Micro Total Analysis Instrument System

FDA classification

FDA Class 2 ·Micro Total Analysis Instrument System

HORTMANN AMDIS-OAE OAE ANALYZER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOSCREENER OAE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

EARLOGIC OAE TESTER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOSCREENER OAE + ABR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOSCREENER OAE+ABR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SELDIFLEX LONG-TERM CENTRAL VENOUS CATHETER(40CM & 60CM IN LENGTH), MODELS 63244J20 & 63246J20

FDA 510(k)

FDA Class 2 ·General Hospital

DYNATRON 500

FDA 510(k)

FDA Class 2 ·Physical Medicine

HORTMANN ECHOMASTER OAE ANALYZER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

HOOK PUNCH FORCEPS FOR ARTHROSCOPY

FDA 510(k)

FDA Class 2 ·Orthopedic

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)

FDA 510(k)

FDA Class 2 ·Ophthalmic

ONE PERSONAL LUBRICANT (SILICONE)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ONE PERSONAL LUBRICANT (WATER BASED)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ER36 Series OAE Test System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ERO SCAN OAE TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

CUE AMBULATORY VOLUMETRIC INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

ETYMOTIC RESEARCH ER-10D OAE PROBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat