8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MANAN CHIBA PTC NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFIED CONCENTRIC RETRIEVER, MODEL 90039
FDA 510(k)
FDA Class 2
·Cardiovascular
PRO-TOE Hammertoe Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MOCRO INCISION VACUUM PHACO PACK
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQC·April 11, 2014
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·October 4, 2010
MEGA NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·November 29, 2012
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