ARx® SAI Implant System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

LCCS VC-S RF Cannula

FDA 510(k)

FDA Class 2 ·Neurology

REVEEL ENDOSCOPIC RETRACTOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ankle Fusion Cage

FDA classification

FDA Class 2 ·Ankle Fusion Cage

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

ASI HEMOSTASIS CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASI CYSTOLASE LASER CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASI UROPLASTY LASER CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AIRPREP SYSTEM - MODEL 9001

FDA 510(k)

FDA Class 2 ·Dental