13 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ACCU-VENT(TM) WITH NEEDLE-PRO(TM)
FDA 510(k)
FDA Class 1
·Anesthesiology
ENDO-SCRUB®
FDA UDI
MEDTRONIC XOMED, INC.·20613994662020·SHEATH 1912043 5PK ES2 STRYKER 4MM/70DEG
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 11, 2021
VACUETTE EDTA K2 GEL TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXIOS Stent and Electrocautery Enhanced Delivery System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 30, 2020
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 7, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·January 13, 2021
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 21, 2020
PRIMING SET FOR ARTERIAL BLOODLINES
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code KOC·May 13, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·January 11, 2013
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 1, 2010
Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
FDA Enforcement
Class II
·Terminated·Integrated Science Systems Inc·June 15, 2016