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

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    MESA AND RANGE SPINAL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MACROPORE ENT RECONSTRUCTION FILM

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

    LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PASS LP

    FDA Adverse Event
    MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    SPIROFLEX® ANGIOJET® THROMBECTOMY SET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DXE·August 17, 2016

    UNKNOWN SUTURE PRODUCT

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

    BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·July 24, 2008

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·April 28, 2011

    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