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U.S. Department of Health and Human Services

510(K) Premarket Notification

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msk-impact (integrated mutation profiling of actionable cancer targets):a hybridization-capture based next generation sequencing assay Memorial Sloan-Kettering Cancer Center den170058 11/15/2017
zenition 90 Philips Medical Systems Nederlands B.V. k240224 05/22/2024
planar led mate Shenzhen Leaflife Technology Co., Ltd k230362 09/11/2023
m9/m9cv/m9t/m8 elite/m10/m10cv/crius m10/m11/m11cv/crius m11/operus m11/m9 premium diagnostic ultrasound system Shenzhen Mindray Bio-Medical Electronics Co.,LTD k230768 06/09/2023
deep learning image reconstruction GE Healthcare Japan Corporation k230807 04/20/2023
single-use latex sterile surgical gloves (sg100) Fitone Latex Products Co., Ltd. Guangdong k231446 09/22/2023
5008x hemodialysis system Fresenius Medical Care k231534 02/02/2024
xo cath microcatheter (e20-090-s, e20-110-s, e20-130-s, e20-150-s, e20-175-s, e20-220-s, e20-090-b, e20-110-b, e20-130-b, e20-150-b, e20-175-b, e20-220-b, e26-090-s, e26-110-s, e26-130-s, e26-150-s, e26-175-s, e26-220-s, e26-090-b, e26-110-b, e26-130-b, e26-150-b, e26-175-b, e26-220-b,) Transit Scientific, LLC k231821 11/29/2023
uc-1800 automatic urine analyzer, urit 11fa urine reagent strips, urit 12fa urine reagent strips URIT Medical Electronic Co., Ltd. k232317 04/26/2024
airkee t900 HealKEE Medical Pte Ltd k232642 05/23/2024

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