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510(k) Data Aggregation

    K Number
    K260257

    Validate with FDA (Live)

    Device Name
    CO2 Laser System
    Manufacturer
    Sanhe Meditech Co., Ltd.
    Date Cleared
    2026-03-28

    (59 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    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
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    K Number
    K252006

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    Device Name
    OTTO™ Disinfecting Cap
    Manufacturer
    Icu Medical, Inc.
    Date Cleared
    2026-03-27

    (273 days)

    Product Code
    QBP
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253572

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    Device Name
    STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device
    Manufacturer
    ETHICON, Inc.
    Date Cleared
    2026-03-27

    (130 days)

    Product Code
    GAW
    Regulation Number
    878.5010
    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
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    K Number
    K252926

    Validate with FDA (Live)

    Device Name
    Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184)
    Manufacturer
    Restore Robotics
    Date Cleared
    2026-03-26

    (192 days)

    Product Code
    QSM
    Regulation Number
    876.1500
    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
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    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
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    K Number
    K252908

    Validate with FDA (Live)

    Device Name
    Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
    Manufacturer
    Sandstone Medical (Suzhou), Inc.
    Date Cleared
    2026-03-25

    (194 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Special
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252023

    Validate with FDA (Live)

    Device Name
    MiraChlor Antimicrobial Wound Solution
    Manufacturer
    Letus Corporation
    Date Cleared
    2026-03-25

    (268 days)

    Product Code
    FRO
    Regulation Number
    N/A
    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
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    K Number
    K253047

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    Device Name
    PRESSONE™
    Manufacturer
    Nipro Medical Corporation
    Date Cleared
    2026-03-24

    (183 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
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    K Number
    K254275

    Validate with FDA (Live)

    Device Name
    HyperSuture All Green Extension Line
    Manufacturer
    Threadstone, LLC
    Date Cleared
    2026-03-23

    (83 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    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
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    K Number
    K260202

    Validate with FDA (Live)

    Device Name
    LED Light Therapy Masks (LumiLips FAC07NA)
    Manufacturer
    Guangdong Newdermo Biotech Co., Ltd.
    Date Cleared
    2026-03-23

    (59 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    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
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