7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
DADE THROMBOPLASTIN IS
FDA 510(k)
FDA Class 2
·Hematology
ELITE MPX LASER SYSTEM WITH CRYO C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NuVasive® Camber Laminoplasty System
FDA 510(k)
FDA Class 2
·Orthopedic
PALL ULTIPOR 100 BREATHING SYSTEM FILTER
FDA Adverse Event
Malfunction
·PALL NEWQUAY·Product code CAH·November 4, 2010
FORTIFY VR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·January 13, 2014
PLMA DVC V11.51 1 R
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·December 21, 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