Infrascanner

FDA 510(k)

FDA Class 2 ·Ophthalmic

IGI-SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

HemoScreen Hematology Analyzer

FDA 510(k)

FDA Class 2 ·Hematology

Disposable Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DECAPINOL ORAL RINSE

FDA 510(k)

FDA Class 2 ·Dental

SINCLAIR ORAL RINSE

FDA 510(k)

FDA Class 2 ·Dental

ESOP S/C FEMORAL STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CABOCHON SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATLAS III ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

FDA 510(k)

FDA Class 2 ·General Hospital

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK COMPUTER AIDED DETECTTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·BREAST COMPANION SOFTWARE SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·ICAD

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK

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 ·CLEARREAD DETECT

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·LOGICON CARIES DETECTOR

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·THE IMAGECHECKER SYSTEM