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510(k) Data Aggregation

    K Number
    K252334

    Validate with FDA (Live)

    Device Name
    PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
    Manufacturer
    Pontemedag
    Date Cleared
    2026-04-17

    (263 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    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
    K252945

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    Device Name
    Novasight Hybrid System
    Manufacturer
    Conavi Medical, Inc.
    Date Cleared
    2026-04-17

    (214 days)

    Product Code
    OBJ,IYO,NQQ
    Regulation Number
    870.1200
    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
    K252237

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    Device Name
    EdgeFlow UW20
    Manufacturer
    Edgecare, Inc.
    Date Cleared
    2026-04-17

    (274 days)

    Product Code
    IYO,ITX,QIH
    Regulation Number
    892.1560
    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
    DEN250033

    Validate with FDA (Live)

    Device Name
    XplantR Explant Tool
    Manufacturer
    Hjarta Care, LLC
    Date Cleared
    2026-04-17

    (253 days)

    Product Code
    SHR
    Regulation Number
    N/A
    Type
    Direct
    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
    K260900

    Validate with FDA (Live)

    Device Name
    DYNEX® External Fixation Systems
    Manufacturer
    Vilex, LLC
    Date Cleared
    2026-04-17

    (30 days)

    Product Code
    KTT,JDW,PIN
    Regulation Number
    888.3030
    Type
    Special
    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
    K252279

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    Device Name
    Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
    Manufacturer
    Chirana T.Injecta,A.S.
    Date Cleared
    2026-04-17

    (269 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    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
    K252338

    Validate with FDA (Live)

    Device Name
    MySleepDash
    Manufacturer
    Somnetics International, Inc. (Dba Transcend Inc)
    Date Cleared
    2026-04-17

    (263 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    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
    K260696

    Validate with FDA (Live)

    Device Name
    MTS Gepotidacin 0.016-256 µg/mL
    Manufacturer
    Liofilchem s.r.l.
    Date Cleared
    2026-04-17

    (45 days)

    Product Code
    JWY
    Regulation Number
    866.1640
    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
    K254279

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    Device Name
    Edwards eSheath+ introducer set
    Manufacturer
    Edwards Lifesciences
    Date Cleared
    2026-04-17

    (108 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    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
    K260929

    Validate with FDA (Live)

    Device Name
    Neonav ECG Tip Location System
    Manufacturer
    Navi Medical Technologies
    Date Cleared
    2026-04-17

    (28 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    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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