BEUDAMED
    954 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 2 ×

    BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Achieve Advance Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Patient Assistant Model PA97000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Magnetic Localization Patch Kit (AFR-00021)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medtronic Model 5392 External Pulse Generator (EPG)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINQ II Insertable Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Reveal LINQ Insertable Cardiac Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)

    FDA 510(k)
    FDA Class 2 ·Hematology

    Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEPARIN ASSAY CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528

    FDA 510(k)
    FDA Class 2 ·Cardiovascular