8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT.
FDA 510(k)
FDA Class 2
·Neurology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450309575·
WVSM (Wireless Vital Signs Monitor) RWC + miniCap
FDA 510(k)
FDA Class 2
·Cardiovascular
CORONIS FUSION 4MP DL
FDA 510(k)
FDA Class 2
·Radiology
PRIMING SET FOR ARTERIAL BLOODLINES
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code KOC·May 13, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 11, 2013
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·December 1, 2010
3) Signa Advantage (K911959 Signa Advantage MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).
FDA Recall
Terminated
·GE Healthcare, LLC·Product code LNH·November 9, 2010