Widex A/S
Widex A/S appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0094-2019, Class II) was initiated on August 31, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0094-2019 | Class II | Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended u | August 31, 2018 |