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U.S. Department of Health and Human Services

510(k) Premarket Notification

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111 to 120 of 500 Results *
Decision Date To: 05/21/2019
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niobe® magnetic navigation system (mns) with navigant workstation (nws) and cardiodri Stereotaxis, Inc. K192775 10/30/2019
atellica im total hcg (thcg) Siemens Healthcare Diagnostics Inc. K192790 10/30/2019
eze sit valvulotome LeMaitre Vascular K190267 10/30/2019
arthrex low profile screws Arthrex Inc. K190921 10/30/2019
every second matters-uterine balloon tamponade (“esm-ubt”) Ujenzi Charitable Trust K191264 10/30/2019
reprocessed reflexion spiral bi-directional variable radius electrophysiology catheter Innovative Health, LLC. K191170 10/30/2019
aristotle 24 guidewire, 200cm, soft profile ; aristotle 24 guidewire, 200cm, standard profile ; aristotle 24 guidewire, 200cm, support profile Scientia Vascular LLC K192783 10/30/2019
ib3d alif Medicrea International S.A. K191134 10/30/2019
treace medical concepts (tmc) plating system Treace Medical Concepts, Inc. K192504 10/30/2019
game ready grpro 2.1 system Cool Systems, Inc. (dba Game Ready) K192114 10/29/2019

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