PROLIXUS TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

FDA 510(k)

FDA Class 2 ·Radiology

ES BOND

FDA 510(k)

FDA Class 2 ·Dental

SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

CUBEScan BioCon-900S

FDA 510(k)

FDA Class 2 ·Radiology

HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology

XGEO GF50

FDA 510(k)

FDA Class 2 ·Radiology

Spectra Q

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SwiftMR

FDA 510(k)

FDA Class 2 ·Radiology

Sleep Apnea Feature

FDA 510(k)

FDA Class 2 ·Anesthesiology

ZEN-2090 Turbo

FDA 510(k)

FDA Class 2 ·Radiology

OPTIGEN TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SwiftMR

FDA 510(k)

FDA Class 2 ·Radiology

R-Sensor, R-Sensor

FDA 510(k)

FDA Class 2 ·Dental

Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

Shina Safety Needle

FDA 510(k)

FDA Class 2 ·General Hospital

LDE4 Lancing Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Absoanchor Microimplant

FDA 510(k)

FDA Class 2 ·Dental

AccelFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry