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

GEMORE OTC TENS

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

ShiNeo Silicone Implant

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ORANGE COLORED CONDOMS ORANGE SCENT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EASYMAX N SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL: EPS08008

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OKLand Patient Return Electrode Pad

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GEM-TONE BODY TRAINING SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

iSR'obot Biopsy Kit

FDA 510(k)

FDA Class 2 ·Radiology

iSR'obot MRI-US Fusion

FDA 510(k)

FDA Class 2 ·Radiology

GEMORE TENS SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BR-FHUS Navigation 1.0

FDA 510(k)

FDA Class 2 ·Radiology

GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)

FDA 510(k)

FDA Class 2 ·Neurology

GIM-STIM OTC TENS/EMS System

FDA 510(k)

FDA Class 2 ·Neurology

GEM-STIM TENS, MODELS GM3XY AND GM3AXY

FDA 510(k)

FDA Class 2 ·Neurology

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator