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U.S. Department of Health and Human Services

510(k) Premarket Notification

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111 to 120 of 500 Results *
Decision Date To: 11/29/2022
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apex 6 RF Innovations, Inc K220122 03/15/2023
tegamen nitrile examination gloves M/S Tegamen Safety Products Private Limited K223102 03/15/2023
comprehensive® shoulder system, comprehensive® reverse shoulder system Biomet Manufacturing Corp. K214001 03/15/2023
echelon linear™ 60 mm cutter (glc60);echelon linear™ 80mm cutter (glc80);echelon linear™ 100 mm cutter (glc100);echelon linear™ cutters 60mm blue reload (glcr60b);echelon linear™ cutters 60mm green reload (glcr60g);echelon linear™ cutters 80mm blue reload (glcr80b);echelon linear™ cutters 80mm gre Ethicon Endo-Surgery K223760 03/15/2023
air compression leg massager (model: emk-701) Xiamen Emoka Health Science & Technology Co., Ltd. K222991 03/15/2023
digital routines GNC Holdings, LLC K221924 03/15/2023
heartbuds electronic stethoscope Heartbuds LLC K212906 03/14/2023
lexie lumen self-fitting otc hearing aids with lexie application hearX SA (Pty) Ltd. K223137 03/14/2023
one-cuf GE Medical Systems Information Technologies, Inc. K230145 03/14/2023
revcore™ thrombectomy catheter. Inari Medical, Inc. K223609 03/14/2023

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