BEUDAMED
    10,000 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Pacemaker/ICD/CRT non implanted components PSW 1602.U, HMSC 3.34.0

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

    FDA Pre-Market Approval
    FDA Class 3 ·Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE (LN 6L22)

    Antigen(Complexed),Prostate Specific,(Cpsa)

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare Left Ventricular Assist System

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AUSAB (LN 1L82)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT HBsAg Qualitative (LN 4P53), ARCHITECT HBsAg Qualitative Confirmatory (LN 4P54)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Onyx Liquid Embolic System

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT Total PSA (LN 6C06)

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT AFP (LN 3P36)

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

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT Free PSA (LN 6C07)

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·GEL-ONE

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards INSPIRIS RESILIA Aortic Valve

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead, and Transvene CS

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead