Med-El Elektromedizinische Geraete GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) | October 9, 2020 |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | July 29, 2020 |
| K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lif | September 18, 2019 |
| K183373 | Bonebridge | March 7, 2019 |
| DEN170009 | Bonebridge | July 20, 2018 |
| K172460 | ADHEAR System | April 27, 2018 |