Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TRIVASCULAR, INC OVATION/OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

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

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TRIVASCULAR,INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TRIVASCULAR, INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

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

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

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

FDA Pre-Market Approval

FDA Class 3 ·AB-CORE K HEPATITIS B CORE ANTIGEN 125I

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS, INC EPTA, ENERGEN, PUNCTUA, C OGNIS CRT-D'S

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROSTATRON

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·MODEL SPF-60 SPINAL FUSION STIMULATOR

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBITT MONOCLONAL PRIMARY ANTIBODY

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC ABLATION CATHETER (NON-IRRIGATED),SAFIRE ABLATION CATHETER (NON-IRRIGATED)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Livewire TC™ Ablation Catheter and Safire™ Bi-Directional Ablation Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Livewire TC Ablation Catheter and Safire Ablation Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE(R) CARDIAC ABLATION SYSTEM