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Spectrum Medical , Ltd.

15 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) (K240908)Spectrum Medical , Ltd.2025-07-08
Quantum Heater-Cooler (K212657)Spectrum Medical , Ltd.2022-05-06
Quantum Mini Ventilation Module (K210669)Spectrum Medical , Ltd.2021-05-04
Quantum Ventilation Module (K202733)Spectrum Medical , Ltd.2020-10-16
Quantum Workstation 12 Elite (K202557)Spectrum Medical , Ltd.2020-10-02
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure (K192838)Spectrum Medical , Ltd.2020-04-13
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) (K190282)Spectrum Medical , Ltd.2019-05-24
Quantum Ventilation Module (K181942)Spectrum Medical , Ltd.2018-10-18
Quantum Workstation 12.1 (K181923)Spectrum Medical , Ltd.2018-08-17
Quantum Pump Console (K173834)Spectrum Medical , Ltd.2018-05-25
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (K173591)Spectrum Medical , Ltd.2018-03-28
Quantum Workstation (K163657)Spectrum Medical , Ltd.2017-01-18
M3 MONITOR (K091908)Spectrum Medical , Ltd.2009-07-10
M3 MONITOR (K072131)Spectrum Medical , Ltd.2007-08-17
M2 MONITOR (K071725)Spectrum Medical , Ltd.2007-07-11

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Every clearance here is in the API, with alerts when new ones post.