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  • Dispositivo 169
  • Fabricante 169
  • Evento 177
  • Implante 0
Alerta De Seguridad para Oxygen Therapy Apparatus-Oxygen Concentrators 7F-10
  • Tipo de evento
    Safety alert
  • Número del evento
    1
  • Fecha
    2015-01-06
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    Packages of medical devices, medical devices themselves and instructions for use shall not bear the ce marking and the notified body no.
  • Acción
    Disallowed to market
Alerta De Seguridad para Parts of orthopedic devices: plates, screws
  • Tipo de evento
    Safety alert
  • Número del evento
    1
  • Fecha
    2015-01-27
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    There is no data on the manufacturer, no instructions for use, labels for medical devices bear the ce marking not complying with the requirements of mn 4: 2009 annex 12.
  • Acción
    Disallowed to market
Alerta De Seguridad para Hinges for orthopedic splints
  • Tipo de evento
    Safety alert
  • Número del evento
    2
  • Fecha
    2015-01-29
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    There is no data on the manufacturer, authorized representative, ce mark, batch / serial number.
  • Acción
    Disallowed to market
Alerta De Seguridad para dental X-ray machine HQY-B
  • Tipo de evento
    Safety alert
  • Número del evento
    1
  • Fecha
    2015-01-29
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    No manufacturer, authorized representative, no ce mark and no notified body number.
  • Acción
    Disallowed to market
Alerta De Seguridad para Needles with special thread for cosmetic treatment Mono, Mono Screw, Tor...
  • Tipo de evento
    Safety alert
  • Número del evento
    1
  • Fecha
    2015-01-29
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    There is no data on the manufacturer and the manufacturer's authorized representative in the european economic area, there is no "ce mark and notified body number, no instructions for use.
  • Acción
    Disallowed to market
Alerta De Seguridad para Orthopedic Hinges AFT-001 and AFT-003
  • Tipo de evento
    Safety alert
  • Número del evento
    3
  • Fecha
    2015-02-12
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    There is no data on the manufacturer, authorized representative, ce mark, batch / serial number.
  • Acción
    Disallowed to market
Alerta De Seguridad para Surgical Instruments: Hirschmann Proctoscopes
  • Tipo de evento
    Safety alert
  • Número del evento
    4
  • Fecha
    2015-02-18
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    There is no ce mark, no mandatory information on the label.
  • Acción
    Disallowed to market
Alerta De Seguridad para Orthopedic hinges
  • Tipo de evento
    Safety alert
  • Número del evento
    5
  • Fecha
    2015-02-19
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    No data on manufacturer, authorized representative, ce mark (on paper), batch / serial number.
  • Acción
    Disallowed to market
Alerta De Seguridad para pulse oximeter
  • Tipo de evento
    Safety alert
  • Número del evento
    6
  • Fecha
    2015-02-24
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    No data on manufacturer, authorized representative, pulse oximeter and instructions for use indicate ce marking and no notified body no.
  • Acción
    Disallowed to market
Alerta De Seguridad para Enteral feeding infusion pumps
  • Tipo de evento
    Safety alert
  • Número del evento
    7
  • Fecha
    2015-03-06
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    Medical devices are not accompanied by instructions for use, medical device information is provided in a language other than the european community, so the information provided on the labels of medical devices cannot be identified.
  • Acción
    Disallowed to market
Alerta De Seguridad para LED spotlights for dental use
  • Tipo de evento
    Safety alert
  • Número del evento
    2
  • Fecha
    2015-03-12
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    The medical devices themselves and their instructions for use do not bear the ce conformity marking, neither the medical devices themselves nor the instructions for use contain information on the manufacturer, authorized representative, batch / serial number, model and date of manufacture of the medical devices themselves.
  • Acción
    Disallowed to market
Alerta De Seguridad para Microelectronics
  • Tipo de evento
    Safety alert
  • Número del evento
    4
  • Fecha
    2015-03-24
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    Packagings of micro-scalers are not marked with the ce conformity marking there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area and no batch / serial number is given.
  • Acción
    Disallowed to market
Alerta De Seguridad para Bone drilling machines used in dentistry
  • Tipo de evento
    Safety alert
  • Número del evento
    3
  • Fecha
    2015-03-24
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    Bone drilling machines and their instructions for use in dentistry do not bear the ce marking and do not indicate the number of the notified body. neither the medical devices themselves nor the instructions for use contain data on the manufacturer and the manufacturer's authorized representative in the european economic area. there are no batch / serial numbers and date of manufacture on the medical devices themselves.
  • Acción
    Disallowed to market
Alerta De Seguridad para Holders for dental drills
  • Tipo de evento
    Safety alert
  • Número del evento
    5
  • Fecha
    2015-03-24
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    Neither the packaging of the drill holders nor the drill holders themselves mark the ce conformity marking. there is no data on the manufacturer and the manufacturer's authorized representative in the european economy and no batch / serial number is given.
  • Acción
    Disallowed to market
Alerta De Seguridad para Blood pressure sensors STBP800B15
  • Tipo de evento
    Safety alert
  • Número del evento
    8
  • Fecha
    2015-03-25
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    The sales packaging does not bear the ce conformity marking and the notified body no. neither the medical devices themselves nor the sales packaging of medical devices nor the instructions for use contain data on the manufacturer and the manufacturer's authorized representative in the european economic area.
  • Acción
    2015-03-25
Alerta De Seguridad para R blood pressure gauges STBP800A4-1
  • Tipo de evento
    Safety alert
  • Número del evento
    9
  • Fecha
    2015-03-25
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    Neither the medical devices themselves nor the instructions for use contain data on the manufacturer and the manufacturer's authorized representative in the european economic area.
  • Acción
    Disallowed to market
Alerta De Seguridad para PAS-200B anesthesia machine
  • Tipo de evento
    Safety alert
  • Número del evento
    10
  • Fecha
    2015-04-02
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    No notified body number, no manufacturer's address, no authorized representative, no instructions for use.
  • Acción
    Disallowed to market
Alerta De Seguridad para Oxygen concentrators for medical breathing apparatus DO25AH
  • Tipo de evento
    Safety alert
  • Número del evento
    11
  • Fecha
    2015-04-03
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    Neither the do2-5ah oxygen concentrators nor the instructions for use indicate the ce conformity marking and the notified body no; neither the medical device itself nor the instructions for use contain data on the manufacturer and the manufacturer's authorized representative in the european economic area.
  • Acción
    Disallowed to market
Alerta De Seguridad para First aid kits
  • Tipo de evento
    Safety alert
  • Número del evento
    2
  • Fecha
    2015-04-09
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    The individual packaging of the medical devices included in the first aid kit does not bear the ce conformity marking, the sterile medical device packages do not include the notified body no. there is no data on the manufacturer's authorized representative in the european economic area. individual packagings for blood stopping for individual packing are not marked with ce marking and notified body no; no data on manufacturer's authorized representative in the european economic area. eye clean sterile eye wash liquid unlabeled ce mark and notified body no; there is no data on an authorized representative in the european economic area.
  • Acción
    Disallowed to market
Alerta De Seguridad para Blood storage containers I-STEAM
  • Tipo de evento
    Safety alert
  • Número del evento
    4
  • Fecha
    2015-04-13
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    The individual packs of i-stem blood storage containers do not contain data on the manufacturer, the manufacturer's authorized representative in the european economic area, the batch / serial number, the expiry date. the individual packs of medical devices are marked with the ce conformity marking, which does not conform to the requirements.
  • Acción
    Disallowed to market
Alerta De Seguridad para Disposable sterile needles
  • Tipo de evento
    Safety alert
  • Número del evento
    3
  • Fecha
    2015-04-13
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    The sterile disposable needle packs do not contain the manufacturer's address. no individual manufacturer information is available on individual sterile disposable packs. neither sterile disposable needle packs nor individual sterile needle packs contain data on the manufacturer's authorized representative in the european economic area. both packs of sterile disposable needles and individual sterile disposable needles contain information in a language other than the european community. cannot be identified on the labels.
  • Acción
    Disallowed to market
Alerta De Seguridad para Dental lamps with stands
  • Tipo de evento
    Safety alert
  • Número del evento
    6
  • Fecha
    2015-04-20
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    Neither medical devices nor their packaging bear the ce conformity marking; neither the medical device itself nor its packaging contains data on the manufacturer and the authorized representative.
  • Acción
    Disallowed to market
Alerta De Seguridad para Dental instruments
  • Tipo de evento
    Safety alert
  • Número del evento
    7
  • Fecha
    2015-04-23
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    No data on manufacturer's authorized representative in the european economic area; all medical device packages contain product identification information in a language other than the european community, so the information provided on the medical device label cannot be identified. the dental mirror holders and lip retractor in their batches are not labeled with the ce conformity marking.
  • Acción
    Disallowed to market
Alerta De Seguridad para Mixing containers
  • Tipo de evento
    Safety alert
  • Número del evento
    10
  • Fecha
    2015-04-30
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    Mixing vessels do not label the ce conformity marking. there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area.
  • Acción
    Disallowed to market
Alerta De Seguridad para Plastic endodontic rulers
  • Tipo de evento
    Safety alert
  • Número del evento
    11
  • Fecha
    2015-04-30
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Notas adicionales en la data
  • Causa
    The ce marking is not affixed to the plastic endodontic lenses or to the medical devices themselves. there is no data on the manufacturer and the manufacturer's authorized representative in the european economic area.
  • Acción
    Disallowed to market
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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.

Descargar la data

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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