Figulla Flex II PFO Occluder Procedure Pack

Device

EU MDR · Eu Md Class 3 ·On the market

Figulla Flex II PFO Occluder Procedure Pack

Device

EU MDR · Eu Md Class 3 ·On the market

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Patent Foramen Ovale (PFO) Occluder

Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cochlear Osia System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Bonebridge

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

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

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Bonebridge

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SAMBA 2 GO w/o manuals

FDA UDI

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.·09008737532925·Audio Processor Streaming Device

SYMFIT 7.0 Package

FDA UDI

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.·09008738515293·Fitting Software

SAMBA 2 GO

FDA UDI

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.·09008737525071·Audio Processor Streaming Device

Remote Control

FDA UDI

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.·09008737527969·Audio Processor Remote Control

SYMFIT 8.0 Download

FDA UDI

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.·09008737531065·Fitting Software

SYMFIT 8.0 Download

FDA UDI

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.·09008737525033·Fitting Software