7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
UNITRON MODEL UL21 HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
METAIZEAU NAILING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AFIAS iFOB with AFIAS-50
FDA 510(k)
FDA Class 2
·Hematology
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code NVN·June 10, 2014
CAPSURE SENSE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 9, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·December 10, 2012
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026