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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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pregsense Nuvo-Group Ltd. k191401 03/27/2020
nebula brand locking bone plates and screws osteosynthesis plating system, nebula brand of dhs plating system Nebula Surgical Private Limited k191793 12/09/2019
flexband plus International Life Sciences k192112 09/27/2019
aegis anterior lumbar plate system, alc dynamized fixation system, anterior isola spine system, bowti anterior buttress staple spinal system, discovery screw system, expedium anterior spine system, frontier anterior scoliosis system, kaneda anterior scoliosis system, kaneda sr anterior spinal syste Medos International SARL k192281 11/20/2019
nuvasive modulus xlif interbody system NuVasive, Incorporated k192760 10/18/2019
patient monitor Shenzhen Mindray Bio-medical Electronics Co., LTD. k192972 05/07/2020
uai easytriage-rib Shanghai United Imaging Intelligence Co., Ltd. k193271 01/15/2021
disposable powder free nitrile examination glove, blue color, tested for use with chemotherapy drugs and fentanyl citrate Ever Global (Vietnam) Enterprise Corp k193555 06/04/2020
verasense for zimmer biomet persona cr c-d/3-9 left, verasense for zimmer biomet persona cr c-d/3-9 right, verasense for zimmer biomet persona cr e-f/3-11 left, verasense for zimmer biomet persona cr e-f/3-11 right, verasense for zimmer biomet persona cr g-h/7-12 left OrthoSensor, Inc. k193580 04/01/2020
physiq heart rhythm module physiQ Inc. k180234 08/10/2018

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