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U.S. Department of Health and Human Services

510(k) Premarket Notification

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61 to 70 of 500 Results *
Decision Date To: 11/29/2022
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qoca image smart cxr image processing system Quanta Computer Inc. K221868 01/27/2023
14hq721g-b LG Electronics Inc. K223546 01/27/2023
360cas Kico Knee Innovation Company Pty Limited K223927 01/27/2023
eva15 insufflator Palliare Ltd. K222901 01/27/2023
f&p airvo 3 Fisher & Paykel Healthcare K221338 01/27/2023
non-sterile, single use, powder-free examination glove, blue, tested for use with chemotherapy drugs and fentanyl small size (ngpf102); medium size (ngpf103); large size (ngpf104); x-large size (ngpf105) Semperit Investments Asia PTE LTD. K223903 01/27/2023
sim&size Sim&Cure K222664 01/27/2023
soltive pro superpulsed laser, soltive premium superpulsed laser, soltive superpulsed laser fibers, and accessories Gyrus ACMI, Inc. K221306 01/27/2023
tacrolimus assay kit Shanghai Genext Medical Technology Co., Ltd. K203833 01/27/2023
tibia and fibula system Auxein Medical Private Limited K213059 01/27/2023

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