7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SURFLO(R) WINGED INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
1-Step Culture Medium
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HALL ARTERIAL OSCILLATOR
FDA 510(k)
FDA Class 2
·Cardiovascular
DUOVISC UNKNOWN
FDA Adverse Event
Malfunction
·ALCON - BELGIUM/S.A. ALCON-COUVRERUR N.V.·Product code LZP·October 29, 2010
UNIFY CRT-D, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CRMD·Product code NIK·January 13, 2014
ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FRN·November 14, 2012
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