E.M.S Electro Medical Systems S.A FDA Approvals

0 new drug approvals and 4 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
GBT Machine Airflow Prophylaxis Master510(k)Jan 28, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 28, 2026
DOLORCLAST Focused Shock Waves510(k)Aug 13, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Aug 13, 2025
Swiss LthoClast Trilogy510(k)Oct 23, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Oct 23, 2023
DolorClast Radial510(k)Jul 11, 2022Physical Medicine	Physical Medicine	510(k)Substantially Equivalent (Traditional)	Jul 11, 2022