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U.S. Department of Health and Human Services

510(K) Premarket Notification
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corelite x-ray specimen cabinet Cirdan Imaging Limited k193317 12/13/2019
benevision central monitoring system Shenzhen Mindray Bio-medical Electronics Co., LTD. k193391 05/21/2020
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
steris patient warming system STERIS Corporation k200446 06/13/2020
echonavigator Philips Medical Systems Nederland B.V. k200713 04/09/2020
spy portable handheld imaging (spy-phi) system Novadaq Technologies ULC. (now a part of Stryker) k200737 05/21/2020
fora advanced gd40 glucose, ß-ketone and cholesterol monitoring system TaiDoc Technology Corporation k201037 06/16/2022
ilab polaris multi-modality guidance system Boston Scientific k201178 05/29/2020
li-battery powered otc tens/ems combination stimulator Everyway Medical Instruments Co., Ltd k201335 10/24/2020
panda ires warmer, giraffe warmer GE Healthcare k201628 02/12/2021

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