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

FDA Pre-Market Approval

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

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·CraniSeal Dural Sealant

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDOLOGIX, INC. POWERLINK SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·DUROLANE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF IMPLANTABLE SPINAL FUSION STIMULATORS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech's Automated External Defibrillator (AED) System

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

FDA Pre-Market Approval

FDA Class 3 ·TARGIS SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX ENDOVASCULAR AAA SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Alto Abdominal Stent Graft System

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·MAXUM

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

FDA Pre-Market Approval

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

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·MAXUM SYSTEM

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