Gambro, Inc. - FDA 510(k) Cleared Devices
86
Total
86
Cleared
0
Denied
64 devices
Cleared
Apr 25, 1984
BLOOD MONITOR BMM 10-4
Gastroenterology & Urology
359d
Cleared
Mar 23, 1984
BLOOD CONCENTRATOR 140
Gastroenterology & Urology
44d
Cleared
Feb 04, 1984
HEMOFILTRATION SYSTEM
Gastroenterology & Urology
247d
Cleared
Oct 14, 1983
LUNDIA 10-2-L PARALLEL PLATE HEMODIALY
Gastroenterology & Urology
49d
Cleared
Jun 24, 1983
GF-180-L HOLLOW FIBER HEMODIALYSIS
Gastroenterology & Urology
37d
Cleared
May 27, 1983
LUNDIA 10-3-L PARALLEL FLOW DIALYZER
Gastroenterology & Urology
32d
Cleared
Apr 27, 1983
ULTRAFILTRATION MONITOR UFM-10-2
Gastroenterology & Urology
62d
Cleared
Apr 12, 1983
BLOOD LINE SETS FOR HEMOFILTRATION
Gastroenterology & Urology
39d
Cleared
Apr 06, 1983
LUNDIA 10-2-N PARALLEL FLOW DIALYZER
Gastroenterology & Urology
16d
Cleared
Mar 02, 1983
FH 101, FH 202 & FH 303 FIBER HEMOFILTER
Gastroenterology & Urology
34d
Cleared
Jan 12, 1983
LUNDIA 10-5-L PARRALLE FLOW DIALYZER
Gastroenterology & Urology
27d
Cleared
Aug 16, 1982
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
Gastroenterology & Urology
35d
Cleared
May 28, 1982
GF-180-M & GF-180-H HEMODIALYZERS
Gastroenterology & Urology
18d
Cleared
Apr 16, 1982
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
Gastroenterology & Urology
25d
Cleared
Mar 02, 1982
GAMBRO GF-80-M, GF-80-H HEMODIALYZER
Gastroenterology & Urology
26d
Cleared
Aug 31, 1981
GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
Gastroenterology & Urology
55d
Cleared
Jul 10, 1981
GAMBRO WATER PURIFICATION MONITOR WRD
Gastroenterology & Urology
25d
Cleared
Jun 12, 1981
GAMBRO PERITONEAL DIALYSIS FLUID LINES
Gastroenterology & Urology
32d
Cleared
Feb 25, 1981
GAMBRO BICARBONATE MODULE, BCM-10
Gastroenterology & Urology
37d
Cleared
Dec 22, 1980
GAMBRO LUNDIA PLATE DISP. DIALYZER
Gastroenterology & Urology
84d
Cleared
Dec 22, 1980
GAMBRO A-V FISTULA NEEDLE SET
Gastroenterology & Urology
32d
Cleared
Dec 18, 1980
GAMBRO PERITONEAL DIALYSIS MONITOR
Gastroenterology & Urology
36d
Cleared
Aug 27, 1980
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
Gastroenterology & Urology
64d
Cleared
Aug 27, 1980
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ
Gastroenterology & Urology
64d
Cleared
Jul 21, 1980
GF-120-L DIALYZER
Gastroenterology & Urology
41d