Electro Medical Systems SA
Medical device manufacturer in Nyon, Swit.
11510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K022328 | EMS Piezon Master 600ELC · Special | 08/13/2002SE |
| K022119 | EMS Air-Flow Handy 2 Dental HandpieceEFB · Special | 07/25/2002SE |
| K012445 | EMS Swiss Lithoclast Master (A.K.A. Swiss Lithoclast Ultra)FFK · Special | 08/24/2001SE |
| K002484 | EMS Swiss Orthoclast Chisels for Non-Cemented Prosthesis RemovalJDX · Traditional | 10/04/2000SE |
| K991857 | Airflow HandyEFB · Traditional | 10/07/1999SE |
| K992251 | Swiss Lithoclast Multipurpose ProbeFFK · Special | 07/27/1999SE |
| K965203 | Radx SystemEHD · Traditional | 03/17/1997SE |
| K963285 | EMS Swiss Lithoclast LithotripterFFK · Traditional | 02/13/1997SE |
| K964111 | Lithovac Suction/Aspiration ProbeKQT · Traditional | 12/16/1996SE |
| K953026 | MinipiezonELC · Traditional | 08/28/1995SE |
| K951531 | Swiss Lithoclast LithotripterFFK · Traditional | 08/24/1995SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1688-2024 Class II | Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111…Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts… | 03/13/2024Open, Classified |
| Z-1687-2024 Class II | Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121…Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts… | 03/13/2024Open, Classified |
| Z-1686-2024 Class II | Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000…Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts… | 03/13/2024Open, Classified |