8 results
·
33ms
·
Sources: EU EUDAMED, US FDA
IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST
FDA 510(k)
FDA Class 2
·Immunology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756622653·BASIC PACK
SCENTED BREATHABLE MINI-SHIELD PRIVATE LABEL BRAND
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ELECATH PULSATILE PERFUSION PUMP
FDA 510(k)
FDA Class 2
·Cardiovascular
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·June 25, 2014
TAXUS® LIBERTÉ®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·January 3, 2013
LIKORALL
FDA Adverse Event
Malfunction
·LIKO AB·Product code FNG·November 4, 2010
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014