8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
URIDROP SPECIAL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PLANMECA PROSENSOR
FDA 510(k)
FDA Class 2
·Dental
CHOLESTEROL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·May 5, 2014
DA+ C SERIES DR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DXY·October 15, 2012
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·May 22, 2015
ULTRACLEAN ELECTRODE 1"BLADE EXTENDED INSULATION
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code GEI·January 3, 2020
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025