7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
NOVADERM
FDA 510(k)
FDA Class 1
·General Hospital
EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE
FDA 510(k)
FDA Class 2
·Radiology
M-50 GOLD BASE DENTAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 16, 2014
QUICKFLEX MICRO LV LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2010
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·November 20, 2012
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025