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  • Dispositivo 418
  • Fabricante
  • Evento 124969
  • Implante 8
Retiro De Equipo (Recall) de Navigation Medical Medical Condition
  • Tipo de evento
    Recall
  • ID del evento
    936
  • Fecha
    2018-09-04
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-03-04
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Number 17-4378
Retiro De Equipo (Recall) de Chemical analyzer
  • Tipo de evento
    Recall
  • ID del evento
    935
  • Fecha
    2018-09-04
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-03-04
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Seoul 14-461
Retiro De Equipo (Recall) de Extracorporeal medical electrode
  • Tipo de evento
    Recall
  • ID del evento
    934
  • Fecha
    2018-08-30
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-28
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Seoul 10-1624
Retiro De Equipo (Recall) de Cardiopulmonary heat exchanger
  • Tipo de evento
    Recall
  • ID del evento
    933
  • Fecha
    2018-08-28
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-28
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Accepted 03-978
Retiro De Equipo (Recall) de Electrode for reusable foot-operated electrosurgical instrument, ele...
  • Tipo de evento
    Recall
  • ID del evento
    932
  • Fecha
    2018-08-28
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-28
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    14-448, 14-2583
Retiro De Equipo (Recall) de Hemoglobin staining test reagent, hemocyte staining test reagent
  • Tipo de evento
    Recall
  • ID del evento
    931
  • Fecha
    2018-08-24
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-24
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Seoul 14-1844, Seoul 14-1845
Retiro De Equipo (Recall) de Secondary Healing Foam Wound Covers
  • Tipo de evento
    Recall
  • ID del evento
    930
  • Fecha
    2018-08-21
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2018-11-21
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Juhu 15-671
Retiro De Equipo (Recall) de Dyeing reagent for cell and histopathology I, Dyeing reagent for cel...
  • Tipo de evento
    Recall
  • ID del evento
    929
  • Fecha
    2018-08-16
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-16
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Seoul Received 13-2881, Seoul Received 13-2859, Received 18-1092, Seoul Received 13-2855, Received 18-1090, Accepted 13-1275, Accepted 13-1832, Received 18-1081 , Su-in 12-2286
Retiro De Equipo (Recall) de Automatic blood type determination device
  • Tipo de evento
    Recall
  • ID del evento
    928
  • Fecha
    2018-09-04
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-03-04
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Seoul 13-28
Retiro De Equipo (Recall) de Digital diagnostic x-ray equipment, diagnostic x-ray equipment
  • Tipo de evento
    Recall
  • ID del evento
    927
  • Fecha
    2018-08-16
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-16
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Number 10-1159, Number 15-4088
Retiro De Equipo (Recall) de Cardiopulmonary marker test reagent
  • Tipo de evento
    Recall
  • ID del evento
    926
  • Fecha
    2018-08-16
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-16
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Accepted 12-1612
Retiro De Equipo (Recall) de Gas anesthesia, gas anesthesia, gas anesthesia
  • Tipo de evento
    Recall
  • ID del evento
    925
  • Fecha
    2018-08-16
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-16
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    15-1550, 13-3629, and 17-398
Retiro De Equipo (Recall) de Blood coagulation test reagent
  • Tipo de evento
    Recall
  • ID del evento
    924
  • Fecha
    2018-08-10
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2018-11-24
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    No. 16-599
Retiro De Equipo (Recall) de Non-transplantable blood vessel connection container, non-transfusio...
  • Tipo de evento
    Recall
  • ID del evento
    923
  • Fecha
    2018-08-13
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-13
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Su-in 08-486, Su-in 03-839, Su-in 08-546
Retiro De Equipo (Recall) de Medical chemical sterilizer
  • Tipo de evento
    Recall
  • ID del evento
    922
  • Fecha
    2018-08-10
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2018-10-12
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    No. 13-2361
Retiro De Equipo (Recall) de Electroencephalogram
  • Tipo de evento
    Recall
  • ID del evento
    921
  • Fecha
    2018-08-10
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-10
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Suh 08-1160
Retiro De Equipo (Recall) de Measuring instruments of immunoassay for medical use, Measuring inst...
  • Tipo de evento
    Recall
  • ID del evento
    920
  • Fecha
    2018-08-07
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-07
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    12-2224 in Seoul, 12-2229 in Seoul
Retiro De Equipo (Recall) de Bone marrow intrinsic rod
  • Tipo de evento
    Recall
  • ID del evento
    919
  • Fecha
    2018-08-07
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-07
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    No. 16-583
Retiro De Equipo (Recall) de Blood gas analysis and electrolyte test reagents
  • Tipo de evento
    Recall
  • ID del evento
    918
  • Fecha
    2018-08-07
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-07
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Su-in 14-88
Retiro De Equipo (Recall) de X-ray fluoroscopy for stationary digital circulators, X-ray fluorosc...
  • Tipo de evento
    Recall
  • ID del evento
    917
  • Fecha
    2018-08-07
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-07
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    13-1969, 13-1971, 14-2146, and 16-327
Retiro De Equipo (Recall) de Medical gloves
  • Tipo de evento
    Recall
  • ID del evento
    916
  • Fecha
    2018-08-06
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-06
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Seoul 13-712
Retiro De Equipo (Recall) de Special material Fracture joint plate
  • Tipo de evento
    Recall
  • ID del evento
    915
  • Fecha
    2018-08-06
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2018-11-20
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    No. 12-1706
Retiro De Equipo (Recall) de Automation System Robot Surgical Machine
  • Tipo de evento
    Recall
  • ID del evento
    914
  • Fecha
    2018-08-06
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-06
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    No. 11-821
Retiro De Equipo (Recall) de X-ray fluoroscopy for stationary digital circulators, angiographic X...
  • Tipo de evento
    Recall
  • ID del evento
    913
  • Fecha
    2018-08-01
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-01
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    No. 08-349, No. 01-1414
Retiro De Equipo (Recall) de Blood coagulation test reagent
  • Tipo de evento
    Recall
  • ID del evento
    912
  • Fecha
    2018-08-06
  • País del evento
    Korea, Republic of
  • Fecha de finalización del evento
    2019-02-06
  • Fuente del evento
    KFDA
  • URL de la fuente del evento
    https://emed.mfds.go.kr
  • Notas / Alertas
    Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and South Korea.
  • Notas adicionales en la data
    Accepted 12-2369
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