10,000 results · 32ms · Sources: EU EUDAMED, US FDA

System, Hemodynamic, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CardioMEMS HF System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·Quickflex µ, Quartet

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Edwards Commander Delivery System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT MODEL 150

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CADENCE FAMILY OF ICDS

Implanted Brain Stimulator For Epilepsy

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

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN PLUS SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval
FDA Class 3 ·PROGEL Pleural Air Leak Sealant

Kit, Rna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·Aptima HPV-GT Assay

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval
FDA Class 3 ·Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·Guardian Glucose Sensor (3)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS INTUITY ELITE Valve System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Juvéderm Hyaluronate Gel Implants

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Endurant II Stent Graft System, Endurant II Aort-Uni-Illac (AUI) Stent Graft System, Endurant IIs Stent Graft System, En

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval
FDA Class 3 ·Hydrus Microstent Delivery System

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MiniMed iPro2 CGM System with Enlite Sensor

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ReZoom 3-Piece Multifocal IOL