Spectrum Medical , Ltd. FDA Approvals

0 new drug approvals and 3 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	What it is	Route	Decided
Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)510(k)Jul 8, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 8, 2025
Quantum Heater-Cooler510(k)May 6, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 6, 2022
Quantum Mini Ventilation Module510(k)May 4, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 4, 2021