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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 185 Results
ProductCode: FPA Applicant: Y Decision Date To: 11/24/2014
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freedomedge syringe infusion system Repro-Medical System, Inc., dba Koru Medical Systems K214045 04/29/2022
safety blood collection / infusion set (with/without needle holder), blood collection / infusion set (with/without needle holder) Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. K214075 04/12/2022
infusion sets for single use Jiangsu Suyun Medical Materials Co., Ltd. K202437 03/25/2022
bd vacutainer ultratouch push button blood collection set Becton, Dickinson and Company K212724 02/04/2022
freedom integrated syringe infusion system Repro-Med Systems, Inc., dba KORU Medical Systems K200176 12/15/2021
freedomedge(r) syringe infusion system Repro-Medical System, Inc., dba Koru Medical Systems K211206 11/09/2021
bd intima ii closed iv catheter system, bd intima ii plus closed iv catheter system Becton, Dickinson and Company K200891 06/02/2021
female luer lock cap MedSafety Solutions LLC K200425 10/29/2020
tk intravascular administration set Anhui Tiankang Medical Technology Co.,Ltd. K191640 08/26/2020
bd intelliport system Becton, Dickinson, and Company K182092 04/30/2019
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