Data / Medical devices / Culture Media, Enriched / United States
FDA-registered makers of Culture Media, Enriched in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Culture Media, Enriched (product code KZI). 1 has a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Culture Media, Enriched
- Product code
- KZI
- Country
- United States
Makers of Culture Media, Enriched in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Remel, Inc. | Lenexa, KS, United States | Manufacturer | 1 | June 2, 1988 | 0 | 1 | 0 | api.fda.gov |
| Alpha Biosciences, Inc. | Baltimore, MD, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anaerobe Systems | Morgan Hill, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Analytichem Usa, Inc. | Winslow, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Sparks, MD, United States | Complaint file establishment, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Becton, Dickinson & Co. | Cockeysville, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Orcutt, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hardy Diagnostics | Springboro, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Legacy Biologicals | Baltimore, MD, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oxyrase, Inc. | Mansfield, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puritan Medical Products Company LLC | Guilford, ME, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S2media | Spokane Valley, WA, 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.