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U.S. Department of Health and Human Services

510(k) Premarket Notification

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111 to 120 of 500 Results *
Decision Date To: 05/21/2019
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arthrex mini comprehensive fixation system - 1.0mm screws Arthrex Inc. K193156 02/10/2020
dermadry Dermadry Laboratories inc. K192749 02/10/2020
ethos treatment management, ethos treatment planning, ethos radiotherapy system, halcyon Varian Medical Systems, Inc. K192377 02/10/2020
sutter swyng non-stick bipolar forceps, single-use Sutter Medizintechnik GmbH K193587 02/10/2020
m.u.s.t. mini posterior cervical screws system Medacta International SA K200130 02/10/2020
cobas influenza a/b nucleic acid test for use on the cobas liat system, cobas influenza a/b & rsv nucleic acid test for use on the cobas liat system, cobas strep a nucleic acid test for use on the cobas liat system Roche Molecular Systems, Inc. K200065 02/10/2020
inpen system Companion Medical, Inc. K192841 02/10/2020
k3pro konus new abutments and implants Argon Med. Productions Vertriebs Gesellschaft MBH Co Kg K190192 02/10/2020
mectafix cl fixation button with continuous loop Medacta International SA K193165 02/10/2020
i-stat chem8+ cartridge with the i-stat 1 system Abbott Point of Care, Inc. K183688 02/07/2020

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