47 results
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29ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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.
FDA Recall
Terminated
·Genzyme Corporation·Product code CHI·April 14, 2008
Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only Product Number: 4301-05
FDA Recall
Terminated
·Genzyme Corporation·April 10, 2008
Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) Product Number: 4301-02
FDA Recall
Terminated
·Genzyme Corporation·April 10, 2008
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 .
FDA Recall
Terminated
·Genzyme Corporation·Product code CHI·April 14, 2008
Genzyme Biosurgery Essentials Kit, Item Number 82004
FDA Recall
Terminated
·Genzyme Corporation·Product code LRO·July 13, 2010
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.
FDA Recall
Terminated
·Genzyme Corporation·Product code MCN·June 13, 2012
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 .
FDA Recall
Terminated
·Genzyme Corporation·Product code CHI·April 14, 2008
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.
FDA Recall
Terminated
·Genzyme Corporation·Product code MCN·June 13, 2012
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 .
FDA Recall
Terminated
·Genzyme Corporation·Product code CHI·April 14, 2008
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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation·June 27, 2012
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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation·June 27, 2012
LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation, A Sanofi Company·September 11, 2013
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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation, A Sanofi Company·September 11, 2013
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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation, A Sanofi Company·September 11, 2013
LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT 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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation, A Sanofi Company·September 11, 2013
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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation, A Sanofi Company·September 11, 2013
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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation, A Sanofi Company·September 11, 2013
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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation, A Sanofi Company·September 11, 2013
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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation, A Sanofi Company·September 11, 2013
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.
FDA Enforcement
Class II
·Terminated·Genzyme Corporation, A Sanofi Company·September 11, 2013