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  • Dispositivo 1149
  • Fabricante 31827
  • Evento 1201
  • Implante 0
Abbot Laboratories
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    TDMDAT
Abbott Medical Optics (AMO) Inc.
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    TDMDAT
Alcon Laboratories Inc.
  • Empresa matriz del fabricante (2017)
    Novartis Ag
  • Source
    TDMDAT
ANADOLU TIP TEKNO.ÜRETİM PAZ.İTH İHRTİC SAN AŞ
  • Source
    TDMDAT
ARCHEM SAĞLIK SANAYİ TİCARET LİMİTED ŞİRKETİ
  • Source
    TDMDAT
ARKRAY Inc.
  • Empresa matriz del fabricante (2017)
    Arkray Inc.
  • Source
    TDMDAT
Arrow International Inc.
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    TDMDAT
Aspen Medical
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    TDMDAT
B. Braun Melsungen AG
  • Empresa matriz del fabricante (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    TDMDAT
Beckman Coulter, Inc.
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    TDMDAT
Beckton Dickinson
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    TDMDAT
Becton Dickinson
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    TDMDAT
Becton Dickinson And Company Limited
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    TDMDAT
bioMerieux SA
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    TDMDAT
Biomerieux SA
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    TDMDAT
BioMerieux SA
  • Empresa matriz del fabricante (2017)
    Compagnie Merieux Alliance
  • Source
    TDMDAT
Biomet Inc.
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    TDMDAT
Biomet Sports Medicine and Trauma
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    TDMDAT
Boston Scientific
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    TDMDAT
ThermoFisher Scientific
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    TDMDAT
Trauson Medical Instrument Co. LTD.
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    TDMDAT
TRUMPF MEDIZIN SYSTEME GmbH+Co.KG
  • Empresa matriz del fabricante (2017)
    Hill-Rom Holdings, Inc
  • Source
    TDMDAT
RESPIRONICS
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    MSHM
Boston Scientific Corporation
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    TDMDAT
Codman US
  • Empresa matriz del fabricante (2017)
    Integra LifeSciences Holdings Corporation
  • Source
    TDMDAT
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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.