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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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3i locater abutment system IMPLANT INNOVATIONS, INC. k012911 09/28/2001
bard utaverse small vessel pta balloon dilatation catheter C.R. BARD, INC. k012913 09/28/2001
sonicwave sonic plaque remover HOMEDICS, INC. k012914 10/01/2001
dinamap pro 1000 monitor, model 1000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES k012915 03/21/2002
frontier anterior scoliosis system DEPUY ACROMED, INC. k012916 11/27/2001
dynarex umbilical cord lamp, models 6833 and 6833-b DYNAREX CORP. k012917 11/28/2001
apex modular alumina femoral head APEX SURGICAL, LLC. k012918 11/27/2001
molded cranial helmet FAIRVIEW ORTHOPEDIC LABORATORY k012920 11/28/2001
sensititre haemophilus/streptococcus pneumoniae (hp) mic plate TREK DIAGNOSTIC SYSTEMS, INC. k012921 11/02/2001
ultraflex ev hemostasis introducer ST. JUDE MEDICAL k012922 09/25/2001

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