BEUDAMED
    17 results · 30ms · Sources: EU EUDAMED, US FDA

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    METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ISODUR PROSTHESIS HEAD 12/14 32MM XL

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014

    KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 7, 2022

    NEONATAL FLOWSENSOR

    FDA Adverse Event
    Malfunction ·DRAEGER MEDICAL INC.·Product code CBK·April 12, 2013

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 28, 2011

    APR HIP SYSTEM ENHANCED ACETABULAR INSERT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code KWB·July 25, 2008

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 8, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·August 2, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·May 27, 2010

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·April 15, 2010

    SYNCHRO-14 STRAIGHT 200-35CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 12, 2023

    SYNCHRO-10 STRAIGHT 200CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·October 13, 2023

    SYNCHRO-14 STRAIGHT 200-35CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·November 13, 2023

    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