System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Gore TAG Thoracic Stent Graft with ACTIVE CONTROL System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX EXPANDED PTFE PROSTHETIC LIGAMENT

Prosthesis, Ligament, Ptfe

FDA Pre-Market Approval

FDA Class 3 ·GORE-TEX{TM} CRUCIATE LIGAMENT PROSTHESIS

M2A MAGNUM SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

TAPERLOC COMPLETE

FDA 510(k)

FDA Class 3 ·Orthopedic

COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

POROUS COATED ACETABULAR COMPONENTS

FDA 510(k)

FDA Class 3 ·Orthopedic

BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS

FDA 510(k)

FDA Class 3 ·Orthopedic

BIOMET MODULAR FEMORAL REVISION SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

RINGLOC + HYBRID ACETABULAR SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

BALANCE HIP SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN

FDA 510(k)

FDA Class 3 ·Cardiovascular

K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFEPAK 12 BIPHASIC

FDA 510(k)

FDA Class 3 ·Cardiovascular