7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AQ-830 SLIM BODY, BODY FAT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
TYRX Neuro Antibacterial Envelope
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 4, 2010
AMBIENT MEGAVAC 90
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·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