BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    RAYDOSE

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170

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

    I-STAT CTNI CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·August 5, 2008

    3.5MM/2.5MM DOUBLE DRILL SLEEVE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code FZX·April 29, 2013

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·May 9, 2011

    31G PEN NEEDLES

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FMI·July 25, 2008

    VITEK® MS INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QBN·September 7, 2022

    VITEK® MS INSTRUMENT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code QBN·September 7, 2022

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018