Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SF NAV UNI-DIRECTIONAL CATHETER (D-1315-XX-S, D-1318-XX-S) AND THERMOCOOL SF UNI-DIRECTIONAL CATHETER

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PROGRAMMABLE PUMP

Automated Insulin Dosing Device System, Bihormonal Control

FDA classification

FDA Class 3 ·Automated Insulin Dosing Device System, Bihormonal Control

Sealant, Dural

FDA classification

FDA Class 3 ·Sealant, Dural

Automated Insulin Dosing Device System, Single Hormonal Control

FDA classification

FDA Class 3 ·Automated Insulin Dosing Device System, Single Hormonal Control

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA classification

FDA Class 3 ·Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA classification

FDA Class 3 ·Tricuspid Valve Repair Device, Percutaneously Delivered

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, 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