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

Belun Ring BLR-200 (BLR-200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABR-2000

FDA 510(k)

FDA Class 2 ·Neurology

AUDIOSCREENER OAE + ABR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIOSCREENER OAE+ABR

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COMPUTERSCOPE CPS-ABR

FDA 510(k)

FDA Class 2 ·Neurology

Belun Ring BLR-100X

FDA 510(k)

FDA Class 2 ·Cardiovascular

Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60) (BBR-E60-02); Electric Wheelchair (Robooter E60) (BBR-E60-03); Electric Wheelchair (Robooter E60) (BBR-E60-04); Electric Wheelchair (Robooter E60) (BBR-E60-05); Electric Wheelchair (Robooter E60) (BBR-E60-06); Electric Wheelchair (Robooter E60) (BBR-E60-07); Electric Wheelchair (Robooter E60) (BBR-E60-08)

FDA 510(k)

FDA Class 2 ·Physical Medicine

STACKED ABR FOR NAVIGATOR PRO

FDA 510(k)

FDA Class 2 ·Neurology

DTX-200 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

MAX-IF1000

FDA 510(k)

FDA Class 2 ·Neurology

FLUORCANASITE DENTAL CERAMIC

FDA 510(k)

FDA Class 2 ·Dental

REUSABLE STIMULATING ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

PUTMAN STABILIZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DTX-100 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

THE SCREENER GSI 55 ABR SCREENER

FDA 510(k)

FDA Class 2 ·Neurology

DURATECH HOSPITAL TOWEL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT

FDA 510(k)

FDA Class 2 ·Neurology