CLEARPOINT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

ARIES® Flu A/B & RSV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI

FDA 510(k)

FDA Class 2 ·Anesthesiology

Lumenis Stellar M22

FDA 510(k)

FDA Class 2 ·Ophthalmic

Valeda Light Delivery System

FDA 510(k)

FDA Class 2 ·Ophthalmic

SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES

FDA 510(k)

FDA Class 2 ·Neurology

GEMORE TRUE SINE INTERFERENTIAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

GEMORE MUSCLE CONDITIONER;

FDA 510(k)

FDA Class 2 ·Physical Medicine

GEM-STIM COMBO STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP

FDA 510(k)

FDA Class 2 ·Neurology

GEM-TWIN TENS/ MODELS GM3XY/Z

FDA 510(k)

FDA Class 2 ·Neurology

GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)

FDA 510(k)

FDA Class 2 ·Neurology

GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.

FDA 510(k)

FDA Class 2 ·Physical Medicine

GEM-TONE BODY TRAINING SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

GEMORE TENS SYSTEM

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

GEM-STIM TENS, MODELS GM3XY AND GM3AXY

FDA 510(k)

FDA Class 2 ·Neurology

CHARTER GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular