Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECONDLOOK DIGITAL V7.2 CAD

INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

INFLUENZA B LINEAGE GENOTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

DIGITAL ADD-ON BUCKY

FDA 510(k)

FDA Class 2 ·Radiology

MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ADD RGP LENS FINISHING LABORATORIES.

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ADD RGP LENS FINISHING LABORATORIES.

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ADD RGP LENS FINISHING LABORATORIES.

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

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ADD RGP LENS FINISHING LABORATORIES.

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ADD RGP LENS FINISHING LABORATORIES.

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·ADD RGP LENS FINISHING LABORATORIES.

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·IMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY

HDS INTRA-ORAL IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

DIGITAL ADD ON MULTI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ADD POWER FAMILY , MICRO ADDSTAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery