7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CO-OXIMETER CONTROL
FDA 510(k)
FDA Class 2
·Hematology
OSSATURA DENTAL
FDA 510(k)
FDA Class 2
·Dental
QUIDEL MOLECULAR RSV + HMPV ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL S.A·Product code GEY·March 6, 2014
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 14, 2012
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES CLONMEL·Product code NIQ·September 8, 2010
Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·September 12, 2012