9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MagnetOs Putty
FDA 510(k)
FDA Class 2
·Orthopedic
PROTEX STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDSOURCE SELECTABLE IV SET
FDA 510(k)
FDA Class 2
·General Hospital
ALINITY C CALCIUM2
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code CJY·March 5, 2026
AVALON ELITE
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY GMBH·Product code DWF·March 8, 2021
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·September 9, 2011
1.8MM FLUTED MATCHSTICK
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025