FDA.report

NIPRO MEDICAL CORPORATION

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
10561861000132332NIPRO MEDICAL CORPORATION1Y2026-01-013150 NW 107TH AVE Doral FL US 33172
30140944273014094427NIPRO MEDICAL OF PUERTO RICO, INC.1Y2026-01-01Jardines de Carolina Industrial Park Lote 4 Julio Matos Ward Carolina PR US 00983

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105711940095743K955053NIPRO SCALP VEIN SET (DISPOSABL PSV SET)FOZ1996-01-04
105711662442586K901471GC-1000 THROUGH GC-3005 ACID CONCENTRATEKPO1990-07-27
105711013047152K223431Citric Complete Liquid Citric Acid ConcentrateKPO2023-08-04
105711524524371K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleFMI2023-05-25
105711156555585K182940Surdial DX Hemodialysis SystemKDI2019-07-19
105711487186963K171750Citric Complete Dry Citric Acid (45X)KPO2018-03-06
105711931480857K131641MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)FMF2013-08-28
105711920383927K131202MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35XKPO2014-04-03
105712069662393K130049MONOJECT 12ML SYRINGEFMF2013-02-14
105711720892706K113471NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SETFPA2012-10-18
105711011747967K113469NIPRO HUBER INFUSION, EXCEL HUBER NEEDLEFMI2012-10-18
105711190582556K112628NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SETFJK2012-09-28
105711524335503K100520NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVERFIE2010-03-17
105711295124603K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1FIB2008-02-21
105711267841372K072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693FJK2007-10-04
105711386006507K071145NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLEMPB2007-09-07
105711648441089K063721NIPRO SAFETOUCH II GAMMAFIE2007-01-12
105711268368564K032777MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLEFOZ2003-11-14
105711516233263K012547HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONKPO2002-01-18
105711598002767K011297NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SETFOZ2001-06-20

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KPO52023-08-04
FOZ32003-11-14
FMI22023-05-25
FMF22013-08-28
FJK22012-09-28
FIE22010-03-17
KDI12019-07-19
FPA12012-10-18
FIB12008-02-21
MPB12007-09-07

PMN

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GUDID

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