Spectrum Medical , Ltd.
Spectrum Medical , Ltd. holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2025, with 4 FDA device recalls on record.
Top product codes for Spectrum Medical , Ltd.
FDA recalls by Spectrum Medical , Ltd.
- Z-1696-2025 — Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.
- Z-1695-2025 — Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.
- Z-0224-2025 — Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
- Z-2238-2019 — Quantum Pump Console
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Spectrum Medical , Ltd.
- K240908 — Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)
- K212657 — Quantum Heater-Cooler
- K210669 — Quantum Mini Ventilation Module
- K202733 — Quantum Ventilation Module
- K202557 — Quantum Workstation 12 Elite
- K192838 — Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
- K190282 — Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
- K181942 — Quantum Ventilation Module
- K181923 — Quantum Workstation 12.1
- K173834 — Quantum Pump Console
- K173591 — Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
- K163657 — Quantum Workstation
- K091908 — M3 MONITOR
- K072131 — M3 MONITOR
- K071725 — M2 MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.