Med-El Elektromedizinische Geraete GmbH
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories2
Latest FDA decision2020-10-09
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) | PFO | 2020-10-09 | View |
| 510(k) | K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | PFO | 2020-07-29 | View |
| 510(k) | K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) | PFO | 2019-09-18 | View |
| 510(k) | K183373 | Bonebridge | PFO | 2019-03-07 | View |
| 510(k) | K172460 | ADHEAR System | LXB | 2018-04-27 | View |
No matching devices.