BEUDAMED
    10,000 results · 30ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3 Left Ventricular Assist System (HM3 LVAS)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·iSert Preloaded IOL System, IPure™ Preloaded IOL System

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

    FDA Pre-Market Approval
    FDA Class 3 ·Mentor MemoryShape Breast Implants

    Ventricular (Assist) Bypass

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

    Kit, Rna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HPV Assay

    Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

    FDA Pre-Market Approval
    FDA Class 3 ·ND:YAG POSTERIOR CAPSULOTOMY MODEL 100

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Avalus Bioprosthesis Valve

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·CentriMag™ Circulatory Support System

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HBV Test

    Implantable Pacemaker Pulse-Generator

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

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·ISOFLEX S LEAD MODEL 1646T

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

    Device, Angioplasty, Laser, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

    Automated Insulin Dosing Device System, Single Hormonal Control

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 670G System

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·HEALON, HEALON GV & HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES

    Implanted Brain Stimulator For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NeuroPace RNS System