BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    HYDRORISE AND HYDROSYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO EBI XFIX DFS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALOKA SSD-4000

    FDA 510(k)
    FDA Class 2 ·Radiology

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·April 29, 2013

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·May 10, 2011

    GE OEC 6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 29, 2008

    PRESIDIO 10 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    PRESIDIO 18 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012