APN Health LLC
FDA Regulatory Profile
APN Health LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0556-2024, Class III) was initiated on November 7, 2023. Its most recent 510(k) clearance was granted on February 23, 2016.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0556-2024 | Class III | Navik 3D v2, REF NAVIK3D, 3D Mapping System | November 7, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K152160 | Navik 3D | February 23, 2016 |