506 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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