Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK (SL) CAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·PROMINENT CALC FEATURE MARKER

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·KODAK MAMMOGRAPHY CAD ENGINE

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL V7.2 CAD

STB YANKAUER SUCKER/NOZZLE

FDA 510(k)

FDA Class 2 ·General Hospital

SAVE-T-BREATH AMBILICAL CORD CLAMP

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M1000

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGE CHECKER (CAD) SYSTEM, M100

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Tek RMD (Tek Robotic Mobilization Device)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Neodent Implant System

FDA 510(k)

FDA Class 2 ·Dental

Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology

BAUSCH & LOMB CLEANING PAD

FDA 510(k)

FDA Class 2 ·Ophthalmic

SR-8230, SR-8230S Portable X-ray Unit

FDA 510(k)

FDA Class 2 ·Radiology

Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System

FDA 510(k)

FDA Class 2 ·Radiology