8 results
·
36ms
·
Sources: EU EUDAMED, US FDA
17-HYDROXYPROGESTERONE TEST SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CELLSEARCH CIRCULATING TUMOR CELL KIT
FDA 510(k)
FDA Class 2
·Immunology
Fixtemp C&B
FDA 510(k)
FDA Class 2
·Dental
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·April 24, 2014
SAGITTAL BLADE
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code GFA·September 28, 2012
INTELLIVUE INFORMATION CENTER
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·July 22, 2010
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·October 18, 2017
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018