Gambro Inc

FDA Filings

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

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K083158 GAMBRO, INC.	EXALIS, SOFTWARE VERSION 1.15	2009-06-05
PMN K070643 GAMBRO, INC.	PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35	2007-11-02
PMN K032431 GAMBRO, INC.	PRISMA M60/M100 SETS	2003-09-15
PMN K896758 GAMBRO, INC.	GAMBRO BICARBONATE MONITOR BCM 10-3	1990-09-28
PMN K896757 GAMBRO, INC.	GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS	1990-08-30
PMN K902481 GAMBRO, INC.	GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER	1990-07-27
PMN K900918 GAMBRO, INC.	GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER	1990-07-16
PMN K892523 GAMBRO, INC.	GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY	1989-05-11
PMN K890112 GAMBRO, INC.	ENGSTROM ELIZA + CO2 ANALYZER	1989-03-15
PMN K890111 GAMBRO, INC.	GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER	1989-02-08
PMN K883589 GAMBRO, INC.	GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER	1988-09-29
PMN K881270 GAMBRO, INC.	GAMBRO MULTIPURPOSE SYSTEM MPS-10	1988-08-24
PMN K872482 GAMBRO, INC.	GAMBRO-ENGSTROM ERICA IV RESPIRATOR	1988-03-03
PMN K880084 GAMBRO, INC.	GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS	1988-02-19
PMN K880083 GAMBRO, INC.	GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS	1988-01-27
PMN K873643 GAMBRO, INC.	GAMBRO ADSORBA 150C	1987-12-29
PMN BK870024 Gambro Inc.	Device, Heat Sealing	1987-11-02
PMN K873155 GAMBRO, INC.	GAMBRO BICART SYSTEM	1987-10-26
PMN K871108 GAMBRO, INC.	GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER	1987-05-15
PMN K864095 GAMBRO, INC.	ENGSTROM EDITH MODELS 500,1000,1500 & 1500F	1987-02-20
PMN K864094 GAMBRO, INC.	GAMBRO FLUID CONTROL MONITOR FCM 10-1	1986-11-07
PMN K864083 GAMBRO, INC.	GAMBRO BICARBONATE MONITOR BCM 10-2	1986-11-06
PMN K862840 GAMBRO, INC.	GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N	1986-09-29
PMN K862716 GAMBRO, INC.	HEMOFILTRATION SYSTEM 10	1986-09-09
PMN K860682 GAMBRO, INC.	GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET	1986-08-29
PMN K862025 GAMBRO, INC.	ENGSTROM ERICA II RESPIRATOR	1986-06-18
PMN K860076 GAMBRO, INC.	GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200	1986-05-30
PMN K860938 GAMBRO, INC.	GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS	1986-04-07
PMN K853406 GAMBRO, INC.	GAMBRO LUNDIA PRO 3 & 5 DIALYZER	1986-01-08
PMN K854309 GAMBRO, INC.	GAMBRO BLOOD CONCENTRATOR SETS 16,60,200	1985-12-13
PMN K852455 GAMBRO, INC.	GAMBRO DIGITAL TELETHERMOMETER TTH 10-200	1985-09-16
PMN K852454 GAMBRO, INC.	CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM	1985-08-16
PMN K850621 GAMBRO, INC.	GAMBRO PLASMAFILTRATION SYSTEM	1985-05-16
PMN K851230 GAMBRO, INC.	GAMBRO PRESSURE MONITOR GUARDS	1985-04-09
PMN K842503 GAMBRO, INC.	GAMBRO PULSATILE MONITOR PLM 10-200	1984-08-10
PMN K831404 GAMBRO, INC.	BLOOD MONITOR BMM 10-4	1984-04-25
PMN K840720 GAMBRO, INC.	FIBER HEMOFILTERS FH55-FH77 & 88	1984-04-24
PMN K840645 GAMBRO, INC.	ENGSTROM ELIZA DUO CO2 & O2 ANALYZ	1984-04-05
PMN K840543 GAMBRO, INC.	BLOOD CONCENTRATOR 140	1984-03-23
PMN K831784 GAMBRO, INC.	HEMOFILTRATION SYSTEM	1984-02-04
PMN K832894 GAMBRO, INC.	LUNDIA 10-2-L PARALLEL PLATE HEMODIALY	1983-10-14
PMN K831677 GAMBRO, INC.	HYPER-HYPOTHERMIA UNIT HYPO 10-200	1983-07-18
PMN K831606 GAMBRO, INC.	GF-180-L HOLLOW FIBER HEMODIALYSIS	1983-06-24
PMN K830673 GAMBRO, INC.	CRAFON ARTHROSCOPY LINES	1983-06-08
PMN K831338 GAMBRO, INC.	LUNDIA 10-3-L PARALLEL FLOW DIALYZER	1983-05-27
PMN K830596 GAMBRO, INC.	ULTRAFILTRATION MONITOR UFM-10-2	1983-04-27
PMN K830677 GAMBRO, INC.	BLOOD LINE SETS FOR HEMOFILTRATION	1983-04-12
PMN K830905 GAMBRO, INC.	LUNDIA 10-2-N PARALLEL FLOW DIALYZER	1983-04-06
PMN K823848 GAMBRO, INC.	CRAFTON ARTHROSCOPY PUMP AP-10	1983-03-08
PMN K830284 GAMBRO, INC.	FH 101, FH 202 & FH 303 FIBER HEMOFILTER	1983-03-02
PMN K823791 GAMBRO, INC.	LUNDIA 10-5-L PARRALLE FLOW DIALYZER	1983-01-12
PMN K823343 GAMBRO, INC.	OXYGENATOR 10	1982-12-15
PMN K822874 GAMBRO, INC.	THERMOSTATIC WATER MIXING VALVE TWV10	1982-10-18
PMN K822822 GAMBRO, INC.	GAMBRO PRESSURE MONITOR PRM 10	1982-10-18
PMN K822821 GAMBRO, INC.	GAMBRO BLOOD LEVEL DETECTOR LCS 10	1982-10-18
PMN K822820 GAMBRO, INC.	GAS-FLOW METER GFL 10	1982-10-18
PMN K822071 GAMBRO, INC.	PUMP MODULES PMO LO-110-PMD 10-210	1982-08-24
PMN K822068 GAMBRO, INC.	GAMBRO PUMP CONSOLE CSL	1982-08-24
PMN K822049 GAMBRO, INC.	LUNDIA 10-5 N PARALLEL FLOW DIALYZER	1982-08-16
PMN K821367 GAMBRO, INC.	GF-180-M & GF-180-H HEMODIALYZERS	1982-05-28
PMN K820769 GAMBRO, INC.	GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL	1982-04-16
PMN K820304 GAMBRO, INC.	GAMBRO GF-80-M, GF-80-H HEMODIALYZER	1982-03-02
PMN K811944 GAMBRO, INC.	GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER	1981-08-31
PMN K811678 GAMBRO, INC.	GAMBRO WATER PURIFICATION MONITOR WRD	1981-07-10
PMN K811294 GAMBRO, INC.	GAMBRO PERITONEAL DIALYSIS FLUID LINES	1981-06-12
PMN K810127 GAMBRO, INC.	GAMBRO BICARBONATE MODULE, BCM-10	1981-02-25
PMN K802956 GAMBRO, INC.	GAMBRO A-V FISTULA NEEDLE SET	1980-12-22
PMN K802389 GAMBRO, INC.	GAMBRO LUNDIA PLATE DISP. DIALYZER	1980-12-22
PMN K802831 GAMBRO, INC.	GAMBRO PERITONEAL DIALYSIS MONITOR	1980-12-18
PMN K801082 GAMBRO, INC.	GAMBRO HEMOFREEZE-BAG	1980-10-31
PMN DK801082 Gambro Inc.	Empty Containers For The Collection & Processing Of Blood/blood Components: Gambro Hemofreeze Bag	1980-10-31
PMN K801480 GAMBRO, INC.	GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ	1980-08-27
PMN K801479 GAMBRO, INC.	GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-	1980-08-27
PMN K801370 GAMBRO, INC.	GF-120-L DIALYZER	1980-07-21
PMN K801045 GAMBRO, INC.	GF120H DIALYZER	1980-06-30
PMN K801016 GAMBRO, INC.	GAMBRO G SERIES BLOOD LINE SETS FOR HEM.	1980-05-30
PMN K800336 GAMBRO, INC.	GAMBRO LUNDIA FIBER	1980-05-02
PMN K800424 GAMBRO, INC.	LUNDIA PLATE DISP.	1980-04-10
PMN K800425 GAMBRO, INC.	GAMBRO AK-10-UDM-10-A ULTRADIFFUSION	1980-04-08
PMN K800174 GAMBRO, INC.	GAMBRO LUNDIA COIL DIALYZER	1980-02-13
PMN K792611 GAMBRO, INC.	GAMBRO LUNDIA PLATE DIALYZER	1980-02-06

Similar & Related FDA Registered Companies

• Gambro Renal Products, Inc.
• GAMBRO BCT, INC.
• GAMBRO SERVICES, INC.
• GAMBRO-HOSPAL, INC.
• GAMBRO-HOSP-COBE, INC.
• GAMBRO UF SOLUTIONS, INC

Related Finance Registrations

NCAGE Code	1BVK4	GAMBRO INC.
NCAGE Code	52493	GAMBRO INC
CAGE Code	1BVK4	GAMBRO, INC.
CAGE Code	52493	GAMBRO INC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020011131430	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	417 PCS
2020011131430	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	417 PCS
2019121128862	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	18 PCS
2019110620214	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	18 PCS
2019100928152	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	10229 PKG
2019100928152	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	10229 PKG
2019091828230	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	5118 PCS
2019091828230	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	5118 PCS
2019081437450	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	25 PKG
2019081437450	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	25 PKG
2019071132923	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	877 PCS
2019061925885	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	24 PAL
2019061925885	Stadersand,Federal Republic of Germany -> Savannah, Georgia	DIALYSE EQUIPMENT	24 PAL