2,051 results · 21ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·ARROW INTERNATIONAL MODEL 3000-50 ML CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Medtronic Deep Brain Stimulation Therapy System

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas® Stent System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·ARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Intracranial Coil-Assist Stent

FDA Pre-Market Approval
FDA Class 3 ·Neuroform Atlas® Stent System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·CORDIS CHECKMATE SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·NAVISTAR & CELSIUS THERMOCOOL CATHETERS

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·Pathway Clinical Trial Cohort

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·Aspire Assist

Aspiration Therapy System

FDA Pre-Market Approval
FDA Class 3 ·AspireAssist