Data / Medical devices / Germany / Mint Medical GMBH
Mint Medical GMBH: FDA-registered device maker in Heidelberg Baden-Wurttemberg, Germany, 1 510(k) clearance
Mint Medical GMBH is registered with the FDA (registration 3011706018) in Heidelberg Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 13, 2015. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011706018
- Address
- Kurfuersten-Anlage 21, Heidelberg Baden-Wurttemberg, Germany, 69115
- Owner or operator
- Mint Medical GmbH (10049287)
- Roles
- Manufacturer
- First device listed
- May 6, 2015
- Registered through
- 2026
- Brand names listed
- mint Lesion
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | 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 |
|---|---|---|---|---|---|---|
| April 13, 2015 | K142647 | mint Lesion | LLZ | Substantially Equivalent | Mint Medical GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 7, 2026 | 98753 | Class II | Ongoing | Mint Lesion; Software Versions: 3.4.0 up to 3.9.5. | If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients. | accessdata.fda.gov |
| November 15, 2024 | 95880 | Class II | Ongoing | mint Lesion, Software Versions: 3.9.0 through 3.9.5. | Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. | accessdata.fda.gov |
Compare with other makers
Updated May 6, 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.