8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
FDA 510(k)
FDA Unclassified
·Unknown
XLTEK SLEEP SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST
FDA 510(k)
FDA Class 2
·Orthopedic
ALIGN URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·January 4, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
FINELINE I
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code DTB·July 9, 2014
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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