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
96118233002807005FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH1N2026-01-01FRANKFURTER STRASSE 6-8 ST. WENDEL Saarland DE D-66606
96118243002806960FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH1N2026-01-01HAFENSTRASSE 9 SCHWEINFURT Bavaria DE D-97424
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
30123641953012364195Fresenius Medical Care de Mexico1N2026-01-01Paseo del Norte No. 5300 Zapopan Jalisco MX 45010
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

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
94131678469843K944767DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTERFIP1995-11-29
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
94131090289636K921134FRESENIUS POLYSULFONE DIALYZERSKDI1993-12-02
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
94131781662731K253518FX CorAL 40; FX CorAL 50KDI2025-12-18
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
2850151018000443K252180Bicarby 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
94131916081967K252180Bicarby 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
94131353571376K251851DIASAFEplusUS (F00013010)FIP2025-10-09
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
94132012938936K243874FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)KDI2025-02-28
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
2850151386783212K243786Bicarby 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
94132042201781K2435055008X Hemodialysis SystemKDI2025-05-30
94142042201781K2435055008X 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
2850151313277838K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)KPO2024-05-10
94131787097501K233159pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504KPO2023-12-01
171261508555187K232953AquaBplus; AquaB LITEFIP2024-06-13
171261114709229K2315345008X Hemodialysis SystemKDI2024-02-02
94131180042780K2315345008X 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
94131865982715K220721FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000KDI2023-05-11
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

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPO422026-01-29
KDI322025-12-18
FKX162022-10-31
KOC122020-09-18
FIP102025-11-14
KDJ102025-04-03
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#

200 records. Showing 1-40. Next

PMA#

PMN#

189 records. Showing 1-40. Next

Applications#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next