BEUDAMED
    409 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Single-Piece Posterior Chamber IOL

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRXCELL COCR CORONARY STENT ON RX SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Multi-Piece Posterior Chamber IOL

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·GELFOAM (ABSORBLE GELTON)STERILE SPONGE

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Single-Piece Anterior Chamber IOL

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF Posterior Chamber INTRAOCULAR LENSES

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System

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

    FDA Pre-Market Approval
    FDA Class 3 ·Avant HF, Entrant HF, Gallant HF, Neutrino NxT HF

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·HYMOVIS®

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·TRILURON®

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS LD ILLIAC PEMOUNTED STENT SYSTEM

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·HYALGAN®

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon PanOptix Pro Trifocal IOLs

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof Intraocular Lenses

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (with and without InhibiZone)