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U.S. Department of Health and Human Services

510(K) Premarket Notification
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voyant maryland fusion device with single-step activation (eb212, eb213, eb214) Applied Medical Resources Corporation k222284 10/14/2022
zavation spinal system Zavation Medical Products, LLC k222614 12/05/2022
alexandrite and nd:yag laser models canlase and torlase Canadian Pioneer Medical Technology Corporation (CPMT LASER) k222673 11/17/2022
arial dental, mistral dental amalgam, world work dental amalgam, bms non gamma 2 alloy, flexi alloy, hi-s alloy, ww dental amalgam, hi - mix, non gamma 2 alloy WorldWork S.R.L k223182 05/01/2023
gmk sphere & gmk spherika cementless Medacta International S.A. k223548 01/20/2023
verifine® ease lancing device, verifine® lancing device Promisemed Hangzhou Meditech Co., Ltd. k223643 02/21/2023
vinno g50, vinno g55, vinno m50, vinno e30, vinno x5, vinno x6, vinno x7, vinno m55, vinno e35, vinno x65, vinno x55, vinno x35, vinno g55e, vinno g55p, vinno m55e, vinno m55p, vinno e35e, vinno e35p VINNO Technology (Suzhou) Co.,Ltd k223920 06/17/2023
dentis s-clean sq-sl narrow implant system Dentis Co., Ltd. k230246 05/25/2023
koh ultramicro injection cannula (26167nn); suction a. irrig. cannula,l. 36cm (37360cp); suction a. irrig. cannula,l. 36cm (37360sc); suction and irrig cannula,l. 36cm (37560lh); suction a. irrig. cannula,l. 30cm (37260lh); koh ultramicro injection needle (26167na); puncture needle, luer-lock (2617 KARL STORZ Endoscopy America, Inc k230359 06/23/2023
legends orthopedics suture anchors (legends orthopedics 5.5 mm suture anchors, legends orthopedics 2.9 mm suture anchor, and legends orthopedics 5.5 mm knotless suture anchor) Jarmon Medical, LLC (DBA Legends Orthopedics) k230517 09/11/2023

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