Medical Device Manufacturer · US , Mchenry , IL

Gambro, Inc. - FDA 510(k) Cleared Devices

86 submissions · 86 cleared · Since 1976
86
Total
86
Cleared
0
Denied
86 devices
51-75 of 86
Cleared Dec 15, 1982
OXYGENATOR 10
K823343 · DTZ
Cardiovascular · 37d
Cleared Oct 18, 1982
GAS-FLOW METER GFL 10
K822820 · DTX
Cardiovascular · 28d
Cleared Oct 18, 1982
GAMBRO BLOOD LEVEL DETECTOR LCS 10
K822821 · DTW
Cardiovascular · 28d
Cleared Oct 18, 1982
GAMBRO PRESSURE MONITOR PRM 10
K822822 · DXS
Cardiovascular · 28d
Cleared Oct 18, 1982
THERMOSTATIC WATER MIXING VALVE TWV10
K822874 · DWC
Cardiovascular · 21d
Cleared Aug 24, 1982
GAMBRO PUMP CONSOLE CSL
K822068 · DTQ
Cardiovascular · 41d
Cleared Aug 24, 1982
PUMP MODULES PMO LO-110-PMD 10-210
K822071 · DWB
Cardiovascular · 41d
Cleared Aug 16, 1982
LUNDIA 10-5 N PARALLEL FLOW DIALYZER
K822049 · KOC
Gastroenterology & Urology · 35d
Cleared May 28, 1982
GF-180-M & GF-180-H HEMODIALYZERS
K821367 · KOC
Gastroenterology & Urology · 18d
Cleared Apr 16, 1982
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL
K820769 · FKQ
Gastroenterology & Urology · 25d
Cleared Mar 02, 1982
GAMBRO GF-80-M, GF-80-H HEMODIALYZER
K820304 · FJI
Gastroenterology & Urology · 26d
Cleared Aug 31, 1981
GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
K811944 · KDI
Gastroenterology & Urology · 55d
Cleared Jul 10, 1981
GAMBRO WATER PURIFICATION MONITOR WRD
K811678 · FIP
Gastroenterology & Urology · 25d
Cleared Jun 12, 1981
GAMBRO PERITONEAL DIALYSIS FLUID LINES
K811294 · KDJ
Gastroenterology & Urology · 32d
Cleared Feb 25, 1981
GAMBRO BICARBONATE MODULE, BCM-10
K810127 · FKR
Gastroenterology & Urology · 37d
Cleared Dec 22, 1980
GAMBRO LUNDIA PLATE DISP. DIALYZER
K802389 · FJG
Gastroenterology & Urology · 84d
Cleared Dec 22, 1980
GAMBRO A-V FISTULA NEEDLE SET
K802956 · FIE
Gastroenterology & Urology · 32d
Cleared Dec 18, 1980
GAMBRO PERITONEAL DIALYSIS MONITOR
K802831 · KPF
Gastroenterology & Urology · 36d
Cleared Oct 31, 1980
GAMBRO HEMOFREEZE-BAG
K801082 · KSR
Hematology · 177d
Cleared Aug 27, 1980
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
K801479 · KDI
Gastroenterology & Urology · 64d
Cleared Aug 27, 1980
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ
K801480 · KDI
Gastroenterology & Urology · 64d
Cleared Jul 21, 1980
GF-120-L DIALYZER
K801370 · FJI
Gastroenterology & Urology · 41d
Cleared Jun 30, 1980
GF120H DIALYZER
K801045 · FJI
Gastroenterology & Urology · 56d
Cleared May 30, 1980
GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
K801016 · FJK
Gastroenterology & Urology · 31d
Cleared May 02, 1980
GAMBRO LUNDIA FIBER
K800336 · FJI
Gastroenterology & Urology · 77d

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