FDA.reportPublic FDA data

FRESENIUS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12257143001451489Fresenius Medical Care Renal Therapies Group, LLC1Y2026-01-01920 WINTER STREET Waltham MA US 02451
16518963003310249Fresenius USA Manufacturing, Inc.1N2026-01-015201 Regent Blvd IRVING TX US 75063
17137471713747Fresenius USA Manufacturing, Inc.1N2026-01-01475 WEST 13TH ST. Ogden UT US 84404
96818193000147578FRESENIUS KABI DEUTSCHLAND GMBH1N2026-01-015 ROBERT-KOCH-STRASSE BAD HERSFELD Hesse DE D-36251
30002407073000240707Fresenius Vial S.A.S.1N2026-01-01Le Grand Chemin Brezins Isere FR F-38590
30037085543003708554FRESENIUS KABI AUSTRIA GMBH1N2026-01-01HAFNERSTRASSE 36 GRAZ Steiermark AT A-8055
30051626181527681Fresenius USA Manufacturing, Inc.1N2026-01-01750 North Lallendorf Rd OREGON OH US 43616
30057784533005778453FRESENIUS KABI WARRENDALE1N2026-01-01770 Commonwealth Dr WARRENDALE PA US 15086
30092429233009242923Fresenius USA Manufacturing, Inc.1Y2026-01-01371 S. Royal Lane DFW Airport TX US 75261
30100393713010039371Fresenius USA Manufacturing, Inc.1Y2026-01-01555 Blue Heron Dr SUITE 100 Oregon OH US 43616
30124173813012417381Fresenius USA Manufacturing, Inc.1Y2026-01-012865 DAVE LYLE BLVD Rock Hill SC US 29730
30127862953012786295Fresenius USA Manufacturing, Inc.1Y2026-01-0169 Tetz Rd, Suite 2A Chester NY US 10918
30135461153013546115Fresenius USA Manufacturing, Inc.1N2026-01-015105 South National Drive Knoxville TN US 37914
30147321573014732157Fresenius Kabi USA, LLC1N2026-01-0150 High Street Suite 50 North Andover MA US 01845
30171250963017125096Fresenius USA Manufacturing, Inc.1Y2026-01-015304 East Governor John Sevier Highway Knoxville TN US 37914
13211163001833549Fresenius Kabi USA, LLC1N2020-04-253159 STALEY RD. GRAND ISLAND NY US 14072
29374572937457FRESENIUS USA, INC.1N2020-04-254040 Nelson Ave Concord CA US 94520
96109693002807758FRESENIUS HEMOCARE NETHERLANDS B.V.1N2020-04-25RUNDE ZZ 41 EMMER-COMPASCUUM Drenthe NL NL-7881 HM
30026080663002608066FRESENIUS KABI NORGE AS1N2020-04-25Svinesundsveien 80 Halden Ostfold NO 1778
30027339563002733956Fresenius Kabi USA, LLC1N2020-04-253 CORPORATE DR STE 300 Lake Zurich IL US 60047
30070845303007084530Fresenius Medical Care Seating (Australia) Pty. Ltd.1N2020-04-25786 Stud Road Scoresby Victoria AU 3179
30123576473012357647Fresenius USA Manufacturing, Inc.1Y2020-04-25885 CORPORATE WOODS DRIVE Alabaster AL US 35007
30125143913012514391Fresenius USA Manufacturing, Inc.1Y2020-04-253415 BRONZE COURT Shasta Lake CA US 96019
30125263023012526302Fresenius USA Manufacturing, Inc.1Y2020-04-2518925 NAVAJO ROAD Apple Valley CA US 92307
30129267633012926763Fresenius USA Manufacturing, Inc.1Y2020-04-2510550 SOUTHPORT DRIVE Orlando FL US 32824

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00811505030573Ivenix - LVP Primary Administration Set+18009336925support@fresenius-kabi.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2043551671507489P990009FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANTPMX1999-12-08
258061171800032P900056ROTABLATOR(R)MCX1993-05-28
258061625784337P160013Organ Care System (OCS™) Lung SystemQBA2018-03-22
171261532449650K994267FRESENIUS 2008KKDI2000-03-16
1622361532449650K994267FRESENIUS 2008KKDI2000-03-16
165661277775605K984586FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRSDTN1999-06-29
165661000885538K984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINECAC1999-02-01
171261527473225K981043DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOLKPO1998-05-26
171321527473225K981043DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOLKPO1998-05-26
171331527473225K981043DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOLKPO1998-05-26
171261300616115K980659DRYALYSATE CONCENTRATEKPO1998-06-11
171321300616115K980659DRYALYSATE CONCENTRATEKPO1998-06-11
165661463244018K971274C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SETCAC1997-06-13
171261009644882K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETFJK1996-11-01
165661483466983K961706P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATORLKN1996-07-31
165661123218824K960006C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEMCAC1996-07-31
171261112799723K955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMKPF1996-07-31
1622361112799723K955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMKPF1996-07-31
171262054002157K944767DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTERFIP1995-11-29
171262021603213K935958CRIT-LINE BLOOD CHAMBER WITH E-BEAMKOC1995-01-19
1622362021603213K935958CRIT-LINE BLOOD CHAMBER WITH E-BEAMKOC1995-01-19
171261962566312K921134FRESENIUS POLYSULFONE DIALYZERSKDI1993-12-02
171261443188506K915628DEXTROLYTE II PERITONEAL DIALYSIS PUMPKDJ1992-03-16
171261270972265K911459GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXINGKPO1991-07-17
171262036418303K904806CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTORKDJ1991-01-11
171262037481116K896764UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5KDJ1990-02-26
165661206380430K895435FRESENIUS AS 104 CELL SEPARATORLKN1990-11-02
1797171687706715K871198BONE MARROW COLLECTION KIT AND STANDLWE1987-11-06
171261591516136K870725FRESENIUS HEMOFLOW F6 AND F8FJI1987-05-01
171311591516136K870725FRESENIUS HEMOFLOW F6 AND F8FJI1987-05-01
171261200009019K822550SAFE LOCK TITANIUM ADAPTER SETFKX1982-10-13
171261224114006K822546SAFE LOCK SEALING CAPSFKX1982-10-13
171261579141212K811986THE AMP 80/2 PEDIATRIC CYCLER SYSTEMFKX1981-08-31
171261673334042K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)KPO2026-01-29
171321673334042K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)KPO2026-01-29
171331673334042K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)KPO2026-01-29
171261647087274K252181AquaAFIP2025-09-09
171261018000443K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)KPO2025-09-09
171261384509466K250471AquaC UNO HFIP2025-11-14
171261534126491K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inchKDJ2025-04-03
171261386783212K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)KPO2025-04-04
171261715745078K2435055008X Hemodialysis SystemKDI2025-05-30
171331715745078K2435055008X Hemodialysis SystemKDI2025-05-30
171261214018675K2432372008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)KDI2025-06-13
171261313277838K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)KPO2024-05-10
171261508555187K232953AquaBplus; AquaB LITEFIP2024-06-13
171261114709229K2315345008X Hemodialysis SystemKDI2024-02-02
171261531732913K2311252008T BlueStar Hemodialysis MachineKDI2023-12-06
171261370941560K2229522008T BlueStar Hemodailysis MachineKDI2022-10-27
171261407461172K222318Fresenius Liberty Select CyclerFKX2022-10-31
165651961927749K221121Volumat Polyethylene I.V. Administration SetFPA2023-06-16
165651809783663K220301Volumat LineFPA2023-06-02
171261413774632K213992CombiSet Hemodialysis Blood Tubing SetFJK2023-05-31
171261267419319K213507AquaAFIP2022-07-27
3054231366991501K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorFPA2021-11-10
171261625657054K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateKPO2022-05-12
171321625657054K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateKPO2022-05-12
171331625657054K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateKPO2022-05-12
165651377032239K212445freeflex+ Transfer AdapterLHI2022-06-01
258061537061547K211314OCS Lung SolutionMSB2021-07-29
714071896345664K210075Vigilant Software Suite – Vigilant Master MedPHC2022-03-01
714071424273206K210074Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB CableFRN2022-03-01
714071920877073K210073Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia DuoFRN2022-03-01
171261726989893K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineKOC2020-09-18
1797171251520254K200530AMICUS Separator SystemGKT2020-09-11
171261458191945K192707Optiflux F180NR DialyzerKDI2020-09-21
171311458191945K192707Optiflux F180NR DialyzerKDI2020-09-21
165661902906108K192368CATSmartCAC2019-09-27
171261681571498K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateKPO2020-05-08
171321681571498K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateKPO2020-05-08
171331681571498K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateKPO2020-05-08
1797171666878956K192150AMICUS Separator SystemLKN2019-11-13
171261107381683K192017Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateKPO2020-04-24
171321107381683K192017Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateKPO2020-04-24
171261082713033K191474NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)KPO2020-02-24
171321082713033K191474NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)KPO2020-02-24
171331082713033K191474NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)KPO2020-02-24
171261473419817K190459Hemoflow F3 and F4 DialyzersFJI2019-08-23
171311473419817K190459Hemoflow F3 and F4 DialyzersFJI2019-08-23
1797171202960113K183311Ivenix Infusion System (IIS)FRN2019-06-07
3054231202960113K183311Ivenix Infusion System (IIS)FRN2019-06-07
171261594909286K182367DIASAFEplusUSFIP2019-01-10
171261831260214K181108Fresenius Liberty Select CyclerFKX2018-05-24
1622361831260214K181108Fresenius Liberty Select CyclerFKX2018-05-24
165661116719526K180831CATSmartCAC2018-12-10
1797171490823893K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterLKN2018-12-04
171261187328696K1739722008T BlueStar Hemodialysis MachineKDI2018-05-10
1622361187328696K1739722008T BlueStar Hemodialysis MachineKDI2018-05-10
171261567630452K173718Liberty Cycler SetFKX2018-05-01
171261957102242K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ2018-02-14
171261055070394K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inchKDJ2018-05-21
171261440169474K173363Cycler Drain Bag SetKDJ2018-01-24
171261695900215K172238CAREline Airless Hemodialysis Blood Tubing SetsKOC2017-12-14
171261071355928K171652Fresenius Liberty Select CyclerFKX2017-09-15
1622361071355928K171652Fresenius Liberty Select CyclerFKX2017-09-15
165651461767317K162826Encore NeutralFPA2017-06-15
171261880094701K162716bibagKPO2017-05-18
171311880094701K162716bibagKPO2017-05-18
2341611880094701K162716bibagKPO2017-05-18
171261022678672K162488Optiflux dialyzerKDI2017-04-06
171311022678672K162488Optiflux dialyzerKDI2017-04-06
1797171436562947K162462AMICUS Separator System, AMICUS Separator System; RefurbishedGKT2016-11-23
171261247313201K160749CRIT-LINE III Blood Chamber IIKOC2016-04-15
165661052083267K160735CATSmartCAC2016-09-16
171261858750875K1534492008K2 Hemodialysis MachineKDI2016-04-26
1622361858750875K1534492008K2 Hemodialysis MachineKDI2016-04-26
171261502160313K152953CRIT-LINE CLIP (CLIC) BLOOD CHAMBERKOC2015-11-05
171261368862327K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineKDI2015-12-10
1622361368862327K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineKDI2015-12-10
171261351527309K143617AquaC UNO HFIP2015-10-19
171261411997792K141997CRIT-LINE IV SYSTEMKOC2015-04-01
1622361411997792K141997CRIT-LINE IV SYSTEMKOC2015-04-01
171261832003599K141145LIBERTY PDX CYCLERFKX2014-07-30
1622361832003599K141145LIBERTY PDX CYCLERFKX2014-07-30
171261473110099K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HFFIP2014-04-22
171261068960956K133299ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLYKDI2014-07-07
1622361068960956K133299ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLYKDI2014-07-07
171261970426534K131611FRESENIUS DRY ACID DISSOLUTION UNITSKPO2013-08-29
1622361970426534K131611FRESENIUS DRY ACID DISSOLUTION UNITSKPO2013-08-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPO372026-01-29
KDI252025-06-13
FKX162022-10-31
KOC122020-09-18
KDJ102025-04-03
FIP82025-11-14
CAC72019-09-27
FJK62023-05-31
FRN62022-03-01
ONW62013-07-03
FPA52023-06-16
LKN52019-11-13
FJI42019-08-23
GKT22020-09-11
INO22011-12-30
NZW22010-06-18
FIL22002-07-23
KPF21996-07-31
LHI12022-06-01
PHC12022-03-01
MSB12021-07-29
QBA12018-03-22
MCW12012-09-13
FIB12000-12-01
PMX11999-12-08
DTN11999-06-29
MCX11993-05-28
LWE11987-11-06

NDC#

Lactulose

Fresenius Kabi Austria GmbH

Lactulose

Cleviprex

Fresenius Kabi Austria GmbH

clevidipine

Delflex

Fresenius Medical Care de Mexico, S.A. de C.V.

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Delflex

Fresenius Medical Care de Mexico, S.A. de C.V.

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Delflex

Fresenius Medical Care de Mexico, S.A. de C.V.

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Sodium Chloride

Fresenius Medical Care de Mexico, S.A. de C.V.

Sodium Chloride

DELFLEX

Fresenius Medical Care North America

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care North America

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

Sodium Chloride

Fresenius Medical Care Renal Therapies Group, LLC

Sodium Chloride

Venofer

Fresenius Medical Care Holdings, Inc.

iron sucrose

Venofer

Fresenius Medical Care Holdings, Inc.

iron sucrose

Velphoro

Fresenius Medical Care Renal Therapies Group, LLC

sucroferric oxyhydroxide

Gentamicin

Fresenius Kabi USA, LLC

GENTAMICIN SULFATE

Gentamicin

Fresenius Kabi USA, LLC

GENTAMICIN SULFATE

Gentamicin

Fresenius Kabi USA, LLC

GENTAMICIN SULFATE

Thiamine

Fresenius Kabi USA, LLC

THIAMINE HYDROCHLORIDE

Thiamine

Fresenius Kabi USA, LLC

THIAMINE HYDROCHLORIDE

Thiamine

Fresenius Kabi USA, LLC

THIAMINE HYDROCHLORIDE

200 records. Showing 1-40. Next

PMA#

PMN#

AquaA

2022-07-27

Fresenius Medical Care Rental Therapies Group, LLC

189 records. Showing 1-40. Next

Applications#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next