Spectrum Medical , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Quantum Micro-Cardioplegia Delivery System, Quantum Heater-Cooler, Quantum Mini Ventilation Module
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Spectrum Medical , Ltd. Cardiovascular ✕
15 devices
Cleared
Jul 08, 2025
Quantum Micro-Cardioplegia Delivery System
Cardiovascular
462d
Cleared
May 06, 2022
Quantum Heater-Cooler
Cardiovascular
256d
Cleared
May 04, 2021
Quantum Mini Ventilation Module
Cardiovascular
60d
Cleared
Oct 16, 2020
Quantum Ventilation Module
Cardiovascular
28d
Cleared
Oct 02, 2020
Quantum Workstation 12 Elite
Cardiovascular
29d
Cleared
Apr 13, 2020
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium...
Cardiovascular
193d
Cleared
May 24, 2019
Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
Cardiovascular
102d
Cleared
Oct 18, 2018
Quantum Ventilation Module
Cardiovascular
90d
Cleared
Aug 17, 2018
Quantum Workstation 12.1
Cardiovascular
30d
Cleared
May 25, 2018
Quantum Pump Console
Cardiovascular
158d
Cleared
Mar 28, 2018
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
Cardiovascular
127d
Cleared
Jan 18, 2017
Quantum Workstation
Cardiovascular
26d