Data / Medical devices / Germany / MTS Medical AG
MTS Medical AG: FDA-registered device maker in KONSTANZ Baden-Wurttemberg, Germany, 5 510(k) clearances
MTS Medical AG is registered with the FDA (registration 3005462245) in KONSTANZ Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 9, 2024. Registered through 2027. 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.
- FDA registration number
- 3005462245
- Address
- ROBERT-BOSCH-STRASSE 18 ROBERT-BOSCH-STRASSE 9 (Production Facility), ROBERT-BOSCH-STRASSE 11 (Purchasing, Incoming goods, Storage), KONSTANZ Baden-Wurttemberg, Germany, 78467
- Owner or operator
- MTS Medical AG (9088139)
- Roles
- Manufacturer
- First device listed
- November 20, 2006
- Registered through
- 2027
- Brand names listed
- DermaGold100, model OW100-US, LITHOGOLD, OW100S, model OW100S-US, OrthoGold100, model OW100-US, Softwave Gold Li
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers | PZL | 2 | Manufacturer | accessdata.fda.gov |
| Lithotriptor, Extracorporeal Shock-Wave, Urological | LNS | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 9, 2024 | K233937 | OW100S | PZL | Substantially Equivalent | Softwave/Trt, LLC | accessdata.fda.gov |
| October 12, 2022 | K213120 | OW100S (model OW100S-US) | ISA | Substantially Equivalent | Tissue Regeneration Technologies, LLC Dba AS Softwave Trt | accessdata.fda.gov |
| May 5, 2021 | K210451 | OrthoGold 100 | ISA | Substantially Equivalent | Tissue Regeneration Technologies, LLC | accessdata.fda.gov |
| August 28, 2020 | K200926 | OrthoGold 100 | PZL | Substantially Equivalent | Tissue Regeneration Technologies, LLC | accessdata.fda.gov |
| November 2, 2006 | K062081 | LITHOGOLD | LNS | Substantially Equivalent | Tissue Regeneration Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Lithotriptor, Extracorporeal Shock-Wave, Urological
- All makers of Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Updated July 9, 2024. 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.