10,000 results · 27ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER- EDWARDS PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER EDWARDS BIOPROSTHESIS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 630G System

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Thoracic Stent Graft With the Captivia Delivery System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·Tridyne Vascular Sealant

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Chilli II ™ Cooled Ablation Catheter and Cable

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Bioprosthesis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Ellipse DR, Ellipse VR

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NeuroPace RNS System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Accent MRI Pacemaker

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·BIOENTERICS LAP-BAND

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL TIME SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE(TM) BETA-CATH(TM) SYSTEM

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval
FDA Class 3 ·Shield

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·SPINALOGIC 1000 BONE GROWTH STIMULATOR