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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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stryker resorbable fixation system Stryker Leibinger GmbH & Co. KG k230733 08/05/2023
tens7000 rechargeable (model:tens7000 rechargeable) Chongqing Rob Linka Science And Technology Co., Ltd. k230829 04/26/2023
c350/c350g lcd monitor; m550/m550g lcd monitor Nanjing Jusha Display Technology Co., Ltd. k231170 06/07/2023
q-fix with needles (q-fix with needles, #0 suture & q-fix with needles, minitape) Smith & Nephew Inc. k231376 08/09/2023
disposable endoscopic bipolar Jiangsu Hope Biomedical Science & Technology Co., Ltd. k231615 12/05/2023
yosemiteview 4343w/yosemiteview 3643w CareRay Digital Medical Technology Co., Ltd. k232058 08/03/2023
sozo pro ImpediMed Limited k232089 10/17/2023
ct 5300 Philips Healthcare (Suzhou) Co., Ltd. k232491 05/03/2024
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
ortho guidance precision knee software; ortho guidance express knee software; ortho guidance versatile hip software; q guidance system Stryker Leibinger GmbH & Co. KG k233542 03/14/2024

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