7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
STABILET
FDA 510(k)
FDA Class 2
·General Hospital
ARGENCO 20 (20 CT) TYPE II DENTAL GOLD ALLOY
FDA 510(k)
FDA Class 2
·Dental
INFINITY KAPPA XLT
FDA 510(k)
FDA Class 2
·Cardiovascular
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 5, 2013
S8 AUTOSET VANTAGE - AMERICAS
FDA Adverse Event
Malfunction
·RESMED LTD·Product code BZD·December 23, 2010
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 17, 2014
2) Signa Advantage SP (K942604 Signa Advantage SP 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