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

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ Steer ThermoCool Nav Deflectable Diagnostic/Ablation Catheter

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus Hybrid L24 Cochlear Implant System

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

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE SYSTEM

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV ASSAY

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Prestiege LP Cervical Disc - Two-Level

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic Attain Ability Model 4196

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MemoryGel, MemoryGel Xtra Silicone Gel-Filled Breast Implants

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Carotid Wallstent Monorail Endoprosthesis

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·IMPLANTABLE MULTI-PROGRAMMABLE QUADRIPOLAR DEEP BRAIN STIMULATION SYSTEM

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS

    Diagnostic Low Electric Field

    FDA Pre-Market Approval
    FDA Class 3 ·MarginProbe System

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Novus MRI SureScan Lead

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS HF System

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Simplify Cervical Artificial Disc

    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Ascension MCP

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·OVATIO DR AND VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·ReSure Sealant

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM THERAPY FOR BOWEL CONTROL

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PRO-Kinetic Energy Cobalt Chromium (CoCr) Coronary Stent System