Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA classification

FDA Class 3 ·Covered Stent Vascular Connector, Hemodialysis Access Circuit

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA classification

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

Biologic Material, Dental

FDA classification

FDA Class 3 ·Biologic Material, Dental

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·HCII HPV TEST (DIGENE HPV TEST USING HYBRID CAPTURE II TECHNOLOGY)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·APTIMA HPV 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

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA classification

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

Mr-Guided Focused Ultrasound System

FDA classification

FDA Class 3 ·Mr-Guided Focused Ultrasound System

Bone Grafting Material, Dental, With Biologic Component

FDA classification

FDA Class 3 ·Bone Grafting Material, Dental, With Biologic Component

Permanent Defibrillator Electrodes

FDA classification

FDA Class 3 ·Permanent Defibrillator Electrodes

Bronchial Thermoplasty System

FDA classification

FDA Class 3 ·Bronchial Thermoplasty System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire II Upper Airway Stimulator

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulation

Material, Embolization, Neurovascular, Polymerizing Or Precipitating

FDA classification

FDA Class 3 ·Material, Embolization, Neurovascular, Polymerizing Or Precipitating

Barrier, Adhesion, Cardiovascular

FDA classification

FDA Class 3 ·Barrier, Adhesion, Cardiovascular