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U.S. Department of Health and Human Services

510(K) Premarket Notification
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reprocessed depuy mitek ablation wand ReNovo, Inc. k173740 03/19/2018
uws-mi Shanghai United Imaging Healthcare Co.,Ltd. k172998 04/05/2018
clottriever thrombectomy system Inari Medical, Inc. k180329 04/09/2018
polychloroprene powder free sterile surgical gloves, white, tested for use with chemotherapy Pt. Medisafe Technologies k173258 04/20/2018
infrared body thermometer HeTaiDa Technology Co., Ltd. k180385 05/11/2018
reusable and self-adhesive electrodes Shaoxing DongZhi Electrical Technology Co., Ltd. k180773 05/22/2018
shear wave quantificational ultrasound diagnostic system Wuxi Hisky Medical Technologies Co., Ltd. k173595 06/22/2018
kestrel™ buttress plate system Innovasis, Inc. k181063 07/13/2018
aplio a550 and a450, software v2.8 diagnostic ultrasound system Canon Medical Systems Corporation k182427 11/02/2018
sol-m blood collection needles, sol-care safety blood collection needles, sol-care safety blood collection needle with holders, sol-m blood collection set Sol-Millennium Medical, Inc. k182146 12/03/2018

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