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Found 19 results
510(k) Data Aggregation
K Number
K033153Device Name
DICOM THEATER
Manufacturer
FERGUSON MEDICAL
Date Cleared
2004-04-23
(206 days)
Product Code
LLZ
Regulation Number
892.2050Why 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
K962615Device Name
TUMORLOCALIZER MRI
Manufacturer
FERGUSON MEDICAL
Date Cleared
1998-03-19
(624 days)
Product Code
MIG
Regulation Number
N/AWhy 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
K963794Device Name
PUNCTURENEEDLE
Manufacturer
FERGUSON MEDICAL
Date Cleared
1998-03-19
(545 days)
Product Code
KNW
Regulation Number
876.1075Why 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
K971813Device Name
EMBLA
Manufacturer
FERGUSON MEDICAL
Date Cleared
1998-01-16
(245 days)
Product Code
OLV
Regulation Number
882.1400Why 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
K972217Device Name
ORTHOPEDIC SCREW SYSTEM
Manufacturer
FERGUSON MEDICAL
Date Cleared
1997-11-20
(161 days)
Product Code
HWC
Regulation Number
888.3040Why 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
K972219Device Name
ORTHOPEDIC PLATE SYSTEM
Manufacturer
FERGUSON MEDICAL
Date Cleared
1997-11-20
(161 days)
Product Code
HRS
Regulation Number
888.3030Why 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
K970819Device Name
TARGOBEAM
Manufacturer
FERGUSON MEDICAL
Date Cleared
1997-07-14
(131 days)
Product Code
JAK
Regulation Number
892.1750Why 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
K970257Device 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
888.3020Why 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
K970258Device 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
888.3030Why 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
K970280Device 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
888.3020Why 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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