7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MEDI-TRACE(R) 500 ECG ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPTIA CMV-TA
FDA 510(k)
FDA Class 2
·Microbiology
SUGAR CHEX LINEARITY FOR THE ONE TOUCH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·February 1, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 30, 2010
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 2, 2014
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 15, 2016