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U.S. Department of Health and Human Services

510(K) Premarket Notification
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straumann blx implant system Institut Straumann AG k210855 06/21/2021
single use electrosurgical knife with fluid pump system Micro-Tech (Nanjing) Co., Ltd. k211172 12/17/2021
encore hip stem Signature Orthopaedics Pty Ltd. k211505 09/24/2021
multi-parameter patient monitor Shenzhen Comen Medical Instruments CO., LTD. k211619 12/29/2022
cefaly dual enhanced with rfid - otc, cefaly dual enhanced with rfid - rx, cefaly dual connected - otc, cefaly dual connected - rx CEFALY Technology k212071 12/13/2022
arsenal ankle plating system Trilliant Surgical k212378 02/23/2022
nbr synthetic nitrile examination gloves Shandong Langtai International Trade Co., Ltd. k212436 12/23/2021
dental high-speed turbine handpiece, dental low-speed turbine handpiece Shenzhen Carejoy Technology Co., Ltd. k212910 11/17/2022
areustm endobronchial ultrasound aspiration needle, tridenttm endobronchial ultrasound aspiration needle Micro-Tech (Nanjing) Co., Ltd. k213060 07/20/2022
fort defiance industries front-line field sterilizer fl120, fort defiance industries front-line field sterilizer fl135 Fort Defiance Industries LLC k213457 03/02/2022

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