BEUDAMED
    10,000 results · 52ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPECTRA, NOVI, MONTAGE MRI AND PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPECTRA, PRECISION MONTAGE AND PRECISION MONTAGE MRI SPINAL CORD STIMULATION(SCS) SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OTW)

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure VDD 2 Lead, Package Adaptor Cable and Vitatron Brilliant S+ VDD Lead

    Material, Dressing, Surgical, Polylactic Acid

    FDA Pre-Market Approval
    FDA Class 3 ·CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and over the wire

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Ablation Catheter

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC VITATRON, THERA-I/PRODIGY AND INSYNC PACEMAKERS/CARDIAC RESYNCHRONIZATION THERAPY PACING PRODUCTS

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Series Product Line/Artificial Urinary sphincter with and without InhibiZone Treatment

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional)

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·PHOTON MICRO, EPIC, ATLAS, EPIC+, AND ATLAS+ FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS)

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim Therapy System, Verify Evaluation System, and InterStim Micro Implantable Neurostimulator (SNS Bowel)

    Lens, Contact, Orthokeratology, Overnight

    FDA Pre-Market Approval
    FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) and (tisilfocon A) Contact Lenses for Overnight Wear

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Integrity RX Coronary Stent System & Resolute Integrity OTW Cornary Stent System

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™),

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·CORDIS PRECISE RX NITINOL STENT SYSTEM & PRECISE PRO RX NITINOL STENT SYSTEM

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus, and Juvéderm Ultra Plus XC

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire.