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

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010

    Stimulator, Autonomic Nerve, Implanted For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·VNS THERAPY SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRFLEX PREMOUNTED STENT

    Intraocular Lens

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

    Tricuspid Valve Repair Device, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·TriClip™ G4 Clip Delivery System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·SJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·WaveWriter Alpha, WaveWriter Alpha 16

    Permanent Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Genus R32, Vercise Genus R16

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·PERCLOSE PROGLIDE SUTURE MEDIATED CLOSURE SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE II LVAS

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume™ BPH Catheter System

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·ARROW INTERNATIONAL MODEL 3000/3000-16/3000-50 IMPLANTABLE INFUSION PUMPS

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGIFLO HEMOSTATIC MATRIX

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·HER2FISH PHARMDX KIT

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SA60T3, SA60T4 AND SA60T5

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5