Edge Biologicals Inc
FDA Regulatory Profile
Edge Biologicals Inc appears in FDA public data with 1 recall, 1 510(k) clearance, 5 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1658-2025, Class II) was initiated on October 2, 2023. Its most recent 510(k) clearance was granted on June 30, 2014.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 5
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1658-2025 | Class II | Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water | October 2, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K132491 | MUELLER HINTON AGAR | June 30, 2014 |