8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
RAICHEM ACID PHASPHATASE REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704261622·
WOLF LONG BONE PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCO·Product code CBK·March 8, 2014
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·November 9, 2012
BIPOL LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 8, 2010
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020