Data / Medical devices / Dressing, Wound, Drug / Germany
FDA-registered makers of Dressing, Wound, Drug in Germany: 8 establishments
8 establishments in Germany are registered with the FDA to make Dressing, Wound, Drug (product code FRO). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Dressing, Wound, Drug
- Product code
- FRO
- Country
- Germany
Makers of Dressing, Wound, Drug in Germany
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| BSN Medical GmbH | Hamburg, Germany | Complaint file establishment, Exporter to the US, Specification developer | 5 | August 21, 2017 | 0 | 0 | 0 | api.fda.gov |
| Solventum Germany GmbH | Kamen North Rhine-Westphalia, Germany | Complaint file establishment, Exporter to the US, Specification developer | 5 | March 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| BSN Medical GMBH | Hamburg, Germany | Contract manufacturer, Manufacturer | 3 | July 1, 2016 | 0 | 0 | 0 | api.fda.gov |
| Nawa Heilmittel GMBH | Nurnberg, Bavaria, Germany | Specification developer | 3 | October 31, 2014 | 0 | 0 | 0 | api.fda.gov |
| Osartis GMBH | Muenster Hesse, Germany | Specification developer | 2 | April 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Paul Hartmann AG | Heidenheim An Der Brenz Baden-Wurttemberg, Germany | Specification developer | 1 | December 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| MedSkin Solutions Dr. Suwelack AG | BILLERBECK North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rommelag CDMO GmbH | Sulzbach-Laufen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.