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

FDA Pre-Market Approval

FDA Class 3 ·Artic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance and Arctic Front Advance Pro

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor TM Cardiac Cryoablation Catheter

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·Rapid fFN for the TLiIQ System, Fetal Fibronectin Enzyme Immunoassay

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advanced Cardiac Cryoablation Catheter, Arctic Front Advanced PRO Cardiac Cryoablation Catheter, 9F Freezor

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·LINX Reflux Management System

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Cryocatheter System

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·TORONTO SPV VALVE

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE® Silicone-Filled Breast Implants

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON®XL MUREX Anti-HBc assay and Control

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE® Saline-Filled Breast Implants

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBc lgM assay and Control

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBeAg assay and Control

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX Anti-HBe assay and Control