Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra® System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Real-Time REVEL System

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·iPro2 System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect System

Implanted Fecal Incontinence Device

FDA classification

FDA Class 3 ·Implanted Fecal Incontinence Device

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

FDA classification

FDA Class 3 ·Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

Microspheres Radionuclide

FDA classification

FDA Class 3 ·Microspheres Radionuclide

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA classification

FDA Class 3 ·Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

Ventricular (Assist) Bypass

FDA classification

FDA Class 3 ·Ventricular (Assist) Bypass

Transcatheter Septal Occluder

FDA classification

FDA Class 3 ·Transcatheter Septal Occluder

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

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE DUO/COOL PATH DUO ABLATION CATHETERS, VERISENSE ENABLED AND VERISENSE SYSTEM AND IBI 1500T9-CP V1.6 CARDIAC

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOR

Digital Breast Tomosynthesis

FDA Pre-Market Approval

FDA Class 3 ·Senographe Pristina 3D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR

Dc-Defibrillator, High Energy, (Including Paddles)

FDA classification

FDA Class 3 ·Dc-Defibrillator, High Energy, (Including Paddles)