8 results
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17ms
·
Sources: EU EUDAMED, US FDA
SNAP M. TUBERCULOSIS COMPLEX
FDA 510(k)
FDA Class 1
·Microbiology
PREMISE MODIFIED
FDA 510(k)
FDA Class 2
·Dental
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 5, 2014
F6 DIALYZER FINISHED ASSY (CASE)
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code FJI·October 25, 2010
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·January 7, 2013
Roller Pump, 4 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·January 13, 2012
Roller Pump, 6 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·January 13, 2012