IMAGENMD

FDA 510(k)

FDA Class 2 ·Radiology

OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700

FDA 510(k)

FDA Class 2 ·Anesthesiology

BASE IT

FDA 510(k)

FDA Class 2 ·Dental

NEOGENESYS 2K

FDA 510(k)

FDA Class 2 ·Neurology

MTI ST#1 SILICONE PESSARY

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

IMAGENPRO

FDA 510(k)

FDA Class 2 ·Radiology

OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

MEC-I-TRON MINI, MODEL M-2

FDA 510(k)

FDA Class 2 ·Neurology

HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500

FDA 510(k)

FDA Class 2 ·General Hospital

MEC-I-TRON, MODEL P-1

FDA 510(k)

FDA Class 2 ·Neurology

3400E series; E5400 series; E6400 series; Sundazzler series

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NTRAINER SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

CATHTONG II PICC Catheter

FDA 510(k)

FDA Class 2 ·General Hospital

SAFETY RELEASE ARCH BAR KIT

FDA 510(k)

FDA Class 2 ·Dental

G Surgical Marksman MIS System

FDA 510(k)

FDA Class 2 ·Orthopedic

G Surgical OCT Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

GPS Cervical Spacers

FDA 510(k)

FDA Class 2 ·Orthopedic

G Surgical Marksman System

FDA 510(k)

FDA Class 2 ·Orthopedic

G Surgical Marksman Spinal Deformity System

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV RNA QUALITATIVE ASSAY