10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AtriCure cryoICE BOX (ACM)
FDA 510(k)
FDA Class 2
·Neurology
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·May 8, 2002
Coronis Fusion 4MP LED
FDA 510(k)
FDA Class 2
·Radiology
VaporMAX LDD; MOJo LDD; MegaJOULE LDD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
I-STAT EC8+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025
PEN NDL 32G 4MM PRO 100 BOX 1200 CA
FDA Adverse Event
Malfunction
·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·May 21, 2024
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·November 21, 2008
POSEY PERSONAL ALARM LOUD
FDA Adverse Event
Malfunction
·J. T. POSEY CO.·Product code KMI·August 31, 2011
HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·July 18, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025