Med-El Elektromedizinische Geraete GmbH
AustriaFDA applicant, unverified FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
Catalogue
- Regimes: 510(k) Registry: 510(k)
Bonebridge Ref DEN170009
Regimes: De Novo Registry: De NovoADHEAR System Ref K172460
Regimes: 510(k) Registry: 510(k)Bonebridge Ref K183373
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) Ref K191457
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Med-El Elektromedizinische Geraete, GmbH INNSBRUCK Tirol · AT FEI 3000249315
Frequently asked questions
How many devices does Med-El Elektromedizinische Geraete GmbH have in the registry?
The registry currently lists 6 devices for Med-El Elektromedizinische Geraete GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Med-El Elektromedizinische Geraete GmbH's devices?
Among its 6 most recently registered devices, Med-El Elektromedizinische Geraete GmbH has devices listed in FDA 510(k) (6 devices).
What risk classes do Med-El Elektromedizinische Geraete GmbH's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Med-El Elektromedizinische Geraete GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Med-El Elektromedizinische Geraete GmbH in the registry?
The most recently registered devices listed for Med-El Elektromedizinische Geraete GmbH include BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote, Bonebridge, ADHEAR System and BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm).
Which FDA establishments are linked to Med-El Elektromedizinische Geraete GmbH?
1 FDA establishment is linked to Med-El Elektromedizinische Geraete GmbH in the registry; they are listed on the company page.