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U.S. Department of Health and Human Services

510(K) Premarket Notification
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bd soloshot mini syringe/ bd auto disable syringe Becton, Dickinson, and Company k201234 07/15/2020
dc-90/dc-90s/dc-90q/dc-95/dc-95s/dc-88/dc-88s/dc-80a/dc-80aexp/dc-80a pro/dc-8x/dc-8q/dc-81/dc-82 diagnostic ultrasound system Shenzhen Mindray Bio-Medical Electronics Co., Ltd. k201693 08/21/2020
vivid t8, vivid t9 GE Medical Systems Ultrasound and Primary Care Diagnostics k200851 09/09/2020
cannulated power driver attachment K2M Inc. k202528 10/26/2020
dental computed tomography x-ray system, green x Vatech Co., Ltd k201627 10/27/2020
parcus gfs ii and gfs mini, gfs naked, gfs ultimate, gfs btb, atlas, synd-ez ti, actiflip naked, actiflip cinch, actiflip whip, and gfs ultimate hip Parcus Medical, LLC k202259 10/28/2020
tp orthodontics clear aligner system TP Orthodontics Inc. k193385 11/12/2020
ceramir restore quikcap Doxa Dental AB k201937 11/13/2020
lnk mis spinal system, pathloc-l mis spinal system, accelfix-mis spinal system L&K BIOMED Co., Ltd. k200789 12/04/2020
bfix orthopedic external fixator systems Aike (Shanghai) Medical Instrument Co., Ltd. k200491 01/05/2021

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