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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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leo iii tx/rx quadrature knee coil; alpha iii tx/rx quadrature wrist coil USA INSTRUMENTS, INC. k023982 02/21/2003
unicryl m UNITED MEDICAL INDUSTRIES CO. LTD. k042285 12/10/2004
xact.cardiac & xpress.cardiac ULTRASPECT LTD. k050815 04/26/2005
tangors polyaxial system ULRICH GMBH & CO. KG k052385 12/27/2005
g4, model igm-0004 U. S. DIAGNOSTICS, INC. k051651 04/14/2006
3.8mm cs facet compression device TRIAGE MEDICAL, INC. k052043 10/17/2005
trans1 facet screws TRANS1 INCORPORATED k051856 09/26/2005
3d angiographic imaging system, model xidf-100a TOSHIBA AMERICA MEDICAL SYSTEMS, INC. k002424 10/27/2000
topez total ankle replacement TOPEZ ORTHOPEDICS, INC k051023 11/15/2005
myotrac infiniti electrical stimulator THOUGHT TECHNOLOGY LTD. k053434 03/15/2006

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