BEUDAMED
    318 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS 24 HYBRID SYSTEM

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·Express LD Iliac Premounted Stent System

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

    Iliac Covered Stent, Arterial

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bulkamid Urethral Bulking System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·ANIMAS VIBE SYSTEM

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 018 Drug Coated Balloon PTA Catheters

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·WAVESCAN WAVEFRONT SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAR S4 IM EXCIMER LASER SYSTEM

    System, Appendage Closure, Left Atrial

    FDA Pre-Market Approval
    FDA Class 3 ·Watchman Left Atrial Appendage Closure Technology

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAR, S41R EXCIMER LASER SYSTEM

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm Voluma XC

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Apollo™ Onyx™ Delivery Micro Catheter 1.5 cm, Apollo™ Onyx™ Delivery Micro Catheter 3.0 cm

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EON NEUROSTIMULATION SYSTEMS

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS