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

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    ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    X-SCRIBE II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INRATIO ASSY, BOX OF STRIPS, MULTILANGUAGE

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 23, 2013

    SGL TRIG PIN COLLET 3.0 - 4.2MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·April 27, 2011

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN-BENNETT CORP.·Product code CBK·July 23, 2008

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·September 27, 2018

    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