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

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·MICRA TRANSCATHETER PACING SYSTEM

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS

    Electrode, Stabilized Epidural Spinal

    FDA Pre-Market Approval
    FDA Class 3 ·SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355

    Gonococcal Antibody Tests

    FDA Pre-Market Approval
    FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS

    Controller, Closed-Loop Blood Glucose

    FDA Pre-Market Approval
    FDA Class 3 ·BIOSTATOR GCIIS

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE Injectable Implant

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·COAPTITE Injectabl Implant

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE (+) Lidocaine Derma Filler

    System, Photopheresis, Extracorporeal

    FDA Pre-Market Approval
    FDA Class 3 ·THERAKOS CELLEX PHOTOPHERESIS SYSTEM

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD

    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·AGENT Paclitaxel-Coated Balloon Catheter

    Tissue Graft Of 6mm And Greater

    FDA Pre-Market Approval
    FDA Class 3 ·Artegraft Collagen Vascular Graft

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

    FDA Pre-Market Approval
    FDA Class 3 ·BLAZER PRIME XP, BLAZER PRIME XP, INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETERS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·Straumann Emdogain

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES