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

ABR-2000

FDA 510(k)

FDA Class 2 ·Neurology

AirRay Subdural Cortical Electrodes

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

CBR-T3RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CBR-DIGOXIN ANTISERUM

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COMPUTERSCOPE CPS-ABR

FDA 510(k)

FDA Class 2 ·Neurology

Yxoss CBR®

FDA 510(k)

FDA Class 2 ·Dental

CBR-T3 UPTAKE KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS

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

PEEP VALVE

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAXVIEW DIAGNOSTIC WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

STACKED ABR FOR NAVIGATOR PRO

FDA 510(k)

FDA Class 2 ·Neurology

THE SCREENER GSI 55 ABR SCREENER

FDA 510(k)

FDA Class 2 ·Neurology

FBC 921 (ALIF)

FDA 510(k)

FDA Class 2 ·Orthopedic

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT

FDA 510(k)

FDA Class 2 ·Neurology

INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION

FDA 510(k)

FDA Class 2 ·Cardiovascular

DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO

FDA 510(k)

FDA Class 2 ·Cardiovascular