Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NIC 1800 NEEDLE DISPOSAL SYSTEM

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·ECONOLITH(TM) LITHOTRIPTER

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·IGEL 67 CONTACT LENS

CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INSCOPE 3-STAGE BALLOON DILATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ST'RIM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOACTIVE BONE GRAFT PUTTY

FDA 510(k)

FDA Class 2 ·Orthopedic

RADIANCE 330 PROTON THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ONCO TRAC MODEL 1, 2, 4

FDA 510(k)

FDA Class 2 ·Radiology

INQU PASTE MIX PLUS

FDA 510(k)

FDA Class 2 ·Orthopedic

SIM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TACTIPEN

FDA 510(k)

FDA Class 2 ·General Hospital

OKAMOTO STUDDED CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MICROVISION SCLERAL BUCKLING COMPONENTS

FDA 510(k)

FDA Class 2 ·Ophthalmic

SPECTRUM V.0

FDA 510(k)

FDA Class 2 ·Radiology

SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY

FDA 510(k)

FDA Class 2 ·Dental

SMILEBOND SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MRI MARKER

FDA 510(k)

FDA Class 2 ·Radiology