11 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ELECTROENCEPHALOGRAPH ACCUTRACE 100
FDA 510(k)
FDA Class 2
·Neurology
7D Surgical System Cranial Application
FDA 510(k)
FDA Class 2
·Neurology
GPS, G SURGICAL PEDICLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORP.·Product code NIQ·February 6, 2007
NA
FDA UDI
Zimmer, Inc.·00889024192317·
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICROTYPING SYSTEMS·Product code KSZ·April 30, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·October 10, 2012
ALARIS PC UNIT
FDA Adverse Event
Injury
·CAREFUSION CORP.·Product code FRN·July 28, 2010
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
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