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NIPRO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10561861000132332NIPRO MEDICAL CORPORATION1Y2026-01-013150 NW 107TH AVE Doral FL US 33172
15288071000142899Nipro Renal Solutions USA, Corporation1N2026-01-01509 Fishing Creek Rd LEWISBERRY PA US 17339
80203473005612924NIPRO CANADA CORPORATION1N2026-01-01199 ST. DAVID STREET LINDSAY Ontario CA K9V 5K7
96109873002807710NIPRO CORPORATION ODATE FACTORY1N2026-01-018-7, Hanukiyachi, Niida ODATE-SHI Akita JP 018-5794
10005330271000533027NIPRO VASCULAR CORPORATION Fujigaoka Building1N2026-01-01108 Fujigaoka Meito-ku Nagoya Aichi JP 465-0032
30031459763003145976NIPRO TECHNICAL SOLUTIONS, INC.1Y2026-01-013110 N Oakland Ste 101 MESA AZ US 85215
30035241713003524171Nipro Vascular Innovations Americas, Inc.1N2026-01-01870 Hermosa Dr SUNNYVALE CA US 94085
30118263383011826338NIPRO VASCULAR CORPORATION Seto Facility / NIPRO VASCULAR CORPORATION Innovation Center1N2026-01-01276-1 Idogane-cho Seto Aichi JP 489-0976
30140944273014094427NIPRO MEDICAL OF PUERTO RICO, INC.1Y2026-01-01Jardines de Carolina Industrial Park Lote 4 Julio Matos Ward Carolina PR US 00983
30155511133015551113Nipro Vascular Innovations Americas, Inc.1Y2026-01-0128 Crosby Drive, Suite 100 Bedford MA US 01730
30300421693030042169NIPRO VASCULAR CORPORATION Aichi Facility1N2026-01-011-176 Shiokusagaoka Seto Aichi JP 489-0899

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
95501432859851K963748BIO-PLEXUS DROP-IT NEEDLE HOLDERFMI1997-06-06
105711713111404K960051NIPRO SAFELET CATHFOZ1996-03-28
105661713111404K960051NIPRO SAFELET CATHFOZ1996-03-28
105711940095743K955053NIPRO SCALP VEIN SET (DISPOSABL PSV SET)FOZ1996-01-04
105711662442586K901471GC-1000 THROUGH GC-3005 ACID CONCENTRATEKPO1990-07-27
1279071991640738K901471GC-1000 THROUGH GC-3005 ACID CONCENTRATEKPO1990-07-27
95501343522491K850009EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETERBSO1985-05-13
95501012974522K833112TUBING FOR CARDIOPULMONARY BYPASSDWF1983-11-28
3404961675915674K243944Aperta NSE PTA Balloon Dilatation CatheterPNO2025-04-22
3404941675915674K243944Aperta NSE PTA Balloon Dilatation CatheterPNO2025-04-22
3404901675915674K243944Aperta NSE PTA Balloon Dilatation CatheterPNO2025-04-22
2330711973671864K241576Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )OGZ2025-02-26
105711013047152K223431Citric Complete Liquid Citric Acid ConcentrateKPO2023-08-04
1279071082520960K223431Citric Complete Liquid Citric Acid ConcentrateKPO2023-08-04
105711524524371K222852Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleFMI2023-05-25
105711156555585K182940Surdial DX Hemodialysis SystemKDI2019-07-19
105661156555585K182940Surdial DX Hemodialysis SystemKDI2019-07-19
1279071049850312K171750Citric Complete Dry Citric Acid (45X)KPO2018-03-06
105711487186963K171750Citric Complete Dry Citric Acid (45X)KPO2018-03-06
580671973444914K170987Captus Vascular Retrieval SystemMMX2017-08-28
2330711971874102K163345TVC Imaging System, TVC CatheterOGZ2017-06-21
105662023620190K160444FB-U HemodialyzerKDI2017-02-08
105712023620190K160444FB-U HemodialyzerKDI2017-02-08
105661411322168K140191ELISIO-H HEMODIALYZERKDI2014-04-14
105711411322168K140191ELISIO-H HEMODIALYZERKDI2014-04-14
105711739293837K131935ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZERKDI2013-12-20
105661739293837K131935ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZERKDI2013-12-20
105711931480857K131641MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)FMF2013-08-28
1279071123704418K131202MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35XKPO2014-04-03
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
95501810651847K080174PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1CLHI2008-04-23
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
95501755157727K04267214F DUAL FLOATING DIALYSIS CATHETER/TRAYMSD2005-03-23
631562044686112K041636H&S-CONDUCTIVITY STANDARD SOLUTIONFKH2004-07-02
105711268368564K032777MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLEFOZ2003-11-14
1279071265639042K012547HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONKPO2002-01-18
105711516233263K012547HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONKPO2002-01-18
105711598002767K011297NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SETFOZ2001-06-20
95501456211774
95502067657039
3404901121871919
3404941121871919
105661165739184
580671182174753
95501307560346
105661319420249
105661331721592
95501424920566
105661662386625
105661666648627
105661698693765
3404901833740132
3404941833740132
95502013830685

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPO102023-08-04
KDI82019-07-19
FOZ52003-11-14
PNO32025-04-22
FMI32023-05-25
OGZ22025-02-26
FMF22013-08-28
FJK22012-09-28
FIE22010-03-17
FKH22004-07-02
MMX12017-08-28
FPA12012-10-18
LHI12008-04-23
FIB12008-02-21
MPB12007-09-07
MSD12005-03-23
BSO11985-05-13
DWF11983-11-28

PMN#

68 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next