ApolloVue S100 Image System

FDA 510(k)

FDA Class 2 ·Radiology

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Reflow System Mini and ReFlow Mini Flusher

FDA 510(k)

FDA Class 2 ·Neurology

INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENTAKE STANDARD AND SAFETY PEG SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STOPWET iontophoresis apparatus (SW01)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Axonpen, Axonmonitor, Axonbox, Tablet

FDA 510(k)

FDA Class 2 ·Neurology

ReFlow System Mini

FDA 510(k)

FDA Class 2 ·Neurology

BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA 510(k)

FDA Class 2 ·General Hospital

BARD MEMOTHERM ENDOSCOPIC BILIARY STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

Armada 18 PTA Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

BARD ENDOSCOPIC SUTURING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RIGHTEST Blood Glucose Monitoring System Max Tel

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NTU-USB Ultrasound USB Box

FDA 510(k)

FDA Class 2 ·Radiology

ENDOXANE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG

FDA 510(k)

FDA Class 2 ·Dental

D2RS_AT Digital Dynamic Remote System

FDA 510(k)

FDA Class 2 ·Radiology