Gallini U.S., LLC
Gallini U.S., LLC has 0 FDA recalls, 0 inspections, 10 510(k) clearances and 0 compliance actions on record.
- Latest 510(k)
- Aug 12, 1999
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 10 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K992499 | GALLINI BIOSYSTEM BONE MARROW ASPIRATION/BIOPSY NEEDLE | Aug 12, 1999 |
| K990645 | GALLINI ATRA-CUT NEEDLE | May 19, 1999 |
| K990716 | GALLINI BYCUT NEEDLE | May 17, 1999 |
| K981301 | SPEED-CUT AUTOMATIC BIOPSY SYSTEM | Jul 8, 1998 |
| K980676 | SPIGAL NEEDLE | May 21, 1998 |
| K980479 | QUICK-CUT AUTOMATIC BIOPSY SYSTEM | May 6, 1998 |
| K980248 | ACRI R NEEDLE | Feb 18, 1998 |
| K974440 | IBI | Jan 30, 1998 |
| K973152 | GALLINI ABS DEVICE | Jan 9, 1998 |
| K972266 | GALLINI COAXIAL INTRODUCER | Jul 29, 1997 |
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