9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MORE-L INJECTOR KIT PLUS
FDA 510(k)
FDA Class 2
·Anesthesiology
RADIO IMMUNO ASSAY KIT/
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIDUS® STEM-FREE SHOULDER, HUMERAL HEAD, 46-16
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSD·August 2, 2023
Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.
FDA Enforcement
Class II
·Terminated·Medtronic Xomed, Inc.·August 21, 2013
V-V ECMO
FDA Adverse Event
Injury
·MEDTRONIC·Product code DTZ·February 7, 2013
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·January 13, 2011
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·July 16, 2014
2.7MM/3.5MM VA-LCP OLECRANON PL 8H/LT/169MM-STER
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·June 6, 2022