Company ยท US
E.M.S Electro Medical Systems S.A
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ELC | Scaler, Ultrasonic | 10 |
| EFB | Handpiece, Air-Powered, Dental | 6 |
| FEO | Lithotriptor, Ultrasonic | 5 |
| FFK | Lithotriptor, Electro-Hydraulic | 3 |
| DZI | Drill, Bone, Powered | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 |
| ISA | Massager, Therapeutic, Electric | 1 |
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 2026 | K253254 | GBT Machine Airflow Prophylaxis Master E.M.S Electro Medical Systems S.A, CH | ELC |
| Aug 13, 2025 | K243279 | DOLORCLAST Focused Shock Waves E.M.S Electro Medical Systems S.A, CH | PZL |
| Oct 23, 2023 | K230893 | Swiss LthoClast Trilogy E.M.S Electro Medical Systems S.A, CH | FEO |
| Jul 11, 2022 | K220538 | DolorClast Radial E.M.S Electro Medical Systems S.A, CH | ISA |
| Oct 20, 2019 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One E.M.S Electro Medical Systems S.A, CH | ELC |
| Aug 16, 2019 | K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED E.M.S Electro Medical Systems S.A, CH | ELC |
| May 29, 2019 | K191124 | Swiss LithoClast Trilogy E.M.S Electro Medical Systems S.A, CH | FFK |
| Oct 9, 2018 | K182490 | Swiss LithoClast Trilogy E.M.S Electro Medical Systems S.A, CH | FEO |
| Aug 30, 2018 | K181997 | Swiss LithoClast Trilogy E.M.S Electro Medical Systems S.A, CH | FEO |
| Jun 20, 2018 | K181364 | Swiss LithoClast Trilogy E.M.S Electro Medical Systems S.A, CH | FEO |
| Jan 10, 2018 | K173234 | Swiss LithoClast Trilogy E.M.S Electro Medical Systems S.A, CH | FEO |
| Dec 18, 2017 | K171174 | PERIO-FLOW nozzle E.M.S Electro Medical Systems S.A, CH | EFB |
| Sep 11, 2017 | K171189 | AIR-FLOW PLUS Prophylaxis powder E.M.S Electro Medical Systems S.A, CH | EJR |
| Feb 3, 2016 | K151912 | AIR-FLOW handy 3.0 PLUS E.M.S Electro Medical Systems S.A, CH | EFB |
| Feb 27, 2015 | K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED E.M.S Electro Medical Systems S.A | ELC |
| Apr 11, 2014 | K132478 | AIR-FLOW HANDY 3.0 E.M.S Electro Medical Systems S.A | EFB |
| Feb 24, 2014 | K132480 | AIR-FLOW HANDY 3.0 PERIO E.M.S Electro Medical Systems S.A | EFB |
| Dec 6, 2013 | K132445 | PIEZON 250 E.M.S Electro Medical Systems S.A | ELC |
| Nov 22, 2013 | K132443 | PIEZON 150 E.M.S Electro Medical Systems S.A | ELC |
| Jan 16, 2013 | K123038 | SWISS LITHOBREAKER E.M.S Electro Medical Systems S.A | FFK |
| Apr 7, 2011 | K110173 | EMS AIR-FLOW MASTER PIEZON E.M.S Electro Medical Systems S.A | ELC |
| Sep 8, 2010 | K093723 | EMS MINIMASTER LED E.M.S Electro Medical Systems S.A | ELC |
| Jul 30, 2010 | K093000 | EMS PIEZON MASTER 700 E.M.S Electro Medical Systems S.A | ELC |
| Oct 20, 2009 | K092289 | EMS AIR-FLOW HANDY PERIO E.M.S Electro Medical Systems S.A | EFB |
| Feb 18, 2009 | K082791 | EMS AIR-FLOW MASTER E.M.S Electro Medical Systems S.A | EFB |
| Dec 18, 2007 | K072146 | EMS PIEZON MASTER SURGERY E.M.S Electro Medical Systems S.A | DZI |
| Aug 10, 2007 | K071722 | DEEP BLUE E.M.S Electro Medical Systems S.A | EBZ |
| Mar 30, 2005 | K050710 | MINIMASTER ULTRASONIC SCALER E.M.S Electro Medical Systems S.A | ELC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2007 | E.M.S. - Electro Medical Systems SA Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System . Terminated |
FFK | K012445 |