VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX Enteric Parasite Panel, BD MAX Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

BioCode Gastrointestinal Pathogen Panel (GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

PROGASTRO SSCS ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BioCode Gastrointestinal Pathogen Panel (GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

xTAG Gastrointestinal Pathogen Panel (GPP)

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX Extended Enteric Bacterial Panel, BD MAX System

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX Enteric Viral Panel, BD MAX Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX Enteric Parasite Panel

FDA 510(k)

FDA Class 2 ·Microbiology

PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

FDA classification

FDA Class 2 ·Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

BLACHLY BITE BLOK & CHEEK FILLER

FDA 510(k)

FDA Class 2 ·Neurology

TANDEMHEART FEMORAL VENOUS CANNULA SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

FDA 510(k)

FDA Class 2 ·General Hospital