8 results
·
24ms
·
Sources: EU EUDAMED, US FDA
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
FDA 510(k)
FDA Class 2
·Immunology
Empulse M90
FDA 510(k)
FDA Class 2
·Physical Medicine
smARTrack Feeding Tube System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·January 7, 2025
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 1, 2014
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·November 21, 2012
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·August 30, 2010
Model #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx, component of the ABL700/800 Blood Gas Analyzers, also included in service kits part no. 905-671
FDA Recall
Terminated
·Radiometer America Inc·Product code CHL·May 22, 2006