BEUDAMED
    1,355 results · 43ms · Sources: EU EUDAMED, US FDA
    Filters FDA Pre Market Approval ×

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VIRTUOSO & ENTRUST

    FDA Pre-Market Approval
    CONCERTO

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS PL70A-OUV, PL70B-OUV, & PL70C-OUV LENSES

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES MODELS PA38E-OUV AND PL52A-OUV

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL PS50C-OUV

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·OUS Vitatron Application Software

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·OUS Vitatron Application Software

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·OUS HeartTone MRI Application Software

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CARDIOMEMS HF SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System pump rotor sub-assembly

    Lens, Contact (Other Material) - Daily

    FDA Pre-Market Approval
    FDA Class 2 ·FLUOROPERM 151 (PAFLUFOCON D) CLEAR & TINTS W/O UV

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MynxGrip, Mynx Ace, and Mynx Control Vascular Closure Device (VCD)

    Catheters, Transluminal Coronary Angioplasty, Percutaneous

    FDA Pre-Market Approval
    FDA Class 2 ·THOR PTCA DILATION CATHETERS

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Apollo Onyx Delivery Micro Catheter, 1.5cm, Straight/Apollo Onyx Delivery Micro Catheter, 3.0cm, Straight

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Certitude Introducer Sheath Set

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR

    Stent, Iliac

    FDA Pre-Market Approval
    FDA Class 3 ·Express LD Iliac Premounted Stent System

    Iliac Covered Stent, Arterial

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis