Data / Medical devices / System, Processing For Frozen Blood / United States
FDA-registered makers of System, Processing For Frozen Blood in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make System, Processing For Frozen Blood (product code KSW). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- System, Processing For Frozen Blood
- Product code
- KSW
- Country
- United States
Makers of System, Processing For Frozen Blood in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | Round Lake, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Cleveland, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Healthcare Corporation | Marion, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fenwal, Inc. | Lake Zurich, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Haemonetics Corporation | Boston, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations Inc. | San Diego, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo BCT, Inc.. | Lakewood, CO, United States | 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.