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  • Dispositivo 124
  • Fabricante 32
  • Evento 124969
  • Implante 6
Retiro De Equipo (Recall) de Dyeing reagents for cell and histopathology II
  • Tipo de evento
    Recall
  • ID del evento
    557
  • Fecha
    2016-10-19
  • País del evento
    South Korea
  • 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. 13-1352
Retiro De Equipo (Recall) de Blood pressure monitor
  • Tipo de evento
    Recall
  • ID del evento
    558
  • Fecha
    2016-11-07
  • País del evento
    South Korea
  • 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
    02-286
Retiro De Equipo (Recall) de Cardiopulmonary marker test reagent
  • Tipo de evento
    Recall
  • ID del evento
    559
  • Fecha
    2016-10-21
  • País del evento
    South Korea
  • 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 12-1617
Retiro De Equipo (Recall) de High-risk sex steroid immunoassay reagent
  • Tipo de evento
    Recall
  • ID del evento
    560
  • Fecha
    2016-11-11
  • País del evento
    South Korea
  • 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. 13-2345
Retiro De Equipo (Recall) de Immunochemical test reagent
  • Tipo de evento
    Recall
  • ID del evento
    561
  • Fecha
    2016-11-02
  • País del evento
    South Korea
  • 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 13-2971
Retiro De Equipo (Recall) de Special Materials Artificial Knee Joint
  • Tipo de evento
    Recall
  • ID del evento
    562
  • Fecha
    2016-12-01
  • País del evento
    South Korea
  • 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. 15-1802
Retiro De Equipo (Recall) de Medical image processing device
  • Tipo de evento
    Recall
  • ID del evento
    563
  • Fecha
    2016-11-07
  • País del evento
    South Korea
  • 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 reception 08-1485
Retiro De Equipo (Recall) de Catheter inserter with hemostatic valve
  • Tipo de evento
    Recall
  • ID del evento
    564
  • Fecha
    2016-12-14
  • País del evento
    South Korea
  • 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. 11-590
Retiro De Equipo (Recall) de Medical shift padded mattress, Medical shift padded mattress
  • Tipo de evento
    Recall
  • ID del evento
    565
  • Fecha
    2016-11-14
  • País del evento
    South Korea
  • 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
    Jane 99-268, Jane 08-134
Retiro De Equipo (Recall) de Remote therapy irradiation device, remote treatment irradiation device
  • Tipo de evento
    Recall
  • ID del evento
    566
  • Fecha
    2016-11-16
  • País del evento
    South Korea
  • 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
    Acquisition 08-1001, Acquisition 15-1774
Retiro De Equipo (Recall) de Electric Medical Handpiece
  • Tipo de evento
    Recall
  • ID del evento
    567
  • Fecha
    2016-11-15
  • País del evento
    South Korea
  • 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 14-1392
Retiro De Equipo (Recall) de Newborns / Pediatric Respirators
  • Tipo de evento
    Recall
  • ID del evento
    568
  • Fecha
    2016-11-25
  • País del evento
    South Korea
  • 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. 14-228
Retiro De Equipo (Recall) de Auxiliary cardiac device
  • Tipo de evento
    Recall
  • ID del evento
    569
  • Fecha
    2017-01-02
  • País del evento
    South Korea
  • 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. 13-3075
Retiro De Equipo (Recall) de X-ray computed tomography apparatus, medical image storage and trans...
  • Tipo de evento
    Recall
  • ID del evento
    570
  • Fecha
    2017-03-08
  • País del evento
    South Korea
  • 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 15-1549, Number 12-238
Retiro De Equipo (Recall) de Cerebral angiography
  • Tipo de evento
    Recall
  • ID del evento
    571
  • Fecha
    2017-02-06
  • País del evento
    South Korea
  • 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. 11-588
Retiro De Equipo (Recall) de Catheter guide for cerebral vascular
  • Tipo de evento
    Recall
  • ID del evento
    573
  • Fecha
    2017-02-02
  • País del evento
    South Korea
  • 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 05-887
Retiro De Equipo (Recall) de Universal ventilator
  • Tipo de evento
    Recall
  • ID del evento
    574
  • Fecha
    2016-12-13
  • País del evento
    South Korea
  • 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. 14-3468
Retiro De Equipo (Recall) de Relocation
  • Tipo de evento
    Recall
  • ID del evento
    575
  • Fecha
    2016-12-28
  • País del evento
    South Korea
  • 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 14-1948
Retiro De Equipo (Recall) de X-ray fluoroscopy diagnostic device for stationary digital circulator
  • Tipo de evento
    Recall
  • ID del evento
    576
  • Fecha
    2016-12-13
  • País del evento
    South Korea
  • 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 08-349
Retiro De Equipo (Recall) de Injection - Drain tube, catheter, universal injection - Drain tube c...
  • Tipo de evento
    Recall
  • ID del evento
    577
  • Fecha
    2017-01-23
  • País del evento
    South Korea
  • 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 07-801, Number 07-802
Retiro De Equipo (Recall) de Universal ventilator
  • Tipo de evento
    Recall
  • ID del evento
    578
  • Fecha
    2017-03-09
  • País del evento
    South Korea
  • 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 09-91
Retiro De Equipo (Recall) de Ophthalmic Optical Microscope
  • Tipo de evento
    Recall
  • ID del evento
    579
  • Fecha
    2017-01-04
  • País del evento
    South Korea
  • 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
    Received 16-376
Retiro De Equipo (Recall) de Immunochemistry test reagents, immunochemistry test reagents
  • Tipo de evento
    Recall
  • ID del evento
    580
  • Fecha
    2016-12-21
  • País del evento
    South Korea
  • 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
    14-75, 14-352
Retiro De Equipo (Recall) de Drill for dental implant surgery
  • Tipo de evento
    Recall
  • ID del evento
    581
  • Fecha
    2017-01-04
  • País del evento
    South Korea
  • 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 13-2251
Retiro De Equipo (Recall) de Medical cutting tool
  • Tipo de evento
    Recall
  • ID del evento
    582
  • Fecha
    2017-01-05
  • País del evento
    South Korea
  • 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
    Reception number 16-1354
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