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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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drx - compass Carestream Health, Inc. k223842 01/20/2023
bloomlife mfm-pro Bloom Technologies NV k222327 02/13/2023
umi panorama Shanghai United Imaging Healthcare Co., Ltd. k223325 03/10/2023
electric wheelchair Shanghai BangBang Robotics Co., Ltd. k223393 03/16/2023
biosci™ disposable virus sampling tubes Shenzhen Dakewe Bio-engineering Co., Ltd. k230035 04/05/2023
maxcon sharps container (1 qt sharps container, ma1112), maxcon sharps container (5.4 qt sharps container, ma1212), maxcon sharps container (5.4 qt sharps container, ma1213), maxcon sharps container (7 liter sharps container, ma1324) Ningbo Maxcon Medical Technology Co., Ltd. k222905 06/01/2023
triathlon® total knee system - triathlon® pro posterior stabilized (ps) femoral component Howmedica Osteonics Corp. dba Stryker Orthopaedics k230952 06/02/2023
zeus solinas borrelia vlse1/pepc10 igg/igm test system; zeus solinas borrelia vlse1/pepc10 igg/igm control kit ZEUS Scientific k230863 07/13/2023
surgical gown (s,m,l,xl,xxl,xxxl); reinforced surgical gown (s,m,l,xl,xxl,xxxl) Xiantao Zhibo Non-Woven Products Co., Ltd. k231510 08/22/2023
brainomix 360 triage lvo Brainomix Limited k231837 09/28/2023

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