BEUDAMED
    666 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·MICRONY II SR MODEL 2525T/MICRONY K SR MODEL 2535K PULSE GENERATORS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK(R) SQ LEAD ARRAY MODEL 0048

    MULTI-FUNCTION DEFIBRILLATION ELECTRODE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

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

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

    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)

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EFH-16; S60-K; S 60-J; S 60-S

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EFH-16; S 60-K; S 60-J; S 60-S

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC . KAPPA 400 SERIES PULSE GENERATORS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ENDOTAK LEAD SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE II LVAS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device