Asept Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

primeMidline Catheters

FDA 510(k)

FDA Class 2 ·General Hospital

NuCath Wedge Pressure Catheter

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

J+PRAS YOUNG'S Thread

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MF SAFECATH

FDA 510(k)

FDA Class 2 ·General Hospital

VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA 510(k)

FDA Class 2 ·Microbiology

VENUS SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA 510(k)

FDA Class 2 ·Microbiology

VENUS BASIC SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

FDA 510(k)

FDA Class 2 ·General Hospital

ANTHRACIS REAL-TIME PCR ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FOCUS MIS SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

VENUS BASIC SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Luce Ceramic Bracket

FDA 510(k)

FDA Class 2 ·Dental

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT

FDA 510(k)

FDA Class 2 ·Microbiology

US/GS ULTRA WIDE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

POLYBONE

FDA 510(k)

FDA Class 2 ·Neurology