Bridge to Life Ltd

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
7
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2157-2025Class IIBridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium ChloJune 12, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
DEN250009VitaSmart Hypothermic Oxygenated Perfusion SystemJanuary 15, 2026
K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)June 17, 2025
K243384Belzer UW® Cold Storage Solution (BTLBUW-001)March 31, 2025
K243840Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)March 26, 2025
K241239OrganProtex HTK SolutionJanuary 24, 2025
K203262Cannula for Organ PerfusionJuly 1, 2021
K191006EasiSlushSeptember 24, 2019