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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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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
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
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
air compression leg massager (mm0520, mm0521, mm0522) Zhangzhou Easepal Medical Science and Technology Co., Ltd. k240373 09/17/2024
mtone evo (mtone evo) M&T S.R.L. k240604 09/20/2024
air compression leg massager Huizhou Xinyi Technology Co., Ltd. k240981 08/02/2024
powered wheelchair (nxn20-208, nxn20-211) Zhejiang Nysin Medical Co., Ltd. k241603 11/20/2024
elvie stride 2 Chiaro Technology, Ltd. k242125 09/27/2024

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