New Medical Technologies Gmbh
FDA Regulatory Profile
New Medical Technologies Gmbh appears in FDA public data with 2 recalls, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-1103-2025, Class II) was initiated on December 19, 2024. Its most recent 510(k) clearance was granted on October 2, 2009.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1103-2025 | Class II | Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516; | December 19, 2024 |
| Z-1104-2025 | Class II | Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517; | December 19, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K091721 | CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 | October 2, 2009 |