Home › Device types › KDL
Set, Perfusion, Kidney, Disposable
FDA product code KDL · Class 2 · Gastroenterology, Urology
34
Registered devices
60
Adverse events
4
Recalls
19
510(k) clearances
Devices with this code
BEL-GEN Cold Storage Solution — INSTITUT GEORGES LOPEZPERF-GEN Pulsatile Perfusion Solution — INSTITUT GEORGES LOPEZLifePort® Kidney Transporter — ORGAN RECOVERY SYSTEMS, INC.Custodiol(R) — Dr. Franz Köhler Chemie GmbHLifePort® Kidney Transporter — ORGAN RECOVERY SYSTEMS, INC.Waters IGL Cold Storage Solution — INSTITUT GEORGES LOPEZSPS-1® (UW Solution) — ORGAN RECOVERY SYSTEMS, INC.PARAGON-W (UW solution) — INSTITUT GEORGES LOPEZWaters IGL Pulsatile Perfusion Solution — INSTITUT GEORGES LOPEZPARAGON-W (UW solution) — INSTITUT GEORGES LOPEZCustodiol — Dr. Franz Köhler Chemie GmbHBEL-GEN Cold Storage Solution — INSTITUT GEORGES LOPEZCustodiol(R) — Dr. Franz Köhler Chemie GmbHCustodiol — Dr. Franz Köhler Chemie GmbHBelzer UW Cold Storage Solution — Bridge To Life Ltd.Custodiol — Dr. Franz Köhler Chemie GmbHLifePort® Kidney Transporter — ORGAN RECOVERY SYSTEMS, INC.LifePort® Kidney Transporter — ORGAN RECOVERY SYSTEMS, INC.SPS-1® (UW Solution) — ORGAN RECOVERY SYSTEMS, INC.Belzer UW Cold Storage Solution — Bridge To Life Ltd.LifePort® Kidney Transporter — ORGAN RECOVERY SYSTEMS, INC.LifePort® Kidney Transporter — ORGAN RECOVERY SYSTEMS, INC.LifePort® Kidney Transporter — ORGAN RECOVERY SYSTEMS, INC.SPS-1® (UW Solution) — ORGAN RECOVERY SYSTEMS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-09 | Dr Franz Koehler Chemie Gmbh | Potential for particles to be present in solution. |
| 2016-12-14 | Organ Recovery Systems, Inc. | Organ preservation fluid recalled due to potential for bacterial contamination. |
| 2016-10-12 | Baxter Healthcare Corp. | Potential presence of particulate matter on the blood side of the dialyzer |
| 2012-03-30 | Teva Pharmaceuticals USA, Inc. | Lack of assurance of sterility |
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