Contract Medical International GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2532-2025 | Class II | Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Mode | July 30, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm (US-34045-F-ST-H) | March 16, 2025 |
| K240957 | Catapult Guide Sheath | August 14, 2024 |
| K221914 | Catapult Guide Sheath | July 29, 2022 |
| K203179 | Fortress Introducer Sheath System | November 20, 2020 |
| K181463 | DuraSheath Introducer Sheath System | December 13, 2018 |
| K153197 | Fortress Introducer Sheath SYstem | January 11, 2016 |
| K142357 | DuraSheath Introducer Sheath System | June 25, 2015 |