Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Aurora EV-ICD System

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA classification

FDA Class 3 ·Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA classification

FDA Class 3 ·Implant, Hearing, Active, Middle Ear, Totally Implanted

Light Source System, Diagnostic Endoscopic

FDA classification

FDA Class 3 ·Light Source System, Diagnostic Endoscopic

Pediatric Esophageal Atresia Anastomosis Device

FDA classification

FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device

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

Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

FDA classification

FDA Class 3 ·Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

Valve, Pulmonary

FDA classification

FDA Class 3 ·Valve, Pulmonary

Biologic Material, Dental

FDA classification

FDA Class 3 ·Biologic Material, Dental

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Aptima HBV Quant Assay

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

FDA classification

FDA Class 3 ·Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

Implantable Cardioverter Defibrillator (Non-Crt)

FDA classification

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-Crt)

Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

FDA classification

FDA Class 3 ·Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA classification

FDA Class 3 ·Implantable Pulse Generator, Pacemaker (Non-Crt)

Electrical Tumor Treatment Fields

FDA classification

FDA Class 3 ·Electrical Tumor Treatment Fields

Leadless Pacemaker

FDA classification

FDA Class 3 ·Leadless Pacemaker

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire II Upper Airway Stimulator

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulation