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 13, 2026, FDA's public records list Gallini U.S., LLC with 10 510(k) clearances. The most recent is a 510(k) clearance dated Aug 12, 1999: GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE.
| Aug 12, 1999 | GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLEK992499 · KNW | 510(k) clearances |
| May 19, 1999 | GALLINI ATRA-CUT NEEDLEK990645 · KNW | 510(k) clearances |
| May 17, 1999 | GALLINI BYCUT NEEDLEK990716 · KNW | 510(k) clearances |
| Jul 8, 1998 | SPEED-CUT AUTOMATIC BIOPSY SYSTEMK981301 · KNW | 510(k) clearances |
| May 21, 1998 | SPIGAL NEEDLEK980676 · KNW | 510(k) clearances |
| May 6, 1998 | QUICK-CUT AUTOMATIC BIOPSY SYSTEMK980479 · KNW | 510(k) clearances |
| Feb 18, 1998 | ACRI R NEEDLEK980248 · KNW | 510(k) clearances |
| Jan 30, 1998 | IBIK974440 · KNW | 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
