Data / Medical devices / System, Blood Collection, Vacuum-Assisted, Manual / United States
FDA-registered makers of System, Blood Collection, Vacuum-Assisted, Manual in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make System, Blood Collection, Vacuum-Assisted, Manual (product code KST). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- System, Blood Collection, Vacuum-Assisted, Manual
- Product code
- KST
- Country
- United States
Makers of System, Blood Collection, Vacuum-Assisted, Manual in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Demetech Corp. | Miami Lakes, FL, United States | Complaint file establishment, Contract manufacturer, 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 | |
| Kentec Medical, LLC | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtox Diagnostics, Inc. | Burlington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDTOX Diagnostics, Inc. | Pleasanton, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexus Medical, LLC | Lenexa, KS, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Monarch Company, LLC | Birmingham, AL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Therapak, LLC | Oakwood, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.