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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
    K260041

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    Device Name
    MDx-Chex for BCP
    Manufacturer
    Streck, LLC
    Date Cleared
    2026-03-27

    (80 days)

    Product Code
    PMN
    Regulation Number
    866.3920
    Type
    Traditional
    Panel
    Microbiology
    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
    K254099

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    Device Name
    EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System
    Manufacturer
    Samsung Medison Co., Ltd.
    Date Cleared
    2026-03-27

    (98 days)

    Product Code
    IYN,ITX,IYO,LLZ
    Regulation Number
    892.1550
    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
    K253392

    Validate with FDA (Live)

    Device Name
    Synergy Disc Instruments
    Manufacturer
    Synergy Spine Solutions, Inc.
    Date Cleared
    2026-03-27

    (178 days)

    Product Code
    QLQ
    Regulation Number
    888.4515
    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
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    K Number
    K254239

    Validate with FDA (Live)

    Device Name
    CyClean Cord
    Manufacturer
    SS GLOBAL
    Date Cleared
    2026-03-27

    (88 days)

    Product Code
    MVL
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    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
    K260294

    Validate with FDA (Live)

    Device Name
    SF Push-in Anchor
    Manufacturer
    Surgical Fusion Technologies GmbH
    Date Cleared
    2026-03-27

    (57 days)

    Product Code
    MAI,GAT,HTY
    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
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    K Number
    K253627

    Validate with FDA (Live)

    Device Name
    Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)
    Manufacturer
    Surgify Medical OY
    Date Cleared
    2026-03-26

    (127 days)

    Product Code
    HBE
    Regulation Number
    882.4310
    Type
    Traditional
    Panel
    Neurology
    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
    K260273

    Validate with FDA (Live)

    Device Name
    Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
    Manufacturer
    Shenzhen Urion Technology Co., Ltd.
    Date Cleared
    2026-03-26

    (56 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    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
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    K Number
    K254278

    Validate with FDA (Live)

    Device Name
    Arterial Pressure Monitoring Set/Tray
    Manufacturer
    Spectrum Vascular
    Date Cleared
    2026-03-25

    (85 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Special
    Panel
    Cardiovascular
    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
    K252432

    Validate with FDA (Live)

    Device Name
    Flex-Z™ Cervical Cage
    Manufacturer
    Spinepoint, LLC
    Date Cleared
    2026-03-25

    (236 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    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
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