CARTO ENT System

FDA 510(k)

FDA Class 2 ·Neurology

TruDi® Navigation System V3 (FG-2000-00)

FDA 510(k)

FDA Class 2 ·Neurology

MALLEABLE SUCTION INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Neurology

TruDi Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

EM ENT Navigated Suctions

FDA 510(k)

FDA Class 2 ·Neurology

GuideWire

FDA 510(k)

FDA Class 2 ·Neurology

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time HCV Amplification Reagent Kit /HCV Control Kit /HCV Calibrator Kit

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.

MD-Temp Plus

FDA 510(k)

FDA Class 2 ·Dental

PROPENCIL Smoke Pencil

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CUTANEOUS ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

Star-X, Intraoral X-ray System

FDA 510(k)

FDA Class 2 ·Dental

DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)

FDA 510(k)

FDA Class 2 ·Radiology

Xcam

FDA 510(k)

FDA Class 2 ·Dental

WillCeph

FDA 510(k)

FDA Class 2 ·Radiology

Metacem

FDA 510(k)

FDA Class 2 ·Dental

AFS Medical Sterile Single-Use Access Port System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes

FDA 510(k)

FDA Class 2 ·Neurology

Metapaste Plus

FDA 510(k)

FDA Class 2 ·Dental