BEUDAMED
    4,960 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·SMART-MSP

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·SMART-MSP

    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

    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

    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

    Oximeter, Fetal Pulse

    FDA Pre-Market Approval
    FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING

    Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

    FDA Pre-Market Approval
    FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech PSA

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS