7 results
·
21ms
·
Sources: EU EUDAMED, US FDA
TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
FDA 510(k)
FDA Class 2
·Anesthesiology
FLOCARE
FDA 510(k)
FDA Class 1
·Anesthesiology
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
TENDRIL SDX
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 9, 2014
AUTOPULUSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·December 14, 2012
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020