Critikon Company, LLC
Medical device manufacturer in Tampa, FL.
51510(k) clearances
0PMA approvals
0recalls
Device types
- DXN System, Measurement, Blood-Pressure… 10
- FRN Pump, Infusion 7
- FOZ Catheter, Intravascular, Therapeutic… 6
- FPA Set, Administration, Intravascular 4
- DYG Catheter, Flow Directed 3
- KLK Monitor, Oxygen, Cutaneous, For Infant Not… 2
- DXG Computer, Diagnostic, Pre-Programmed… 2
- DPS Electrocardiograph 2
- FPB Filter, Infusion Line 2
- MHX Monitor, Physiological, Patient(With… 2
- DQA Oximeter 2
- LLE Stimulator, Spinal-Cord, Implanted For… 1
- MWI Monitor, Physiological, Patient (Without… 1
- MSX System, Network And Communication… 1
- FGO Dislodger, Stone, Flexible 1
- LDF Electrode, Pacemaker, Temporary 1
- DQY Catheter, Percutaneous 1
- CCL Analyzer, Gas, Oxygen, Gaseous-Phase 1
- BZT Stethoscope, Esophageal, With Electrical… 1
- DSF Recorder, Paper Chart 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K002248 | Dinamap Pro 1000 Monitor, Model 1000DXN · Traditional | 09/21/2000SE |
| K000500 | Dinamap Advanced Nibp ModuleDXN · Traditional | 05/26/2000SE |
| K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400MWI · Traditional | 02/24/2000SE |
| K982342 | Dinamap MPS Select Portable MonitorMSX · Traditional | 08/14/1998SE |
| K943709 | Dinamap Plus Vital Signs MonoitorDPS · Traditional | 06/16/1995SE |
| K942700 | Dinamap Vital Signs Monitor Models 9300 and 9320/9340MHX · Traditional | 03/01/1995SE |
| K933404 | Critikon Central Statin MonitorDPS · Traditional | 02/09/1994SE |
| K933050 | Changes to Protectiv(Tm) & Jelco(Tm) Winged CathFOZ · Traditional | 12/14/1993SE |
| K915697 | Critikon Vital Signs ModuleDXN · Traditional | 07/01/1993SE |
| K921295 | Intravenous Catheters ModificationsFGO · Traditional | 05/17/1993SE |
| K912188 | Dinamap Plus Physiological Monitor Model 8700MHX · Traditional | 12/04/1991SE |
| K911769 | Rateminder(Tm) V Infusion Pump, ModificationFRN · Traditional | 06/03/1991SE |
| K902092 | Rateminder V Infusion Pump W/Secondary CapabilityFRN · Traditional | 07/26/1990SE |
| K894100 | Oxytrak(Tm) Pulse OximeterDQA · Traditional | 05/09/1990SE |
| K893546 | Optically Clear Radiopaque CatheterFOZ · Traditional | 11/01/1989SE |
| K874546 | Sim ModuleFRN · Traditional | 05/11/1988SE |
| K875174 | Rateminder V Infusion PumpFRN · Traditional | 03/29/1988SE |
| K874442 | Dinamap Vital Signs Monitor/Pulse OximeterDQA · Traditional | 02/18/1988SE |
| K875177 | J&J Scalp Vein Infusion SetsFOZ · Traditional | 01/14/1988SE |
| K874378 | Dinamap Vital Signs Monitor, Model 8100TDXN · Traditional | 12/30/1987SE |
| K873729 | Rate-Mate Nitroglycerin I.V. Administration SetFPA · Traditional | 12/29/1987SE |
| K871418 | Vitalnet(Tm) System (Dinamap(Tm), Model 2200)DXN · Traditional | 07/29/1987SE |
| K861644 | Critikon 48-HOUR Air Eliminating FilterFPB · Traditional | 07/22/1986SE |
| K854434 | Dinamap Vital Signs Monitor Model 8100DXN · Traditional | 05/16/1986SE |
| K853701 | Jelco & Cathlon IV Striped IV Catheters-RadiopagulFOZ · Traditional | 10/17/1985SE |
| K844116 | Critikon Cardiac Output Computer W/HemodynamicDXG · Traditional | 05/28/1985SE |
| K844839 | Dinamap Vital Signs Monitor 1846 SX & 1846P SXDXN · Traditional | 04/01/1985SE |
| K850507 | Critikon I.V. Administraion SetFPA · Traditional | 03/07/1985SE |
| K843141 | Critikon Heparin-Coated CardiovascularLDF · Traditional | 09/04/1984SE |
| K842316 | Critikon Triple-Lumen Central VenousDQY · Traditional | 07/20/1984SE |
| K842075 | Critikon I.V. FilterFPB · Traditional | 06/28/1984SE |
| K833939 | Nitroglycerin I.V. Administration SetFPA · Traditional | 02/21/1984SE |
| K833918 | Infusion Port Balloon ThermodilutionDYG · Traditional | 01/30/1984SE |
| K833572 | Heparin-Coated Balloon ThermodilutDYG · Traditional | 01/30/1984SE |
| K832916 | Inivox Electrode/Catheter SysLLE · Traditional | 11/14/1983SE |
| K832656 | Dinamap Vital Signs Monitor #1846PDXN · Traditional | 11/07/1983SE |
| K831967 | Critikon Cardiac Output ComputerDXG · Traditional | 10/28/1983SE |
| K831761 | Simplicity PlusFRN · Traditional | 08/12/1983SE |
| K831515 | Dinamap Vital Signs Monitor #1846DXN · Traditional | 06/30/1983SE |
| K830972 | I.V. Catheter Placement Unit PolyurethFOZ · Traditional | 04/27/1983SE |
| K823433 | Balloon Thermodilution Catheter #7164&DYG · Traditional | 11/30/1982SE |
| K821936 | Critikon Oxygen Monitor, Model 8030KLK · Traditional | 08/16/1982SE |
| K821890 | Critikon #817 Esophageal Multi-ProbeBZT · Traditional | 08/03/1982SE |
| K813347 | Critikon Transcutaneous Gas MonitorsKLK · Traditional | 01/26/1982SE |
| K813527 | Dinamap Adult/Ped./Neonatal Vital SignsDXN · Traditional | 01/12/1982SE |
| K813345 | Critikon I.V. Catheter Placement UnitFOZ · Traditional | 01/12/1982SE |
| K811107 | IV SetsFPA · Traditional | 06/12/1981SE |
| K803078 | Simplicity Infusion Pump Model 2100AFRN · Traditional | 01/28/1981SE |
| K801546 | The Simplicity Pump #2100 Infusion PumpFRN · Traditional | 08/27/1980SE |
| K792105 | Critikon Dual Channel RecorderDSF · Traditional | 10/26/1979SE |
| K782114 | Monitor, Oxychek OxygenCCL · Traditional | 01/18/1979SE |