7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TRIGLYCERIDE C-37 RAPID STAT KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Fluent Fluid Management System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
FDA 510(k)
FDA Class 2
·Cardiovascular
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY INTL., LTD - 8010379·Product code KWA·April 30, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 10, 2012
ACCU-CHEK SPIRIT
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 27, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025