Luminesse PMMA

FDA 510(k)

FDA Class 2 ·Dental

aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices

FDA 510(k)

FDA Class 2 ·Orthopedic

HD Steth

FDA 510(k)

FDA Class 2 ·Cardiovascular

syngo Application Software

FDA 510(k)

FDA Class 2 ·Radiology

CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERI-SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

KYPHON INFLATION SYRINGE

FDA 510(k)

FDA Class 2 ·Orthopedic

MASIMO RADICAL Y PULSE CO-OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Ion Endoluminal System (IF1000)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VirtuOst

FDA 510(k)

FDA Class 2 ·Radiology

DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EarLens Contact Hearing Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SimPro™ Now, GentleCath™ Hydrophilic

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENSO (Model 2)

FDA 510(k)

FDA Class 2 ·Neurology

SIMPLICITY EASY SOFT INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

TENSOR® Suture Button System

FDA 510(k)

FDA Class 2 ·Orthopedic

OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NEUROTRAC II

FDA 510(k)

FDA Class 2 ·Neurology