Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES

Zenius Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

FOLEY CATHETER TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MEDYSSEY ANTERIOR CERVICAL FUSION CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

SERVOMED BASIC BEDSIDE UNIT SMV 110TP

FDA 510(k)

FDA Class 2 ·Cardiovascular

Zenius™, lliad™ and Kora™ Spinal Fixation Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

RECOMED CARDIAC OUTPUT METER 236067-

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCINTRON IV

FDA 510(k)

FDA Class 2 ·Radiology

SUPER STRENGTH DENTURE ADHESIVE CREAM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Iliad® Pedicle Screw System and Zenius® Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Triton Cage

FDA 510(k)

FDA Class 2 ·Orthopedic

DUAL VALVE ASPIRATION/LAVAGE CANNULA AND ASPIRATION/SUCTION PROBE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MASC Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000

FDA 510(k)

FDA Class 2 ·Radiology

TAURUS PEEK Cage System

FDA 510(k)

FDA Class 2 ·Orthopedic

SERVOMED PULSE AMPLIFIER MODULE-206-

FDA 510(k)

FDA Class 2 ·Cardiovascular

ETYMOTIC RESEARCH ER-10D OAE PROBE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

KIT PAK IRRIGATION TRAY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Medussa-PL Cage

FDA 510(k)

FDA Class 2 ·Orthopedic