Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM, MINILINK REAL-TIME SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, MINILINK REAL-TIME SYSTEM, GUARDIAN REAL TIME SYSTEM

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Catheter, Intravascular, Plaque Morphology Evaluation

FDA classification

FDA Class 2 ·Catheter, Intravascular, Plaque Morphology Evaluation

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA classification

FDA Class 3 ·Aortic Valve, Prosthesis, Percutaneously Delivered

Graft Insertion Instrument For Endothelial Keratoplasty

FDA classification

FDA Class 1 ·Graft Insertion Instrument For Endothelial Keratoplasty

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·THUNDER HIGH SCAFFORDING OVER-THE-WIRE AND RAPID EXCHANGE SAPHENOUS VEIN GRAFT STENT SYSTEMS

Tongue Suspension System

FDA classification

FDA Class 2 ·Tongue Suspension System

Micro Total Analysis Instrument System

FDA classification

FDA Class 2 ·Micro Total Analysis Instrument System

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

FDA classification

FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

FDA classification

FDA Class 2 ·Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Dermal Cooling Pack/Vacuum/Massager

FDA classification

FDA Class 2 ·Dermal Cooling Pack/Vacuum/Massager

Laser Aiming Product, Non-Visible

FDA classification

FDA Not Classified ·Laser Aiming Product, Non-Visible

Dental Amalgam

FDA classification

FDA Class 2 ·Dental Amalgam

Infusion Pump, Drug Specific, Pharmacy-Filled

FDA classification

FDA Class 2 ·Infusion Pump, Drug Specific, Pharmacy-Filled

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA classification

Pulmonary Valve Prosthesis Percutaneously Delivered