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U.S. Department of Health and Human Services

510(K) Premarket Notification
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pulse oximeter Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. k203854 04/23/2021
prolift lateral helo fixated Life Spine, Inc. k210061 04/30/2021
liteaire basic dual-valved, collapsible mdi holding chamber Thayer Medical Corporation k210558 04/01/2022
bencox mirabo z cup cortinium Corentec Co.,Ltd. k210614 05/24/2022
blue non sterile powder free nitrile examination gloves, tested for use with chemotherapy drugs, with gastric acid and fentanyl permeation resistance claims. Central Medicare Sdn Bhd k211022 12/22/2021
philips incisive ct on trailer Philips Healthcare (Suzhou) Co., Ltd. k211168 11/22/2021
khelix steerable electrophysiology catheters, khelix loop fixed electrophysiology catheters, khelix fixed loop steerable electrophysiology catheters, khelix variable loop steerable electrophysiology catheters CathRxLtd k211327 02/10/2022
ulab systems dental aligner kit uLab Systems, Inc. k211510 02/24/2022
latex surgical gloves, powder free with protein claim (50 micrograms or less) Careplus (M) SDN BHD k211621 10/06/2021
synecare 1100 deep vein thrombosis prevention therapy system Jiangsu Synecoun Medical Technology Co., Ltd. k211937 11/18/2021

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