8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
VITEK RAPID CALL-GRAM NEGATIV IDENT CARD
FDA 510(k)
FDA Class 1
·Microbiology
CAPNOMED 100 STAND-ALONE ETCO2 MODULE
FDA 510(k)
FDA Class 2
·Anesthesiology
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ENDOLOOP LIGATURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GEA·December 27, 2018
ADULT INSPIRATORY HEATED BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 22, 2013
MARQUIS VR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code LWS·December 14, 2010
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 10, 2014
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020