8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MODEL 80-1983, ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LF900
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFIED CONCENTRIC MICROCATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·January 4, 2013
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·December 17, 2010
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 14, 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