8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209114788·
PolarCath Peripheral Dilatation System
FDA 510(k)
FDA Class 2
·Cardiovascular
GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
LIVIAN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 4, 2010
AMBIENT HIPVAC 50
FDA Adverse Event
Malfunction
·ARTHROCARE CORP·Product code GEI·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