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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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biomoneta avata rx Biomoneta Research Private Limited k251872 11/14/2025
fibergraft™ bg putty gps bone graft substitute fibergraft™ bg putty bone graft substitute fibergraft™ aeridyan™ matrix bone graft substitute fibergraft™ bg matrix bone graft substitute Prosidyan, Inc. k253147 10/22/2025
minnesota medical technologies fecal incontinence insert (my miracle) Minnesota Medical Technologies k243367 07/22/2025
the acumed wrist fixation system - plates; the acumed wrist fixation system - screws Acumed, LLC k251132 07/14/2025
diode laser device (rf3120-bi) Risu Medical Technology Co., Ltd. k251329 06/27/2025
disposable intermittent catheter (tpu catheter) Chengdu Daxan Innovative Medical Tech. Co., Ltd. k243175 06/26/2025
flexible ureterorenoscope (us27f-12-eu; us27f-12-us) Shanghai AnQing Medical Instrument Co., Ltd. k243857 04/11/2025
dewin reproductive media (dewin vitrification kit, dewin thawing kit) Donnevie Medical Technology (Shanghai) Co. , Ltd. k242561 04/10/2025
dsps-prominent® baseplate, mr (113820); dsps-prominent® baseplate (113120); dsps-prominent® cradle-i (113140); dsps-prominent® cradle-ii (113150); dsps-prominent® cradle-iii (113160); dsps-prominent® cradle-iv (113170); dsps-prominent® cradle-vi (113180); dsps-prominent® cradle-vii (113260); mask dsps®-proscvrl set/5 (113760); mask dsps®-prosc set/5 (113770); mask dsps®-proscvr set/5 (113780); mask dsps®-proscl set/5 (113790); mask dsps®-proshvrl set/5 (113890); mask dsps®-prosh set Macromedics BV k250429 03/19/2025
powered wheelchair (nxn20-208, nxn20-211) Zhejiang Nysin Medical Co., Ltd. k241603 11/20/2024

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