7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
URINARY DRAINAGE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ensizor Monopolar Endoscopic Scissors
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)
FDA 510(k)
FDA Class 2
·Physical Medicine
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 7, 2014
INGENIO
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 10, 2012
COAGUCHEK S SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JPA·September 21, 2007
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018