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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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dimension lithium (li) flex reagent cartridge, model df 132 Dade Behring, Inc. k011033 06/07/2001
trapease permanent vena cava filter and introduction kit, model 466-p306a Cordis Corp. k010083 06/06/2001
uss-line extension Synthes k010108 06/06/2001
modification to tsrh spinal system Medtronic Sofamor Danek, Inc. k011029 06/05/2001
denver pleural effusion shunt with external pump chamber Denver Biomedicals, Inc. k011020 06/01/2001
fortaflex surgical sling Organogenesis, Inc. k011027 05/30/2001
screw-vent dental implant system Sulzer Dental, Inc. k011028 05/21/2001
gem posterior stabilized total knee system Kinamed, Inc. k010101 05/17/2001
rd-3008 Heraeus Kulzer, Inc. k011036 05/10/2001
white mta material Dentsply International k011009 05/02/2001

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