BEUDAMED
    9,270 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: FDA Class 3 ×

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER Muscular VSD Occluder

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE EPI

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SYNVISC & SYNVISC-ONE

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·TENDRIL LEADS

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENTS

    Occluder, Patent Ductus, Arteriosus

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER Duct Occluder

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·REALIZE ADJUSTABLE GASTRIC BAND

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra Transcatheter Pacemaker System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE

    Device, Dermal Replacement

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·DERMAGRAFT

    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, Impella 5.5 with SmartAssist, and Impella LD Systems

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·SELECTSECURE LEAD/SLEEVE KIT

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES

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

    FDA Pre-Market Approval
    FDA Class 3 ·Blazer Open Irrigated Temperature Ablation Catheter

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035 Drug Coated Balloon PTA Catheters

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·SOLETRA, KINETRA IMPLANTABLE NEUROSTIMULATOR

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens