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510(k) Data Aggregation

    K Number
    K072644
    Device Name
    UNICRYL QUICK
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2007-11-07

    (50 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K072645
    Device Name
    UNIGLACTIN
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2007-11-07

    (50 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K072646
    Device Name
    UNICAPRONE
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2007-11-07

    (50 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K042287
    Device Name
    UNIPLAIN & UNICHROM
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2005-09-07

    (379 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniPlain & UniChrom are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.
    Device Description
    Not Found
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    K Number
    K042288
    Device Name
    UNICRYL
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-27

    (125 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniCryl is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.
    Device Description
    Not Found
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    K Number
    K042285
    Device Name
    UNICRYL M
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-10

    (108 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniCryl M is indicated for use in general soft tissue approximation and/or ligation, including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery but not for use in cardiovascular, neurological procedures, or microsurgery.
    Device Description
    Not Found
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    K Number
    K042284
    Device Name
    UNIMIDE
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-03

    (101 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniMide is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Not Found
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    K Number
    K042282
    Device Name
    UNISILK
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-01

    (99 days)

    Product Code
    GAP
    Regulation Number
    878.5030
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniSilk is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Not Found
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    K Number
    K042283
    Device Name
    UNIPRO
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-01

    (99 days)

    Product Code
    GAW
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniPro is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Nonabsorbable ploypropylene surgical suture
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    K Number
    K042286
    Device Name
    UNIESTER C
    Manufacturer
    UNITED MEDICAL INDUSTRIES CO. LTD.
    Date Cleared
    2004-12-01

    (99 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED MEDICAL INDUSTRIES CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UniEster C is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurological cardiovascular, procedures.
    Device Description
    Not Found
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