7 results
·
31ms
·
Sources: EU EUDAMED, US FDA
FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MAVERICK External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
BAROguard
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RA CATH SET: 22 GA X 1-3/8-
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL INC.·Product code DQX·August 24, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·November 11, 2014
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 23, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025