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    K Number
    K251913
    Device Name
    OsteoCentric® UnifiMI® TCS Plating System
    Manufacturer
    OsteoCentric Technologies
    Date Cleared
    2025-08-16

    (54 days)

    Product Code
    HRS
    Regulation Number
    888.3030
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    Applicant Name (Manufacturer) :

    OsteoCentri**c **Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    Device Description
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    K Number
    K251972
    Device Name
    Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
    Manufacturer
    Healgen Scientific LLC
    Date Cleared
    2025-08-15

    (50 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Healgen Scientifi**c **LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K252236
    Device Name
    CP Relief Wand Rx - TENS/NMES
    Manufacturer
    N & C Holdings, LLC
    Date Cleared
    2025-08-15

    (29 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    N & **C **Holdings, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
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    K Number
    K251327
    Device Name
    XERF
    Manufacturer
    Lutronic Corporation
    Date Cleared
    2025-08-11

    (103 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lutroni**c **Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
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    K Number
    K252211
    Device Name
    Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
    Manufacturer
    CnC Technologies
    Date Cleared
    2025-08-11

    (27 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cn**C **Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K243395
    Device Name
    MICOR 700 with Auto I/A
    Manufacturer
    Carl Zeiss Meditec Cataract Technology Inc.
    Date Cleared
    2025-08-08

    (281 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carl Zeiss Medite**c **Cataract Technology Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K243765
    Device Name
    LuMon(TM) System
    Manufacturer
    Sentec AG
    Date Cleared
    2025-08-07

    (244 days)

    Product Code
    QEB
    Regulation Number
    868.1505
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sente**c **AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K251247
    Device Name
    GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
    Manufacturer
    Boston Scientific Neuromodulation Corporation
    Date Cleared
    2025-08-07

    (106 days)

    Product Code
    GXD
    Regulation Number
    882.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Boston Scientifi**c **Neuromodulation Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    K Number
    K250950
    Device Name
    CUTIVA™ Topical Skin Adhesive (RM1700); CUTIVA™ PLUS Skin Closure System (RM1739)
    Manufacturer
    Okapi Medical LLC dba Resivant Medical
    Date Cleared
    2025-08-04

    (129 days)

    Product Code
    MPN
    Regulation Number
    878.4010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Okapi Medical LL**C **dba Resivant Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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    Device Description
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    K Number
    K252094
    Device Name
    eZSURE™ Empty Fluid Container
    Manufacturer
    Epic Medical Pte. Ltd.
    Date Cleared
    2025-08-01

    (29 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    Epi**c **Medical Pte

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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