9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MIC-CONCEPT SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111221132·GUYON SOUND W/THREAD 13FR
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209111602·KIT, BLEEDING CONTROL, INDV ADV BCD - (vac) - C...
True Flow Valvuloplasty Perfusion Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Unscented menstrual three-piece applicator tampon
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
MULTI-LUMEN/PSI KIT
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DYB·November 14, 2012
MAXIMOVE
FDA Adverse Event
ARJOHUNTLEIGH·Product code FNG·September 28, 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