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U.S. Department of Health and Human Services

510(K) Premarket Notification
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spy portable handheld imaging (spy-phi) system Novadaq Technologies ULC. (now a part of Stryker) k200737 05/21/2020
ilab polaris multi-modality guidance system Boston Scientific k201178 05/29/2020
steris patient warming system STERIS Corporation k200446 06/13/2020
sperm freeze, sperm fridge Kitazato Corporation k192845 08/17/2020
nuvasive thoracolumbar interbody systems: coroent thoracolumbar system, coroent xl interfixated system, brigade standalone system and brigade hyperlordotic system, brigade lateral system, base interfixated titanium system, coalesce thoracolumbar interbody fusion system, cohere thoracolumbar interbo NuVasive, Incorporated k201820 09/25/2020
coolseal generator/csl-200-50, coolseal trinity (30 cm shaft)/csl-tr105-30, coolseal trinity (37 cm shaft)/csl-tr105-37, coolseal trinity (44 cm shaft)/csl-tr105-44, coolseal mini (20cm shaft)/csl-mn103-20 Bolder Surgical, LLC k202114 10/06/2020
sequential culture media (fertilization medium [without hsa/rha, with hsa, with rha], cleavage medium [without hsa/rha, with hsa, with rha], blastocyst medium [without hsa/rha, with hsa, with rha]) Kitazato Corporation k200249 10/23/2020
li-battery powered otc tens/ems combination stimulator Everyway Medical Instruments Co., Ltd k201335 10/24/2020
disposable powered articulating endoscopic linear cutter stapler & reloads Fengh Medical Co., Ltd. k202467 12/14/2020
aidite pmma Aidite (Qinhuangdao) Technology Co., Ltd. k190217 12/17/2020

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