Code
    Regulation Number
    892.2050
    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 9836