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U.S. Department of Health and Human Services

510(K) Premarket Notification
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conformity stem, cemented United Orthopedic Corporation k191056 01/03/2020
dental electrical motor iroot pro ChangZhou BoMedent Medical Technology Co., Ltd. k191276 06/30/2020
intellijoint® navigation system Intellijoint Surgical Inc. k191507 10/01/2019
infrared forehead thermometer (model ir-ft) Comper Chuangxiang (Beijing) Technology Co., Ltd. k191668 10/18/2019
faico dental implant system FAICO Medical LLC k192015 04/03/2020
dental glass ceramics blocks Aidite (Qinhuangdao) Technology Co., Ltd. k192231 07/08/2020
epic 980 Biolase, Inc. k192430 12/04/2019
acclarix ax8 diagnostic ultrasound system / acclarix lx9 series diagnostic ultrasound system Edan Instruments, Inc k192879 05/21/2020
puritan bennett 980 series ventilator system Covidien, LLC k193056 11/20/2020
snugkap HeadStart, Ltd. k193383 06/07/2021

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