(Ems Sa) Electro Medical Systems: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “(Ems Sa) Electro Medical Systems” (first 1999, latest 2007), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 75 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 | 1 |
Review panels
- Dental (4)
- Orthopedic (1)
Most recent (Ems Sa) Electro Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073284 | AIR-FLOW MASTER STANDARD | EFB | 2007-12-14 | 23 |
| K032099 | SWISS MASTER LIGHT | EBZ | 2003-10-27 | 111 |
| K992504 | EMS KERMIT | ELC | 2000-01-27 | 184 |
| K991874 | EMS SURFACE MOUNT SCALER | ELC | 1999-07-30 | 58 |
| K991588 | EMS SWISS ORTHOCLAST | HSZ | 1999-07-21 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named (Ems Sa) Electro Medical Systems.
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 (Ems Sa) Electro Medical Systems?
FDA lists 5 510(k) clearances under the applicant name “(Ems Sa) Electro Medical Systems” (first 1999, latest 2007), across 4 product codes in 2 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 (Ems Sa) Electro Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name (Ems Sa) Electro Medical Systems is 75 days.
Which FDA product codes appear under (Ems Sa) Electro Medical Systems?
The most frequent FDA product codes under this applicant name are ELC (Scaler, Ultrasonic, 2); EBZ (Activator, Ultraviolet, For Polymerization, 1); EFB (Handpiece, Air-Powered, Dental, 1).
Next steps
- See all 5 (Ems Sa) Electro Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code ELC, (Ems Sa) Electro Medical Systems'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.