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U.S. Department of Health and Human Services

510(k) Premarket Notification

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51 to 60 of 500 Results *
Decision Date To: 11/29/2022
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vx1+ Volta Medical K223516 01/21/2023
duetto suprema; domino suprema; suprema vt; suprema vt+; suprema 4v Quanta System, S.p.A. K223404 01/20/2023
flowart® needle-free split septum valve Asset Medikal Tasarim San Tic As. K222889 01/20/2023
highlander™ 014 pta balloon dilatation catheter C.R. Bard, Inc. K223177 01/20/2023
insupen pen needle, insupen original pen needle, insupen advanced pen needle Pikdare S.p.A K203792 01/20/2023
semi-automatic biopsy-needle (bim 18/20); semi-automatic biopsy-needle (bim 18.15); semi-automatic biopsy-needle (bim 18/10);semi-automatic biopsy-needle (bim 16/20);semi-automatic biopsy-needle (bim 16/15);semi-automatic biopsy-needle (bim 16/10);semi-automatic biopsy-needle (bim 14/20);semi-autom ITP Innovative Tomography Products GmbH K222462 01/20/2023
blueprint mixed reality system Tornier SAS K222510 01/20/2023
cysto-nephro videoscope (olympus cyf-v2), cysto-nephro videoscope (olympus cyf-v2r), cysto-nephro videoscope (olympus cyf-vh) and cysto-nephro videoscope (olympus cyf-vhr) Olympus Medical Systems Corporation K221683 01/20/2023
digital thermometer, model: dt007, dt008 Guangzhou Berrcom Medical Device Co., Ltd. K214077 01/20/2023
gmk sphere & gmk spherika cementless Medacta International S.A. K223548 01/20/2023

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