7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
ACA GENTAMICIN TEST PACK
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Cajun Commando 4x4
FDA 510(k)
FDA Class 2
·Physical Medicine
CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 4, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY 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