BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvederm Ultra, Ultra XC, Ultra Plus, Ultra Plus XC, 30; Juvedern Ultra XC

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    FDA Pre-Market Approval
    FDA Class 3 ·TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Ascendra+ Delivery System; Balloon Aortic Valvuloplasty Catheter; NovaFlex+ Delivery System; Crimper; Edwards Ballon Cat

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas KRAS Mutation Test

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·Precise Nitinol Stent Systems

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LifeVest Wearable Defibrillator

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·ANCHORING SLEEVE KIT, SELECTSECURE LEAD

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VERIFLEX (LIBERTE) MONORAIL & OTW CORONARY STENT SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MARQUIS/MAXIMO/INTRINSIC/ENTRUST/VIRTUOSO/MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ATTAIN/INSYNC/INSYNC III

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·RADIESSE

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VIRTUOSO ICD/VIRTUOSO II ICD/SECURA ICD/MAXIMO II ICD

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MARQUIS/MAXIMO& MAXIMO II IPG/INTRINSIC/ENTRUST/VIRTUOSO II DR/VR/ONYX/VIRTUOSO FAMILY OF ICDS/SECURA ICD

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·APTIMA HPV 16 18/45 GENOTYPE ASSAY

    Shunt, Portosystemic, Endoprosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System