Home › Device types › KDN
System, Perfusion, Kidney
FDA product code KDN · Class 2 · Gastroenterology, Urology
124
Registered devices
41
Adverse events
6
Recalls
44
510(k) clearances
Devices with this code
Belzer MPS (UW Machine Perfusion Solution ) — PRESERVATION SOLUTIONS INCRM3 Accessory - Filter/Adapter — WATERS MEDICAL SYSTEMS, LLCKidneyVault — Paragonix Technologies IncPancreasPak — Paragonix Technologies IncCANNULA 15MM TEFLON STERILE - 1/packaging — WATERS MEDICAL SYSTEMS, LLCDCM100 Training Cassette - Non Sterile — WATERS MEDICAL SYSTEMS, LLCWaters IGL Cold Storage Solution — INSTITUT GEORGES LOPEZCustodiol(R) — Dr. Franz Köhler Chemie GmbHBelzer UW Cold Storage Solution — Bridge To Life Ltd.Custodiol — Dr. Franz Köhler Chemie GmbHCANNULA 5MM TEFLON STERILE - 1/packaging — WATERS MEDICAL SYSTEMS, LLCWAVES CONTROL UNIT — WATERS MEDICAL SYSTEMS, LLCCANNULA 14MM TEFLON STERILE - 1/packaging — WATERS MEDICAL SYSTEMS, LLCRM3 Accessory Filter — WATERS MEDICAL SYSTEMS, LLCBAROguard — Paragonix Technologies IncX°Port Lung Preservation Solution — Traferox Technologies IncLIVERguard — Paragonix Technologies IncServator B SALF Solution — S.A.L.F. SPA LABORATORIO FARMACOLOGICOKidney Assist Transport — XVIVO B.V.LUNGguard — Paragonix Technologies IncCustodiol(R) — Dr. Franz Köhler Chemie GmbHBelzer UW Cold Storage Solution — PRESERVATION SOLUTIONS INCCANNULA 4MM TEFLON STERILE - 1/packaging — WATERS MEDICAL SYSTEMS, LLCKidneyVault Portable Renal Perfusion System — 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.