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510(k) Data Aggregation

    K Number
    K990323
    Device Name
    TE ME NA POLYSTIM NERVE STIMILATOR
    Manufacturer
    TE ME NA S.A.R.L.
    Date Cleared
    2001-09-28

    (969 days)

    Product Code
    BXN
    Regulation Number
    868.2775
    Why did this record match?
    Applicant Name (Manufacturer) :

    TE ME NA S.A.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOR NEAVE STIMULATION AND TOENTIFICATION FOR 26616 WAL ANESTHESIA
    Device Description
    Not Found
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    K Number
    K002405
    Device Name
    SPINAL EPIDURAL NEEDLES
    Manufacturer
    TE ME NA S.A.R.L.
    Date Cleared
    2001-06-01

    (298 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    TE ME NA S.A.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K991259
    Device Name
    TE ME NA EPIDURAL CATHETER
    Manufacturer
    TE ME NA S.A.R.L.
    Date Cleared
    2001-02-21

    (680 days)

    Product Code
    BSO
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TE ME NA S.A.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Te me na Polymedic Epidural Anesthesia Catheter is intended for administration of local anesthetic and/or analgesic solutions into the epidural or Caudal space for up to 72 hours.
    Device Description
    Not Found
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    K Number
    K990100
    Device Name
    POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
    Manufacturer
    TE ME NA S.A.R.L.
    Date Cleared
    2000-08-02

    (576 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    TE ME NA S.A.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Polymedic UPA and UPC Nerve Stimulator Needles, and the Polyplex N and Polyplex C Nerve Stimulation needle kits are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves (when used with a nerve stimulator) and administration of anesthesia drugs.
    Device Description
    Polymedic UPA, UPC, Polyplex N, and Polyplex C Nerve Stimulation Needles
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    K Number
    K990020
    Device Name
    TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
    Manufacturer
    TE ME NA S.A.R.L.
    Date Cleared
    1999-06-24

    (171 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TE ME NA S.A.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THE LOSS OF RESISTANCE SYRINGE IS INTENDED TO BE USED FOR THE DETECTION AND CONFIRMATION OF THE PLACEMENT OF THE EPIDURAL NEEDLE INTO THE EPIDURAL SPACE PRIOR TO EPIDURAL ANESTHESIA. THIS SYRINGE IS INTENDED FOR THE LOSS OF RESISTANCE TECHNIQUE ONLY. IT IS NOT INTENDED FOR ASPIRATION OR INJECTION.
    Device Description
    Not Found
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