M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VOCALIS AND VOCALIS SM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AT235

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

BRACKMANN EMG MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MD5 AUTOMATIC AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NERVE LOCATOR/MONITOR SYSTEM, MODIFICATION

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Medrobotics Flex System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Hearing Healthcare Pro

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GlideScope BFlex 3.8 Single-Use Bronchoscope

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HAPEX MALLEABLE TORP

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AMPLAID 309 CLINICAL AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SENTIO MMG Pedicle Access Needles

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LARYNGEAL ELECTRODE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AOC SOLUBLE IMPLANT MATERIAL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUREX-3

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat