BEUDAMED
    10,000 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Wave Writer Alpha™ Spinal Cord Stimulator (SCS) System, Spectra Wave Writer™ Spinal Cord Stimulator (SCS) System, Precis

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline Flex Embolization Device

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·STYLE UV40 POSTERIOR CHAMBER LENS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VISION & ML8 CORONARY STENT SYSTEM

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·INAMED SILICONE-FILLED BREAST IMPLANTS

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Therapy Ablation Catheter (including Bi-Directional Catheter) Therapy 4mm Thermistor Ablation Catheter

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT THORACIC STENT GRAFT WITH THE XCELERANT DELIVERY SYSTEM

    Agent, Injectable, Embolic

    FDA Pre-Market Approval
    FDA Class 3 ·Apollo Onyx Delivery Micro Catheter

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·DURATA FAMILY OF HIGH VOLTAGE LEADS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRITY AFX DR (MODEL 5342) & SR (MODEL 5142) PULSE GENERATORS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-LINK RX/OTW PENTA CORONARY STENT SYSTEM

    Ventricular (Assist) Bypass

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·iSert Preloaded System/ iSert Micro Injector

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·ThermoCool SmartTouch Catheter

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·cobas® HPV Test

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech free PSA Reagents/Calibrator Kit Immunoassay Systems

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Progel Pleural Air Leak Sealant

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·TENDRIL 1688T/TC LEADS

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC VASCULAR ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM