800 results · 17ms · Sources: EU EUDAMED, US FDA

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline™ Flex Embolization Device with Shield Technology™ (PED2), Pipeline™ Vantage Embolization Device with Shield Tec

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Surpass Elite Flow Diverter System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline Flex Embolization Device

Scaffold, Dissection Repair

FDA Pre-Market Approval
FDA Class 3 ·Tack Endovascular System (4F, 1.5-4.5mm)

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Surpass Elite Flow Diverter System

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·LDR Spine Mobi-C® Cervical Disc Prosthesis

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·LDR Spine Mobi-C Cervical Disc Prosthesis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Sapien 3 Transcatheter Heart Valve

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 INFLATABLE PENILE PROSTHESIS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·MARA Water Vapor Ablation System

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval
FDA Class 3 ·BIOTRIN INTERNATIONAL'S PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval
FDA Class 3 ·Watchman LAA Closure Technology

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·RHA® Redensity, RHA®2, RHA®3 and RHA® Dermal Fillers

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)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·BIODIVYSIO AS OTW

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·H.E.L.P. Futura Apheresis System