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  • Dispositivo 72
  • Fabricante 72
  • Evento 73
  • Implante 0
Retiro De Equipo O Alerta De Seguridad para ETHILON. Suture, ETHIBOND. and MERSILENE. Polyester F...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    RECALL: ETHILON. Suture, ETHIBOND. and MERSILENE. Polyester Fiber SUTURES and MERSILK. SUTURES, MULTIPLE LOTS1. Letter from MDB 2. Letter from Johnson & Johnson
Retiro De Equipo O Alerta De Seguridad para CoreValve Delivery System (DCS) Model:- DCS-C3-18FR o...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    RECALL: Medtronic CoreValve Delivery System (DCS) Model:- DCS-C3-18FR or DCS-C4-18FR1. Letter from MDB 2. Letter from Medtronic
Retiro De Equipo O Alerta De Seguridad para Surgical Blades
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/R/2008/006
  • Fecha
    2008-05-08
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/R/2008/006 - Surgical Blades manufactured by ConMed Linvatec Hall, in blister packaging - single use device.  Holes have been discovered in the corners of the blister packaging for these devices.  This may compromise the sterility of the device and lead to the possibility of infection.Read more.
Retiro De Equipo O Alerta De Seguridad para Symbiq One-Channel Infuser and Symbiq Two-Channel Inf...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    RECALL: Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser1. Letter from MDB 2. Letter from Hospira
Retiro De Equipo O Alerta De Seguridad para BD Microlance 30G x Needle
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2011-04-01
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    RECALL: BD Microlance 30G x Needle by Becton Dickinson & Co.1. Letter from MDB
Retiro De Equipo O Alerta De Seguridad para 1•DAY ACUVUE® TRUEYETM BRAND CONTACT LENSES
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    RECALL: JOHNSON & JOHNSON 1•DAY ACUVUE® TRUEYETM BRAND CONTACT LENSES1. Letter from MDB 2. Letter from Johnson & Johnson
Retiro De Equipo O Alerta De Seguridad para IntraStent Unmounted Balloon Expandable Stent
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/R/2008/005
  • Fecha
    2008-05-06
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/R/2008/005 - IntraStent Unmounted Balloon Expandable Stent.  The manufacturer has advised the Irish Medicines Board of a recall of specific lots of the IntraSrent Unmounted Balloon Expandable Stent.Read more.
Retiro De Equipo O Alerta De Seguridad para Robertshaw endotracheal tubes (PVC, disposable) all s...
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/R/2008/008
  • Fecha
    2008-05-15
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/R/2008/008 - Robertshaw endotracheal tubes (PVC, disposable) all sizes - manufactured by Phoenix Medical, a P3 Medical Ltd company.  Due to a manufacturing defect there is a risk of damage to the intubating stylet on its removal from the endotracheal tube. Read more.
Retiro De Equipo O Alerta De Seguridad para Implantable Cardioverter Defibrillator (ICD) lead. S...
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/R/2008/001
  • Fecha
    2008-05-06
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/R/2008/001 - Implantable Cardioverter Defibrillator (ICD) lead.  Sprint Fidelis manufactured by Medtronic.   ICD lead recall due to risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss of pacing output, caused by fracture of the lead conductor.Read more.
Retiro De Equipo O Alerta De Seguridad para Durex Real Feel
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2018-10-10
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    Recall : Voluntary Recall Of Durex Real Feel Batch1. Letter from MDB
Retiro De Equipo O Alerta De Seguridad para Exel Huber Needles, Exel Huber Infusion Sets, and Exe...
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2010-02-05
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    RECALL: Exel Huber Needles, Exel Huber Infusion Sets, and Exel "SecureTouch+" Safety Huber Infusion 1. Letter from MDB 2.  Reference
Retiro De Equipo O Alerta De Seguridad para Electrosurgical single-use, sterile blades and needle...
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/R/2008/010
  • Fecha
    2008-07-03
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/R/2008/010  -  A limited number of electrosurgical blades and needles may have an inadequate packaging seal, potentially compromising the sterility of the device.Read more.
Retiro De Equipo O Alerta De Seguridad para Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    RECALL: Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and Measurement System.1. Letter from MDB 2. Letter from Arrow [Page 1 ] [Page 2 ]
Retiro De Equipo O Alerta De Seguridad para Clear & Simple Digital Pregnancy Test
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2018-10-10
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    RECALL: Voluntary Recall of Clear & Simple Digital Pregnancy Test 1. Letter from MDB.
Retiro De Equipo O Alerta De Seguridad para SynchroMed II infusion pumps
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/R/2008/009
  • Fecha
    2008-07-02
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/R/2008/009  -  Small number of SynchroMed II infusion pumps may have been manufactured without propellant, according to report.  8 SynchroMed II pump have been returned to Medtronic and confirmed to have a missing propellant.Read more.
Retiro De Equipo O Alerta De Seguridad para Sterrad Sterilisers
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/006
  • Fecha
    2008-07-01
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/006 - Reports received from users stating that the Sterrad Sterilisers emitting a mist due to a premature mechanical failure in its oil mist filter and/or filter assemblies.Read more.
Retiro De Equipo O Alerta De Seguridad para SleepStyle Series CPAP – Power Cord
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2016-02-11
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    ALERT: Fisher & Paykel Healthcare SleepStyle Series CPAP – Power Cord1. Letter from MDB 2. Letter from Fisher & Paykel 1 3. Letter from Fisher & Paykel 2 4. Letter from Fisher & Paykel3
Retiro De Equipo O Alerta De Seguridad para Polydent Denture Adhesive Cream
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    ALERT : Polydent Denture Adhesive Cream1. Letter from MDB 2. Letter from GlaxoSmithKline
Retiro De Equipo O Alerta De Seguridad para H-1200 Fast Fluid Warmer with integrated Air Detector...
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/002
  • Fecha
    2008-05-05
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/002 - H-1200 Fast Fluid Warmer with integrated Air Detector/Clamp and H-31B and H-30 Air Detector/Clamp Accessory.   The risk of air embolism if the power of the fluid warmer unit is interrupted either manually or through power failure during an air detection event.Read more.
Retiro De Equipo O Alerta De Seguridad para Maximo II ICD, DR ICD and CRT-D
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/011
  • Fecha
    2008-08-05
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/011  -  Maximo II ICD, DR ICD and CRT-D by Medtronics.  The company is notifying customers that some of the above mentioned models have a configuration issue.Read more.
Retiro De Equipo O Alerta De Seguridad para All TomoTherapy Hi-ART Treatment Systems – operating ...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    ALERT: All TomoTherapy Hi-ART Treatment Systems – operating on Version 4.0.0, 4.0.1 and 4.0.2 software1. Letter from MDB 2. TomoTherapy Notice 1 3. TomoTherapy Notice 2 4. TomoTherapy Notice 3 5. TomoTherapy Notice 4
Retiro De Equipo O Alerta De Seguridad para Thoratec Heartmate II Left Ventricular Assist System ...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    ALERT: Thoratec Heartmate II Left Ventricular Assist System (HM II LVAS) System Controllers1. Letter from MDB 2. Letter from THORATEC
Retiro De Equipo O Alerta De Seguridad para Prostiva RF Model 8929 Hand Piece Device
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/012
  • Fecha
    2008-08-21
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/012  -  Prostiva RF Model 8929 Hand Piece Device - field corrective action letter dated 4 August 2008 from Medtronic International Ltd.Read more.
Retiro De Equipo O Alerta De Seguridad para Baxter Colleague Triple Channel Mono, CX and CXE Volu...
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/008
  • Fecha
    2008-07-11
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/008  -  Baxter Colleague Triple Channel Mono, CX and CXE Volumetric Infusion Pumps - upgrading of software.  Users of the abovementioned device should contact the distributor/supplier of this device.Read more.
Retiro De Equipo O Alerta De Seguridad para Procedure packs from various manufacturers which cont...
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/009
  • Fecha
    2008-07-23
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, 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 Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/009  -  Procedure packs from various manufacturers which contain BD Medical Surgical Syatems 2ml, 5ml, and 10ml Plastipak Luer Slip syringes.  Potential for the BD Luer slip syringes supplied in procedure packs to spontaneously disconnect or fail to maintain a secure connection to Luer fittings of other devices.Read more.
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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.