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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: 07/22/2019
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carto 3 ep navigation system, version 7.1 and accessories Biosense Webster, Inc. K191660 07/20/2019
cerusendo microcatheter Cerus Endovascular, Inc. K182487 07/20/2019
aplio i900/i800/i700/i600 diagnostic ultrasound system, v4.0 Canon Medical Systems Corporation K191467 07/19/2019
infyna chic Hollister Incorporated K191633 07/19/2019
kidscore d3 Vitrolife A/S K182798 07/19/2019
mariner mis pedicle screw system; seaspine navigation system SeaSpine Orthopedics Corporation K191648 07/19/2019
empty containers for the collection & processing of blood/blood components: Plasmalink Bottle with Locking Luer Adapter fresenius kabi ag BK190362 07/19/2019
exceed microneedling device Mt. Derm GmbH K182407 07/19/2019
nvisionvle low-profile optical probe NinePoint Medical, Inc K191117 07/19/2019
stat profile prime es comp plus analyzer system Nova Biomedical Corporation K191365 07/19/2019

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