506 results · 19ms · Sources: EU EUDAMED, US FDA

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·THINLINE II/FINELINE II STEROX PACING LEADS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOCURVE SOFT CONTACT LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·KAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·OCUCOAT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·RX5000 PROGRAMMER

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·WALL STENT ILIAC ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·HYDROVIEW IOL BLANK MATERIAL

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·VISULAS 690S LASER AND VISULINK PDT ADAPTER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HC2 SYSTEM SOFTWARE

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval
FDA Class 3 ·QUANTIFERON-TB GOLD IN-TUBE

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval
FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·DIGENE HYBRID CAPTURE 2 HPV DNA TEST

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

FDA Pre-Market Approval
FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM