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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 500 Results *
Decision Date To: 11/29/2022
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wireless/wired x-ray flat panel detectors Allengers Medical Systems Limited K223009 11/27/2022
dentcare aligners DentCare Dental Lab Pvt Ltd. K222918 11/25/2022
powder-free latex examination gloves Guangdong Kingfa Sci.&Tech. Co., Ltd. K222612 11/25/2022
vsi holomedicine ApoQlar GmbH K213215 11/25/2022
disposable automatically retractable safety syringes (with detachable needle) Shantou Wealy Medical Instrument CO.,Ltd. K222452 11/23/2022
echogo heart failure Ultromics Limited K222463 11/23/2022
glenoid reconstruction system Medacta International S.A. K213459 11/23/2022
closed system transfer device Shinva Ande Healthcare Apparatus Co., Ltd. K201460 11/23/2022
lde4 lancing device i-SENS, Inc. K222656 11/23/2022
medical protective mask (model: 8862, 8862a, 8862b, 8862c, 8862d, 8862e) Guangdong Golden Leaves Technology Development Co., LTD K223068 11/23/2022

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