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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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modification to tsrh spinal system Medtronic Sofamor Danek, Inc. k011067 05/04/2001
modification to steathstation treatment guidance platform Medtronic Surgical Navigation k001153 05/03/2000
modification to nc-stat Neurometrix, Inc. k000565 06/27/2000
modification to isobar spinal system Encore Orthopedics, Inc. k000020 02/03/2000
modification to envoy patient monitor Mennen Medical , Ltd. k000563 05/17/2000
model k7 evaluation device Myotronics-Noromed, Inc. k003287 11/06/2000
model a-8000 ultrasonic handpiece cord Advanced Medical Technology, Inc. k862777 08/11/1986
model 4815 adapter Pace Medical k002496 10/10/2000
model 4810 analyzer output adapter Pace Medical k002497 10/10/2000
model 455ge phased array wrist coil Medical Advances, Inc. k010074 04/03/2001

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.
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