DTX-200 BONE DENSITOMETER

FDA 510(k)

FDA Class 2 ·Radiology

Exablate Prostate System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMART WAVE GS100

FDA 510(k)

FDA Class 2 ·Physical Medicine

MDX 2000, DIGITAL ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

IIF-APCA TEST KIT

FDA 510(k)

FDA Class 2 ·Immunology

SYNELISA PARIETAL CELL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454

FDA 510(k)

FDA Class 2 ·Anesthesiology

ODFS Pace XL

FDA 510(k)

FDA Class 2 ·Neurology

SIGMA ALPHA VAPORIZER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PROLONG

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ODFS PACE

FDA 510(k)

FDA Class 2 ·Neurology

Pump In Style Advanced, Advanced Personal Double Breastpump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SOL-GUARD Safety Pull Button Collection Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Alivio Ventricular Catheter and Flusher System (Alivio System)

FDA 510(k)

FDA Class 2 ·Neurology

TUTOPATCH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Pump In Style

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CRAIGWELL AID FITTING SYSTEM AFS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CRAIGWELL MASTER HEARING AID MHA

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

DEFLEX ACRILATO

FDA 510(k)

FDA Class 2 ·Dental