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510(k) Data Aggregation

    K Number
    K033153
    Device Name
    DICOM THEATER
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    2004-04-23

    (206 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DICOM Theater device is Intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
    Device Description
    The DICOM Theater device is a digital image display system. The DICOM Theater consists of components to provide high resolution visualization of digital images.
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    K Number
    K962615
    Device Name
    TUMORLOCALIZER MRI
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1998-03-19

    (624 days)

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

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use to identify by standard radiologic mark or techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.
    Device Description
    The TumorLocalizer MRI is a standard needle and hookwire device used for the localization of non-palpable lesions.
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    K Number
    K963794
    Device Name
    PUNCTURENEEDLE
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1998-03-19

    (545 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PunctureNeedle device is intended for use in puncturing precise anatomical locations (including but not limited to cysts, lesions, fluid spaces, etc.) and aspirating or injecting various fluids or contents. The device may be utilized under MRI guidance.
    Device Description
    The PunctureNeedle is a standard needle to puncture precise anatomical locations and inject or aspirate various fluids or contents. The proposed device is different than many needles in that the PunctureNeedle device has components manufactured of titanium alloy, which yields less artifact than stainless steel when utilized under magnetic resonance conditions.
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    K Number
    K971813
    Device Name
    EMBLA
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1998-01-16

    (245 days)

    Product Code
    OLV
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Embla is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where patients require documentation of various sleep or other physiological disorders.
    Device Description
    The device is an EEG and physiological signs recorder. Embla is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to EEG and other physicians. The device will be used in hospitals, institutions, sleep centers used in hospitals, institutions, environments where of various or clinics, of ocure documentation patients require doodaologic disorders. The Embla device is a totally digital recorder utilizing 16 channels of input Gata. The device is available in ambulatory as well as desktop configurations.
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    K Number
    K972217
    Device Name
    ORTHOPEDIC SCREW SYSTEM
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-11-20

    (161 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.
    Device Description
    The device is an assortment of various sizes and configurations of stainless steel bone screws.
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    K Number
    K972219
    Device Name
    ORTHOPEDIC PLATE SYSTEM
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-11-20

    (161 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to be implanted for use in the fixation of long bone fractures and for long bone reconstructions.
    Device Description
    The device is an assortment of various sizes and configurations of stainless steel bone plates.
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    K Number
    K970819
    Device Name
    TARGOBEAM
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-07-14

    (131 days)

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

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TarqoBeam is an aiming device intended to be used to verify and control correct angulation of interventional -----devices such as needles used in CT- or MRI-quided punctures, biopsies, and related procedures.
    Device Description
    The TargoBeam is an aiming device which utilizes lasers to precisely place the correct angulation and position on interventional device such as a biopsy an needle.
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    K Number
    K970257
    Device Name
    FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-05-22

    (119 days)

    Product Code
    HSB, HRS
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use in the fixation of subtrochanteric fractures.
    Device Description
    The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Sub-Trochanterian Fractures is an implantable device be used in orthopedic trauma to procedures.
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    K Number
    K970258
    Device Name
    FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-05-22

    (119 days)

    Product Code
    HRS, HSB
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use in the fixation of unstable femoral neck fractures.
    Device Description
    The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures is an implantable device to be used in orthopedic trauma procedures. The D.S.S. System For Osteosynthesis of Unstable Femoral Neck Fractures is a hip screw mechanism that allows a natural, weight-bearing compression. The D.S.S. screws can be utilized alone, or in combination with a mini-plate, allowing most flexibility in configurations of osteosynthesis in unstable femoral neck fractures.
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    K Number
    K970280
    Device Name
    FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    1997-05-22

    (119 days)

    Product Code
    HSB, HRS
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    FERGUSON MEDICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is indicated for use in the fixation of pertrochanteric fractures.
    Device Description
    The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Per-Trochanterian Fractures is an implantable orthopedic trauma device to be used in procedures.
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