9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CEDIA(R) DIGOXIN R' ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
FDA 510(k)
FDA Unclassified
·Unknown
CHOYANG THERMAL MASSAGER
FDA 510(k)
FDA Class 2
·Physical Medicine
PRIMING SET FOR ARTERIAL BLOODLINES
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code KOC·May 13, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 24, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 11, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR CLONMEL·Product code NIQ·July 28, 2010
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·July 28, 2010
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; 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