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    K Number
    K243427
    Device Name
    QuickSleeper 5
    Manufacturer
    Dentalhitec
    Date Cleared
    2025-08-01

    (269 days)

    Product Code
    EGM
    Regulation Number
    872.4475
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dentalhitec

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243462
    Device Name
    Diazyme Colorimetric Lithium Assay
    Manufacturer
    Diazyme Laboratories, Inc.
    Date Cleared
    2025-08-01

    (266 days)

    Product Code
    NDW
    Regulation Number
    862.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diazyme Laboratories, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243496
    Device Name
    MycoMEIA Aspergillus Assay
    Manufacturer
    Pearl Diagnostics, Inc.
    Date Cleared
    2025-08-01

    (262 days)

    Product Code
    NOM
    Regulation Number
    866.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pearl Diagnostics, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243841
    Device Name
    Sparta Infusion Set for Insulin
    Manufacturer
    DEKA Research and Development
    Date Cleared
    2025-08-01

    (231 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEKA Research anD Development

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250381
    Device Name
    Deepsight NeedleVue LC1 Ultrasound System
    Manufacturer
    DeepSight Technology, Inc.
    Date Cleared
    2025-08-01

    (171 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    DeepSight Technology, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250541
    Device Name
    Self-Forming Magnet (Flexagon Plus OTOLoc)
    Manufacturer
    GI Windows, Inc.
    Date Cleared
    2025-08-01

    (158 days)

    Product Code
    SAH
    Regulation Number
    878.4816
    Why did this record match?
    Applicant Name (Manufacturer) :

    GI Windows, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250790
    Device Name
    INNOVISION-DXII
    Manufacturer
    DK MEDICAL SYSTEMS Co., Ltd
    Date Cleared
    2025-08-01

    (140 days)

    Product Code
    KPR
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    DK MEDICAL SYSTEMS Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250941
    Device Name
    Revolution Vibe
    Manufacturer
    GE Medical Systems, LLC
    Date Cleared
    2025-08-01

    (126 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical Systems, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251252
    Device Name
    NOBILCAM IMPAK Disc
    Manufacturer
    Shandong Huge Dental Material Corporation
    Date Cleared
    2025-08-01

    (100 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Huge dental Material Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251652
    Device Name
    Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo
    Manufacturer
    American Medical Endoscopy, Inc. (DBA Strauss Surgical)
    Date Cleared
    2025-08-01

    (64 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    American Medical Endoscopy, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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