VIBERECT PENILE VIBRATORY STIMULATION DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

VitreJect® Needle; OcuSafe® Needle

FDA 510(k)

FDA Class 2 ·General Hospital

GRAMS POLYPROPYLENE NONABSORBABLE SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cytosponge Cell Collection Device

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

APRO 70 Swift Catheter and Alembic Aspiration Tubing

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hintermann Series H2 Total Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)

FDA 510(k)

FDA Class 2 ·Orthopedic

TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

DOSE VOLUME HISTOGRAM (DVH) EVALUATOR

FDA 510(k)

FDA Class 2 ·Radiology

AMID STAPLER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OsteoRemedies Hip Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

WITTMANN PATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

X-ray Imaging System for the McLaren Proton Treatment System

FDA 510(k)

FDA Class 2 ·Radiology

BREAST VOLUME NAVIGATOR

FDA 510(k)

FDA Class 2 ·Radiology

K7 LUMBAR SPACERS

FDA 510(k)

FDA Class 2 ·Orthopedic

INNOCURE IMRT FILTER (COMPENSATORS)

FDA 510(k)

FDA Class 2 ·Radiology

StimSox(TM) System

FDA 510(k)

FDA Class 2 ·Physical Medicine

VIROGEN RUBELLA MICROTITER TEST

FDA 510(k)

FDA Class 2 ·Microbiology

ALARA Neuro Access Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

COMPLETE CONTROL System Gen2

FDA 510(k)

FDA Class 2 ·Neurology