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

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    MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0830090·Persuader, Rod Reduction, Kerrison Type

    BD NANO¿ ULTRA FINE¿ PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·April 10, 2023

    SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSOMAT P

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACIST

    FDA Adverse Event
    Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·August 1, 2013

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

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

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·May 5, 2011

    ETS FLEX ARTICNG LNR CUTR 45MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 23, 2008

    SOLITAIRE FR4

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·April 13, 2021

    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