LUNG CAR 1.1

FDA 510(k)

FDA Class 2 ·Radiology

MEDICHEART, MODEL RELEASE 1

FDA 510(k)

FDA Class 2 ·Radiology

COLON CAR 1.2

FDA 510(k)

FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM

Tetraphenyl Borate, Colorimetry, Potassium

FDA classification

FDA Class 2 ·Tetraphenyl Borate, Colorimetry, Potassium

Media, Culture, Ex Vivo, Tissue And Cell

FDA classification

FDA Class 2 ·Media, Culture, Ex Vivo, Tissue And Cell

MODULAR PORP AND TORP MODEL TBD

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NASOPHARYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DESKREM-1000

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AUDIO EXPERT AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TruDi Curette

FDA 510(k)

FDA Class 2 ·Neurology

Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MACHIDA NASOPHARYNGO-LARYNGOSCOPE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

TRACOR RA 410 AUDIOMETER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MONTG. LARYNGEAL KEEL

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

POLY PISTON

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat