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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: 04/22/2019
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capsocam plus (sv-3) CapsoVision, Inc. K183192 04/19/2019
cepheid xpert c. difficile/epi control panel Microbiologics, Inc. K190463 04/19/2019
assure® anterior cervical plate system Globus Medical, Inc. K183056 04/19/2019
fusion plus curing light DentLight Inc. K180065 04/19/2019
ez3d-i/e3 EwooSoft Co., Ltd. K190791 04/19/2019
spy portable handheld imaging (spy-phi) system Novadaq Technologies ULC. (now a part of Stryker) K190729 04/19/2019
atlas plating system MiRus, LLC K190415 04/19/2019
oasys oral/nasal airway system and oasys herbst with dentitrac patient monitor Mark Abramson, D.D.S., Inc K181571 04/19/2019
relieva tract balloon dilation system Acclarent, Inc. K183090 04/19/2019
microscan dried gram negative mic/combo panels with eravacycline (erv) (0.016-32 ug/ml) Beckman Coulter, Inc. K190109 04/18/2019

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