HELENA SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Cervical Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY Pedicle Screw Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

FIREFLY® Pedicle Screw Navigation Guide

FDA 510(k)

FDA Class 2 ·Orthopedic

ALOE CADABRA LUBRICANT, ALOE CADABRA FLAVORED/SCENTED LUBRICANTS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

OAKTREE Anterior Lumbar Plate and Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Fixxsure Anterior Lumbar Plate and Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

INTERX5000

FDA 510(k)

FDA Class 2 ·Neurology

DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISPOSABLE NON-ADHESIVE SPO2 SENSORS

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPO2 WRAP SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SURGI LIGHT NON-CONTACT FIBERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE

FDA 510(k)

FDA Class 2 ·Neurology

FLEXI-STAT SP02 EAR SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPO2 WRAP SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)

FDA 510(k)

FDA Class 2 ·Neurology

DNA/RNA Shield SafeCollect Saliva Collection kit

FDA 510(k)

FDA Class 2 ·Microbiology