San Carlos, CA, US · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | Class II | General, Plastic Surgery | 2 | 2026-06-03 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-01-27 | Class II | Ongoing | Z-1294-2025 | TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP | — | Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in… |