10 results
·
36ms
·
Sources: EU EUDAMED, US FDA
OKTAS STEREO VIEWING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA ALPHA 1 MICROGLOBULIN KIT
FDA 510(k)
FDA Class 2
·Immunology
HOMECLINIC ONE STEP PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER, Z.I DU TALHOUET·Product code FNL·January 9, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 6, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 18, 2014
BD PLASTIPAK LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·August 30, 2019
SYRINGE PLASTIPAK 20ML LL S/SU
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·May 3, 2019
BD SYRINGE PLASTIPAK 20ML LL S/SU
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·July 2, 2019
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020