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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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ct 5300 Philips Healthcare (Suzhou) Co., Ltd. k232491 05/03/2024
transcutaneous electrical nerve stimulator (9029scm) Hong Kong Etech Groups Limited k240292 03/25/2024
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
black nitrile powder free patient examination glove, non sterile W.A. Rubbermate Co., Ltd. k233740 02/13/2024
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
disposable endoscopic bipolar Jiangsu Hope Biomedical Science & Technology Co., Ltd. k231615 12/05/2023
sozo pro ImpediMed Limited k232089 10/17/2023
legends orthopedics suture anchors (legends orthopedics 5.5 mm suture anchors, legends orthopedics 2.9 mm suture anchor, and legends orthopedics 5.5 mm knotless suture anchor) Jarmon Medical, LLC (DBA Legends Orthopedics) k230517 09/11/2023
q-fix with needles (q-fix with needles, #0 suture & q-fix with needles, minitape) Smith & Nephew Inc. k231376 08/09/2023
stryker resorbable fixation system Stryker Leibinger GmbH & Co. KG k230733 08/05/2023

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