Home › Device types › KDN
System, Perfusion, Kidney
FDA product code KDN · Class 2 · Gastroenterology, Urology
114
Registered devices
34
Adverse events
6
Recalls
44
510(k) clearances
Devices with this code
Belzer MPS (UW Machine Perfusion Solution ) — PRESERVATION SOLUTIONS INCCANNULA 8MM TEFLON STERILE - 1/packaging — WATERS MEDICAL SYSTEMS, LLCBEL-GEN Cold Storage Solution — INSTITUT GEORGES LOPEZCannula 6mm SS, Non-Sterile — WATERS MEDICAL SYSTEMS, LLCPancreasPak — Paragonix Technologies IncRM3 RENAL PERFUSION MONITOR — WATERS MEDICAL SYSTEMS, LLCCANNULA 4MM TEFLON STERILE - 1/packaging — WATERS MEDICAL SYSTEMS, LLCCannula 14mm SS, Non-Sterile — WATERS MEDICAL SYSTEMS, LLCDCM100 Training Cassette - Non Sterile — WATERS MEDICAL SYSTEMS, LLCWaters IGL Pulsatile Perfusion Solution — PRESERVATION SOLUTIONS INCBAROguard — Paragonix Technologies IncRM3 Filter — WATERS MEDICAL SYSTEMS, LLCCustodiol(R) — Dr. Franz Köhler Chemie GmbHBAROguard — Paragonix Technologies IncX°Port Lung Preservation Solution — Traferox Technologies IncPERFADEX Plus® — Xvivo Perfusion ABEasiSlush — Bridge To Life Ltd.Waters IGL Cold Storage Solution — PRESERVATION SOLUTIONS INCBelzer UW Cold Storage Solution — PRESERVATION SOLUTIONS INCLIVERguard — Paragonix Technologies IncDCM-100 DUAL KIDNEY CASSETTE — WATERS MEDICAL SYSTEMS, LLCPerfadex with THAM — Xvivo Perfusion ABRM3 Accessory - Filter/Adapter — WATERS MEDICAL SYSTEMS, LLCKidneyVault — Paragonix Technologies Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | Paragonix Technologies Inc. | Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed preservati |
| 2025-06-12 | Bridge to Life Ltd | 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 |
| 2022-03-21 | Waters Medical Systems LLC | There is a potential for the WCM cassette pump head leaking solution. |
| 2020-01-30 | Organ Recovery Systems, Inc. | Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. |
| 2018-02-26 | Preservation Solutions, Inc. | Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag.. |
| 2010-09-24 | Preservation Solutions Inc | Mislabeled volume - 2 liter bags of Belzer UW Cold Storage Solution were labeled as 1 liter. |
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