Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

MED-TECH CLINICAL BLOOD GAS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MED-TECH LASER GAS MIXTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROSA Spine

FDA 510(k)

FDA Class 2 ·Neurology

ROSA SURGICAL DEVICE

FDA 510(k)

FDA Class 2 ·Neurology

ROSA ONE Spine application

FDA 510(k)

FDA Class 2 ·Neurology

ROSA BRAIN (v3.0.0.5)

FDA 510(k)

FDA Class 2 ·Neurology

ROSA ONE Brain Application

FDA 510(k)

FDA Class 2 ·Neurology

ROSA ONE Spine application

FDA 510(k)

FDA Class 2 ·Neurology

ROSA ONE Brain application

FDA 510(k)

FDA Class 2 ·Neurology

ROSA ONE Brain application

FDA 510(k)

FDA Class 2 ·Neurology

ROSA SURGICAL DEVICE, MODEL ROSA 1.1

FDA 510(k)

FDA Class 2 ·Neurology

THERMALGRAPHIC ANALYSER

FDA 510(k)

FDA Class 2 ·Neurology

REJOYN PENILE SUPPORT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PREPEX SYSTEM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QHRV 1 - HEALTH ASSESSMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular