Medical Device Manufacturer · US , North Attleboro , MA

E.M.S Electro Medical Systems S.A

28 submissions · 28 cleared · Since 2005
28
Total
28
Cleared
0
Denied

E.M.S Electro Medical Systems S.A — FDA 510(k) Submissions

E.M.S Electro Medical Systems S.A has submitted 28 FDA 510(k) premarket notifications since 2005, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Scaler, Ultrasonic, Handpiece, Air-powered, Dental, Lithotriptor, Ultrasonic, Lithotriptor, Electro-hydraulic, Agent, Polishing, Abrasive, Oral Cavity . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
GBT Machine Airflow Prophylaxis Master
K253254 · ELC Scaler, Ultrasonic · Dental
Jan 2026 121d
DOLORCLAST Focused Shock Waves
K243279 · PZL Extracorporeal Shock Wave... · General & Plastic Surgery
Aug 2025 301d
Swiss LthoClast Trilogy
K230893 · FEO Lithotriptor, Ultrasonic · Gastroenterology & Urology
Oct 2023 206d
DolorClast Radial
K220538 · ISA Massager, Therapeutic,... · Physical Medicine
Jul 2022 136d
EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
K190124 · ELC Scaler, Ultrasonic · Dental
Oct 2019 268d
Piezon Built-in Kit, Piezon Built-in Kit LED
K191079 · ELC Scaler, Ultrasonic · Dental
Aug 2019 115d
Swiss LithoClast Trilogy
K191124 · FFK Lithotriptor,... · Gastroenterology & Urology
May 2019 30d
Swiss LithoClast Trilogy
K182490 · FEO Lithotriptor, Ultrasonic · Gastroenterology & Urology
Oct 2018 28d
Swiss LithoClast Trilogy
K181997 · FEO Lithotriptor, Ultrasonic · Gastroenterology & Urology
Aug 2018 35d
Swiss LithoClast Trilogy
K181364 · FEO Lithotriptor, Ultrasonic · Gastroenterology & Urology
Jun 2018 28d
Swiss LithoClast Trilogy
K173234 · FEO Lithotriptor, Ultrasonic · Gastroenterology & Urology
Jan 2018 97d
PERIO-FLOW nozzle
K171174 · EFB Handpiece, Air-powered,... · Dental
Dec 2017 241d
AIR-FLOW PLUS Prophylaxis powder
K171189 · EJR Agent, Polishing,... · Dental
Sep 2017 140d
AIR-FLOW handy 3.0 PLUS
K151912 · EFB Handpiece, Air-powered,... · Dental
Feb 2016 205d
EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
K140990 · ELC Scaler, Ultrasonic · Dental
Feb 2015 316d
AIR-FLOW HANDY 3.0
K132478 · EFB Handpiece, Air-powered,... · Dental
Apr 2014 246d
AIR-FLOW HANDY 3.0 PERIO
K132480 · EFB Handpiece, Air-powered,... · Dental
Feb 2014 200d
PIEZON 250
K132445 · ELC Scaler, Ultrasonic · Dental
Dec 2013 122d
PIEZON 150
K132443 · ELC Scaler, Ultrasonic · Dental
Nov 2013 108d
SWISS LITHOBREAKER
K123038 · FFK Lithotriptor,... · Gastroenterology & Urology
Jan 2013 110d
EMS AIR-FLOW MASTER PIEZON
K110173 · ELC Scaler, Ultrasonic · Dental
Apr 2011 77d
EMS MINIMASTER LED
K093723 · ELC Scaler, Ultrasonic · Dental
Sep 2010 279d
EMS PIEZON MASTER 700
K093000 · ELC Scaler, Ultrasonic · Dental
Jul 2010 305d
EMS AIR-FLOW HANDY PERIO
K092289 · EFB Handpiece, Air-powered,... · Dental
Oct 2009 83d
EMS AIR-FLOW MASTER
K082791 · EFB Handpiece, Air-powered,... · Dental
Feb 2009 148d
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