Kalila Medical
Kalila Medical appears in FDA public data with 2 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0563-2018, Class II) was initiated on December 14, 2017. Its most recent 510(k) clearance was granted on March 7, 2017.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0563-2018 | Class II | Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is | December 14, 2017 |
| Z-0564-2018 | Class II | Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a | December 14, 2017 |