95 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code HSB·June 30, 2016
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fractures proximal to a total knee arthroplasty, (8) Fractures distal to a hip joint and (9) Non-unions and malunions
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code HSB·June 30, 2016
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.
FDA Recall
Terminated
·Helena Laboratories, Inc.·Product code JPB·April 20, 2016
Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021
FDA Recall
Terminated
·Organogenesis, Inc.·Product code MGR·December 26, 2007
Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers.
FDA Recall
Terminated
·Organogenesis, Inc.·Product code MGR·September 27, 2009
Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute
FDA Recall
Terminated
·Organogenesis, Inc.·Product code MGR·February 21, 2011
Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
FDA Recall
Terminated
·Organogenesis, Inc.·Product code MGR·August 2, 2010
Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute
FDA Recall
Terminated
·Organogenesis, Inc.·Product code MGR·January 30, 2011
Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..
FDA Recall
Terminated
·Smith and Nephew Wound Management (La Jolla)·Product code MGR·May 2, 2003
Apligraf (Graftskin)
FDA Recall
Terminated
·Organogenesis, Inc.·Product code MGR·September 29, 2006
Invacare 2G Tarsys Seating System, Model 2GR.
FDA Recall
Terminated
·Invacare Corporation·Product code ITI·December 15, 2003
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·September 4, 2019
Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.
FDA Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019