Elmed USA
Country not established
- Devices
- 1
What Elmed USA makes
Elmed USA manufactures the Vibrolith and Vibrolith Plus, which are intracorporeal lithotriptors designed for breaking kidney and ureteral stones using shockwave technology.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Elmed USA have in the registry?
The registry currently lists 1 device for Elmed USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elmed USA's devices?
Among its 1 most recently registered device, Elmed USA has devices listed in FDA 510(k) (1 device).
What risk classes do Elmed USA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Elmed USA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elmed USA in the registry?
The most recently registered devices listed for Elmed USA include VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR.