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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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omnibotics knee system Corin Ltd. K200888 06/27/2020
duohex ch cannulated hammertoe system Nextremity Solutions, Inc. K200840 06/26/2020
jdentalcare implant system jdicon J Dental Care S.r.l. K182081 06/26/2020
megadyne smoke evacuator, megadyne filter, megadyne fluid trap, megadyne connect cable, 1 m and 2.1 m, megadyne rf sensor Megadyne Medical Products, Inc. K200250 06/26/2020
msdi dental implants system Medical Systems and Devices International Ltd. K191443 06/26/2020
d-stat radial topical hemostat Vascular Solutions LLC K200720 06/26/2020
noveos specific ige (sige), capture reagent cat dander - e001, felis domesticus; noveos specific ige (sige), capture reagent timothy grass- g006, phleum pratense Hycor Biomedical K200825 06/26/2020
retrofix Retrofix Screws, LLC K200226 06/26/2020
drx-compass Carestream Health, Inc K201373 06/26/2020
ion endoluminal system Intuitive Surgical, Inc. K201146 06/26/2020

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