E.M.S Electro Medical Systems S.A

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253254GBT Machine Airflow Prophylaxis MasterJanuary 28, 2026
K243279DOLORCLAST Focused Shock WavesAugust 13, 2025
K230893Swiss LthoClast TrilogyOctober 23, 2023
K220538DolorClast RadialJuly 11, 2022
K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneOctober 20, 2019
K191079Piezon Built-in Kit, Piezon Built-in Kit LEDAugust 16, 2019
K191124Swiss LithoClast TrilogyMay 29, 2019
K182490Swiss LithoClast TrilogyOctober 9, 2018
K181997Swiss LithoClast TrilogyAugust 30, 2018
K181364Swiss LithoClast TrilogyJune 20, 2018
K173234Swiss LithoClast TrilogyJanuary 10, 2018
K171174PERIO-FLOW nozzleDecember 18, 2017
K171189AIR-FLOW PLUS Prophylaxis powderSeptember 11, 2017
K151912AIR-FLOW handy 3.0 PLUSFebruary 3, 2016
K140990EMS PIEZON 707 BIK AND PIEZON 707 BIK LEDFebruary 27, 2015
K132478AIR-FLOW HANDY 3.0April 11, 2014
K132480AIR-FLOW HANDY 3.0 PERIOFebruary 24, 2014
K132445PIEZON 250December 6, 2013
K132443PIEZON 150November 22, 2013
K123038SWISS LITHOBREAKERJanuary 16, 2013