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  • Dispositivo 124
  • Fabricante 32
  • Evento 124969
  • Implante 6
Notificaciones De Seguridad De Campo acerca de tapered screw-vent implants, 4.1 mm d x 11.5 mm l,...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1610
  • Fecha
    2014-11-14
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-dental-dotycz%C4%85ca-wycofania-z-obrotu-i-z-u%C5%BCywania-implant%C3%B3w
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Zimmer Dental safety note regarding withdrawal from the market and using Tapered Screw-Vent implants, 4.1 mm D x 11.5 mm L, catalog number TSV4B11, LOT 62658448
Notificaciones De Seguridad De Campo acerca de trauma implants
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1082
  • Fecha
    2017-06-06
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-dotycz%C4%85ca-wycofania-z-obrotu-i-u%C5%BCywania-okre%C5%9Blonych-serii
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Zimmer safety note regarding withdrawal from use and use of certain series of trauma implants
Notificaciones De Seguridad De Campo acerca de tiles of the universal locking system 3.5 mm: stra...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2434
  • Fecha
    2016-01-07
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-dotycz%C4%85ca-wycofania-p%C5%82ytek-uniwersalnego-systemu-blokowania-35
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Zimmer safety note regarding the withdrawal of tiles of the universal locking system 3.5 mm: straight 144 mm reconstruction tile, cat. No. 00-4936-011-13, series number 62968956 and 105 mm compression plate, catalog no. 00-4936-008- 07, lot number 62968974
Notificaciones De Seguridad De Campo acerca de certain series of trilogy bone screws - 6.5 mm x 3...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2283
  • Fecha
    2014-12-19
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-dotycz%C4%85ca-wycofania-z-obrotu-i-z-u%C5%BCywania-okre%C5%9Blonych-serii-%C5%9Brub
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Zimmer safety note regarding the withdrawal from the market and the use of certain series of Trilogy bone screws - 6.5 mm x 35 mm and 6.5 mm x 25 mm
Notificaciones De Seguridad De Campo acerca de gentle threads series of interference screws
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    772
  • Fecha
    2018-05-15
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-biomet-dotycz%C4%85ca-wycofania-z-obrotu-i-z-u%C5%BCywania-niekt%C3%B3rych-4
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Zimmer Biomet security note regarding the withdrawal and use of some Gentle Threads series of interference screws
Notificaciones De Seguridad De Campo acerca de nails to supply a hip fracture
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    298
  • Fecha
    2018-10-19
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/aktualizacja-notatki-bezpiecze%C5%84stwa-zfa-2018-00344-firmy-zimmer-biomet-dotycz%C4%85cej-wycofania-z-obrotu
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Updating of the Zimmer Biomet safety note (ZFA 2018-00344) regarding the withdrawal and use of certain series of nails to supply a hip fracture (Affixus Hip Fracture Nail)
Notificaciones De Seguridad De Campo acerca de guides with a rounded tip, smooth shoulder, bracke...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2704
  • Fecha
    2015-09-24
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-biomet-dotycz%C4%85cy-wycofania-z-obrotu-i-u%C5%BCywania-niekt%C3%B3rych-serii
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Zimmer Biomet security note regarding the withdrawal and use of some series of guides with a rounded tip, smooth, shoulder bracket with a rounded tip, smooth and with a ball tip
Notificaciones De Seguridad De Campo acerca de charcot chisel-osteotomes
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    582
  • Fecha
    2018-05-10
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-biomet-gmbh-dotyczaca-wycofania-z-obrotu-i-u%C5%BCywania-d%C5%82uto
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Zimmer Biomet GmbH safety notice regarding the withdrawal and use of Charcot chisel-osteotomes
Notificaciones De Seguridad De Campo acerca de zimmer versys system and temporary femoral heads w...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1819
  • Fecha
    2012-12-14
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-zimmer-dotycz%C4%85ca-systemu-zimmer-versys-oraz-tymczasowych-g%C5%82%C3%B3w-ko%C5%9Bci
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Zimmer safety note regarding the Zimmer Versys system and temporary femoral heads with slots
Notificaciones De Seguridad De Campo acerca de Clean Testing HIV Home Test Kit
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2615
  • Fecha
    2009-07-03
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-w-sprawie-test%C3%B3w-clean-testing-hiv-home-test-kit-03072009
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Message on the Clean Testing HIV Home Test Kit. (03.07.2009)
Notificaciones De Seguridad De Campo acerca de activplast thermo heating patch
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2770
  • Fecha
    2015-11-05
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-medica-dotycz%C4%85ca-plastra-rozgrzewaj%C4%85cego-activplast-termo
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Medica safety note regarding the Activplast Termo warming patch
Notificaciones De Seguridad De Campo acerca de amber operating tables.
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1904
  • Fecha
    2011-07-26
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-konkret-sp-j-dotycz%C4%85ca-sto%C5%82%C3%B3w-operacyjnych-amber
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Security note from Konkret Sp. J. regarding Amber operating tables.
Notificaciones De Seguridad De Campo acerca de counterfeit medical device - detartrine polishing ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    111
  • Fecha
    2018-09-12
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-prezesa-urz%C4%99du-z-dnia-11-wrze%C5%9Bnia-2018-roku-w-sprawie-w-sprawie-podrobionego-wyrobu
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Announcement of the President of the Office of September 11, 2018 regarding the counterfeit medical device - Detartrine polishing paste, pack of 45g
Notificaciones De Seguridad De Campo acerca de fake durex extra safe condoms
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2686
  • Fecha
    2014-06-25
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-prezesa-urz%C4%99du-w-sprawie-sfa%C5%82szowanych-prezerwatyw-durex-extra-safe
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Announcement of the President of the Office regarding fake Durex Extra Safe condoms
Notificaciones De Seguridad De Campo acerca de fake durex extra safe condoms
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    608
  • Fecha
    2016-09-27
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-prezesa-urz%C4%99du-w-sprawie-sfa%C5%82szowanych-prezerwatyw-durex-extra-safe-znajduj%C4%85cych-si%C4%99-w
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Announcement of the President of the Office regarding fake Durex Extra Safe condoms in circulation on the territory of the Republic of Poland
Notificaciones De Seguridad De Campo acerca de balloon catheters cordis empira nc rx ptca and cor...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2117
  • Fecha
    2014-07-16
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firm-cordis-corporation-i-creganna-tactx-medical-dotycz%C4%85ca-bezpiecze%C5%84stwa
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Safety note from Cordis Corporation and Creganna-Tactx Medical regarding the safety of balloon catheters Cordis EMPIRA NC RX PTCA and Cordis EMPIRA RX PTCA
Notificaciones De Seguridad De Campo acerca de battery chargers and vision sciences lithium-ion ...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2778
  • Fecha
    2014-09-30
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-vision-sciences-dotycz%C4%85ca-%C5%82adowarek-akumulator%C3%B3w-modele-novacell-nv
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Vision Sciences safety note for battery chargers (NOVACELL NV-LC02 and VANSON V-95 models) and Vision Sciences lithium-ion batteries
Notificaciones De Seguridad De Campo acerca de Bilirubin
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2114
  • Fecha
    2010-10-13
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/komunikat-firmy-medan-dotycz%C4%85cy-restandaryzacji-metod-oznaczania-bilirubiny-ca%C5%82kowitej-zestawami
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    MEDAN's announcement on the restalization of total bilirubin determination methods with Bilirubin Auto Total FS and Bilirubin Jendrassik-Gróf FS reagent sets from DiaSys
Notificaciones De Seguridad De Campo acerca de bio-agonist reformer bv-harmonic
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2617
  • Fecha
    2013-12-24
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-bona-vita-international-sa-dotycz%C4%85ca-wyrobu-rezonator-biofotonowy-bv
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Bona-Vita International SA safety note regarding the product bio-agonist BV-Harmonic
Notificaciones De Seguridad De Campo acerca de infusion devices infu-med p
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1617
  • Fecha
    2012-03-15
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-medica-dotycz%C4%85ca-przyrz%C4%85d%C3%B3w-do-przetaczania-p%C5%82yn%C3%B3w-infuzyjnych-infu-med
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    MEDICA safety note regarding infusion transfusion devices INFU-MED P
Notificaciones De Seguridad De Campo acerca de bio-energy rezonator bv-harmonic
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1757
  • Fecha
    2014-01-13
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/decyzja-prezesa-urz%C4%99du-w-sprawie-wycofania-z-obrotu-i-u%C5%BCywania-wyrobu-medycznego-rezonator
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Decision of the President of the Office regarding the withdrawal from use of the medical device of the bio-energy REZONATOR BV-Harmonic, whose manufacturer is Bona-Vita International SA, ul. Środkowa 1, 40-584 Katowice
Notificaciones De Seguridad De Campo acerca de Bioresonance therapy
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2418
  • Fecha
    2014-06-11
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/decyzja-w-sprawie-wycofania-z-obrotu-i-z-u%C5%BCywania-maty-rehabilitacyjnej-dostarczanej-z-instrukcj%C4%85
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    The decision on the withdrawal from the market and the use of the rehabilitation mat provided with the instruction "Bioresonance therapy" marked with the name of Nafra Medical Sp. z oo or with the instruction "Care instructions biorezonanz therapy"
Notificaciones De Seguridad De Campo acerca de Bivona tracheostomy tubes: neonatal, pediatric and...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    1872
  • Fecha
    2011-12-20
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-bivona-dotycz%C4%85ca-rurek-tracheostomijnych-bivona-noworodkowych
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Bivon's safety note regarding BIVON's tracheostomy tubes - neonatal, pediatric and FlexTend.
Notificaciones De Seguridad De Campo acerca de bone cement kryptonite
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    2747
  • Fecha
    2012-10-16
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-drg-dotycz%C4%85ca-cementu-kostnego-kryptonite-kryp-z-10-kryp-z-05
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    DRG safety note for bone cement Kryptonite (KRYP-Z-10, KRYP-Z-05)
Notificaciones De Seguridad De Campo acerca de bioavailable implant of the small joint regjoint
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    212
  • Fecha
    2018-04-19
  • País del evento
    Poland
  • Fuente del evento
    ORMPMDBP
  • URL de la fuente del evento
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-scaffdex-oy-dotycz%C4%85ca-zmiany-instrukcji-u%C5%BCytkowania-bioprzyswajalnego
  • Notas / Alertas
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
  • Notas adicionales en la data
  • Acción
    Scaffdex Oy safety note regarding the change of the instructions for use of the RegJoint small joint bioadhesive implant
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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.

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