Bridge to Life Ltd
FDA Regulatory Profile
Bridge to Life Ltd appears in FDA public data with 1 recall, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2157-2025, Class II) was initiated on June 12, 2025. Its most recent 510(k) clearance was granted on January 15, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2157-2025 | Class II | Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chlo | June 12, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN250009 | VitaSmart Hypothermic Oxygenated Perfusion System | January 15, 2026 |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | June 17, 2025 |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | March 31, 2025 |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | March 26, 2025 |
| K241239 | OrganProtex HTK Solution | January 24, 2025 |
| K203262 | Cannula for Organ Perfusion | July 1, 2021 |
| K191006 | EasiSlush | September 24, 2019 |