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Spectrum Medical , Ltd.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories6
Latest FDA decision2025-07-08
TypeNumberDevice NameCodeDateActions
510(k) K240908 Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)DTR2025-07-08 View
510(k) K212657 Quantum Heater-CoolerDWC2022-05-06 View
510(k) K210669 Quantum Mini Ventilation ModuleDTX2021-05-04 View
510(k) K202733 Quantum Ventilation ModuleDTX2020-10-16 View
510(k) K202557 Quantum Workstation 12 EliteDRY2020-10-02 View
510(k) K192838 Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureDWA2020-04-13 View
510(k) K190282 Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ2019-05-24 View
510(k) K181942 Quantum Ventilation ModuleDTX2018-10-18 View
510(k) K181923 Quantum Workstation 12.1DRY2018-08-17 View
510(k) K173834 Quantum Pump ConsoleDTQ2018-05-25 View
510(k) K173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasDRY2018-03-28 View
510(k) K163657 Quantum WorkstationDRY2017-01-18 View
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