Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS LASER SHEATH (SLS)

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ATLAS II+ HF CRT-D & PROMOTE CRT-D

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENTS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance, Arctic Front Advance Pro™ Cardiac Cryoablation Catheter and Manual Retraction Kit

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Cath

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere, Biofinity Toric

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT® Structured Breast Implant

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·BSD-500 HYPERTHERMIA SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·BSD-500 HYPERTHERMIA SYSTEM

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval

FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval

FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM(R)

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND II SYSTEM

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval

FDA Class 3 ·CLINI-THERM MARK I/IV