BEUDAMED
    10,000 results · 28ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT TOTAL PSA

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·THERAPY CATHETER

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS HYBRID L24 IMPLANT SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (ILIAC)

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

    Iliac Covered Stent, Arterial

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

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EMS-SWISS DOLORCLAST

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER DUCT OCCLUDER II

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

    FDA Pre-Market Approval
    FDA Class 3 ·INSYNC MARQUIS, INSYNC SENTRY, AND INSYNC MAXIMO FAMILIES

    Mr-Guided Focused Ultrasound System

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

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·CoreValve Evolut R and Evolut PRO System

    Ablation Catheter, Renal Denervation

    FDA Pre-Market Approval
    FDA Class 3 ·Symplicity Spyral™ Multi-Electrode Renal Denervation Catheter, Symplicity G3™ Renal Devervation RF Generator

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THINPREP 2000 SYSTEM