PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PULLUP® Adjustable Juxtacortical Fixation Device

FDA 510(k)

FDA Class 2 ·Orthopedic

SIMPSON PERIPHERAL ATHEROCATH(TM)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ROTATING HEMOSTATIC VALVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

FDA 510(k)

FDA Class 2 ·Neurology

GE CT/T MODEL NO. B7800 A

FDA 510(k)

FDA Class 2 ·Radiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit

FDA 510(k)

FDA Class 2 ·Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

i-Cut

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

FDA 510(k)

FDA Class 2 ·Microbiology

CAREMIBRAIN

FDA 510(k)

FDA Class 2 ·Radiology

FIXIT Threaded Anchor System

FDA 510(k)

FDA Class 2 ·Orthopedic

LEGIONELLA INDIRECT FLUOR. ANTIBODY

FDA 510(k)

FDA Class 2 ·Microbiology

KIMSTIM AURICULAR ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

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

FDA 510(k)

FDA Class 2 ·Microbiology