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U.S. Department of Health and Human Services

510(k) Premarket Notification

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41 to 50 of 500 Results *
Decision Date To: 07/22/2019
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digix fdx Allengers Medical Systems Limited K192541 10/16/2019
pitkar external fixation system S H Pitkar Orthotools Pvt Ltd. K190486 10/16/2019
focus 35c detector, trimax 35c detector iRay Technology Taicang Ltd. K192512 10/16/2019
secure screw A.M. Surgical, Inc. K191771 10/16/2019
nuface mini device Carol Cole Company dba NuFACE K191672 10/15/2019
totalshield ii surgical helmet system Zimmer Surgical, Inc K192194 10/15/2019
arthrex mini comprehensive fixation system – 1.4mm & 1.6mm module Arthrex Inc. K191326 10/15/2019
infared thermometer Shenzhen Calibeur Industries Co., Ltd. K191251 10/15/2019
vial adapter ø20 mm Avenir Performance Europeenne Medical (APEM) K190149 10/15/2019
dualx lumbar intervertebral body fusion device Amplify Surgical Inc K192434 10/15/2019

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