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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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yuwell infrared ear thermometer: yht101, yht200 Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. k203583 05/20/2021
transpara 1.7.0 Screenpoint Medical B.V. k210404 06/02/2021
disposable nitrile examination gloves Shenzhen Shiqiao Science and Technology Co., Ltd. k211264 07/30/2021
nitrile examination gloves Niujian Technology Co., Ltd. k210706 10/19/2021
ortho aligner system Ortho Lab Services, LLC k212496 11/04/2021
midas rex mr8 depth stop attachment, midas rex mr8 depth stop tool 2.4mm, midas rex mr8 depth stop tool 3.2mm, midas rex mr8 depth stop tool 3.2mm long, midas rex mr8 depth stop tool 7.5mm Medtronic Powered Surgical Solutions k213454 11/23/2021
kyphon vue bone cement Tecres S.P.A. k220131 04/18/2022
blue powder free nitrile examination glove with grape scented, chemotherapy drugs and fentanyl test claim Riverstone Resources Sdn Bhd k220672 06/03/2022
ultrasonic scalpel system Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. k212614 07/18/2022
ipl sapphire ice cooling hair remove device Shenzhen Desida Technology Co., Ltd. k221635 08/31/2022

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