10,000 results · 49ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Implantable Cardioverter Defibrillator (ICD) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOMENTUM, VIGI

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·LATITUDE Wave Communicator Model 6290

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MitraClip NTR/XTR System, MitraClip G4System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·Epic Vascular Self-Expanding Stent System

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Oncomine Dx Target Test

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA Single-Piece Anterior Chamber Intraocular Lens

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval
FDA Class 3 ·GELSYN-3

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·H55 HYDROPHILIC CONTACT LENS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGIFOAM® Absorbable Gelatin Sponge

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval
FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open-Irrigated Ablation Catheter

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Restore, Itrel®, Synergy®, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectr

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (etafilcon A) Brand Contact Lenses