Biorep Technologies
FDA Regulatory Profile
Biorep Technologies appears in FDA public data with 1 recall, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1538-2014, Class II) was initiated on March 19, 2014. Its most recent 510(k) clearance was granted on March 4, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1538-2014 | Class II | Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool fo | March 19, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K210006 | MI DeTACH | March 4, 2021 |