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U.S. Department of Health and Human Services

510(K) Premarket Notification
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stratafix symmetric pds plus knotless tissue control devices, stratafix spiral pds plus knotless tissue control devices, stratafix spiral monocryl plus knotless tissue control devices, stratafix spiral monocryl knotless tissue control devices Ethicon, Inc. k182873 01/10/2019
zimmer segmental system proximal femoral component Zimmer, Inc. k183136 01/30/2019
flexible sensor-ureterorenoscopes boa vision ef, flexible sensor-ureterorenoscopes cobra vision ef Richard Wolf Medical Instruments Corporation k183188 05/03/2019
vanguard complete knee system Zimmer Inc. k183583 05/10/2019
phasix st mesh with open positioning system C.R. Bard, Inc. k190185 06/12/2019
klassic knee system - sombrero patella with standard poly, klassic knee system - sombrero patella with e-link poly Total Joint Orthopedics, Inc. k190280 03/15/2019
marigen wound extra Kerecis Limited k190528 07/10/2019
e240ag lcd monitor, e240a lcd monitor, jusha-e240ag lcd monitor, jujsha-e240a lcd monitor, c230a lcd monitor, jusha-c230a lcd monitor, c230m lcd monitor, jusha-c230m lcd monitor Nanjing Jusha Display Technology Co., Ltd k190831 05/31/2019
xvision spine system (xvs) Augmedics Ltd. k190929 12/20/2019
inclusive titanium abutments compatible with: dentsply implants astra tech implant system ev Prismatik Dentalcraft, Inc. k191222 08/05/2019

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