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U.S. Department of Health and Human Services

510(k) Premarket Notification

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31 to 40 of 500 Results *
Decision Date To: 05/21/2019
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sandshark injectable anchor (sia) system Stimwave Technologies Inc. K191466 11/07/2019
elevation breast biopsy driver, elevation breast biopsy probe - 10g, elevation breast biopsy probe - 14g Bard Peripheral Vascular, Inc. K192948 11/07/2019
precice plating system NuVasive Specialized Orthopedics, Inc. K192181 11/07/2019
salem sump dual lumen stomach tube with enfit connection Cardinal Health K190923 11/07/2019
digital radiography cxdi-702c wireless, digital radiography cxdi-402c wireless Canon, Inc. K192632 11/07/2019
hydrofera blue ready - border Hydrofera, LLC K190268 11/06/2019
sensititre 18-24 hour mic or breakpoint susceptibility system with lefamulin in the dilution range of 0.008-16ug/ml Thermo Fisher Scientific K192729 11/06/2019
somatom x.cite Siemens Medical Solutions USA, Inc. K191891 11/06/2019
conformis hip system Conformis, Inc. K192198 11/06/2019
bio-ray a-1 anchor screw system Microware Precision Co., Ltd. K182929 11/06/2019

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