7 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KATOR, LLC
FDA UDI
KATOR, LLC·B18610305910·KATOR Suture Anchor, Open, 5.0mm x 20mm, 2mm Su...
KATOR, LLC
FDA UDI
KATOR, LLC·B18610305900·KATOR Suture Anchor, Open, 5.0mm x 20mm, #2 Suture
KATOR, LLC
FDA UDI
KATOR, LLC·B18610305930·KATOR Suture Anchor, Arthroscopic, 5.0mm x 25mm...
KATOR, LLC
FDA UDI
KATOR, LLC·B18610305920·KATOR Suture Anchor, Arthroscopic, 5.0mm x 25mm...
KATOR SUTURE ANCHOR 5MM X 25MM, #2 SUTURE, ARTHROSCOPIC
FDA Adverse Event
Malfunction
·KATOR LLC·Product code MBI·February 8, 2017
KATOR SUTURE ANCHOR 5MM X 25MM, #2 SUTURE, ARTHROSCOPIC
FDA Adverse Event
Malfunction
·KATOR LLC·Product code MBI·March 30, 2018
The box label states: "AT1 Autotransfusion Set 9005101 STERILE...FRESENIUS KABI...Fresenius Kabi AG 61345 Bad Hamburg Germany...Federal (USA) Law restricts this device to sale by or on order of a physician". The AT1 Autotransfusion Set is distributed by Fresenius Kabi on its own or as part of a ATF40 kit or ATF120 kit. AT1 Autotransfusion set is a disposable set, dedicated component of the Fresenius CATS Continuous Autotransfusion System, which in turn is an Autotransfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
FDA Recall
Terminated
·Fresenius Kabi, LLC·Product code CAC·March 29, 2010