iSR'obot MRI-US Fusion

FDA 510(k)

FDA Class 2 ·Radiology

STOPWET iontophoresis apparatus (SW01)

FDA 510(k)

FDA Class 2 ·Physical Medicine

GEMORE TENS SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BR-FHUS Navigation 1.0

FDA 510(k)

FDA Class 2 ·Radiology

Axonpen, Axonmonitor, Axonbox, Tablet

FDA 510(k)

FDA Class 2 ·Neurology

Alcyone MEMS Cannula (AMC) System

FDA 510(k)

FDA Class 1 ·Neurology

CRYSTAL

FDA 510(k)

FDA Class 1 ·Ophthalmic

ReFlow System Mini

FDA 510(k)

FDA Class 2 ·Neurology

GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)

FDA 510(k)

FDA Class 2 ·Neurology

GIM-STIM OTC TENS/EMS System

FDA 510(k)

FDA Class 2 ·Neurology

WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H

FDA 510(k)

FDA Class 2 ·General Hospital

GEM-STIM TENS, MODELS GM3XY AND GM3AXY

FDA 510(k)

FDA Class 2 ·Neurology

ibiomedi Electronic Stethoscope ES-2020

FDA 510(k)

FDA Class 2 ·Cardiovascular

WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)

FDA 510(k)

FDA Class 2 ·General Hospital

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

Armada 18 PTA Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

RIGHTEST Blood Glucose Monitoring System Max Tel

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

NTU-USB Ultrasound USB Box

FDA 510(k)

FDA Class 2 ·Radiology

iNSIGHT Color Doppler Ultrasound System

FDA 510(k)

FDA Class 2 ·Radiology