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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 500 Results *
Decision Date To: 05/21/2019
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xport lens fragmentation system Carl Zeiss Meditec Cataract Technology Inc. K191024 08/13/2019
modular power standing system Motion Concepts K191376 08/13/2019
prostep™ tbi™ (tailors bunion implant) system Wright Medical Technology, Inc. K190970 08/13/2019
critical care suite GE Medical Systems, LLC. K183182 08/12/2019
evol® -si joint fusion system Cutting Edge Spine, LLC K190025 08/12/2019
atec lateral interbody system Alphatec Spine, Inc. K191311 08/12/2019
cervical spinal truss system-stand alone (csts-sa) 4Web, Inc. K190870 08/12/2019
blue sky bio zygomatic implant system Blue Sky Bio, LLC. K190491 08/12/2019
facilis™ spinal system Baui Biotech Co., Ltd. K191494 08/12/2019
arsenal plating system Trilliant Surgical K191009 08/12/2019

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