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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Epic™ Max Tissue Heart Valves

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

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·Freezor Max Cardiac Cryoablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR MAX CARDIAC CRYOBLATION CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·Freezor MAX Cardiac Cryoablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PULSAR/PULSAR MAX/ DISCOVERY/MERIDIAN

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

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR MAX CARDIAC CRYOABLATION CATHETER

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Freezor TM Cardiac Cryoablation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·FREEZOR MAX CARDIAC CRYO ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·9F Freezor MAX Cardiac Cryoablation Catheter

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON - TB

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

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE-FILLED BREAST IMPLANTS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·9F FREEZOR MAX SURGICAL CARDIAC CRYOABLATION DEVICE