BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    4CIS SOLAR AND APOLLON SPINE SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IPC® STYLUS TRANSNASAL BUR

    FDA Adverse Event
    Death ·MEDTRONIC XOMED INC.·Product code ERL·February 4, 2015

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·April 16, 2013

    PRECISION XTRA

    FDA Adverse Event
    Injury ·Product code NBW·May 10, 2011

    TORQUE LIMITING SCREWDRIVER

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code HXX·July 22, 2008

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LGD·January 13, 2012

    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