5 results
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63ms
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Sources: EU EUDAMED, US FDA
ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
FDA Recall
Terminated
·Smisson-Cartledge Biomedical, LLC·Product code LGZ·February 18, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
FDA Recall
Terminated
·Smisson-Cartledge Biomedical, LLC·Product code LGZ·February 18, 2021
ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed fluid to rewarm patients after surgery or hypothermia -warmed fluid for irrigation in urology procedures
FDA Recall
Terminated
·Smisson-Cartledge Biomedical, LLC·Product code LGZ·February 18, 2021
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
FDA Recall
Completed
·Fresenius Medical Care Holdings, Inc.·Product code FKX·September 12, 2020