FDA 510(k) Applications Submitted by Nipro Medical Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K122952 09/25/2012 NIPRO PUREFLUX-L HEMODIALYZER NIPRO MEDICAL CORPORATION
K140191 01/27/2014 ELISIO-H HEMODIALYZER NIPRO MEDICAL CORPORATION
K131381 05/14/2013 ELISIO-H HEMODIALYZER NIPRO MEDICAL CORPORATION
K131935 06/27/2013 ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER NIPRO MEDICAL CORPORATION
K122343 08/03/2012 PUREFLUX-H HEMODIALYZER NIPRO MEDICAL CORPORATION
K122347 08/03/2012 ELISIO-H AND ELISIO-M HEMODIALYZERS NIPRO MEDICAL CORPORATION
K120490 02/17/2012 QUICK SAMPLER HOLDER NIPRO MEDICAL CORPORATION
K100520 02/23/2010 NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER NIPRO MEDICAL CORPORATION
K071145 04/24/2007 NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE NIPRO MEDICAL CORPORATION
K091279 05/01/2009 NIPRO DISPOSABLE SYRINGE NIPRO MEDICAL CORPORATION
K092246 07/28/2009 NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 NIPRO MEDICAL CORPORATION
K112628 09/09/2011 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET NIPRO MEDICAL CORPORATION
K072988 10/23/2007 NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 NIPRO MEDICAL CORPORATION
K113429 11/21/2011 SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER NIPRO MEDICAL CORPORATION
K113469 11/22/2011 NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE NIPRO MEDICAL CORPORATION
K113470 11/22/2011 NIPRO SAFE TOUCH HUBER INFUSION SET NIPRO MEDICAL CORPORATION
K113471 11/22/2011 NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET NIPRO MEDICAL CORPORATION
K130049 01/08/2013 MONOJECT 12ML SYRINGE NIPRO MEDICAL CORPORATION
K140136 01/17/2014 NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE NIPRO MEDICAL CORPORATION
K160444 02/17/2016 FB-U Hemodialyzer NIPRO MEDICAL CORPORATION
K151141 04/29/2015 Cronus HP - High Pressure Peripheral Balloon Catheter NIPRO MEDICAL CORPORATION
K191359 05/21/2019 Nipro Syringe Nipro Medical Corporation
K131641 06/04/2013 MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) NIPRO MEDICAL CORPORATION
K161681 06/17/2016 Nipro SafeTouch IV Catheter NIPRO MEDICAL CORPORATION
K132153 07/12/2013 SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER NIPRO MEDICAL CORPORATION
K212677 08/24/2021 aboNT SYRINGE Nipro Medical Corporation
K222852 09/21/2022 Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle Nipro Medical Corporation
K173029 09/28/2017 Nipro Syringe Nipro Medical Corporation
K182940 10/23/2018 Surdial DX Hemodialysis System Nipro Medical Corporation
K190037 01/08/2019 Cronus HP PTA Balloon Catheter Nipro Medical Corporation
K051828 07/06/2005 NIPRO SUREFUSER AMBULATORY INFUSION PUMP NIPRO MEDICAL CORPORATION
K060034 01/05/2006 NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE NIPRO MEDICAL CORPORATION


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