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

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Adaptor Assembly Cable, ECG Cable, Patient Cable, and Analyzer Cable

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

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

    FDA Pre-Market Approval
    FDA Class 3 ·AFFINITY/INTEGRITY, PHOTON, ATLAS, EPIC & PSA FAMILIES OF DEVICES

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·HOUSECALL PLUS WITH TRANSMITTER SOFTWARE VERSION 3.0, RECEIVER SOFTWARE VERSION 3.0 AND TRANSMITTER HARDWARE VERSION H

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A)

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·Orchestra/Orchestra Plus C3PR/C3PRH, Orchestra Plus Link, USB adapter for CPR3H, Smart ECG

    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

    FDA Pre-Market Approval
    FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ECG CABLE/CAPSURE VDD LEADS/VITATRON BRILLANT S+ VDD LEADS/VITATRON LEGACY/LEGACY II/VISA

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·BATTERY CHECK MONITOR, CAPSURE LEAD, CARELINK PROGRAMMER, CARELINK PROGRAMMER RF HEAD, DESKTOP BOSS SOFTWARE, ECG CABLE

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Lifeline/ReviveR, Lifeline/ReviveR Auto, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Lifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·TheraSphere

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Cardinal Health Multifunctional Defibrillation Electrode

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ECG CABLE/CAPSURE VDD LEADS DRUG COMBINATION/SERVICE KIT PACEMAKER REPAIR KIT/PRODIGY IPG/BRILLIANT S+ VDD VITATRON LEAD

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE LEAD/CAPSURE MODEL LEAD/PRODIGY IPG/LEAD WRENCH/SERVICE KIT/CAPSURE (DRUG ELUTING) LEAD/ECG CABLE/CONNECTOR PORT