Electro Medical Systems SA
Electro Medical Systems SA holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2002, with 3 FDA device recalls on record.
Top product codes for Electro Medical Systems SA
FDA recalls by Electro Medical Systems SA
- Z-1686-2024 — Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
- Z-1687-2024 — Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
- Z-1688-2024 — Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Electro Medical Systems SA
- K022328 — EMS PIEZON MASTER 600
- K022119 — EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE
- K012445 — EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
- K002484 — EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL
- K992251 — SWISS LITHOCLAST MULTIPURPOSE PROBE
- K963285 — EMS SWISS LITHOCLAST LITHOTRIPTER
- K964111 — LITHOVAC SUCTION/ASPIRATION PROBE
- K953026 — MINIPIEZON
- K951531 — SWISS LITHOCLAST LITHOTRIPTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.