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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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r&d series nova compo-b plus bottle, r&d series nova compo-b plus single dose Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. k192913 01/19/2021
surgical mask Jiangsu Medpure Biological Technology Co., Ltd. k202640 01/22/2021
panda ires warmer, giraffe warmer GE Healthcare k201628 02/12/2021
catalyst orthoscience r1 reverse shoulder system Catalyst OrthoScience, Inc. k202611 02/12/2021
itotal identity cruciate retaining (cr) knee replacement system, itotal identity posterior stabilizing (ps) knee replacement system Conformis Inc. k210252 02/17/2021
classic Orthoapnea S.L. k203477 02/25/2021
unimed co2 mainstream module model capno-m, unimed co2 mainstream module model capno-m+ Unimed Medical Supplies, Inc. k210019 03/04/2021
adaptable ortho innovations intramedullary nail system Adaptable Ortho Innovations, LLC k210285 03/18/2021
spacelabs lifescreen pro analyzer Spacelabs Healthcare Ltd. k201921 03/26/2021
briefcase, rib fractures triage (ribfx) Aidoc Medical, Ltd. k202992 04/14/2021

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