8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
URETERAL DILATION SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
1077 EARTIP 9-13 FOAM 50 PCS
FDA UDI
PATH medical GmbH·04260223141287·
Butterfly iQ3 Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUM XL PLS MIC/MAC
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·March 17, 2014
ENDURANT STENT GRAFT SYSTEM
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·November 14, 2012
FREESTYLE FREEDOM
FDA Adverse Event
Injury
·Product code NBW·September 13, 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