Fresenius Usa Inc

FDA Filings

This page includes the latest FDA filings for Fresenius Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2937457
• FEI Number: 2937457
• Name: FRESENIUS USA, INC.
• Owner & Operator: Fresenius Medical Care North America
• Contact Address: 920 WINTER STREET --; Waltham MA 02451 US
• Official Correspondent:
  • DENISE OPPERMANN
  • x-781-6994479-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 4040 Nelson Ave ; Concord, CA 94520 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00840861102280 Fresenius Usa, Inc.	VersiPD	2023-08-09
GUDID 00840861102297 Fresenius Usa, Inc.	VersiPD	2023-02-22
GUDID 00840861102198 Fresenius Usa, Inc.	VersiPD	2023-02-22
GUDID 10840861102027 Fresenius Usa, Inc.	Crit-Line® 191058	2018-07-06
GUDID 00840861102112 Fresenius Usa, Inc.	2008T BlueStar Hemodialysis Machine	2018-07-06
GUDID 00840861102105 Fresenius Usa, Inc.	2008T BlueStar Hemodialysis Machine	2018-07-06
GUDID 00840861102099 Fresenius Usa, Inc.	2008T BlueStar Hemodialysis Machine	2018-07-06
GUDID 00840861102082 Fresenius Usa, Inc.	2008T BlueStar Hemodialysis Machine	2018-07-06
GUDID 00840861102068 Fresenius Usa, Inc.	Liberty® Select Cycler	2018-07-06
GUDID 00840861101122 Fresenius Usa, Inc.	Crit-Line®	2018-07-06
GUDID 00840861101023 Fresenius Usa, Inc.	WetAlert™ wireless wetness detector	2018-07-06
GUDID 00840861100965 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-07-06
GUDID 00840861100941 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-07-06
GUDID 00840861100934 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-07-06
GUDID 00840861100903 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-07-06
GUDID 00840861100897 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-07-06
PMN K181108 | FKX FRESENIUS USA, INC. [Fresenius Medical Care North America]	Fresenius Liberty Select Cycler	2018-05-30
PMN K173972 | KDI FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008T BlueStar Hemodialysis Machine	2018-05-15
GUDID 10840861100559 Fresenius Usa, Inc.	Crit-Line® CL10041021	2018-03-29
GUDID 00840861101139 Fresenius Usa, Inc.	Crit-Line®	2018-03-29
GUDID 00840861101009 Fresenius Usa, Inc.	Dry Acid Dissolution Unit	2018-03-29
GUDID 00840861100996 Fresenius Usa, Inc.	Dry Acid Dissolution Unit	2018-03-29
GUDID 00840861100989 Fresenius Usa, Inc.	Liberty® PDx	2018-03-29
GUDID 00840861100972 Fresenius Usa, Inc.	Liberty®	2018-03-29
GUDID 00840861100958 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-03-29
GUDID 00840861100927 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-03-29
GUDID 00840861100910 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-03-29
GUDID 00840861100873 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-03-29
GUDID 00840861100866 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-03-29
GUDID 00840861100859 Fresenius Usa, Inc.	2008® Series Hemodialysis Machines	2018-03-29
PMN K171652 | FKX FRESENIUS USA, INC. [Fresenius Medical Care North America]	Fresenius Liberty Select Cycler	2017-09-26
PMN K153449 | KDI FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K2 Hemodialysis Machine	2017-09-26
PMN K150708 | ONW FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K Hemodialysis Machine, 2008K@home Heomdialysis Machine, 2008T Hemodialysis, 2008T Hemodialysis Machine	2016-01-26
PMN K150708 | KDI FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K Hemodialysis Machine, 2008K@home Heomdialysis Machine, 2008T Hemodialysis, 2008T Hemodialysis Machine	2016-01-26
PMN K141997 | KOC FRESENIUS USA, INC. [Fresenius Medical Care North America]	CritLine IV System	2015-04-29
PMN K124035 | ONW FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@home Hemodialysis Machine with bibag System	2014-08-07
PMN K124035 | ODX FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@home Hemodialysis Machine with bibag System	2014-08-07
PMN K124035 | KPO FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@home Hemodialysis Machine with bibag System	2014-08-07
PMN K121421 | ONW FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@Home HD Machine w/WWD (WETALERT)	2014-08-07
PMN K121421 | ODX FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@Home HD Machine w/WWD (WETALERT)	2014-08-07
PMN K121421 | KDI FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@Home HD Machine w/WWD (WETALERT)	2014-08-07
PMN K935958 | KOC FRESENIUS USA, INC. [Fresenius Medical Care North America]	CRITLINE BLOOD CHAMBER	2011-07-08
PMN K011741 | MQS FRESENIUS USA, INC. [Fresenius Medical Care North America]	Crit-line III TQa URR Monitor	2011-07-08
PMN K011741 | FIL FRESENIUS USA, INC. [Fresenius Medical Care North America]	Crit-line III TQa URR Monitor	2011-07-08
PMN K070049 | ONW FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@HOME HEMODIALYSIS MACHINE	2011-05-04
PMN K070049 | ODX FRESENIUS USA, INC. [Fresenius Medical Care North America]	2008K@HOME HEMODIALYSIS MACHINE	2011-05-04
PMN K955762 | KPF FRESENIUS USA, INC. [Fresenius Medical Care North America]	PACK-PD Peritoneal Dialysis Urea Kinetic Modeling Software Program	2008-03-18
PMN K002892 | FKX FRESENIUS USA, INC. [Fresenius Medical Care North America]	Fresenius PD+ IQ Card Cycler	2008-03-18
PMN K992275 FRESENIUS USA, INC.	FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS	1999-08-04
PMN K970700 FRESENIUS USA, INC.	FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX	1998-09-15
PMN K974584 FRESENIUS USA, INC.	FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS	1998-05-14
PMN K973378 FRESENIUS USA, INC.	C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61	1997-11-03
PMN K961465 FRESENIUS USA, INC.	2008H ON LINE CLEARANCE MONITOR	1997-07-03
PMN K961706 FRESENIUS USA, INC.	P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104 CELL SEPARATOR	1996-07-31
PMN K955762 FRESENIUS USA, INC.	PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM	1996-07-31
PMN K941460 FRESENIUS USA, INC.	FRESENIUS BLOOD TEMPERATURE MONITOR	1996-07-03
PMN K955423 FRESENIUS USA, INC.	PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM	1996-06-13
PMN K944767 FRESENIUS USA, INC.	DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER	1995-11-29
PMN K930181 FRESENIUS USA, INC.	BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE	1995-11-29
PMN K922088 FRESENIUS USA, INC.	FRESENIUS DIALYSATE ACID CONCENTRATE	1994-10-17
PMN K926005 FRESENIUS USA, INC.	FRESENIUS HEMOFLOW, VARIOUS MODELS	1994-08-23
PMN K921456 FRESENIUS USA, INC.	FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM	1994-04-20
PMN K922005 FRESENIUS USA, INC.	GRANULYTE DIALYSATE CONCENTRATE	1994-03-30
PMN K921134 FRESENIUS USA, INC.	FRESENIUS POLYSULFONE DIALYZERS	1993-12-02
PMN K915634 FRESENIUS USA, INC.	FRESENIUS PD+ EXCHANGE DEVICE	1993-07-01
PMN K921052 FRESENIUS USA, INC.	FRESENIUS VARIABLE FILL MONITOR	1993-02-25
PMN K912208 FRESENIUS USA, INC.	FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE	1991-07-24
PMN K911459 FRESENIUS USA, INC.	GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING	1991-07-17
PMN K904806 FRESENIUS USA, INC.	CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTOR	1991-01-11
PMN K895435 FRESENIUS USA, INC.	FRESENIUS AS 104 CELL SEPARATOR	1990-11-02
PMN K902394 FRESENIUS USA, INC.	RESUBMITTED MULTIORGAN PERFUSION CANNULA	1990-09-27
PMN K901042 FRESENIUS USA, INC.	IONOMETER EF-HK AND ACCESSORIES	1990-07-31
PMN K901040 FRESENIUS USA, INC.	IONOMETER EH-F AND ACCESSORIES	1990-07-19
PMN K901039 FRESENIUS USA, INC.	IONOMETER EH	1990-06-28
PMN K901041 FRESENIUS USA, INC.	IONOMETER EH-HK AND ACCESSORIES	1990-06-18
PMN K895366 FRESENIUS USA, INC.	ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE	1990-05-02
PMN K896111 FRESENIUS USA, INC.	FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB	1989-12-27
PMN K890824 FRESENIUS USA, INC.	FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM	1989-05-11
PMN K890329 FRESENIUS USA, INC.	FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM	1989-05-11
PMN K892262 FRESENIUS USA, INC.	FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M	1989-04-25
PMN K884609 FRESENIUS USA, INC.	EURO-COLLINS SOLUTION SETS	1989-01-26
PMN K883195 FRESENIUS USA, INC.	FRESENIUS F8 DIALYZER	1988-09-13
PMN K881155 FRESENIUS USA, INC.	MODEL BPS08 BLOOD PRESSURE MODULE	1988-07-28
PMN K874106 FRESENIUS USA, INC.	GLANDOSANE (SALIVART) SYNTHETIC SALIVA	1988-04-15
PMN K841104 FRESENIUS USA, INC.	ENTERNAL FEEDING PUMP BATTERY OPER.	1985-04-30
PMN K841718 FRESENIUS USA, INC.	FREKATHETER VENOUS CATHETERISATION SYS	1984-04-25

Similar & Related FDA Registered Companies

• Fresenius USA/Seratronics Inc.

Related Finance Registrations

NCAGE Code	0NJV1	FRESENIUS USA, INC.!DBA FRESENIUS MEDICAL CARE
NCAGE Code	309T7	FRESENIUS USA INC!DBA BRANDON ARTIFICIAL KINDEY CENTER
NCAGE Code	31WV6	FRESENIUS USA INC!DBA BIOMEDICAL APPLICATIONS OF EAST!ORLANDO
NCAGE Code	64J52	FRESENIUS USA INC.!DBA INLAND NORTHWEST DIV FRESENIUS!MEDICAL CARE-NORTH AMERICA
NCAGE Code	5DVX4	FRESENIUS USA INC.!DBA DESERT VALLEY DIALYSIS DIV!FRESENIUS MEDICAL CARE-NORTH AMERICA
NCAGE Code	5CB51	FRESENIUS USA INC.!DBA BMA RED MOUNTAIN DIALYSIS DIV!FRESENIUS MEDICAL CARE-NORTH AMERICA
NCAGE Code	5E3J4	FRESENIUS USA INC.!DBA RENAL CARE GROUP NATIVE AMERICAN!DIV FRESENIUS MEDICAL CARE-NORTH!AMERICA
NCAGE Code	5DV26	FRESENIUS USA, INC.!DBA SOUTHEASTERN NEW MEXICO KIDNEY!CENTER!DIV FRESENIUS MEDICAL CARE-NORTH!AMERICA
CAGE Code	0NJV1	FRESENIUS USA, INC. FRESENIUS MEDICAL CARE
CAGE Code	309T7	FRESENIUS USA, INC BRANDON ARTIFICIAL KINDEY CENTER
CAGE Code	31WV6	FRESENIUS USA, INC BIOMEDICAL APPLICATIONS OF EAST ORLANDO
CAGE Code	4MJC0	FRESENIUS USA, INC. FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	4MJD2	FRESENIUS USA, INC. FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5CB51	FRESENIUS USA, INC. BMA RED MOUNTAIN DIALYSIS FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5CBA3	FRESENIUS USA, INC. FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5DV26	FRESENIUS USA, INC. SOUTHEASTERN NEW MEXICO KIDNEY CENTER FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5DVA5	FRESENIUS USA, INC. FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5E3J4	FRESENIUS USA, INC. RENAL CARE GROUP NATIVE AMERICAN FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5P8H4	FRESENIUS USA INC. FRESENIUS MEDICAL CARE TRI-CITY FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	64HB2	FRESENIUS USA, INC. FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	64J52	FRESENIUS USA, INC. INLAND NORTHWEST FRESENIUS MEDICAL CARE-NORTH AMERICA
CAGE Code	5DVX4	FRESENIUS USA INC. DBA DESERT VALLEY DIALYSIS DIV FRESENIUS MEDICAL CARE-NORTH AMERICA
S.A.M. Registration	0NJV1 [76594100]	FRESENIUS USA, INC. FRESENIUS MEDICAL CARE
DUNS	789960452	FRESENIUS USA, INC.
SEC	0000320185	FRESENIUS USA INC of MASSACHUSETTS

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092825636	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	PURCHASE ORDER NO: 4511047859 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES,BLUE COLORED,TESTED FOR USE WITH CHEMOTHERAPHY DRUGS BRAND: CIRCUS 800 BLUE -2,190 CARTONS BRAND: CIRRUS 800 BLUE (XL)	2390 CTN
202009176282	Singapore,Singapore -> Tacoma, Washington	PURCHASE ORDER NO: 4511041767 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES,BLUE COLORED,TESTED FOR USE WITH CHEMOTHERAPHY DRUGS BRAND: CIRCUS 800 BLUE -2,290 CARTONS BRAND: CIRRUS 800 BLUE [XL]	2390 CTN
2020091435212	Singapore,Singapore -> New York/Newark Area, Newark, New Jersey	PURCHASE ORDER NO: 4511047870 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES,BLUE COLORED,TESTED FOR USE WITH CHEMOTHERAPHY DRUGS BRAND: CIRCUS 800 BLUE -2,190 CARTONS BRAND: CIRRUS 800 BLUE [XL]	2390 CTN
202009142238	Tanjung Pelepas,Malaysia -> New York/Newark Area, Newark, New Jersey	PURCHASE ORDER NO: 4511041765 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES,BLUE COLORED,TESTED FOR USE WITH CHEMOTHERAPHY DRUGS BRAND: CIRCUS 800 BLUE -2,090 CARTONS BRAND: CIRRUS 800 BLUE (XL)	2390 CTN
2020091111822	Yantian,China (Mainland) -> Long Beach, California	PURCHASE ORDER NO: 4511041766 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES,BLUE COLORED,TESTED FOR USE WITH CHEMOTHERAPHY DRUGS BRAND: CIRCUS 800 BLUE -2,290 CARTONS BRAND: CIRRUS 800 BLUE (XL)	2390 CTN
2020082420277	Port Swettenham,Malaysia -> Los Angeles, California	PURCHASE ORDER NO: 4511041768 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES,BLUE COLORED,TESTED FOR USE WITH CHEMOTHERAPHY DRUGS BRAND: CIRCUS 800 BLUE -2,190 CARTONS BRAND: CIRRUS 800 BLUE (XL)	2390 CTN
2020080820466	Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey	PURCHASE ORDER NO: 4511012019 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES,BLUE COLORED,TESTED FOR USE WITH CHEMOTHERAPHY DRUGS BRAND: CIRCUS 800 BLUE -2,240 CARTONS BRAND: CIRRUS 800 BLUE (XL)	2390 CTN
2020080520934	Port Swettenham,Malaysia -> Los Angeles, California	PURCHASE ORDER NO: 4511028524 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES,BLUE COLORED,TESTED FOR USE WITH CHEMOTHERAPHY DRUGS BRAND: CIRCUS 800 BLUE -2,390 CARTONS COUNTRY OF ORIGIN: MALAYSIA	2390 CTN