8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DAVOL ELECTROSUGICAL PROBES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
OSTEONICS HIP REVISION WEDGES
FDA 510(k)
FDA Class 2
·Orthopedic
INTERGRATED APD SET
FDA Adverse Event
Malfunction
·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code LZS·June 18, 2014
MOD REV 29MM STD CONE TRIAL COMPONENT LEVEL 9006-2-029
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code LXH·January 22, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 14, 2010
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; 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