7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
STRYKER 988 ICU BED
FDA 510(k)
FDA Class 2
·General Hospital
CONTACT LENS OPHTHALMODYNAMOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
Solo Pace Fusion System (SOLOFUSE1)
FDA 510(k)
FDA Class 2
·Cardiovascular
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
VITALITY AVT
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMELRY NELLCO·Product code CBK·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