BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad, Compia MRI, C

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Trifecta™ and Trifecta™ Valve with Glide Technology (Trifecta™ GT) valves

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template

    Stent, Iliac Vein

    FDA Pre-Market Approval
    FDA Class 3 ·Abre™ Venous Self-expanding Stent System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Epsila EV Extravascular Lead

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·PROVSIC™ Ophthalmic Viscosurgical Device

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Thermocool Deflectable Diagnostic/ Ablation Catheter

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DuraSeal Exact Spinal Sealant

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ADAPTA/VERSA/SENSIA & RELIA IPGS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·KAPPA 400 IPG

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASCULAR CLOSURE SYSTEMS

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·RESTOREPRIME NEUROSTIMULATOR, PRIMEADVANCED NEUROSTIMULATOR, ITREL 4 PROGRAMMABLE NEUROSTIMULATOR FOR SPINAL CORD

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·CERVISTA HPV 16/18 ASSAY

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·SMART CONTROL VASCULAR STENT SYSTEMS

    Device, Impotence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE-WIRE)

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·ARISTA AH, ARISTA AH FLEXITIP/ FLEXITIP XL/FLEXITIP XL-R