LTU-904 PORTABLE LASER THERAPY UNIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Light, Lymphedema Reduction, Low Energy

FDA classification

FDA Class 2 ·Light, Lymphedema Reduction, Low Energy

STRATUS PRIMIDONE FLOROMETRIC ENZY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VASCUMED EZ Y-CONNECTOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Osteo-site Vertebral Balloon

FDA 510(k)

FDA Class 2 ·Orthopedic

CPR EZY MASK AND PAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENZY-WELL SYPHILIS IGG, MODEL 91106

FDA 510(k)

FDA Class 2 ·Microbiology

ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HZI CEEG/EP SYSTEM SOFTWARE (CEEG-SCAN)TM

FDA 510(k)

FDA Class 2 ·Neurology

NAVIGABLE BRAIN BIOPSY CANNULA SET

FDA 510(k)

FDA Class 2 ·Neurology

Assure Titanium Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ReVene Thrombectomy Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLUCOCARD® W onyx Blood Glucose Monitoring System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTION ELEVEN Semi-Automated Urinalysis System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTION MAX AX-4060 Urinalysis System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AUTION EYE AI-4510 Urine Particle Analysis System

FDA 510(k)

FDA Class 2 ·Hematology

DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System

FDA 510(k)

FDA Class 2 ·Neurology

MDT Navigable Brain Biopsy Cannula

FDA 510(k)

FDA Class 2 ·Neurology

CushionCast Moldable Cushions

FDA 510(k)

FDA Class 2 ·Radiology

Navigated Pedicle Access Kit

FDA 510(k)

FDA Class 2 ·Neurology