800 results · 19ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TALENT THORACIC STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION / MULTI-LINK MINI VISION / MULTI-LINK 8 CORONARY STENT SYSTEMS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTAPRO™ Rotational Atherectomy System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTAK AV/VENTAK PRIZM DR/VR/VITALITY ICDS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VOYAGER RX CORONARY DILATATION CATHETER

Device, Angioplasty, Laser, Coronary

FDA Pre-Market Approval
FDA Class 3 ·SPECTRANETICS EXCIMER CORONARY LASER ATHERECTOMY (ELCA) CATHETERS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·LDR Spine Mobi-C Cervical Disc Prosthesis (One Level)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK CD & EASYTRAK CRT-D SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·ENLITE SENSOR

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Biofinity XR Toric, Biofinity Toric Multifocal

Device, Removal, Pacemaker Electrode, Percutaneous

FDA Pre-Market Approval
FDA Class 3 ·SPECTRANETICS LASER SHEATHS (SLS)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·LDR Spine Mobi-C Cervical Disc Prosthesis (Two Level)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS AND EXPRESS2 CORONARY STENT SYSTEMS

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·Gynecare Interceed Absorbable Adhesion Barrier

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·LIFE STENT VASCULAR STENT SYSTEMS

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGICELTM Family of Absorbable Hemostats

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

System, Esophageal Pacing

FDA Pre-Market Approval
FDA Class 3 ·ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·WOLVERINE CORONARY CUTTING BALLOON MONORAIL (MR) AND OVER-THE WIRE (OTW)