BEUDAMED
    872 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·SONATATI100 COCHLEAR IMPLANT

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·Inspire Upper Airway Stimulation

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

    FDA Pre-Market Approval
    FDA Class 3 ·THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER

    Implant, Hearing, Active, Middle Ear, Totally Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type-1 System

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense Continuous Glucose Monitoring System

    Electrosurgical, Radio Frequency, Refractive Correction

    FDA Pre-Market Approval
    FDA Class 3 ·VIEWPOINT(TM) CK SYSTEM

    Implant, Auditory Brainstem

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

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Neuro Cochlear Implant System

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·MEDITEC MEL 80 EXCIMER LASER SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·MEL 80 EXCIMER LASER SYSTEM

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ARCHITECT FREE PSA

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·MEL90

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITIORING SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

    Implanted Brain Stimulator For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NEUROPACE RNS SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·CORMET HIP RESURFACING SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System