Medical, Inc.
Medical device manufacturer in Amersfoort, NL.
22510(k) clearances
0PMA approvals
0recalls
Device types
- JOD Filter, Blood, Cardiotomy Suction Line… 4
- DTM Filter, Blood, Cardiopulmonary Bypass… 4
- FJG Dialyzer, Parallel Flow 3
- KRJ Filter, Prebypass, Cardiopulmonary Bypass 3
- CAK Microfilter, Blood Transfusion 2
- CCL Analyzer, Gas, Oxygen, Gaseous-Phase 2
- FPB Filter, Infusion Line 1
- BZC Calculator, Pulmonary Function Data 1
- CAI Circuit, Breathing (W Connector, Adaptor, Y… 1
- OMP Negative Pressure Wound Therapy Powered… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K082311 | Exsudex Wound Drainage PumpOMP · Abbreviated | 10/08/2008SE |
| K926454 | Anesthesia Respiratory Breath Circuit Packs/ComponCAI · Traditional | 06/22/1993SEKD |
| K894839 | OS-1 Occlusion System - 1BZC · Traditional | 10/24/1989SE |
| K872001 | Model TPC-1A Oxygen AnalyzerCCL · Traditional | 06/15/1987SE |
| K863806 | Model A-1 Oxygen AnalyzerCCL · Traditional | 10/15/1986SE |
| K862609 | Interface Arterial Blood Filter, Model 44DTM · Traditional | 09/04/1986SE |
| K862591 | Interface Arterial Blood Filter, Model 42DTM · Traditional | 09/04/1986SE |
| K861226 | Interface Crystalloid Cardioplegic Filter Model 70KRJ · Traditional | 06/02/1986SE |
| K851370 | Interface Transfusion Blood Filter #35CAK · Traditional | 06/27/1985SE |
| K823261 | Interface Transfusion Blood Filter #30CAK · Traditional | 01/07/1983SE |
| K823260 | Interface Cardiotomy Blood Filter #51JOD · Traditional | 11/24/1982SE |
| K823259 | Interface Cardiotomy Blood Filter #50JOD · Traditional | 11/24/1982SE |
| K823258 | Interface Arterial Blood Filter #40DTM · Traditional | 11/24/1982SE |
| K813131 | Interface Arterial Blood FilterDTM · Traditional | 11/27/1981SE |
| K812244 | Interface Pre Bypass Prime Filter #90KRJ · Traditional | 08/25/1981SE |
| K812243 | Interface Cardiotomy Blood Filter #51JOD · Traditional | 08/25/1981SE |
| K812240 | Interface Pre Bypass Prime FilterKRJ · Traditional | 08/25/1981SE |
| K801451 | Isonephros-Pediatric, Standard, OptimumFJG · Traditional | 09/26/1980SE |
| K790758 | Hemoclear U-Nephros 1.0 DialyzerFJG · Traditional | 05/08/1979SE |
| K781795 | Dialyzer, Parallel Flow DisposableFJG · Traditional | 12/15/1978SE |
| K781383 | Interface Cardiotomy Blood FilterJOD · Traditional | 09/27/1978SE |
| K771862 | Transfusion Blood FilterFPB · Traditional | 10/13/1977SE |