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  • Dispositivo 1211
  • Fabricante 31827
  • Evento 5885
  • Implante 4142
Biomet RINGLOC Instrumentation Impactor Plate
  • Modelo / Serial
    Lot Number: 038690.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.
  • Descripción del producto
    Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.
  • Manufacturer
    Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Biomet RINGLOC Instrumentation Impactor Plate
Biomet RINGLOC Instrumentation Impactor Plate
  • Modelo / Serial
    Lot Number: 038700.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.
  • Descripción del producto
    Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Biomet Orthopedics, Inc., Warsaw, IN.
  • Manufacturer
    Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Biomet RINGLOC Instrumentation Impactor Plate
Biomet RINGLOC Instrumentation Impactor Plate
  • Modelo / Serial
    Lot Number: 038710.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.
  • Descripción del producto
    Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet Orthopedics, Inc., Warsaw, IN.
  • Manufacturer
    Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Biomet RINGLOC Instrumentation Impactor Plate
Biomet RINGLOC Instrumentation Impactor Plate
  • Modelo / Serial
    Lot Number: 038730.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.
  • Descripción del producto
    Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.
  • Manufacturer
    Biomet, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Biomet RINGLOC Instrumentation Impactor Plate
Stryker Cordless Driver 3 Handpiece
  • Modelo / Serial
    Serial number 723505023 through 804326503.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Cordless Driver 3 Handpiece. Stryker Instruments, Kalamazoo, MI; REF 4300. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker Cordless Driver 3 Handpiece
Stryker System 6 Rotary Handpiece
  • Modelo / Serial
    Serial numbers 0614504853 through 0825902483.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker System 6 Rotary Handpiece
Stryker System 6 Rotary Handpiece
  • Modelo / Serial
    Serial numbers 0817003173 through 0825905983.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Rotary Handpiece, Single Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6203-000-000S1. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker System 6 Rotary Handpiece
Stryker System 6 Rotary Handpiece
  • Modelo / Serial
    Serial numbers 0615001103 through 0826001573.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker System 6 Rotary Handpiece
Stryker System 6 Rotary Handpiece
  • Modelo / Serial
    Serial numbers 0807117993 through 0811212433.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Rotary Handpiece, Dual Trigger, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6205-000-000S1. || The device is intended for use in surgical procedures involving drilling, reaming, driving wire or pins, and cutting bone and hard tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker System 6 Rotary Handpiece
Stryker System 6 Reciprocating Saw
  • Modelo / Serial
    Serial numbers 0613702313 through 0826201253.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Reciprocating Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6206. || Product is a linear cutting device used for cutting bone and bone related tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker System 6 Reciprocating Saw
Stryker System 6 Sternum Saw
  • Modelo / Serial
    Serial numbers 0613902933 through 0826101223.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Sternum Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6207. || The product is a linear cutting device used for cutting bone and bone related tissue including the sternum.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker System 6 Sternum Saw
Stryker System 6 Sagittal Saw
  • Modelo / Serial
    Serial numbers 0615000953 through 0826200893.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208. Note: The product label declares the product to be a handpiece. || The product is an oscillating cutting device used for cutting bone and bone related tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker System 6 Sagittal Saw
Stryker System 6 Sagittal Handpiece
  • Modelo / Serial
    Serial numbers 0801802893 through 0801802913.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Sagittal Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6208-000-000S4. || The product is an oscillating cutting device used for cutting bone and bone related tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker System 6 Sagittal Handpiece
Stryker System 6 Oscillating Tip Saw
  • Modelo / Serial
    Serial numbers 0620602123 through 0825317713.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Brazil, Canada, Chile, Colombia, Costa Rica, England, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan and Turkey.
  • Descripción del producto
    Stryker Precision Oscillating Tip Saw, For use with Stryker System 6. Stryker Instruments, Kalamazoo, MI; REF 6209. || The product is an oscillating cutting device used for cutting bone and bone related tissue.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker System 6 Oscillating Tip Saw
Integra Ruggles Surgical Instrument ACF Distraction Screws
  • Modelo / Serial
    lot code 326081; and lot code 327081.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Integra Ruggles Surgical Instrument ACF Distraction Screws || Sterile, Rx only || Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), || Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536
  • Manufacturer
    Integra LifeSciences Corp.
  • 1 Event
    • Retiro De Equipo (Recall) de Integra Ruggles Surgical Instrument ACF Distraction Screws
Smith and Nephew, Endo Femoral Aimer
  • Modelo / Serial
    Lot Number 50278012.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States including Puerto Rico, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.
  • Descripción del producto
    AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) || Part Number 72201714. || The product is an orthopedic device.
  • Manufacturer
    Smith & Nephew, Inc., Endoscopy Div.
  • 1 Event
    • Retiro De Equipo (Recall) de Smith and Nephew, Endo Femoral Aimer
SYNTHES 2.0MM DRILL BIT STRYKER JLATCH/60MM
  • Modelo / Serial
    Lot # N64648, 6082633, and 6107223.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- State of CA.
  • Descripción del producto
    SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853. || Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
  • Manufacturer
    Synthes USA (HQ), Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de SYNTHES 2.0MM DRILL BIT STRYKER JLATCH/60MM
Smith and Nephew, Endo Femoral Aimer
  • Modelo / Serial
    Lot Number 502780141
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States including Puerto Rico, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.
  • Descripción del producto
    AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. || The product is an orthopedic device.
  • Manufacturer
    Smith & Nephew, Inc., Endoscopy Div.
  • 1 Event
    • Retiro De Equipo (Recall) de Smith and Nephew, Endo Femoral Aimer
Smith and Nephew, Endo Femoral Aimer
  • Modelo / Serial
    Lot Number 50278014.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States including Puerto Rico, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland.
  • Descripción del producto
    AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device.
  • Manufacturer
    Smith & Nephew, Inc., Endoscopy Div.
  • 1 Event
    • Retiro De Equipo (Recall) de Smith and Nephew, Endo Femoral Aimer
Mini Max Torque Drill Bit & Countersink
  • Modelo / Serial
    Lot NG808, Lot NG861, & Lot 1048031.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- CO, OH, PA, SD, TX & VA.
  • Descripción del producto
    Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. || Used to drill or cut bone prior to implantation of screws
  • Manufacturer
    Orthohelix Surgical Designs Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Mini Max Torque Drill Bit & Countersink
Quick Connect Adapter
  • Modelo / Serial
    Model #CSS-QA-Adapter Lot #: GB759, GB-924, 1014001 & 1101011
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: CA, CO, FL, GA, IL, KY, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA , and WI.
  • Descripción del producto
    Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH || The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.
  • Manufacturer
    Orthohelix Surgical Designs Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Quick Connect Adapter
TRIGEN SURESHOT Distal Targeting System
  • Modelo / Serial
    All serial numbers prior to and including ACA5
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Turkey, and the UK.
  • Descripción del producto
    smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 || Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.
  • Manufacturer
    Smith & Nephew Inc
  • 1 Event
    • Retiro De Equipo (Recall) de TRIGEN SURESHOT Distal Targeting System
Modified 7.0 mm Modified Depth Gauge for MaxTorque Screw System
  • Modelo / Serial
    CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: to the states of GA and MO.
  • Descripción del producto
    CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
  • Manufacturer
    Orthohelix Surgical Designs Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Modified 7.0 mm Modified Depth Gauge for MaxTorque Screw System
Modified 5.5 mm Modified Depth Gauge for MaxTorque Screw System
  • Modelo / Serial
    CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: to the states of GA and MO.
  • Descripción del producto
    CSS-059-55-4, Modified 5.5 mm Modified Depth Gauge, Lot 0985021
  • Manufacturer
    Orthohelix Surgical Designs Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Modified 5.5 mm Modified Depth Gauge for MaxTorque Screw System
Modified 4.0mm Modified Depth Gauge for MaxTorque Screw System
  • Modelo / Serial
    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: to the states of GA and MO.
  • Descripción del producto
    CSS-059-40-4 Modified 4.0mm Modified Depth Gauge, Lot 0985011
  • Manufacturer
    Orthohelix Surgical Designs Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Modified 4.0mm Modified Depth Gauge for MaxTorque Screw System
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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.

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