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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SIEMENS 1.5T TXRX 15 CH KNEE

    FDA Adverse Event
    Other ·QUALITY ELECTRODYNAMICS·Product code MOS·October 5, 2011

    MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    RADIFOCUS OPTITORQUE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    PREFYX PPS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FTL·April 29, 2013

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP·Product code FPA·April 29, 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