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U.S. Department of Health and Human Services

Premarket Approval - PMA
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Device Name
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Applicant
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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lens fresh(tm) lubricating & rewetting soln ADVANCED MEDICAL OPTICS, INC. N18020S019 12/02/1986
hydro marc lenses (hydrophilic) VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. N18033S013 12/15/1986
acuvue 2 colors brand (etafilcon a) contact lens with uv blocker VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. N18033S035 04/12/2001
vitek 2 gram negative ast for piperacillin BIOMERIEUX VITEK, INC. N50510S096 12/10/1999
vitex 2 gram negative ast for ampicillin/sulbactam BIOMERIEUX VITEK, INC. N50510S097 12/03/1999
vitek 2 gram negative ast for levofloxacin BIOMERIEUX VITEK, INC. N50510S098 11/05/1999
vitek 2 gram positive ast for benzylpenicillin BIOMERIEUX VITEK, INC. N50510S099 11/15/1999
oxycell BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC N5798S007 07/24/1995
ams 700 inflatable penile prosthesis Boston Scientific Corp. N970012S103 04/07/2015
keramos ceramic/ceramic total hip system DJO SURGICAL N980003S007 02/13/2009

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