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U.S. Department of Health and Human Services

510(K) Premarket Notification
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flonavi endoscopic fluorescence imaging system Guangdong OptoMedic Technologies, Inc. k221861 02/18/2023
preview-iii™ anterior cervical plate system Nexus Spine, LLC k223627 02/02/2023
accuryn monitoring system, accuryn smartfoley iap uo temp tray system 12 f, accuryn smartfoley iap uo temp tray system 14 f Potrero Medical, Inc. k221020 01/13/2023
silentcloud Aureliym GmBH k221125 01/04/2023
well-life probe electrode for stimulation/emg probe (model: sa), well-life incontinence stimulation/emg electrode probe, well-life probe electrode Well-Life Healthcare Limited k222528 12/29/2022
pulse oximeter (uc-200, uc-201, uc-202, uc-203, uc-204, uc-100, uc-101, uc-102, uc-103, uc-104) Unimed Medical Supplies, Inc. k222213 12/19/2022
disposable hemoclip Beijing ZKSK Technology Co.,Ltd k213217 11/14/2022
vortex surgical laser probes, vortex surgical illuminated laser probes, vortex surgical endoilluminators, vortex surgical chandeliers Vortex Surgical Inc k220263 11/03/2022
disposable medical rubber examination gloves (xs/s/m/l/xl) Hebei Titans Hongsen Medical Technology Co., Ltd. k221374 10/26/2022
tera harz denture Graphy Inc. k222414 08/11/2022

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