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
FDA 510(k) Regulatory Record - Critikon Company, LLC Cardiovascular
24 devices
1-24 of 24
Cleared Sep 21, 2000
DINAMAP PRO 1000 MONITOR, MODEL 1000
K002248 · DXN
Cardiovascular · 58d
Cleared May 26, 2000
DINAMAP ADVANCED NIBP MODULE
K000500 · DXN
Cardiovascular · 102d
Cleared Feb 24, 2000
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
K992638 · MWI
Cardiovascular · 202d
Cleared Aug 14, 1998
DINAMAP MPS SELECT PORTABLE MONITOR
K982342 · MSX
Cardiovascular · 39d
Cleared Jun 16, 1995
DINAMAP PLUS VITAL SIGNS MONOITOR
K943709 · DPS
Cardiovascular · 319d
Cleared Mar 01, 1995
DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340
K942700 · MHX
Cardiovascular · 266d
Cleared Feb 09, 1994
CRITIKON CENTRAL STATIN MONITOR
K933404 · DPS
Cardiovascular · 212d
Cleared Jul 01, 1993
CRITIKON VITAL SIGNS MODULE
K915697 · DXN
Cardiovascular · 556d
Cleared Dec 04, 1991
DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700
K912188 · MHX
Cardiovascular · 201d
Cleared Dec 30, 1987
DINAMAP VITAL SIGNS MONITOR, MODEL 8100T
K874378 · DXN
Cardiovascular · 65d
Cleared Jul 29, 1987
VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)
K871418 · DXN
Cardiovascular · 112d
Cleared May 16, 1986
DINAMAP VITAL SIGNS MONITOR MODEL 8100
K854434 · DXN
Cardiovascular · 192d
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 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 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 07, 1983
DINAMAP VITAL SIGNS MONITOR #1846P
K832656 · DXN
Cardiovascular · 91d
Cleared Oct 28, 1983
CRITIKON CARDIAC OUTPUT COMPUTER
K831967 · DXG
Cardiovascular · 130d
Cleared Jun 30, 1983
DINAMAP VITAL SIGNS MONITOR #1846
K831515 · DXN
Cardiovascular · 49d
Cleared Nov 30, 1982
BALLOON THERMODILUTION CATHETER #7164&
K823433 · DYG
Cardiovascular · 14d
Cleared Jan 12, 1982
DINAMAP ADULT/PED./NEONATAL VITAL SIGNS
K813527 · DXN
Cardiovascular · 27d
Cleared Oct 26, 1979
CRITIKON DUAL CHANNEL RECORDER
K792105 · DSF
Cardiovascular · 4d
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