Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·LENS PLUS(R) OXYSEPT(R) ONE STEP NEUTRAL. TABLET

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPY Elite Intraoperative Perfusion Assessment System

FDA 510(k)

FDA Class 2 ·Radiology

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PINPOINT Endoscopic Fluorescence Imaging System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPY-PHI System with SPY-PHI Fluorescence Assessment Software

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPY Portable Handheld Imaging (SPY-PHI) System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PressureWire X

FDA 510(k)

FDA Class 2 ·Cardiovascular

RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

FDA 510(k)

FDA Class 2 ·Hematology

DAVIS AND GECK HANDHELD INST. STERILIZATION TRAY

FDA 510(k)

FDA Class 2 ·General Hospital

LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOFIX* BIODEGRADABLE FIXATION ROD

FDA 510(k)

FDA Class 2 ·Orthopedic

LUKENS SILK SURGICAL SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE

FDA 510(k)

FDA Class 2 ·General Hospital

DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT

FDA 510(k)

FDA Class 2 ·Cardiovascular

LUKENS NYLON SURGICAL SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery