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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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blue powder free nitrile examination glove with grape scented, chemotherapy drugs and fentanyl test claim Riverstone Resources Sdn Bhd k220672 06/03/2022
kyphon vue bone cement Tecres S.P.A. k220131 04/18/2022
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
ortho aligner system Ortho Lab Services, LLC k212496 11/04/2021
nitrile examination gloves Niujian Technology Co., Ltd. k210706 10/19/2021
disposable nitrile examination gloves Shenzhen Shiqiao Science and Technology Co., Ltd. k211264 07/30/2021
transpara 1.7.0 Screenpoint Medical B.V. k210404 06/02/2021
yuwell infrared ear thermometer: yht101, yht200 Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. k203583 05/20/2021
system 1e liquid chemical sterilant processing system, system 1 endo liquid chemical sterilant processing system, model p6800, system 1 endo liquid chemical sterilant processing system, model p6900, s40 sterilant concentrate Steris Corporation k210737 05/12/2021
surgical face mask Hunan Eexi Technology & Service Co., Ltd. k202161 03/10/2021

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