Northbrook, IL, US · 6 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KDN | System, Perfusion, Kidney | Class II | Gastroenterology, Urology | 4 | 2025-06-17 |
| SGY | Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant | Class II | Gastroenterology, Urology | 1 | 2026-01-15 |
| KDL | — | — | — | 1 | 2025-01-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-06-12 | Class II | Ongoing | Z-2157-2025 | Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP… | — | The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quart… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-15 | DEN250009 | VitaSmart Hypothermic Oxygenated Perfusion System | SGY | Class II | Gastroenterology, Urology |
| 2025-06-17 | K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | KDN | Class II | Gastroenterology, Urology |
| 2025-03-31 | K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | KDN | Class II | Gastroenterology, Urology |
| 2025-03-26 | K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | KDN | Class II | Gastroenterology, Urology |
| 2025-01-24 | K241239 | OrganProtex HTK Solution | KDL | — | — |
| 2021-07-01 | K203262 | Cannula for Organ Perfusion | KDN | Class II | Gastroenterology, Urology |