MED-EL Elektromedizinische Gereate, Gmbh
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2356-2024 | Class II | Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) | April 18, 2024 |
| Z-2136-2019 | Class II | MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: | October 16, 2018 |
| Z-2137-2019 | Class II | MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATA | October 16, 2018 |
| Z-2138-2019 | Class II | MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an | October 16, 2018 |
| Z-1395-2017 | Class II | SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONN | October 25, 2016 |