8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
WUJIN #3 FEMORAL BONE PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
BD NEXIVA CLOSED IV ACCESS SYSTEM
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·November 23, 2010
ISOGEL 2860 W/MEDSURG FRAME
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNM·July 3, 2014
VITEK® 2 AST-GN80 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·October 18, 2017
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