8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
RTLX
FDA 510(k)
FDA Class 2
·Dental
POLYPHOS
FDA 510(k)
FDA Class 1
·Radiology
DiaPlus
FDA 510(k)
FDA Class 2
·Dental
TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS
FDA Adverse Event
Malfunction
·TORNIER INC.·Product code HSD·June 18, 2009
BIGBORE (BB) ONCOLOGY
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.·Product code JAK·March 1, 2013
SPRINT QUATTRO SECURE S
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011
SPRINT QUATTRO SECURE S
FDA Adverse Event
Injury
·MPRI·Product code LWS·August 8, 2014
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025