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U.S. Department of Health and Human Services

510(k) Premarket Notification

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71 to 80 of 500 Results *
Decision Date To: 05/21/2019
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kendall npwt incision management dressing kit Cardinal Health K191101 07/31/2020
vibrantvue scleral saline Dry Eye Innovations, LLC K201069 07/31/2020
cemented origin hip stem Signature Orthopaedics Pty Ltd. K201951 07/31/2020
clear guide scenergy Clear Guide Medical K201898 07/31/2020
urolift 2 system (formerly ul500), urolift 2 delivery handle, urolift 2 implant cartridge NeoTract, Inc. K201837 07/31/2020
carto octaray mapping catheter with trueref technology Biosense Webster, Inc. K193237 07/31/2020
corbel spacers Globus Medical, Inc. K201087 07/31/2020
navigation enabled intruments Medos International, SARL K200791 07/31/2020
cyber blade Sidam s.r.l K192499 07/31/2020
liver incytes, model 1005 Sonic Incytes K201597 07/31/2020

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