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U.S. Department of Health and Human Services

510(k) Premarket Notification

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21 to 30 of 500 Results *
Decision Date To: 07/22/2019
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Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
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Sort by Decision Date [9-0]
suprasorb a + ag “r” Speciality Fibres and Materials Ltd. K183208 08/15/2019
hct empty eva container pack Health Care Technologies K190328 08/15/2019
onedraw a1c test system Drawbridge Health, Inc. K183230 08/15/2019
tulsa-pro system PROFOUND MEDICAL INC. K191200 08/15/2019
acuson p200 diagnostic ultrasound system Siemens Medical Solutions USA, Inc. K191922 08/15/2019
biovitals analytics engine Biofourmis Singapore Pte. Ltd K183282 08/15/2019
heartflow ffrct analysis HeartFlow, Inc. K190925 08/15/2019
viola MEDITIME Co., Ltd K190264 08/15/2019
triathlon tritanium central femoral cone augment, triathlon femoral distal augment Howmedica Osteonics Corp. (aka Stryker Orthopaedics) K190991 08/15/2019
signalmark breast marker View Point Medical, Inc. K190689 08/14/2019

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