7 results
·
27ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
Hi-Fatigue Bone Cement
FDA 510(k)
FDA Class 2
·Orthopedic
SIRCAM 106
FDA 510(k)
FDA Class 2
·Radiology
SYMBIQ SINGLE CHANNE
FDA Adverse Event
Injury
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·March 1, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
ADVISA DR MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014
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