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

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU-

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN Ultrasound Bone Healing System

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF IMPLANTABLE BONE GROWTH STIMULATOR

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX Endovascular AAA System

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

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIX SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK WITH INTUITRAK DELIVERY SYSTEM

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

FDA Pre-Market Approval

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

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Durolane

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF-4T IMPLANTABLE SPINAL FISION STIMULATOR

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·MAXUM SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·SPINALOGIC BONE GROWTH STIMULATOR

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·I-FACTOR Peptide Enhanced Bone Graft

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Lifeline, Defibtech Lifeline AUTO, Defibtech Lifeline VIEW, Defibtech Lifeline VIEW AUTO, Defibtech Lifeline E