7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
GAMMAMED 12I
FDA 510(k)
FDA Class 2
·Radiology
Solidence Multipockets
FDA 510(k)
FDA Class 2
·General Hospital
PELVIC FLOOR REPAIR SYSTEM
FDA 510(k)
FDA Class 3
·Obstetrics/Gynecology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 24, 2014
PROXIMATE*ILS CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 4, 2010
MAXPLUS CLEAR NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·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