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510(k) Data Aggregation

    K Number
    K033293
    Device Name
    MED-LOGICS, MODEL ML7090
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    2004-01-13

    (91 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MED-LOGICS ML7090 microkeratome blades are to be used, as replacement blades for the AMO Amadeus TM Microkeratome, to perform lamellar keratectomy procedures.
    Device Description
    Microkeratome Blade
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    K Number
    K022982
    Device Name
    MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    2002-11-15

    (67 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Med-Logics 7050CLB microkeratome blades are to be used, as replacement blades for the Moria M2™ microkeratome, to perform lamellar keratectomy procedures.
    Device Description
    Microkeratome Blade
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    K Number
    K022716
    Device Name
    MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    2002-10-11

    (57 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Med-Logics 7020CLB microkeratome blades are to be used as replacement blades for the Moria C-B™ microkeratome.
    Device Description
    Microkeratome Blade
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    K Number
    K010872
    Device Name
    ML BLADE, MODEL ML7030
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    2001-06-22

    (91 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K010353
    Device Name
    MED-LOGICS DISPOSABLE ALK TUBING
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    2001-04-27

    (80 days)

    Product Code
    KYG
    Regulation Number
    886.4360
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002515
    Device Name
    MEDLOGICS ML 4000, MODEL 4000
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    2001-02-22

    (191 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002279
    Device Name
    ML EYE SPEAR, MODEL ML 27 ES
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    2000-08-18

    (23 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K983448
    Device Name
    ML UNIVERSAL TUBING
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    1998-12-18

    (79 days)

    Product Code
    MSR
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Irrigation and Aspiration of fluids during Ophthalmic phacoemulsification procedures.
    Device Description
    Med-Logics, Inc., Administration Set (UT 3004) Med-Logics, Inc., Drainage Bag (UT 3002) Med-Logics, Inc., Universal Tubing Set (UT 3000)
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    K Number
    K981071
    Device Name
    ML MICROKERATOME
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    1998-07-23

    (121 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ML Microkeratome is used to perform lamellar keratoplasty procedures. This procedure is no I he ML MICrokeratome is used to perform athin circular corneal cap.
    Device Description
    Not Found
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    K Number
    K972522
    Device Name
    ML-DISPOSABLE PAK
    Manufacturer
    MED-LOGICS, INC.
    Date Cleared
    1997-09-30

    (85 days)

    Product Code
    MSR
    Regulation Number
    886.4150
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED-LOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in cataract surgery to irrigate and aspirate cataract material.
    Device Description
    Not Found
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