Medical Device Manufacturer · US , Mchenry , IL

Critikon Company, LLC - FDA 510(k) Cleared Devices

51 submissions · 51 cleared · Since 1979
51
Total
51
Cleared
0
Denied
51 devices
26-50 of 51
Cleared May 28, 1985
CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC
K844116 · DXG
Cardiovascular · 217d
Cleared Apr 01, 1985
DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX
K844839 · DXN
Cardiovascular · 110d
Cleared Mar 07, 1985
CRITIKON I.V. ADMINISTRAION SET
K850507 · FPA
General Hospital · 27d
Cleared Sep 04, 1984
CRITIKON HEPARIN-COATED CARDIOVASCULAR
K843141 · LDF
Cardiovascular · 26d
Cleared Jul 20, 1984
CRITIKON TRIPLE-LUMEN CENTRAL VENOUS
K842316 · DQY
Cardiovascular · 38d
Cleared Jun 28, 1984
CRITIKON I.V. FILTER
K842075 · FPB
General Hospital · 36d
Cleared Feb 21, 1984
NITROGLYCERIN I.V. ADMINISTRATION SET
K833939 · FPA
General Hospital · 98d
Cleared Jan 30, 1984
HEPARIN-COATED BALLOON THERMODILUT
K833572 · DYG
Cardiovascular · 110d
Cleared Jan 30, 1984
INFUSION PORT BALLOON THERMODILUTION
K833918 · DYG
Cardiovascular · 77d
Cleared Nov 14, 1983
INIVOX ELECTRODE/CATHETER SYS
K832916 · LLE
Neurology · 77d
Cleared Nov 07, 1983
DINAMAP VITAL SIGNS MONITOR #1846P
K832656 · DXN
Cardiovascular · 91d
Cleared Oct 28, 1983
CRITIKON CARDIAC OUTPUT COMPUTER
K831967 · DXG
Cardiovascular · 130d
Cleared Aug 12, 1983
SIMPLICITY PLUS
K831761 · FRN
General Hospital · 72d
Cleared Jun 30, 1983
DINAMAP VITAL SIGNS MONITOR #1846
K831515 · DXN
Cardiovascular · 49d
Cleared Apr 27, 1983
I.V. CATHETER PLACEMENT UNIT POLYURETH
K830972 · FOZ
General Hospital · 30d
Cleared Nov 30, 1982
BALLOON THERMODILUTION CATHETER #7164&
K823433 · DYG
Cardiovascular · 14d
Cleared Aug 16, 1982
CRITIKON OXYGEN MONITOR, MODEL 8030
K821936 · KLK
Anesthesiology · 48d
Cleared Aug 03, 1982
CRITIKON #817 ESOPHAGEAL MULTI-PROBE
K821890 · BZT
Anesthesiology · 39d
Cleared Jan 26, 1982
CRITIKON TRANSCUTANEOUS GAS MONITORS
K813347 · KLK
Anesthesiology · 60d
Cleared Jan 12, 1982
CRITIKON I.V. CATHETER PLACEMENT UNIT
K813345 · FOZ
General Hospital · 48d
Cleared Jan 12, 1982
DINAMAP ADULT/PED./NEONATAL VITAL SIGNS
K813527 · DXN
Cardiovascular · 27d
Cleared Jun 12, 1981
IV SETS
K811107 · FPA
General Hospital · 50d
Cleared Jan 28, 1981
SIMPLICITY INFUSION PUMP MODEL 2100A
K803078 · FRN
General Hospital · 54d
Cleared Aug 27, 1980
THE SIMPLICITY PUMP #2100 INFUSION PUMP
K801546 · FRN
General Hospital · 51d
Cleared Oct 26, 1979
CRITIKON DUAL CHANNEL RECORDER
K792105 · DSF
Cardiovascular · 4d
Filters