Gambro, Inc. - FDA 510(k) Cleared Devices
86
Total
86
Cleared
0
Denied
11 devices
Cleared
May 30, 1986
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200
Cardiovascular
142d
Cleared
Sep 16, 1985
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
Cardiovascular
98d
Cleared
Aug 10, 1984
GAMBRO PULSATILE MONITOR PLM 10-200
Cardiovascular
45d
Cleared
Jul 18, 1983
HYPER-HYPOTHERMIA UNIT HYPO 10-200
Cardiovascular
56d
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