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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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subdural electrode, strip/intraoperative strip, grid/intraoperative grid, multi-strip and split grid, intraoperative mapping grid Spes Medica Srl k211954 11/10/2022
iroot bp root repair material bioaggregate paste;iroot fs fast set root repair material ;iroot bp plus root repair material Innovative Bioceramix, Inc. k222992 11/22/2022
pulse oximeter Beijing Choice Electronic Technology Co., Ltd. k220101 03/08/2023
huvex interspinous fusion system Dio Medical Corp. k223790 03/09/2023
capenergy c equipment rf system - c25, c50, c100, c200, c300, c400, c500 Capenergy Medical S.L. k222260 03/28/2023
k-shield zen (model numbers: pbmh/ pbma/ pbm) Sb-Kawasumi Laboratories, Inc. k230408 06/01/2023
breathe+ Peep Medical, LLC Dba Go2 Devices k222018 06/02/2023
polaris bipolar electrosurgical generator (29-1000); polaris irrigation module (29-1600); polaris light source module (29-1900); dual footswitch (29-1020) Kirwan Surgical Products, LLC k231872 08/25/2023
ipl hair removal, model: w-1095, w-1098 Shenzhen Wochuan Electronic Co., Ltd. k232124 09/14/2023
overjet periapical radiolucency assist Overjet, Inc. k231678 09/21/2023

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