Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Shield

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ANS GENESIS NEUROSTIMULATION (IPG) SYSTEM

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ETHYLENE OXIDE (EO)STERILIZATION EQUIPMENT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINALOGIC 1000 BONE GROWTH STIMULATOR

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF-XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PUREVISION 2/PUREVISION 2 MULTI-FOCAL/PUREVISION 2 TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS 2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST ICD, INTRINSIC 30 ICD, INTRINSIC ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO VR IC

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM