9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF
FDA 510(k)
FDA Class 2
·Cardiovascular
PAQ.126X150X110/QT-HS80/ESAOTE P-120
FDA UDI
AB MEDICA GROUP, S.A.·08428763038412·
Malibu™
FDA UDI
Seaspine Orthopedics Corporation·10889981143381·Malibu Instrument Tray 1, Inner Tray 1
21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)
FDA 510(k)
FDA Class 2
·Radiology
Servo-air 4.0 Ventilator System
FDA 510(k)
FDA Class 2
·Anesthesiology
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·June 13, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 13, 2013
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·December 2, 2010
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