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  • Dispositivo 2
  • Fabricante 2
  • Evento 124969
  • Implante 0
Notificaciones De Seguridad De Campo acerca de Contour NEXT Control Solution
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(06)
  • Fecha
    2016-02-09
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/contour-next-control-solution.-priority-2-warning&id=855a0426-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de G4 PLATINUM and G5 Mobile Receivers
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(07)
  • Fecha
    2016-03-15
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/g4-platinum-and-g5-mobile-receivers.-priority-2-warning&id=e77b0426-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Cross Reactivity Of Fulvestrant in Estradiol Assays
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(03) Re-issue
  • Fecha
    2016-04-25
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/cross-reactivity-of-fulvestrant-in-estradiol-assays.-priority-3-advisory&id=324b0426-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Endobon Xenograft Granules
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(10)
  • Fecha
    2016-04-29
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/endobon-xenograft-granules.-priority-2-warning&id=5a850526-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de LOVEXOK One Step Pregnancy (HCG) Test Strips
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(11)
  • Fecha
    2016-04-29
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/lovexok-one-step-pregnancy-(hcg)-test-strips.-priority-2-warning&id=9f850526-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Zelos PTA Balloon Catheter
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(09)
  • Fecha
    2016-04-29
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/zelos-pta-balloon-catheter.-priority-1-for-immediate-action&id=0e850526-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de V-MAX
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    2014123755
  • 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/v-max/
  • 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 Counterfeit Prime & Bond NT Refill
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(12) Revision 1
  • Fecha
    2016-05-12
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/counterfeit-prime-bond-nt-refill---priority-3---advisory&id=81850526-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de FLUOROCELL PLT
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(13)
  • Fecha
    2016-06-02
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/fluorocell-plt.-priority-2-warning&id=dd6d0626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de M2a 38mm Acetabular System
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(14)
  • Fecha
    2016-06-03
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/m2a-38mm-acetabular-system.-priority-2-warning&id=0c710626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Telefunken AED Model HR1 & FA1
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(15)
  • Fecha
    2016-06-15
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/TelefunkenAED&id=fe790626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de RightSign HIV 1.2.O Rapid Test Cassette, HCV Rapi...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(16)
  • Fecha
    2016-06-20
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/SN201616&id=29860626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Pro-PICC CT & Pro-Line CT
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(18)
  • Fecha
    2016-07-01
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/SN201618&id=69d70626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Taperloc Lateralised PC Stem
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(19)
  • Fecha
    2016-07-05
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/SN201619&id=f4db0626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de TRUEresult Blood Glucose Test Strips (GDH-PQQ)
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(21)
  • Fecha
    2016-07-21
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/trueresult-blood-glucose-test-strips-(gdh-pqq).-priority-2-warning&id=d7eb0626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de VITEK®2 AST-YS07 Test Kit
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(22)
  • Fecha
    2016-08-04
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/vitek-2-ast-ys07-test-kit.-priority-2-warning&id=e1f80626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Flocare Infinity Enteral Feeding Pumps
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(24)
  • Fecha
    2016-08-05
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/flocare-infinity-enteral-feeding-pumps.-priority-2-warning&id=8afb0626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Immucor Gamma Kleihauer Kit
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(23)
  • Fecha
    2016-08-05
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/immucor-gamma-kleihauer-kit.-priority-2-warning&id=09fb0626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de ETEST® COLISTIN
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(25)
  • Fecha
    2016-08-15
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/etest-colistin.-priority-2-warning&id=4d020726-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de W11054 Columbia Blood Agar 90m Double Wrap - lot 0...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(20)
  • Fecha
    2016-08-24
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/SN201620&id=16ea0626-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Klerpack BD Syringe Multi-Pack
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(26)
  • Fecha
    2016-09-12
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/SN201626&id=63270726-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Comfort Shield Barrier Cream Cloths
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(27)
  • Fecha
    2016-09-16
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/comfort-shield-barrier-cream-cloths.-priority-2-warning&id=f2310726-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Klerpack BD Syringe Multi-Pack
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(28)
  • Fecha
    2016-09-19
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/klerpack-bd-syringe-multi-pack.-priority-1-for-immediate-action&id=59340726-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Spinocath® Models: 4517717 & 4517725
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(29)
  • Fecha
    2016-09-21
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/spinocath-models-4517717-4517725.-priority-1-for-immediate-action&id=23360726-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Beacon Tip Angiographic Catheters / William Cook P...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2016(30)
  • Fecha
    2016-09-23
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/beacon-tip-angiographic-catheters-william-cook-procedure-packs.-priority-2-warning&id=d9370726-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notas adicionales en la data
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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.

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La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

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