7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MEDI GUARD DRAPES
FDA 510(k)
FDA Class 1
·General Hospital
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KENL-ECG
FDA 510(k)
FDA Class 2
·Cardiovascular
LAP-BAND AP STD WITH ACCESS PORT II
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·June 30, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·January 11, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·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