Data / Medical devices / Lithotriptor, Extracorporeal Shock-Wave, Urological
Lithotriptor, Extracorporeal Shock-Wave, Urological (LNS): 12 FDA-registered makers in 7 countries
12 establishments in 7 countries are registered with the FDA to make Lithotriptor, Extracorporeal Shock-Wave, Urological (product code LNS, Class 2, 21 CFR 876.5990). 11 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 56 510(k) clearances under this code, the latest on April 29, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- LNS
- Device class
- 2
- Regulation
- 876.5990
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Germany | 4 |
| Israel | 2 |
| United States | 2 |
| Switzerland | 1 |
| France | 1 |
| South Korea | 1 |
| China | 1 |
Makers of Lithotriptor, Extracorporeal Shock-Wave, Urological
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Storz Medical AG | TAEGERWILEN Thurgau, Switzerland | Manufacturer | 8 | March 30, 2021 | 1 | 0 | 0 | api.fda.gov |
| Dornier Medtech GMBH | WESSLING Bavaria, Germany | Complaint file establishment, Exporter to the US, Manufacturer | 7 | February 22, 2023 | 1 | 0 | 0 | api.fda.gov |
| Initia, Ltd. | Petah Tikva Central, Israel | Manufacturer | 3 | March 1, 2012 | 0 | 0 | 0 | api.fda.gov |
| Medispec, Ltd. | YEHUD Central, Israel | Manufacturer | 2 | March 9, 2007 | 1 | 0 | 0 | api.fda.gov |
| Siemens Healthineers AG | FORCHHEIM Bavaria, Germany | Exporter to the US, Manufacturer | 3 | June 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| EDAP TMS France SA | Vaulx en Velin Rhone, France | Manufacturer | 1 | August 1, 2011 | 0 | 0 | 0 | api.fda.gov |
| Huons Meditech Co., Ltd | Seongnam-si Gyeonggi, South Korea | Manufacturer | 1 | July 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| MTS Medical AG | KONSTANZ Baden-Wurttemberg, Germany | Manufacturer | 1 | November 2, 2006 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Wikkon Precision Technologies Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | June 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Softwave Tissue Regeneraton Technologies, LLC | Alpharetta, GA, United States | Complaint file establishment, Specification developer | 1 | November 2, 2006 | 0 | 0 | 0 | api.fda.gov |
| United Service Solutions, LLC | Westborough, MA, United States | Specification developer | 1 | January 30, 2008 | 0 | 0 | 0 | api.fda.gov |
| Richard Wolf GMBH | KNITTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.