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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Device Recall TissueTrans Product Line
  • Modelo / Serial
    Lot Numbers 12005, 12019, 12044, 61286, 61421.
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WV. and the countries of: Italy, Austria, Turkey, United Arab Emirates, Germany, Spain, Saudi Arabia, Switzerland, Japan Kuwait, Denmark, Sweden, United Kingdom, Belgium, France, Australia, Netherlands, Greece, South Korea.
  • Descripción del producto
    Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: || Intended for fat transfer and liposuction.
  • Manufacturer
    Shippert Medical Technologies
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall TissueTrans Product Line
Device Recall Dermabond "Prineo" System
  • Modelo / Serial
    LEJ230 LEJ246 LEJ259 LEJ368 LGP375 LGP605 LGP606 LGP675 LGP814 LGR689 LGR710 LGR756 LHH468 LHH469 LHH560 LHH608 LHH686 LHH784 LHP498 LHP599 LHP602 LHP868
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    DERMABOND" PRINEO" Skin Closure System || Product Usage: || DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND PRINEO System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound durinQ application of the liquid adhesive
  • Manufacturer
    Ethicon, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Dermabond "Prineo" System
Device Recall Medtronic AVE
  • Modelo / Serial
    Lot Number: 122596
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    AL, AR, KY, LA, MT, NH, NY, PA, WI Foreign: Japan, Hungary
  • Descripción del producto
    Z2 Guiding Catheter 6 F JR3.5 SH || Item No. : Z26JR35SH
  • Manufacturer
    Medtronic, Inc.
  • 2 Events
    • Retiro De Equipo (Recall) de Device Recall Medtronic AVE
    • Retiro De Equipo (Recall) de Device Recall Medtronic AVE
VALVE ACCESSORY PACK
  • Modelo / Serial
    Catalog Number CPA-3648 Lot Numbers 000004282, 000005469, 000005896, 000005639, 000006725
  • Distribución
    The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
  • Descripción del producto
    VALVE ACCESSORY PACK
  • Manufacturer
    Windstone Medical, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de VALVE ACCESSORY PACK
Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral ...
  • Modelo / Serial
    lot 03030232.
  • Clasificación del producto
    Orthopedic Devices
  • Distribución
    United States, Canada, Italy, Japan and United Kingdom
  • Descripción del producto
    Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.
  • Manufacturer
    Stryker Instruments, Instruments Div.
  • 1 Event
    • Retiro De Equipo (Recall) de Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.
Device Recall 9 French Super ArrowFlex Percutaneous Sheath Introducer Kit
  • Modelo / Serial
    Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    The products were shipped to hospitals, distributors, dealers and sales representatives nationwide. The product was also shipped to export dealers in Finland, Australia, Italy, Brazil, Taiwan, New Zealand, Poland, United Kingdom, and Belgium and subsidiaries in Germany, France, Africa, Canada, Netherlands, SPain, and Greece.
  • Descripción del producto
    9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
  • Manufacturer
    Arrow International Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall 9 French Super ArrowFlex Percutaneous Sheath Introducer Kit
Device Recall Boston Scientific Scimed
  • Modelo / Serial
    Lot number 5562834
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    The recalled products were shipped to hospitals located nationwide in the United States.
  • Descripción del producto
    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-4015 || , Product Number H7493791540150
  • Manufacturer
    Boston Scientific Scimed
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
Device Recall Boston Scientific Scimed
  • Modelo / Serial
    Lot number 5455553
  • Clasificación del producto
    Cardiovascular Devices
  • Distribución
    The recalled products were shipped to hospitals located nationwide in the United States.
  • Descripción del producto
    Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-5015
  • Manufacturer
    Boston Scientific Scimed
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Boston Scientific Scimed
Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. || Kit: AMPLICOR M. avium...
  • Modelo / Serial
    Amplicor [3] AV-HRP, Lot No. E09569 found in kit lot:  Lot E12990, Material No. 20759880018, Exp. 11/2004.
  • Distribución
    ♦ Amplicor CT/NG CT Detection Kit, Lot No.E12231, Material No.20759392018, Expiration 2/2005 , Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor CT/NG NG Detection Kit, Lot No.E12647, Material No.20759406018, Expiration 2/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor HCV Detection Kit, v2.0, Lot No.F01023, Material No.21118439018, Expiration 5/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. ♦ Amplicor IC Detection Kit, 96 tests, Lot No.E09554, Material No.20751952018, Expiration 5/2005, Shipped To: Roche Diagnostics Corporation, 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457. Export-U.S Distributed Products: AmpliCap HCV Monitor Test, Lot No.E09193, Material No.21111337018, Expiration 8/2004 , Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan. Amplicor IC Detection Kit, Lot No.E13115, Material No.20763306122, Expiration 7/2005, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada; Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. Amplicor M. avium Detection Kit, Lot No.E12990, Material No.20759880018, Expiration 11/2004, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan. Amplicor MTB Detection Kit, Lot No.E13307, Material No.20757462122, Expiration 9/2004, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. Amplicor NG Detection Kit, Lot No.E10894, Material No.20744026122, Expiration 2/2005, Shipped To: Roche Diagnostics KK, Nippon Roche KK, Kamakura Factory 200, Aza Sotokochi, Kajiwara, Kamakura City, Kanagawa Pref, Japan ; Shipped To: Roche Diagnostics Canada, 201 Boulevard Armand-Frappier, Laval QC H7V 4A2, Canada; Shipped To: Roche Diagnostics GmbH, GX-OSW, Sandhoferstr. 116, D-68305 Mannheim. There are no Govt. accounts.
  • Descripción del producto
    Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. || Kit: AMPLICOR M. avium Detection Kit, Export,RUO.
  • Manufacturer
    Roche Molecular Systems Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Amplicor [3] AV-HRP, Avidin-HRP (Horseradish Peroxidase) BGG Conjugate. || Kit: AMPLICOR M. avium Detection Kit, Export,RUO.
PlusRite Power Strike Metal Halide Lamps
  • Modelo / Serial
  • Distribución
    Nationwide
  • Descripción del producto
    PlusRite Power Strike Metal Halide Lamps
  • Manufacturer
    Fanlight Corporation Inc
  • 1 Event
    • Retiro De Equipo (Recall) de PlusRite Power Strike Metal Halide Lamps
GSK
  • Modelo / Serial
    Shipper case lot #8008580, Retal Carton Lot #4543U8008580
  • Distribución
    US Nationwide
  • Descripción del producto
    Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
  • Manufacturer
    GSK Consumer Healthcare
  • 1 Event
    • Retiro De Equipo (Recall) de GSK
VITEK 2 AST N211
  • Modelo / Serial
    6110117203 23/Mar/18
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N211), REF 413043, 20 cards per carton.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VITEK 2 AST N211
VITEK 2 AST N344
  • Modelo / Serial
    7840209103 23/Jun/18 7840245203 29/Jul/18
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N344), IVD, REF 420440, 20 cards per carton.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VITEK 2 AST N344
VITEK 2 AST N355
  • Modelo / Serial
    7950149203 24/Apr/18 7950197203 11/Jun/18 7950243403 27/Jul/18
  • Distribución
    Nationwide distribution in the U.S, including military and government sites. The product was also distributed to Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroun, Canada, Chad, Chile, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Gambia, Georgia, Germany, Greece, Grenada, Guatemala, Guinea, Haiti, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Uganda, Kuwait, Laos, Latvia, Lebanon, Lithuania, Malaysia, Mali, Malta, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Zimbabwe.
  • Descripción del producto
    VITEK¿ 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 cards per carton.
  • Manufacturer
    Biomerieux Inc
  • 1 Event
    • Retiro De Equipo (Recall) de VITEK 2 AST N355
Device Recall PSA Test Card (Serum)
  • Modelo / Serial
    Catalog number: 72003, All lots
  • Distribución
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Descripción del producto
    PSA Test Card (Serum); || LumiQuick. || Santa Clara, CA 95054
  • Manufacturer
    LumiQuick Diagnostics Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PSA Test Card (Serum)
Device Recall Methamphetamine Strip
  • Modelo / Serial
    Catalog number: 74027, All lots
  • Distribución
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Descripción del producto
    Methamphetamine Strip; || LumiQuick, || Santa Clara, CA 95054
  • Manufacturer
    LumiQuick Diagnostics Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Methamphetamine Strip
Device Recall Morphine Strip (300
  • Modelo / Serial
    Catalog number: 74029, All lots
  • Distribución
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Descripción del producto
    Morphine Strip (300); || LumiQuick, || Santa Clara, CA 95054
  • Manufacturer
    LumiQuick Diagnostics Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Morphine Strip (300
Device Recall Morphine Test Card (300
  • Modelo / Serial
    Catalog number: 74030, All lots
  • Distribución
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Descripción del producto
    Morphine Test Card (300); || LumiQuick, || Santa Clara, CA 95054
  • Manufacturer
    LumiQuick Diagnostics Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Morphine Test Card (300
Device Recall INTELECT ADVANCED
  • Modelo / Serial
    Serial numbers 1000 - 3993
  • Clasificación del producto
    Physical Medicine Devices
  • Distribución
    Worldwide Distribution - including USA
  • Descripción del producto
    INTELECT ADVANCED, Model No. 2762CC, Chattanooga Group, Hixson, TN 37343, Made in the USA, Not for sale in the U.S.A.
  • Manufacturer
    Chattanooga Corp Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall INTELECT ADVANCED
Device Recall Epic II VR Model V158
  • Modelo / Serial
    all serial codes
  • Distribución
    Nationwide and Internationally: Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia,Mexico, Netherlands, New Zealand, Norway, Peru. Poland, Portugal, Republic of Panama, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, United Kingdom, Uruguay and Venezuela.
  • Descripción del producto
    Implantable Cardioverter Defibrillator || EPIC II VR Tiered-therapy cardioverter/defibrillator, Model V-158
  • Manufacturer
    St Jude Medical CRMD
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Epic II VR Model V158
Device Recall ATLAS DR Model V242
  • Modelo / Serial
    all serial numbers
  • Distribución
    Nationwide and Internationally: Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia,Mexico, Netherlands, New Zealand, Norway, Peru. Poland, Portugal, Republic of Panama, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, United Kingdom, Uruguay and Venezuela.
  • Descripción del producto
    Implantable Cardioverter Defibrillator || ATLAS DR Tiered-therapy cardioverter/defibrillator, Model V-242
  • Manufacturer
    St Jude Medical CRMD
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall ATLAS DR Model V242
Device Recall PRIMEVIEW 3i System 2.0
  • Modelo / Serial
    Serial numbers associated with RTT2.0 and RTT2.1
  • Clasificación del producto
    Radiology Devices
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139847 || Medical charged-particle radiation therapy system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall PRIMEVIEW 3i System 2.0
Device Recall QuantumPulse machine
  • Modelo / Serial
    All serial numbers.
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    QuantumPulse machine. Vibe Technologies, Greeley, CO. || The device is used to create light wave frequencies to effect cellular activity.
  • Manufacturer
    VIBE Technologies
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall QuantumPulse machine
Portex
  • Modelo / Serial
    Lot numbers starting with: 0, 1, 911, 912, K1, K2, K50, K51, K52
  • Distribución
    Nationwide
  • Descripción del producto
    Fiberoptic Bronchoscope Dual-Axis Swivel Adapter || Catalog Number: 625191
  • Manufacturer
    Smiths Medical ASD, Inc.
  • 1 Event
    • Retiro De Equipo (Recall) de Portex
RL Sense
  • Modelo / Serial
    Model Proto6, Rev-J Firmware; and Protypes 1-5 Various
  • Distribución
    Nationwide Distribution including Texas
  • Descripción del producto
    RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware || RLSense is a pair of disposable adhesive patches applied to the dorsum of the feet. Each patch contains a microprocessor, memory, movement sensor, and a small coin-type battery. The devices record periodic movements of the feet and legs during the night.
  • Manufacturer
    Sleep Modus
  • 1 Event
    • Retiro De Equipo (Recall) de RL Sense
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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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