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  • Dispositivo 3
  • Fabricante 3
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de CoreValve EnVeo R Loading System
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2014123753
  • Fecha
    2014-12-30
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2014/corevalve-enveo-r-loading-system/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de EnVeo R Delivery Catheter System
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2016081766
  • Fecha
    2016-08-16
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/08/enveo-r-delivery-catheter-system/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de FlexCath Advance™ Steerable Sheath
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2017112864
  • Fecha
    2017-11-19
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/11/flexcath-advance-steerable-sheath/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de FlexCath Select Steerable Sheath
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2015030492
  • Fecha
    2015-03-30
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/03/flexcath-select-steerable-sheath/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Software Application Card 8870 for N'Vision
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2013101307
  • Fecha
    2013-10-10
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/software-application-card-8870-for-nvision/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Dual-Chamber External Pulse Generator
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2015035233
  • Fecha
    2015-03-25
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/03/dual-chamber-external-pulse-generator/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Vectris™ Lead Kits
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2018072431
  • Fecha
    2018-07-17
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/07/vectris-lead-kits/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de DLP®
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2017063529
  • Fecha
    2017-06-24
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/06/dlp/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de RestoreSensor and RestoreSensor SureScan MRI Recha...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2016051301
  • Fecha
    2016-05-11
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/05/restoresensor-and-restoresensor-surescan-mri-rechargeable-implantable-neurostimulators/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de SynchroMed Implantable Infusion Pump
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    LMST-2012111463
  • Fecha
    2012-11-20
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2012/synchromed-implantable-infusion-pump/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Emprint™ Percutaneous Antenna with ThermosphereTM
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2017082491
  • Fecha
    2017-08-18
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/08/emprint-percutaneous-antenna-with-thermospheretm/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de InterStim, InterStim II, Itrel 3 and Enterra
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2015011806
  • Fecha
    2015-01-13
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/01/interstim,-interstim-ii,-itrel-3-and-enterra/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de DBS Lead Kit for Deep Brain Stimulation
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2017032654
  • Fecha
    2017-03-17
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/03/dbs-lead-kit-for-deep-brain-stimulation/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Deep Brain Stimulation (DBS™) Lead Kits
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2013021920
  • Fecha
    2013-02-11
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/deep-brain-stimulation-dbs-lead-kits/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de AFFINITY NT Cardiotomy/Venous Reservoir Stand-Alone
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2018022818
  • Fecha
    2018-02-19
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/02/affinity-nt-cardiotomyvenous-reservoir-stand-alone-/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Deep Brain Stimulation Therapy
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2016053999
  • Fecha
    2016-05-27
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/05/deep-brain-stimulation-therapy/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de interventional wires and hybrid attain guidewire
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2013111605
  • Fecha
    2013-11-13
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2013/interventional-wires-og-hybrid-attain-guidewire/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de activa®, restore®, surescan®, primeadvanced® and i...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2014022245
  • Fecha
    2014-02-18
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2014/activa,-restore,-surescan,-primeadvanced-og-itrel/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de CareLink™ 2090 Programmer and CareLink Encore™ 299...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2018102318
  • Fecha
    2018-10-15
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2018/10/carelink-2090-programmer-and-carelink-encore-29901-programmer/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de DBS Extension Kit
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2015043776
  • Fecha
    2015-04-25
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/04/dbs-extension-kit/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Mosaic™ Aortic Bioprosthesis
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2014012587
  • Fecha
    2014-01-20
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2014/mosaic-aortic-bioprosthesis/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de DBS Extension
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2016104340
  • Fecha
    2016-11-02
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/11/dbs-extension/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de medtronic strata ii and strata nsc valves
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2017020158
  • Fecha
    2017-02-01
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2017/02/medtronic-strata-ii-og-strata-nsc-valves/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D ...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2016122019
  • Fecha
    2016-12-14
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2016/12/claria-mri-crt-d-surescan-and-amplia-mri-crt-d-surescan/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de InSync III Cardiac Resynchronization Therapy Pacin...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2015112077
  • Fecha
    2015-11-27
  • País del evento
    Denmark
  • Fuente del evento
    DMA
  • URL de la fuente del evento
    https://laegemiddelstyrelsen.dk/da/udstyr/sikkerhedsmeddelelser/2015/11/insync-iii-cardiac-resynchronization-therapy-pacing-crt-p/
  • Notas / Alertas
    Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
  • Notas adicionales en la data
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Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

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Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.