FDA.reportPublic FDA data

NIPRO CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30002478733000247873NIPRO CORPORATION1N2026-01-013-26, Senriokashinmachi Settsu Osaka JP 566-8510

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2141371417253688K992729NIPRO LUER ADAPTORFMI2000-01-13
2141371131997617K992699NIPRO BLOOD COLLECTION NEEDLEFMI2000-02-14
2141371200255498K983825NITRILE LATEX POWDER FREE EXAMINATION GLOVELZA1998-12-04
2141371918206271K981619VACUETTE MULTIPLE SAMPLE LUER ADAPTERFMI1998-07-15
2141371533504244K980414VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SETJKA1998-03-03
2141371110329707K973620VACUETTE MULTI-SAMPLE NEEDLEFMI1997-12-17
2141371713111404K960051NIPRO SAFELET CATHFOZ1996-03-28
2141371301453505K955182NIPRO ARTERIAL VENOUS FISTULA NEEDLEFIE1996-06-04
2141371940095743K955053NIPRO SCALP VEIN SET (DISPOSABL PSV SET)FOZ1996-01-04
2141371507242319K944355NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLESFMF1994-12-07
2141371836456247K932521POWDERFREE LATEX EXAMINATION GLOVESLYY1994-12-13
2141372062724660K913409LATEX EXAMINATION GLOVESLYY1991-09-27
2141371779308276K903777WRP FOLEYCATHEZL1990-12-13
2141371898241496K861152EXEL VACUUM BLOOD COLLECTING SYSTEMFMI1986-05-06
2141371303591265K861150EXEL DENTAL NEEDLEDZM1986-04-11
2141371915036957K261399ELISIO™-HXQAX2026-07-28
2141371988661620K260533ELISIO™-HKDI2026-03-19
2141371448233533K243944Aperta NSE PTA Balloon Dilatation CatheterPNO2025-04-22
2141371803477117K210258NovoFineFMI2021-06-23
2141371045457778K202005NovoFine Plus 32G Tip x 4 mmFMI2020-12-19
2141371861501162K190037Cronus HP PTA Balloon CatheterLIT2019-10-24
2141371156555585K182940Surdial DX Hemodialysis SystemKDI2019-07-19
2141371565555997K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)FMI2018-01-17
2141371555764879K161681Nipro SafeTouch IV CatheterFOZ2017-03-08
2141372023620190K160444FB-U HemodialyzerKDI2017-02-08
2141371411322168K140191ELISIO-H HEMODIALYZERKDI2014-04-14
2141371658845196K140136NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICEFOZ2014-02-14
2141371401803320K132153SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTERFOZ2013-12-05
2141371739293837K131935ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZERKDI2013-12-20
2141371931480857K131641MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)FMF2013-08-28
2141372069662393K130049MONOJECT 12ML SYRINGEFMF2013-02-14
2141371521821980K122687BLOOD CULTURE HOLDERJKA2013-01-10
2141371459467599K121908SAFETY INFUSION SETFMI2012-07-25
2141371720892706K113471NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SETFPA2012-10-18
2141371678168029K113470NIPRO SAFE TOUCH HUBER INFUSION SETFPA2012-10-17
2141371011747967K113469NIPRO HUBER INFUSION, EXCEL HUBER NEEDLEFMI2012-10-18
2141371190582556K112628NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SETFJK2012-09-28
2141371524335503K100520NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVERFIE2010-03-17
2141371835477986K093773AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETSFPA2010-03-10
2141371901048813K080235SAFETY INFUSION SETFMI2008-04-24
2141371295124603K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1FIB2008-02-21
2141371267841372K072024NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693FJK2007-10-04
2141371386006507K071145NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLEMPB2007-09-07
2141371648441089K063721NIPRO SAFETOUCH II GAMMAFIE2007-01-12
2141371491584805K061483VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLESFMI2006-08-14
2141371770774031K060034NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USEOCY2006-02-28
2141371918428176K052474NIPRO HYPODERMIC NEEDLEFMI2005-11-10
2141371664806126K051574NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLEFMF2005-08-26
2141371268368564K032777MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLEFOZ2003-11-14
2141371377955983K030683NIPRO DISPOSABLE SYRINGESFMF2003-10-31
2141371297668016K011786VACUETTE SAFETY BLOOD COLLECTION SETFMI2001-07-12
2141371598002767K011297NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SETFOZ2001-06-20
2141371714532173K010197EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SETFPA2001-05-14
2141371649069362K001251SNIPER, MODEL OR-3872XX SERIESDQX2000-07-07
2141371334080148
2141371466131946
2141371605301088
2141371688399198
2141371710492825
2141371968689100

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMI142021-06-23
FOZ72017-03-08
KDI52026-03-19
FMF52013-08-28
FPA42012-10-18
FIE32010-03-17
JKA22013-01-10
FJK22012-09-28
LYY21994-12-13
QAX12026-07-28
PNO12025-04-22
LIT12019-10-24
FIB12008-02-21
MPB12007-09-07
OCY12006-02-28
DQX12000-07-07
LZA11998-12-04
EZL11990-12-13
DZM11986-04-11