Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Medical Specialties with 40 510(k) clearances. The most recent is a 510(k) clearance dated Apr 18, 1995: STAND, INFUSION.
| Apr 18, 1995 | STAND, INFUSIONK946201 · FOX | 510(k) clearances |
| Jun 18, 1993 | CHECKPOINTK931947 · JPK | 510(k) clearances |
| Jan 26, 1993 | REFRACTROL-SPK926095 · JJX | 510(k) clearances |
| Jan 7, 1993 | MSI-HCTK924926 · GLK | 510(k) clearances |
| Feb 9, 1990 | MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEK896566 · JWY | 510(k) clearances |
| Nov 22, 1988 | MSI-CAL 7K883703 · KRZ | 510(k) clearances |
| Nov 22, 1988 | MSI-CAL 8K883851 · KRZ | 510(k) clearances |
| Nov 22, 1988 | MSI-CAL 16K883850 · KRZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built