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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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intracept intraosseous nerve ablation system (rf probe), intracept intraosseous nerve ablation system (access instruments), relievant rf generator Relievant Medsystems k190504 05/03/2019
axs vecta aspiration catheter Stryker Neurovascular k190833 12/15/2019
pulse oximeter Shenzhen Aeon Technology Co., Ltd. k190869 09/13/2019
retractable safety syringe, retractable safety insulin syringe, retractable safety tuberculin syringe, retractable safety allergy syringe Jiangsu Caina Medical Co., Ltd. k191490 10/03/2019
gabriel feeding tube with balloon, and enfit connector Syncro Medical Innovations, Inc. k191784 11/15/2019
compact intuitiv system, compact intuitiv wireless remote control, compact intuitiv four-button foot pedal, compact intuitiv closed-toe foot pedal Johnson & Johnson Surgical Vision, Inc. k191933 08/16/2019
optomonitor Opsens Inc k192340 12/12/2019
aneroid sphygmomanometer with stethoscope, aneroid sphygmomanometer Honsun(Nantong)Co.,Ltd k192500 04/06/2020
sperm freeze, sperm fridge Kitazato Corporation k192845 08/17/2020
r&d series nova compo-b plus bottle, r&d series nova compo-b plus single dose Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. k192913 01/19/2021

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