PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPQ TM TEST SYSTEM II FOR CRP

FDA 510(k)

FDA Class 2 ·Immunology

HBM HEMOGLOBINOMETER

FDA 510(k)

FDA Class 2 ·Hematology

FilmArray Pneumonia/Pneumoniaplus Control

FDA 510(k)

FDA Class 2 ·Microbiology

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

TURBO-RAST SPECIFIC IGE ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR COMPLEMENT C3

FDA 510(k)

FDA Class 2 ·Immunology

BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ(TM) ANTIBODY REAGENT SET II FOR TRF

FDA 510(k)

FDA Class 2 ·Immunology

VALIDATE D-Dimer Calibration Verification/Linearity Test Kit

FDA 510(k)

FDA Class 2 ·Hematology

Normandy VBR System

FDA 510(k)

FDA Class 2 ·Orthopedic

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

Zavation IBF System

FDA 510(k)

FDA Class 2 ·Orthopedic

LABYRINTH

FDA 510(k)

FDA Class 2 ·Orthopedic

CHILLBUSTER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PREMISE SERIES BED

FDA 510(k)

FDA Class 2 ·General Hospital

LOW AIR LOSS BED

FDA 510(k)

FDA Class 2 ·General Hospital

SteriZign Signatur Device Protection System

FDA 510(k)

FDA Class 2 ·General Hospital

ShurFit Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic