CLARUJUST

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ICS MEDICAL CHARTR OAE WITH TYMP

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DPOAE20 , ECLIPSE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MIDDLE EAR ANALYZER (IMPEDANCE AUDIO

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)

FDA 510(k)

FDA Class 2 ·Neurology

PROPHET

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

PORTAREM-3000, PFS-6000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ARTICULATE FITTING SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

GSI 70 AUDIOPATH SCREENER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TRACOR RA500 AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INTERACOUSTICS CLINICAL AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VSP PEEK Cranial Implant

FDA 510(k)

FDA Class 2 ·Neurology

PORTABLE AUDIOMETERS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT

FDA 510(k)

FDA Class 2 ·Neurology

Needle, Conduction, Anesthetic (W/Wo Introducer)

FDA classification

FDA Class 2 ·Needle, Conduction, Anesthetic (W/Wo Introducer)

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·STREPTOMYCIN SUEFATE DIAGNOSTIC SUSCEPTIBILITY POW