OMEZA LLC
FDA Regulatory Profile
OMEZA LLC appears in FDA public data with 2 recalls, 1 510(k) clearance, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (D-0289-2024, Class II) was initiated on January 19, 2024. Its most recent 510(k) clearance was granted on September 1, 2021.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0289-2024 | Class II | Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials | January 19, 2024 |
| D-0288-2024 | Class II | Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS | January 19, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211972 | Omeza Collagen Matrix | September 1, 2021 |