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

FDA Pre-Market Approval

FDA Class 3 ·FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER OPEN-IRRIGATED ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·POLARx and POLARxFIT Cryoablation Catheters

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS ELECTROPHYSIOLOGY CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Endoscopic Ablation System

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

FDA Pre-Market Approval

FDA Class 3 ·ARTIC FRONT CARDIC CRYOABLATION CATHETERS, ARTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETERS, FREEZOR MAX CARIAC CRYOAB

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·Gambro Prismaflex TPE 2000 Set

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance Cardiac CryoAblation Catheters

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA Pre-Market Approval

FDA Class 3 ·Optune Lua

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM

Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

FDA Pre-Market Approval

FDA Class 3 ·GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Reactiv8 Implantable Neurostimulation System

Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

FDA Pre-Market Approval

FDA Class 3 ·GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA Pre-Market Approval

FDA Class 3 ·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval

FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System