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

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    TOGGLELOC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTEX RECONSTRUCTION SYSTEM

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

    Resonance

    FDA UDI
    COOK IRELAND LTD·10827002341781·Resonance, Stent Introducer

    ETHIBOND EXCEL VALVE LOOP SUTURE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JAMSHIDI BIOPSY NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 30, 2024

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    ARCHITECT CREATINE KINASE

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code CGS·July 21, 2018

    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

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·May 10, 2011

    SETROX S 53

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013

    CLARION

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