BEUDAMED
    2,258 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·LOTUS Edge Valve System

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Powerheart® G3, G3 Plus and G5 AEDs

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone

    Stent, Urethral, Prostatic, Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur (XP/XPT, CP) AFP; Atellica IM AFP

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Envision Mammography Platform

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·EMODOGAIN

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·HYDRELLE

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5 and Impella CP Ventricular Support System

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·Synvisc, Synvisc-One

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation (SNM) System for Urinary Control

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM (AUS)

    Occluder, Internal Vessel, Temporary

    FDA Pre-Market Approval
    FDA Class 3 ·LEGOO

    Spinal Pedicle Screw, Fixation, Appliance System

    FDA Pre-Market Approval
    FDA Class 3 ·LUMBAR I/F CAGE SYSTEM

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·AED Plus and Fully Automatic AED Plus

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ENROUTE® Transcarotid Stent System

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone

    Antigen(Complexed),Prostate Specific,(Cpsa)

    FDA Pre-Market Approval
    FDA Class 3 ·BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·CraniSeal Dural Sealant