BEUDAMED
    483 results · 39ms · Sources: EU EUDAMED, US FDA
    Filters FDA Pre Market Approval ×

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·MACROPLASTIQUE IMPLANTS, MPQ-2.5

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS Opt

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS 3-Piece Acrylic Monofocal

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS 3-Piece Multifocal

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ADVISA DR

    FDA Pre-Market Approval
    PROTECTA CRT-D, PROTECTA XT CRT-D

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·REVO MRI SURESCAN

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ATTAIN ABILITY/ABILITY PLUS/ABILITY STRAIGHT

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·PROTECTA DR/PROTECTA VR/PROTECTA XT DR/PROTECTA XT VR

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    FDA Pre-Market Approval
    FDA Class 2 ·DORNIER MPL 9000 - MOBILE LITHOTRIPTER

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    FDA Pre-Market Approval
    FDA Class 2 ·DORNIER MPL 9000 - RENAL APPLICATION

    Lithotriptor, Extracorporeal Shock-Wave, Urological

    FDA Pre-Market Approval
    FDA Class 2 ·DORNIER MPL 9000 - RENAL APPLICATION

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System, Impella RP with SmartAssist System

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Allure RF, Quadra Allure, Quadra Allure MP, Quadra Allure MP RF

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·ALLURE QUADRA, RF, MP

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Quadra Allure™, Quadra Allure MP™

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·TANDEM-MP PSA IMMUNOENZYMETRIC ASSAY