Medical Device Manufacturer · AT , Innsbruck

Med-El Elektromedizinische Geraete GmbH - FDA 510(k) Cleared Devices

6 submissions · 5 cleared · Since 2018

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)

View 6 510(k) Devices ↓

6

Total

5

Cleared

1

Denied

FDA 510(k) Regulatory Record - Med-El Elektromedizinische Geraete GmbH Ear, Nose, Throat ✕

6 devices

1-6 of 6

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

Ear, Nose, Throat · 91d

Not Cleared Jul 20, 2018

DEN170009 · PFO

Ear, Nose, Throat · 522d

Cleared Apr 27, 2018

Ear, Nose, Throat · 256d