BEUDAMED
    2,328 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (FLX)

    Nitric Oxide Generator And Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·LungFit PH

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK® CR2 Defibrillator

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·Rotlex IOLA MFD

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

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D,

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

    FDA Pre-Market Approval
    FDA Class 3 ·PROMOTE+,UNIFY,UNIFY ASSURA,UNIFY QUADRA, & QUADRA ASSURA CRT-DS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Avive Automated External Defibrillator (AED) System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR

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

    FDA Pre-Market Approval
    FDA Class 3 ·MICRONY CRT-P'S

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NovaSure Impedance Controlled Endometrial Ablation System

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

    FDA Pre-Market Approval
    FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

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

    FDA Pre-Market Approval
    FDA Class 3 ·G124 MOMENTUM™ CRT-D, G125 MOMENTUM™ CRT-D, G126 MOMENTUM™ CRT-D, G128 MOMENTUM, G138 MOMENTUM™ X4 CRT-D, G140 INOGEN™ C

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·DUOVISC LABELING INSERT FOR PROVISC(R) SODIUM HYALURONATE PMA

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare Ventricular Assist System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·NG3 DEVICES: ORIGEN, INOGEN, DYNAGEN ICDS; PROGENY DEVICES: PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD