BEUDAMED
    10,000 results · 493ms · Sources: EU EUDAMED, US FDA

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS INTUITY Elite Valve System

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS2 CORONARY STENT SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·PHEMFILCON A SOFT (HYCROPHILIC) CONTACT LENS

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

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

    FDA Pre-Market Approval
    FDA Class 3 ·TRUMATCH SOLUTIONS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Consulta, Syncra, and Viva CRT-P

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·STARCLOSE VASCULAR CLOSURE SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Evera MRI DF ICD /MRI ICD / S DR / S VR / XT DR /XT VR ICD's; Visia AF MRI DFI ICD / AF MRI VR ICD / AF VR ICD.

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG REAGENT PACK & CALIBRATORS

    Implant, Cochlear

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

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

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

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Synergy II Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Synergy Megatron Everolimus-Eluting Platinum C

    Agent, Absorbable Hemostatic, Non-Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·SURGICEL™ Fibrillar Absorbable Hemostat, SURGICEL SNoW™ Absorbable Hemostat

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Ranger Paclitaxel-Coated PTA Balloon Catheter OTW, Ranger Paclitaxel-Coated PTA Balloon Catheter SL

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·PROVISC

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCTAIL

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·TRANSVENE SVC LEAD MODEL 6937/SUBCUTANEOUS LEAD MODEL 6996SQ & VARIOUS ACCESSORIES