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U.S. Department of Health and Human Services

510(k) Premarket Notification

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51 to 60 of 500 Results *
Decision Date To: 05/21/2019
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dr j spinal and epidural needles Dr. Japan Co., Ltd. K183316 08/12/2019
turnpike catheter; turnpike spiral catheter; turnpike gold catheter; turnpike lp catheter Vascular Solutions LLC K191560 08/09/2019
elan 4 tools Aesculap, Inc. K183203 08/09/2019
ellipsys vascular access system (ellipsys system), power controller, ellipsys vascular access system (ellipsys system), catheter, ellipsys vascular access system (ellipsys system), needle Avenu Medical K191114 08/09/2019
soltive™ laser system(soltive™ pro superpulsed laser, soltive™ premium superpulsed laser, soltive™laser fibers, and accessories) Olympus Surgical Technologies America K183647 08/09/2019
versana active GE Medical Systems Ultrasound and Primary Care Diagnostics K191798 08/09/2019
automated differential cell counter: ADAMII CD34 System nanoentek, inc. BK180283 08/09/2019
dr 100s Agfa N.V. K191884 08/09/2019
nxstage cartridge express with speedswap NxStage Medical, Inc. K183158 08/09/2019
versana balance GE Medical Systems Ultrasound and Primary Care Diagnostics K191792 08/09/2019

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