BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    THEKEN ATOLL CERVICO-THORACIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·January 10, 2018

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·January 4, 2016

    SEED LINK

    FDA 510(k)
    FDA Class 2 ·Radiology

    INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·March 22, 2019

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 14, 2018

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 5, 2018

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

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

    ON-Q PAINBUSTER, SILVERSOAKER 5IN

    FDA Adverse Event
    Malfunction ·I-FLOW CORP.·Product code MEB·April 1, 2011

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·March 12, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025

    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