LUMINESCENCE PHOTOMETER 100 SERIES

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ARx® SAI Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

LATEX EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

Ormco Spark Aligner System

FDA 510(k)

FDA Class 2 ·Dental

Ankle Truss System (ATS)

FDA 510(k)

FDA Class 2 ·Orthopedic

TIDAL Fusion Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

FreeStyle Freedom Lite Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Freestyle Freedom Blood Glucose Monitoring Sytem

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle InsuLinx Blood Glucose Monotioring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Lite Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE

FDA 510(k)

FDA Class 1 ·General Hospital

NETRA WORKSTATION SYSTEM & NETRA MD SOFTWARE

FDA 510(k)

FDA Class 1 ·Radiology

NON-PRESCRIPTION SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

LCCS VC-S RF Cannula

FDA 510(k)

FDA Class 2 ·Neurology

REVEEL ENDOSCOPIC RETRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System

FDA 510(k)

FDA Class 2 ·Orthopedic

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

FDA 510(k)

FDA Class 2 ·Microbiology

ASI REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ASI Evolution

FDA 510(k)

FDA Class 2 ·Microbiology

ASI Plethysmogrpah Analyzer

FDA 510(k)

FDA Class 2 ·Cardiovascular