2,350 results · 18ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CHANGE IN MANUFACTURING PROCESS TO CLEAN EYE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TRIVASCULAR, INC. OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·MAXUM SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·AFX Endovascular AAA System

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·SpineSeal Spine Sealant

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·TARGIS SYSTEM

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·SOUNDTEC DIRECT IPCA SYSTEM

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval
FDA Class 3 ·OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulators

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval
FDA Class 3 ·SPF-4 IMPLANTABLE BONE GROWTH STIMULATOR

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·i-FACTOR™ Peptide Enhanced Bone Graft

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TIER A MODELS 24050,24150,25050,25350-125 LENSES

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval
FDA Class 3 ·MAXUM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·MACROPLASTIQUE IMPLANTS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·POWERLINK SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·POWERLINK SYSTEMWITH INTUITRAK DELIVERY SYSTEM

Stent Graft, Bypass, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·DETOUR System