Electro Medical Systems SA: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Electro Medical Systems SA” (first 1995, latest 2002), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 51 days. 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FFK | Lithotriptor, Electro-Hydraulic | 4 | 4 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 1 | 1 |
| KQT | Evacuator, Gastro-Urology | 1 | 1 |
Review panels
- Gastroenterology and Urology (5)
- Dental (3)
- Orthopedic (1)
Most recent Electro Medical Systems SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022328 | EMS PIEZON MASTER 600 | ELC | 2002-08-13 | 26 |
| K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE | EFB | 2002-07-25 | 24 |
| K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | FFK | 2001-08-24 | 23 |
| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | JDX | 2000-10-04 | 51 |
| K992251 | SWISS LITHOCLAST MULTIPURPOSE PROBE | FFK | 1999-07-27 | 21 |
| K963285 | EMS SWISS LITHOCLAST LITHOTRIPTER | FFK | 1997-02-13 | 176 |
| K964111 | LITHOVAC SUCTION/ASPIRATION PROBE | KQT | 1996-12-16 | 62 |
| K953026 | MINIPIEZON | ELC | 1995-08-28 | 60 |
| K951531 | SWISS LITHOCLAST LITHOTRIPTER | FFK | 1995-08-24 | 143 |
Recalls
3 product recalls in 1 recall events; 3 initiated in the last five years. Most recent: 2024-03-13.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Electro Med Supply, Inc. (8 510(k)s)
- Electro Therapeutic Devices, Inc. (8 510(k)s)
- Electro Fiberoptics Corp. (3 510(k)s)
- Electro Medical Systems (Ems Sa) (2 510(k)s)
- Electro Medica Office (2 510(k)s)
- Electro Medical Systems, Inc. (2 510(k)s)
- Electro Science Technologies, Inc. (2 510(k)s)
- Electro Kinetic Technologies, LLC (1 510(k)s)
- Electro Medical Development (1 510(k)s)
- Electro Medical Equipment Co., Inc. (1 510(k)s)
- Electro Optical Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Electro Medical Systems SA?
FDA lists 9 510(k) clearances under the applicant name “Electro Medical Systems SA” (first 1995, latest 2002), across 5 product codes in 3 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 Electro Medical Systems SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electro Medical Systems SA is 51 days.
Which FDA product codes appear under Electro Medical Systems SA?
The most frequent FDA product codes under this applicant name are FFK (Lithotriptor, Electro-Hydraulic, 4); ELC (Scaler, Ultrasonic, 2); EFB (Handpiece, Air-Powered, Dental, 1).
Next steps
- See all 9 Electro Medical Systems SA clearances with predicates and recalls
- Run predicate analysis for product code FFK, Electro Medical Systems SA'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.