10 results
·
29ms
·
Sources: EU EUDAMED, US FDA
MEDI GUARD UNDERPAD
FDA 510(k)
FDA Class 1
·General Hospital
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DRUGS OF ABUSE MULTI-TEST STRIP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
8015 ALARIS SYSTEM PC UNIT
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 12, 2021
8015 ALARIS SYSTEM PC UNIT
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 15, 2021
8015 ALARIS SYSTEM PC UNIT
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 8, 2021
OPTIFLUX 60NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Malfunction
·OGDEN MANUFACTURING·Product code FJI·May 13, 2014
THINLINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 11, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·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