Company ยท US
Electro Medical Systems SA
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2002. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2002 | K022328 | EMS PIEZON MASTER 600 Electro Medical Systems SA | ELC |
| Jul 25, 2002 | K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE Electro Medical Systems SA | EFB |
| Aug 24, 2001 | K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) Electro Medical Systems SA | FFK |
| Oct 4, 2000 | K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL Electro Medical Systems SA | JDX |
| Oct 7, 1999 | K991857 | AIRFLOW HANDY Electro Medical Systems, Inc. | EFB |
| Jul 27, 1999 | K992251 | SWISS LITHOCLAST MULTIPURPOSE PROBE Electro Medical Systems SA | FFK |
| Mar 17, 1997 | K965203 | RADX SYSTEM Electro Medical Systems, Inc. | EHD |
| Feb 13, 1997 | K963285 | EMS SWISS LITHOCLAST LITHOTRIPTER Electro Medical Systems SA | FFK |
| Dec 16, 1996 | K964111 | LITHOVAC SUCTION/ASPIRATION PROBE Electro Medical Systems SA | KQT |
| Aug 28, 1995 | K953026 | MINIPIEZON Electro Medical Systems SA | ELC |
| Aug 24, 1995 | K951531 | SWISS LITHOCLAST LITHOTRIPTER Electro Medical Systems SA | FFK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2024 | Electro Medical Systems SA 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 so Open, Classified |
ELC | K190124 |
| Apr 24, 2024 | Electro Medical Systems SA 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 dent Open, Classified |
ELC | K190124 |
| Apr 24, 2024 | Electro Medical Systems SA 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 Open, Classified |
ELC | K190124 |