7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
AVATRON DISPOSABLE I.P.P.B. CIRUCIT
FDA 510(k)
FDA Class 1
·Anesthesiology
Variolink Esthetic
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 1, 2014
LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code KZL·October 22, 2012
PARIETEX UGYTEX PP ANTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·September 17, 2010
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017