Data / Medical devices / Switzerland / B. Braun Medical AG
B. Braun Medical AG: FDA-registered device maker in Sempach Luzern, Switzerland, 4 510(k) clearances
B. Braun Medical AG is registered with the FDA (registration 3007120504) in Sempach Luzern, Switzerland. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated May 23, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3007120504
- Address
- Seesatz 17, Sempach Luzern, Switzerland, CH-6204
- Owner or operator
- B. BRAUN MELSUNGEN AG (8010484)
- Roles
- Manufacturer, Specification developer
- First device listed
- June 24, 2008
- Registered through
- 2026
- Brand names listed
- Helimatic Cleaner Alcaline, Helimatic Cleaner MA, Prontosan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 23, 2017 | K163430 | Prontosan Wound Gel | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| November 10, 2016 | K161623 | Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| October 8, 2013 | K130857 | PRONTOSAN WOUND GEL X | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 19, 2008 | K072876 | PRONTOSAN WOUND IRRIGATION SOLUTION | FRO | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 23, 2017. 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.