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U.S. Department of Health and Human Services

510(K) Premarket Notification
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510(K)
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paige prostate Paige.AI den200080 09/21/2021
woundchek bacterial status Alere Scarborough, Inc. den180014 12/02/2019
bd max vaginal panel, bd max instrument GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) den160001 10/28/2016
transcutaneous electrical nerve stimulator (9029scm) Hong Kong Etech Groups Limited k240292 03/25/2024
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
stryker resorbable fixation system Stryker Leibinger GmbH & Co. KG k230733 08/05/2023
tens7000 rechargeable (model:tens7000 rechargeable) Chongqing Rob Linka Science And Technology Co., Ltd. k230829 04/26/2023
c350/c350g lcd monitor; m550/m550g lcd monitor Nanjing Jusha Display Technology Co., Ltd. k231170 06/07/2023

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