Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Spiration® Valve System

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·APLIGRAF

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Gevia Deep Brain Stimulation (DBS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Cord Stimulatort (SCS) System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD Inogen VR, ICD Dynagen VR, ICD Dynagen DR, Momentum EL ICD VR, Momentum EL ICD DR, Vigilant EL ICD VR, Vigilant EL I

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EBI BONE HEALING SYSTEM(R)

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OsteoGen Implantable Bone Growth Stimulators

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 Spinal Fusion Stimulators

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Biomet OrthoPak Non-invasive Bone Growth Stimulator System; Biomet SpinalPak Non-invasive Spine Fusion Stimulator System

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OsteoGen Implantable Bone Growth Stimulators

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Biomet EBI Bone Healing System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EBI BONE HEALING SYSTEM(R)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·OSTEOGEN IMPLANTABLE SPINAL FUSION STIMULATOR

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OsteoGen Implantable Bone Growth Stimulators

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·EBI BONE HEALING SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD SYSTEM