PRE' VAGINAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

StimQ Peripheral Nerve Stimulator (PNS) System

FDA 510(k)

FDA Class 2 ·Neurology

SYPHER SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Golden Isles Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CELLTRACKS AUTOPREP SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

ProstatID

FDA 510(k)

FDA Class 2 ·Radiology

Vivio® LVEDP System

FDA 510(k)

FDA Class 2 ·Cardiovascular

FIRST RESPONSE 1-STEP PREGNANCY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

ATLAS Plating System

FDA 510(k)

FDA Class 2 ·Orthopedic

GraftGun Universal Graft Delivery System (GDS)

FDA 510(k)

FDA Class 2 ·General Hospital

LEVITRONIX CENTRIMAG PRIMARY CONSOLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352

FDA 510(k)

FDA Class 2 ·Physical Medicine

ChoiceSpine Navigation System

FDA 510(k)

FDA Class 2 ·Neurology

RTapp

FDA 510(k)

FDA Class 2 ·Radiology

SpineNet SSP System

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHOSIZE

FDA 510(k)

FDA Class 2 ·Radiology

PHONAK TINNITUS BALANCE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat