IN THE EAR HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC TOTAL READYPACK REAGENTS AND ADVIA CENTAUR HBC TOTAL QUALITY CONTROL MATERIALS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

BLUEDIAMOND IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

INNOVERSE Navigation Instruments

FDA 510(k)

FDA Class 2 ·Neurology

imani i2

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AVIEW

FDA 510(k)

FDA Class 2 ·Radiology

TiGEN Abutment, PMMA Abutment and Scan Healing Abutment

FDA 510(k)

FDA Class 2 ·Dental

SIGNEX

FDA 510(k)

FDA Class 2 ·Orthopedic

INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET

FDA 510(k)

FDA Class 2 ·Microbiology

INNOVERSE Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

CDC DENV-1-4 REAL TIME RT-PCT ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

AVIEW CAC

FDA 510(k)

FDA Class 2 ·Radiology

SIGNEX

FDA 510(k)

FDA Class 2 ·Orthopedic

CUBEScan BioCon-1100

FDA 510(k)

FDA Class 2 ·Radiology

ANAX™ 5.5 Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

A View LCS

FDA 510(k)

FDA Class 2 ·Radiology

CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

Eco Abutment, Multiunit Abutment

FDA 510(k)

FDA Class 2 ·Dental

N2

FDA 510(k)

FDA Class 1 ·Dental