BEUDAMED
    53 results · 42ms · Sources: EU EUDAMED, US FDA
    Filters FDA Pre Market Approval ×

    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 (LVAS)

    Light Source System, Diagnostic Endoscopic

    FDA Pre-Market Approval
    FDA Class 3 ·KARL STORZ PHOTODYNAMIC D-LIGHT C (PDD) SYSTEM

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·R Series MCU 20.01 software release

    System, Imaging, Fluorescence

    FDA Pre-Market Approval
    FDA Class 3 ·KARL STORZ AUTOFLUORESCENCE SYSTEM

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·CONTACT LENSES

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·OCU-FLEX

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·STERILIZED FINISHED OCUFILCON B LENSES

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·OCU-FLEX

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·OCU-FLEX-53 SOFT CONTACT LENSES

    Lenses, Soft Contact, Daily Wear

    FDA Pre-Market Approval
    FDA Class 2 ·PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Neuroform Atlas® Stent System

    Phakic Toric Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Visian Toric ICL (IMPLANTABLE COLLAMER LENS)

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.