Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel and Intellis Spinal Cord Stimulation Systems

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 & CVX-300P EXCIMER LASER SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 and CVX-300P Excimer Laser Systems

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

FDA Pre-Market Approval

FDA Class 3 ·Freezer MAX

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

FDA Pre-Market Approval

FDA Class 3 ·Freezor MAX

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS EXCIMER LASER

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 and CVX-300-P Excimer Laser Systems

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 and CVX-300-P EXCIMER LASER SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 AND CVX-300-P EXCIMER LASER SYSTEMS

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 EXCIMER LASER VERSION V3.7.12/V3.8.12

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·SPECTRANETICS EXCIMER LASER

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 LASER SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·CVX-300 EXCIMER LASER SYSTEM

ZIMMER THREADED ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic