7 results
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17ms
·
Sources: EU EUDAMED, US FDA
DRENOVAC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
O.B. BASIN SET
FDA 510(k)
FDA Class 2
·General Hospital
MODEL IV 100B-DA INFANT VENTILATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVANTAGE FIT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 21, 2012
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·October 21, 2010
PROCEDURAL STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·February 14, 2014
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