10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CHANGING METHOD OF STERILITY RELEASE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102671·CHANG COMBINATION CHOPPER, RIGHT
SONOMA ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VAPOR CERAMIC BRACKET
FDA 510(k)
FDA Class 2
·Dental
SAFETY NEEDLE 25 X 5 8
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMI·April 25, 2019
UNKNOWN DEPUY CEMENT
FDA Adverse Event
Injury
·DEPUY CMW 9610921·Product code LOD·May 27, 2014
EXPRESS¿ LD VASCULAR
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·November 14, 2012
KNIFE
FDA Adverse Event
Malfunction
·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·September 3, 2010
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
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025