Medical Electronic Systems , 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
SQA-iOw Sperm Quality Analyzer510(k)May 2, 2025Hematology	Hematology	510(k)Substantially Equivalent (Dual Track)	May 2, 2025
YO Home Sperm Test510(k)Nov 29, 2024Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Nov 29, 2024
SQA-iO Sperm Quality Analyzer510(k)Aug 7, 2023Hematology	Hematology	510(k)Substantially Equivalent (Traditional)	Aug 7, 2023