HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS

FDA 510(k)

FDA Class 2 ·General Hospital

KONRAD, MODEL V.2.0

FDA 510(k)

FDA Class 2 ·Radiology

HYBRID CAPTURE II CT/GC TEST

FDA 510(k)

FDA Class 2 ·Microbiology

OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACE CEDIA PHENOBARBITAL ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000

Radiation Therapy Marking Device

FDA classification

FDA Class 2 ·Radiation Therapy Marking Device

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 ·ONGUARD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY

Automatic Event Detection Software For Polysomnograph With Electroencephalograph

FDA classification

FDA Class 2 ·Automatic Event Detection Software For Polysomnograph With Electroencephalograph

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER LX AND IMAGECHECKER DX (SOFTWARE VERSION 6.0)

Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

FDA classification

FDA Class 2 ·Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·RAPIDSCREEN RS-2000D

Sheet, Recording, Breast Examination

FDA classification

FDA Class 2 ·Sheet, Recording, Breast Examination

Temporary Tissue Marker

FDA classification

FDA Class 2 ·Temporary Tissue Marker

Neurosurgical Laser With Mr Thermography

FDA classification

FDA Class 2 ·Neurosurgical Laser With Mr Thermography

Orthopaedic Surgical Planning And Instrument Guides

FDA classification

FDA Class 2 ·Orthopaedic Surgical Planning And Instrument Guides

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM