Data / Medical devices / Set, Perfusion, Kidney, Disposable / United States
FDA-registered makers of Set, Perfusion, Kidney, Disposable in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Set, Perfusion, Kidney, Disposable (product code KDL). 1 has a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Set, Perfusion, Kidney, Disposable
- Product code
- KDL
- Country
- United States
Makers of Set, Perfusion, Kidney, Disposable in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Organ Recovery Systems, Inc. | Itasca, IL, United States | Manufacturer | 1 | March 11, 2010 | 0 | 1 | 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 | |
| Biovire, Inc. | Brighton, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bridge to Life Ltd | Duluth, GA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lifecycle Biotechnologies, LLC | Cleburne, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marizyme, Inc. | West Palm Bch, FL, United States | Manufacturer for export | 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.