10,000 results · 24ms · Sources: EU EUDAMED, US FDA

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM, & WITH SURESOUND ULTRINE SOUND, NOVASURE RF CONTROLLER 115V

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·BLAZER RPM CARDIAC ABLATION CATHETERS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·EZE-FIT(TM)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·OCUCOAT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP STEERABLE GUIDE CATHETER

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

FDA Pre-Market Approval
FDA Class 3 ·SAFIRE TX CATHETER

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·LIBERTE CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE

Glue, Surgical, Arteries

FDA Pre-Market Approval
FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed 670G System

Automated Insulin Dosing , Threshold Suspend

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Connect System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Medtronic MiniMed 530G System

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

FDA Pre-Market Approval
FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Consulta, Syncra, Viva CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE

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

FDA Pre-Market Approval
FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Tecnis 3-Piece Acrylic Monofocal