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

ZIRBLANK-PS AND ZIRBLANK-FS

FDA 510(k)

FDA Class 2 ·Dental

1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613

FDA 510(k)

FDA Class 2 ·General Hospital

BR-ABVS Viewer 1.0

FDA 510(k)

FDA Class 2 ·Radiology

SIRIUS Endoscope System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BR-FHUS Viewer 1.0

FDA 510(k)

FDA Class 2 ·Radiology

ODRC-DYNAMIC HIP SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

E3-80 PORTABLE ECG RECORDER & ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular