Company ยท US
Critikon Company, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2000. Name variants (Inc, Corp, punctuation) are merged.
51510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 10 |
| FRN | Pump, Infusion | 7 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 6 |
| FPA | Set, Administration, Intravascular | 4 |
| DYG | Catheter, Flow Directed | 3 |
| DPS | Electrocardiograph | 2 |
| DQA | Oximeter | 2 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 |
| FPB | Filter, Infusion Line | 2 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DQY | Catheter, Percutaneous | 1 |
| DSF | Recorder, Paper Chart | 1 |
| FGO | Dislodger, Stone, Flexible | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 |
| LLE | Stimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease | 1 |
| MSX | System, Network And Communication, Physiological Monitors | 1 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 21, 2000 | K002248 | DINAMAP PRO 1000 MONITOR, MODEL 1000 Critikon Company, LLC | DXN |
| May 26, 2000 | K000500 | DINAMAP ADVANCED NIBP MODULE Critikon Company, LLC | DXN |
| Feb 24, 2000 | K992638 | DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 Critikon Company, LLC | MWI |
| Aug 14, 1998 | K982342 | DINAMAP MPS SELECT PORTABLE MONITOR Critikon Company, LLC | MSX |
| Jun 16, 1995 | K943709 | DINAMAP PLUS VITAL SIGNS MONOITOR Critikon Company, LLC | DPS |
| Mar 1, 1995 | K942700 | DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340 Critikon Company, LLC | MHX |
| Feb 9, 1994 | K933404 | CRITIKON CENTRAL STATIN MONITOR Critikon Company, LLC | DPS |
| Dec 14, 1993 | K933050 | CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH Critikon Company, LLC | FOZ |
| Jul 1, 1993 | K915697 | CRITIKON VITAL SIGNS MODULE Critikon Company, LLC | DXN |
| May 17, 1993 | K921295 | INTRAVENOUS CATHETERS MODIFICATIONS Critikon Company, LLC | FGO |
| Dec 4, 1991 | K912188 | DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 Critikon Company, LLC | MHX |
| Jun 3, 1991 | K911769 | RATEMINDER(TM) V INFUSION PUMP, MODIFICATION Critikon Company, LLC | FRN |
| Jul 26, 1990 | K902092 | RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY Critikon Company, LLC | FRN |
| May 9, 1990 | K894100 | OXYTRAK(TM) PULSE OXIMETER Critikon Company, LLC | DQA |
| Nov 1, 1989 | K893546 | OPTICALLY CLEAR RADIOPAQUE CATHETER Critikon Company, LLC | FOZ |
| May 11, 1988 | K874546 | SIM MODULE Critikon Company, LLC | FRN |
| Mar 29, 1988 | K875174 | RATEMINDER V INFUSION PUMP Critikon Company, LLC | FRN |
| Feb 18, 1988 | K874442 | DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER Critikon Company, LLC | DQA |
| Jan 14, 1988 | K875177 | J&J SCALP VEIN INFUSION SETS Critikon Company, LLC | FOZ |
| Dec 30, 1987 | K874378 | DINAMAP VITAL SIGNS MONITOR, MODEL 8100T Critikon Company, LLC | DXN |
| Dec 29, 1987 | K873729 | RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET Critikon Company, LLC | FPA |
| Jul 29, 1987 | K871418 | VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200) Critikon Company, LLC | DXN |
| Jul 22, 1986 | K861644 | CRITIKON 48-HOUR AIR ELIMINATING FILTER Critikon Company, LLC | FPB |
| May 16, 1986 | K854434 | DINAMAP VITAL SIGNS MONITOR MODEL 8100 Critikon Company, LLC | DXN |
| Oct 17, 1985 | K853701 | JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL Critikon Company, LLC | FOZ |
| May 28, 1985 | K844116 | CRITIKON CARDIAC OUTPUT COMPUTER W/HEMODYNAMIC Critikon Company, LLC | DXG |
| Apr 1, 1985 | K844839 | DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX Critikon Company, LLC | DXN |
| Mar 7, 1985 | K850507 | CRITIKON I.V. ADMINISTRAION SET Critikon Company, LLC | FPA |
| Sep 4, 1984 | K843141 | CRITIKON HEPARIN-COATED CARDIOVASCULAR Critikon Company, LLC | LDF |
| Jul 20, 1984 | K842316 | CRITIKON TRIPLE-LUMEN CENTRAL VENOUS Critikon Company, LLC | DQY |
| Jun 28, 1984 | K842075 | CRITIKON I.V. FILTER Critikon Company, LLC | FPB |
| Feb 21, 1984 | K833939 | NITROGLYCERIN I.V. ADMINISTRATION SET Critikon Company, LLC | FPA |
| Jan 30, 1984 | K833918 | INFUSION PORT BALLOON THERMODILUTION Critikon Company, LLC | DYG |
| Jan 30, 1984 | K833572 | HEPARIN-COATED BALLOON THERMODILUT Critikon Company, LLC | DYG |
| Nov 14, 1983 | K832916 | INIVOX ELECTRODE/CATHETER SYS Critikon Company, LLC | LLE |
| Nov 7, 1983 | K832656 | DINAMAP VITAL SIGNS MONITOR #1846P Critikon Company, LLC | DXN |
| Oct 28, 1983 | K831967 | CRITIKON CARDIAC OUTPUT COMPUTER Critikon Company, LLC | DXG |
| Aug 12, 1983 | K831761 | SIMPLICITY PLUS Critikon Company, LLC | FRN |
| Jun 30, 1983 | K831515 | DINAMAP VITAL SIGNS MONITOR #1846 Critikon Company, LLC | DXN |
| Apr 27, 1983 | K830972 | I.V. CATHETER PLACEMENT UNIT POLYURETH Critikon Company, LLC | FOZ |
| Nov 30, 1982 | K823433 | BALLOON THERMODILUTION CATHETER #7164& Critikon Company, LLC | DYG |
| Aug 16, 1982 | K821936 | CRITIKON OXYGEN MONITOR, MODEL 8030 Critikon Company, LLC | KLK |
| Aug 3, 1982 | K821890 | CRITIKON #817 ESOPHAGEAL MULTI-PROBE Critikon Company, LLC | BZT |
| Jan 26, 1982 | K813347 | CRITIKON TRANSCUTANEOUS GAS MONITORS Critikon Company, LLC | KLK |
| Jan 12, 1982 | K813527 | DINAMAP ADULT/PED./NEONATAL VITAL SIGNS Critikon Company, LLC | DXN |
| Jan 12, 1982 | K813345 | CRITIKON I.V. CATHETER PLACEMENT UNIT Critikon Company, LLC | FOZ |
| Jun 12, 1981 | K811107 | IV SETS Critikon Company, LLC | FPA |
| Jan 28, 1981 | K803078 | SIMPLICITY INFUSION PUMP MODEL 2100A Critikon Company, LLC | FRN |
| Aug 27, 1980 | K801546 | THE SIMPLICITY PUMP #2100 INFUSION PUMP Critikon Company, LLC | FRN |
| Oct 26, 1979 | K792105 | CRITIKON DUAL CHANNEL RECORDER Critikon Company, LLC | DSF |
Newest 50 of 51.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||