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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: 05/28/2020
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invictus™ ct spinal fixation system Alphatec Spine, Inc. K200936 05/22/2020
surgical gown Shandong Kangli Medical Equipment Technology Co., Ltd. K192560 05/22/2020
kalera vacuum aspiration catheter (k-vac) Kalera Medical, Inc. K200419 05/22/2020
premium warming personal lubricant, premium anal warming lubricant, all-in-one warming CC Wellness LLC K200457 05/22/2020
adeor medical nxt non-stick bipolar forceps, adeor medical nxt single-use non-stick bipolar forceps Adeor Medical AG K191847 05/22/2020
co2 sidestream module Beijing Kingst Commercial & Trade Co.,Ltd. K192488 05/22/2020
jps juniortho plating system Orthofix Srl K200246 05/22/2020
smartport+ implantable ports, smartport plastic implantable ports AngioDynamics, Inc. K190559 05/22/2020
vader®one pedicle system mis and lightmore® pedicle system 6.0 Icotec AG K193423 05/22/2020
verify assert self-contained biological indicator STERIS Corporation K200126 05/22/2020

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