BEUDAMED
    11 results · 18ms · Sources: EU EUDAMED, US FDA

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    PENTAX BRONCHOFIBERSCOPE #FB-19E

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SYNTHES RESORBABLE CONTOURABLE MESH

    FDA 510(k)
    FDA Class 2 ·Dental

    INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDF·March 2, 2023

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·February 20, 2007

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·February 5, 2014

    MAMMOTOME - MAM 3008

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY LLC·Product code FZP·October 26, 2012

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·August 30, 2010

    INSPIRE HVR DUAL

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTN·November 12, 2024

    INSPIRE HVR DUAL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA SRL·Product code DTZ·November 18, 2022

    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