FilmArray Respiratory Panel 2 (RP2)

FDA 510(k)

FDA Class 2 ·Microbiology

U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

REMI

FDA 510(k)

FDA Class 2 ·Neurology

COMFORT ELECTRIC SCOOTER, LY-EW408

FDA 510(k)

FDA Class 2 ·Physical Medicine

OEC FLUOROTRAK 9800 PLUS

FDA 510(k)

FDA Class 2 ·Radiology

U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

FilmArray Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FlexiGo 3D Delivery Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE

FDA 510(k)

FDA Class 2 ·Neurology

ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL

FDA 510(k)

FDA Class 2 ·General Hospital

ARTHROPLAST & ARTHRO-CUTTER

FDA 510(k)

FDA Class 2 ·Orthopedic

Pinpoint GT Needle Guide Kits

FDA 510(k)

FDA Class 2 ·Radiology

S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D

FDA 510(k)

FDA Class 2 ·Neurology

XPER Technology PREMIUM Pro Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

QUITETIP

FDA 510(k)

FDA Class 2 ·Ophthalmic

3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology

FDA 510(k)

FDA Class 2 ·General Hospital

Digital NeuroPort Biopotential Signal Processing System

FDA 510(k)

FDA Class 2 ·Neurology

LED CURING LIGHT

FDA 510(k)

FDA Class 2 ·Dental

PressON Pro Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic