Los Angeles, CA, US · 2 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OLR | Oral Wound Dressing | Unclassified | Unknown | 2 | 2025-10-23 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-02-21 | Class II | Terminated | Z-0856-2022 | Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm | — | Due to failure of microbial testing for total aerobic microbial count (TAMC). |