BEUDAMED
    1,017 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT FAMILY OF PERICARDIAL BIOPROSTHESES

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·Rebel Platinum Chromium Coronary Stent System Monorail and Over the Wire

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·Wolverine Coronary Cutting Balloon Monorail Over The Wire

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip NTR/XTR Clip Delivery System, MitraClip G4 System, MitraClip G5 Delivery System

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis with InhibiZone™

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter with InhibiZone™

    Implant, Anti-Gastroesophageal Reflux

    FDA Pre-Market Approval
    FDA Class 3 ·LINX Reflux Management System

    Permanent Defibrillator Electrodes

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

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Durata Family Of High Voltage Leads

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems/ Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems

    Tricuspid Valve Repair Device, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·TriClip G4 System, TriClip G5 Delivery System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ENDURANT, ENDURANT 11, ENDURANT IIS STENT GRAFT SYSTEM AND ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM

    Material, Dressing, Surgical, Polylactic Acid

    FDA Pre-Market Approval
    FDA Class 3 ·CollaCote, Colla Tape, CollaPlug, Absorable Collagen Wound Dressing for Dental Surgery

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II'S STENT GRAFT SYSTEM

    IMPLANT AID SPLICING CRIMP & SLEEVE

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS 2 MR & OTW CORONARY STENT SYSTEM