Sensory Medical Inc
FDA Regulatory Profile
Sensory Medical Inc appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0918-2022, Class I) was initiated on March 14, 2022. Its most recent 510(k) clearance was granted on December 18, 2013.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0918-2022 | Class I | Cub 2 Enclosed Bed Canopy System | March 14, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN110011 | SYMPHONY DEVICE | December 18, 2013 |