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Vista de la lista Vista de las tarjetas
  • Dispositivo 42
  • Fabricante 18
  • Evento 124969
  • Implante 1
LeGoo Endovascular Occlusive Gel
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Genzyme
  • 1 Event
    • Retiro De Equipo (Recall) de LeGoo Endovascular Occlusive Gel
Gel for endovascular occlusion LeGoo
  • Modelo / Serial
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo O Alerta De Seguridad para Gel for endovascular occlusion LeGoo
Bordetella pertussis ELISA (EC115.00) IgA cut off control
  • Modelo / Serial
  • Descripción del producto
    In-vitro diagnostics
  • Manufacturer
    Genzyme
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de Bordetella pertussis ELISA (EC115.00) IgA cut off control
LeGoo endovascular occlusion gel
  • Modelo / Serial
  • Descripción del producto
    Disposable products
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Notificaciones De Seguridad De Campo acerca de LeGoo endovascular occlusion gel
Seprafilm
  • Modelo / Serial
    Lot number: 07NP181 Exp June 2010
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Distribución
    Nationwide Korea, Taiwan, Japan
  • Descripción del producto
    Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only || Product Number: 4301-05
  • Manufacturer
    Genzyme Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Seprafilm
Seprafilm
  • Modelo / Serial
    Lot Numbers:  07NP135 Exp Date: April 2010; 07NP177 Exp Date: May 2010;  07NP199 Exp Date: June 2010;  07NP216 Exp. Date: July 2010;  07NP311 Exp. Date: May 2010
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Distribución
    Nationwide Korea, Taiwan, Japan
  • Descripción del producto
    Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) || Product Number: 4301-02
  • Manufacturer
    Genzyme Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Seprafilm
Equal Diagnostics Lipase Color Reagent Kit
  • Modelo / Serial
    Reagent lot Number 491686, Lot #7EPP31 exp 01/15/09
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Equal Diagnostics Lipase Color Reagent Kit || Part Number: 905-E || For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
  • Manufacturer
    Genzyme Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Equal Diagnostics Lipase Color Reagent Kit
Genzyme
  • Modelo / Serial
    Reagent lot Number 491686, Lot #7EP027 exp 01/15/09
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Equal Diagnostics Lipase Color Reagent Kit || Part Number: 905-D || For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
  • Manufacturer
    Genzyme Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Genzyme
Genzyme
  • Modelo / Serial
    Reagent lot Number 491686, Lot #7EPN32 Exp 01/15/09
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Equal Diagnostics Lipase Color Reagent Kit || Part Number: 905-C || For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .
  • Manufacturer
    Genzyme Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Genzyme
Genzyme
  • Modelo / Serial
    Reagent lot Number 491686, Lot #: 7EPM30 exp 01/15/09
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Equal Diagnostics Lipase Color Reagent Kit || Part Number: 905-B || For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01.
  • Manufacturer
    Genzyme Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Genzyme
Device Recall Genzyme
  • Modelo / Serial
    Lot number: 11NP685 . Exp 2014- 11
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and the country of S. Korea
  • Descripción del producto
    seprafilm¿ Single Site ADHESION BARRIER || Re-order Number: 6641-01 || Product Usage: || Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
  • Manufacturer
    Genzyme Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Genzyme
Device Recall Genzyme
  • Modelo / Serial
    Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and the country of S. Korea
  • Descripción del producto
    seprafilm¿ Procedure Pack ADHESION BARRIER || Re-order Number: 5086-02 || Product Usage: || Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
  • Manufacturer
    Genzyme Corporation
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Genzyme
Device Recall LeGoo Internal Vessel Occluder 2.5mL
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo Internal Vessel Occluder 2.5mL || Product Number: 10-0250 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Internal Vessel Occluder 2.5mL
Device Recall LeGoo Internal Vessel Occluder 1mL
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo Internal Vessel Occluder 1mL || Product Number: 10-0100 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Internal Vessel Occluder 1mL
Device Recall Le Goo
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo Internal Vessel Occluder .5mL || Product Number: 10-0050 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall Le Goo
Device Recall LeGoo Internal Vessel Occluder .25mL
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo Internal Vessel Occluder .25mL || Product Number: 10-0025 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Internal Vessel Occluder .25mL
Device Recall LeGoo Endovascular Occlusion Gel2.5 mL LeGoo with 1 Cannula Pouch
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch || Product Number: LG250 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Endovascular Occlusion Gel2.5 mL LeGoo with 1 Cannula Pouch
Device Recall LeGoo Endovascular Occlusion Gel 1.0 mL LeGoo with 3 Cannula Pouch
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch || Product Number: LG100 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Endovascular Occlusion Gel 1.0 mL LeGoo with 3 Cannula Pouch
Device Recall LeGoo Endovascular Occlusion Gel 0.5 mL LeGoo with 3 Cannula Pouch
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch || Product Number: LG50 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Endovascular Occlusion Gel 0.5 mL LeGoo with 3 Cannula Pouch
Device Recall LeGoo Endovascular Occlusion Gel2.5 mL LeGoo w/ no Cannula
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula || Product Number: PV-250 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Endovascular Occlusion Gel2.5 mL LeGoo w/ no Cannula
Device Recall LeGoo Endovascular Occlusion Gel 1.0 mL LeGoo w/ no Cannula
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula || Product Number: PV-100 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Endovascular Occlusion Gel 1.0 mL LeGoo w/ no Cannula
Device Recall LeGoo Endovascular Occlusion Gel0.5 mL LeGoo w/ no Cannula
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula || Product Number: PV-50 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Endovascular Occlusion Gel0.5 mL LeGoo w/ no Cannula
Device Recall LeGoo Endovascular Occlusion Gel1.0 mL LeGoo with 3 Cannula Pouch
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch || Product Number: CS-100 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Endovascular Occlusion Gel1.0 mL LeGoo with 3 Cannula Pouch
Device Recall LeGoo Endovascular Occlusion Gel0.5 mL LeGoo with 3 Cannula Pouch
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch || Product Number: CS-50 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Endovascular Occlusion Gel0.5 mL LeGoo with 3 Cannula Pouch
Device Recall LeGoo Endovascular Occlusion Gel0.25 mL LeGoo with 3 Cannula Pouch
  • Modelo / Serial
    All lot codes
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.
  • Descripción del producto
    LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch || Product Number: CS-25 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.
  • Manufacturer
    Genzyme Corporation, A Sanofi Company
  • 1 Event
    • Retiro De Equipo (Recall) de Device Recall LeGoo Endovascular Occlusion Gel0.25 mL LeGoo with 3 Cannula Pouch
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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.