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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: 07/22/2019
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powerdr Radiology Information Systems, Inc. K191504 08/16/2019
stat profile prime es comp plus analyzer system Nova Biomedical Corporation K191626 08/16/2019
trimax implant system CrossRoads Extemity Systems, LLC K190722 08/16/2019
aptus foot system Medartis AG K191636 08/16/2019
combined aerobika opep and versapap device Trudell Medical International K183108 08/16/2019
endoskeleton ta interbody fusion device, endoskeleton tas and tas hyperlordotic interbody fusion device, endoskeleton to interbody fusion device, endoskeleton tt interbody fusion device, endoskeleton tc interbody fusion device, endoskeleton tcs interbody fusion device, endoskeleton tl interbody fus Titan Spine, Inc K192018 08/16/2019
piezon built-in kit, piezon built-in kit led E.M.S Electro Medical Systems S.A K191079 08/16/2019
latex powder free surgical glove with protein labeling claim of 50 microgram or less per gram of glove Hartalega Ngc Sdn. Bhd. K183536 08/16/2019
safecare® thc urine strip test Safecare Biotech (Hangzhou) Co., Ltd. K191924 08/16/2019
skr 4000 Konica Minolta, Inc. K191645 08/16/2019

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