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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: 05/21/2019
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novalung system Fresenius Medical Care Renal Therapies Group, LLC K191407 02/21/2020
aptus® forearm shaft plates and aptus® wrist 2.5 system Medartis AG K193554 02/16/2020
swan-ganz catheters Edwards Lifesciences, LLC K193466 02/16/2020
i-stat chem8+ cartridge with the i-stat 1 system Abbott Point of Care, Inc. K191360 02/14/2020
affinity Hermes Medical Solutions AB K193152 02/14/2020
dunamis punchtac suture anchors Dunamis LLC K193245 02/14/2020
onetouch verio reflect blood glucose monitoring system LifeScan Europe GmbH K193475 02/14/2020
real intelligence cori Blue Belt Technologies, Inc. K193120 02/14/2020
biograph vision, biograph mct family of pet/cts Siemens Medical Solutions USA, Inc K193248 02/14/2020
cardiq flow GE Medical Systems SCS K192277 02/14/2020

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