BIODUCT

FDA 510(k)

FDA Class 2 ·Orthopedic

A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE A.I.S.)

FDA 510(k)

FDA Class 2 ·Orthopedic

SLEEPWEAVER NASAL CPAP MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

BIA / VITALITY ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Duo Hands-free Breast Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Firebow Wire Torque Assist Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN

FDA 510(k)

FDA Class 2 ·Dental

CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PROCEM

FDA 510(k)

FDA Class 2 ·Dental

Molecular Flow Simulations

FDA 510(k)

FDA Class 2 ·Neurology

OARtrac System with Skin Sensors

FDA 510(k)

FDA Class 2 ·Radiology

dima Print Teeth & Temp

FDA 510(k)

FDA Class 2 ·Dental

CELLTRACKS AUTOPREP SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PreferX Delivery System

FDA 510(k)

FDA Class 2 ·General Hospital

FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Nucleus Image Management System

FDA 510(k)

FDA Class 2 ·Radiology

IMPLANTER DENTAL PLANNING SOFTWARE

FDA 510(k)

FDA Class 2 ·Radiology

Venus Bulk Flow ONE

FDA 510(k)

FDA Class 2 ·Dental

ARTEMIS

FDA 510(k)

FDA Class 2 ·Radiology