Med-El Elektromedizinische Geraete GmbH - FDA 510(k) Cleared Devices
Recent clearances: BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm), BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote, BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
6
Total
5
Cleared
1
Denied
FDA 510(k) Regulatory Record - Med-El Elektromedizinische Geraete GmbH Ear, Nose, Throat ✕
6 devices
Cleared
Oct 09, 2020
BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4...
Ear, Nose, Throat
84d
Cleared
Jul 29, 2020
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
Ear, Nose, Throat
149d
Cleared
Sep 18, 2019
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602...
Ear, Nose, Throat
110d
Cleared
Mar 07, 2019
Bonebridge
Ear, Nose, Throat
91d
Not Cleared
Jul 20, 2018
Bonebridge
Ear, Nose, Throat
522d
Cleared
Apr 27, 2018
ADHEAR System
Ear, Nose, Throat
256d