Gambro, Inc.

FDA 510(k) & PMA Approved Devices — 86 products

Total Devices86

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K083158	EXALIS, SOFTWARE VERSION 1.15	KDI	2009-06-05	View
510(k)	K070643	PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35	KDI	2007-11-02	View
510(k)	K032431	PRISMA M60/M100 SETS	KDI	2003-09-15	View
510(k)	K896758	GAMBRO BICARBONATE MONITOR BCM 10-3	FKP	1990-09-28	View
510(k)	K896757	GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS	FKP	1990-08-30	View
510(k)	K902481	GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER	FJI	1990-07-27	View
510(k)	K900918	GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER	KDI	1990-07-16	View
510(k)	K892523	GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY	FJI	1989-05-11	View
510(k)	K890112	ENGSTROM ELIZA + CO2 ANALYZER	CCK	1989-03-15	View
510(k)	K890111	GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER	FJI	1989-02-08	View
510(k)	K883589	GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER	FJI	1988-09-29	View
510(k)	K881270	GAMBRO MULTIPURPOSE SYSTEM MPS-10	FII	1988-08-24	View
510(k)	K872482	GAMBRO-ENGSTROM ERICA IV RESPIRATOR	CBK	1988-03-03	View
510(k)	K880084	GF 120M, 120H, 180M & 180H HOLLOW FIBER DIALYZERS	FJI	1988-02-19	View
510(k)	K880083	GAMBRO ALWALL GFE 11 & 15 HOLLOW FIBER DIALYZERS	FJI	1988-01-27	View
510(k)	K873643	GAMBRO ADSORBA 150C	FLD	1987-12-29	View
510(k)	K873155	GAMBRO BICART SYSTEM	FKP	1987-10-26	View
510(k)	K871108	GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER	KDI	1987-05-15	View
510(k)	K864095	ENGSTROM EDITH MODELS 500,1000,1500 & 1500F	BYD	1987-02-20	View
510(k)	K864094	GAMBRO FLUID CONTROL MONITOR FCM 10-1	FKP	1986-11-07	View