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

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

FDA 510(k)

FDA Class 2 ·Microbiology

Advanced Diffusion Analysis (ADA) application

FDA 510(k)

FDA Class 2 ·Radiology

Longitudinal Brain Imaging (LoBI) application

FDA 510(k)

FDA Class 2 ·Radiology

ALLURA XPER FD10

FDA 510(k)

FDA Class 2 ·Radiology

Multi-Modality Tumor Tracking (MMTT) application

FDA 510(k)

FDA Class 2 ·Radiology

The Multimodality Advanced Vessel Analysis

FDA 510(k)

FDA Class 2 ·Radiology

KODEX EPD System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VITROS BRAHMS PCT Reagent Pack and Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

B.R.A.H.M.S PCT sensitive KRYPTOR

FDA 510(k)

FDA Class 2 ·Microbiology

VIDAS B.R.A.H.M.S. PCT (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Atellica IM BRAHMS Procalcitonin (PCT)

FDA 510(k)

FDA Class 2 ·Microbiology

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

FDA 510(k)

FDA Class 2 ·Microbiology

BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML

FDA 510(k)

FDA Class 2 ·General Hospital

ARTISAN AESTHETIC SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE

PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

FloPatch (FP110)

FDA 510(k)

FDA Class 2 ·Cardiovascular