BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POWER LED

    FDA 510(k)
    FDA Class 2 ·Dental

    STERI-MATE STERILIZABLE HANDPIECE

    FDA 510(k)
    FDA Class 2 ·Dental

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·April 29, 2013

    QUICKFLEX XL LV LEAD

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

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQL·July 28, 2008

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 28, 2020

    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