COLLACARE DENTAL

FDA 510(k)

FDA Unclassified ·Unknown

COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID

FDA 510(k)

FDA Unclassified ·Unknown

AERONEB PROFESSIONAL NEBULIZER SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

INNOVO

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EMPHASYS Femoral Stems

FDA 510(k)

FDA Class 2 ·Orthopedic

ATTUNE Cemented Tibial Base, Fixed Bearing

FDA 510(k)

FDA Class 2 ·Orthopedic

True Form Reshapable Guide Wire

FDA 510(k)

FDA Class 2 ·Cardiovascular

014 Hydrophilic Coated PTA Balloon Dilatation Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

Boss Crossing Support Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

DePuy Actis DuoFix Hip Prosthesis

FDA 510(k)

FDA Class 2 ·Orthopedic

Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm

FDA 510(k)

FDA Class 2 ·Physical Medicine

PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EMBOTRAP III Revascularization Device

FDA 510(k)

FDA Class 2 ·Cardiovascular

BionicGym Powered Muscle Stimulator

FDA 510(k)

FDA Class 2 ·Physical Medicine

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ANTENNA AND PORTABLE CHARGER

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·GEL-ONE

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval

Harmony™ TPV System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)