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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
Number
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Decision
Date
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taper oxinium femoral head SMITH & NEPHEW, INC. k110101 04/11/2011
journey ii unicompartmental knee system Smith & Nephew, Inc. k191211 07/25/2019
hotline 2 fluid warmer SIMS LEVEL 1, INC. k001764 08/09/2000
roccia® plif Silony Medical GmbH k181899 12/13/2018
procedure #430 & reagents for acetamin SIGMA CHEMICAL CO. k822313 08/24/1982
syngo dual energy with extended functionally SIEMENS MEDICAL SOLUTIONS, INC. k073003 02/07/2008
v5ms transducer SIEMENS MEDICAL SOLUTIONS USA, INC. k121807 07/10/2012
syngo application software SIEMENS MEDICAL SOLUTION USA, INC. k163285 02/14/2017
sysmex automated blood coagulation analyzer cs-2100i SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH k161312 09/01/2016
dimension vista loci ca 15-3 flex reagent cartridge, dimension vista loci 7 calibrator, models: k6456 and kc605 SIEMENS HEALTHCARE DIAGNOSTICS k100344 04/18/2011

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