BEUDAMED
    3,100 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Barrier, Absorbable, Adhesion

    FDA Pre-Market Approval
    FDA Class 3 ·SEPRAFILM

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL ABSORBABLE HEMOSTAT (SURGICEL, SURGICEL NU-KNIT AND SURGICEL FIBRILLAR ABSORBABLE HEMOSTATS)

    Fluid, Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·PERFLUORON

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·SENZA SPINAL CORD STIMULATION (SCS) SYSTEM

    Catheter, Balloon, Urethral, Drug-Coated

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume Urethral Drug Coated Balloon

    Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·remede® System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·3F AORTIC BIOPROSTHESIS

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Revanesse Ultra (Revanesse Versa)

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TREO Abdominal Stent-Graft System

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·OPTUNE

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

    FDA Pre-Market Approval
    FDA Class 3 ·Natrelle Silicone-Filled Breast Implants

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

    FDA Pre-Market Approval
    FDA Class 3 ·QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NOVASURE IMPENDANCE CONTOLLED ENDOMETRIAL ABLATION SYSTEM

    Computer-Assisted Personalized Sedation System

    FDA Pre-Market Approval
    FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Aorfix AAA Flexible Stent Graft System with Aorflex Delivery Device

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·LUTONIX DRUG COATED BALLOON PTA CATETER

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·LCS TOTAL KNEE SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Carpentier-Edwards PERIMOUNT, Plus, Theon, RSR, Magna,Magna Ease, Mega Mitral Pericardial Aortic Bioprosthesis with Ther