Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·SOFT SITE (HEFILCON A) CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS TRASKAR 18 PTCA DILITATION CATHETERS

Lens, Contact (Other Material) - Daily

FDA Pre-Market Approval

FDA Class 2 ·O-PERM F60 RGP CONTACT LENS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CORDIS PREDATOR PTCA DILATATION CATHETER

CORDIS 13F CATHETER SHEATH INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

FM-9000 PLUS FETAL AND MATERNAL MONITOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY

FDA 510(k)

FDA Class 2 ·Orthopedic

HRB-127-32 HIGH RESOLUTION BRAIN COIL

FDA 510(k)

FDA Class 2 ·Radiology

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BONETRAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PBN GUIDEWIRES

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT

FDA 510(k)

FDA Class 2 ·Orthopedic

RATEMINDER(TM) V INFUSION PUMP, MODIFICATION

FDA 510(k)

FDA Class 2 ·General Hospital

Arthrex SwiveLock Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic

TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

Arthrex iBalance Partial Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

DFS-2100

FDA 510(k)

FDA Class 2 ·Radiology

Apyx Plasma/RF Handpiece

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMRON MODEL 514N TYMPANIC THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital