3,003 results · 19ms · Sources: EU EUDAMED, US FDA

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval
FDA Class 3 ·Ranger™ Paclitaxel-Coated PTA Balloon Catheter

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·LIPOSORBER LA-15 System

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval
FDA Class 3 ·Plasmaflo OP-05W(A)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·AngioJet Rheolythic Thrombectomy Catheter

Implant, Auditory Brainstem

FDA Pre-Market Approval
FDA Class 3 ·Nucleus Auditory Brainstem Implant System

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·Nucleus 24 Cochlear Implant System

System, Hemodynamic, Implantable

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

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Innova Vascular Self-Expanding Stent with Delivery System

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens

Stent, Iliac

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

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·Protege RX Carotid Stent Systems and Protege GPS Peripheral Stent Systems

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·MINERVA ENDOMETRIAL ABLATION SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·FREESTYLE NAVIGATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·REPLY SR AND DR, ESPRIT SR AND DR