7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
POLYESTER SPONGE PATTIE
FDA 510(k)
FDA Class 2
·Neurology
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON® Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
DRILL BIT Ø2.5 L
FDA Adverse Event
Injury
·SYNTHES·Product code HTW·December 10, 2012
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code FPA·June 23, 2015
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026