7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ELECSYS TROPONIN T STAT TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
FDA 510(k)
FDA Class 2
·Immunology
PVS 1500 SDS
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 8, 2013
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·May 9, 2008
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 6, 2011
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019