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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 171 Results
ProductCode: FPA Applicant: Y Decision Date To: 01/18/2022
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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
high-flo super26 subcutaneous needle sets Repro-Med Systems, Inc. dba RMS Medical Products K180843 04/04/2019
infusion sets with precision filter for single use, precision infusion filter for single use, extended infusion sets for single use Wuhan W.E.O Science & Technology Development Co., Ltd. K181870 02/26/2019
bd flowsmart set/minimed pro-set Becton, Dickinson and Company K181718 10/18/2018
integrated catch-up freedom syringe driver infusion system Repro-Med Systems, Inc., DBA RMS Medical Products K162613 08/31/2017