Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN XT TRANSCATHETER HEART VALVE

HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA

FDA 510(k)

FDA Class 3 ·Cardiovascular

CERYX6, 611, CERYX 3 311 & CERYX 1 111

FDA 510(k)

FDA Class 3 ·Cardiovascular

TP 1

FDA 510(k)

FDA Class 3 ·Cardiovascular

Mitral Valve Repair Devices

FDA classification

FDA Class 3 ·Mitral Valve Repair Devices

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification

FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Intraocular Pressure Lowering Implant

FDA classification

FDA Class 3 ·Intraocular Pressure Lowering Implant

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA classification

FDA Class 3 ·Aortic Valve, Prosthesis, Percutaneously Delivered

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA classification

FDA Class 3 ·Prosthesis, Mitral Valve, Percutaneously Delivered

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA classification

FDA Class 3 ·Percutaneously Delivered Prostheses And Tricuspid Valves

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA classification

FDA Class 3 ·Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA classification

FDA Class 3 ·Continuous Glucose Monitor, Implanted, Adjunctive Use

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA classification

FDA Class 3 ·Stimulator, Autonomic Nerve, Implanted (Depression)

Bronchial Thermoplasty System

FDA classification

FDA Class 3 ·Bronchial Thermoplasty System

Filler, Bone Void, Synthetic Peptide

FDA classification

FDA Class 3 ·Filler, Bone Void, Synthetic Peptide

Sensor, Glucose, Invasive

FDA classification

FDA Class 3 ·Sensor, Glucose, Invasive

Automated External Defibrillators (Non-Wearable)

FDA classification

FDA Class 3 ·Automated External Defibrillators (Non-Wearable)

Over-The-Counter Automated External Defibrillator

FDA classification

FDA Class 3 ·Over-The-Counter Automated External Defibrillator

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification

FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar