8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
PEMBUSH
FDA 510(k)
FDA Class 1
·Dental
GN Otometrics A/S
FDA UDI
Natus Medical Denmark ApS·05713315008412·
WIDE 1MP LCD MONITOR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Biomet Spine Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
FDA Adverse Event
Injury
·COCHLEAR LTD.·Product code MCM·February 4, 2013
CE INTERMATE LV 250, SINGLE-POUCH, 24 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·December 30, 2010
DEPUY ASR XL FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·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