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U.S. Department of Health and Human Services

510(k) Premarket Notification

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131 to 140 of 500 Results *
Decision Date To: 05/21/2019
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attune all-polyethylene tibia DePuy Ireland UC K193057 01/30/2020
hysil super fast impression materials Osstem Implant Co., Ltd. K192941 01/30/2020
linshom respiratory monitoring device (lrmd) Linshom Management LLC K190734 01/30/2020
neo eemagine Medical Imaging Solutions GmbH K192889 01/30/2020
teslatome bipolar sphincterotome, tesla bipolar active cord Wilson-Cook Medical, Inc. K192339 01/30/2020
truabutment ds TruAbutment Inc. K183106 01/29/2020
unismile clear aligner system Vitang Technology, LLC K191837 01/29/2020
dexcom g6 glucose program continuous glucose monitoring (cgm) system Dexcom, Inc. K193642 01/29/2020
wvsm (wireless vital signs monitor) rwc + minicap Athena GTX K191989 01/29/2020
biopsy needle Ushare Medical Inc. K191472 01/29/2020

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