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510(k) Data Aggregation

    K Number
    K260724

    Validate with FDA (Live)

    Device Name
    MAGENTIQ-COLO (ME-APDS)
    Manufacturer
    Magentiq Eye, Ltd.
    Date Cleared
    2026-04-03

    (29 days)

    Product Code
    QNP
    Regulation Number
    876.1520
    Type
    Special
    Panel
    Gastroenterology/Urology
    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
    K254153

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    Device Name
    Single-use Video Scope; PB Digital Controller
    Manufacturer
    Mirco-Tech (Nanjing) Co., Ltd.
    Date Cleared
    2026-04-03

    (102 days)

    Product Code
    FBN
    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
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    K Number
    K260720

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    Device Name
    mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);
    Manufacturer
    MED-EL Elektromedizinische Geräte GmbH
    Date Cleared
    2026-04-03

    (29 days)

    Product Code
    ETB
    Regulation Number
    874.3450
    Type
    Special
    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
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    K Number
    K260718

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    Device Name
    mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)
    Manufacturer
    MED-EL Elektromedizinische Geräte GmbH
    Date Cleared
    2026-04-03

    (29 days)

    Product Code
    ETB
    Regulation Number
    874.3450
    Type
    Special
    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
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    K Number
    K260719

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    Device Name
    mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50
    Manufacturer
    MED-EL Elektromedizinische Geräte GmbH
    Date Cleared
    2026-04-03

    (29 days)

    Product Code
    ETA
    Regulation Number
    874.3495
    Type
    Special
    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
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    K Number
    K252198

    Validate with FDA (Live)

    Device Name
    Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
    Manufacturer
    Medical Brands Laboratories B.V.
    Date Cleared
    2026-04-02

    (262 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    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
    K250518

    Validate with FDA (Live)

    Device Name
    SMART M-CELL Bone Marrow Concentration System
    Manufacturer
    Miracell Co., Ltd.
    Date Cleared
    2026-04-02

    (405 days)

    Product Code
    QBV
    Regulation Number
    862.2050
    Type
    Traditional
    Panel
    Hematology
    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
    K250516

    Validate with FDA (Live)

    Device Name
    SMART M-CELL PRP Concentration System
    Manufacturer
    Miracell Co., Ltd.
    Date Cleared
    2026-04-02

    (405 days)

    Product Code
    QBV
    Regulation Number
    862.2050
    Type
    Traditional
    Panel
    Hematology
    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
    K253029

    Validate with FDA (Live)

    Device Name
    RW-1
    Manufacturer
    Mediott, Inc.
    Date Cleared
    2026-03-31

    (193 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
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    K Number
    K252158

    Validate with FDA (Live)

    Device Name
    Sagami Original 002 Polyurethane Male Condom
    Manufacturer
    Mayer Laboratories
    Date Cleared
    2026-03-30

    (264 days)

    Product Code
    MOL
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    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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