Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS CEMENT

Bone Cement

FDA Pre-Market Approval

FDA Class 2 ·NORIAN SRS BONE CEMENT

NEBA SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ERCHONIA ML SCANNER (MLS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WEST NILE VIRUS IGM CAPTURE ELISA

FDA 510(k)

FDA Class 2 ·Microbiology

DECAPINOL ORAL RINSE

FDA 510(k)

FDA Class 2 ·Dental

NEUROSTAR TMS SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

INTROL CF PANEL I CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA 510(k)

FDA Class 2 ·Microbiology

Kerasave

FDA 510(k)

FDA Class 2 ·Ophthalmic

TEPHAFLEX ABSORBABLE SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AXIOS STENT AND DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General Hospital

ZELTIQ AESTHETICS DERMAL COOLING DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MANDOMETER III

FDA 510(k)

FDA Class 2 ·Neurology

NOVA View Automated Fluorescense Microscope

FDA 510(k)

FDA Class 2 ·Immunology

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

FDA 510(k)

FDA Class 2 ·Microbiology

XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)

FDA 510(k)

FDA Class 2 ·Microbiology