BEUDAMED
    10,000 results · 44ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·META DDDR PACING SYSTEM

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity, Assurity+, Endurity, Endurity Core, Zenus, Zenex Family of Pacemakers

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·TEMPO PULSE GENERATORS

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP REAGENTS ON THE UNICEL DXL 800 ACCESS IMMUNOASSAY SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Avant™ VR, Neutrino™ NxT VR, Gallant™ VR, Entrant™ VR, Avant™ DR, Neutrino™ NxT DR, Gallant™ DR, Entrant™ DR

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV CATH NAVISTAR RMT THERMOCOOL & THERMOCOOL CATH, THERMOCOOL SMARTTOUCH

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·AFX VELA PROXIMAL ENDOGRAFT SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPINALCORD STIMULATION

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY SYSTEMS

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HBV Quant Assay

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS INTUITY Elite Aortic Valve

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·DERMAGRAFT

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

    FDA Pre-Market Approval
    FDA Class 3 ·SILICONE-FILLED NATRELLE BIOCELL TEXTURED SHELL SURFACE

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·MMT-7002 & MMT-7003 GLUCOSE SENSORS

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·BESTENT 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Juvederm Injectable Gel Implants