8 results
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55ms
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Sources: EU EUDAMED, US FDA
HAVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60
FDA Adverse Event
Injury
·HARVEST TECHNOLOGIES CORPORATION·Product code JQC·May 24, 2012
HARVEST SMARTPREP2 CENTRIFUGE SYSTEM,APC-120
FDA Adverse Event
Injury
·HARVEST TECHNOLOGIES CORPORATION·Product code JQC·February 23, 2011
HARVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60
FDA Adverse Event
Injury
·HARVEST TECHNOLOGIES CORPORATION·Product code JQC·November 16, 2011
HARVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60
FDA Adverse Event
Injury
·HARVEST TECHNOLOGIES CORPORATION·Product code JQC·November 16, 2011
HARVEST GRAFT DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·HARVEST TECHNOLOGIES CORPORATION·Product code FMF·September 9, 2013
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
FDA Recall
Terminated
·Harvest Technologies Corporation·Product code FMF·September 11, 2013
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
FDA Enforcement
Class II
·Terminated·Harvest Technologies Corporation·October 23, 2013
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