Spectrum Medical , Ltd.
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories6
Latest Approval2025-07-08
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | DTR | 2025-07-08 | View |
| 510(k) | K212657 | Quantum Heater-Cooler | DWC | 2022-05-06 | View |
| 510(k) | K210669 | Quantum Mini Ventilation Module | DTX | 2021-05-04 | View |
| 510(k) | K202733 | Quantum Ventilation Module | DTX | 2020-10-16 | View |
| 510(k) | K202557 | Quantum Workstation 12 Elite | DRY | 2020-10-02 | View |
| 510(k) | K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | DWA | 2020-04-13 | View |
| 510(k) | K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | DTQ | 2019-05-24 | View |
| 510(k) | K181942 | Quantum Ventilation Module | DTX | 2018-10-18 | View |
| 510(k) | K181923 | Quantum Workstation 12.1 | DRY | 2018-08-17 | View |
| 510(k) | K173834 | Quantum Pump Console | DTQ | 2018-05-25 | View |
| 510(k) | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | DRY | 2018-03-28 | View |
| 510(k) | K163657 | Quantum Workstation | DRY | 2017-01-18 | View |
No matching devices.