BU-CAD

FDA 510(k)

FDA Class 2 ·Radiology

OCCLUFAST CAD

FDA 510(k)

FDA Class 2 ·Dental

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

REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK

FDA 510(k)

FDA Class 2 ·Dental

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

PRODOSE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

HALOLITE AAD SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

syngo.CT Lung CAD

FDA 510(k)

FDA Class 2 ·Radiology

SYNGO LUNG CAD

FDA 510(k)

FDA Class 2 ·Radiology

Z-CAD smile

FDA 510(k)

FDA Class 2 ·Dental

syngo.CT Lung CAD

FDA 510(k)

FDA Class 2 ·Radiology

CVERNE CAD DETECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

syngo.CT Lung CAD

FDA 510(k)

FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL CAD SYSTEM FOR MAMMOGRAPHY