5,480 results · 21ms · Sources: EU EUDAMED, US FDA

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR

Heart-Valve, Non-Allograft Tissue

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

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·HEALON, HEALON GV/HEALON 5 SODIUM HYALURONATE OPHTHALMIC VISCOSURGICAL DEVICES

Device, Dermal Replacement

FDA Pre-Market Approval
FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·CODMAN 3000 SERIES CONSTANT FLOW IMPLANTABLE INFUSION PUMP

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·Myopore Sutureless Myocardial Pacing Lead

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval
FDA Class 3 ·Seprafilm Adhesion Barrier

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·MYOPORE SUTURELESS MYOCARDIAL PACING LEAD

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·DISCOVISC OPTHALMIC VISCOSURGICAL DEVICE (OVD) & DUOVISC VISCOELASTIC SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHETIC

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut PRO System, Medtronic CoreValve Evolut PRO+ System

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·REGENT MECHANICAL HEART VALVE, STANDARD AND MASTERS MECHANICAL HEART VALVE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE TAG Thoracic Endoprosthesis

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·PRODIGY

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTEC HD INTRAOCULAR LENS (IOL)

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM