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510(k) Data Aggregation

    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
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K253609

    Validate with FDA (Live)

    Device Name
    TRAUMAGEL® 2.0 Hemostatic Gel
    Manufacturer
    Cresilon, Inc.
    Date Cleared
    2025-12-12

    (24 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Type
    Special
    Panel
    General & Plastic Surgery
    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
    K252745

    Validate with FDA (Live)

    Device Name
    Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
    Manufacturer
    Micro-Energy Medical Technology Co., Ltd.
    Date Cleared
    2025-12-12

    (105 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    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
    K251177

    Validate with FDA (Live)

    Device Name
    Self-Seal Sterilization Pouch and Roll
    Manufacturer
    Guangdong Maidi Medical Co., Ltd.
    Date Cleared
    2025-12-12

    (240 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    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
    K251089

    Validate with FDA (Live)

    Device Name
    EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
    Manufacturer
    Exelint International, Co.
    Date Cleared
    2025-12-12

    (246 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K250847

    Validate with FDA (Live)

    Device Name
    VaporShield
    Manufacturer
    Vault Paragon Group, Inc.
    Date Cleared
    2025-12-12

    (267 days)

    Product Code
    MEG,FMF,FMI,ONB
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    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
    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
    Intended Use
    Device Description
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    K Number
    K252941

    Validate with FDA (Live)

    Device Name
    HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
    Manufacturer
    O&M Halyard, Inc.
    Date Cleared
    2025-12-11

    (87 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    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
    K250192

    Validate with FDA (Live)

    Device Name
    Verisafe Safety Retractable Insulin Syringes
    Manufacturer
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Cleared
    2025-12-10

    (321 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K253706

    Validate with FDA (Live)

    Device Name
    Lancing device (HH-XV-T)
    Manufacturer
    Tianjin Huahong Technology Co., Ltd.
    Date Cleared
    2025-12-09

    (15 days)

    Product Code
    QRL
    Regulation Number
    878.4850
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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