Data / Medical devices / System, Perfusion, Kidney / United States
FDA-registered makers of System, Perfusion, Kidney in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make System, Perfusion, Kidney (product code KDN). 5 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Perfusion, Kidney
- Product code
- KDN
- Country
- United States
Makers of System, Perfusion, Kidney in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Bridge to Life Ltd | Duluth, GA, United States | Manufacturer, Specification developer | 5 | June 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Waters Medical Systems, LLC | Rochester, MN, United States | Complaint file establishment, Manufacturer | 5 | October 15, 2021 | 0 | 1 | 0 | api.fda.gov |
| Paragonix Technologies, Inc. | Waltham, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | October 23, 2024 | 0 | 1 | 0 | api.fda.gov |
| Organ Recovery Systems, Inc. | Itasca, IL, United States | Manufacturer | 2 | July 31, 2003 | 0 | 1 | 0 | api.fda.gov |
| Preservation Solutions, Inc. | Elkhorn, WI, United States | Manufacturer | 2 | August 8, 2008 | 0 | 2 | 0 | api.fda.gov |
| August Bioservices, LLC | Nashville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biocure Solutions, LLC Dba Biocure, Inc. | Peachtree Corners, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biovire, Inc. | Brighton, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ILC Dover | Lillington, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifecycle Biotechnologies, LLC | Cleburne, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marian Chicago, Inc. | West Chicago, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Packaging Compliance Medical, LLC | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Santa Rosa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Somerset, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tricor Systems | Elgin, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Us Specialty Formulations | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.