FDA 510(k) Applications Submitted by MED-EL Elektromedizinische Geraete GmbH
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200504 |
03/02/2020 |
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote |
MED-EL Elektromedizinische Geraete GmbH |
| DEN170009 |
02/13/2017 |
Bonebridge |
MED-EL Elektromedizinische Geraete GmbH |
| K172460 |
08/14/2017 |
ADHEAR System |
MED-EL Elektromedizinische Geraete GmbH |
| K191457 |
05/31/2019 |
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) |
MED-EL Elektromedizinische Geraete GmbH |
| K201983 |
07/17/2020 |
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) |
Med-El Elektromedizinische Geraete GmbH |
| K183373 |
12/06/2018 |
Bonebridge |
MED-EL Elektromedizinische Geraete GmbH |
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