BEUDAMED
    1,141 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·Vistag Surpoint External Process Unit (EPU)

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS® Total Knee System

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·CERAMAX Ceramic Total Hip System

    Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

    FDA Pre-Market Approval
    FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·INNOVA(TM)VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·R3 DELTA CERAMIC HIP SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK PRIZM DR/VR AND VENTAK PRIZM DR/VR HE ACID SYSTEMS

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS® Total Knee System

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)

    Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

    FDA Pre-Market Approval
    FDA Class 3 ·BIRMINGHAM HIP SYSTEM (BHR)

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MERIDEAN, DISCOVERY AND PULSAR PACEMAKERS

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM