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

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    HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO HANDMASTER

    FDA 510(k)
    FDA Class 2 ·Neurology

    RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

    BD BBL¿ MUELLER HINTON II AGAR

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code JTZ·June 28, 2023

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 28, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·July 24, 2008

    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