BEUDAMED
    12 results · 33ms · Sources: EU EUDAMED, US FDA

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    MENTOR CYLINDER PROTECTOR TOOL (INFLATABLE PENILE)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377035509·RELINE-C Bender Tip, Ø4.0 Ang Sagittal R

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065661·INTRAORAL ELASTICS 2,5 oz 5/16" blue

    EMIT-QUINIDINE CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    Triathlon Total Knee System-Additional Components

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GIALLOY CB-H

    FDA UDI
    SRL Dental GmbH·ESRL58904021·Aufbrennfähige Nichtedelmetall-Dental-Gusslegie...

    PROMOTE QUADRA CRT-D, DF-4, CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NIK·January 13, 2014

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT·Product code MCX·November 3, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·December 29, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012