7 results
·
35ms
·
Sources: EU EUDAMED, US FDA
MT II SYSTEM - SERUM ALBUMIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
FDA 510(k)
FDA Class 2
·Hematology
INFINITY MASIMO SET SP02 POD
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDO PADDLE RETRACT 12MM INSTRUMENT
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY USSC PUERTO RICO, INC.·Product code GAD·January 2, 2014
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Other
·ROCHE DIAGNOSTICS·Product code LFR·July 20, 2007
CONSERVE(R) TOTAL HEAD W/BFH
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·September 26, 2012
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025