Mint Medical GmbH
FDA Regulatory Profile
Mint Medical GmbH appears in FDA public data with 3 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2068-2026, Class II) was initiated on January 7, 2026. Its most recent 510(k) clearance was granted on April 13, 2015.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2068-2026 | Class II | Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.; | January 7, 2026 |
| Z-0709-2025 | Class II | mint Lesion, Software Versions: 3.9.0 through 3.9.5. | November 15, 2024 |
| Z-0710-2025 | Class II | mint Lesion, Software Versions: 3.10.0 and 3.10.1. | November 15, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142647 | mint Lesion | April 13, 2015 |