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U.S. Department of Health and Human Services

510(K) Premarket Notification
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disposable surgical gown um-148 Unimax Medical Products Co., Ltd. k221717 09/20/2022
self-adhesive electrode Guangdong Comytens Medical Technology Co., Ltd k222453 11/04/2022
vha radiotherapy bolus VHA DEAN k222639 11/04/2022
disposable medical face mask (df3-001) Wellmed Dental Medical Supply Co., Ltd. k222697 11/04/2022
empatica health monitoring platform Empatica S.r.l. k221282 11/20/2022
wearable breast pump (model s1dw) Shenzhen TPH Technology Co.,Ltd. k222045 01/04/2023
handx instrument - monopolar spatula Human Xtensions Ltd. k222011 01/12/2023
teligen system peripheral motor nerve stimulation indications Medos International, SARL k223438 02/10/2023
tritanium c anterior cervical cage, tritanium pl cage, tritanium tl curved posterior lumbar cage, tritanium x pl expandable posterior lumbar cage, tritanium x tl expandable curved posterior lumbar cage, stryker spine vlift vertebral body replacement system, vlift-s vertebral body replacement system Stryker Spine k221490 02/14/2023
carestation 750/750c Datex-Ohmeda, Inc. k213867 03/28/2023

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