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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 500 Results *
Decision Date To: 05/21/2019
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atomica planner Atomica Technology, Inc. K230012 02/02/2023
digital flat panel detector Ray Imaging Technology (Haining) Limited K230059 02/03/2023
14f isleeve™ introducer set Boston Scientific Corporation K230051 02/03/2023
briefcase Aidoc Medical, Ltd. K230020 02/01/2023
1 series phototherapy equipment Daavlin Distributing Co. K220840 04/22/2022
1.5 t/r quad extremity coil, 1.5t 8ch t/r knee coil Invivo Corporation (Business Trade Name: Philips) K222257 08/23/2022
120v neptune s rover (0711-001-000);v2 4-port manifold (0750-400-000);v2 specimen collection manifold kit (0750-200-000);v2 specimen collection tray (0750-210-000) Stryker Instruments K222552 12/09/2022
14hq721g-b LG Electronics Inc. K223546 01/27/2023
16ch breast coil / 16ch breast coils, 1.5t 16ch breast coil, 3.0t 16ch breast coil, 1.5t 16ch breast coil, 3t 16ch breast coil NeoCoil, LLC K222407 10/14/2022
17hq701g-b LG Electronics Inc. K221434 07/13/2022

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