Electro Medical Systems (Ems Sa)

FDA registration: United States Last updated 23 May 2026

Catalogue12

Ems Swiss Lithoclast Lithotripter Ref K963285

Class II FDA 510(k) Active
Lithovac Suction/Aspiration Probe Ref K964111

Class II FDA 510(k) Active
Ems Swiss Orthoclast Chisels For Non-Cemented Prosthesis Removal Ref K002484

Class II FDA 510(k) Active
Air Flow Sii Ref K900709

Class II FDA 510(k) Active
Swiss Lithoclast Multipurpose Probe Ref K992251

Class II FDA 510(k) Active
Minipiezon Ref K953026

Class II FDA 510(k) Active
Ems Swiss Lithoclast Master (A.K.A. Swiss Lithoclast Ultra) Ref K012445

Class II FDA 510(k) Active
Piezon Master 400 Ref K896749

Class II FDA 510(k) Active
Ems Piezon Master 600 Ref K022328

Class II FDA 510(k) Active
Ems Air-Flow Handy 2 Dental Handpiece Ref K022119

Class I FDA 510(k) Active
Swiss Lithoclast Lithotripter Ref K951531

Class II FDA 510(k) Active
Ems Swiss Dolorclast Ref P050004

Class III FDA PMA Active

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

2003
- 3 Oct 2003 Z-0078-04 Unclassified (pre-2012) Terminated Failure of foot pedal to activate device