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U.S. Department of Health and Human Services

510(K) Premarket Notification

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510(K)
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disposable safety lancet (impress); disposable safety lancet (impress pro); disposable safety lancet (lite4); disposable blood lancet (elite); disposable blood lancet (elite pro) SteriLance Medical (Suzhou) Inc. k233796 01/16/2024
pentax medical single use video bronchoscope eb11-s01, pentax medical single use video bronchoscope eb15-s01, pentax medical mobile processor one-m, pentax medical mobile processor plug-in one-dock PENTAX of America, Inc. k231970 01/12/2024
halyard fluidshield 3 n95 particulate filter respirator and surgical mask with so soft lining, orange, regular and small, halyard fluidshield 3 n95 particulate filter respirator and surgical mask with safety seal and so soft lining, orange, regular and small, halyard fluidshield 2 n95 particulate f Owens & Minor (O&M) Halyard, Inc. k233022 01/12/2024
dual lumen extended length catheter (delc), 6f, 12 cm (320101), dual lumen extended length catheter (delc), 6f, 16 cm (320102) Nuwellis Inc. k233515 12/26/2023
pocket ultrasound system (c10) Beijing Konted Medical Technology Co., Ltd. k231354 12/20/2023
bd minidraw capillary blood collection system with bd minidraw h&h capillary blood collection tube Becton Dickinson and Company k230493 11/27/2023
medical nitrile examination gloves Jiangsu Complete Sincerity Medical New Materials Co., Ltd. k232576 11/21/2023
microwave ablation system (bd-gt) Betters (Suzhou)Medical Co., Ltd. k232240 11/13/2023
skypro, surgical gown 6021 Skypro Medical Supplies Company k230707 10/12/2023
qdose® multi-purpose voxel dosimetry (personalized dosimetry in molecular radiotherapy) Versant Medical Physics and Radiation Safety k230221 08/28/2023

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