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U.S. Department of Health and Human Services

510(k) Premarket Notification

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11 to 20 of 175 Results
ProductCode: FPA Applicant: Y Decision Date To: 01/18/2022
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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
encore neutral RyMed Technologies, LLC K162826 06/15/2017
closed male luer Yukon Medical K171101 06/02/2017
bd nexiva closed iv catheter system (single port) with maxzero needleless connector Becton, Dickinson and Company K170336 03/10/2017
burette-type infusion sets for single use, disposable infusion sets with precision filters, disposable infusion set BEIJING FERT TECHNOLOGY CO., LTD K161898 03/08/2017
halo ii ambulatory infusion system (also with trade names nimbus ii ambulatory infusion system, evaa ambulatory infusion system) ZYNO MEDICAL LLC K153193 08/30/2016
orbit infusion set YPSOMED AG K150921 04/12/2016