System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK STENT GRAFT WITH INTUITRAK DELIVERY SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid)

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·i-FACTOR™ Peptide Enhanced Bone Graft

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL COCR-CORONARY STENT ON RX SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOLOGIC 1000 BONE GROWTH STIMULATOR

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·OVATION ABDOMINAL STENT GRAFT SYSTEM, OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, OVATION IX ILIAC STENT GRAFT

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·SpineSeal Spine Sealant

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Alto Abdominal Stent Graft System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM WITH INTUITRAK DELIVERY SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Lifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·DUROLANE

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·MACROPLASTIQUE IMPLANTS