Surgeon Controlled Arm

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DEKA ARM SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

ETCHONIA ZERONA ARMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MANUAL SWING ARM

FDA 510(k)

FDA Class 2 ·Physical Medicine

FLUOROSCOPE, C-ARM

FDA 510(k)

FDA Class 2 ·Radiology

Arm Electronic Sphygmomanometer

FDA 510(k)

FDA Class 2 ·Cardiovascular

iC-GPC Assay TM for use on the iC-SystemTM

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Blood Culture Identification (BCID) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

FDA 510(k)

FDA Class 2 ·Microbiology

iC-GN iC-Cassette for use on the iC-System

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Blood Culture Identification 2 (BCID2) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch

FDA 510(k)

FDA Class 2 ·Microbiology

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON PLEX Gram-Negative Blood Culture Assay

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

FDA 510(k)

FDA Class 2 ·Microbiology