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U.S. Department of Health and Human Services

510(k) Premarket Notification

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31 to 40 of 500 Results *
Decision Date To: 07/23/2019
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510(K)
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mountaineer oct spinal system, summit si oct spinal fixation system, symphony oct system, summit fixation system Medos International Sarl K190895 07/18/2019
ziacom dental implant systems Ziacom Medical SL K182908 07/18/2019
montage-qs settable, resorbable hemostatic bone Orthocon, Inc. K191140 07/18/2019
spar-k instruments (for use with gemini sl total knee system) Waldemar Link GmbH & Co. KG K191755 07/18/2019
immucise Terumo Corporation K190427 07/18/2019
peralta stone removal catheter Calcula Technologies, Inc K190492 07/18/2019
ortholoc™ sps shoulder plating system Tornier Inc. K191711 07/17/2019
silent nite sl Prismatik Dentalcraft, Inc. K183270 07/17/2019
pegasus system A.M. Surgical, Inc. K191345 07/17/2019
advia centaur zika test, advia centaur zika ab (100 tests), advia centaur zika igm (50 tests), advia centaur zika ab quality control, advia centaur zika igm quality control Siemens Healthcare Diagnostics Inc. K191578 07/17/2019

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