E.M.S Electro Medical Systems S.A: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “E.M.S Electro Medical Systems S.A” (first 2005, latest 2026), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 129 days. Since 2017 the median was 121 days, against 196 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 110 |
| 2014 | 2 | 223 |
| 2015 | 1 | 316 |
| 2016 | 1 | 205 |
| 2017 | 2 | 190 |
| 2018 | 4 | 32 |
| 2019 | 3 | 115 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 136 |
| 2023 | 1 | 206 |
| 2024 | 0 | — |
| 2025 | 1 | 301 |
| 2026 | 1 | 121 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name E.M.S Electro Medical Systems S.A took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 196 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | 10 | 10 |
| EFB | Handpiece, Air-Powered, Dental | 6 | 6 |
| FEO | Lithotriptor, Ultrasonic | 5 | 5 |
| FFK | Lithotriptor, Electro-Hydraulic | 2 | 2 |
| DZI | Drill, Bone, Powered | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
| PZL | Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | 1 | 1 |
Review panels
Most recent E.M.S Electro Medical Systems S.A 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253254 | GBT Machine Airflow Prophylaxis Master | ELC | 2026-01-28 | 121 |
| K243279 | DOLORCLAST Focused Shock Waves | PZL | 2025-08-13 | 301 |
| K230893 | Swiss LthoClast Trilogy | FEO | 2023-10-23 | 206 |
| K220538 | DolorClast Radial | ISA | 2022-07-11 | 136 |
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | ELC | 2019-10-20 | 268 |
| K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | ELC | 2019-08-16 | 115 |
| K191124 | Swiss LithoClast Trilogy | FFK | 2019-05-29 | 30 |
| K182490 | Swiss LithoClast Trilogy | FEO | 2018-10-09 | 28 |
| K181997 | Swiss LithoClast Trilogy | FEO | 2018-08-30 | 35 |
| K181364 | Swiss LithoClast Trilogy | FEO | 2018-06-20 | 28 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named E.M.S Electro Medical Systems S.A.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under E.M.S Electro Medical Systems S.A?
FDA lists 28 510(k) clearances under the applicant name “E.M.S Electro Medical Systems S.A” (first 2005, latest 2026), across 9 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by E.M.S Electro Medical Systems S.A?
The median time from FDA receipt to decision across 510(k)s cleared under the name E.M.S Electro Medical Systems S.A is 129 days. Since 2017: 121 days, versus 196 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under E.M.S Electro Medical Systems S.A?
The most frequent FDA product codes under this applicant name are ELC (Scaler, Ultrasonic, 10); EFB (Handpiece, Air-Powered, Dental, 6); FEO (Lithotriptor, Ultrasonic, 5).
Next steps
- See all 28 E.M.S Electro Medical Systems S.A clearances with predicates and recalls
- Run predicate analysis for product code ELC, E.M.S Electro Medical Systems S.A's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.