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U.S. Department of Health and Human Services

510(K) Premarket Notification
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radiforce rx360, rx360-ar EIZO Corporation k182591 10/18/2018
iconn revolution knotless suture anchor ICONN Orthopedics, LLC k182264 10/19/2018
k2 zirkon blank white classic; k2 zirkon blank translucent; k2 blanks extreme translucent Yeti Dentalprodukte Gmbh k173971 11/15/2018
6mp color lcd monitor (c61w+) Shenzhen Beacon Display Technology Co., Ltd. k182291 11/20/2018
visor system Cerebrotech Medical Systems, Inc. k182967 11/23/2018
glidescope bflex single-use bronchoscope system Verathon Medical (Canada) ULC k183256 01/04/2019
dc-70/dc-70t/dc-70 pro/dc-70 exp/dc-75/dc-78/dc-70s diagnostic ultrasound system Shenzhen Mindray Bio-Medical Electronics Co., LTD k181637 01/09/2019
contec oxygen concentrator Contec Medical System Co., Ltd. k180837 01/10/2019
rhino-laryngo videoscope olympus enf-vh2, rhino-laryngo videoscope olympus enf-v4 Olympus Medical Systems Corp. k182102 02/06/2019
sensus healthcare tvm balloon applicator Sensus Healthcare, Inc k190255 02/21/2019

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