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U.S. Department of Health and Human Services

510(k) Premarket Notification

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31 to 40 of 500 Results *
Decision Date To: 05/21/2019
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aortastat occlusion device RenalPro Medical, Inc. K210602 07/09/2021
apache ultrasound system Aco Healthcare Co,. Ltd. K211232 06/25/2021
apex 3d total ankle replacement system Paragon 28, Inc. K210390 03/06/2021
apogee 1000/ apogee 1000neo/ apogee 1000lite/ apogee 1000exp/ apogee 1000b/w / apogee 1u/ apogee 1t/ apogee 1g digital color doppler ultrasound imaging system Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) K210317 08/19/2021
aquasplash (polymacon) soft (hydrophilic) daily wear contact lens VP Optics K210609 04/27/2021
astra spine system SpineCraft, LLC K211323 06/03/2021
atriclip laa exclusion system AtriCure, Inc. K210293 03/03/2021
atricure isolator encompass ablation system, glidepath magnetic guide AtriCure Inc. K210477 07/26/2021
auto disable syringe Anhui Tiankang Medical Technology Co.,Ltd. K210464 08/24/2021
avitus(r) bone harvester Avitus Orthopaedics, Inc. K210631 03/31/2021

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