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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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dess dental smart solutions Terrats Medical SL K191986 11/10/2019
latera absorbable nasal implant system Entellus Medical, Inc. (Aka Stryker ENT) K192661 11/10/2019
neodent implant system JJGC Industria e Comercio de Materiais Dentarios S.A. K190958 11/09/2019
omics core NantHealth, Inc. K190661 11/09/2019
dragonfly opstar™ imaging catheter, aptivue™ software version e.5.1 Abbott Medical K192019 11/08/2019
halyard sterling* nitrile powder-free exam gloves, halyard sterling sg* nitrile sensi-guard powder-free exam gloves O & M Halyard, Inc. K191230 11/08/2019
peripheral blood processing device for wound management: RD2 System reddress ltd BK190349 11/08/2019
ipl home use hair removal device model(s): d-1128, d-1103, d-1119, d-1129, d-1130 Shenzhen Bosidin Technology Co., Ltd. K192432 11/08/2019
oryx cervical plate system Innovasis, Inc. K192049 11/08/2019
cerenovus large bore catheter Codman & Shurtleff, Inc. K191237 11/08/2019

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