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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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cytoplast titanium-reinforced ptfe membranes Osteogenics Biomedical, Inc. K201187 01/23/2021
patient monitor Edan Instruments, Inc. K202336 01/23/2021
clearpoint array system ClearPoint Neuro, Inc. K202575 01/22/2021
ev1000 clinical platform non-invasive (ni) or clearsight system, ev1000 clinical platform Edwards Lifesciences, LLC K203131 01/22/2021
flex-threadtm distal fibula intramedullary nail system Conventus Orthopaedics, LLC K202858 01/22/2021
nerivio, fgd000075-4.7 Theranica Bioelectronics ltd K203181 01/22/2021
piccolo medical smartpicc system Piccolo Medical, Inc K200037 01/22/2021
platinum drf imaging system Apelem-DMS Group K203010 01/22/2021
sprint pns system SPR Therapeutics, Inc. K202660 01/22/2021
surgical mask Jiangsu Medpure Biological Technology Co., Ltd. K202640 01/22/2021

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.