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Spectrum Medical S.R.L. FDA Approvals
0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W510(k)Mar 12, 2026Cardiovascular |
| Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);510(k)Mar 12, 2026Cardiovascular |
| Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)510(k)Aug 4, 2025Cardiovascular |
| Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)510(k)Jun 24, 2025Cardiovascular |
| Quantum Perfusion Hybrid System510(k)Jul 18, 2024Cardiovascular |
| Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)510(k)May 31, 2024Cardiovascular |