DePuy Reclaim Monobloc Revision Femoral Stem

FDA 510(k)

FDA Class 2 ·Orthopedic

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Toricolors (hioxifilcon D) Soft Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OLYMPUS AFP - ALPHA-FETOPROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

FDA 510(k)

FDA Class 2 ·Orthopedic

GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAGNA OBSTETRICAL PACKS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional

FDA 510(k)

FDA Class 2 ·Orthopedic

GLOBAL UNITE Platform Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

Neuromark System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII

FDA 510(k)

FDA Class 2 ·Cardiovascular

PneumoLiner

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411

FDA 510(k)

FDA Class 2 ·Neurology

EVA15 insufflator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

NR5000 E.C.G. AND PULSE OXIMETER MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPIRALE DRUG DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

RedEx

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Neon EEG

FDA 510(k)

FDA Class 2 ·Neurology

KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411

FDA 510(k)

FDA Class 2 ·Physical Medicine