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

CUE FERTILITY MONITOR

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

POWER FLOSS AND BRUSH EW 129 & EW 120

FDA 510(k)

FDA Class 1 ·Dental

IONODENT (TOOTHBRUSH)

FDA 510(k)

FDA Class 1 ·Dental

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

VITAL SURGICAL GLOVES

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

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

PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

MULTI-PURPOSE HEALTH DEVICE

FDA 510(k)

FDA Unclassified ·Unknown

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

VESSEL LOOPS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery