Gambro, Inc. - FDA 510(k) Cleared Devices
86
Total
86
Cleared
0
Denied
86 devices
Cleared
Dec 15, 1982
OXYGENATOR 10
Cardiovascular
37d
Cleared
Oct 18, 1982
GAS-FLOW METER GFL 10
Cardiovascular
28d
Cleared
Oct 18, 1982
GAMBRO BLOOD LEVEL DETECTOR LCS 10
Cardiovascular
28d
Cleared
Oct 18, 1982
GAMBRO PRESSURE MONITOR PRM 10
Cardiovascular
28d
Cleared
Oct 18, 1982
THERMOSTATIC WATER MIXING VALVE TWV10
Cardiovascular
21d
Cleared
Aug 24, 1982
GAMBRO PUMP CONSOLE CSL
Cardiovascular
41d
Cleared
Aug 24, 1982
PUMP MODULES PMO LO-110-PMD 10-210
Cardiovascular
41d
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
Oct 31, 1980
GAMBRO HEMOFREEZE-BAG
Hematology
177d
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
Cleared
Jun 30, 1980
GF120H DIALYZER
Gastroenterology & Urology
56d
Cleared
May 30, 1980
GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
Gastroenterology & Urology
31d
Cleared
May 02, 1980
GAMBRO LUNDIA FIBER
Gastroenterology & Urology
77d
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