BEUDAMED
    322 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ALTRUA™ 2, ESSENTIO™, PROPONENT™, ACCOLADE™

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone, and the AMS Ambicor Inflatable Penile Prosthesis

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·ACTIVA TREMOR CONTROL SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC SPINAL CORD STIMULATION SYSTEM

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Ranger™ Paclitaxel-Coated PTA Balloon Catheter

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·LIPOSORBER LA-15 System

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    FDA Pre-Market Approval
    FDA Class 3 ·Plasmaflo OP-05W(A)

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·AngioJet Rheolythic Thrombectomy Catheter

    Implant, Auditory Brainstem

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus Auditory Brainstem Implant System

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus 24 Cochlear Implant System

    System, Hemodynamic, Implantable

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

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Innova Vascular Self-Expanding Stent with Delivery System

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·Epic Vascular Self-Expanding Stent System

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Protege RX Carotid Stent Systems and Protege GPS Peripheral Stent Systems