Medical Device Manufacturer · AT , Innsbruck

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

6 submissions · 5 cleared · Since 2018

6

Total

5

Cleared

1

Denied

Med-El Elektromedizinische Geraete GmbH has 5 FDA 510(k) cleared medical devices. Based in Innsbruck, AT.

Last cleared in 2020. Active since 2018. Primary specialty: Ear, Nose, Throat.

Browse the FDA 510(k) cleared devices submitted by Med-El Elektromedizinische Geraete GmbH Filter by specialty or product code using the sidebar.

6 devices

1–6 of 6

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

K201983 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

K200504 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

K191457 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat

K183373 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat

DEN170009 · PFO Active Implantable Bone Conduction Hearing System · Ear, Nose, Throat

K172460 · LXB Hearing Aid, Bone Conduction · Ear, Nose, Throat

Data Source

FDA 510(k) public files . 174,402 total devices indexed.